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Assessment and proposal of controls to reduce cytotoxic drugs exposure in pharmacy personnel Griffiths, Andrea Dawn 2014

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        ASSESSMENT AND PROPOSAL OF CONTROLS TO REDUCE CYTOTOXIC DRUG EXPOSURE IN PHARMACY PERSONNEL  by ANDREA DAWN GRIFFITHS B.Sc., Malaspina University-College, 2000 M.Sc., The University of British Columbia, 2006  A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY  in  THE FACULTY OF GRADUATE AND POSTDOCTORAL STUDIES (Occupational and Environmental Hygiene)  THE UNIVERSITY OF BRITISH COLUMBIA (Vancouver) April 2014 ? Andrea Dawn Griffiths, 2014    ii Abstract In health care settings, cytotoxic drugs are utilized for the treatment of various conditions such as cancer and arthritis.  The properties of these products make them powerful drugs that have the capacity to elicit toxic effects indiscriminately on a variety of cell types and in some cases can cause cancer and adverse reproductive outcomes.  Health care workers can be exposed to these products through dermal absorption, ingestion or inhalation.  There are presently no occupational exposure limits for these products, but WorkSafeBC Regulations, the British Columbia Cancer Agency and United States Pharmacopeia 797 standards guide best practices for working safely with these products.   The goals of this thesis research were to evaluate current practices and to propose occupational hygiene controls to reduce exposure to cytotoxic drugs in hospital pharmacy personnel.   The research was conducted in five iterative parts:  1. An environmental assessment of selected hospital pharmacies was conducted to determine presence of cytotoxic pharmaceuticals on work surfaces, and to examine factors related to presence of workplace contamination. 2. A questionnaire was developed to assess hospital pharmacy employees? perception of cytotoxic agents, their level of training and education, and their use of personal protective equipment.  3. Focus group sessions with pharmacy personnel were conducted to obtain feedback on information collected in the first two phases of research, to identify barriers to safe working practices, and to help propose safety initiatives.   iii 4. Safety initiatives were designed, pilot tested and evaluated by employees based on information obtained in parts 1 through 3 above. 5. A second worksite assessment was performed to evaluate controls to reduce exposure to cytotoxic agents. This is the first study in Canada aimed at assessing and proposing controls to reduce occupational exposure to cytotoxic drugs in acute care hospital pharmacies utilizing a strategy that included multiple methods and employee engagement to enhance a traditional occupational hygiene paradigm evaluation.    iv Preface Ethics Approval Information: 1. University of British Columbia Behavioral Research Ethics Board Certificate Number: H08-02926 2. Vancouver Island Health Authority Health Research Ethics Board  Certificate Number: H200915 Student?s Contribution: The research design, execution and statistical analysis were 95% the contribution of the PhD student.  Chemical analyses of surface wipe tests were 100% carried out by the laboratory personnel at University of British Columbia?s School of Population and Public Health.   v Table of Contents ABSTRACT ................................................................................................................................................. ii PREFACE ................................................................................................................................................... iv TABLE OF CONTENTS ............................................................................................................................ v LIST OF TABLES ..................................................................................................................................... vii LIST OF FIGURES .................................................................................................................................. viii ACKNOWLEDGEMENTS ......................................................................................................................... x CHAPTER 1 INTRODUCTION ........................................................................................................1 1.1 CYTOTOXIC DRUGS ................................................................................................................................... 1 1.2 HEALTH EFFECTS AND MECHANISM OF ACTION ASSOCIATED WITH CYTOTOXIC DRUGS ........................................ 2 1.3 DRUGS IN THE ENVIRONMENT .................................................................................................................... 5 1.4 OCCUPATIONAL EXPOSURE TO CYTOTOXIC DRUGS ........................................................................................ 6 1.5 EXPOSURE OF HEALTH CARE PERSONNEL TO CYTOTOXIC DRUGS IN HOSPITAL SETTINGS ...................................... 7 1.6 EVIDENCE OF EXPOSURE TO CYTOTOXIC DRUGS IN HOSPITAL PERSONNEL ......................................................... 9 1.7 HEALTH STUDIES ON HEALTH CARE WORKERS AND EXPOSURES TO CYTOTOXIC DRUGS ..................................... 11 1.8 RISK OF OCCUPATIONAL EXPOSURE TO PHARMACY PERSONNEL IN BRITISH COLUMBIA ...................................... 19 1.9 INFORMATION ON CERTIFICATION AND TRAINING OF PHARMACY TECHNICIANS ................................................ 21 1.10 PRESENT REGULATIONS, STANDARDS AND RECOMMENDATIONS .................................................................. 23 1.11 BRITISH COLUMBIA HEALTH AUTHORITY INFORMATION ............................................................................. 26 1.12 MOTIVATION FOR STUDY ...................................................................................................................... 27 1.13 OVERVIEW OF THESIS ........................................................................................................................... 29 CHAPTER 2 PHASE I: ENVIRONMENTAL ASSESSMENT....................................................... 32 2.1 INTRODUCTION TO PHASE 1: ENVIRONMENTAL ASSESSMENT ........................................................................ 32 2.2 OBJECTIVES OF PHASE 1: ENVIRONMENTAL ASSESSMENT ............................................................................. 32 2.3 HYPOTHESIS FOR PHASE 1: ENVIRONMENTAL ASSESSMENT .......................................................................... 33 2.4 METHODS FOR PHASE 1: ENVIRONMENTAL ASSESSMENT ............................................................................. 33 2.5 RESULTS OF PHASE 1: ENVIRONMENTAL ASSESSMENT ................................................................................. 37 2.6 DISCUSSION OF PHASE 1: ENVIRONMENTAL ASSESSMENT ............................................................................ 59 2.7 SUMMARY OF PHASE 1: ENVIRONMENTAL ASSESSMENT .............................................................................. 74 CHAPTER 3 PHASE 2: EMPLOYEE QUESTIONNAIRE ............................................................ 76 3.1 INTRODUCTION TO PHASE 2: EMPLOYEE QUESTIONNAIRE ............................................................................ 76 3.2 OBJECTIVES OF PHASE 2: EMPLOYEE QUESTIONNAIRE .................................................................................. 76 3.3 HYPOTHESES FOR PHASE 2: EMPLOYEE QUESTIONNAIRE .............................................................................. 77 3.4 METHODS FOR PHASE 2:  EMPLOYEE QUESTIONNAIRE ................................................................................. 77 3.5 RESULTS OF PHASE 2: EMPLOYEE QUESTIONNAIRE ...................................................................................... 79 3.6 DISCUSSION OF PHASE 2: EMPLOYEE QUESTIONNAIRE ................................................................................. 86 3.7 SUMMARY OF PHASE 2: EMPLOYEE QUESTIONNAIRE PHASE ......................................................................... 98 CHAPTER 4 PHASE 3: FOCUS GROUP ACTIVITIES ............................................................. 101 4.1 INTRODUCTION TO PHASE 3: FOCUS GROUP ACTIVITIES ............................................................................. 101   vi 4.2 OBJECTIVES FOR PHASE 3: FOCUS GROUP ACTIVITIES ................................................................................ 101 4.3 METHODS FOR PHASE 3: FOCUS GROUP ACTIVITIES .................................................................................. 102 4.4 RESULTS FOR PHASE 3: FOCUS GROUP ACTIVITIES ..................................................................................... 104 4.5 DISCUSSION OF PHASE 3: FOCUS GROUP ACTIVITIES .................................................................................. 119 4.6 SUMMARY FROM PHASE 3: FOCUS GROUP ACTIVITIES ............................................................................... 132 CHAPTER 5 PHASE 4: PILOTING OF SAFETY INITIATIVES ................................................. 134 5.1 INTRODUCTION TO PHASE 4: PILOTING OF SAFETY INITIATIVES .................................................................... 134 5.2 OBJECTIVES OF PHASE 4: PILOTING OF SAFETY INITIATIVES ......................................................................... 135 5.3 METHODS FOR PHASE 4: PILOTING OF SAFETY INITIATIVES ......................................................................... 135 5.4 RESULTS FOR PHASE 4: PILOTING OF SAFETY INITIATIVES ............................................................................ 141 5.5 DISCUSSION OF PHASE 4: PILOTING OF SAFETY INITIATIVES ......................................................................... 146 5.6 SUMMARY OF PHASE 4: PILOTING OF SAFETY INITIATIVES ........................................................................... 158 CHAPTER 6 PHASE 5: FINAL WORKSITE ASSESSMENTS.................................................. 160 6.1 INTRODUCTION PHASE 5: FINAL WORKSITE ASSESSMENTS.......................................................................... 160 6.2 OBJECTIVE OF PHASE 5: FINAL WORKSITE ASSESSMENTS ............................................................................ 160 6.3 METHODS FOR PHASE 5: FINAL WORKSITE ASSESSMENTS .......................................................................... 160 6.4 RESULTS FOR PHASE 5: FINAL WORKSITE ASSESSMENTS ............................................................................. 161 6.5 DISCUSSION FOR PHASE 5: FINAL WORKSITE ASSESSMENTS ........................................................................ 169 6.6 SUMMARY OF PHASE 5: FINAL WORKSITE ASSESSMENTS............................................................................ 183 CHAPTER 7 CONCLUSIONS FROM ASSESSMENT AND PROPOSAL OF CONTROLS TO REDUCE CYTOTOXIC DRUG EXPOSURE IN PHARMACY PERSONNEL ............................ 187 7.1 GENERAL SUMMARY ............................................................................................................................ 187 7.2 SIGNIFICANCE OF THIS RESEARCH............................................................................................................ 188 7.3 THE OCCUPATIONAL HYGIENE PARADIGM ................................................................................................ 197 7.4 CONTEXTUALIZING THE RESEARCH WITHIN THEORETICAL MODELS OF HEALTH BEHAVIOR ................................ 202 7.5 SAFETY CULTURE AND SAFETY CLIMATE ................................................................................................... 207 7.6 STRENGTHS OF RESEARCH AND SCIENTIFIC CONTRIBUTIONS ........................................................................ 209 7.7 LIMITATIONS ....................................................................................................................................... 211 7.8 FUTURE DIRECTIONS ............................................................................................................................ 214 REFERENCES ............................................................................................................................ 218 APPENDIX A ............................................................................................................................... 226 Table A1 WorkSafeBC Regulations Specific to Cytotoxic Drugs ................................................... 226 Table A2 Summary of Information of USP 797 ................................................................................. 232 APPENDIX B: RESOURCES FOR ENVIRONMENTAL ASSESSMENT PHASE .................... 234 APPENDIX C: EMPLOYEE QUESTIONNAIRE ......................................................................... 240 APPENDIX D: SUMMARY OF FOCUS GROUP RESULTS ..................................................... 250 APPENDIX E: SAFETY INITIATIVES ........................................................................................ 252 APPENDIX F: FINAL WORKSITE ASSESSMENT TOOL ........................................................ 261   vii List of Tables Table 1.1: List of antineoplastic products that are known or probable human carcinogens??... 3 Table 1. 2: Occupations and tasks in hospital settings with potential contact with cytotoxic drugs determined through observations made by occupational hygienist ...................................... 8 Table 1.3: Summary of information collected from health authority facilities on Vancouver Island ..........................................................................................................................................29 Table 2.1: Assessment of controls in place to reduce exposure to cytotoxic drugs at health authority worksites. ............................................................................................................39 Table 2.2: Summary of similarities and differences between WorkSafeBC (WSBC) Regulations, British Columbia Cancer Agency (BCCA) Certification and United States Pharmacopeia (USP) 797 ..........................................................................................................................41 Table 2.3: Meeting requirements of WorkSafeBC, USP 797 and BCCA  ...................................42 Table 2.4: Descriptive statistics for surface wipe tests conducted in environmental assessment phase of study. ..................................................................................................................43 Table 2.5 : Statistical results comparing wipe test results above or below the limit of detection 57 Table 2.6: Information gathered on cyclophosphamide purchased and surface wipes ..............58 Table 2.7: Information gathered on methotrexate purchased and surface wipes .......................58 Table 3.1: Descriptive statistics for general information about participants  ...............................80 Table 3.2: Summary of information collected from participants on training  ...............................81 Table 3.3: Summary of participants responses on degree of agreement with statements  ........83 Table 3.4 Summary of statistical testing for employee questionnaire for select questions .........84 Table 4.1: Characteristics of focus group participants????????..?????????105 Table 5.1: Criteria used to bring forward safety initiatives for selection???..????.??..137 Table 5.2: Overview of results from evaluations from safety initiatives???..??????...142  Table 5.3: What ?New? and ?Existing? employees liked about standardized ?New Worker    _____Orientation: Hazardous Drug Handling???????...?????...?????.???145 Table 6.1: Comparing the number of worksites with safe work procedures or protocols in place ____for Phase 1: Environmental Assessment versus Phase 5: Final Worksite Assessment?163 Table 7.1: Hierarchy of controls reducing occupational exposure to cytotoxic drugs ????.201 Table 7.2: Linkage of research to theoretical models of health behavior????????.?.204        viii List of Figures  Figure 1.1: Map of Vancouver Island Health Authority showing locations of worksites that dispense cytotoxic drugs. ................................................................................................................ 26 Figure 1.2: Overview of Griffiths PhD Thesis Work ?Assessment and Proposal of Controls to Reduce Cytotoxic Drug Exposure in Pharmacy Personnel? ...................................................... 31 Figure 2.1: Schematics of the layout and locations of wipe tests for cyclophosphamide at Worksite #1. ...................................................................................................................................... 45 Figure 2.2: Schematics of the layout and locations of wipe tests for methotrexate at Worksite #1. ............................................................................................................................................................ 46 Figure 2.3: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #2. ...................................................................................................................................... 47 Figure 2.4: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #2. ....................................................................................................................................................... 48 Figure 2.5: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #3. ...................................................................................................................................... 50 Figure 2.6: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #3. ....................................................................................................................................................... 51 Figure 2.7: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #4. ...................................................................................................................................... 53 Figure 2.8: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #4. ....................................................................................................................................................... 54 Figure 2.9: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #5. ...................................................................................................................................... 55 Figure 2.10: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #5. ....................................................................................................................................................... 56 Figure 3.1: Tasks that participants reported on the employee questionnaire associated with working with cytotoxic drugs ........................................................................................................... 80 Figure 3.2: Topics that pharmacy personnel indicated were covered in past training sessions on cytotoxic drugs.  The results displayed showed are divided into those who indicated they had training and the total participants in the questionnaire. ...................................................... 82   ix Figure 3.3. Personal protective equipment reported to be used when mixing cytotoxic drugs from employee questionnaire. ........................................................................................................ 85 Figure 5.1: Results from evaluations received from participants that attended the training session entitled Standardized New Worker Orientation Hazardous Drug Handling. ........... 146 Figure 6.1: Comparing the use of respiratory protection used for mixing cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. ........................... 165 Figure 6.2:Comparing the use of respiratory protection used for decontamination of the Biological Safety Cabinet in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. ................................................................................................................... 165 Figure 6.3:Comparing the use of respiratory protection used for spill clean-up of cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. .......... 166 Figure 6.4:Comparing the types of gloves used for used for mixing of cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. ........................... 166 Figure 6.5: Comparing the types of gloves used for used for receiving cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. ........................... 167 Figure 6.6: Comparing the types of gloves used for used for spill cleanup of cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. .............. 167 Figure 6.7: Comparing the types of gloves used for used for decontamination of the biological safety cabinet in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. ................................................................................................................................... .168 Figure 6.8: Comparing some additional types of personal protective equipment  (i.e. hair cover, shoe cover, and impermeable gown) used for mixing cytotoxic drugs and decontamination of the biological safety cabinet in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessments. ............................................................................................................... ..168 Figure 7.1: Linking theoretical models of health behavior to each phase of research??.??203     x Acknowledgements  Firstly, I would like to thank my supervisors Dr. Karen Bartlett and Dr. Winnie Chu for all their excellent guidance and support throughout my research.  In addition, I would like to express my gratitude to my committee members Dr. Paul Demers, Dr. Mieke Koehoorn and Dr. Adil Virani for their direction during this research.  I am also indebted to the laboratory personnel at University of British Columbia?s School of Population and Public Health who carried out the analysis of my environmental samples.  I would also like to thank those who worked collaboratively with Dr. Chu to develop and refine the methods to enable me to investigate cytotoxic drug surface contamination at worksites.   For moral support, I would like to thank my husband Michael Armstrong and my parents Robert and Darlyne Griffiths, your encouragement and sense of humor during this endeavor has been invaluable.  I don?t think that I will ever be able to thank you enough!    I would also like to thank my manager, Darren Buckler at Vancouver Island Health Authority (Occupational Health and Safety), without your backing, this research would not have gone forward. Finally, I gratefully acknowledge the members of the Vancouver Island Health Authority Pharmacy Department who participated in this study.  Your contribution to this study has been vital to uncovering information to help reduce occupational exposure to hazardous drugs.     1 Chapter 1: Introduction Across Canada, thousands of health care workers are required to manipulate and administer cytotoxic drugs as part of the treatment of patients with a variety of conditions, including cancer.  As cases of cancer in the population continue to increase, the potential for health care workers to be exposed to the drugs for cancer treatment will also increase.   As such, it is imperative to have an understanding of what controls are currently in place to reduce occupational exposure to these products and also to propose controls where deemed necessary.  The Canadian Cancer Society reported that in 2009 there were approximately 75,300 deaths from cancer and another 171,000 newly diagnosed cases.  Although lung cancer was the leading cause of cancer-related deaths, a number of other cancers such as breast, colorectal and prostate figured prominently in newly diagnosed cases (Canadian Cancer Society, 2009).  Cancer impacts all age groups but about 43% of new cancer cases and 60% of deaths occur in individuals 70 years and older.  Young and middle-aged adults (20-59 years of age) account for 30% of all new cancer cases and about 17% of cancer-related deaths. (Canadian Cancer Society, 2009).   1.1 Cytotoxic Drugs A cytotoxic drug may be considered any drug that prevents or inhibits the function of a cell.  These drugs are used to treat cancer, but are also used to treat certain skin conditions (e.g. psoriasis) and arthritis (Saskatchewan Labour, 2007).  For more than 30 years, chemotherapy has been used for the treatment of cancer.  One of the very first pieces of evidence that certain chemicals could be utilized to treat   2 cancer was abnormal changes observed in the bone marrow of hospitalized World War I Veterans many years after returning from war.  The health effects of this uncontrolled occupational exposure were not apparent until many years after exposure.  The compound identified to have caused these changes in bone marrow was sulfur mustard gas, which was then evaluated for effectiveness as an anti-cancer agent.  Subsequently, chemicals less toxic than nitrogen mustards were shown to cause tumor regression in patients with lymphoma. There are now more than 100 different antineoplastic drugs to treat cancers that can improve quality of life, and in some cases cure cancer (Connor & McDiarmid, 2006).  1.2 Health Effects and Mechanism of Action Associated with Cytotoxic Drugs Despite the benefit of cytotoxic drugs for the treatment of cancer and other health conditions, there are also negative health effects associated with their use.  Most of the antineoplastic drugs are ?non-selective? in their mechanism of action and thus demonstrate their effects in both cancerous and healthy cells in the body.  Some examples of known effects in patients that have been treated with these products include the following: immunotoxicity, ototoxicity, cardiotoxicity, hepatic, renal, hematopoietic, pulmonary, and dermal toxicity (Barton-Burke & Wilkes, 2006).  The International Agency for Research on Cancer (IARC) has determined there is sufficient evidence of carcinogenicity in humans (Group 1) for thirteen antineoplastic agents and of probable carcinogenicity in humans for twelve antineoplastic drugs (Group 2A) (Table 1.1).  IARC cites studies (Kaldor et al., 1990, Nandakumar et al.,   3 1991, Valagussa et al.1994,) to support this and identifies that both acute non-lymphocytic leukemia and leukemia have been demonstrated in those treated with cyclophosphamide (IARC Monograph Summary Volume 26, 1987, IARC Monograph Volume 100A, 2012).  For example, in a German case-control study, it was demonstrated that there was a relative risk of 14.6 (90% CI 2.4-88.7) of developing leukemia as a secondary cancer for patients treated with cyclophosphamide for ovarian cancer.  This same study demonstrated that patients treated for breast cancer using cyclophosphamide had a relative risk of 2.7 (90% CI 1.2-6.3) for developing leukemia as a secondary cancer (Haas et al., 1987).    Table 1.1: List of antineoplastic products that are known or probable human carcinogens.  Group 1: Human Carcinogen Group 2A: Probable Human Carcinogen ? Arsenic trioxide  ? Azathioprine  ? Chlorambucil  ? Chlornaphazine  ? Cyclophosphamide  ? Melphalan  ? Semustine  ? Tamoxifen  ? Thiotepa  ? Treosulfan  ? Mustargen-Oncovin-Procarbazine-Prednisone (MOPP)  ? Etoposide-Cisplatin-Bleomycin (ECB) ? Azacitidine  ? Carmustine (BiCNU)  ? Lomustine (CCNU)  ? Chlorozotocin  ? Cisplatin  ? Doxorubicin HCl  ? N-Ethyl-N-nitrosourea  ? Etoposide  ? Mechlorethamine HCl  ? N-Methyl-nitrosourea  ? Procarbazine HCl Teniposide Adapted from Connor and McDiarmid (2006) from IARC Additionally, other studies have shown increased incidences of chromosomal aberrations and sister chromatid exchanges in peripheral blood lymphocytes, including   4 in bone-marrow cells, of patients who were treated with cyclophosphamide (IARC Monograph Summary Volume 26,1987, IARC Monograph Volume 100A, 2012).  In addition to mutagenic and carcinogenic properties, many antineoplastic drugs have been found to cause adverse reproductive outcomes in a variety of animal species including humans.  Teratogenic outcomes have been reported in laboratory animals and patients that were treated with antineoplastic drugs during pregnancy. The United States Food and Drug Administration classify fetal risks due to pharmaceutical use into six categories. ?Pregnancy Category A? represents no evidence of risk to the fetus in any trimester whereas subsequent categories, that is B,C,D and X, are classified as more harmful to the fetus.   There are 45 antineoplastic drugs that have been classified as ?Pregnancy Category D? indicating risk to the human fetus.  However in some cases, the benefits may outweigh the risks for a pregnant woman with a potentially fatal condition. Some examples of antineoplastics that are classified as ?D? include: Fluorouracil, Cyclophosphamide and Cisplatin. Some antineoplastic drugs have been classified as ?X? which indicates there is strong evidence that medication use causes abnormalities in the fetus.  Therefore, risks of using drugs with an ?X? classification would outweigh any possible benefits for women who are pregnant.  Some examples of antineoplastics that would be classified as ?X? include: Methotrexate, Leflunomide and Thalidomide (US Food and Drug Administration Center for Drug Evaluation and Research, 2006).   Cytotoxic drugs exert their effects by actively binding to proteins, RNA and DNA.  Some examples of mechanisms of action include: microtubule function inhibition (i.e. mitotic inhibitors), DNA cross-linking (i.e. alkylating agents), and RNA function inhibition (i.e.   5 antimetabolites) (Gilman et al., 1990).  The mechanisms of action for anti-cancer drugs have evolved to some degree in that they can target more specific pathways depending on the type of cancer. However, according to researchers, ?biologically, the cancer cell is notoriously wily; each time we throw an obstacle in its path, it finds an alternate route that must then be blocked.? (Winer et al., 2009).  The mechanism of blocking each of the routes or pathways to cell proliferation is through the use of combinations of cytotoxic drugs.  1.3 Drugs in the Environment Pharmaceutical products make their way into the environment through manufacturing, consumer use or disposal. The presence of pharmaceuticals in surface or ground water has started to gain attention.  The primary concern is that although these products are intended to have biological activity in humans, theoretically, they could exert effects on organisms in the aquatic environment.  Despite the expected low concentrations of cytotoxic drugs that could be found in the environment, there is still cause for concern due the powerful mechanism of action of these compounds (Buerge et al., 2006).  These compounds have the potential to exert adverse effects on reproduction and immune systems in aquatic organisms such as fish.  In a study conducted in Switzerland, Buerge and colleagues assayed wastewater for the presence of cyclophosphamide and ifosfamide.  These compounds were detected in wastewater at concentrations of <0.3 ng/L to 11 ng/L, which corresponded with the predicted consumption rate of these products and renal excretion by patients (Buerge et al., 2006).   A study in China by Yin et al. in 2010 assayed wastewater from hospitals for nine cytotoxic products: methotrexate, azathioprine, doxo-rubicin, doxorubicinol,   6 vincristine, ifosfamide, cyclophosphamide, etoposide, and procarbazine.  Five of the nine products were found in the 65 effluent samples analyzed. The median concentrations for methotrexate, azathioprine, ifosfamide, cyclophosphamide and etoposide were 17, 15, 151, 100 and 42 ng/L, respectively.  These results suggest that effluent from hospitals is an important source of cytotoxic drugs in the aqueous environment (Yin et al.,  2010).  1.4 Occupational Exposure to Cytotoxic Drugs Occupational exposure to cytotoxic drugs has been demonstrated in hospital personnel during the course of their duties (Sessink et al. 1992, Sessink et al. 1994, Fransman et al., 2004, Fransman et al., 2005, Connor et al., 2010 Sugiura et al., 2011, Hama et al., 2012).  However, occupational exposure can occur in a variety of other workplaces.  Work by Meijster et al. in 2006 examined other possible occupational settings and estimated there were between 5,000 and 15,000 workers in the Netherlands exposed to cytotoxic products outside the hospital setting.  These other occupational settings included: residential care facilities, home care, community pharmacies, industrial laundries, waste treatment, pharmaceutical industry, veterinary clinics, and universities.  Of the eight proposed sectors, four were considered at higher risk of exposure; residential care facilities, home care, industrial laundries and veterinary clinics.  For example, exposure measurements from surface sampling in veterinary clinics showed levels of cytotoxic drugs that were 15 times higher compared to values from acute care hospitals.  In addition, it was shown that workers in the industrial laundry settings were exposed via inhalation to cytotoxic dugs when sorting contaminated laundry from hospitals.  Furthermore, for those working in residential care facilities and in home care   7 it was shown that workers were exposed to cytotoxic drugs when cleaning toilets or washing patients who were being treated with these products.  Overall, this study concluded that exposure levels in these other settings could potentially be higher compared to the hospital environment because exposure routes may be complex, control measures may be sub-optimal and there was a general lack of awareness of the hazards associated with cytotoxic drugs (Meijster et al. 2006).   1.5 Exposure of Health Care Personnel to Cytotoxic Drugs in Hospital Settings Multiple studies both internationally (Sessink et al. 1992, Sessink et al. 1994, Connor et al., 2010, Sugiura et al., 2011) and in Canada (Schulz et al., 2005, Chu et al., 2011, Hon, 2012) have demonstrated the presence of cytotoxic drug contamination inside the hospital work environment.  Within the hospital setting, cytotoxic drugs are handled by many personnel as the products progress through receiving, preparation, administration to patients and disposal.  As such, a number of different work groups within the hospital setting have the potential to be exposed to these products.  By observation, an overview of the occupations that are at risk for exposure is outlined in Table 1.2.  The observations were made by the investigator working in the capacity as an Occupational Hygienist at a health authority on Vancouver Island, Canada.        8 Table 1. 2: Occupations and tasks in hospital settings with potential contact with cytotoxic drugs determined through observations made by occupational hygienist. Occupation Tasks Where Exposure Could Occur Pharmacy technician  ? Receiving ? Mixing ? Decontamination of biological safety cabinet ? Spill clean up ? Waste disposal Pharmacist ? Product checking ? Spill clean up ? Mixing (limited circumstances) Chemotherapy nurse ? Administration of products ? Contact with patient blood/body fluids ? Waste disposal Environmental service workers ? Cleaning patient and pharmacy areas ? Waste disposal Stores personnel ? Receiving ? Shipping/transport  Occupational exposure within the hospital setting could commence upon receipt of the product.  It has been reported that the surface of drug vials and packaging may be contaminated with cytotoxic drugs as supplied by the manufacturer (Nygren et al., 2002, Mason et al., 2003, Schulz et al., 2005, Hama et al., 2012).  Contaminated drug packaging and vials represent a risk of dermal exposure to cytotoxic drugs for employees involved in handling the containers prior to preparation of products for patient treatment.  To the knowledge of the investigator, there are no regulatory requirements within Canada or internationally for a manufacturer to demonstrate that the packaging materials of these products are free of cytotoxic drugs.   There is evidence that cytotoxic drugs can persist on surfaces, despite cleaning and controls being in place to reduce indoor environmental contamination.  A 2011 pilot   9 study by Chu et al. in British Columbia (BC) hospitals examined surface contamination before and after cleaning in pharmacy departments.  The results showed that although post-cleaning wipe test values for methotrexate and cyclophosphamide were lower than pre-cleaning levels, current cleaning practices in BC hospitals may not be effective in removing residual drug from work surfaces (Chu et al., 2011).  1.6 Evidence of Exposure to Cytotoxic Drugs in Hospital Personnel It has been demonstrated that cytotoxic drugs can be recovered from work surfaces within the hospital setting (Sessink et al. 1992, Sessink et al. 1994, Connor et al., 2010, Sugiura et al., 2011, Schulz et al., 2005, Chu et al., 2011, and Hon, 2012).  Personnel who handle cytotoxic drugs have two main routes of occupational exposure to these products: dermal contact and inhalation.  A 2011 pilot study in British Columbia hospitals by Hon et al. to evaluate dermal contamination among pharmacy study revealed that 28% of samples from three out of six worksites had pharmacy personnel with measurable levels of methotrexate or cyclophosphamide on their hands.  The investigators suggested that although further studies were required to confirm the results, hospital pharmacy workers in the metropolitan area of Vancouver were likely exposed to antineoplastic drugs during the course of their duties (Hon et al., 2011).   In order to prevent direct dermal exposure and the potential for subsequent uptake, barrier protection is required.  One type of personal protective equipment frequently recommended for prevention of dermal exposure is the use of gloves.  However, studies have demonstrated that latex gloves may not protect workers from cytotoxic drug exposure during preparation.  Work by Sessink et al. in 1994 demonstrated that cotton gloves worn underneath latex gloves had measurable contamination with both   10 cyclophosphamide and fluorouracil.  Furthermore, this study showed under actual use conditions, these drugs could penetrate latex gloves within ten minutes (cyclophosphamide) to 67 minutes (methotrexate) (Sessink et al., 1994).  Another potential route of exposure for health care workers manipulating cytotoxic drugs is inhalation.  Sessink et al. in 1994 used personal air sampling to estimate the amount of airborne cyclophosphamide workers were exposed to while preparing drugs.  Cyclophosphamide was present in personal air samples ranging from < 0.5 ?g/m3 to 10.1 ?g/m3.  Using this information, Sessink reasoned that the amount of cyclophosphamide inhaled by a worker, based on the amount of drug prepared, cumulative urinary excretion and respiratory volume, would range from < 0.07 ?g to 2.2 ?g over a 24-hour period.  This work also demonstrated that even those who did not handle these products, but worked in the same environment had cyclophosphamide detected in their urine.  In 1997, Sessink et al. also carried out a study on pharmacy technicians to determine if the introduction of additional protective measures would result in lower amounts of cyclophosphamide being detected in their urine.  The outcome of the study was that despite the introduction of additional protective measures (e.g. double gloving, modified drug ampoules and changes made to biological safety cabinet), the concentration of cyclophosphamide metabolites still present in the urine of workers was not significantly lower than in previous studies (Sessink et al., 1997).   Work similar to Sessink et al. carried out in Japan (Yoshida et al.,) in 2010 demonstrated that cytotoxic drugs could be detected from air samples and contamination was present on multiple surfaces in the areas where the products were   11 prepared.  Furthermore this confirmed the results that cyclophosphamide could be detected in the urine of workers handling the products.  In 2010, research by Connor et al. evaluated cytotoxic drug exposure of health care workers at cancer centres in the United States.  The research examined environmental samples from both nursing and pharmacy areas and assayed urine to look for the presence of five cytotoxic drugs.  Environmental analysis confirmed at least one of five drugs were present on 60% of work surfaces tested and three of 68 urine samples tested positive for one drug (cyclophosphamide).  The authors concluded that despite recommended safe handling practices being in place, environmental contamination and worker exposure was still occurring (Connor et al., 2010).  More locally, on the lower mainland of British Columbia, research completed by Hon in 2012 examined both surface contamination and urinary excretion (n=223) across the hospital system.  Hon concluded in his work that drug residual (i.e. cyclophosphamide) was present throughout the hospital environment and that being a pharmacy technician, pharmacy receiver, unit clerk, porter or nurse was associated with increased drug concentration in urine.  1.7 Health Studies on Health Care Workers and Exposures to Cytotoxic Drugs Evidence from the literature has demonstrated that cytotoxic drugs are present on various surfaces in the work environment where cytotoxic drugs are handled (Sessink et al. 1992, Sessink et al. 1994, Connor et al., 2010, Sugiura et al., 2011, Schulz et al., 2005, Chu et al., 2011, and Hon, 2012) and can be measured in the air when products are being manipulated (Sessink et al., 1994, Yoshida et al., 2010).  Furthermore, the products (cyclophosphamide and/or methotrexate) have been isolated from workers?   12 hands (Hon et al., 2011) and from the urine of personnel working with cytotoxic drugs and as such evidence of occupational exposure and uptake of the products (Sessink et al. 1994, Sessink et al., 1997, Yoshida et al., 2010, Connor et al. 2010, Hon, 2012).   The health impact of cytotoxic drugs for patients receiving treatment was described in a previous section.  It is acknowledged that patients are receiving much higher doses of exposure to cytotoxic drugs during treatments compared to health care personnel.  However, these workers are at risk of exposure over a cumulative period of time (Ratner et al., 2010).   A publication by Heron and Pickering in 2003 reviewed the health effects of active pharmaceutical products and the potential exposure to workers.  According to this publication, the health risk to exposed workers is theoretically high.  Therapeutic doses of cytotoxic drugs often entail ?pushing doses to the limits of toxicity? and the products have the capacity to ?exert biological effects even at very low levels of absorption? (Heron & Pickering, 2003).  There are studies that have examined the health impact of those handling cytotoxic drugs primarily in the areas of genotoxicity, cancer, and reproductive health.  Examples of each of these studies will be described within the sections to follow.  Genotoxicity and Cancer Studies As IARC has classified multiple cytotoxic drugs as human carcinogens and these products have mutagenic properties, studies have investigated if those who are occupationally exposed are at risk of genetic damage.   One of the earliest studies that examined occupational exposure to cytotoxic drugs involved nurses.  Falck et al. (1979) demonstrated that oncology nurses handling cytotoxic drugs exhibited increased levels   13 of mutagenic activity in their urine.  The consequences to health based on these results are unknown, however the outcome indicated that nurses were being exposed to mutagenic cytotoxic drugs.   Similarly, in 1982, a study by Anderson et al. determined that pharmacy personnel preparing injectable cytotoxic drugs also had mutagenic substances detected in their urine.   Other studies have examined occupational exposure to cytotoxic drugs in relation to changes at the molecular level.  A study of Japanese nurses in 2008 documented that those who handled antineoplastic drugs had increased DNA damage based on the results from a Comet Assay compared to those who did not handle the products (Sasaki et al., 2008).  The Comet Assay is a molecular technique utilized to detect DNA damage at the level of the indivdual cell and was developed by ?stling and Johansson in 1984.  Research carried out by Cavallo et al. (2005) analyzed chromosomal aberrations in health care personnel handling cytotoxic drugs.  The outcome of the study confirmed the genotoxic effect of cytotoxic drugs in those occupationally exposed based on the genetic damage observed in circulating blood lymphocytes.  The frequency of sister chromatid exchanges is often used to test the mutagenicity of products and use of this technique was published by Taylor in 1958.  In 2011, Gultan et al. published a study that investigated genotoxicity and medical oncology nurses working in Turkey.  The results of this study indicated no statisitically significant differences in frequencies of sister chromatid exchanges (the exchange of genetic material between two identical sister chromatids) in those occupationally exposed and those not exposed.  The investigators attributed the lack of genotoxicity of those working with antineoplastics to   14 good working conditions characterized by ?high standards of technical equipment and improved personal protection?.   A study by Skov et al. (1992) investigated the risk of developing leukemia among nurses who handled cytotoxic drugs in Denmark. The outcome was a significantly increased relative risk (RR) for leukemia (RR=10.65, 95% CI 1.29-38.5), however this was based on only two cases.  The investigators acknowledged that this research had limitations and should be followed up with larger studies.  This same group of investigators determined that physicians who had worked in an area where patients were undergoing cancer treatment had an increased risk of developing leukemia (RR=2.85, 95% CI 0.51-16.0) but the increase was not statistically significant (Skov et al., 1990).   More recently, work carried out by Ratner et al. in 2010 examined the incidence of cancer in nurses that were potentially exposed to cytotoxic drugs (n=56 213) in British Columbia.  This was a retrospective cohort study that was able to examine potential occupational exposures and link the information with a provincial cancer registry.  The results of the study indicated that female nurses that had potential exposure to anticancer drugs did not have an excess risk of leukemia.  However, nurses that had ever worked in an oncology unit had a greater risk of developing breast cancer (RR=1.83, 95% CI 1.03-3.23) and an excess risk of rectal cancer (RR=1.87, 95% CI=1.07-3.29).   The authors acknowledged that there were limitations to this study in that they had no information on potential confounding factors or on exposure to other carcinogenic chemicals within the workplace.   The authors also noted that, based on   15 the ways in which exposure was classified, they may in fact have underestimated the health risk associated with working with cytotoxic drugs (Ratner et al., 2010) Reproductive Health Studies Cytotoxic drugs have been found to cause adverse reproductive outcomes in a variety of species including humans and as such the reproductive health of those who work with these products should be considered (Connor & McDiarmid, 2006).  However, there is conflict within the literature as to the impact of occupational cytotoxic drugs on reproductive health.  A meta-analysis examined the association of adverse reproductive health outcomes and occupational exposure to female health care workers in the United States and Europe.  The investigators examined health studies from 1966 to 2004 and identified seven studies that could be used in their statistical analysis.  The researchers concluded, based on the studies examined, female health care workers that handled cytotoxic drugs in the course of their duties had a ?small incremental risk for spontaneous abortions? (Dranitsaris et al., 2005).  A cross-sectional study by Suarel-Cubizolles et al. (1993) collected information on occupational exposures and pregnancy outcomes of personnel working in Paris hospitals form 1987 to 1988.  The study demonstrated a significant association between exposure to antineoplastics in the first trimester and ectopic pregnancies.  However, the researchers concluded that their results should be confirmed with a larger study.  Based on the time period when this study took place, it is likely that nurses included were preparing products at the bedside.    16 A cross-sectional study by Valanis et al. (1999) examined pregnancy outcomes and occupational exposure to antineoplastics for pharmacy and nursing personnel in the United States from 1988 to 1989.  The results of this study indicated that exposure of the mother or the handling of antineoplastic products during pregnancy was associated with a significantly increased risk of spontaneous abortion (OR =1.5, 95% CI 1.2 to 1.8).  This study was included as part of the meta-analysis conducted by Dranitsaris et al., 2005. Work carried out by Fransman et al. (2007) examined reproductive outcomes in nurses who had dermal exposure to antineoplastic drugs.  This study utilized a self-reported questionnaire on exposures at work, lifestyle and pregnancy outcomes.  The results of this study showed that nurses classified as being ?highly exposed? took longer to conceive compared to the reference group of nurses.  Furthermore, this study reported that exposure to antineoplastics was associated with premature deliveries and lower birth weights.  However, congenital anomalies, stillbirth and spontaneous abortion did not appear to be related to exposure to antineoplastic drugs (Fransman et al. 2007).   A study by Ratner et al. published in 2010 reported that female nurses that had potential exposure to anticancer drugs did not have an excess risk of stillbirth or congenital anomalies in offspring, with the exception of congenital eye anomalies (OR = 3.46, 95% CI = 1.08 - 11.14, 3 cases). Immunotoxicity It is known that patients who have been treated with various chemotherapy agents experience health effects that include immunotoxicity.  Immunotoxicity has subsequently   17 been examined in health care workers.  Work carried out by Biro et al. published in 2011, monitored immunotoxicity in hospital staff that were exposed to cytostatic drugs.   The study involved 306 nurses who worked in oncology units in Hungary.  The results of the study indicated that major sub-populations of lymphocytes are impacted resulting in a decrease in activated T Lymphocytes and increased ?oxidative burst of neutrophil granulocytes?.  Overall, the investigators concluded that low dose occupational exposure to cytotoxic drugs could cause immunotoxicity (Biro et al. 2011). Summary of Health Effects There is sufficient evidence that has indicated multiple cytotoxic drugs are either carcinogenic or probable human carcinogens based on studies of patients receiving treatment (IARC Monograph Summary Volume 26, 1987, IARC Monograph Volume 100A, 2012).  Furthermore, in patients many of these drugs are known to cause immunotoxicity, ototoxicity cardiotoxicity, hepatic, renal, hematopoietic, pulmonary, and dermal toxicity (Barton-Burke & Wilkes, 2006).  Cytotoxic drugs act indiscriminately on both healthy and diseased cells and mechanism of action associated with these drugs is typically by binding to DNA, RNA or proteins.  At the molecular level, genotoxicity has been demonstrated in individuals who have been exposed occupationally to cytotoxic drugs (Cavallo et al., 2005, Sasaki et al., 2008).  If DNA is unable to repair correctly following damage, this can lead to the development of cancer.  Two studies from the 1990?s determined those working in health care that were exposed to cytotoxic drugs during their course of duties were at risk for developing cancer, in particular an increased risk of leukemia (Skov et al., 1990, Skov et al., 1992).  Despite the acknowledged limitations of these early studies the results should not be overlooked.    18 The development of leukemia is an example of a second malignancy observed in patients who have undergone treatment with cytotoxic drugs (Connor & McDiarmid, 2006).  Another more recent study demonstrated that nurses that had ever worked in an oncology unit had a greater risk of developing breast cancer and an excess risk of rectal cancer (Ratner et al., 2010).  At this time, there is insufficient data to conclusively assign a quantifiable risk of developing cancer as a result of occupational exposure to cytotoxic drugs among health care personnel, but sufficient evidence to indicate that the risk is plausible.  Many cytotoxic drugs have been found to cause adverse reproductive outcomes in patients that were treated with antineoplastic drugs during pregnancy. There are 45 cytotoxic drugs classified as ?Pregnancy Category D? indicating a risk to the human fetus.  Studies that examined the reproductive health risk to those handling cytotoxic drugs have not consistently had the same conclusions.  For example, some studies have shown women occupationally exposed are at risk of spontaneous abortions (Dranitsaris et al., 2005) while other studies have not (Fransman et al. 2007).  Another study reported that workers who were occupationally exposed took longer to conceive and had a higher risk of pre-term births.  Two studies concluded that health care personnel involved with handling cytotoxic agents did not have an excess risk of stillbirth or congenital anomalies in offspring (Fransman et al. 2007, Ratner et al., 2010).    Many of these health studies took place prior to stringent safe handling practices being in place, and as such the acute and long-term health risk to health care personnel has likely declined within the last 20 to 25 years.  However, a risk to health may still exist among workers handling cytotoxic drugs because it has been shown that despite   19 controls being present, there is evidence of occupational exposure taking place (Dranitsaris et al., 2005). 1.8 Risk of Occupational Exposure to Pharmacy Personnel in British Columbia Pharmacy Population In BC, there are approximately 3750 pharmacists working in various public and private settings including institutional (hospital, government) and community settings (Canadian Institute for Health Information, 2008).  Those who are most likely to be exposed to cytotoxic drugs would be working in hospital settings where they may be compounding or dispensing products.  The approximate number of pharmacists who work in a hospital setting is 18.5% of total pharmacists across Canada and based on the information above it is estimated to be approximately 695 pharmacists in BC hospitals (Canadian Institute for Health Information, 2008).   Within BC hospitals, pharmacy technicians also carry out tasks such as dispensing and compounding of cytotoxic drugs within the hospital setting.  According to a 2006 report, it is difficult to determine the number of pharmacy technicians working in Canada, but it is estimated that there are between 40,000 and 80,000 (Canadian Pharmacists Association, 2007). A survey of pharmacy technicians across Canada (n=3000) demonstrated approximately 16% were employed in BC and of those in BC, 51% were employed within a health care setting. Using the information from both of these reports, a crude estimate of pharmacy technicians working in BC health care settings would be between 3200 and 6500 (Canadian Pharmacists Association, 2007).  Therefore, within   20 BC there are between 3800 and 7100 pharmacy personnel that could be occupationally exposed to cytotoxic drugs within the health care sector.  Risk of Exposure During the Course of Duties Before the mid 1980?s, nurses were responsible for the preparation and administration of cytotoxic drugs, and this took place on the unit with minimal protective standards in place.  Around the mid 1980?s international standards stipulated that cytotoxic drugs must be prepared in an accredited pharmacy with specialized equipment to minimize exposure (Dranitsaris et al., 2005). In British Columbia hospital settings, pharmacy personnel handle and manipulate cytotoxic drugs prior to patient administration and care by nurses.   Pharmacy personnel involved in the preparation of cytotoxic drugs are expected to don personal protective equipment and manipulate cytotoxic drugs inside a biological safety cabinet.   By taking these precautions, one would expect that there would be limited evidence of occupational exposure.  However, it has been demonstrated that despite all of the measures taken to prevent product from becoming dispersed, surface contamination persists (Sessink et al. 1992, Sessink et al. 1994, Connor et al., 2010, Sugiura et al., 2011, Schulz et al., 2005, Chu et al., 2011, and Hon, 2012).  Several studies have demonstrated detectable levels of products in the urine of workers, indicating exposure to and uptake of cytotoxic agents from the work environment (Sessink et al. 1994, Sessink et al., 1997, Yoshida et al., 2010, Connor et al. 2010, Hon, 2012).   Based on the aforementioned literature, there is evidence to support that pharmacy personnel   21 working in BC are at risk of exposure to cytotoxic drugs during the course of their duties within the hospital workplace setting.   As the Canadian population ages, it has been predicted that the cases of cancer within Canada will also increase (Canadian Cancer Society, 2009).  If there are more cases of cancer, there will be an increase in the number of patients accessing treatment with cytotoxic drugs.  Therefore, it is likely that exposure to cytotoxic drugs among healthcare personnel will continue and potentially increase in the coming years.  At this time it is not possible to quantify the health risk of BC pharmacy personnel who are occupationally exposed to cytotoxic drugs.  Furthermore, occupational exposure limits for cytotoxic drugs have not yet established a safe concentration to minimize toxic effects in the majority of workers.  As previously discussed, many cytotoxic drugs are carcinogenic.  As per WorkSafeBC regulations, when a carcinogen that is part of a work process cannot be eliminated or substituted, measures must be taken to ensure that occupational exposure is as low as reasonably achievable: ?If it is not practicable to substitute a material which reduces the risk to workers, in accordance with subsection (1), the employer must implement an exposure control plan to maintain workers' exposure as low as reasonably achievable? (WorkSafeBC, Section 5.57).  It is not possible to eliminate or substitute cytotoxic drugs in the pharmacy setting at this time, and as such steps should be taken to evaluate factors within the workplace that could impact measures aimed at prevention of exposure.   1.9 Information on Certification and Training of Pharmacy Technicians  In acute care hospitals, it is often the pharmacy technicians that carry out the majority of tasks associated with preparation of cytotoxic drugs.  This role may put them at risk of   22 occupational exposure to cytotoxic drugs more so than other professionals working with these products.  Therefore, having information on the training of pharmacy technicians working in Canada may provide insight into prevention opportunities. A survey of pharmacy technicians carried out in 2007 (n=3000) collected information on training, certification and education in the occupation.  The survey participants were asked to report ?what statement best described their formal training as a pharmacy technician? and the results were as follows (Canadian Pharmacists Association, 2007): ? 8% of respondents had no formal training as a pharmacy technician ? 21% had taken courses given by their employers ? 62% had graduated from a one-year course, either at a private career college or a community college  ? 7% of respondents had completed a two-year community college program to become a pharmacy technician Survey respondents were also asked whether they had completed a pharmacy technician certification program.  The responses to this question indicated a variety of types of certification across Canada ranging from voluntary certification programs to certification in a particular task by employers. The authors of the survey noted that the term ?certification? might have a variety of meanings depending on the jurisdictions or workplaces and there is no standardization of certification in Canada (Canadian Pharmacists Association, 2007).   23 An online literature search of the database PubMed using the key words: ?cytotoxic drugs? or ?antineoplastic drugs? in combination with ?safety? or ?education? or ?training? did not reveal any literature related to safe handling, training or education for pharmacy personnel that utilize these products.  The literature that was most closely related to this topic addressed safe handling practices for cytotoxic drugs with reference only to nurses. One publication from Israel specifically examined the influence of nurses? knowledge, attitudes and health beliefs on their safe behaviors (Ben-Ami et al., 2001).    This study identified a significant gap between the nurses? knowledge on safe work practices reported in a survey and the observed use of protective measures by the same cohort (Ben-Ami et al., 2001).  A study of Turkish nurses published by Kosgeroglu in 2005 examined safe work practices and procedures pertaining to both patient safety and personal safety (Kosgeroglu et al., 2005).   The results of this study indicated that 86% of nurses failed to use the biological safety cabinet when carrying out cytotoxic drug preparations, 43% disposed of contaminated gloves improperly and 87% disposed of mixing gowns improperly (Kosgeroglu et al., 2005).  1.10 Present Regulations, Standards and Recommendations Within the acute care pharmacy settings that manipulate cytotoxic drugs, there are regulations and standards that govern safe work practices.  In British Columbia, employers are legally required to comply with WorkSafeBC regulations for occupational health and safety.  The United States Pharmacopeia (USP) sets standards for the pharmaceutical industry, and the British Columbia Cancer Agency (BCCA) details best practices for the use of antineoplastic drugs.     24 WorkSafeBC Regulations Under the British Columbia Workers Compensation Act (Part 3 Division 3) ?Every employer must ensure the health and safety of all workers working for that employer, and any other workers present at a workplace at which that employer's work is being carried out, and comply with this Part, the regulations and any applicable orders.  In addition, an employer must remedy any workplace conditions that are hazardous to the health or safety of the employer's workers and ensure that the employer's workers are made aware of all known or reasonably foreseeable health or safety hazards to which they are likely to be exposed by their work? (Part 3, Division 3 of the of the Workers? Compensation Act).  At present there are no occupational exposure limits for cytotoxic drugs in BC, but WorkSafeBC provides a number of regulations outlined in Part 6 of the regulations ?Substance Specific Requirements? in section 6.42 to 6.58 regarding the use of such agents.  A summary of this information may be viewed Appendix A, Table 1 (WorkSafeBC, 2006).   USP Chapter 797-Compounding Sterile Preparations The United States Pharmacopeia (USP) is an official public authority that sets the standards for all prescription and over?the?counter medicines and other health care products manufactured or sold in the United States.  This standard is one that is frequently referred to in Canadian pharmacy settings for the preparation of sterile products. The USP Revised General Chapter 797 Pharmaceutical is a standard that specifically outlines practices for compounding sterile preparations that includes cytotoxic drugs.  The aim of this document is to define standards for ensuring that   25 compounded sterile preparations are of high quality.  Within this document, there is also information pertaining to worker and patient safety, which to some degree overlap.  For example, there are specifications on personal protective equipment and biological safety cabinets that protect both the product and the worker (U.S. Pharmacopeia's (USP), 2008).  A summary of the information that specifically pertains to safe handling practices for workers within this document may be viewed in Appendix A, Table A2.  British Columbia Cancer Agency Pharmacy Chemotherapy Certification Program The British Columbia Cancer Agency (BCCA) has a Pharmacy Chemotherapy Certification program. This voluntary certification program was developed by BCCA in 2007 and is based on practices outlined in a ?BCCA Pharmacy Practice Standards for Hazardous Drugs Manual? created and posted online in 2008.  The certification process assesses practices of both worksites and individuals who handle hazardous drugs.  The mandate of the certification program is to address safety of patients and those who handle hazardous drugs (J. Fabbro, BCCA Chemotherapy Certification Pharmacist, personal communication September 6, 2012).   A more detailed comparison of WorkSafeBC regulations, USP 797 and the BC Cancer Agency is contained in the results section (Table 2.2 Summary of Similarities and Differences between WorkSafeBC (WSBC) Regulations, British Columbia Cancer Agency (BCCA) Certification and United States Pharmacopeia (USP) 797) in Chapter 2 of this dissertation.     26 1.11 British Columbia Health Authority Information  In December 2001, the 52 administrative health authorities in British Columbia were consolidated into five organizations based on geographic location (Province of British Columbia, 2004).  One of the five organizations that emerged from this consolidation, Vancouver Island Health Authority, provides services to more than 752,000 people who live on Vancouver Island as well as islands in the Georgia Straight.  This health authority is comprised of a network of hospitals, clinics, centres, residential care facilities and health units. Within this health authority, there are at least seven facilities that administer cytotoxic agents (Figure 1.1).   Figure 1. 1: Map of a British Columbia Health Authority that provides service to residents of Vancouver Island showing locations of worksites that dispense cytotoxic drugs. Adapted from http://www.viha.ca/finding_care/facilities/   27 1.12 Motivation for Study Prior to this present research, a collaboration between British Columbia (BC) Health Authorities and the University of British Columbia?s (UBC) School of Environmental Health (SOEH) was established to refine methods to identify surface contamination from cytotoxic drugs.  The health authority participating in this research and UBC?s SOEH had a memorandum of understanding that included laboratory analysis and the two organizations were able to work together to gather information on cytotoxic drug surface contamination.  Prior to July 2007, there was no information on the potential for exposure of workers to cytotoxic drugs in Vancouver Island health care facilities because no environmental monitoring had been conducted.  Through the collaboration between UBC?s SOEH and the health authority?s Occupational Health and Safety Department (Occupational Hygienist Andrea Griffiths), a preliminary investigation took place to investigate surface contamination in worksites.  The method to assay for surface contamination was based on work reported by Chu et al., (2011).    Three acute care hospital pharmacies on Vancouver Island that manipulate cytotoxic drugs were chosen to monitor for the presence of the following: methotrexate, cyclophosphamide and fluorouracil (Griffiths, 2007).  The surfaces selected for sampling at each of the sites were chosen in conjunction with input from pharmacy supervisors and staff.  At hospital ?A?, it was determined that eight out of fourteen surfaces sampled were contaminated with at least one of the cytotoxic drugs.  Additionally, at this site, both fluorouracil and cyclophosphamide were detected on the clean air bench and on the doorknob inside the chemotherapy mixing room.   At hospital ?B?, four out of twenty surfaces sampled were contaminated.  Also, the counter located beside the biological   28 safety cabinet was contaminated with both methotrexate and cyclophosphamide.  A marking pen located inside the biological safety cabinet was also contaminated with both methotrexate and cyclophosphamide.  At hospital ?C?, nine out of the fourteen surfaces sampled were contaminated.  The presence of all three products could be detected on the surface of a chair in the room where chemotherapy products were manipulated.  Additionally, a chair located in a waiting room outside of the cancer clinic had fluorouracil detected on it.  Finally, one of the most interesting results obtained from this worksite was that four contaminated surfaces sampled in the main pharmacy area were located on a separate floor from where the chemotherapy products were manipulated. During the site visits to carry out surface wipes, other observations were made that led the organization?s Occupational Hygienist (Andrea Griffiths) to determine that practices for safe handling of cytotoxic drugs were not consistent between each of these three worksites.  In subsequent worksite visits to other locations and to further investigate safe work practices for handling cytotoxic in other facilities cytotoxic drugs, the following observations were made during the course of work duties by the Occupational Hygienist.  1. Each facility had different physical layouts and configurations of pharmacy areas.  2. Biological safety cabinets were present, but models were of different ages and styles. 3. Units had independently developed their own work procedures and practices for handling cytotoxic agents.   29 4.  No facility had a fully implemented training and educational program on how to handle cytotoxic drugs safely. Additionally, other preliminary information on these facilities and handling of cytotoxic products was collected during the site visits (Table 1.3). Overall, the preliminary results suggested a lack of consistency in practices across worksites within this BC health authority and the need to further assess and propose controls to reduce occupational exposure.  Table 1.3: Summary of information collected from health authority facilities on Vancouver Island.  Geographic location *Approximate hours staff spent annually mixing cytotoxic drugs Number of staff mixing cytotoxic drugs Central Island Rare task, projected to increase in coming years. 9 South Island 10 or less 1 North Island 624 4 Central Island 780-1560 9 Central Island 1560 46 (technicians rotate) South Island 1560-1820 13 South Island 1560-1820 11 * The range shown in the approximate hours is due to various staff appointments (i.e. a full time vs. part time vs. casual role) 1.13 Overview of Thesis  The overall goal of this research was to examine current occupational hygiene controls and propose strategies to reduce occupational exposure to cytotoxic drugs in pharmacy personnel in a sample of hospitals within the Vancouver Island Health Authority.  The specific occupational hygiene controls that were examined included: engineering controls, administrative controls and the use of personal protective equipment.  It should be noted that the intent of this research was not to establish a quantifiable risk of   30 exposure to cytotoxic drugs or determine health outcomes in pharmacy personnel as a result of exposure.  This thesis work was a five-part project with each piece providing information to inform the part that followed. An environmental assessment was initially carried out as Phase I to gather information on the layout, design and safe work practices that are presently in place in the health authority?s pharmacies and determine the presence of surface contamination.  This initial information-gathering phase acted as a baseline to establish the present state of controls with the aim of formulating recommendations for best practices to reduce occupational exposure.  In Phase 2 of the study, an employee questionnaire was administered that was developed based on results from Phase 1 of the study.  The aim of the questionnaire was to assess if differences existed among health authority?s pharmacy personnel when considering factors such as knowledge of hazards associated with the products, current practices, use of personal protective equipment, and level of training or education for his or her present occupation.  This information was combined with the information gathered from the environmental assessment to guide discussion for the focus group sessions in Phase 3. In the focus group phase of the study, information from the environmental assessment and participant questionnaire was presented to five focus groups in three different geographical areas.   The aim of holding these focus groups sessions was to gain insight from frontline workers to understand their barriers to working safely with cytotoxic drugs, and for their input into the development of consistent safe work procedures, education or training initiatives.  In the Phase 4 of the study, all of the information gathered from the first three phases of the project was utilized in the development and piloting of safety initiatives.  In the last Phase 5 of the study, final   31 assessments took place to determine if changes in controls had taken place at the worksites when compared to the initial environmental assessment in the study.  In the following chapters (Chapter 2 to Chapter 6) specific details and results for each of the phases are reported.  A visual representation of the the structure of this project is shown in Figure 1.2.  Figure 1.2: Overview of Griffiths PhD Thesis Work ?Assessment and Proposal of Controls to Reduce Cytotoxic Drug Exposure in Pharmacy Personnel?.    32 Chapter 2 Phase I: Environmental Assessment 2.1 Introduction to Phase 1: Environmental Assessment An environmental assessment is an essential first step by occupational health and safety professionals to gather information on the types of workplace measures that are in place to control occupational exposure to a hazardous agent.  In the field of occupational hygiene this information-gathering phase is known as a ?walk through? (Perkins, 1997, Ch.13).  After this information has been gathered, the occupational hygienist must commence making decisions as to whether she or he believes the controls in place are acceptable to reduce or eliminate the risk of exposure to the hazards within the workplace.  Quite frequently, further measurements and evaluations must be undertaken to collect information on concentrations of contaminants to assess risk (Perkins, 1997, Ch.13). Based on preliminary work done by the health authority occupational hygienist, cited in Chapter 1, there was evidence to support the presence of hazardous drugs on surfaces in three hospital pharmacies on Vancouver Island. In addition, this early work also suggested inconsistent methods for controlling occupational exposures to pharmacy personnel at these worksites.  As such, a need was identified to systematically examine all health authority pharmacies that handled cytotoxic drugs within this health authority to formally assess controls and the presence of cytotoxic drugs on surfaces inside the pharmacies.  2.2 Objectives of Phase 1: Environmental Assessment The objectives for the environmental assessments at facilities handling cytotoxic drugs were as follows: 1.) determine the layout designs for pharmacies; 2.) document   33 protocols for safe work practices and procedures for cytotoxic drugs in the pharmacies; 3.) measure levels of surface contamination for selected cytotoxic products and investigate differences between sites; 4.) examine controls based on worksite results from objectives 1 through 3 (e.g. safe work procedures, practice, layout, and design); 5.) compare WorkSafeBC regulations, USP 797 standards, and BC Cancer Agency Certification program overall; and 6.) determine if the facility was meeting the requirements of the regulations and standards.  2.3 Hypothesis for Phase 1: Environmental Assessment Differences in the presence of surface contamination will exist among the hospital pharmacies that manipulate cytotoxic drugs. 2.4 Methods for Phase 1: Environmental Assessment Assessment of Worksite Design and Controls The environmental assessment portion of this research consisted of two parts; a worksite assessment followed by surface wipes to detect environmental contamination.  Initially, visits were carried out at seven worksites within the health authority on Vancouver Island to gather information about physical layout and design, engineering controls, and administrative controls for six safe work procedures (i.e. preparation, cleaning, spill clean-up, exposure, transport, disposal) (the full protocol is found in Appendix B).  Airflow in the rooms where product was mixed was visualized using smoke tubes to determine if the rooms were under positive or negative pressure compared to adjacent rooms.  Contact was made with individual worksite pharmacy managers to explain the project and a date was set to carry out the site visit.    34 Information gathered in this portion was used to make comparisons between sites and to identify similar surfaces among worksites to carry out the subsequent surface wipe tests.  During this process, information was collected with the intention to compare present practices as a facility to the following regulations or standards: 1. WorkSafeBC Regulations. (WorkSafeBC, 2006) 2. British Columbia Cancer Agency (BCCA) Pharmacy Practice Standards. (BC Cancer Agency, 2012) 3. United States Pharmacopeia (USP) 797. (United States Pharmacopeia, 2008) Assessment of Surface Contamination Of the seven pharmacies that handle cytotoxic drugs in the health authority, five hospital-based pharmacy worksites were included to assay for the presence of cytotoxic drug surface contamination. Two of the pharmacies were not included for further evaluation because the cytotoxic drugs are handled very rarely (i.e. less than once annually).  The rationale for selection of a particular surface to be assayed was based on the following:  information gathered from pilot work carried out at worksites prior to commencing this study, examples of surfaces shown to be contaminated in the literature and input from pharmacy worksite personnel.  Five surfaces that were common to all evaluated worksites were selected to have surfaces sampled and assayed for the presence of methotrexate and cyclophosphamide.  Methotrexate and cyclophosphamide were selected for analysis for three reasons: 1.) both of these products are commonly used for the treatment of cancer and other health conditions, and utilized by all worksites included in this study; 2.) the methods for detection are well   35 established and tested; and 3.) these two products serve as markers for contamination and as such any values obtained from this study could be compared to other studies.  The common surfaces that were sampled included: inside the biological safety cabinet, doorknobs to enter and exit the drug preparation room, counter beside the sink in the chemotherapy area and the chairs utilized with the biological safety cabinet. Additional surfaces that were sampled at select worksites included chemotherapy drug trays, transport boxes, pass-through, and service counters.   A ten centimeter (cm) by ten cm grid was placed on surfaces selected for testing and a small (11.2 x 21.3cm) low-lint wipe (KimWipes?, Kimberly-Clark, Dallas, Texas) pre-moistened with a 0.1mol/L ammonia acetate solution was used to wipe the test surface 20 times (Chu et al., 2011); the wipe was then placed into a pre-labeled 20 mL vial and placed in a cooler with ice packs.  The investigator carrying out the wipe tests donned a fresh pair of nitrile gloves for each wipe test.  Any surface that was not flat (i.e. door knob) was measured in order to calculate the surface area at a later time.   The overall sampling strategy was to sample up to six surfaces that would be common among worksites in areas within the pharmacy department where cytotoxic drugs were handled.  The number of wipe tests carried out at each worksite was limited to 12 per site based on funding allocated to this study. Funding was provided through the British Columbia Environmental & Occupational Health Research Network (BCOEHRN) and a memorandum of understanding between the School of Environmental Health and Vancouver Island Health Authority.  A complete list of surfaces sampled is shown in Appendix B, Table B1.    36 Samples were analyzed by the laboratory at the School of Environmental Health at the University of British Columbia, Vancouver, B.C. (SOEH Laboratory). Samples were transported overnight on ice packs to the SOEH laboratory where they were transferred from the portable cooler and placed in a -200C freezer until analysis took place.   Each of the samples was analyzed simultaneously for the presence of methotrexate and cyclophosphamide using an analytical method that was initially developed by Sabatini et al. (2005) and modified by Chu et al. (2011). High-performance liquid chromatography tandem mass spectrometry was used to determine levels of both methotrexate and cyclophosphamide on a total of 75 wipes. There were 61 surfaces sampled, ten field blanks and four travel blanks. The limit of detection reported by the laboratory for cyclophosphamide was 0.0036 ng/cm2 and 0.00024 ng/cm2 for methotrexate.  The full description of the analysis is presented in Appendix B.   Statistical Analyses of Wipe Test Data All values for cyclophosphamide and methotrexate reported by the SOEH Laboratory were converted into values of nanograms of drug per cm2 for each surface sampled.  Concentrations from wipe tests that were below the limit of detection were substituted to one-half of the limit of detection for each analyte (Hornrung and Reed, 1990).  Descriptive statistics including: arithmetic mean, standard deviation, range, geometric mean and geometric standard deviation for concentrations of methotrexate and cyclophosphamide were calculated for each worksite.  The data did not fit a normal distribution and as such non-parametric statistical tests were applied to the data.  The dataset consisted of 61 values; they were classified as either above or below the limit of detection to increase the power of the Chi-square statistical testing. Variables obtained   37 from initial worksite visits were chosen for hypothesis testing using the categorical values above or below the limit of detection for methotrexate or cyclophosphamide. The information gathered from visual inspection of all of the worksites as part of the study included physical layout and design, engineering controls, administrative controls, work procedures, and surface contamination for the two cytotoxic drugs.   In addition, data collected at the worksites were examined to determine if the requirements of WorkSafeBC and USP 797 were being met. The five variables selected for testing were: worksite, the presence of an ante room attached to a mixing room, contracted versus non-contracted cleaning services, implementation of an in-house pharmacy training program and the presence of a clean air bench inside the mixing room. 2.5 Results of Phase 1: Environmental Assessment Assessment of Worksite Design and Controls The primary reference point for assessment of design and controls was WorkSafeBC regulatory requirements.  All worksites that prepared cytotoxic drugs manipulated the products within biological safety cabinets that had been serviced within the recommended one-year period.  As noted in the methods, airflow in the rooms where product was mixed was visualized using smoke tubes to determine if the rooms where the products are prepared were under positive or negative pressure compared to adjacent rooms.  Of the seven sites, four sites had rooms under negative pressure, one under positive pressure and in two it was not possible to visualize airflow.  Two of the seven sites, one of which rarely handled cytotoxic drugs, had anterooms connected to the rooms for mixing the products.     38 At each worksite, it was determined whether six safety protocols associated with handling the products were present: spill cleanup, transport, disposal, exposure, cleaning, and preparation.   No information for either transport or disposal procedures was present at any worksite. Only one site had information posted on what to do in case of exposure and how to clean the area prior to and after handling product.   Six of the seven worksites had spill kits present that had information on how to clean up a cytotoxic drug spill.  Personal protective equipment utilized for handling cytotoxic drugs varied from site to site depending on the task.  For example, two of the worksite supervisors indicated that disposable N95 respirators were worn during mixing of the products, one site indicated no respiratory protection was utilized and the remaining four sites indicated that surgical masks were worn.  A summary of the information collected from the sites on the types of controls in place to reduce exposure is summarized in Table 2.1.              39 Table 2.1: Assessment of controls in place to reduce exposure to cytotoxic drugs at health authority worksites.  Control Worksites with Controls in Place n=7 (%) Engineering Controls Biological safety cabinet present & serviced annually 7/7 (100) Presence of dedicated anteroom 1/7 (14) Use of isolator or closed system transfer device 0/7 (0) Administrative Controls Pharmacy training program  2/7 (29) Job rotation utilized for mixing of products 4/7 (57) Safe work procedures posted/available Cleaning  Preparation  Spill cleanup  Transport  Exposure  Disposal  3/7 (43) 1/7 (14) 2/7 (29) 0/7 (0) 1/7 (14) 0/7 (0) Personal Protective Equipment  Utilized During Select Tasks  Mixing Biological safety cabinet Decontamination Spill Clean Up Receiving Surgical Mask 4/7 (57) 2/7 (29) 0/7(0) 0/7 (0) Disposable N95 Respirator 2/7 (29) 0/7 (0) 3/7 (43) 0/7 (0) Full/Half Face Respirator 0/7 (0) 2/7 (29) 3/7 (43) 0/7 (0) Latex Gloves 0/7 (0) 4/7 (57) 0/7 (0) 1/7 (14) Double Latex Gloves 6/7 (86) 3/7 (43) 0/7 (0) 1/7 (14) Nitrile Gloves 0/7 (0) 0/7 (0) 0/7 (0) 2/7(29) Rubber/Dishwashing Gloves 0/7 (0) 0/7 (0) 6/7 (86) 0/7 (0) Hair Covers 6/7 (86) 6/7 (86) 7/7 (100) 0/7 (0) Shoe Covers 2/7 (29) 2/7 (29) 3/7 (43) 0/7 (0) Impermeable Gown 7/7(100) 6/7 (86) 7/7(100) 1/7 (14)  Meeting Requirements of WorkSafeBC, USP 797 and BCCA as an Organization During this phase of the project, similarities and differences between WorkSafeBC, BCCA Pharmacy Practice Standards and standards set by the United States Pharmacopeia were identified: 1. WorkSafeBC is primarily concerned with the protection of workers, whereas USP 797 is primarily concerned with the protection of patients (although these guidelines   40 also indirectly serve to protect workers); BCCA Certification aims to address both worker and patient protection.  2. WorkSafeBC regulations are enforceable whereas the standards in USP 797 and recommendations in BCCA Certification are not.   All three documents are similar in that they emphasize the need to: 1. Communicate hazards associated with working with the products to workers, 2. Provide adequate/appropriate education and training,  3. Provide personal protective equipment, and  4. Use biological safety cabinets when manipulating these products.  A summary of these similarities and differences are reported in Table 2.2.                 41 Table 2.2 Summary of similarities and differences between WorkSafeBC (WSBC) Regulations, United States Pharmacopeia (USP) 797 and British Columbia Cancer Agency (BCCA) Certification.  WorkSafeBC (WSBC) Regulations United States Pharmacopeia (USP) 797 British Columbia Cancer Agency (BCCA) Certification Similarities ? Need for use of biological safety cabinet during product preparation ? Information on hazards with handling need to be communicated to workers ? Specifications on training (i.e. types of training workers should have) ? The use of personal protective equipment Differences ? Specifies information on signage required in areas where products handled and labeling on products ? Requires exposure control plan ? Specifies that records are kept on administering, handling and training ? Includes information on personal hygiene ? Outlines information on waste disposal ? Specifies need for supervision  ? Preparation room needs to be under negative pressure ? Surfaces wipes to assay for drug contamination needs to be carried out every six months ? Outlines number of air exchanges required for rooms where product is mixed in order to remove contaminants   ? More prescriptive, document details recommended procedures and techniques for topics such as: o Receipt of products o Steps to take in case of exposure o Clean-up o Disposal   The results for examples of controls that must be present in worksites that handle cytotoxic drugs are noted in the above section.  The results of reviewing whether the organization was meeting requirements under WSBC regulations, BCCA and USP 797 during the environmental assessment are listed in Table 2.3       42 Table 2.3: Meeting requirements of WorkSafeBC, USP 797 and BCCA (n=7). Requirement Is this part of WSBC Regulations?  Is this part of USP 797 Standard? Is this part of the BCCA Program? Is this BC health authority meeting this requirement? Personnel training for handling Yes all agencies require this.  Inconsistent training provided. Specifications for storage No Yes  A single worksite meets this requirement. Room specifications for ventilation Biological safety cabinet only Yes No Biological safety cabinets meet a portion of the requirement. Personal protective equipment Yes all agencies require this & some are more prescriptive/specific on types.  Partially, but inconsistent practice and recommendations Environmental sampling for surface contamination No Yes No No Exposure Control Plan Yes, this is regulatory requirement No  No Signage, lists and labeling for cytotoxic drugs Yes, this is regulatory requirement No Yes Yes Instruction and supervision Yes all agencies recommend this  Variable between worksites. Safe Work Procedures Yes, this is regulatory requirement No  For some tasks Records of mixing and administering Yes, this is regulatory requirement No  Yes, but variability in practice between worksites Information for those with reproductive capability Yes, this is regulatory requirement Yes No No  Assessment of Surface Contamination Results for surface wipe tests and schematics for the worksites are described in the subsequent sections for five of the seven worksites.  Only five of the seven sites were included in this portion.  Following initial assessment of controls at the worksites, it was determined that two worksites (Worksite #6 and #7) handled the products less than or   43 equal to once annually and thus were not included in the wipe test portion of this study.  Overall, 39% of surfaces sampled tested above the limit of detection for cyclophosphamide, 59% of surfaces tested were above the limit of detection for methotrexate and 25% of surfaces tested were above the limit of detection for both products (n=61).   Descriptive statistics are summarized below in Table 2.4 and the full set of wipe test data is shown in Appendix B (Table B1).  The concentrations cannot be compared to occupational exposure limits as they do not exist; however values reported represent markers of contamination.  In further analyses, values are described as being either above (positive result) or below (negative result) the limit of detection. The distribution of the wipe test data is best described as being right skewed.  Details of worksite characteristics along with the results of surface wipe sampling are outlined in the subsequent sections.  Table 2.4 Descriptive statistics for surface wipe tests (n=61) conducted in environmental assessment phase of study. Drug Assayed for at Five Worksites  Arithmetic Mean (ng/cm2) Standard Deviation Range (ng/cm2) Geometric Mean (ng/cm2) Geometric Standard Deviation Percent of Wipe Tests Above Limit of Detection Methotrexate 0.0072 0.035 < 0.00024  to 0.26 0.00072 6.18 54% Cyclophosphamide 1.12 7.47 <0.0036  to 57.95 0.0048 7.59 34%  Worksite #1 Worksite #1 was located in the central island region of Vancouver Island and the primary handling of the cytotoxic drugs took place inside a room housed within the hospital?s cancer clinic.  The set up differed from all other sites within this health   44 authority in three main ways: 1.) it was located on a separate floor from the main pharmacy, 2.) the room had a service window that was open to the hallway, and 3.) personnel not handling the products were working inside the room in close proximity to where the products were being mixed (e.g. pharmacist working at a computer less than five meters from biological safety cabinet where drugs were being mixed).  Wipe tests for the presence of cyclophosphamide were carried out on eleven surfaces at this site and eight of the eleven tested above the limit of detection.  The values for wipes above the limit of detection ranged from 0.0062 ng/cm2 on the cart inside the room where products were mixed to 0.036 ng/cm2 on the receiving cart located in the main pharmacy area.  The results of the wipe tests for the presence of methotrexate at this site indicated that seven of the eleven tested above the limit of detection.  The values for wipes above the limit of detection ranged from 0.00042 ng/cm2 on the doorknob outside of the chemotherapy mixing room to 0.0038 ng/cm2 on the cart inside the room where products are mixed.   At this worksite there were three surfaces found to be positive for both cyclophosphamide and methotrexate: 1.) the receiving cart located inside the main pharmacy on a different floor in the worksite; 2.) the cart inside the cytotoxic drug mixing room; and 3.) the counter beside the sink inside the cytotoxic drug mixing room.  Two schematics for this worksite and wipe test results are presented in Figure 2.1 and Figure 2.2.   45  Figure 2.1: Schematics of the layout and locations of wipe tests for cyclophosphamide at Worksite #1.   46  Figure 2.2: Schematics of the layout and locations of wipe tests for methotrexate at Worksite #1. Worksite #2 Worksite #2 was located in central Vancouver Island and this location opened a new pharmacy area during the study period that included a new room to mix cytotoxic drugs.  At the time of the environmental assessment for this study, the new mixing room was not functional yet, and the assessment was conducted in both the new and old pharmacy area.  The room for mixing cytotoxic drugs at this site was housed inside the former main pharmacy. Wipe tests for the presence of cyclophosphamide were carried out on twelve surfaces at this site, three of which were above the limit of detection. The   47 values ranged from 0.005 ng/cm2 on the counter used to check products to 0.51 ng/cm2 from the surface of a chair inside the room where products are mixed. At this worksite, wipe tests carried out for methotrexate showed that three of the twelve surfaces were above the limit of detection.  Of the surfaces that were above the limit of detection, values ranged from 0.00028 ng/cm2 on the doorknobs both inside and outside of the room, to 0.00045 ng/cm2 on the marking pen inside the room where products are mixed.  A schematic of the layout of Worksite #2 and the surfaces that were sampled may be viewed in Figure 2.3 and Figure 2.4.    Figure 2.3: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #2.   48  Figure 2.4: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #2.  Worksite #3 Worksite #3 was located in the southern part of Vancouver Island and this is one of two hospitals that service the largest city on the island.  The layout of this worksite has been designed in a manner intended to contain cytotoxic products to one area.  The room where the products are being mixed was accessible only through an anteroom and products enter through one pass-through window and exit through another.  Personnel were not permitted inside the mixing room unless all personal had donned personal   49 protective equipment inside the anteroom.  Upon completion of the tasks inside the mixing room, personnel exited back into the anteroom and removed all personal protective equipment.  Wipe tests for the presence of cyclophosphamide were carried out on thirteen surfaces at this site, four of which were above the limit of detection.  The values above the limit of detection ranged from 0.0036 ng/cm2 on a counter beside a sink in a room where the products are stored to 0.049 ng/cm2 inside the transport box where products moved to hospital units.  The results of the wipe tests for the presence of methotrexate at this site indicated that eight of the thirteen surfaces selected for testing were above the limit of detection.  The values for wipes above the limit of detection ranged from 0.0012 ng/cm2 on the doorknob inside of the chemotherapy mixing room to 0.0037 ng/cm2 on the counter adjacent to a sink inside a room where the products are housed.   At this worksite there were three surfaces found to be positive for both cyclophosphamide and methotrexate: 1.) the transport box utilized to move products to units; 2.) the doorknob inside the cytotoxic drug mixing room; and 3.) the counter next to the sink inside the room where the products are stored.  Two schematics for this worksite and wipe test results may be viewed in Figure 2.5 and Figure 2.6.   50  Figure 2. 5: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #3.   51  Figure 2.6: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #3.  Worksite #4 Worksite #4 was located in the southern part of Vancouver Island and is the second of two hospitals that service the largest city on the island.  The mixing of cytotoxic drugs took place in a room inside the main pharmacy area.  The configuration of this worksite was such that personnel must put on personal protective equipment outside of the main mixing room, but this site would not be considered to have a true anteroom.  The door to enter the mixing room was a swinging door that was not present at any other worksite and the room contained two biological safety cabinets, one dedicated to cytotoxic drugs,   52 and one clean air bench. Wipe tests for the presence of cyclophosphamide were carried out on twelve surfaces at this site and six were above the limit of detection.   The values above the limit of detection ranged from 0.015 ng/cm2 on the surface of the door outside of the cytotoxic drug mixing room to 57.95 ng/cm2 on the surface of a permanent marking pen located inside the biological safety cabinet.  The results of the wipe tests for the presence of methotrexate at this site indicated that seven of the twelve surfaces tested were above the limit of detection.  The values for wipes above the limit of detection ranged from 0.00088 ng/cm2 on the doorknob inside the chemotherapy mixing room to 0.019 ng/cm2 inside the transport box utilized to move products to care units.  At this worksite there were four surfaces found to be positive for both cyclophosphamide and methotrexate: 1.) the transport box utilized to move products to units; 2.) the doorknob inside the cytotoxic drug mixing room; 3.) the marking pen; and 4.) the biological safety cabinet.  Two schematics for this worksite may be viewed in Figure 2.7 and Figure 2.8.   53  Figure 2.7: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #4.   54  Figure 2.8: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #4. Worksite #5 Worksite #5 was located in the northern part of Vancouver Island and the location of the cytotoxic drug mixing room for this worksite was inside the main pharmacy area. The primary difference between this site and other sites was that the door to the mixing room remained open to the main pharmacy area.  The room contained one biological safety cabinet and one clean air bench. Wipe tests for the presence of cyclophosphamide were carried out on twelve surfaces at this site and three were above the limit of detection.   The values above the limit of detection ranged from 0.0044 ng/cm2 on the doorknob outside of the cytotoxic drug mixing room to 9.15 ng/cm2 on the surface of a permanent marking pen located inside the biological safety   55 cabinet.  The results of the wipe tests for the presence of methotrexate at this site indicated that nine of the twelve surfaces tested were above the limit of detection.  The values for wipes above the limit of detection ranged from 0.0024 ng/cm2 on the receiving cart in the main pharmacy area to 0.26 ng/cm2 on the marking pen inside the biological safety cabinet.  At this worksite there were three surfaces found to be positive for both cyclophosphamide and methotrexate: 1.) the outside of the transport box utilized to move products to units; 2.) the doorknob outside the cytotoxic drug mixing room; and 3.) the marking pen located inside the biological safety cabinet.  Two schematics for this worksite and wipe test results above and below the limit of detection for cyclophosphamide and methotrexate may be viewed in Figure 2.9 and Figure 2.10.  Figure 2.9: A schematic of the layout and locations of wipe tests for cyclophosphamide at Worksite #5.   56 Figure 2.10: A schematic of the layout and locations of wipe tests for methotrexate at Worksite #5. Statistical Results Comparing Wipe Test Results among Worksites As outlined in the above section of the results, there were different layouts and features for the worksites that mix cytotoxic drugs in this health authority. Results from Chi-square testing to determine if surface contamination (above or below the limit of detection) was dependent on specific worksite variables (Table 2.5) and no statistical differences were found for any variables (?=>0.05).      57 Table 2.5: Statistical results comparing wipe test results above or below the limit of detection Variables Examined Cytotoxic Drug Assayed For ??Value obtained from Chi-square testing Percent of Wipe Tests Above the Limit of Detection  Worksite Location Methotrexate ?? 0.068 See Table 2.7 Cyclophosphamide ?? 0.147 See Table 2.6 In-house housekeeping services and contracted housekeeping services cleaning the pharmacy areas. Methotrexate ??0.209? In-house Housekeeping (n= 12) Contracted Housekeeping (n= 49) 75% 55% Cyclophosphamide ??0.256 In-house Housekeeping (n=12) Contracted Housekeeping (n= 49) 25% 43% Presence of an anteroom attached to preparation room.  Methotrexate ???0.234? Anteroom (n=13) No Anteroom (n= 48) 77% 54% Cyclophosphamide ?? 0.930 Anteroom  (n= 13) No Anteroom (n= 48) 31% 42% Presence of a clean air bench inside preparation room. Methotrexate ???0.234? Clean Air Bench (n= 36) No Clean Air Bench (n= 25) 53% 68% Cyclophosphamide ?? 0.249 Clean Air Bench (n= 36) No Clean Air Bench (n= 25) 33% 48% In-house pharmacy based certification training program Methotrexate ??0.234? In-house  Program (n= 25) No In-house  Program (n= 36) 68% 53% Cyclophosphamide ??0.930 In-house  Program (n= 25) No In-house  Program (n=36) 40% 39%  The percent of wipe tests above the limit of detection, average amount detected on surfaces and amount of product purchased per worksite in 2010 for cyclophosphamide and methotrexate is shown in Table 2.6 and Table 2.7 respectively.  No relationship   58 could be determined between the levels of contamination, amounts of product purchased or samples above the limit of detection.  Table 2.6: Information gathered on cyclophosphamide purchased and surface wipes. Worksite Amount of cyclophosphamide purchased annually (2010) (mg) Arithmetic mean amount of cyclophosphamide detected from all wipes (ng/cm2)  Number of wipe tests at worksite Percent of wipe tests above the limit of detection  #1 631000           0.0078  12 67% #2 111000 0.047 12 25% #3 204800 0.0064 13 31% #4 11000 4.84 12 50% #5 152000 0.77 12 25%  Table 2.7: Information gathered on methotrexate purchased and surface wipes. Worksite Amount of methotrexate purchased annually (2010)  (mg) Arithmetic mean amount of methotrexate detected from all wipes (ng/cm2)  Number of wipe tests at worksite Percent of wipe tests above the limit of detection  #1 4500          0.00095   12 58% #2 1500 < 0.00024 12 25% #3 259270 0.0017 13 77% #4 8230 0.0035 12 58% #5 7750 0.030 12 75%      59 2.6 Discussion of Phase 1: Environmental Assessment For this phase of the study, the two goals were to examine differences in pharmacy design and safe work practices among the organization?s pharmacies.  The information gathered in this phase demonstrated that a number of differences exist in design and the controls to prevent exposure to cytotoxic drugs.  Another goal of the environmental assessment was to determine if levels of surface contamination for methotrexate and cyclophosphamide differed among the health authority?s pharmacies.  Overall, no statistically significant differences were found on surfaces selected for testing among worksites or by worksite design or safe work practice characteristics.  Comparing worksite design, regulations and standards WorkSafeBC (WSBC) regulations, USP 797 and BC Cancer Agency (BCCA) standards were considered when conducting the worksite assessments.  All three agencies specify that personnel must be trained to work safely with cytotoxic products.  Overall, based on the worksite assessments, there was inconsistent practice across the organization for provision of training.  For the most part, only one worksite appeared to have in place an initial standardized process for training.   Each worksite had different layouts and physical design for the handling of cytotoxic drugs as illustrated in the results section for this phase of the study.  The differences in worksite design could be attributed to the age of the facility.  For example, the worksite that was the newest facility that handled cytotoxic drugs, had features such as a pass through window and dedicated anteroom as recommended in USP 797.  Specifications for room ventilation are also defined in USP 797, indicating that the room where the products are prepared must be under negative pressure relative to the anteroom.    60 During the initial worksite visits, a smoke tube was used to visualize airflow, as no information was available on the relative pressure of each room.  Just over half of the worksites appeared to have mixing rooms under negative pressure, one site had a room with positive pressure relative to the rest of the pharmacy and in two sites it was not possible to visualize the airflow. BCCA and USP 797 also indicate that all cytotoxic products should be stored in dedicated spaces.  Moreover, USP 797 recommends that the storage area should be under negative pressure as many hazardous drugs can volatilize at room temperature.   It was observed at worksite visits that only one worksite had products stored in a dedicated area, and the remainder of worksites had various storage practices.  When speaking to personnel at other worksites, the rationale for mixed storage practices was attributed to limited availability of storage space.   USP 797 contains a provision for environmental sampling every six months to document cytotoxic drug containment.  This practice was not carried out within the health authority as this type of testing is cost prohibitive.   Both WSBC and BCCA recommend that signage and labeling be present to indicate cytotoxic drugs, along with a list of cytotoxic drugs.  The source of information that these two organizations use is from the American authority, the National Institute for Occupational Safety and Health (NIOSH). The document published by NIOSH (2010) specifies a list of hazardous and other antineoplastic drugs. This NIOSH list does not match information contained in WSBC regulations.  For example, isotretinoin is considered to be a cytotoxic drug by WSBC, but is not included in the most recent list   61 published by NIOSH.  A variation in information provided by NIOSH that conflicts with regulatory requirements could put this health authority and other BC Health Authorities in a difficult situation.  If the health authority chooses to follow the guidance provided by NIOSH, WSBC could determine the organization is not following regulatory requirements and issue an order instructing the employer to comply with regulation.  The information provided by WSBC was last updated in 2004, and as such may require updating or reviewing based on the most recent direction from NIOSH.   Overall, this health authority meets some of the standards and regulatory requirements outlined by BCCA, USP 797 and WSBC.  However, due to fiscal limitations, physical worksite design constraints, and conflicting direction from the above agencies in some cases it may not be possible to meet the expectations of all three agencies.   Assessment and proposal of controls  The controls to reduce exposure to cytotoxic drugs in the pharmacy settings examined in this project were: engineering, administrative and personal protective equipment.  WorkSafeBC regulations that pertain to the safe handling of cytotoxic drugs specify that an exposure control plan (ECP) must be in place to reduce the risk exposure to these products.  Furthermore, within the ECP, the controls noted above must be specified. Overall, the initial assessment of controls revealed there are various practices and types of equipment being utilized to reduce exposure to cytotoxic drugs within this health authority.   The main engineering control listed as a requirement for working with cytotoxic drugs is the biological safety cabinet (BSC), and more specifically one that is a Class II, Type B   62 model.   All worksites within this health authority had biological safety cabinets that met this requirement and were inspected annually to ensure proper functioning.  Interestingly, the BC Cancer Agency recommends that the BSC should be certified twice per year, which is not consistent with the once per year requirement specified by WorkSafeBC.   Only one site within the organization had a dedicated anteroom attached to the preparation room.  The presence of such a control is intended to limit contamination from entering and leaving the area where product is prepared.    Requirement for an anteroom is not specified in WorkSafeBC regulations.  However, in USP 797 the section on room specifications outlines that rooms where handling takes place should be separated from other rooms and under slightly negative pressure to prevent hazardous drugs from leaving the area.  An additional advantage of having an anteroom is to enable pharmacy personnel to don and doff personal protective equipment in a dedicated area.  The donning and doffing of the personal protective equipment in a dedicated area should limit the migration of contaminants into the room from the outside and taking contaminants out of the room into other common areas.   Moreover, at two worksites, the room where the products were being mixed was not fully enclosed.  At one worksite, a service window was open to the hallway inside the cancer clinic and at the other worksite the door to the room where the products are mixed was permanently propped open to the main pharmacy area. In most healthcare settings, biological safety cabinets are the engineering control recommended for use when manipulating cytotoxic drugs. However, recent work by Sessink et al. (2010) has demonstrated that along with the biological safety cabinet, the   63 use of a closed system transfer device (CSTD) was an effective means of reducing surface contamination.  The study results indicated that surface level values for cyclophosphamide, ifosfamide and 5-fluorouracil were reduced significantly when a CSTD was used in comparison to standard drug preparation techniques.  The utilization of a CSTD in combination with a BSC should be considered for future studies as a proposed strategy to reduce environmental contamination.  The presence of administrative controls was examined in this project, more specifically, the presence of safe work procedures and job rotation.  Safe work procedures have been developed for some tasks associated with the handling of cytotoxic drugs but these procedures had only been implemented in some worksites.  Based on the results in this assessment, there is a need to implement consistent safe work procedures across all worksites within this organization that manipulate cytotoxic drugs.   Job rotation is an occupational hygiene administrative control strategy aimed to limit exposure time to a particular agent and is an example of a method that could be used to reduce occupational exposure to cytotoxic drugs.  This is a strategy that was utilized at three of the seven worksites that had larger numbers of staff in the pharmacy compared to smaller community hospitals.  Using job rotation as a means to reduce occupational exposure may be challenging in smaller communities because there are fewer staff members available within the department to mix cytotoxic drugs.  Another example of an administrative control is the presence of a pharmacy-based training program on working with cytotoxic drugs; this program was not fully implemented in the organization and was reported in only two of the worksites.   64 Personal protective equipment (PPE) was examined during the environmental assessments.  Based on site visits, it was determined that there was variation in the types of personal protective equipment being utilized across the organization during different tasks.  For example, worksites located in one region utilized disposable N95 respirators when mixing cytotoxic drugs; however, the other worksites used surgical masks during mixing.  Another example of a variation in the use of PPE was that one half of the worksites used disposable N95 respirators for spill clean-up and the other half of sites used re-useable elastomeric respirators outfitted with organic vapour cartridges with a P100 filter which offer a greater level of protection compared to disposable respirators.  Overall, there were varying practices observed in the use and types of personal protective equipment when working with cytotoxic drugs.   The types of personal protective equipment to be utilized when working with cytotoxic drugs should be standardized across the organization using equipment that meets or exceeds regulations and standards by WorkSafeBC, USP797 and the BC Cancer Agency.  Some examples of regulations put forward for personal protective equipment from WorkSafeBC include: ?medical gloves that are manufactured and designed for use when handling cytotoxic drugs, a moisture resistant, long-sleeved gown with cuffs, if there is a risk of contact with aerosols, an approved respirator, and if there is a risk of eye contact, eye and face protection? (WorkSafeBC, 2006).  Utilizing personal protective equipment as it is intended to include proper donning and doffing procedures should be an effective means to reduce both personal exposures and environmental contamination.     65 Comparison of wipe test results for the presence of cytotoxic drugs on surfaces  Surface wipes to assay for the presence of methotrexate and cyclophosphamide were carried out at five hospital pharmacies during the environmental assessment.  Overall, 39% of surfaces sampled tested above the limit of detection for cyclophosphamide, 59% of surfaces tested were above the limit of detection for methotrexate and 25% of surfaces tested had both products detected. In general, when considering cyclophosphamide and methotrexate as overall markers for environmental contamination of cytotoxic products it has been demonstrated that these products along with likely many others are present on many surfaces that workers could come in contact with.  It is possible to compare the actual values gathered in this study with recent publications by others who measured surface contamination in the health care industry.   One surface that is commonly sampled in the health care setting to assay for the presence of cytotoxic drugs is the biological safety cabinet.  The results from this study indicated that the level of cyclophosphamide inside the biological safety cabinet ranged from below the limit of detection (0.0036 ng/cm2) up to 0.040 ng/cm2.  Values reported in three other studies (Sugiura et al., 2010, Sessink et al., 2010 and Yoshida et al., 2010) report surface contamination ranging from 0.01ng/cm2 to 17.19 ng/cm2 and thus some values from this study fall within the range reported in other studies.  Sugiura et al. (2010) also looked at a work surface near the biological safety cabinet and reported the level of cyclophosphamide was 0.040 ng/cm2, higher than the levels found in the present study which ranged from below the limit of detection up to 0.0080 ng/cm2.  The study by Yoshida et al. (2010) also looked at the presence of cyclophosphamide on   66 drug trays and reported values ranging from below the limit of detection up to 0.12 ng/cm2, which is slightly higher than the values found in this study up to 0.049 ng/cm2.    The results from this study can also be compared to a study that took place in British Columbia health care settings that examined cyclophosphamide and methotrexate on surfaces (Chu et al., 2011).  Two surfaces that were measured for comparison between the previous work and the current work were the biological safety cabinet surface and drug transfer tray.  In the Chu et al. study, the levels of cyclophosphamide and methotrexate detected on the drug transfer tray were 1.25 ng/cm2 and 0.03 ng/cm2 respectively.  In the present study, the level of methotrexate was below the limit of detection for all drug transfer trays sampled, and the level of cyclophosphamide was detectable at only one worksite at 0.024 ng/cm2.  In the Chu et al. study, the highest levels of cyclophosphamide and methotrexate detected inside the biological safety cabinet were 8.53 ng/cm2 and 0.04 ng/cm2 respectively.  The highest values detected in this thesis work were 0.040 ng/cm2 for cyclophosphamide and 0.0035 ng/cm2 for methotrexate, both inside the biological safety cabinet. Thus values collected from worksites in this health authority were lower compared to the other study carried out in other British Columbia hospital pharmacies.  USP 797 has recommended that operations that prepare large volumes of cytotoxic drugs should be carrying out surface wipe testing routinely (e.g. every 6 months) to ensure that hazardous drugs are being contained.  Additionally, within the USP 797 standard, any surfaces with detectable levels of drugs warrant an action plan to identify, document and contain the source of contamination.  The document also indicates that levels of surface contamination of 1 ng/cm2 are associated with human uptake.  When   67 the values from this study were examined, the marking pens at two worksites had values up to 58 times higher than the value indicated for human uptake and as such action should be taken to determine how the marking pens are becoming contaminated.  Furthermore, if the marking pens are contaminated, there is a strong possibility that workers who handle the pens could have contaminated gloves or hands that could lead to contaminating other items or surfaces within the work environment.  A study that took place in 2012 in Sweden in a hospital pharmacy setting suggested that one strategy to aid heath care workers to have a better understanding of surface contamination would be routine wipe tests.  The authors indicated that wipe test data on the worksite would enable workers to make changes in practice that would reduce the chances of dermal uptake of cytotoxic drugs through implementing changes.  One example the Swedish investigators used to illustrate this was the implementation or expansion of a cleaning protocol to include surfaces that were not previously part of the cleaning routine (Hedmar & Wohlfart, 2012). It should be noted that laboratory analysis are costly ranging from $100 per wipe when carried out by an academic institutional laboratory to greater than $1000 per wipe when analyzed by a commercial laboratory.  However, despite the cost of this analysis, it could help to inform pharmacy personnel of tasks or locations within the work environment where dermal exposure could occur.  Information was collected from worksites on the amount of product purchased annually and was considered when looking at overall worksite results.  The worksite that purchased the greatest amount of cyclophosphamide annually, had the greatest percentage of surfaces above the limit of detection, but had one of the lowest average values for amount of product detected on the surfaces.  Conversely, the worksite that   68 purchased the least amount of cyclophosphamide, had the second highest number of surfaces detected above the limit of detection and the highest average value for the product on the surface.  The worksite that purchased the greatest amount of methotrexate annually had the greatest percentage of wipe tests above the limit of detection.  The worksite that purchased the least amount of methotrexate, had the lowest percentage of wipe tests above the limit of detection.  No clear relationship could be observed between the amount of drug (methotrexate and cyclophosphamide) purchased annually and the levels of surface contamination or the percent of contaminated surfaces above the level of detection.  Based on the results of this study, the volumes of cytotoxic drugs handled at the worksites were not a factor that impacted the percent of work surfaces being above or below the limit of detection.  Chi-square testing was carried out to compare the wipe test results above or below the limit of detection and the variables for testing included individual worksite, an ante room attached to a mixing room, the presence of a clean air bench inside the mixing room, contracted versus non-contracted cleaning and whether an organization-based pharmacy training program for handling cytotoxic drugs was in place at worksites.  As each worksite had a different layout and design, one hypothesis tested was that differences in the number of surfaces above or below the limit of detection would exist across individual worksites.  The presence of an anteroom attached to the mixing room was another factor examined.  The intent of having an anteroom connected to a mixing room is to limit contamination from entering or leaving the area where the products are   69 being manipulated.  Another physical characteristic tested was the presence of a clean air bench being in the same room as products are being mixed.  When in operation, a clean air bench may interfere with the functionality of a biological safety cabinet, which is intended to protect the product and worker.  Overall, surface contamination above the limit of detection was independent of the worksite location and the specific physical features mentioned above.  Therefore, despite variable physical features between worksites, significant statistical differences were not found for surface contamination.  In initial worksite visits, there was discussion with worksite supervisors about the presence of an in-house-based training program for the handling of cytotoxic drugs. The intent of such a program was to ensure both worker and patient safety and as such, an administrative control to reduce occupational exposure. This program was not fully implemented among worksites, and as such was considered a variable that should be examined.  Chi-square testing demonstrated that surface contamination above the limit of detection was also independent of this administrative control.   As such, this type of training could not be attributed to differences in presence of surface contamination.   During worksite assessments, it was learned that some pharmacies have contracted cleaning personnel, whereas others have in-house trained housekeepers.  Many site personnel expressed concern regarding the effectiveness of housekeeping practices when a worksite had contracted housekeeping services.  Chi-square testing was carried out on the data to determine if there was a difference in contamination based on this variable.   The outcome was that surface contamination above the limit of detection was independent of housekeeping provider.   70 Overall, statistical testing showed that surface contamination above the limit of detection was independent of all factors selected for testing. One possible explanation for this result was that the sample size was not large enough to show that physical design, layout or other factors selected impacted surface contamination being above the limit of detection.   An alternative explanation was that despite the presence of variable physical designs and controls being in place, individual practices influenced by worksite culture may impact surface contamination being above or below the limit of detection.  A study by de Vries and Lechner (2000) examined the motives for protective behavior among Dutch workers that work with carcinogenic substances.  The conclusions from that study were that those who were non-compliant with protective behavior thought there were fewer benefits, experienced less social support and encountered more barriers to complying with safety recommendations.  The investigators suggested that a strategy to address non-compliant workers would be to ensure the above items specified are addressed in health education programs at the worksites. In order to promote workers? health, it is essential that workers undertake protective behaviors towards chemical hazards, but this in turn requires appropriate information and training (Hambach et al. 2010) and this is a legal requirement in Canada.  Therefore, in the design of future education and training programs within the pharmacy, it could be valuable to promote the benefits of protective behaviors (e.g. reduction of personal exposure and worksite contamination), investigate barriers to protective behavior and investigate strategies for building a stronger safety climate within the pharmacy.  This study is an example of how health behavioral models can be examined and applied when a population is working with   71 carcinogenic substances.  How health behavioral models can be used within the parameters of research focusing on assessing and proposing controls to reduce occupational exposure to cytotoxic drugs will be discussed in the following section.  Applicability of Health Behavior Models to Environmental Assessment A systematic occupational hygiene approach was utilized in this phase of the study to evaluate a workplace carcinogen and assess the state of occupational hygiene controls in place to reduce exposure.  From an occupational hygiene perspective, it can be established that a workplace hazard exists and evidence of surface contamination suggests that workers are at risk for dermal exposure.   In the discussion of the surface contamination results, it was possible to situate the results in the context of other occupational hygiene studies that have examined this hazard.  However, there was no evidence to suggest that any specific occupational hygiene control was effective in preventing the workplace environment from becoming contaminated.  This led the investigator to theorize about other explanations that contribute to workplace contamination and to protective behaviors.  In a publication by Moore et al. (2005), the investigators referred to work by DeJoy (1986) that described three general areas that influence the overall effectiveness of a health initiative as it related to self-protective behavior.  The three general areas thought to contribute included environmental, individual and organizational factors.  A subsequent publication by DeJoy (1996) discussed theoretical models of health behavior and the relationship to workplace self-protective behavior that have been grouped into three main categories: 1.) value-expectancy models, 2.) environmental   72 (contextual) models, and 3.) behavioral change process models (DeJoy, 1996).  Furthermore, other types of models including those that are linked to safety climate or culture as well as risk communication help explain the study results in terms of the observed risks and protective actions (DeJoy, 1996).   Within the context of results of the environmental assessment phase of this study it is the environmental or contextual models of health belief that should be considered.  The applicability of value-expectancy models and behavioral change process models will be discussed further as they apply to results of other phases in this study.   In environmental models, there is a theory that both individual and environmental factors in combination will influence the behavior within a workplace (DeJoy & Southern, 1993).  More specifically, within these types of models the environmental element of the PRECEDE/PROCEED model described by Green and Kreuter (1991) can be applied to the environmental phase results.  ?PRECEDE is an acronym for ?predisposing, reinforcing and enabling causes in educational diagnosis and evaluation?? and the framework of the model has been modified to apply to workplace self-protective behavior (DeJoy, 1996).  The predisposing factors take into account the beliefs, values and attitudes of an individual that influence self-protective behavior.  The reinforcing factors involve the anticipation of positive or negative feedback following an individual?s behavior.  The enabling factors are those aspects within the environment that are objective (e.g. training programs, personal protective equipment) and can hinder or promote an individual?s self-protective behavior (DeJoy, 1996). Within the PRECEDE/PROCEED model both behavioral and environmental diagnosis are recommended to take place to commence planning for intervention.  This phase of the   73 study revealed there were various designs of facilities, variable personal protective equipment available and different or absent safe work procedures and training practices in place.  All of these enabling factors identified through the environmental diagnosis could be considered job-related barriers and as such any actions taken to encourage employees to work safely with cytotoxic drugs could fail (DeJoy, 1996) because the work environment does not lend itself to supporting their actions.  If one were to consider the environmental assessment of this research as a portion of the diagnosis factor within this model, it is then possible to begin the identification of targets that require change (DeJoy, 1996) within a safety program.  Some examples of potential environmental targets could include the development of standard safe work procedures, engineering controls, use and availability of personal protective equipment and consistent training.  Additionally, in the context of the PRECEDE model it was possible to take into account not only an environmental diagnosis, but also an administrative diagnosis.  The intent of examining the results from this perspective is to look at factors such as regulations and policies that can impact the way in which a program functions or is implemented (Green and Ottoson, 2008).  In the case of this research, assessing how the organization was able to meet WSBC regulations and standards from USP 797 served as a type of administrative diagnosis.  The inability of the organization to meet regulations and standards can impact the way in which a program intended to reduce occupational exposure functions. Furthermore, the administrative diagnosis, like the environmental diagnosis can aid also in the process to identify targets of change within the program.     74 For example, one potential target could be to aim to meet all regulations pertaining to working with cytotoxic drugs at all worksites or all recommended standards.    2.7 Summary of Phase 1: Environmental Assessment Overall, the seven worksites included in this study had various layouts and designs in the pharmacy areas where cytotoxic and hazardous drugs were prepared.  Through the process of completing the environmental assessment it was shown that there were variable practices within the organization. When examining the controls that were in place at the time of the assessment, some improvements could be made to include standardized safe work procedures, training, and personal protective equipment.  When considering the organization as a whole, regulatory requirements set by WorkSafeBC, standards from the British Columbia Cancer Agency and from United States Pharmacopeia Standard 797 were not being met in their entirety.  This environmental assessment demonstrated that cytotoxic drug surface contamination was present at all worksites examined, despite the various types of occupational hygiene controls being in place along with various designs of hospital pharmacies.  Values for surface contamination for cyclophosphamide and methotrexate appeared to be lower than information reported in other publications. Chi-square testing demonstrated surface contamination above the limit of detection was independent of all factors selected for testing (i.e. worksite, presence of anteroom, clean air bench, pharmacy training program).  However, surface contamination still persisted on multiple surfaces where pharmacy personnel work.  This contamination is not visible and therefore the possibility of occupational exposure through dermal absorption exists.    75 Surface contamination is a valuable marker to demonstrate that cytotoxic drugs are not fully contained despite workplace controls.  One possible engineering control that could be implemented would be closed system transfer devices.  A future direction to consider may be routine surface wipes for monitoring, as it could aid in the identification of areas that require frequent cleaning or the identification of changes to processes. For example, if transport boxes were contaminated, a process to clean them more frequently or change liners inside them could be adopted.  The information obtained from this phase of research, demonstrated workplace practices and designs for prevention of occupational exposure to cytotoxic drugs were not consistent.  The inconsistent workplace practices contributed to a workplace culture that may not minimize the risk of exposure to as low as reasonably achievable.  At the conclusion of this phase of the research, it was possible commence theorizing how the results could be explained within the context of health behavior models.  The use of such models could aid those planning interventions to reduce occupational exposure to cytotoxic drugs to identify potential targets for future programs.           76 Chapter 3 Phase 2: Employee Questionnaire  3.1 Introduction to Phase 2: Employee Questionnaire Employee questionnaires are a valuable tool that health and safety professionals can utilize to gather information about a present state of a safety program   There are a number of benefits to using such a tool including: providing baseline information that can be used for future comparisons, and getting front-line employees involved in safety processes in a relatively straight-forward and inexpensive manner (National Safety Council, 2013). Information was gathered from the environmental assessment on occupational hygiene controls and the presence of cytotoxic drug contamination on pharmacy surfaces.  Using an employee questionnaire was the next step in this study to gain insight into the practices of a group of workers handling cytotoxic drugs in pharmacies within the health authority.  Prior to this phase of the study, information on topics such as education and use of personal protective equipment could only be gathered from the perspective of the investigator from worksite visits and interactions with a few pharmacy personnel.   This group of workers handles cytotoxic drugs in the most concentrated form and obtaining more detailed information from them should provide additional insight into current practices. 3.2 Objectives of Phase 2: Employee Questionnaire The objectives of the employee questionnaire were as follows: 1.) to gain information on the population of pharmacy personnel (e.g. age, gender), 2.) to assess the use of personal protective equipment when working with cytotoxic drugs, 3.) to gather information on present level of training/education, and 4.) to gain insight into the   77 perceptions of those working with cytotoxic drugs (e.g. ?Cytotoxic drugs can be absorbed through skin?). 3.3 Hypotheses for Phase 2: Employee Questionnaire Responses to questions on the use of personal protective equipment and perceptions of working with cytotoxic drugs would differ depending on: 1.) Worksite (e.g. training and protocols differed among worksites, therefore participants may respond differently to questions) 2.) Years of experience in present occupation (e.g. older workers may have more experience or younger workers may have more current knowledge) 3.) Level of education (e.g. those with technical training may have more experience with hands-on safety training) 3.4 Methods for Phase 2:  Employee Questionnaire An employee questionnaire was administered to five of the seven worksites that manipulated cytotoxic drugs.  The types of questions posed to participants were categorized into four main groups: 1.) general Information, 2.) training and education, 3.) what I think and know about working with cytotoxic drugs and 4.) personal protective equipment.  A copy of the participant questionnaire is located in Appendix C. Initially an e-mail correspondence was sent to managers and supervisors of the pharmacies to detail the importance of the study, information on ethics approval, and time commitment required for the completion of employee questionnaire. The e-mail indicated that the investigator would be in touch shortly to determine a time frame to come to the worksite and present information to staff on the study.  The two managers that oversee all of the   78 pharmacies within the health authority invited the investigator to speak at a monthly meeting of supervisors as an opportunity for them to pose questions about this phase of the study.  Following this, worksite visits were arranged with each supervisor.  Once at the worksite the investigator provided prospective participants the following information at a staff meeting:  1.) a brief summary of the research project, 2.) the significance of the study, 3.) anticipated outcome of the project, 4.) how the results would be made available to participants, and 5.) the steps taken to ensure confidentiality of responses to questionnaires. Those personnel who were interested in participating in this study completed a questionnaire and were provided with a cover sheet that detailed information about the project. Completed participant questionnaires were anonymous and were sent to the study coordinator in individual, pre-addressed envelopes.  Participants retained the cover sheet.  It was not possible for subjects to withdraw their surveys from this portion of the study because the questionnaire was anonymous.  Both the University of British Columbia and Vancouver Island Health Authority ethics boards approved this protocol.  To be eligible for the study, each participant had to be greater than 19 years of age and employed by the health authority within an acute care hospital setting.  Additionally, those eligible to participate in this study had to work in a hospital pharmacy that handled or manipulated cytotoxic drugs. The participant questionnaire was disseminated to five worksites within the health authority that manipulate cytotoxic drugs.   Descriptive statistics (Chi-square or Fisher?s Exact Tests) were utilized to report questionnaire results.  Furthermore, data was stratified by: worksite, years of experience in present occupation, and level of education.    79 3.5 Results of Phase 2: Employee Questionnaire A total of 62 participants completed the employee questionnaire across the five worksites, for a response rate of 48%.  Of those who responded to this questionnaire, 98% indicated that he or she worked in an area where cytotoxic drugs were present and 94% of participants worked in an area where the drugs were manipulated.   A summary of results, stratified by worksite, education and years of experience is shown in Table 3.4. General Information about Participants  Of those who participated in the questionnaire, 89% indicated that she or he worked directly with cytotoxic drugs in the course of his or her work duties and 66% were pharmacy technicians and 34% were pharmacists.  The majority of study participants indicated that they were female (81%), and were either in the 40 to 49 (34%) or 50-59 (31%) years of age category.   The participants were experienced with more than an average of 15 years in their present occupation and an average of 30 hours per month handling cytotoxic drugs (Table 3.1).  Information was also collected on the types of tasks participants were involved in with cytotoxic drugs at the worksite (Figure 3.1), illustrating that most common task among participants was mixing followed by transporting and disposal of cytotoxic drugs.       80 Table 3.1 Descriptive statistics for general information about participants (n=62). General Information About Participants  Arithmetic Mean  Standard Deviation Range  Number of years that participants indicated he or she had worked in his or her present occupation 15.8 years 11.4 years 3 months to 40 years Number of Hours Spent Handling Cytotoxic Drugs Monthly 30.1 hours 39.4 hours 30 minutes to *150 hours * This value reported likely represented a pharmacy technicians working full-time rotations handling cytotoxic drugs.  Figure 3.1: Tasks that participants reported on the employee questionnaire associated with working with cytotoxic drugs (n=62). Training and Education There were seven questions on the employee questionnaire that focused on training and education pertaining to safe handling cytotoxic drugs.  A total of 71% of participants indicated that she or he had received some form of training on this topic, although this training was not always considered adequate or resulted in awareness of the safety standards and regulations for working with cytotoxic drugs (Table 3.2).  A question was also posed to participants about the types of topics covered in training she or he had 25 25 27 32 42 58 0 10 20 30 40 50 60 70 80 90 100 Receiving  Spills Checking Disposal Transport Mixing Percent of Participants (%) Receiving  Spills Checking Disposal Transport Mixing   81 received in the past and the results are displayed in Figure 3.2.  The results showed more than 87% of participants who had received training in the past indicated topics such as spill response, use of personal protective equipment and handling techniques were included in training.  Table 3.2 Summary of information collected from participants on training (n=62). Question Posed to Participant Summary of Information Collected What is your highest level of education or training? ? Certificate or Diploma (61%) ? Bachelor?s Degree (34%) ? Graduate Degree (5%) How often do you receive training related to the workplace health and safety of cytotoxic drugs? ? Every 6 months (2%) ? Annually (14%) ? Every few years (19%) ? When I commenced working (37%) ? I have never received training (29%) The training provided on cytotoxic drugs that I have received to date is adequate to protect myself. ? Strongly agree (13%) ? Agree (42%) ? Disagree (13%) ? Strongly disagree (12%) ? Don?t know (20%) If you indicated that you received workplace health and safety training, where did you receive it?  Note: In some cases employees selected both of the responses listed ? During post-secondary education for present occupation (43%) ? On the job, present employer (76%) Which of following factors would influence your decision to attend training? (More than one can be selected) ? If training were offered in my geographic region (54%) ? Personal interest in topic being presented (48%) ? If training was offered during work hours (70%) ? My interest in my own health and safety when working with cytotoxic drugs (78%) Which of the following documents are you familiar with regarding the safe use or practice associated with the use of cytotoxic drugs? ? In-house pharmacy program (61%)  ? USP 797 (41%),  ? BC Cancer documents (41%),  ? WSBC regulations on this topic (36%), ? NIOSH (20%)  ? None of those listed (17%).      82  Figure 3.2: Topics that pharmacy personnel indicated were covered in past training sessions on cytotoxic drugs. (n=62).  The results displayed showed are divided into those who indicated they had training and the total participants in the questionnaire.   What I know and think about working with cytotoxic drugs The employee questionnaire had ten questions that focused on what employees think and know about working with cytotoxic drugs. A total of 92% of participants indicated it was true that cytotoxic drugs could enter the skin through drug-contaminated surfaces and 88% indicated one possible health effect from occupational exposure is cancer. Greater than 90% of participants indicated a response of ?yes? to questions on whether they knew safe work procedures for the disposal of products, procedures for the safe handling of cytotoxic drugs and procedures for spill clean-up. Two-thirds of participants 56 66 68 68 73 87 89 89 0 10 20 30 40 50 60 70 80 90 100 Known health effects Proper Use of PPE Relevant Handling Techniques Spill clean up Percent of Participants (%) % of total participants % of  those with training   83 (66%) believed that the risk to personal health and the health of others from exposure to cytotoxic drugs was either low or very low.  Additionally, the majority (73%) of participants indicated that the risk of personal exposure to these products was either low or very low; although this differed statistically by educational level (??0.008).   There was a difference (? =0.003, Fisher?s Exact test? in responses among worksites for the question: ?The training provided on cytotoxic drugs that I have received to date is adequate to protect myself.?   Additionally, when data was stratified by level of education, a difference (?=0.029) was found for the response to the question: ?I know the procedures to following to reduce exposure to cytotoxic drug exposure during spills and leaks?.  Participants were asked the degree of agreement on statements regarding three different safety specific topics, and these results are summarized in Table 3.3. ?Table 3.3 Summary of participants responses on degree of agreement with statements from ?What I know and think about working with Cytotoxic Drugs? (n=62). Question Posed Strongly Agree Agree Disagree Strongly Disagree Don?t  Know I believe the present safety measures in place reduce contamination of the work area. 15% 58% 15% 5% 17% Workers around me are aware of the precautions associated with working with cytotoxic drugs. 17% 62% 13% 0% 8% I know the procedures to following to reduce exposure to cytotoxic drugs during spills and leaks 17% 55% 15% 3% 10%    84 Table 3.4 Summary of statistical testing for employee questionnaire for select questions stratified by worksite, experience and education (n=62).  ` * Fisher?s Exact Test ** Chi-Square Test Note: Values of statistical significance are in bold  Personal Protective Equipment The employee questionnaire included ten questions pertaining to the use of personal protective equipment.  The first three questions asked participants about the use and availability of personal protective equipment.  For the general question regarding whether or not personal protective equipment should be worn when handling cytotoxic drugs, 90% of participants indicated a response of ?yes?.  The responses from participants to the question of whether he or she felt able to use personal protective Question from Employee Survey  Value obtained from statistical testing   By Worksite  By Years of Experience  By Level of Education The training provided on cytotoxic drugs that I have received to date is adequate to protect myself. ??? ????????????????? ?????????I would assess my risk of exposure to cytotoxic drugs in my current position as? ??=0.59? ????????? ??????????I believe the level of risk to my health and the health of others associated with working with or near cytotoxic is? ??? ????? ????????? ?????????I believe the present safety measure in place reduce contamination of the work areas ??? ????? ????????? ???0.050??Workers around me are aware of the precautions associated with working with cytotoxic drugs. ??? ????? ????????? ??=0.98 I know the procedures to follow to reduce exposure to cytotoxic drug exposure during spills and leaks. ??? ????? ???????? ?????????I feel that the personal protective equipment required to protect me from cytotoxic drugs is readily available for my use. ??? ?????????????? ????????  85 equipment to reduce exposure to cytotoxic drugs indicated 86% of participants either agreed or strongly agreed.  The response to the statement regarding the availability of personal protective equipment indicated that 88% of participants either agreed or strongly agreed that the equipment was readily available.  The next group of questions in this section examined the use of specific types of personal protective equipment during preparation of cytotoxic drugs and the results for participant responses can be viewed in Figure 3.3.  The main difference in use of personal protective equipment during drug preparation was the type of respiratory protection used (i.e. N95 respirator versus a surgical mask).    Figure 3.3. Personal protective equipment reported to be used when mixing cytotoxic drugs from employee questionnaire (n=62).  0 10 20 30 40 50 60 70 80 90 100 Gloves Hair Cover Shoe Cover Surgical Mask Respirator Impermeable Gown Percent of Participants (%) All of the time Most of the time Some of the time Rarely Not at all Not applicable   86 3.6 Discussion of Phase 2: Employee Questionnaire The four main objectives to this phase of the study were: to gain information about the population working in pharmacies that handle cytotoxic drugs in the health authority, to assess the use of personal protective equipment when working with cytotoxic drugs, to gather information on present levels of training and education; and to gain insight into the perceptions of those working with cytotoxic drugs and whether they differed by education, experience or worksite.   General Information The majority of respondents (81%) that completed the employee questionnaire indicated they were female.  This value falls within the range described in two other Canadian reports on personnel working in the pharmacy setting, ranging from 74% of pharmacists (Canadian Institute for Health Information, 2008) and 94% of technicians (Canadian Pharmacists Association, 2007).  The age category indicated by most participants in this study was 40 to 49 (34%) or 50-59 (31%) years.  When considering the two other Canadian reports on those working in pharmacy settings, the majority of pharmacy technicians were 30-39 (31%) and 40-49 (26%) years (Canadian Pharmacists Association, 2007), and the majority of pharmacists were also 30-39 (29%) and 40-49 (28%) years of age (Pharmacists in Selected Provinces and Territories in Canada 2008, 2009). Therefore the participants from the health authority in this study may represent a slightly older working population compared with the reports on the Canadian pharmacy population.  In this study, the average years reported by participants for working in his or her present occupation was 15.8 years (SD 11.4 years) and this value was within the range reported   87 in the Canadian pharmacy technician report.  The pharmacy technician report indicated that more than one third of participants who worked within the hospital setting had worked in their present occupation between 10 and 19 years; no information was available on years of service for pharmacists the Canadian pharmacy report.  Training and Education The level of post-secondary education for the participants in this survey was: 61% Certificate or Diploma, 34% Bachelor?s Degree and 5% Graduate Degree.  These values are representative of the occupations of the participants in the study as 66% were pharmacy technicians and 34% were pharmacists.  The Canadian technician report indicated that 10% of those working across Canada in hospitals reported a high school diploma as their highest level of education (Canadian Pharmacists Association, 2007).  Within the Canadian pharmacy report, 94.5% indicated having a Bachelors Degree and 3.5% had a graduate degree (i.e. Master?s, Pharm D or Doctorate) (Pharmacists in Selected Provinces and Territories in Canada 2008, 2009), and these values are similar to the pharmacists that participated in this study.    The majority of participants indicated that he or she received training from the employer and most participants either agreed or strongly agreed ?the training I have received to date is adequate to protect myself?.  Interestingly, responses among worksites for the question on the above noted question on training reached statistical significance. (?= 0.003).  When examining the data more closely by worksite on this question, it was observed that the two worksites with the health authority-based training program in place had a greater percentage of participants who either agreed or strongly agreed that the training received to date ?is adequate to protect myself?.   As a future direction, it   88 would seem that the implementation of this training program within the organization could increase the personal protection or the perception of protection amongst health authority pharmacy personnel.  However prior to implementing any program, the organization must make some decisions internally to harmonize practices as the remaining worksites did not have the in-house training program in place.  It should be noted that some worksites did have protocols in place that were influenced by the British Columbia Cancer Agency voluntary certification process.   Approximately one third of participants indicated on the employee questionnaire that they had never received training from the organization on working with cytotoxic drugs.  When the data were examined more closely, it was noted that this one third of the population was representative of pharmacists that responded to the questionnaire.  Within the organization, the primary role of pharmacists was to check cytotoxic drug preparations prior to the product leaving the pharmacy, but preparation of the products by pharmacists is not a common task.  However, if the pharmacists had not had training on working safely with products, there is a chance that environmental contamination or occupational exposure could occur.  A study by Harrison et al. (1996) used an intervention strategy to train and refresh pharmacists on safe handling of cytotoxic drugs.  The results of the study were that prior to the training intervention there was evidence of surface contamination in 92% of pharmacies and following training this value decreased to 23% (Harrison et al., 1996). However, further work should be carried out to determine what impact training and refreshing on safe handling would have on the degree of worksite contamination.  A question in the employee questionnaire posed to participants asked what factors influenced him or her to attend training and the   89 majority of respondents indicated that his or her interest in their health and safety would be a factor.  This value was a positive sign that personnel consider personal safety when handling cytotoxic drugs. However, the value must be interpreted with caution as it is possible that those who responded to the employee questionnaire were those that had an interest in health and safety.    What I Think and What I Know about Working with Cytotoxic Drugs The majority of employees that participated in this questionnaire considered the risk to personal health and the health of others, along with the risk of personal exposure to cytotoxic drugs either low or very low, although results differed by education level.  Those with a certificate (pharmacy technicians) responded less favorably when compared to those with a bachelor?s degree (pharmacists).  The most probable explanation for this apparent difference in perception of risk of exposure to cytotoxic drugs would be because those with a certificate (pharmacy technicians) have a more direct role in working with cytotoxic drugs in comparison to those with a bachelor?s degree or higher (pharmacists).  The questionnaire also revealed that most of pharmacy personnel agreed or strongly agreed they were aware of the procedures to reduce exposure during a leak or spill of cytotoxic drugs. From initial worksite visits carried out in the health authority, it was observed that spill procedures were only posted in two out of seven worksites, but spill kits were present at all sites.  Statistical analysis of the question on dealing with leaks and spill clean-up revealed a difference again by level of education.  From examining the data set, it appeared that those with Bachelor level degrees (pharmacists) responded less favorably than those with diplomas (technicians). The most probable explanation for this difference is that pharmacy technicians are   90 primarily responsible for handling cytotoxic drugs and as such were likely more familiar with spill response procedures compared to pharmacists.  The majority of participants in this study were aware that cytotoxic drugs can enter the body through skin contact with drug-contaminated surfaces and that one possible health effect from workplace exposure to cytotoxic drugs is cancer.  A Turkish study from 2001 (Ben-Ami et al.) posed questions to nurses who worked with cytotoxic drugs to determine whether participants believed the products could be absorbed into their bloodstream and 68% disagreed.   Although there is a difference in the question posed to participants in the Ben-Ami et al. study and in this thesis work, there appears to be a difference in the knowledge of participants of how cytotoxic drugs could be taken up by the body.  The difference in knowledge of participants may be accounted for by the time difference between the two studies (i.e. approximately ten years), location (Turkey versus Canada) and occupational role (nursing versus pharmacy).  Future training initiatives for pharmacy personnel should always contain information for participants on both routes of exposure along with information on health effects of occupational exposure as a means to remind staff of the importance of protecting their health and the health of their co-workers.  Participants were asked questions on agreement with statements on perception of safety.  It is possible to indirectly compare the responses to these questions to results of a safety culture review survey carried out in the health authority in 2009 by a consulting company called First Aid and Survival Technologies Limited (F.A.S.T).  Questions from this review posed to those within the organization also utilized a Likert scale to gather information on perceptions of safety.  For example, one question in the review posed to   91 the health authority employees was: I know about [the organization?s] Health and Safety Policies and Procedures.  The results for front-line staff (n=188) indicated that 46% either agreed or strongly agreed.  The question posed to pharmacy personnel on spills response and leaks in the present study is an example of a safety procedure and 70% participants indicated they either agreed or strongly agreed they were aware of the procedures. Another question posed in the health authority review was: Employees in my workplace are generally competent to work safely.  The results from the health authority review were that 53% of frontline staff either agreed or strongly agreed with the statement.  A similar question from the pharmacy survey asked the degree of agreement as to whether participants thought those working around him or her were aware of safety precautions required when working with these products.  The response was that 78% participants agreed or strongly agreed with the statement.  Overall, the responses for those in the pharmacy employee questionnaire reflected a larger percentage of those who agreed or strongly agreed with statements pertaining to safety when compared to the health authority-wide review carried out by F.A.S.T. in 2009.  The explanation for this may be a bias in that the pharmacy sample that participated in the current employee questionnaire may have had an interest in health and safety.  Personal Protective Equipment The use of personal protective equipment (PPE) when handling cytotoxic drugs varied across the organization.  One the greatest variations across the organization for PPE usage was respiratory protection; about half of participants indicated wearing a surgical mask and about a quarter indicated the use of a disposable N95 respirator when mixing cytotoxic drugs.  The use of a disposable N95 respirator would provide the end-user   92 with a greater level of protection from cytotoxic drugs when mixing product.  The employee questionnaire results showed that a quarter of participants wore shoe covers all of the time and half not at all.  According to USP 797 (2008), shoe covers should be worn by those who compound cytotoxic drugs.    Interestingly, some of the participants indicated that the use of personal protective equipment was not applicable to him or her for mixing cytotoxic drugs.  When this portion of the participants were examined more closely, it was determined that these were pharmacists who do not mix cytotoxic drugs, as the role for most pharmacists is to check these products prior to patient treatments.  In future designs of employee questionnaires, alternative wording for this question would likely be selected to replace the term ?mixing? with ?handling? to get a better sense of what personal protective equipment pharmacists utilize when checking cytotoxic drugs.   Furthermore, the use of eye protection, recommended under the USP 797 standard, should be included on future employee questionnaires.  Overall, the results of the employee questionnaire indicated that participants are utilizing different PPE when mixing cytotoxic drugs.  The standardization of PPE across the organization would be one step to promote the practice of employees wearing the full complement of equipment and PPE is one method to control exposure to hazardous drugs.    A study by Martin and Larson (2003) examined the practices of members of the Oncology Nursing Society in the United States in comparison to the Occupational Safety and Health Administration?s (OSHA?s) guidelines for handling cytotoxic drugs.  The information in their study was gathered in a similar format to this thesis work for comparison purposes in that it was a self-reported type survey.  The current thesis work revealed that 82% of participants wore gloves when mixing cytotoxic drugs, which is   93 similar to the Martin and Larson study that indicated that 83% of participants wore chemotherapy gloves when preparing the products.  In this thesis work, 76% of participants that mixed cytotoxic drugs indicated that he or she wore an impermeable chemotherapy gown.  This value was greater than the Martin and Larson study that reported 67% of participants wearing a chemotherapy-designated gown.   The Martin and Larson study reported that 38% of participants wore laboratory coats for preparation and, although this information was not gathered in the current employee survey, the investigator did observe pharmacists wearing laboratory coats while handling product.  For respiratory protection, the Martin and Larson study reported that 55% of participants wore a mask during preparation, but the type of mask was not specified.  Personnel surveyed in the health authority for the current study reported that 58% wore a surgical mask during preparation and 24% wore a disposable N95 respirator and thus overall, more personnel reported wearing respiratory protection during this task than in the previous study.  It is positive that a greater number of personnel reported wearing respiratory protection, but it should be noted that there is no specific type of respiratory protection specified by WorkSafeBC, USP 797 or the BC Cancer Agency. Applicability of Health Behavior Models to Employee Questionnaire When considering the results of this phase of the research, the results could also be contextualized in models of health behavior.  The theoretical models that best help understand and explain the results from the employee questionnaire phase of the research are the value-expectancy models which are based on the idea that individuals will evaluate the seriousness of a risk, examine the costs and benefits of taking a   94 specific action and then select the course of action. It should be noted that the value-expectancy models and the predisposing factors that make up a diagnostic factors of the PRECEDE model are overlapping (e.g. threat related beliefs, efficacy expectancies)  (DeJoy, 1996).  Some examples of models that are grouped under the value-expectancy models are: 1.) health belief model 2.) theory of reasoned action and 3.) protective motivation theory.  According to DeJoy (1996), each of these models has overlapping constructs that can be applied to worker health and safety.  The constructs from these models include: 1.) threat-related beliefs, 2.) self-efficacy, 3.) response efficacy, 4.) barriers and 5.) normative expectations (DeJoy, 1996). Threat-related beliefs are those beliefs that individuals have about a ?hazard susceptibility and severity? and this construct is a feature in all of the value-expectancy models. In the health belief model, two of the components to help understand or explain health behavior are the perception of an individual of his or her susceptibility and the perceived seriousness of the problem (DeJoy, 1996).  Information collected in the employee questionnaire about pharmacy personnel working with cytotoxic drugs provides some information about the beliefs this group of workers have who work with this hazard.  Within the results of the employee questionnaire, the majority of participants believed that the risk to his or her risk health and the health of others from exposure to cytotoxic drugs (perceived seriousness) was either low or very low.  Also, the majority of participants indicated that the risk of his or her exposure (perceived susceptibility) to these products was also either low or very low.  Statistical testing did show a difference in responses on the question posed on the perception of risk of exposure when stratified by level of education.  It should be noted that education in this   95 case might have acted as a surrogate measure for differences in work tasks (i.e. pharmacy technicians may have tasks that involve direct contact with cytotoxic drugs compared to pharmacists).  This information was important as it demonstrated that those with a certificate (pharmacy technicians) appeared to perceive their risk of exposure as being higher when compared to those with a bachelor?s degree or higher (pharmacists). If one were to consider these results representative of the threat-related beliefs of this group of employees working with cytotoxic drugs, this piece of information contributes to the investigator?s knowledge of how these workers view the hazard.  Having a better understanding of the threat-related beliefs of working with cytotoxic drugs is part of the process in learning what influences the choices that employees will make about his or health and safety in the workplace.  At this point in the research, the investigator was aware that surface contamination was present at the worksites, but employees did not yet have this knowledge.   Perhaps if this information had been made available to employees prior to answering the questionnaire, responses to the questions posed on risk may have differed.  In future studies, it may be possible to test this hypothesis, however based on the information collected, the direction taken should be to incorporate a component of communicating the risk to personal health and risk of exposure within a program.  The type of information that could be shared with employees could be possible health outcomes related to exposure, routes of exposure and how to control exposure.  Within the value-expectancy models, another construct that applied to the results in the employee questionnaire was self-efficacy.  The idea of self-efficacy has been included in all of the value-expectancy models and it takes into consideration the confidence that   96 a worker has in his or her abilities to perform a required behavior on a day-to-day and long-term basis.  Within the value-expectancy models when examining the protection motivation theory model, self-efficacy is factored into how motivated a worker will be to protect him or herself.   The employee questionnaire included a question about the degree of agreement participants had on the statement:  ?I know the procedures to follow to reduce exposure to cytotoxic drug exposure during spills and leaks?.   The majority of study participants either agreed or strongly agreed with the above statement. However, statistical analysis differentiated responses based on level of education.  The information from this group of workers indicated to the investigator, that pharmacists may not have the same sense of self-efficacy compared to pharmacy technicians when faced with a leak or spill of cytotoxic drugs in his or her worksite.  This difference in responses to this question may be related to work tasks for the two occupations, which could influence the perception of risk (i.e. pharmacy technicians may have a larger role in spill clean-up compared to pharmacists).  The question posed to participants on the employee questionnaire as to the degree of agreement to the statement ?The training provided on cytotoxic drugs that I have received to date is adequate to protect myself? showed that workers at sites with an in-house training program in place responded more favorably.  This information has lead the investigator to theorize that workers at sites that do not have an in-house training program in place, may not have the same sense of self-efficacy in performing required safety measures covered in training compared to those that have had in-house training.  It must be acknowledged that this study population was small, and these results have limitations, however future studies could include more pharmacy personnel within British   97 Columbia or Canada to further investigate these results.  Despite the limitations, within the context of this research, measures can be recommended that may impact self-efficacy in this group of workers.  Two steps that could be taken that are relevant in this workplace setting are: hands-on training for cleaning up spills or leaks of cytotoxic drugs and training program that includes personnel from all worksites handling cytotoxic drugs.   The implementation of a standardized training program at the worksite would contribute to the provision of a supportive workplace culture that could improve the degree self-efficacy within this group of workers.  Within the value-expectancy models, another construct that applies to the results of the employee questionnaire is barriers, and both the health belief and the protective motivation theory models include this factor.  Within the health belief model, barriers perceived by individuals has been demonstrated to be a strong predictor across all studies of health behavior (DeJoy, 1996).  In the results of the employee questionnaire, it was identified that the use of the type of personal protective equipment across the organization during preparation of cytotoxic was inconsistent.  This information helped the investigator have a better understanding of the barriers of working with cytotoxic drugs as another part of the process in learning about what could influence the choices that employees make about his or her health and safety in the workplace.  In order to limit or reduce the chance of personal protective equipment being a job-related barrier, steps could be taken to ensure the use of the equipment is clearly defined for employees and readily available at all worksites.   Individual beliefs of workers that are highlighted in the value-expectancy models are important to consider in the area of self-protective behaviour.  However, the behaviour   98 of individual workers is also influenced by his or her workplace culture or setting. Within the PRECEDE model, DeJoy (1996) noted that enabling factors within a worksite can either facilitate or hinder self-protective actions.  Some examples of enabling factors within the pharmacy setting included the availability of personal protective equipment, engineering controls and training.  In the absence of these enabling factors within the work environmental, workers cannot aspire to protect themselves from exposure to cytotoxic drugs.  In addition to the enabling factors, it is also important to consider reinforcing factors within the worksite that would include feedback on performance, social approval or disapproval from coworkers as well as supervisors.  The social approval and feedback from those within the workplace setting all contribute to the culture of safety at the worksite. If the work environment does not reinforce working safely, even an individual that is well-trained and motivated may not respond to safety initiatives.  It is thought that the both performance feedback along with ?safety-related attitudes and actions? of those in a managerial role are of utmost importance in influencing individual safe work practices (DeJoy, 1996).  3.7 Summary of Phase 2: Employee Questionnaire Phase Overall, the sample surveyed in this study was primarily female and represented a slightly older population when compared to the Canadian population working in the pharmacy industry.  All participants in this phase of the study reported having some form of post-secondary education, which ranged from diploma to a master?s level.  Statistical testing revealed a difference in responses among worksites on the adequacy of training for protection that may be attributed to the presence of a health authority-based training program being present in two of the five worksites. This piece of   99 information was significant as it demonstrated that employees with a form of in-house safety training on this topic were in agreement with the adequacy of training to protect him or herself.  Information such as this can be communicated to the employer and broader investigations could take place to determine if the information is applicable in other BC health care pharmacy settings.   However, in order to determine if this result can be applied beyond this workplace setting, additional hospital pharmacies within the province could be surveyed.  Statistical testing also showed a difference in responses to two questions when stratified by level of education, which could also be acting as a surrogate measure for workplace tasks and ultimately exposure risks.  One question pertained to the knowledge of dealing with spills of cytotoxic drugs and showed that those with a certificate (pharmacy technicians) responded more favorably in comparison to those with a bachelor?s degree or higher (pharmacists).   The other question that showed a difference in responses when stratified by education was a question related to the risk of exposure to cytotoxic drugs, whereby it appeared that those with a certificate appeared to rank their risk of exposure higher when compared to those with a bachelor?s degree (pharmacists).  These pieces of information were important because they illustrate potential differences in perception of risk and knowledge either by education or by work tasks or both.  Having this information, although limited by sample size of questionnaire, can aid in identifying groups that requires additional support or training on the topic of working safely with cytotoxic drugs.  However, it would be prudent to survey a larger sample of pharmacy personnel to establish if these results apply in other hospital pharmacy settings.  On the whole, within the organization there is   100 a need to investigate the standardization of training practices for working safely with these products.   The use of personal protective equipment when handling cytotoxic drugs was inconsistent across the health authority, more specifically, the use of respiratory protection.  Personal protective equipment should be standardized for handling cytotoxic drugs and if there are discrepancies amongst worksites or other health authorities, consultation could take place with other agencies such as BC Cancer or WorkSafeBC.   The results of this phase of the research can be situated within a collection of constructs from the value-expectancy models and environmental or contextual models that are part of health behavior models.   The constructs that could be applied from the results in this portion of the research included: threat-related beliefs, self-efficacy and barriers.  Additionally, it could be theorized that the enabling and reinforcing factors within the work environment impact an individual?s ability to act in a self-protective manner.  By examining the applicability of the results with the constructs of the models, it was possible to continue adding to the body of information obtained from the environmental assessment phase of research to help identify additional targets within a program to limit occupational exposure to cytotoxic drugs.      101  Chapter 4 Phase 3: Focus Group Activities 4.1 Introduction to Phase 3: Focus Group Activities  Focus groups are a qualitative data collection method that uses group interaction to enable participants to ask questions, make comments and share experiences with other study participants.   Using this approach, a researcher is able to gather expanded information indicative of the needs and points of view of employees (Kitzinger, 1995; Brown, 1993).  The environmental assessment and employee questionnaire were valuable, structured means of obtaining information on the present state of a safety program and also identifying aspects that could be targeted to help reduce occupational exposure.  However, to add strength to these results and help to formulate directions for improvements to safety when working with cytotoxic drugs, expanded input from frontline workers was sought.   The aim of the focus groups was to gain insights from those working directly with cytotoxic drugs in this health authority to try to add depth to the results from the first two phases of the study.  By undertaking this phase of research, the investigator sought to learn more about the workforce and how information could be factored into strategies intended to reduce occupational exposure to cytotoxic drugs.  4.2 Objective for Phase 3: Focus Group Activities The objective for the focus group phase of this project was to expand and deepen insights derived from the earlier phases of the study.  Toward this end, a structured set   102 of questions was designed to address the following: 1.) to review the results from the environmental assessments and employee questionnaires with pharmacy staff; 2.) to help propose future directions for helping pharmacy personnel to work safely with cytotoxic drugs, for example, the development of safe work procedures, education or training initiatives; 3.) to identify if there are barriers to working safely; and 4.) to gain insight into participants? views on working with cytotoxic drugs.  4.3 Methods for Phase 3: Focus Group Activities Planning and Organization of Focus Group Activities Following the completion and analysis of environmental assessments and participant questionnaires, focus group sessions were held at each of the five worksites included in Phase 1 and Phase 2 of the project.   The sampling for these focus group participants was purposive in that it made use of those available to meet the goals of this phase of the research (Morgan, 1998).  The general criteria for inclusion were that  participants were either pharmacists or pharmacy technicians, employed within an acute care pharmacy that handled or manipulated cytotoxic drugs and was included in the first two phases of the study. To recruit focus group participants, the investigator attended worksite staff meetings to explain  the focus group sessions and to answer questions.  Following this step, recruitment posters that contained details on how to be part of the focus group sessions were disseminated to the worksite supervisors. Focus group sessions were scheduled for two hours during work hours and the aim was to recruit between four and six   103 employee participants per worksite.  Both the University of British Columbia and Vancouver Island Health Authority ethics boards approved this protocol. Focus Group Session Structure The focus groups were guided by a general structure whereby a series of questions was posed by the investigator to stimulate feedback and discussion.  The investigator acted as a moderator of each of the sessions, aiming to ensure that all members had an opportunity to speak and to try and keep to the topic being discussed.  At the beginning of each session, the investigator explained the format of the focus group session and set the stage to ensure that all members participated. Each focus group session commenced by posing the following question: ?What are your thoughts on working with cytotoxic drugs??  Following this, partipants were shown the results of the environmental assessment (Phase 1) for their worksite that included a schematic of the locations of cytotoxic drug contamination and asked: ?What are your thoughts on these findings??  Next, particpants were shown the results of the employee questionnaire (Phase 2) and asked: ?What are your thoughts on the findings of the employee questionnaire??  The final  questions posed to participants were:  ?Are there barriers to working safely with cytotoxic drugs?? and ?What strategy(ies) should be used to promote working safely with cytotoxic drugs??  At the conclusion of each focus group session, participants were invited to share any final thoughts.  All focus group sessions were audiotaped by the investigator and notes were made with respect to flow of dialogue and group interaction.      104 Analysis of Focus Group Data The data was subjected to analysis included the focus group audiotape recordings and the notes recorded following each group session. A  ?tape-based analysis? approach, whereby the audio recording of the session was listened to and an abridged transcript was created focusing on the participant responses to each of the questions (Onwuegbuzie et al, 2009). This allowed for a manifest content analysis reflecting an approach to organizing the basic descriptive themes within a predetermined content structure, rather than a more inductive effort to extract latent content (Berg, 2000). Within each grouping, a coding process (Charmaz 2006) allowed for interpretation of common patterns and variations within the data as well as thematic groupings of the content. 4.4 Results for Phase 3: Focus Group Activities General Information Focus group sessions took place over a one-month period at the five worksites that were included in Phase 1: Environmental Assessment and Phase 2: Employee Questionnaire of this study.  The focus group sessions included nine pharmacists and 17 pharmacy technicians for a total of 26 participants from the five worksites.  Additional information about those that particpated in focus group sessions is displayed in Table 4.1.        105 Table 4.1: Characteristics of focus group participants (n=26). Worksite Number of Participants Sex Occupation Female Male Pharmacist Technician #1 5 5 0 1 4 #2 6 6 0 1 5 #3 6 4 2 3 3 #4 5 5 0 3 2 #5 4 3 1 1 3 TOTAL 26 23 3 9 17  Focus Group Dynamics As part of the data collection process, notes had been recorded with respect to focus group dynamics. Although most groups functioned with a smooth flow of conversation, minor departures to the intended plan occurred in a few instances.  In one focus group, a department supervisor attended as a participant, which had not been intended in the original plan.  However, this participant indicated that he performed the same role as the others attending (i.e. mixing cytotoxic drugs) and was not considered ?management? because he was under the terms of a collective agreement.   Another  focus group was somewhat disrupted by members coming in and out of the room throughout the session due to  a requirement to complete work tasks.  Finally, at another focus group session,  one participant frequently attempted to dominate the discussion and seemed dismissive of the results presented by the investigator.  This individual also took a position in the room that was at a distance from other members.  In interpreting the recorded data, the investigator attempted to maintain a thoughtful stance as to how these dynamics might have influenced the quality and nature of information being expressed or suppressed.      106 Organization of the Findings The findings  from the focus group sessions are presented here in the general structure of the questions that were posed for each focus group. Within the report of findings for each question, the discussion content is organized into main thematic groupings. Key ideas arising within these groupings, and the number of focus group sessions within which each idea was represented, is summarized in (Appendix D, Table D1).   What are your thoughts on working with cytotoxic drugs? Personal Health Ideas The focus group session participants were initially asked what their thoughts were regarding working with cytotoxic agents.   Opinions related to health were shared.   In three of the five focus groups, participants brought up concerns that were related to past work practices with cytotoxic drugs and the long-term health outcome from occupational exposure being unknown.  One participant said: ??there is always information coming forward on this is how you should work with cytotoxic drugs and it makes me a little bit nervous I?ve done this for ten years and ten years ago I wasn?t doing these things and five years from now are things going to be different and what are we being exposed to and coming into contact with?? Another participant said: ?I think that in the past our practices at this hospital were not protective enough?.   Another idea that was discussed by participants in two of the five focus groups was the employer not having a health-monitoring program in place for those that handle cytotoxic drugs.  At these two sessions, participants discussed how former places of employment had annual health testing done for employees that handled cytotoxic drugs.    107 An example of a quote from a participant was:  ?When I worked at [named workplace] we had blood work done every year, just basic and we used to mix chemo in an incubator [sic] and there were no standards to safety and things have changed big-time since I started mixing chemo?.  Another participant said: ??and I worked out of province and your physician had to fill out a form.  [Organization] does nothing.  I can?t remember there was a form that you filled out and took to your physician.  I don?t know that it was a specific test more like a general health?.   In two of the five focus groups, participants expressed concerns about their risk of musculoskeletal injuries from mixing cytotoxic drugs.  Two examples of quotes from participants expressing this concern were:  ?And when is enough, enough?  How much can you do in a day?  Can you go on for two weeks in a row? And then you get injuries?? and ?MSI?s [musculoskeletal injuries] are a concern?we have discussed not being in there five days straight, it used to be two weeks and then ten days?and months at a time?and then it was?and now we?re down to a week and I brought it up and said I don?t think these girls can do it anymore, maybe it should be a day on, a day off?like switch?? Safety in the Workplace There were two ideas that were discussed in focus group sessions that were related to safety in the worksite.   Within three of five focus groups, there were participants that felt the current practices were protective against exposure to cytotoxic drugs. One pharmacy technician said ?I?m pretty comfortable with our present safety measures and policies and I have no issues or anything like that?? and one pharmacist said, ??with   108 all of the procedures that are in place with the safety hoods etcetera, I probably wouldn?t be worried at all about working with them.?   In three of the five focus group sessions, ideas about individual practices when working with cytotoxic drugs were discussed.  One pharmacist revealed that she/he did not follow safe work practices and said this ?I?m not too worried about adverse health effects for myself, I?m a pharmacist and I don?t mix, I check and I don?t wear gloves when I check?.  Conversely, in another focus group session a worker shared observations of those around him or her not following procedures and said  ?people not respecting it [safe work procedures] they say ?it?s my own health? and for example they don?t wear two pairs of gloves.?  What are your throughts on the findings of the Environmental Assessment? Participants were shown the results from the Environmental Assessment (Phase 1) for the organization as a whole, plus a schematic of their worksite that displayed the results of the surface wipe testing for cyclophosphamide and methotrexate.  One commonality in all five focus group sessions was discussion on why participants? believed surface contamination was present at their worksite.   Sources of Surface Contamination In two of the five focus groups sessions, participants said that current housekeeping practices could be a contributing factor to the presence of cytotoxic drugs on surfaces.  One participant said ??the person cleaning runs the same dirty cloth over the counter and the door knob and all over the prep room? and at the same worksite, another participant said ?We were having some housekeeping issues which when you [the investigator] were here was in full effect?.    At another worksite, a pharmacy technician   109 said in response to learning a counter had drug detected on it ??that counter was never cleaned ever??  At four of the five focus groups, participants hypothesized that the improper use of personal protective equipment could lead to surfaces being contaminated with cytotoxic drugs.  At three of the worksites, participants spoke of improper use of gloves being a factor leading to contamination.  One pharmacy technician said ?they still have gloves on and they are touching the door...?.  One pharmacist said ?they recycle their gloves and they have them in their lab coat and so it travels around?.   At one of the worksites, the participants discussed how the combination of dirty gloves and lab coats were responsible for a contaminated chair and someone said ?Lab coats, dirty lab coats?the same lab coats weeks on end?.   A third idea that was discussed by participants for the cause or source of surface contamination was the cytotoxic products arriving from the manufacturer.  The participants spoke of how the packaging was contaminated when it arrived at the worksite and as such surface contamination may be unavoidable because of manufacturing processes.   This idea was discussed at two of the five focus group sessions.  Two examples of quotes that relate to this idea were: ?I have always been told by people who have long since gone from here that the outside packaging can be the most contaminated area which one wouldn?t think? and ??they just manufacture things powder flying everywhere, they don?t wipe anything, it [the product] just goes out.?        110 Variable Practices For Safe Handling of Cytotoxic Drugs During the participant dialogue pertaining to the environmental assessment, three of the focus groups spoke of how there were varying safe work procedures within the organization that may not be enforced.  One participant referred to this in the context of results showing a contaminated receiving cart at the worksite: ?my point is that [named employee] doesn?t scrub down her cart every time she receives chemo.  There is no present procedure for that, it?s an individual thing?.  In the context of discussing worksite contamination and safe work procedures, one participant said: ?not everyone gets it [procedures] or has the same understanding about things and there?s nobody that polices it or is authorized to police it.?    What Level is Harmful? When the results for the environmental assessment for surface contamination were shared with focus groups, participants at two of the sessions wanted to know what level of contamination was considered harmful to their health? At both of these focus group sessions participants spoke of how they believed if the health impact of surface contamination was not proven, staff members may not be concerned with the presence of the product on work surfaces.  One participant said ?I still believe that until they are shown there is a level of drug on surfaces that is harmful, they won?t care...?.  One participant asked the investigator what some examples of amounts were for surface contamination.  When the investigator provided some examples of values, the participant responded:  ?Say five nanograms? I?m just thinking, I?m not so worried about chemotherapy, I?m more worried about latex and antibiotics on exposure?but anyway?that?s more what I am worried about??   111 What are your thoughts on the findings of the Employee Questionnaire? During the focus group sessions, participants were shown a summary of results for the employee questionnaire.  Participants discussed the results that were related to training and education as well as the use of personal protective equipment, specifically the use of respiratory protection.   Inconsistent Training Practices  From the employee survey and environmental assessment phases of the research, it was learned there were different practices in place for training and education across worksites and occupations.  In four of the five worksites, participants spoke of how they understood that training across the organization for working with cytotoxic drugs had not been standardized.  One participant spoke of multiple personnel within the worksite that lacked training: ?That?s the point [named employee] had no training the pharmacist has had no training so how can you say that anyone had training?  There is no training?a pharmacist can?t come from a retail background and start training [other staff]??.  At another worksite, a pharmacist said: ??you?re not trained to be in there [the room where products are prepared] and I think you need to have proper training to go in there...?.  One participant at a worksite thought people may have different ideas as to what training was and said: ?I think everyone has a different idea about what training is?some people are going to want weeks and weeks and some people are going to want something short and be on their way and then someone who is getting training might think the person who is training them doesn?t know anything at all?.    112 Use of Respiratory Protection At four of the five focus group sessions, discussions took place about the inconsistent use of respiratory protection when handling cytotoxic drugs.  There was one participant that said she/he would not use any respiratory protection when handling cytotoxic drugs: ?Does anyone else not wear a mask when they mix?  I don?t, it?s useless to protect me?.  When the investigator showed a focus group that 40% of worksites had N95 respirators one participant said: ?When mixing?  Because we just wear surgical masks. I wouldn?t wear one [N95], I can barely breathe with the surgical mask on. The green one with the foam, the smell, the heat, the moisture?I wouldn?t wear one.?   At another worksite that had N95 respirators available for use, one participant was not convinced of the value in wearing this type of respirator and said ?I have an understanding of what they [N95 respirators] do or don?t do and working beside the cancer agency, they don?t use N95?s at all mixing, surgical masks really aren?t doing much other than keeping your own body fluids away from the products, but you have a glass shield in front of you, how effective is the N95, when it?s not protecting you from vapours? The argument is how much protection is it providing anyway??.  Are there barriers to working safely with cytotoxic drugs? During the focus group sessions, participants were asked: Are there barriers to working safely with cytotoxic drugs?   There were four main ideas discussed by focus group members related to barriers to working safely that included: limited time and resources, relationships between staff members, the physically demanding nature of the job and worker complacency.    113 Limited Time and Resources One barrier that was spoken about at all five focus group session was limited time and resources to complete daily tasks safely.  Two participants said that because of heavy workloads they did not feel they had the time to complete their tasks safely. One technician said: ?Time is a factor, I know that when I have lots to do, I?m not as careful as I should be? and another technician at a different worksite said ?You can?t do a job properly in eight hours that takes ten hours and you have to cut somewhere?so where do you cut??   When participants spoke of limited resources, one pharmacist said: ?Another barrier is money, so obviously [organization] is saving money by not having these techs on-call?.  This comment was made in the context of a discussion by participants about recent changes made in after-hours staffing for the preparation of cytotoxic drugs.   This change in resourcing by the organization was discussed at two separate focus group sessions.  The availability of space and the physical design of worksites was a barrier to working safely that was spoken about in two of the five focus groups.  One participant spoke about how the design of the worksite did not lend itself to working safely and said: ?I think one of the main barriers is how the sites are designed where you have the chemo hood in beside the sterile prep hood where the you have a place to hang up your lab coat, take your gloves off before you touch the door?not having the proper site to work in.?  Another participant at a different worksite expressed concern that the workspace was too small to work safely and said: ?Would you consider tight space a barrier? That?s the one I think of, our space issues.?   114 Relationships Within the Department and Outside of the Department Relationships between various health care professionals were identified as a barrier to working safely.  There were two focus group sessions that discussed the relationship between those providing oncology services and the pharmacy personnel, one participant said: ??personally in this facility I feel there is a lack of willingness to be on the same page with the chemotherapy department, there is a weekly push me, pull you where my idea is that we should go upstairs for a shift and they should come downstairs for a shift because there is a lack of acknowledgement of what each other does and each department does?.  At one worksite, there was a participant that indicated those around him or her were a barrier to working safely and said:  ?Some people will say, I worked for the last 20 or 30 years and had lots of exposure and things were way worse then so why should I change? It?s not a personal choice. But for them not doing it, it?s affecting everyone else?s safety as well.? Complacency and Individual Technique Another barrier identified to working safely with cytotoxic drugs was complacency and individual technique and this idea was discussed at three of the five focus group sessions.  One participant said: ?it [working safely] still comes down to technique??.   Another participant at a different worksite said: ?I know some people will just not wear gloves and just go and grab the drug for whoever [sic] and give it to them, and it?s the same pair of gloves from earlier in the day?.  One participant felt that his or her co-workers were complacent with safe handling practices and said: ??people become complacent, ?I?ve been doing it for so long nothing is going to happen to me? or I?m   115 trained, I know what I?m doing?.  One participant spoke of how he or she observed those around him or her not following proper procedures despite having the resources to do so and said: ?I guess you can do all you want with people, but the bottom line is people, we have all the resources here, still people don?t even follow the rules, it?s up to the person and their choice. Me personally, I like to follow the rules, but I see people go in and they have just one pair of gloves, no shoe covers, or tramp around the pharmacy with their hair cover on.?   A Physically Demanding Job When focus group sessions commenced with asking participants what their thoughts were on working with cytotoxic drugs, there were participants in two of the five sites that spoke about their concern for musculoskeletal injuries from preparing products.  When discussing barriers to working safely, the same two worksites brought up this idea once more.  Participants at these two worksites spoke of how the physical nature of mixing cytotoxic drugs leads to injury. One participant spoke of how an external agency had recommended extra steps to clean off vials in the preparation process and said: ??we are doing a lot of wiping and a lot of cleaning and that is starting to affect me, I?m getting pain through here [gestures to shoulder] because when you are doing this a hundred times a day, and slaving away, and when you?re in a hurry you start to wear out and your thumbs start to hurt from pushing syringes??.  At another worksite, a participant spoke of the impact that she/he felt the mixing had on everyone in the department and said:  ?But it?s breaking our body, there isn?t one person that their body doesn?t hurt and whether it?s long-term or short term modality??.  Finally, one participant spoke of a long-term injury she/he believed was because of mixing cytotoxic drugs and said: ?WCB   116 will x-ray your shoulder and what they said is that it?s no different from anyone else in the population, but I know it?s [shoulder injury] from sitting in the hood and mixing.?  What approach should be used to promote working safely with cytotoxic drugs? The final question that was posed to participants in focus group sessions was: What approach should be used to promote working safely with cytotoxic drugs?  The intent of asking this question was to help to generate ideas for safety inititiatives that could be designed and piloted at worksites.  There were three main ideas that were spoken of by participants, one was implementation of standardized protocols and policies for working with the products, another one was training and education and the final idea was related to supervisory practices at the worksite.  Implementing Standardized Protocols and Polcies From being shown the results of the environmental assessment and employee questionairre, employees gained an increased awarenes that there were varying processes in place for safe handling of cytotoxic drugs in the organization.  In three of the five worksite sessions, participants spoke of the need to have consistent procedures and policies in place across the organization.  One participant said: ??safe handling procedures is number one [priority], handling the drugs all the way through...?. Another participant wanted the protocols from another worksite shared and made available to all personnel and said: ?I want them [supervisors] to look at the policies and procedures at [one worksite] and get them [policies and procedures] over here and get them to techs and make sure they are given the time to read them and make it evident that we all have a part to play in this?.     117 Training and Education At all five focus group sessions, participants spoke about how they wanted to have consistent training and education on working safely with cytotoxic drugs.  One pharmacist spoke of how there was no training specifically for pharmacists to work safely with cytotoxic drugs and said this: For pharmacists, there is nothing [training] available. I?m working there [area with cytotoxic drugs], but there is no safety orientation?.  There were two participants at two different worksites that talked about the need to have on-going training and one of them said: ?I think training when you start to work there [mixing cytotoxic drugs] and also re-training? Some examples of quotations from participants to support this idea were: ?I think training when you start to work there [mixing cytotoxic drugs] and also re-training?.  Another participant felt that if all personnel worked for the same organization, she or he should be able to go to any worksite and be sure that everyone had the same safety training and he or she said: ?We should be able to go from site-to-site [to carry out work] and know everyone has had the same training?.  In three of the five focus group sessions, participants spoke of the need to have training for spill response and one participant said: ?Just talking about the spill kit, like there was a kit, but what?s in it and how do we use it? It?s just that little exposure, but that hasn?t been used, but what is that box and how do we use it?  That is not in place. We?ve had spill kits for years, but no training to use them.?    Supervision A final idea discussed by participants in three of the five focus groups was:  increased supervision and enforcement of procedures will help to promote working safer with   118 cytotoxic drugs.  One participant expressed frustration about how he or she felt there were no consequences to not following a safe work procedures and said: ?What happens if someone doesn?t follow a policy or procedure? Nothing?? Another technician talked about how he or she followed all the rules, but his/her coworkers were not and said: ??there are techs in there that say ?I?m not doing that? and they don?t keep mixing records as per the protocols and procedures. Who is monitoring it?  But that goes back to supervision. Who is checking and enforcing??.  Finally, one participant wanted his or her supervisor to follow up with those staff members not following safe work practices and said: ??we have policies and procedures and how do you deal with people that keep breaking the rules? That goes from management not following up.? Additional Observations Three additional ideas raised in individual focus group sessions that did not relate directly to the health and safety issues pertaining to working with cytotoxic drugs still seemed pertinent to the context of this study and therefore are reported here.  One pharmacist was concerned about occupational exposure to other workplace hazards such as antibiotics, latex and antibioitic resistant organisms.  This participant said ?I?m more worried about MRSA [methicillin resistant Staphylococcus aureus] and VRE [vancomycin-resistant Enterococci], am I taking that home to my kids??  At one focus group session, a participant spoke of his/her belief regarding the environmental impact of the practices related to mixing cytotoxic drugs.  The participant said:  ?I think there is a lot of waste, too much waste, we are wrecking the environment with all of the waste for this [mixing cytotoxic drugs]?that is a barrier for me.  When   119 they came they told us that we had to use an alcohol swab to wipe each vial down, and I don?t understand why, they said it?s for our safety, but it?s really wasteful??.   A final idea that was discussed in one focus group was the relationship between worker health and safety and patient safety.  One participant said: ?If people are interested in their own health and safety then they are unlikely to jeopardize the health and safety of those around them?so they?ll take care of their patients and their co-workers?. Another participant in this session said: ?It?s just work ethic, working safe will transcend into good quality patient care?. 4.5 Discussion of Phase 3: Focus Group Activities Overall, many different ideas were discussed during the focus group sessions and will be described in the following sections based on the questions posed by the investigator.  What are your thoughts on working with cytotoxic drugs? At the start of focus group sessions, participants were asked what their thoughts were on working with cytotoxic drugs and ideas were shared by participants that related to personal health.   A recent study by Hambach et al. (2011) utilized focus groups to examine workers? perceptions of chemical risks at the worksite prior to implementation of a workplace health program.  One of the main reasons Hambach et al. carried out their study was to learn more about workers? perceptions of chemical risks at the worksite that could influence behavior.  Although the Hambach et al. study took place in Belgium among those working in the chemical industry, there were some similarities in results from the current work with pharmacy personnel.  For example, participants in the Hambach et al. study expressed worry about the ?long-term effects of chemical agents   120 on their health?.  When responding to the question of what participants thoughts were on working with cytotoxic drugs, two focus groups discussed concerns of how the long-term health outcome of occupational exposure to cytotoxic drugs is unknown and can be disconcerting.   Participants in two focus group sessions also identified musculoskeletal injuries (MSI?s) as a health concern that they attributed to the physical nature of tasks associated with the preparation of cytotoxic drugs.  A report generated internally by the health authority?s Occupational Health and Safety Department indicated that since 2008, there were 42 incidents of MSI?s reported within the pharmacy departments that participated in this study.  Over this same time period, within the entire health authority there were more than 8800 MSI?s reported based on internal information accessed from the organization in September 2012.  To the knowledge of the investigator, there is no specific training on prevention of MSI?s to pharmacy personnel within the health authority.  The pharmacy department?s MSI?s accounted for less than 0.5% of all reported MSI?s in the organization.  As such, it is hypothesized by the investigator that resources for MSI prevention within the organization may be allocated to other larger groups of (e.g. nursing personnel) that account for more injuries.  A study by Ngan et al. (2010) examined risks and causes of MSI?s among health care workers with an emphasis on workers that are not direct patient care providers.  The gender and age demographic of those in the Ngan et al. study were very similar to those who participated in the employee questionnaire phase of this thesis work (i.e. greater than 80% female and greater than 60% between 40 and 59 years of age).   This study indicated that for those working in non-patient care occupations the leading cause of   121 MSI?s were force (23%) and awkward posture (25%).  The researchers recommended that future preventative measures for MSI?s in healthcare should be directed at those in non-patient care jobs, and attention should be paid to occupational-specific causes and activities.  One possible direction to investigate MSI?s within the pharmacy setting would be to conduct a risk assessment for those preparing cytotoxic drugs.  Additionally, if a future employee questionnaire was to be developed a question could be posed to probe personnel as to their degree of concern for MSI?s.    In two of the focus group sessions, participants discussed the idea that past employers had a component of health screening in place for those that handle or work with cytotoxic drugs.  Health screening is not a requirement that is specified within the WorkSafeBC regulations for cytotoxic drugs, however, it is described within Occupational Health and Safety Administration (OHSA) recommendations (OSHA Technical Manual (OTM) Section VI: Chapter 2, 1999) which is applicable in the United States.   What are your throughts on the findings of the Environmental Assessment? The results of the environmental assessment generated a large amount of dilaogue from participants.  Participants shared hypotheses with the investigator and one another to help explain why they believed work surfaces were contaminated with cytotoxic drugs.   One hypothesis shared with the investigator in two of the focus group sessions was that packaging from the drug manufacturer was contaminated and as such a source of worksite contamination.   A study by Schulz et al. (2005) in Alberta cancer centres demonstrated that the exterior of vials containing cyclophosphamide were contaminated with product.   Schulz et al. noted that external contamination of the vials   122 was a concern as it could introduce cytotoxic contamination into the working environment resulting in exposure to the pharmacy staff.  Focus group participants in four of the five groups also spoke of how the improper use of personal protective equipment could lead to work surfaces becoming contaminated.   Studies that have taken place within oncology wards and pharmacy settings have demonstrated that cytotoxic drugs can be recovered from the gloves of workers that are handling these products (Ziegler et al., 2002, Mason et al., 2005, Meijster, et al., 2006).  If personnel working within the pharmacy were wearing contaminated gloves, and came into contact with common surfaces this could be a possible source of environmental contamination.  Communicating Risk Within the context of discussing locations of work surface contamination, participants at two of the focus group sessions wanted to know what level of contamination was considered harmful to their health?  At both of these focus group sessions participants spoke of how they believed that the health impact of surface contamination had to be proven, otherwise staff members might not be concerned with the presence of the product on work surfaces.   Within the field of infection control, research has been carried out to explore explanations for poor hand hygiene among hospital workers (Erasmus et al., 2008).  This type of research, although dealing with a different challenge faced by the healthcare system, may provide some insight into possible behavioral determinants of healthcare workers for compliance with a different safety topic.   The Erasmus et al., study collected information from focus group sessions and one key result was that physicians were not convinced of the evidence hand hygiene was an effective means of preventing hospital-acquired infections.  Similarly, not all   123 focus group members were convinced that occupational exposure to cytotoxic drugs was an issue despite the presence of drugs on multiple surfaces within their own worksite and inconsistent safe work practices being disclosed during focus group sessions (?I want to know what the significance is of the problem. Do I have to worry??).  Based on this information being communicated to the investigator, one possible approach to aid pharmacy personnel in having a better understanding of their risk to personnel health would be to develop a risk communication strategy.  The development of a risk communication plan will help to determine what messages are provided to personnel working with cytotoxic drugs and how potential conflicts are managed. In the case of communicating the risk of exposure to cytotoxic drugs, this would be considered what Lundgren and McMackin have termed ?care communication? and more specifically, ?industrial risk communication? (Lundgren & McMackin 2013, p.4).  There are multiple models that are utilized to communicate the risks associated with environmental and occupational health and safety hazards (Lundgren & McMackin 2013, p.12).  An example of a risk communication model that could be used to approach health care personnel when communicating about the presence of surface contamination could be the ?Hazard Plus Outrage? approach.  According to risk communcation specialist Peter Sandman, one may define ?risk? as a fuction of both hazard and outrage.  For those who only assess ?risk?, this primarily addresses a ?hazard?, which is the product of  probability and magnitude.  The other component of Sandman?s definition of ?risk?, is  ?outrage?  and he explains this as the things the public (in this case workers) would be concerned about that ?experts ignore? (Sandman, 1993).  If one were to use the approach to communicate the risk of exposure to cytotoxic drugs to pharmacy   124 personnel or other health care workers using the ?Hazards Plus Outrage? approach,  it would be important to hear the feelings and concerns of the workers before communicating any technicial information (Lundgren & McMackin 2013, p.17).  The development of a future risk communication plan could include having additional focus group sessions as a means to learn more about the ?outrage? componment of healthcare workers that handle cytotoxic drugs prior to communicating technical information about this hazard.  Within the focus group sessions facilitated by the investigator, it was possible to begin hearing ?outrage? from this group of workers that handle carcinogens as part of their daily work.  Another possible risk communication model that could be considered in the context of future communications with pharmacy personnel pertaining to the risk of exposure to cytotoxic drugs and the risk to health could be the social constructivist approach.  This type of approach to communicating risk assumes that both technical information and beliefs, values and emotions come from both the stakeholders and those communicating the risk.   The key idea behind using a social constructivist approach to communicate risk is that when information, values, beliefs and attitudes flow between both the stakeholders and party communicating risk the outcome will aid to  ?build better risk decisions? (Lundgren & McMackin, 2013, p.16). This type of risk communication model could be utilized in future focus group sessions as a strategy to exchange ideas between pharmacy and health and safety personnel to speak about value, attitudes and beliefs related to prevention of cytoxic drug exposure.     125 What are your throughts on the findings of the Employee Questionnaire? Employees were shown results of the employee questionnaire and then asked what their thoughts were.  Results shared with participants showed that the use of personal protective equipment (PPE) when preparing cytotoxic was inconsistent across the organization.  At four of the five focus group sessions, participants discussed their views regarding the inconsistent use of respiratory protection when handling cytotoxic drugs.  Two participants expressed views of how they were not convinced that the respiratory protection was effective in protecting them from exposure to cytotoxic drugs.  Another participant spoke of how she/he would not wear a respirator because of the discomfort associated with using one.  A study by Hambach et al. (2011) studied the views of workers in Belgium in the chemical industry prior to implementing a safety program.  Hambach et al. also found that focus group participants indicated that there was discomfort associated with the use of PPE and workers would be willing to run health risks to avoid the use of it.  In a Canadian study that explored health care worker?s views in the aftermath of Severe Acute Respiratory Syndrome (SARS) (Moore et al., 2005) participants spoke of the discomfort associated with wearing PPE and availability of equipment as factors that impact their safety.  If one wanted to probe further into pharmacy personnel?s views related to PPE, future employee questionnaires could include questions related to the use of PPE and factors that influence the choice to utilize it.  Are there Barriers to Working Safely With Cytotoxic Drugs? One of the objectives of the focus group sessions was to identify potential barriers to working safely with cytotoxic drugs.  Some examples of barriers heard at focus group   126 sessions included: a lack of time and resources to complete daily tasks safely, complacency and individual technique, relationships amongst health care professionals, the physical nature of mixing and handling the cytotoxic drugs, and the physical design of the worksite, whether it was the layout or the size of the facility that participants worked in.  Some examples of barriers expressed by those in the pharmacy focus group sessions were comparable to another study that took place involving Canadian health care workers. The study by Moore et al. in 2005 utilized focus group sessions to gain insight into worker perceptions of occupational health and infection control practices following the Severe Acute Respiratory Syndrome (SARS) outbreak in 2003.  Interestingly, despite the different exposure agents (i.e. a virus versus a hazardous drug) similar ideas emerged from focus group participants.   For example, participants in the Moore et al. study and in the pharmacy focus groups both brought forward the issue that the physical design and space was not adequate to meet the standards recommended to control the spread of infection or exposure respectively (e.g. no anterooms, limited number of negative pressure rooms).  Participants in the pharmacy focus groups indicated that physical space and design of worksite was a barrier to working safely with cytotoxic drugs.  Pharmacy focus group members also expressed concerns regarding workplace attitudes towards health and safety during discussions to identify barriers to working safely with cytotoxic drugs.  These same ideas were also raised during dialogue about working safely with cytotoxic drugs, the environmental assessment results and when talking about the approach that should be used to promote working safely with products. Participants in the Moore et al. (2005) study discussed ideas about workplace attitudes   127 towards safety (e.g. perception of importance of occupational health and safety, safety climate) and this was seen as being important factors for self-protection in the workplace.  Individual factors were an additional group of key issues identified by the Moore et al. (2005) study that was important for self-protection at work.  Participants from the aforementioned study mentioned that fatigue was a cause for not following correct guidelines for infection control.  Similarly, participants from the pharmacy focus groups brought forward the issue of fatigue and lack of time to carry out their work safely as an example of a barrier to working safely.  At two pharmacy focus group sessions, participants indicated that the job of mixing the products was very physically intensive and this combined with workload load can lead to having to ?cut somewhere?.  In addition, within two of the pharmacy focus group sessions, relationships between workers both inside the pharmacy department and outside of the department were spoken of as examples of barriers to working safely with cytotoxic drugs.  Within the context of the study on the healthcare workers during SARS, both attitudes (e.g. professionalism) and peer environment (e.g. peer compliance and peer feedback) were identified as individual factors in self-protection (Moore et al., 2005).  At the outset of the focus group sessions, knowledge of individual factors as barriers that could impact working safely with cytotoxic drugs was mostly unknown.  At the conclusion of this phase of the study, it can be seen that there are future opportunities to explore the information provided by focus group participants.  For example, a future employee questionnaire could be used as a tool to gather more information on views of attitudes and the peer environment.     128 What Strategies should be used to Promote Working Safely with Cytotoxic Drugs? The third objective of the focus group session was to engage pharmacy personnel in the process of proposing strategies to promote working safely with cytotoxic drugs.  Various ideas came forward throughout the discussions on how the organization could strategize to promote working safely with the products.  In particular, consistent safe handling procedures and protocols was a strategy identified by participants in these sessions.  Inconsistent safe work procedures were also a concern of health care workers involved in the Moore et al. study (2005) and an example of an organizational factor that impacted self-protection during the 2003 SARS outbreak.  Based on results from the environmental assessment and employee questionnaire the investigator also identified the need for consistent safe work procedures for working with cytotoxic drugs.  One quote from a participant ??safe handling procedures is number one [priority], handling the drugs all the way through...? expressed the idea that safe handling of these products needs to begin upon arrival at the worksite, and continue throughout the processes within the pharmacy department.  A protocol for receipt of the products was proposed as a safety initiative to bring forward.  Additionally, a protocol for checking products safely, one of the last steps of product handling within the pharmacy department, was also a potential initiative to propose.  Increased supervision, along with enforcement of policies and protocols was brought forward by participants in three of five groups during the discussion of strategies to   129 promote working safely with cytotoxic drugs.  This information should be shared with managers and supervisors within the pharmacy department at the conclusion of the research project.  As a side note, manager and supervisor training for safety responsibilities has been available within the organization since 2007.   Training was identified by the investigator from the employee questionnaire as an area that required attention and also from participants throughout focus group sessions.   A desire for training was discussed by the participants when reviewing the results of the employee questionnaire and also during the discussion of strategies to work safely with cytotoxic drugs.  Deficiencies in training were another organizational factor identified as impacting self-protective behavior during the SARS outbreak (Moore et al., 2005).  Two possible safety initiatives could be a standardized new worker orientation focusing on working safely with cytotoxic drugs and standardized training for spill cleanup.   The new worker orientation could act as an initial baseline piece of information to inform workers of protective measures, routes of exposure and risk to health; it would also aid in meeting the requirement for training under WorkSafeBC (WSBC) regulations.  A standardized process to clean up cytotoxic drugs was a deficiency noted in the environmental assessment, discussed by focus group participants and would also aid in meeting WSBC regulations and recommendations by BC Cancer Agency.   Additional Observations from Focus Group Sessions  In one focus group session, the relationship between occupational health and safety and patient safety was discussed.  Across Canada, there is an emphasis on patient safety and the ability to access high quality patient care.  The ability to provide quality care is impeded by a number of factors that include a reduced availability of health care   130 professionals as a result of workplace injuries, illness, long-term disability as well as incidence of infection control quarantines.   Research carried out by Yassi and Hancock in 2005 within the BC health care sector suggested that taking care of healthcare worker well being is an essential component of improving the quality and safety of patient care.  As this idea was only discussed at a single focus group session, it is unknown how other personnel working in other worksites would view the message ?working safe will transcend into good quality patient care?.  Another idea that arose from a single focus group session was a concern that exposure to antibiotic resistant organisms and latex were a greater risk than exposure to cytotoxic drugs.  The rationale for this is unknown but there may be several possible explanations.  One possible explanation for fear of exposure to antibiotic resistant organisms could be that the effect is immediate for the most part and could put a family member at risk for an infection (?I?m more worried about MRSA [methicillin resistant Staphylococcus aureus] and VRE [vancomycin-resistant Enterococci], am I taking that home to my kids??).  Conversely, the individual may have thought the health effects of exposure to cytotoxic drugs would not be transmissible to family members and take some time before showing any health effects (e.g. I just think that nine nanograms [of cytotoxic drug] is going to take a while to kill me off).  In addition, antibiotic resistant organisms in hospital settings may receive a greater degree of media and research attention, and as such may make workers more aware of the risk and presence of such issues.  Conversely, workplace exposure to cytotoxic drugs and potential health outcomes from exposure to these products may not garner as much interest.  If workers were unconvinced of health evidence for the impact of occupational exposure to   131 cytotoxic drugs, one possible approach to address this would be to establish a risk communication strategy to share information with those handling the products.  However, prior to moving forward on this idea, it would be important to investigate further to determine if this idea is specific to a single worksite or a single individual.       A final theme from one focus group was the impact from an environmental perspective and safe work procedures related to cytotoxic drugs (?there is a lot of waste, too much waste, we are wrecking the environment with all of the waste for this?).  The participants that brought forward this idea indicated that following safe work procedures that resulted in increased environmental waste was an overall barrier to working safely with the products.  A 2009 publication by Cotton and Cohen raise the issue of eco-conservation and health care ethics.  These investigators cite several points regarding medical waste in the United States such as:  1.) US hospitals generate more than 7,000 tons of waste per day; 2.) hospitals reportedly throw up to 70% of their waste into the biohazardous waste stream, although much of this waste is similar to that generated by a hotel or large office building (i.e., mostly paper, cardboard, and food waste); and 3.) the US Centre for Disease Control has indicated that only about 2% to 3% of the waste from hospitals needs to be disposed of as biohazardous waste.  Although this information is from the US, it is likely that the values for hospital waste in Canada would be similar just on a smaller scale based on our population size.  An interesting future direction may be to examine safe work procedures for cytotoxic drugs from both an occupational safety and environmental impact perspective.  However, as this idea was brought forward in isolation by only a single focus group session; it would make sense to probe further to see if this is a concern or seen as a barrier for following safe work procedures by   132 personnel working in other pharmacy settings.  It is unknown as to why this idea was brought forward by a single focus group.  It may be related to relatively recent recommendations that were made by an external agency (i.e. BC Cancer Agency) to follow processes that were new to the worksite at the time of the focus group session (??When they came they told us that we had to use an alcohol swab to wipe each vial down, and I don?t understand why, they said it?s for our safety, but it?s really wasteful??).   4.6 Summary from Phase 3: Focus Group Activities The overall  objective for the focus group phase of the thesis work was achieved.  The group interaction approach allowed me to obtain further depth and detail on participants? views on working with cytotoxic drugs, which ranged from concerns about risk of present and past personal health to no concerns about personal safety.  Barriers to working safely with cytotoxic drugs were revealed including challenges such as a lack of time, physical space and resources (training and supervisor support), complacency, and the physical demands of the job.  These barriers to working safely can assist in recommending areas where improvements can be made in process or additional support is needed for pharmacy personnel. When results from the environmental phase of the study were shared, participants hypothesized why surface contamination was present and some participants questioned the significance of the levels of contamination.   Another outcome of the focus group was the engagement of employees in proposing potential safety initiatives for working with cytotoxic drugs.  Some examples from participants for safety initiatives included   133 protocols for safe handling of cytotoxic drugs, training for new employees, and spill response.   The knowledge gained from focus group participants was invaluable to this research.  The focus group sessions were an opportunity to gain insight into the perspective of front-line pharmacy personnel on the topic of working safely with cytotoxic drugs and yielded important information to move forward with initiatives aimed at making the workplace safer. Furthermore, many of the different ideas that focus group participants shared with the investigator could be used to generate questions for future investigations.                      134 Chapter 5  Phase 4: Piloting of Safety Initiatives 5.1 Introduction to Phase 4: Piloting of Safety Initiatives Professionals working in the area of human resources for corporations have indicated that the engagement of stakeholders in the decision-making processes can enhance performance within an organization as well as improve a corporation?s reputation.  Furthermore, having employee input as key stakeholders is notably one of the methods known to be progressive in performance management of a company (Simmons, 2008).   The structure of this research has been to engage pharmacy personnel as key stakeholders through dialogue during worksite environmental assessments, an employee questionnaire and focus group sessions.    The next step in the study was aimed at gaining stakeholder feedback on safety initiatives selected based on information collected in the preceding phases and piloted in the five participating worksites.  It was a necessary step in the study to commence trialing preventative strategies, based on results from the first three phases, that included direct input from frontline workers handling cytotoxic drugs in pharmacy worksite.  Furthermore, another goal of this phase of the study was for pharmacy personnel to evaluate the initatives that would inform changes to the initiatives prior to future formal implementation.       135 5.2 Objectives of Phase 4: Piloting of Safety Initiatives The objectives of this phase of the research were:  1.) To create and implement standard safe work procedures and training based on results from the environmental assessment, participant questionnaire and focus group sessions.  2.) To obtain feedback on the safety initiatives from pharmacy personnel who handle cytotoxic drugs. 5.3 Methods for Phase 4: Piloting of Safety Initiatives Selection of Initiatives From the information gathered in the first two phases of the project it was possible to identify protocols and procedures initially in place pertaining to the handling of cytotoxic drugs across the organization.  In the third phase of the project, focus group participants provided input as to what approaches should be utilized to promote working safely with cytotoxic drugs.  The following criteria were used to select the initiatives that would be developed, piloted and evaluated in this phase of the research: 1.) the initiatives had to be examples of ideas identified in a preceding phase of the research (i.e. a result discussed in the environmental assessment, employee questionnaire or focus group sessions); 2.) initiatives must have limited fiscal impact on pharmacy department operations (e.g. would not require the purchase of capital equipment or impact staffing levels); and 3.) the initiatives should help to address gaps in the organizational ability to meet WorkSafeBC regulatory requirements, BC Cancer Agency recommendations or standards in USP 797 (Table 5.1).  The investigator proposed six ideas for potential   136 safe work procedures or training initiatives to be piloted in this phase of the study: 1.) Standardized Spill Response; 2.) Implementation of N95 Fit Testing (and other respiratory protection); 3.) Personal Protective Equipment for Handling Hazardous Drugs; 4.) Protocol for Checking Products; 5.) Protocol for Receiving Products and 6.) Standardized New Worker Orientation for Hazardous Drug Handling.                       137 Table 5.1: Criteria used to bring forward safety initiatives for selection by pharmacy supervisors. Proposed Initiative (Target group) 1. Identified in another phase of research 2. Inclusion will have limited impact on worksite resources 3. Inclusion will aid in meeting a regulatory requirement or standard Can initiative be seen to fit within a construct or diagnosis factor in a health behavior model? Standardized spill response protocol and training (All pharmacy) ? Environmental Assessment ? Employee questionnaire ? Focus Group Sessions Investigator responsible for development of protocol Hands-on exercise approximately 30 minutes in length.  Yes, required under WorkSafeBC regulations. Recommended by BC Cancer Agency. Yes, diagnosis factor in environmental/contextual model (PRECEDE)   Yes, in construct of value-expectancy model ?self efficacy? Implementation of N95 Fit Testing and other respiratory protection. (All pharmacy) ? Environmental Assessment ? Employee questionnaire ? Indirectly in focus group sessions (i.e. standardization of protocols)  Fit testing approximately between 20-40 minutes per employee Investigator to arrange steps for exercise Protocols to be updated by pharmacy personnel Yes, required under WorkSafeBC regulations. Recommended by BC Cancer Agency for specific tasks. Yes, diagnosis factor in environmental/contextual model (PRECEDE).  Yes, in construct of value-expectancy model (Health belief model) ?barriers? Consistent Personal Protective Equipment for handling hazardous drugs. (All pharmacy) Development of matrix for tasks and required personal protective equipment to be created by investigator with input from pharmacy Recommended by BC Cancer Agency for specific tasks and within USP 797 standards Protocol for checking cytotoxic drugs (Pharmacists) Designed by investigator Approximately 30 minutes for workers to review each protocol as applicable to occupation time to complete evaluation.  Safe work procedures required under WorkSafeBC requirements, protocols for checking and receiving not clearly defined by other two agencies Yes, in construct of value-expectancy model both ?self efficacy? and ?response efficacy? Protocol for receiving cytotoxic drugs inside pharmacy (Pharmacy technicians) Standardized New Worker Orientation for Hazardous Drug Handling ? Employee questionnaire ? In focus group sessions (i.e. standardization of training)  Designed by investigator with input from pharmacy personnel, approximately 60 minutes in duration for worker attendance plus time to complete evaluation Requirement under WorkSafeBC regulations. Yes, diagnosis factor in environmental/contextual model (PRECEDE).     138 Pharmacy site supervisors were contacted by e-mail by the investigator with information to explain that the next phase in research was to create and pilot safety initiatives.  The investigator included a brief description of each initiative and requested that pharmacy supervisors communicate their three preferences for initiatives. Following the input from pharmacy site supervisors, the investigator reviewed communications and four initiatives were selected for piloting at the five work sites.  Initiatives that were not selected were noted for future action items in the pharmacy department.   The four initiatives selected by show of majority from worksite supervisors were: 1. Protocol for Receiving Products. 2. Protocol for Checking Products. 3. Standardized Spill Response 4. Standardized New Worker Orientation for Hazardous Drug Handling Design of Initiatives The Protocol for Receiving Cytotoxic Drugs was designed to cover the key steps for receipt of the products, and the identification of potential hazards and precautions to be taken.  Prior to the creation of this protocol an online search was carried out to determine if protocols for this task already existed.  The National Institute for Occupational Health and Safety (NIOSH) recommended in 2004 that those who receive cytotoxic drugs should be wearing chemotherapy gloves, protective clothing and eye protection when opening packages (NIOSH, 2004).     139 The design of the Protocol for Checking Cytotoxic Drugs was based on the investigator observing the task of checking the products with a pharmacist.  The pharmacist took the investigator through each step of checking the chemotherapy products and both identified areas that could cause injury or risk of exposure during the process.  The design of the protocol for checking followed the same format as the protocol for receiving in terms of the key steps, potential hazards and precautions.   The pharmacy departments in the study all had internal policies that addressed spill response.  This information was compared with protocols from the British Columbia Cancer Agency recommendations and information was combined to create a one-page procedure for spill response.  Two additional sections were added to this procedure:  personal protective equipment to be worn during spill response and steps to be taken in case of accidental exposure. Another component built into piloting the standardized spill response was to have participants use the protocol in a hands-on, mock spill exercise.   The final initiative, Standardized New Worker Orientation for Hazardous Drug Handling was designed to be a presentation combined with a practical spill clean-up exercise.  The information in the presentation was divided into two sections:  ?What do you need to know?? covering topics on routes of exposure, health effects from exposure, and regulations and policies; and ?What do you need to do?? covering topics on location of your spill kit, participation in a site-based spill drill, and location of your nearest eyewash station and shower.        140 Piloting of Initiatives The order in which the safety initiatives were introduced was as follows:  Spill Response Protocol, Receipt of Hazardous Drugs Protocol, New Employee Orientation and Checking of Hazardous Drugs Protocol.  To gain insight into the spill response protocol tool, the investigator travelled to each worksite to facilitate a spill drill.  During the spill drill, site personnel followed the spill response protocol provided.  While on-site, the investigator spoke with those staff members who received cytotoxic drugs and introduced the new protocol for this task.  Staff members then had an opportunity to pose questions to the investigator about the new protocol.  The draft protocol for checking cytotoxic drugs was disseminated by pharmacy management to pharmacists to receive feedback.  For the Standardized New Worker Orientation Hazardous Drug Handling, the investigator was invited to present this initiative at a pharmacy new employee orientation day.  Additionally, this was also piloted on a group of existing employees.  The presentation for existing employees took place with employees at worksite #1.   Feedback on Initiatives For each initiative introduced at a worksite, evaluation forms were provided to staff to enable the investigator to receive feedback.  The number of evaluations provided by the investigator was based on communication with the worksite supervisors.  The investigator tracked the number of evaluations provided to worksite in order to be able to calculate an overall rate of participation for the initiatives.  All evaluations were anonymous and sent to the investigator in pre-addressed envelopes.  The evaluation form asked for responses to the following questions using a Likert scale:     141 1. This information on cytotoxic drugs is applicable to me in my job. 2. This information increased my knowledge on working safely with cytotoxic drugs. 3. I will be able to use this information when performing my duties at work  4. The use of this information will help reduce my potential exposure to cytotoxic drugs.  In addition, there was a section on the evaluation form for participants to indicate what he or she liked about the initiative and what she or she would do differently.  A copy of the feedback form may be viewed in Appendix D.   5.4 Results for Phase 4: Piloting of Safety Initiatives Overview of Results The four initiatives were introduced to the worksites over a three-month period and 95 evaluations were disseminated to staff in for feedback.  The total overall response rate for the evaluations was 78% (n=74).  As outlined in the Methods section above, employees answered four different questions about the initiatives using a Likert scale response.  The results for evaluations received from all participants for all initiatives combined may be viewed in Table 5.2.           142 Table 5.2: Overview of results expressed in percent from evaluations from all safety initiatives shown in percent (%) of participants (n=74).  Question Posed Strongly Agree Agree Neutral Disagree Strongly Disagree This information on cytotoxic drugs is applicable to me in my job 60.8 29.7 5.4 4.1 0.0 This information increased my knowledge on working safely with cytotoxic drugs 45.9 39.2 13.5 1.4 0.0 I will be able to use this information when performing my duties at work 45.9 43.2 10.8 0.0 0.0 The use of this information will help reduce my potential exposure to cytotoxic drugs 48.6 43.2 8.1 0.0 0.0  Protocol for Receiving Cytotoxic Drugs and Protocol for Checking Cytotoxic Drugs Overall, these initiatives acquired the least amount of feedback from worksite personnel with seven evaluations received for the Receiving Products Protocol and four for the Checking Products Protocol.  For the protocol for receiving hazardous products within the pharmacy, some examples of positive comments from participants were: ?Very Clear, easy to read & understand nice to have something easy to read and refer to? and ?Straight forward step by step instructions?.  Some examples of constructive feedback from participants on what they would change about the protocol were: ?Use of disposable gown + goggles may be a bit 'overkill' for handling outside of mixing?, ?Do not agree with protocol in receiving chemo drugs, too much? and ?question the level of PPE used at initial stage of inspection?.  For this protocol, all respondents agreed or   143 strongly agreed that the protocol was applicable to them in their role.  All respondents also indicated that they agreed or strongly agreed they would be able to use the information when performing their duties at work.  When answering the question as to whether the information increased their knowledge on working safely with cytotoxic drugs, three participants were neutral and the other four either agreed or strongly agreed.  Finally, all participants agreed or strongly agreed that the use of the information will help reduce their potential exposure to cytotoxic drugs.  For the checking of product protocol, as stated above, only four responses were received.  Some examples of positive comments from participants were: ?Good to have feedback to know what we are doing right or wrong and how to be up to date in handling cytotoxic drugs?, ?Not applicable to our procedure, information is good?, ?Clear, concise and provides rationale behind? and ?Good information on precautions?.  Some examples of constructive comments on what participants would do differently were: ?Some of the protocol did not apply to my worksite as pharmacist checks chemo while tech still has drug in hood, therefore pharmacist does not directly handle in most circumstances?, ?Our product is bagged in the mix room so the checker is not exposed directly to Rx? and ?Not applicable to all sites-my site has the pharmacist check the final product in the hood?.  Two of the four participants indicated that they disagreed that the protocol was applicable to them in their job whereas the other two participants agreed or strongly agreed that it was applicable.  Three of the four participants agreed the protocol increased their knowledge on working safely with cytotoxic drugs.  Finally, three of the four participants agreed or strongly agreed the information would help to reduce their   144 occupational exposure to cytotoxic drugs and also that they would be able to use the information in the course of their duties.   Standardized Spill Response A total of 46 evaluations were received from participants across the five worksites for the standardized spill response initiative.  For the section on the evaluation that enabled participants to indicate what he or she liked about the initiative, 87% of participants entered information in the comment box.  Some examples of positive comments from participants were: ?Step by step safety involving clean up of cytotoxic spill in pharmacy?, ?I found it helpful to do a walkthrough of the clean-up procedures? and ?Directly related to my job. Good review since spills don't happen frequently therefore out of practice?.    For the question ?what I would do differently?, 28% of participants entered information.  Some examples of what participants indicated she or he would change about the initiative were: ?redesign one-page to ensure steps are followed in correct order?, ?Update spill kits, add another to the department in a different location, update contents list, procedure to be reviewed more often? and ?Our group didn't really take this serious, that's our fault. It would be great if proper spill kits were enforced but this department can't handle change?.   When asked about the applicability of the initiative, 91% of participants either strongly agreed or agreed that it was applicable to their job.  For the question regarding whether the spill response initiative had increased the knowledge of the participant, 87% of respondents indicated that they strongly agreed or agreed.  For this initiative, 91% of participants either agreed or strongly agreed they would be able to use this information when ?performing my duties? at work.  Finally, for the question about whether using the information from the standardized spill response safety   145 initiative would help reduce potential exposure to cytotoxic drugs, 94% of participants either strongly agreed or agreed.  Standardized New Worker Orientation Hazardous Drug Handling A total of 18 evaluations for the Standardized New Worker Orientation were received from participants, seven were from new employees and 11 were from existing employees.  Only new employees provided feedback for what she or he would do differently with this safety initiative and the suggestions were as follows: ?Some information about dispensing Tablets in the dispensary (creams/ointments) [sic] would be helpful? and ?Would be good to hand out the checklist of what to look for at your site?.    Both existing and new employees provided feedback to the investigator on what he or she liked about the safety initiative.  Some examples of comments from both groups are shown in Table 5.3. Table 5.3: What ?New? and ?Existing? Employees liked about ?Standardized New Worker Orientation: Hazardous Drug Handling? (n=18). New Employees Existing Employees ? This is a subject of high interest to me ? Lots of good information. Will be useful if I ever work in the chemo department ? Very practical information, I like the checklist of what to look for at your site ? Informative ? Interactive and informative and will come into use when I get my chance to go into the hood ? It was informative ? Short, sweet, easy to follow ? Was a good refresher ? Distribute sampling result study for chemotherapy    146 Results for both existing and new employees from the standard questions used in the evaluations are shown in Figure 5.1.  No responses were received that indicated participants disagreed or strongly disagreed.  Figure 5.1: Results from evaluations received from participants that attended the training session entitled Standardized New Worker Orientation Hazardous Drug Handling.  This Figure shows responses from both new (n=7) and existing (n=11) employees.  5.5 Discussion of Phase 4: Piloting of Safety Initiatives The overall objectives for this phase of the study were to design and pilot safety initiatives based on results from previous phases and receive feedback from key stakeholders that handle cytotoxic drugs.  This phase of the research had a 30% higher 33 64 50 36 50 36 50 27 50 36 50 55 17 55 50 55 17 0 0 9 33 9 0 18 0 10 20 30 40 50 60 70 80 90 100 New  Existing New  Existing New  Existing New  Existing This information on cytotoxic/hazardous drugs is applicable to me in my job This information increased my knowledge on working safely with cytotoxic/hazardous drugs I will be able to use this information when performing my duties at work The use of this information will help reduce my potential exposure to cytotoxic/hazardous drugs Percent of Participants (%) Strongly Agree Agree Neutral    147 overall participation rate when compared to the employee questionnaire phase of the research.   The greatest amount of feedback from participants came from the spill response initiative and the standardized new employee orientation. Protocol for Receiving Cytotoxic Drugs and Protocol for Checking Cytotoxic Drugs The protocol for receiving hazardous drugs received feedback from seven participants across the health authority.  Overall, participants either agreed or strongly agreed that using the information would help reduce their potential exposure to cytotoxic drugs, would be able to use the information while performing duties at work, and that it was applicable to him or her in their role.  However, there were also comments indicating that the level of personal protective equipment was too stringent.  Prior to the creation of this protocol, no safe work procedure was in place at any worksite for this task and like all of the safety initiatives, this was also suggested by focus group members and selected by pharmacy supervisors to pilot.   The rationale for selection of personal protective equipment to be worn while receiving hazardous drugs was based on information gathered by the investigator from the literature that reports cytotoxic drug contamination on product packaging and the United States Department of Labor Occupational Health and Safety Administration (OHSA) recommendations (OSHA Technical Manual (OTM) Section VI: Chapter 2, 1999). Furthermore, there is evidence in the literature that suggests hazardous drug containers that make their way to healthcare facilities are contaminated from the manufacturer.  For example, a Canadian pilot study from 2008 (Touzin et al.) looked for the presence of cyclophosphamide on the outside of containers.  The study demonstrated that cyclophosphamide could be   148 found on the external surfaces of vials from two Canadian manufactured products.  Therefore, if containers with these products arrive at healthcare facilities with surface contamination, it would be important to wear personal protective equipment when unpacking the products as well as cleaning the vials during subsequent handling to reduce occupational exposure. As an additional factor to consider, work completed in 2012 by Hon reported that pharmacy receivers in BC hospitals had detectable levels of cyclophosphamide in their urine.  This information was not known at the time of piloting this initiative, but provides further evidence to support the need to use personal protective equipment during tasks associated with receiving cytotoxic drugs.  Future work with pharmacy technicians should include an investigation into elements that would impact workplace self-protective behavior following a safe work procedure for receiving cytotoxic drugs.  The protocol for checking hazardous drugs received the least amount of feedback from participants, with only four responses received.   The development and piloting of this protocol was suggested by focus group participants and selected by worksite supervisors.  The design of this protocol was carried out under the guidance of a pharmacist who routinely checks hazardous drugs, and the intent was to standardize the process while reducing the potential for environmental and personal contamination.  The rationale as to why such limited feedback was received from pharmacists who check cytotoxic drugs is unknown.  Interestingly, in three of the four evaluations received, there were statements in the comments section indicating that the protocol would not be applicable to the worksite based on current practice, one of which indicated because ?Our product is bagged in the mix room so the checker is not   149 exposed directly to Rx?.  Having the product bagged within the room where the product was mixed was a standard practice within the organization; however, based on wipe test results from the environmental assessment phase of this study, there was evidence to support surface contamination where products were checked and inside transport boxes.  Therefore, there is the potential for pharmacists checking product to have exposure to these products through dermal contact.  Furthermore, a study published by Hon et al. in 2011 demonstrated that cytotoxic drugs were detected on the hands of a pharmacist whose role was to check product in a BC hospital.  One possible strategy to promote this protocol with the pharmacists who check these products would be to share the results of the environmental phase of this study along with the results of the Hon et al. study.  Along with the promotion of personal safety to reduce dermal contact and environmental contamination, another element that could be included is an emphasis on patient safety (e.g. wearing personal protective equipment will reduce microbial contamination of products leaving the pharmacy area).   However, prior to moving forward on a formal implementation of a protocol for checking cytotoxic drugs, more work is likely needed to investigate elements that would impact workplace self-behavior in pharmacists.   Standardized Spill Response The piloting of the safety initiative that was aimed at standardizing spill response overall received the greatest amount of feedback.  The number of evaluations received on this particular initiative accounted for greater than half of all responses received for the initiatives and nearly all participants included positive comments on the form.  The most likely explanation for the large amount of feedback was that spill response protocols and   150 exercises could be applied to the majority of pharmacy personnel, whereas the initiatives for receiving, checking and orientation for new workers were applicable to a smaller population.  Feedback on this standardized protocol was integrated into a final product that was disseminated to worksites.   This initiative was important for many reasons as the issue of spill response was identified during the environmental assessment of worksites and during the focus group sessions.  Furthermore, having a consistent spill response plan in place should enable the organization to meet regulatory requirements from WorkSafeBC.   Ideally, spills working with these products should not occur on a regular basis. However, having the tools and knowledge is important to reduce the risk of environmental contamination and potential exposure to personnel.   Standardized New Worker Orientation Hazardous Drug Handling All new employees that work for the health authority receive a general, new employee orientation that includes various components of occupational health and safety training (e.g. violence prevention, musculoskeletal injury prevention, general safety).  However, the aim of the particular training included in this dissertation was to focus on introducing new pharmacy employees to working safely with cytotoxic drugs in a standardized format.  This module served as an introductory step in providing information to employees about routes of exposure, health effects and ways to prevent exposure to cytotoxic drugs.  As described in the methods and results, this initiative was piloted on both new and existing employees and both groups provided positive feedback about the orientation.    When comparing the feedback on this initiative between new and existing employees, there were some differences.  For example, when asked if the information   151 was applicable to employees in their work, two thirds of existing employees surveyed indicated they strongly agreed with the statement versus only one third of new employees strongly agreed.  For the remaining questions on the evaluation, half of the new employees strongly agreed with the statements, compared to existing employees where the values for strongly agreeing ranged from 27% to 36%.  However, existing employees overall had fewer neutral responses on the evaluation compared to the new employees.  The difference in response to the question on applicability of the initiative to one?s present job may be because the existing employees who attended the session are likely those that already work with the products and as such may be more aware of how the safety information applies to the workplace.  Work carried out by Massoomi et al. in 2008 conducted a gap analysis to design a safety program pertaining to handling cytotoxic drugs in a community hospital in the U.S.  One key component that was identified as a gap in the assessment portion of the work was insufficient knowledge among hospital personnel regarding the risk and severity of workplace exposure to cytotoxic drugs.  This group indicated this deficit was a critical issue that should be a priority and a formal education plan was implemented for all staff that handled these products.  Another study by Sheyn et al. from 2008 implemented a radiation safety education initiative with the aim of reducing occupational exposure to radiation in a U.S. hospital.  The results of the study indicated that there was an overall increase in the use of personal protective equipment amongst the team of health care providers and thus a potential reduction in occupational exposure if equipment was used correctly.  Prior to piloting this standardized training module, the practice at worksites for orienting new employees varied across the health authority.    152 Given the positive feedback from both new employees and existing employees, it would be beneficial to formally implement a standardized training module to ensure that all workers are aware of the risks of working with cytotoxic drugs and the precautions that need to be taken to reduce exposure.  Furthermore, the standardized training could be modified slightly to include those that administer products at worksites in acute, home and community or residential care.   Applicability of Health Behavior Models to Piloting Safety Initiatives This phase of research piloted four safety initiatives as a starting point to target preventative strategies to reduce occupational exposure to cytotoxic drugs.  Based on the feedback obtained from stakeholders that participated in the evaluation of the initiatives, additional information can be factored into the theoretical models of health behavior.   Standardized Spill Response  The first safety initiative that was piloted was a standardized approach to the clean-up of cytotoxic drug spills.  This initiative was selected as it was identified in multiple phases of this research as a target.  The feedback provided by pharmacy personnel on spill response can be factored into a theoretical model of health behavior as additional pieces of defined constructs.  When considering feedback on spill response, this can be situated as new information that can be factored into a value-expectancy model as an element of the self-efficacy construct.  In focus group sessions and the employee questionnaire, it was theorized by the investigator that not all workers felt confident about their ability to perform a cytotoxic drug spill clean-up.  In contrast, based on the   153 new information obtained from the piloting of a standardized spill response, there was evidence to suggest that an element of self-efficacy on this safe work procedure may be emerging.  There is no way to objectively measure a change in self-efficacy because the tools used to gather information on spill response have all been variable.  However, based on the responses of participants who completed the evaluations, it can be said that 87% of participants agreed or strongly agreed the initiative had increased their knowledge on spill response.  Furthermore, 91% of participants agreed or strongly agreed they would be able to use the information on spill response when performing their duties at work. When considering the element of response-efficacy for spill response, no information had been seen in the results of the previous phases of research.  However, the evaluations completed by participants in this phase of the study showed that 94% of participants indicated the use of the information from the standardized spill response would help reduce potential exposure to cytotoxic drugs and thus leading the investigator to surmise that the recommended precautions were perceived as being effective.  Protocol for Receiving Cytotoxic Drugs and Protocol for Checking Cytotoxic Drugs The feedback received from employees on the protocols for receiving cytotoxic drugs and checking cytotoxic drugs was limited by sample size.  However, even with this limited information, it was still possible to begin theorizing how this feedback can be integrated into the models of health behavior.   What was common to the feedback received on both of the protocols was that information could be situated within the construct of threat-related beliefs that is a piece of the value-expectancy models.    The   154 threat-related beliefs are the beliefs that a worker may have about the severity of a hazard and susceptibility (DeJoy, 1996).    In the evaluations of the protocol for receiving cytotoxic drugs (n=7), each participant that completed the evaluation either agreed or strongly agreed that using the information would help reduce their potential exposure to cytotoxic drugs, would be able to use the information while performing duties at work and that it was applicable to him or her in their role.  However, there were also comments on three of the seven evaluations that indicated the level of personal protective equipment was too stringent.  This led the investigator to theorize how these comments fit into the value-expectancy constructs.  The challenge was that the investigator does not know the rationale behind the belief expressed by three of seven participants that the level of personal protective equipment recommended for receiving products is too stringent.   For example, it could be that workers do not believe he or she is at risk to exposure during a task such as receiving in the absence of wearing personal protective equipment, as such a threat related belief.  Perhaps, it may be that the use personal protective equipment was a barrier and not readily available in the area where products are received inside the pharmacies or that the worker perceived the use of the equipment will cause discomfort.  There may also be an element of normative expectations that factor into the use of personal protective equipment when receiving cytotoxic drugs in that there are social or organizational factors influencing behavior.  For example, perhaps the pharmacy technician did not observe his or her co-workers wearing personal protective equipment while receiving cytotoxic drugs.   At this point, before formally implementing this protocol, more information should be gathered from pharmacy technicians as to their   155 beliefs related to following the protocol based the results from this phase and limited sample size.    The protocol for checking cytotoxic drugs within the pharmacy setting received the least amount of feedback for all safety initiatives (n=4).  The rationale as to why such limited feedback was received from pharmacists who check cytotoxic drugs was unknown.  However, the written feedback on three of the four evaluations received included statements from participants indicating that the protocol would not be applicable to the worksite based on current practice, one of which indicated because ?Our product is bagged in the mix room so the checker is not exposed directly to Rx?.   Despite the feedback being so limited, the information can be placed in a theoretical model of health behavior such as the PRECEDE model.  Within the PRECEDE model, the knowledge conveyed by participants could be considered an enabling factor for the motivation to follow a new safe work procedure. If participants (based on their understanding of the drug preparation process) believed the person checking the drugs would not be exposed, this could block the self-protective action (DeJoy, 1996) for following the recommended safe work procedure.  However, those that completed the evaluations of the product checking initiative may not have had the knowledge piece at their disposal to know that drugs have been isolated from work surfaces where the products are being checked, along with the boxes that the products are being transported to units at the hospital despite the drugs being packaged in a bag.    This type of information provided on the evaluations could also be situated in the value-expectancy models.  For example, it could be that workers who completed the evaluation do not believe he or she is at risk to exposure during checking the product, as such this could be a threat   156 related belief.  As discussed following an examination of focus group results, a risk communication strategy may help to address and learn more about threat related beliefs and exposure. Standardized New Worker Orientation Hazardous Drug Handling The results on evaluations (n=18) received from piloting the standardized new worker orientation for handling hazardous drugs can also be theorized to fit within a theoretical model of health behavior.   Nearly all participants that completed the evaluation for this initiative either agreed or strongly agreed that the initiative increased their knowledge on working safely with cytotoxic drugs.  This information can be situated as new information that can be factored into a contextual or environmental model as an enabling factor in the PRECEDE model.   In this case, it would be that this group of workers who participated in the new worker orientation now had a piece of knowledge that could facilitate self-protective actions (DeJoy, 1996) in the area of routes of exposure, health effects and ways to prevent exposure to cytotoxic drugs.   In the value-expectancy constructs, results from piloting the training can also be situated as new information in the response-efficacy construct.    Prior to piloting this initiative, there was no concise means of communicating the available safety measures to new employees on working with cytotoxic drugs.  Of those who participated in the evaluation following the module, nearly all participants either agreed or strongly agreed that the use of the information from the training module would help reduce potential exposure to cytotoxic drugs, thus leading the investigator to surmise that the recommended precautions were perceived as being effective.   Similar to the feedback received on the spill response initiative, there is no means to objectively measure a change in response-efficacy   157 because the tools used to gather information on training have all been variable.  However, based on the responses of participants who completed the evaluations, it can be said that more information from frontline employees has come forward for consideration in the theoretical models of health behavior. Behavior Change Models When theoretical models of health behavior were initially discussed in the first phase of research, it was noted that behavior change models are also included within this group.  When considering this phase of research, the goals were to develop and pilot safety initiatives for frontline stakeholders and receive their input.  However, with the introduction of any new process or piece of information for working safely with cytotoxic products, the role of behavioral change models should be considered.   According to DeJoy (1996), when focusing on any changes in behavior in the Transtheoretical Model (Prochaska et al., 1992) and Precaution-adoption process (Wienstein, 1988) can be applied.  In the Transtheoretical Model, there are five stages described in the process of behavioral change: 1.) pre-contemplation, 2.) contemplation 3.) preparation, 4.) action and 5). maintenance (Prochaska et al., 1992).  In the precaution-adaption process, there are also five stages that assume: 1.) the person has heard of the hazard, 2.) believes in susceptibility for others 3.)  acknowledges personal susceptibility 4.) decides to take a precaution and 5.) takes the precaution.  Within both of these models, there is a view that different kinds of information and interventions will have different impacts depending on where a worker is in the change process (DeJoy, 1996).  For example, when examining the protocol for receiving cytotoxic drugs, even if one were to ensure that workers had all personal protective equipment available, he or she still may not use   158 the equipment because they are not aware that they could be exposed or that the exposure could impact his or her health.  A limitation of this current work is that investigator has no knowledge as to where pharmacy personnel are at in the realm of behavioral change.  However, according to these models of behavioral change, in order for individuals to commence moving towards the contemplation stage, they must be seeking information (DeJoy, 1996). The provision of information to this group of workers can be considered in this context for this phase of the research.  More work may be required to investigate what stage pharmacy personnel are at prior to formal implementation of any safety initiatives. 5.6 Summary of Phase 4: Piloting of Safety Initiatives The overall aims of this phase of the research were to create and pilot safety initiatives based on results from earlier in the study and engage stakeholders to provide feedback.    These aims were achieved and positive responses were received on both the Standardized New Employee Orientation and Standardized Spill Response.  The protocols for receiving hazardous drugs and checking hazardous drugs received the least amount of feedback.  This was likely because the protocols apply to fewer personnel in the pharmacy program because a limited group of personnel are responsible for checking drugs and receiving drugs.  Overall, it seemed that personnel who reviewed both of the protocols were not in favor of the recommended level of personal protective equipment for both checking and receiving.  One future direction should be to seek a larger population within the pharmacy department to review the protocols to make revisions prior to formal implementation.   Furthermore, additional pharmacy and occupational health and safety professionals within the province that   159 work with cytotoxic drugs should review these protocols and provide feedback.   The contribution of this phase to the study was the value of gathering more information from frontline employees on what was positive or what required changes in the safety initiatives.   Furthermore, gathering information from frontline workers on these initiatives has provided more insight into what constructs of the theoretical models of health behavior apply that included knowledge, self-efficacy, and response-efficacy.                   160 Chapter 6 Phase 5: Final Worksite Assessments 6.1 Introduction Phase 5: Final Worksite Assessments An occupational health and safety professional such as an occupational hygienist may make multiple visits to a worksite to determine if best practices are being followed to reduce exposure to a hazardous agent.    In follow up worksite visits, the occupational hygienist continues to gather additional information (Perkins, 1997).  For this research project, the purpose of the final worksite assessment was to gather information on the most current practices in place.  Leading up to this stage of the research, four key steps had taken place that had an overall goal of assessing and proposing controls to reduce occupational exposure to cytotoxic drugs for those working in acute care pharmacies in a BC health authority.  Over the course of the research, the investigator engaged the workforce through a variety of methods including worksite assessments, employee questionnaires, focus groups, and evaluation of safety initiatives.  Each stage of the research built on the information collected in the previous phase.  The aim of carrying out final worksite assessments was to identify changes in practice and contribute to the knowledge for future initiatives and planning. 6.2 Objective of Phase 5: Final Worksite Assessments The objective of conducting final environmental assessments was as follows: To assess the status of workplace controls aimed at reducing exposure to cytotoxic drugs.  6.3 Methods for Phase 5: Final Worksite Assessments  All five pharmacies were visited for the final worksite assessments approximately six months following the piloting of safety initiatives.   The overall purpose was to carry out   161 a final visit to collect information on the status of controls at each worksite.  The types of information gathered in this phase of the project included the use of personal protective equipment, access to safe work procedures, and the overall set-up and controls in place where cytotoxic drugs were prepared.  The information collected in this phase of the study was similar to the information gathered from the environmental assessment phase of the study.  A copy of the tool utilized to assess the final state of controls may be viewed in Appendix F. The information gathered in this phase of the study was compared with data from the initial environmental assessment phase of the study.   6.4 Results for Phase 5: Final Worksite Assessments  The final worksite visits yielded information that can best be described in different categories of occupational hygiene controls as follows: engineering controls, administrative controls (safe work procedures and protocols) and personal protective equipment.  Engineering Controls  Firstly, worksites were examined to gather information on the status of the main engineering controls designated for handling of cytotoxic drugs.  All worksites examined had the main recommended engineering control required by WorkSafeBC, BC Cancer Agency and USP 797, a biological safety cabinet (Class II, Type B).  Two of the worksites (Worksite #4 and Worksite #5) had clean-air benches present in the room that could impact the effectiveness of the biological safety cabinets.  However, the investigator was informed that the two devices are seldom or never in operation at the same time.   The overall layout and design of the area where cytotoxic drugs were   162 prepared changed in two of the five worksites since the research project commenced.  The two worksites (#1 and #2) were fully reconstructed to include many new features that were absent in the initial assessment, such as dedicated mixing rooms with pass through set-ups and anterooms.  The three other worksites had no changes to layout or design; however Worksite #3 did not require any changes as it met all standards.  Worksite #4 had no layout or design changes throughout the duration of the project.  In terms of areas of remaining areas of concern for engineering controls, Worksite #4 still had a room that was outside of the preparation room that served multiple purposes, including donning and doffing personal protective equipment, checking final products and storage.  The preparation room for Worksite #4 also had two biological safety cabinets and a clean-air bench inside it. Worksite #5 continued to lack an anteroom, and as such there was no space to don or doff personal protective equipment.  Furthermore, products were stored within the preparation room and final product checking also took place in this room.  Although Worksite #5 reported to keep the door to the preparation room closed while working with products, a gap between the door and the wall was observed during the final worksite assessment and as such the preparation room was not fully closed or contained.       Administrative Controls During worksite visits, information was gathered once more on the presence of safe work procedures and protocols pertaining to the safe handling of hazardous drugs.  The presence or absence of these procedures and protocols can be compared to the initial environmental assessment.  In all five worksites, protocols for preparation, accidental   163 exposure and spill clean-up were present.  The results for this may be viewed below in Table 6.1. Table 6.1: Comparing the number of worksites with safe work procedures or protocols in place for Phase 1: Environmental Assessment versus Phase 5: Final Worksite Assessment (n=5 worksites). Safe Work Procedure or Protocol Applicable to Pharmacy Technicians Applicable to Pharmacists Present in Phase 1: Environmental Assessment Present in Phase 5: Final Worksite Assessment *Checking  ? 0% 80% Cleaning ?  60% 80% Disposal ?  0% 40% Exposure ? ? 20% 100% Preparation ?  20% 100% *Receiving ?  0% 40% *Spill Clean up ? ? 40% 100% Transport ? ? 0% 40% * Protocols/Safe Work Procedures focused on during Phase 4: Piloting of Safety Initiatives Personal Protective Equipment Information on the use of personal protective equipment (PPE) for various tasks related to handling cytotoxic drugs were gathered in the initial environmental assessment, employee questionnaire and final worksite visit.  The results for the use of PPE during certain tasks are shown in the following figures. The rationale for displaying these results in figures rather than text despite only having data from the five worksites was based on the complexity of describing all personal protective equipment.   Results were divided into various categories: respiratory protection (Figures 6.1 to 6.3), gloves (Figure 6.4 to 6.7) and additional equipment (i.e. hair cover, shoe covers, impermeable gown, eye protection, dedicated scrubs) (Figure 6.8).  Furthermore, the results shown   164 compare the results from the first phase of the study with the final phase.  It was reported that no type of respiratory protection was worn for receiving or checking products.   During the initial environmental assessment, no information on the use of PPE was collected for checking cytotoxic drugs.  However, information was collected in the final worksite assessment and it was reported that nitrile gloves were used for checking product in 60% of the worksites.  The use of eye protection and dedicated scrubs was not included in the initial environmental assessments, but information on the use of both of these for various tasks was gathered in the final worksite assessments. The use of dedicated scrubs during mixing of products and spill cleanup was reported in four of the five worksites and during spill cleanup in two of the five worksites.   The use of eye protection in the form of safety goggles or a full face respirator was observed in four of the five worksites in two specific tasks, which were: decontamination of the biological safety cabinet and spill cleanup.   For spill cleanup, the types of other PPE (i.e. shoe covers, hair covers and impermeable gowns) were the same in both the first and final assessments for the study.  All worksites reported wearing hair covers and impermeable gowns for spill cleanup and 60% of worksites reported wearing shoe covers for this same task.      165  Figure 6.1: Comparing the use of respiratory protection used for mixing cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites).  Figure 6.2: Comparing the use of respiratory protection used for decontamination of the Biological Safety Cabinet in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites). 80 40 40 80 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Surgical Mask N95 Respirator Percent of Participants (%) 40 0 0 20 40 100 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Surgical Mask N95 Respirator Full or Half Face Elastomeric Respirator Percent of Participants (%)   166  Figure 6.3: Comparing the use of respiratory protection used for spill clean-up of cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites).  Figure 6.4:Comparing the types of gloves used for used for mixing of cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites). 60 0 40 100 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment N95 Respirator Full or Half Face Elastomeric Respirator Percent of Participants (%) 100 60 0 60 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Latex Gloves Neoprene Gloves Percent of Participants (%)   167  Figure 6.5: Comparing the types of gloves used for used for receiving cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites).  Figure 6.6: Comparing the types of gloves used for used for spill cleanup of cytotoxic drugs in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites). 40 20 40 60 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Latex Gloves Nitrile Gloves Percent of Participants (%) 0 60 0 60 100 80 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Latex Gloves Nitrile Gloves Rubber Gloves Percent of Participants (%)   168  Figure 6.7: Comparing the types of gloves used for used for decontamination of the biological safety cabinet in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessment. (n=5 worksites).  Figure 6.8: Comparing some additional types of personal protective equipment (i.e. hair cover, shoe cover, and impermeable gown) used for mixing cytotoxic drugs and decontamination of the biological safety cabinet in Phase 1: Environmental Assessment and Phase 5: Final Worksite Assessments. (n=5 worksites).  100 80 0 40 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Latex Gloves Neoprene Gloves Percent of Participants (%) 100 100 40 60 100 100 0 10 20 30 40 50 60 70 80 90 100 Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Phase 1: Environmental Assessment Phase 5: Final Worksite Assessment Hair Cover Shoe Covers Impermeable Gown Percent of Participants (%)   169 6.5 Discussion for Phase 5: Final Worksite Assessments Engineering Controls Overall, all worksites included in this study had the main engineering control, a biological cabinet (Type II B), that is specified under WorkSafeBC regulatory requirements.  Two of the five worksites underwent a complete renovation during the time this research took place, and thus were better able to meet standards specified under USP 797.   One example of a standard designated by USP 797 is the requirement for an anteroom. In the final worksite assessment three of the five worksites had this feature where only one of these five sites had an anteroom initially. There are multiple reasons for having an anteroom attached to a clean room such as: 1.) a means to limit the introduction of microbes into the clean room, thereby enhancing patient safety, and 2.) a physical space to don and doff personal protective equipment associated with the preparation of hazardous drugs; thereby ensuring any potentially contaminated equipment is contained in the anteroom.  A 2011 study by Adams et al. suggested that increasing the pressure differential in the anteroom is one strategy to limit airborne bacterial migration. This strategy could be employed in the existing health authority anterooms as a means to further limit hazardous drug migration from the preparation area.  Although the Adams et al. study was focused on bacterial transmission and infection control, this principle could be applied to hazardous drugs.  By this, it is meant that having the anteroom under slightly negative pressure compared to main outside area (e.g. pharmacy or hallway) could limit the migration of hazardous drugs.  The two remaining worksites that did not have an anteroom were in this situation for three primary reasons:  the time period when the facility was constructed, the   170 absence of designated capital funds to carry out renovations and a lack of physical space to make changes.   In the absence of an anteroom, a zone should be designated outside of the mixing room as an area to don and doff personal protective equipment.  This would serve as an interim means of limiting potentially contaminated personal protective equipment from being worn in other areas of the pharmacy.  Additionally, from a product and patient safety perspective, this would limit the number of personnel entering the mixing area without wearing adequate personal protective equipment. The intent of wearing the personal protective equipment when preparing cytotoxic drugs is to protect both the worker and the product from contamination.  A 2009 publication by Hung and Anderson describes the approach the Mayo Clinic utilized to meet the standards of USP 797 in their nuclear medicine pharmacies through a renovation project.  The investigators describe the primary challenge for meeting these standards as having ?limited space of each laboratory and existing antiquated mechanical systems? that would be similar to the challenges that the organization?s worksites face.  The primary difference between the two organizations would be that the Mayo Clinic is funded differently than a British Columbia Health Authority.  However, the strategic design principles used by the Mayo Clinic personnel could be taken into consideration for future pharmacy renovation projects.  When considering engineering controls, one worksite has a biological safety cabinet, but no other controls to limit hazardous drugs from going into other areas of the pharmacy.  The additional protocol of keeping the door shut would enhance the   171 functionality and effectiveness of the biological safety cabinet.  However, there is a gap between the door and the frame that was observed on multiple site visits (e.g. initial environmental assessment, administration of employee questionnaire, focus group sessions, piloting safety initiatives, and final worksite visit), and the door was usually kept open.  As a general safety concern, a change should be made to tighten the gap between the door and the frame, and a window should be put into the door to enable workers inside and outside of the room to visualize one another. Within the next five years, the pharmacy services at this worksite will be relocated to one or both of the two new hospital sites that are presently in the design phase.  To the knowledge of the investigator, the principles detailed in USP 797 have been taken into consideration for the design of the two new pharmacies.  Administrative Controls The administrative controls in the form of safe work procedures examined in the final worksite assessment were: ? Checking ? Cleaning ? Disposal ? Exposure ? Preparation ? Receiving ? Spill Clean up ? Transport Of the safe work procedures or protocols listed above, three initiatives were piloted in Phase 4: checking, receiving and spill cleanup.  Pharmacists in the organization primarily carried out the checking of final product.  At the start of this study, no worksite   172 had a written protocol available to provide to pharmacists for checking cytotoxic drugs.  However, this protocol was introduced in the fourth phase of the study.  At the final worksite visits, four of the five sites indicated they had the protocol for checking cytotoxic drugs available to them.  The one site that did not have the protocol indicated that it did not apply, as the pharmacist never handles the product. Rather, he or she visualizes the product by way of the technician holding the product up to the viewing window in the biological cabinet. Although it was reported that the protocols for checking the product were available, no observations of pharmacists checking product were made and as such it was not possible to determine if protocols were being followed.   Receiving the cytotoxic drugs was another protocol that was introduced in the fourth phase of the study.  In the final worksite assessment, only two of the worksites indicated that the protocol was available.  In discussion with worksite supervisors, it was learned that some staff that receive products were not convinced of the need to have a protocol for this process.  However, the recommendation for use of gloves in the protocol had been adopted by all but one worksite.  As a means to support the supervisors in providing information to employees on the possibility of contaminated packaging and cytotoxic drugs, the investigator provided literature on this topic and had offered to provide an in-service on the topic.   An example of literature on this topic was a publication from Alberta (Schulz et al., 2005) that investigated the presence of antineoplastic agents in two cancer clinics.   This publication demonstrated that external contamination of drug vials was found and as such there is a possibility that the boxes arriving from the manufacturer are also contaminated with cytotoxic drugs.  This contamination could be transferred from bare hands or gloves to other areas and   173 surfaces in the pharmacy that could result in exposure to more pharmacy personnel beyond the person whose role it is to receive product.   A protocol for spill response increased from two worksites in the initial phase of the study to all sites in the final assessment.   The presence of the protocol in all worksites in the final worksite visits is most likely because it made up a portion of the spill response training that was piloted in the fourth phase of the study.  To increase the likelihood of personnel being confident with the protocol, spill response exercises should be carried out annually at a minimum.  This would also help to identify any potential modifications that may be required for the protocol.  An overall future direction should be to discuss with the pharmacy management team a strategy to update and formally implement the safe work procedures that were piloted at the worksites where uptake has not occurred.  As part of this process it will be recommended that pharmacy personnel have a role in modifying the protocols prior to formal implementation.   The availability of two other protocols, ?accidental exposure? and ?preparation of products?, increased from a single worksite having these procedures to all of the worksites having them in the final assessment.   The process for addressing an exposure to cytotoxic drugs was noted to be both a stand-alone protocol and the investigator also embedded it into the written spill response procedure.  The increase in the presence of a protocol for preparation could be due in part to a combination of the accreditation processes in BC healthcare settings, worksite visits conducted by BC Cancer Agency, or awareness as a result of the research study.      174 The presence of having a protocol for cleaning the biological safety cabinet was present at all but one worksite.  However, the protocol has not been standardized within the organization or across BC Health Authorities.  Within the health authority, some work surfaces are cleaned with Wet Ones? (0.3% Benzethonium Chloride), followed by 70% isopropyl alcohol, whereas others are cleaned with a solution of Chlorhexidine di(acetate) (Hibitane) and then alcohol.   Biological safety cabinets are to be cleaned between preparations, at the beginning and end of each workday and intensively each week.  Within the organization, a standard protocol for cleaning should be established that includes the specific products to be used and when they should be used.  A recent publication by Queruau-Lamerie et al. (2012) evaluated various cleaning solutions on stainless steel and glass that was contaminated by ten antineoplastic agents.  The outcome of the study was that bleach was found to be most effective, removing 98% of all contaminant.  The same study demonstrated that isopropyl alcohol/water was less effective at 80.7% and ultrapure water at 76.8%.  The challenge with using one type of cleaner is that the properties of the cytotoxic drugs may make some cleaning products more effective than others.  Therefore, it may be prudent to recommend the use of various cleaning products in a step-wise protocol and rinsing with water in between steps to remove surface contamination.   Having a protocol for the transport of hazardous drugs increased from having no worksites with a protocol in the first phase of the study, to 40% in the final worksite assessment.  In the environmental assessment phase of the study, three of four worksites showed evidence of cytotoxic drug contamination above the limit of detection on transport boxes.   This information was shared with focus group participants during   175 that phase of the study, and this may have prompted some worksites to develop a protocol for this task.  Personal Protective Equipment There is a substantial amount of personal protective equipment used with various tasks associated with the handling of cytotoxic drugs.  The discussion will address the personal protective equipment by category of protection. Respiratory Protection When mixing cytotoxic drugs, there was a shift in the use of surgical masks to disposable N95 respirators from the first phase of the study to the final assessment.  Initially, only one worksite was using disposable N95 respirators, but in the final phase four worksites were using disposable N95 respirators.  Some worksites had both surgical masks and respirators available for pharmacy personnel, and left it up to the discretion of the worker to decide which to use.  There is no organization (e.g. WorkSafeBC, USP, or BCCA) that indicates disposable N95 respirators are required when mixing cytotoxic drugs in the biological safety cabinet.  However, historically, health authority personnel have worn them at some worksites as a result of past orders from WorkSafeBC.   The use of full or half face elastomeric respirators during the decontamination of the biological cabinet had increased from less than half of all sites to all sites in the final worksite assessment.  However, one of the worksites indicated that not all employees would wear elastomeric respirators for this task and as such had made both disposable N95 respirators and fitted full face or half face elastomeric respirators.  The task of   176 decontamination of the biological safety cabinet involves raising the protective glass shield, removing the tray underneath the work surface and cleaning thoroughly using a multiple step process.  All of which could lead to the end user being exposed to any residual cytotoxic drugs left behind from the preparation of products.  The information contained in Section VI Chapter 2, of the Occupational Safety and Health Administration (OHSA, 1999) technical manual ?Controlling Occupational Exposure to Hazardous Drugs? has indicated when ?splashes, sprays or aerosols are possible? employees should wear a respirator with a full face piece or alternatively a respirator along with a face shield or splash goggles (OHSA, 1999).  As such, the use of full face fitted elastomeric respirators or half face elastomeric respirators with a face shield or goggles should be utilized for decontamination of biological safety cabinets.   All worksites had available full or half face elastomeric respirators for clean-up of cytotoxic drug spills.  However, some of the worksites still had disposable N95 respirators (generally one size and brand) remaining in the in-house prepared spill kit that had been distributed to three of the worksites.  The employees on-site during the final site visit were aware that disposable N-95 respirators were not approved respiratory protection.  Any worksite that has this respirator as a part of the spill clean-up kit should remove it as one model and size does not fit all employees and it offers less protection when compared to a fitted elastomeric respirator.       177 Gloves Gloves were used across all worksites for mixing, spill clean-up, and decontamination of the biological safety cabinet. The gloves being used for these tasks were latex (multiple tasks), nitrile (receiving only) and neoprene (multiple tasks). The primary shift that occurred was the availability of neoprene gloves at two worksites for decontamination of the biological safety cabinet and three of the worksites for preparation of cytotoxic drugs.  A literature search on PubMed did not reveal any publications that specifically recommended the use of neoprene gloves for preparation of cytotoxic drugs.   The rationale for the use of neoprene gloves at some worksites that had the gloves on-site was to reduce the risk for an allergic reaction in patients who have a latex allergy.  A 2006 survey carried out by Abd El-Atti et al. in the United States indicated that overall there was a need for institutions to become more aware of the potential for latex allergies in the population they are caring for and develop pharmacy practice standards to address this issue.  Health authority pharmacies should also develop a formal protocol to address the potential for both employee and patient allergies to latex.   As mentioned in the administrative controls section, two worksites indicated there was a protocol available for receiving cytotoxic drugs.  One portion of the protocol was a recommendation for the use of gloves when handling the products.  The final worksite visit revealed one of the sites had latex gloves available for receiving and three had nitrile gloves.  Based on this information, only one worksite had not adopted the use of gloves for receiving of products.  As part of future training for new staff and reminders for existing personnel, it is important to communicate that wearing gloves when receiving products is a minimum piece of personal protective equipment.  It would also   178 be important to investigate the rationale at the worksite for not wearing gloves for receipt of product.  Other Personal Protective Equipment Some of the other personal protective equipment utilized when handling cytotoxic drugs included gowns, shoe covers, hair covers and eye protection.  The use of eye protection was not examined in the first phase of the study, but was examined in the final worksite assessment.  Eye protection in the form of safety goggles or a full-face respirator was practiced in four of the five worksites for decontamination of the biological safety cabinet and spill cleanup.  In the worksite where eye protection was not used, recommendations were made by the investigator to commence this practice.  Eye protection should also be used when receiving cytotoxic drugs in the event the packaging has been damaged.   According to OHSA, the employer should provide eye protection whenever splashes, sprays, or aerosols of cytotoxic drugs may be generated and could result in the contamination of eyes (OHSA, 1999).  As a means to identify tasks where pharmacy personnel are at risk for eye exposure to cytotoxic drugs, a risk assessment should be carried out on handling tasks to determine the possibility of splashes, sprays or aerosols.    The additional personal protective equipment such as gowns and hair covers were worn by all worksites during the mixing of cytotoxic drugs and the decontamination of the biological safety cabinet.  In the phase of the study where piloting of safe work procedures such as receiving and checking cytotoxic drugs took place, the protocols recommended use of a gown for both tasks. The rationale behind this was the same for   179 both protocols.  It was intended to protect staff from potential exposure to cytotoxic drugs in the event of the presence of residual drug on the outside of the containers, or breakage or leakage of the containers.  Additionally, when checking the product the wearing of an impermeable gown would be an added step in quality control from a patient safety perspective in that the final person who handles the product prior to the transport to a patient care unit has taken steps to reduce the chances of microbial contamination of the product.  To the knowledge of the investigator, no worksites had uptake for the use of the impermeable gowns for either of these protocols.  The OHSA technical manual recommends that impermeable gowns should be worn during multiple tasks associated with handling cytotoxic drugs such as: ? Mixing ? Spill Clean up ? Waste disposal ? Receipt of damaged packages ? Administration of cytotoxic drugs ? Patient care 48 hours after cytotoxic drugs administration when handing patient waste  It has not been investigated if pharmacy or housekeeping personnel are utilizing impermeable gowns for disposal of cytotoxic drug waste in the pharmacy area, patient care areas or by patient care tasks.   It is recommended that as part of future actions, the use of impermeable gowns be examined more in-depth for pharmacy, nursing and housekeeping.   The use of shoe covers when mixing cytotoxic drugs and decontamination of the biological safety cabinet increased from two to three of the five of worksites over the study period.  The worksites that were not using shoe covers during either of these   180 tasks may be at risk for introducing contamination into the preparation room via street shoes.  In addition, cytotoxic drug residue from the floor may be tracked around the room, outside of the room and beyond.  A 2005 study in the United Kingdom (Mason et al.) investigated the presence of cytotoxic drugs on the floor in preparation areas at two different pharmacy units.  The outcome of their investigation was that four drugs they were assaying for (methotrexate, cyclophosphamide, isfosfamide and platinum-based products) were detected in both preparation areas on the floor.  Another study that took place in 2005 in Italy (Acampora et al.) assayed for the presence of cyclophosphamide on multiple surfaces at two worksites.  The outcome of their study also demonstrated that the floors inside the preparation areas were contaminated with cyclophosphamide.  These two studies demonstrate that cytototoxic drug contamination on the floors could also be possible in BC health authority pharmacies.   Applicability of Health Behavior Models to Final Worksite Assessments Information collected in this phase of research has shown that some changes have taken place in administrative controls in the form of safe work procedures along with the use of personal protective equipment when compared to the results from the initial environmental assessment.  This final step in the research process has yielded further information that can be situated in the theoretical models of health behavior.    Engineering Controls Within the field of occupational hygiene, it is not always possible to eliminate the risk of exposure to a hazard through elimination or substitution.  As a result, implementation of engineering controls is the next option. When the results of the final worksite   181 assessment are situated in a theoretical model of health behavior, the information collected best fits into the enabling factors that make up the PRECEDE model (Green and Kreutner, 1991).  A shift had taken place in the enabling factors in terms of the engineering controls available at the worksites.  During the course of the research work, two of the worksites underwent complete renovations that yielded dedicated mixing rooms with pass through set-ups and anterooms.  In the final worksite assessment, it was possible to observe that three of the five worksites had the aforementioned engineering controls in place to reduce exposures, however the two remaining worksites did not.   The information obtained from the final assessments indicated that two worksites still had some enabling factors that were not equivalent to other worksites.  Based on this information, engineering controls could be identified as future targets in a program to reduce the potential for occupational exposure to cytotoxic drugs.  If one were to consider the absence of a full complement of engineering controls as barriers, this could block the workers at these sites from taking protective actions.   For example, in the absence of an anteroom, workers would not have a dedicated, contained environment to don and doff personal protective equipment, which could lead to contamination of the work environment.      Administrative Controls The results of assessing the administrative controls in the final worksite assessment could also be situated in a theoretical PRECEDE model of health behavior.  If one were to consider the administrative controls in the form of safe work procedures as enabling factors, it could be determined that an increase in the availability of safe work procedures was observed for checking, cleaning, disposing, preparing, transporting and    182 spill clean-up of cytotoxic drugs.  Of the initiatives piloted by the investigator in the fourth phase of research, the increase in the presence of protocols ranged from 40% (receiving protocol) to 80% (checking protocol).  While encouraging to see an increase in the presence of the safe work procedures at the worksites, it is unknown if the protocols are being utilized.  When the initiatives were piloted, it was theorized that a shift would occur in the element of self-efficacy.  However, information collected on evaluations for both the receiving and checking protocols suggested that threat-related beliefs could impact the ability of workers to engage in self-protective behavior.  Future work with this group of workers could include collecting information on the use of the protocols to contribute to the diagnostic pieces of the PRECEDE framework along with the constructs from the value-expectancy models.  Personal Protective Equipment   The results of assessing the presence of personal protective equipment in the final worksite assessment could also be situated in the theoretical PRECEDE model of health behavior.   The increased presence of personal protective equipment that was observed to be available for specific tasks could be considered a target that was met within an environmental diagnosis, most specifically in the area of respiratory protection.  More stringent forms of respiratory protection were observed to be both accessible and available for tasks such as spill response, preparation of cytotoxic drugs and decontamination of biological safety cabinets.  For the majority of worksites the availability and accessibility of respiratory protection would not be considered a barrier to following recommended precautions in a safe work procedure.  However, as could be theorized with the increased presence of administrative controls, a limitation of this   183 information was that it is unknown as to whether the personal protective equipment was used for all tasks where required by all pharmacy personnel.   During the focus group sessions of this research, the investigator learned that some pharmacy personnel were not convinced of the effectiveness of respiratory protection for prevention of exposure to cytotoxic drugs, which showed that response-efficacy may play a role in self-protective behavior.  In addition, information collected on evaluations for checking protocols suggested that not all employees were in agreement with the recommended personal protective equipment.  A combination of threat-related beliefs and response-efficacy could impact the ability of those working in the pharmacy setting to use personal protective equipment and engage in self-protective behavior.  Also, at the conclusion of this phase of research, it was not possible to conclude what impact normative expectations within the pharmacy could have on the use of personal protective equipment.  Future work with this group of workers could include collecting information on more of the constructs of the value-expectancy models by formulating questions or tools that would contribute to learning more about self-protective behavior and the use of personal protective equipment in the pharmacy setting.   6.6 Summary of Phase 5: Final Worksite Assessments The final objective of this thesis work was to re-visit worksites and examine the status of controls at the worksite intended to reduce occupational exposure to cytotoxic drugs.  Overall, information collected in this phase of the study demonstrated that changes in practice had occurred at worksites when compared to the initial worksite visits during the environmental assessment phase of this research.  When administrative controls were examined, it was observed that the presence of all safe work procedures for safe   184 handling of cytotoxic drugs increased.  These protocols included checking product; cleaning the biological safety cabinet; disposing, preparing, receiving and transporting product; and spill clean-up.  The protocols for exposure and preparation of products were the two procedures that showed the greatest increase at the worksites when compared to initial environmental assessments.  These two protocols were only present at one worksite initially and all worksites by the final visit.  Further work is required to more formally implement the protocol of receiving and checking cytotoxic drugs.  Additionally, a standardized protocol for transporting these products should also be developed with input from frontline personnel.   All worksites both in the beginning of this study and at the conclusion have in place the primary engineering control designated under regulatory requirements, which is the biological safety cabinet.  The presence of an anteroom increased from a single worksite to three sites during the time period of this study as a result of capital improvements and renovations at worksites.  Future construction projects carried out by the health authority will likely include the presence of anterooms attached to the preparation rooms as part of meeting standards such as USP 797.  In the environmental assessment phase of the study, the idea of implementing closed system transfer devices for safe handling of cytotoxic drugs was proposed in the discussion based on information in the literature that demonstrated a reduction in environmental contamination.  This idea should be brought forward in the organization for discussion and also proposed to the other health authorities in BC and the BC Cancer agency as a potential control.     185 For the use of personal protective equipment, there were changes in the use and type of respiratory protection.  For example, during the initial phase of study, surgical masks were worn at nearly all worksites for preparation of product but by the final worksite assessment, disposable N95 respirators were available for all but one worksite. Furthermore, when considering respiratory protection, the presence of elastomeric fitted respirators for use during spill cleanup and decontamination of the biological safety cabinet also increased to all sites for both tasks.  Finally, two areas that require improvement is the use of gloves when receiving products and the use of shoe covers when mixing product as the failure to use either of these controls may lead to an increase in environmental contamination and in turn cause personnel to be exposed to the products through surface contact.   The results from the final worksite assessment could also be situated within the theoretical models of health-behavior.   The final assessment was similar to the initial assessment in that the results could be placed in the PRECEDE model acting as a diagnostic factor for objective aspects of the work environment.  Some of the targets initially identified in the environmental assessment were achieved, however future work should include additional investigations into how the constructs that make up the value-expectancy model can impact self-protective behavior as it relates to reducing occupational exposure to cytotoxic drugs.   The final worksite assessment has demonstrated that changes have taken place for the different types of occupational hygiene controls aimed at reducing occupational exposure to cytotoxic drugs.  Furthermore, this phase of the study revealed opportunities for improvements to controls within this organization and this information   186 can be shared with stakeholders in other British Columbia Health Authorities. The information gained from this final assessment will help to inform other occupational health and safety professionals and pharmacy personnel in the province for future exposure control planning pertaining to reducing occupational exposure to cytotoxic drugs.                       187 Chapter 7 Conclusions from Assessment and Proposal of Controls to Reduce Cytotoxic Drug Exposure in Pharmacy Personnel  7.1 General Summary The goal of this thesis work was to assess and propose controls to reduce occupational exposure to cytotoxic drugs in pharmacy personnel working in a British Columbia Health Authority setting. The strategy to meet this goal encompassed five main steps that combined quantitative and qualitative research methods.  Firstly, the environmental assessment in the pharmacy at each worksite revealed variations in occupational hygiene controls along with evidence demonstrating surface contamination.   Following this, an employee questionnaire demonstrated how pharmacy personnel perceive the handling of cytotoxic agents, the level of training and education, and the use of personal protective equipment when handling cytotoxic drugs.  The third step applied the results from the first two phases and used qualitative focus group sessions to obtain feedback from front-line personnel on findings, learn about safety concerns of staff and for staff to aid in the proposal of various safety initiatives aimed at reducing exposure.  The next phase in the study combined information from the first three phases of the study to design and pilot safety initiatives at the worksites and feedback was obtained from stakeholders at the sites.  The final step was to re-visit worksites; a similar assessment tool that was used in initial environmental assessment showed changes that had occurred in the controls intended to reduce occupational exposure to cytotoxic drugs.      188 7.2 Significance of this Research  In summary, the significance of this research was that a multi-faceted approach using qualitative and quantitative methods was used as a strategy to assess and propose controls aimed at reducing occupational exposure to cytotoxic drugs.   In brief, the key contributions to knowledge on this topic were: ? Cytotoxic drug surface contamination was present at all worksites examined, despite the various types of occupational hygiene controls being in place along with various designs of hospital pharmacies.  ? Multiple agencies set out guidelines and regulations on working safely with cytotoxic drugs that may be challenging for smaller organizations to meet. ? There were gaps in knowledge regarding best practices for safe handling of cytotoxic drugs between pharmacy personnel based on education (i.e. certificate versus bachelor?s degrees). ? Pharmacy personnel spoke of barriers to working safely with cytotoxic drugs and raised concerns about present and past health effects related to working with these products. ? Engagement of frontline personnel to provide ideas for safety initiatives and obtaining feedback during piloting of the initiatives provided valuable insight into what these stakeholders felt would make their work safer.   189 ? Results of each phase of the research could be situated into theoretical models of health behavior as a strategy to identify targets in a program to prevent occupational exposure to cytotoxic drugs.  When considering the environmental assessment phase of the research that examined the presence of surface contamination, it was demonstrated that 25% to 66% of all work surfaces sampled had cytotoxic drugs above the limit of detection.  This information has demonstrated that there is indeed an issue of environmental contamination.  The assay only looked for two types of drugs, leaving open the possibility these surfaces could be contaminated with multiple other cytotoxic drugs.  When examining the measured values for methotrexate and cyclophosphamide on the surfaces sampled, it was possible to situate them amongst other studies in the field.  It was shown that each worksite was unique in physical layout, and the use of controls in place to reduce exposure. Hypothesis testing was not able to demonstrate that worksite design, in-house pharmacy training program, service provider for housekeeping, presence of anteroom or use of a clean-air bench inside a mixing room could account for surface contamination being above or below the limit of detection.  If evidence had shown that the worksite with the best occupational hygiene controls in place had significantly lower surface contamination, this would have been an opportunity to emphasize these practices.  Without this evidence, it was theorized that workplace practices and procedures contribute to contamination.  For example, once a worker has donned a pair of gloves, and begins handling the cytotoxic products, he or she would not be aware of the point at which the glove now has the drug on it.  Theoretically, the worker would then continue in the course of his or her duties and could touch many different surfaces,   190 thus leading to environmental contamination and the possibility of other workers contacting the contaminated surface.  Raising awareness about best practices, supporting best practice and sharing the results of this study are three strategies that could be employed to shift individual behavior.   Until there is a shift in practices at the worksite and amongst individual pharmacy personnel, it is likely environmental contamination will persist.  The employee survey served as a valuable tool to learn more about the pharmacy population working in the health authority.  The group who took part in the survey was made of up 81% females and represented a slightly older group when compared with the overall population of Canadians working in the field of pharmacy.   The information gathered in the survey on the use of personal protective equipment (PPE) was valuable as it revealed similar conclusions that were gathered in the environmental assessment phase of the study.  It also showed that despite the availability of personal protective equipment at worksites, some personnel reported varying use of the equipment.  For example, at least one participant reported wearing no respiratory protection when mixing cytotoxic drugs.  The survey results reinforced the concept that PPE needs to be standardized across the organization and beyond for safe handling cytotoxic drugs in hospital pharmacy settings. A question on the employee questionnaire regarding the adequacy of training for self-protection from cytotoxic drug exposure demonstrated variable responses among worksites.  The difference in responses appeared to be in those worksites that had received health authority based training versus those that had not. Worksites with the   191 official training had a greater number of participants that either agreed or strongly agreed with the statement compared to the other worksites.  Results from the questionnaire also indicated that one third of participants never received training on working safely with cytotoxic drugs, and these responses were representative of pharmacists.  This was concerning as pharmacists within the organization were responsible for checking cytotoxic drugs prior to the product leaving the department and in some cases were responsible for the preparation of products during on-call duty circumstances (i.e. during hours when pharmacy technicians were not scheduled such as evenings).  If pharmacists were not aware of the safe work procedures for handling cytotoxic drugs, they may have been unknowingly exposed to the products or contributed to environmental contamination.   Furthermore, the survey revealed a gap in the knowledge of safe work procedures for handling cytotoxic drugs between pharmacists and pharmacy technicians.  For example, it was possible to show from questionnaire results that pharmacists were not consistently aware of the procedures to follow in the case of a leak or spill of cytotoxic drugs, whereas pharmacy technicians were aware of the procedures.  Hospital pharmacists may not have had hands-on knowledge about cytotoxic drugs as their academic background most likely would not have focused on practical safe handling techniques.  In contrast, pharmacy technicians responded more favorably to the question posed on how to handle leaks and spills. The most likely explanation for this is that pharmacy technicians would have received practical safe handling information while undertaking a post-secondary program.   All personnel working in hospital   192 pharmacies should receive the same type of safe handling training regardless of his or her education or profession.     The focus group sessions revealed insight into how pharmacy personnel felt about working with cytotoxic drugs, and many of them expressed concerns about their personal health that have not been discussed in the literature from a worker perspective.  More specifically, participants revealed that as the long-term health outcome of occupational exposure is unknown, it could be disconcerting working with the products.  An example of a health concern that has never been reported in the literature on this topic is the issue of musculoskeletal injuries for those handling these products.  The job requires personnel to work in a biological safety cabinet for many hours per day while manipulating the products and participants spoke of pain in shoulders and digits.  When reviewing the results of the environmental assessment, a large amount of dialogue took place amongst participants.  This discussion generally commenced with participants sharing theories as to how and why environmental contamination was taking place.  Many of these ideas were used to begin generating safety initiatives that could be tried out at their workplaces. Some participants indicated that they felt there was no evidence that surface contamination was harmful, while others expressed concern that co-workers were not following procedures and would continue to work unsafely.   Through discussions centering on results of the employee survey, it was possible to gain information as to why variability existed among sites and personnel for the use of   193 personal protective equipment (PPE).  For example, some participants said wearing the PPE was uncomfortable and/or ineffective for preventing exposure.  Also some participants indicated that even if they wanted to wear certain types of PPE, it was not available at their worksite and in some cases workers said they intended to follow up to obtain the equipment.  The focus groups were a means to confirm results of gaps in working safely with cytotoxic drugs and also identify additional needs.  Although some safe work procedures were available for working with these products, participants were able to help select ones to be brought forward to the next phase of the study based on what was important to them.   Some additional information gained from focus group sessions was hearing examples of barriers to working safely from pharmacy personnel.  For example, participants in one session explained that the day may start out with a full workload of chemotherapy preparations, but as patient conditions were dynamic, new patients could be added, taken away or treatments modified.   Further to this, some medications needed to be prepared within a certain time frame to ensure effectiveness and quality and patients may arrive late, early or not at all thus adding to the complexity of timing preparations.  As an added factor, those preparing the products indicated that both nursing and/or pharmacists may check in to seek information on the status of a preparation causing distraction and in some cases left technicians feeling pressured.  This example of a scenario explained to the investigator by participants illustrated three of the five barriers brought forward: a lack of time and resources to complete tasks safely, the physical nature of mixing the products and relationships among health care professionals.    194 In a single focus group session, participants spoke about the amount of waste generated when working on pharmaceutical preparations in general and the long-term impact on the environment.  These participants discussed how at their worksite more steps had been added for wiping preparations and they acknowledged this change would remove drug residue, but in turn would generate more waste and damage the environment.  Another idea discussed in a single focus group was the linkage between patient safety and worker safety.  At least two participants in this session felt strongly that if one was working safely that this yielded the safest product for patients and also ensured a safe working environment for everyone.  The linkage to patient safety and worker safety in the pharmacy setting as it related to cytotoxic drugs has not been reported in the literature to date.  Designing and piloting safety initiatives aimed at reducing exposure within the pharmacy setting was the phase in the study that synthesized information from the environmental assessment, employee questionnaire and focus group sessions.   The safety initiatives were not costly to pilot and all pharmacy personnel had an opportunity to provide feedback to the investigator that would enable modifications to be made. From the environmental assessment and information in the literature, the possibility of cytotoxic drug residue being present on products entering the site and being in the area where the products are received is a possibility. Prior to the creation of the receiving protocol, no information was available through literature searches or consulting with other BC health authorities as to the key steps that should be taken for this receiving; the information available was focused on what to do in the case of damaged products arriving on site.  Most participants that evaluated the receiving protocol felt that it   195 applied to them, that they could use the information while working and that it would help reduce their potential occupational exposure.   Similarly to the receiving protocol, the development of a safe work procedure for checking products was a novel initiative.  Feedback was limited on this protocol from pharmacists who are responsible for checking products.  In three of four evaluations received on this protocol the participants indicated the protocol did not apply at their worksite; one note in the comments section indicated that the products were bagged in the preparation room and as such the pharmacist would not be exposed to products.  This comment alone was extremely important because this indicated that pharmacists were not aware that contamination on the outside of a bag was possible.  From this study, there is evidence to suggest that there is contamination on the outside of the bags. This occurs because the counter where they were checked has cytotoxic drugs present, or that the transport boxes used for finished product become contaminated.   The most successful initiative in terms of feedback received was the standardized spill response that included a one-page protocol along with a practical exercise for spill cleanup.  A gap in a standardized process for addressing cytotoxic spills and concern was expressed at multiple worksites during focus group sessions that this was an issue.  Of those who completed an evaluation on this initiative, 89% included a written positive comment for the investigator about the initiative, which demonstrated that personnel appreciated that a tool such as this was created with their safety in mind.  The standardized new employee orientation that introduced the topic of working safety with cytotoxic drugs was piloted on two separate groups:  new employees and existing   196 employees.  General new employee orientation takes place within the organization, but prior to this initiative; nothing formal has been created for pharmacy personnel specifically who would be working with cytotoxic drugs.  The need for standardized training had been identified during the first three phases of the study, and targeting new employees is a vital first step to promoting the practice of working safely with cytotoxic drugs.   Obtaining feedback from the key stakeholders on the safety initiatives was an important step that will help shape a successful formal implementation in the pharmacy program within the health authority.  This was yet another step in this research that was valuable because of the engagement of front-line workers in the process and has provided information that can be shared with a variety of professionals who work in the healthcare sector.  The final step in this research yielded information on the state of controls at the worksites intended to reduce occupational exposure to cytotoxic drugs as compared with data that was collected in the initial Environmental Assessment phase of this project.  The results demonstrated changes in worksite practices pertaining to the safe handling of cytotoxic drugs.  For example, the presence of written safe work procedures assessed in this project increased at all five worksites.  The increase in safe work procedures represents an improvement in administrative controls aimed at reducing exposure.   Another example of a change in a control aimed at reducing exposure to cytotoxic drugs was the increased use of disposable N95 respirators during product preparation.  The use of this type of respiratory protection will reduce the risk of the pharmacy personnel being exposed to cytotoxic drugs as previously 60% of worksites   197 were using surgical masks during preparation which are intended to protect the product from contamination and do not protect pharmacy worker from potential exposure.  An additional change in worksite practices pertaining to the use of more stringent respiratory protection was the increased use of elastomeric respirators during spill response and decontamination of the biological safety cabinet.  Previously, disposable N95 respirators were recommended for both of these tasks, but which do not provide the same level of protection that a fitted elastomeric respirator has in the case of an accidental spill or release of cytotoxic drugs or when working to clean the biological safety cabinet with alcohol based products.   7.3 The Occupational Hygiene Paradigm Occupational hygiene may be defined as a combination of ?science and art?; it is a field where the principles of natural science and mathematics are applied.  In order to reduce the chances of a worker becoming injured or ill, the occupational hygienist must utilize the key principles of occupational hygiene.  The occupational hygiene paradigm consists of three main steps: recognition, evaluation, and control (Perkins, 1997).  In the following sub-sections, a description as to the relevance of this dissertation within this paradigm will be discussed.  Recognition At the outset of this research, a literature search was carried out to determine if those working in health care and hospital pharmacies could be at risk due to occupational exposure to cytotoxic drugs.  The potential for health impact for those handling these products was clear.  Health studies of health care personnel working with these   198 products demonstrated an increased risk of developing breast and colorectal cancer, adverse reproductive outcomes, and damage to DNA.  These health studies were for the most part based on nursing personnel, however, it is those who work in the pharmacy setting who handle the most concentrated forms of the drugs.  Work carried out in other British Columbia hospital settings (Hon et al., 2011) demonstrated that measurable levels of methotrexate or cyclophosphamide could be found on the hands of pharmacy personnel.  The evidence of occupational exposure combined with information from health studies provided support for the need to assess and propose controls where necessary to reduce exposure.  Evaluation The evaluation portion of this research was accomplished as a multi-step process.  The first step in the evaluation was to determine if cytotoxic drugs were a workplace contaminant, and was achieved through surface wipe testing for cyclophosphamide and methotrexate.  The outcome from surface wipe tests was that all five hospital pharmacies tested within this health authority had cytotoxic drugs present on work surfaces.  During the assessment to look for contaminants, an environmental scan provided information on the types of controls that were in place aimed at reducing exposure.  This environmental scan demonstrated there was variability in the use and types of controls being utilized.  Through the employee questionnaire and focus group sessions, it was possible to gain information from the pharmacy population within this health authority as to current knowledge and practices for working with cytotoxic drugs.  These two phases of the study confirmed variable practices and aided the investigator   199 in moving forward to recommend controls to reduce occupational exposure to these hazardous products.    Control In the field of occupational hygiene, the way in which a hazard or contaminant is controlled is done in a hierarchical fashion based how efficient or reliable a control is (DiNardi, 1997).  In the following table (Table 7.1), a description of the hierarchy of controls and their application to reduce occupational exposure to cytotoxic drugs within this research work is shown.  In the context of this research, engineering and administrative controls, and personal protective equipment are most applicable for controlling occupational exposure to cytotoxic drugs.  An example of an engineering control that could be implemented in addition to the present controls would be closed system transfer devices as a means to contain products being prepared within the biological safety cabinets.  In the case of administrative controls, beyond the use of safe work procedures, as mentioned in Phase 2 of this dissertation, job rotation for pharmacy technicians would be one example.  However, the ability to rotate pharmacy personnel in the role of drug preparation may be limited by worksite specific factors.  For example, one worksite may have more pharmacy personnel available for job rotation compared to another worksite.  Beyond the number of personnel available, it would be important to consider the skills of those working to prepare cytotoxic drugs.  For example, if a worker is more familiar with the processes for preparation she or he may be at less of a risk for exposure as compared to someone who does not prepare the products as frequently.   The use of personal protective equipment to prevent occupational exposure to cytotoxic drugs may be considered the least preferred in the hierarchy of controls.  However, in   200 the case where there is evidence of worksite surface contamination, it would be important to utilize personal protective equipment as a barrier to protect workers from dermal exposure.  Furthermore, the use of respiratory protection would be important in the case where there is a risk of exposure through inhalation.  An example of a task that would require respiratory protection would be during the decontamination of a biological safety cabinet.  The rationale for using respiratory protection for this task would be two-fold because during the task chemicals are used for cleaning and the airflow of the cabinet is disrupted thus creating an environment that could facilitate airborne exposure to contaminants.                    201 Table 7.1: Hierarchy of controls as it applies to reducing occupational exposure to cytotoxic drugs within health authority pharmacies. Most Efficient/Reliable                 Least Efficient/Reliable Control Applicability within this research work Elimination Within the health care sector, it is not possible to treat cancer without the use of pharmaceutical products.  Substitution In some cases, various cytotoxic drugs may be used in place of others based on the condition of the patient, but the products still remain hazardous Engineering Biological safety cabinets for preparation of the products were present at all worksites that manipulate these drugs. These are intended to contain products during preparation, protect workers and the product from contamination. One worksite had in place an ante-room as an added engineering control to limit the migration of contaminants either into or out of the preparation area. It is recommended that all future projects ensure an ante-room is included in the design as per USP 797.  Closed system transfer devices should be implemented for preparation of cytotoxic drugs. Administrative Safe work procedures were introduced for receiving and checking of cytotoxic drugs. Standardized spill response procedures and exercises were piloted at the worksites. Standardized new worker orientation for working safely with cytotoxic drugs was introduced. Job rotation was in place in some worksites to limit the amount of time workers are potentially exposed to cytotoxic drugs. Personal protective equipment Personal protective equipment was in place at the beginning of the study, but the types and what tasks it was used for was inconsistent Improvement in the type and availability of respiratory protection was observed at the final worksite assessments.       202 7.4 Contextualizing the Research within Theoretical Models of Health Behavior The intent of this research was to assess and propose controls to reduce occupational exposure to cytotoxic drugs in pharmacy personnel.  The foundation of the research was based on the occupational and environmental hygiene paradigm that relies on recognition, evaluation and control of a hazard to protect both health and the environment. Traditionally in the field of occupational hygiene, there is a framework that is utilized to evaluate a chemical hazard within a workplace.   The framework includes gathering basic information about the worksite, qualitative surveying (the walk-though), and quantitative surveying that includes exposure assessment.  Within this framework, there are recommended practices to follow for gathering information about workplace hazards that include engaging the workforce to ask questions about processes  (Perkins, 1997, p. 283-317).  However, what has not been taken into account in traditional evaluation frameworks of occupational hygiene is the way in which the work-related environmental, organizational and individual factors interact and ultimately influence self-protective behavior.  The environmental, organizational and individual factors make up components of the theoretical models of health behavior.  Within the discussion of each phase of the research, the investigator examined the results to theorize the relevance of theoretical models of health behavior to the results. Figure 7.1 displays how all of these factors interact in the context of this research and can influence self-protective behavior (adapted and modified from Moore et al., 2005). In addition, from looking at the constructs of the behavioral model, the investigator was able to commence the identification of potential targets in the occupational health   203 program intended to reduce risk of occupational exposure to pharmacy personnel (Table 7.2).  Figure 7.1: Linking theoretical models of health behavior to each phase of research to illustrate how all of these factors interact to influence self-protective behavior (adapted and modified from Moore et al., 2005).           204 Table 7.2 1: Linkage of research to theoretical models of health behavior.   Research Phase Behavior Health Model(s) Example(s) of Relevant Construct (s) or Diagnostic Factor(s) Examples of Information Gained During Research Phase Identification of Possible Targets for Cytotoxic Drug Exposure Control Plan Phase 1: Environmental Assessment Environmental/Contextual Model (PRECEDE) Enabling factors (includes barriers): Environmental diagnosis Administrative diagnosis Various layouts, designs, personal protective equipment, training and procedures in place Unable to meet all regulations and standards Re-design of worksites Consistent training, safe work procedures and use of PPE Examine ways to better meet standards and regulations Phase 2: Employee Questionnaire Value-Expectancy Models (Health Belief Model, Protective Motivation Theory, Theory of reasoned action) Threat related beliefs Self-efficacy Barriers Workers believe risk to health and exposure low Workers at sites without training responded less favorably to question linked self-efficacy and training Difference in response by education (occupation) to question on spill response/leaks  Different types of PPE used for preparation of products  Provide information on routes of exposure, sources of exposure, and health risk  Standardize training Spill response protocol  Standardize use and availability of PPE     205 Table 7.2 Continued2: Linkage of research to theoretical models of health behavior.    Research Phase Behavior Health Model(s) Example(s) of Relevant Construct (s) or Diagnostic Factor(s) Examples of Information Gained During Research Phase Identification of Possible Targets for Cytotoxic Drug Exposure Control Plan Phase 3: Focus Group Sessions Value-Expectancy Models Threat related beliefs Self-efficacy Response-efficacy Barriers Normative expectations Some workers concerned about long-term health, others not Not confident in spill response Not confident in adequacy of respiratory protection PPE not available or standardized Safe work procedures not standardized (checking receiving, spill clean-up, transport) No consistent training for personnel Complacency, lack of supervision and enforcement of practices Provide information on routes of exposure, sources of exposure, and health risk  (Risk communication strategy?) Standardize PPE ? Use of respiratory protection Commence standard training ? Introductory module ? Spill response Safe Work Procedures ? Receipt of product ? Checking product ? Spill response      206 Table 7.2 Continued3: Linkage of research to theoretical models of health behavior.   Behavior Health Model(s) Behavior Health Model(s) Behavior Health Model(s) Behavior Health Model(s) Behavior Health Model(s) Phase 4: Piloting of Safety Initiatives Environmental/  Contextual Model (PRECEDE) Value-Expectancy Models Behavior Change Models Enabling factors (includes barriers): Threat related beliefs Self-efficacy Response-efficacy Barriers Normative expectations  Knowledge on where contamination is present may not be known (e.g. bags, products arriving) May not be concerned that can be exposed cytotoxic drugs, may not be aware (links back to knowledge) Self-efficacy and response-efficacy communicated positively in spill response evaluations Response-efficacy communicated positively in introductory training evaluations Barriers expressed use of PPE, unknown as to rationale behind, could be due to any factors to include discomfort, actions of peers, safety climate?  Unknown as to where pharmacy personnel are at in change behavior Investigate strategies to communicate risk and knowledge on topic Investigate ways to gauge behavioral change in pharmacy Foster environment to continue to build self-efficacy in spill response (e.g. routine mock spill drills) Further investigate response-efficacy in relation to provision of training and other protocols Re-visit protocols on receiving and checking to explore barriers to use Phase 5: Final Worksite Assessments Environmental/ Contextual Model (PRECEDE) Value-Expectancy models Enabling factors (includes barriers): Environmental diagnosis Response-efficacy Threat-related beliefs Increase in presence and availability of personal protective equipment, (respiratory protection to include N95, elastomeric respirators) Increase in presence of safe work procedures at worksites No information available as to whether PPE or protocols are being used Identification of protocols not in place at all worksites Further investigate constructs in value-expectancy model as they relate to presence/absence of protocols and personal protective equipment   207 7.5 Safety Culture and Safety Climate  The relationship between safety culture and safety climate is complex to describe as it relates to this research on assessment and proposal of controls to reduce occupational exposure to cytotoxic drugs.  To commence this discussion, it is important to understand that the definition of safety culture and safety climate has been defined in many different ways, and a publication by Guldenmund (2000) cites 18 definitions and 16 different models to explain safety culture and safety climate.  When considering all of the information summarized by Guldenmund, the work of Zohar (1980) on safety culture and climate applies best to this dissertation work.  According to Guldenmund (2000), Zohar defines safety culture as: ?A summary of molar perceptions that employees share about their work environments (safety climate)?.  The causal model described for safety culture and safety climate is as follows ?Based on a variety of cues present in their work environment, employees develop coherent sets of perceptions and expectations regarding behavior-outcome contingencies and behave accordingly?.  The rationale for describing the information obtained from this dissertation research based using the principles defined by Zohar is the linkage between the work environment and the impact on worker behavior.  As has been discussed in this dissertation research, environmental, individual and organizational factors are theorized to contribute to self-protective behavior.  Through this research, it was possible to commence learning about individual factors that could contribute to the ability of pharmacy personnel to protect themselves from exposure to cytotoxic drugs.  Information about knowledge, attitudes and beliefs of workers in relation to working safely with cytotoxic drugs was revealed in employee questionnaires, focus group sessions and evaluations received from piloting   208 safety initiatives.  For example, information on threat-related beliefs of workers handling cytotoxic drugs was revealed in employee questionnaires, focus group sessions and on evaluations of safety initiatives.  Through this research it was also possible to commence learning about organizational factors that could impact pharmacy personnel to engage in self-protective behavior.  Some of the organization factors that could be taken into consideration were objective in nature.  For example, the availability of a training program for working safely with cytotoxic drugs as an organizational factor was an objective measure in that the program was present or absent.  Some additional examples of organizational factors that could be measured objectively included the presence of standardized safe work procedures and additional controls such as personal protective equipment.  However, a factor that stems from the value-expectancy models that could not be objectively measured was normative expectations.  An example of information that was shared by focus group participants was the idea around limited supervision while working with cytotoxic drugs in relation to following safe work procedures. Collectively, organizational factors such as worksite controls, supervision and awareness of the potential of exposure contribute to the creation of a culture that impacts worker behavior.  209 7.6 Strengths of Research and Scientific Contributions Strengths of Research This was the first study in Canada that combined results from environmental assessments, employee questionnaires and focus group sessions to assess, propose and pilot controls with the goal of reducing occupational exposure to cytotoxic drugs in the acute care pharmacy setting. This approach differed from the traditional occupational hygiene evaluation model in that the investigator continuously engaged frontline workers throughout the process.  By situating results from all phases of the study, it was possible to commencing theorizing the way in which the work environmental, organizational and individual factors interact and ultimately influence self-protective behavior when working with cytotoxic drugs. Some examples of additional strengths were: ? Values obtained from surface wipe sampling could be situated among other studies that have taken place globally and in other British Columbia health authorities, thus adding to the body of knowledge on this topic.  ? Qualitative data in the form of focus groups and evaluations from safety initiatives ensured the views of frontline workers were documented and integrated into this research.  ? New protocols developed for receiving products and checking products can be shared among other BC health authority safety professionals for feedback and integration into other BC health care facilities.     210 Scientific Contributions   ?Despite an intensified hygienic regimen, exposure to antineoplastic agents cannot be reduced if the reasons for exposure remain unknown? (Sessink et al., 1997).  This quotation from a publication 16 years ago still holds true today because researchers continue to demonstrate the presence of cytotoxic drugs contaminating work environments, augmented by evidence of uptake of cytotoxic drugs from occupational exposures in health care personnel (Hon et al. 2011).   The scientific contribution that this research has made was in the area of methods as demonstrated by how an added element to the traditional evaluation component of the occupational hygiene model can be applied.   The goal of this research was to assess and propose controls to reduce occupational exposure to cytotoxic drugs in pharmacy personnel.  The foundation of the research was based on the principles of occupational and environmental hygiene that utilizes the principles of recognition, evaluation and control of a hazard to protect both health and the environment.  In conventional occupational hygiene practice, the occupational hygienist follows a specific methodology during the evaluation phase of examining the chemical hazard in the workplace.  During the evaluation phase of the work, an occupational hygienist will gather basic information about a worksite followed by a qualitative survey and finally an exposure assessment through the measurement of a chemical compound.  Following this step, the occupational hygienist examines the results from the evaluation phase and recommends controls to reduce or eliminate exposure to the workplace hazard.     211 To date, this strategy has been employed by occupational hygienists to aid health care personnel in reducing the risk of exposure to cytotoxic drugs in the workplace.  It should be acknowledged that occupational exposure to these products has likely declined substantially since the introduction of more stringent policies and controls approximately 25 years ago.  What has not been taken into account in traditional evaluation frameworks of occupational hygiene is the way in which the work environmental, organizational and individual factors interact and ultimately influence self-protective behavior in the realm of controlling exposure to cytotoxic drugs.  The investigator in this research took an alternative approach for the evaluation of a workplace hazard by engaging stakeholders in the evaluative process.  The value of this approach was that for program planning to prevent exposure to cytotoxic drugs, the investigator has uncovered novel information that can aid occupational health and safety professionals in understanding why workplace exposure to cytotoxic drugs continues.    7.7 Limitations Phase 1: Environmental Assessment The environmental site assessments provide a limited sense of what goes on at these worksites, and practices are dynamic in nature.  The number of worksites (five) and the number of surface wipe tests was limited and as such statistical modeling could not be applied and the power to discern statistical relationships was diminished.  As only two types of cytotoxic drugs were assayed, this provides a marker of the presence of the products, but limited information on how many other types of products could be on the surfaces. The presence of contaminants on work surfaces will be very dynamic overall based on a number of factors.  For example, the wipe tests could have been carried out   212 on a day when there was a larger volume of products being handled or lesser volume of products.  Additionally, the presence of contamination could be related to who is working that day and the techniques that he or she uses for cleaning or handling of products.  Although it is important to have information that worksites have contamination present on surfaces, the distribution and concentration of contamination will change continuously.   Phase 2: Employee Questionnaire The quality of responses obtained from the employee questionnaire may have varied depending on a number of factors such as time available to complete the survey or the participant?s interest in the subject.  For example, if a participant had a limited amount of time to complete the survey, he or she may not have read questions adequately.  Furthermore, those who took the time to complete the survey may have already had a strong interest in health and safety that could bias results.  For example, if a participant that responded was very keen on health and safety he or she could have indicated that a particular piece of personal protective equipment was worn at all times or he or she was aware of the steps to take in case of a spill.  Finally, the limited sample size obtained from the employee questionnaire prevented the investigator from carrying out more complex statistical modeling.  Phase 3: Focus Group Sessions Within the focus group sessions there were also limitations based on who attended the sessions.  In the focus group sessions, there was variability in participant input that may   213 be based on the degree of comfort of an individual has in expressing an opinion.  In some sessions, the following behavior was observed:  ? One worksite had a participant that sat apart from others and attempted to dominate the discussion. ? At some sessions participants brought forward an idea that led the group off track of the discussion at hand. ? A supervisor attended at one worksite that may have impacted the responses of participants in the room. All of the above may have impacted the outcome of results from the focus group sessions. For example, a participant that is very safety minded may have used the session as a means to move an idea forward.  Conversely, a participant that believed the worksite did not require any changes could have used the focus group as a means to try and limit any changes pertaining to safety.   Furthermore, additional information on focus group dynamics may have been missed because the investigator was solely responsible for facilitating sessions.  Phase 4: Piloting Safety Initiatives The selection of safety initiatives to be piloted was carried out in consultation with supervisors.  Although all initiatives were brought forward through information collected in the environmental assessment, employee questionnaire and focus group sessions, supervisors may have selected those initiatives that required fewer resources.  Furthermore, the personnel that evaluated the initiatives may have had similar biases to   214 those that completed employee questionnaires. For example, if an employee that completed an evaluation was very safety minded and wanted the initiative to succeed, he or she may put positive comments on the form only.   Conversely, if an employee did not want a protocol to be put in place, the comments on an evaluation may have been very negative or indicated that the protocol was not required.  There was an inability to measure changes in surface contamination at the conclusion of this project.  Although final worksite visits provide information on changes that have taken place in safe work practices, this research is unable to measure uptake of safe work practices on an individual basis.  Therefore even if a protocol is present at a worksite, information on whether the protocol is being adhered to by workers is not available, and as such the final information collected at worksites may not represent true conditions at the worksite.   7.8 Future Directions There is a need to continue to focus efforts on reducing occupational exposure to cytotoxic drugs through the implementation of occupational hygiene controls.   The implementation of controls should not be carried out in isolation, but through a collaborative effort with frontline personnel and other health and safety professionals.  Furthermore, the traditional occupational hygiene evaluation framework should move towards the inclusion of health behavioral models when planning for an intervention to reduce occupational exposure to cytotoxic drugs.  Through the inclusion of factors considered in the health behavioral models, it should be possible to begin understanding barriers that frontline workers face to protect themselves from exposure.     215 Future Directions Inside the Hospital Pharmacy Setting When considering future directions, there is a need to continue working with pharmacy personnel, as this is where products are primarily manipulated and then disseminated into the acute care setting.  Some examples of future work needed with pharmacy personnel on a local level include: ? Development of a biological health monitoring program. ? A formalized approach to implementing the protocols and training piloted in Phase 4 of this thesis work.   ? Exploring the use of devices beyond the biological safety cabinet to control exposure during manipulation of products such as closed system transfer devices. ? Engaging all pharmacy personnel to include pharmacists and pharmacy technicians in training on an ongoing basis.  Some examples could include initial training on working safely with the products and spill response exercises on an annual basis. ? Establishment of standardized use of personal protective equipment across the organization for tasks associated with handling cytotoxic drugs. ? Engagement of pharmacy leadership to facilitate a culture of safety around the importance of working safety with cytotoxic drugs.  For example, if a worker was observed not following a safe work procedures to work collaboratively to overcome barriers to working safely. Future Directions Outside of the Pharmacy Setting The work with pharmacy personnel within this BC health authority is only the beginning of the work that needs to take place within the health care sector.  A future focus needs   216 to be on those beyond the pharmacy setting.  Some examples of other groups that require work to reduce the possibility of occupational exposure to cytotoxic drugs include: ? Those who work in the stores department in hospitals that receive cytotoxic drugs need to be aware of recognizing cytotoxic drugs and the safe handling procedures in the event of products arrive on-site damaged. ? Housekeeping personnel need to be trained on how to safely clean areas where products are handled, clean up spills and handle cytotoxic drug waste. ? Those working in residential care facilities and in home and community care also require training on safe handling of these products to include care protocols for their residents and clients.   ? Nursing personnel that work with these products also require standardized safe work procedures and training on working safely with cytotoxic drugs.   ? Those that transport the products around the worksites, generally porters, also require both awareness training on these products and information on the procedures on what to do in case of a leak or spill.  As an added note for future directions, in 2012 across the province, occupational health and safety personnel from all British Columbia health authorities commenced working on a number of topics pertaining to health and safety related to working with cytotoxic drugs.  One of the first areas to be addressed was the creation of a harmonized exposure control plan.  Beyond this step, work will commence on standardizing training for working safely with these products as well as addressing issues related to groups such as housekeeping personnel, acute care nursing and those working within home   217 and community care and residential facilities.  The BC Cancer Agency has also been invited to participate with this team and all parties have been working diligently to streamline practices and processes across the province.  Future Directions Using Theoretical Models of Health Belief  Typically in practice a health and safety professional would examine the constructs of an exposure control to determine what elements require either development or implementation within an industry or organization.  Within British Columbia, WorkSafeBC specifies that an exposure control plan with specific elements must be in place to control exposure to cytotoxic drugs in the workplace (WorkSafeBC, 2006).  Future program planning for controlling exposure to cytotoxic drugs should be examined from the perspective of the theoretical models of health belief.  The value in undertaking the use of such models would help to better inform occupational health and safety professionals as to potential individual, environmental and organizational factors that can influence the ability of workers to engage in self-protective behavior.   218 References Abd El-Atti S, Martinelli B, Yourich B, Wasicek K, Weber R. (2006).  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Journal of Applied Psychology, 65(1): 96-102.                    226  Appendix A Table A1 WorkSafeBC Regulations Specific to Cytotoxic Drugs Regulation Section Topic Details 6.43 Exposure control plan  If a worker is or may be occupationally exposed to a cytotoxic drug, the employer must develop and implement an exposure control plan meeting the requirements of section 5.54 6.44 Information  If a cytotoxic drug is received, prepared, administered, stored or disposed of at a workplace, the employer must maintain and make readily available to workers information on its (a) acute and chronic toxicity, including any potential reproductive hazard, (b) acute exposure treatment, and (c) safe handling.         [Amended by B.C. Reg. 21/2006, effective May 17, 2006.]   6.45 Labels A container of a cytotoxic drug and a shelf or bin where a cytotoxic drug is regularly stored must be appropriately labeled. 6.46 Signs Warning signs which are clearly visible and clearly state the identified hazards must be posted in all areas where cytotoxic drugs are stored or mixed.  6.47 List Storage and preparation areas for cytotoxic drugs must be posted with a list of all cytotoxic drugs present in the workplace.      227 Regulation Section Topic Details 6.48 Procedures (1) When a cytotoxic drug is received, prepared, administered, stored or disposed of, written safe work procedures must be developed and implemented for applicable aspects of receiving, storage, preparation, administration and waste handling. (2) The work procedures required by subsection (1) must be readily available for reference by workers and where practicable, summaries of relevant procedures must be posted in the appropriate work areas.        [Amended by B.C. Reg. 21/2006, effective May 17, 2006.]   6.49 Reproductive toxins (1) At any worksite where a worker is occupationally exposed to a cytotoxic drug that is a reproductive toxin, the employer must develop policy and procedures appropriate to the risk, which may include protective reassignment. (2) The policy and procedures must inform workers about the reproductive toxin and identify ways to minimize exposure to the reproductive toxin for a worker who has advised the employer of pregnancy or intent to conceive a child      228 Regulation Section Topic Details 6.50 Instruction 1) A worker involved in any aspect of handling a cytotoxic drug must receive pre-job education and on-the-job training on the handling of this substance. (2) The instruction required by subsection (1) must address the (a) known health risks, including any potential reproductive hazards, (b) relevant techniques and procedures for safe handling, (c) proper use of protective equipment and materials, and (d) spill and waste disposal procedures.  (3) The adequacy of instruction must be assessed when required by a change in the substance used, information available on the substance or a change in work procedures, and retraining provided where necessary.      229 Regulation Section Topic Details 6.51 Supervision A worker involved in any aspect of cytotoxic drug handling must be effectively supervised 6.52 Records (1) The employer must maintain a record of all workers who prepare or administer cytotoxic drugs, including the name of the drugs handled, and when practicable, the number of preparations or administrations per week. (2) Exposure records must be maintained for the duration of employment plus 10 years, and training records for 3 years from the date that the training occurred.  6.53 Drug preparation and administration (1) All mixing, preparation and priming of administration sets with a cytotoxic drug must be performed in one centralized area in a specially designated Class II Type B biological safety cabinet that (a) is exhausted to the outside atmosphere in a manner that prevents recirculation into any work area, (b) has exhaust and ventilation systems that remain in operation for a sufficient period of time to ensure that no contaminants escape from the biological safety cabinet into the workplace, and (c) is equipped with a continuous monitoring device to permit confirmation of adequate airflow and cabinet performance. (2) The administration of cytotoxic drugs must be done by following safe work procedures.         [Amended by B.C. Reg. 21/2006, effective May 17, 2006.] 6.54 Disconnects Syringes and intravenous sets used for cytotoxic drugs must have appropriate fittings, such as Luer locking fittings, which prevent accidental disconnection.  [Amended by B.C. Reg. 21/2006, effective May 17, 2006.]     230 Regulation Section Topic Details 6.55 Personal protective equipment (1) Adequate personal protective equipment must be provided and worn whenever there is a risk of contact with a cytotoxic drug. (2) For the purposes of subsection (1) personal protective equipment includes (a) medical gloves that are manufactured and designed for use when handling cytotoxic drugs,  (b) a moisture resistant, long-sleeved gown with cuffs, (c) if there is a risk of contact with aerosols, an approved respirator, and (d) if there is a risk of eye contact, eye and face protection. (3) Used gowns and gloves must not be worn outside the preparation, administration or storage area and must be handled as hazardous waste or contaminated linen. (4) All other non-disposable personal protective equipment must be cleaned immediately after use.        [Amended by B.C. Reg. 21/2006, effective May 17, 2006.]  6.56 Personal hygiene Eating, drinking, smoking, application of cosmetics or storage of food is prohibited in any area where a cytotoxic drug is mixed, administered or stored. 6.57 Waste disposal (1) Adequate, leak-proof waste disposal containers, including sharps and solids containers, and distinctive plastic waste bags must be available in every area where cytotoxic drugs are prepared, administered or stored, and all cytotoxic drug-related waste must be placed into these containers or bags. (2) Any excreta from a patient being treated with cytotoxic drugs that is handled by a worker must be treated as cytotoxic drug-related waste.  [Amended by B.C. Reg. 21/2006, effective May 17, 2006.]     231 Regulation Section Topic Details 6.58 Spills (1) Written emergency procedures to address spills of a cytotoxic drug must be developed and implemented which address requirements for small spill cleanup, both inside and outside the biological safety cabinet, large spill cleanup, and personal decontamination. (2) Spill kits, clearly labeled, must be kept in or near cytotoxic drug preparation, administration and storage areas and a sign detailing spill procedures must be posted in all such areas.        [Amended by B.C. Reg. 21/2006, effective May 17, 2006.]       232 Table A2-Summary of Information of USP 797 Topic  Information in USP 797 1. Personnel training for handling ? Audiovisual training, pass written & practical test of manipulation.   ? Aseptic technique demonstration at least annually, bi-annually for high risk ? All personal trained in storage, handling & disposal prior to use and at least annually ? Training needs to include information on teratogenic, mutagenic & carcinogenic properties ? Training for every new compound on properties that enters the worksite.  ? Training needs to include also: Safe aseptic manipulation, negative pressure techniques when using a BSC, correct use of CSTD devices, containment, clean-up, & disposal for breakages & spills, treatment for personnel contact & inhalation exposure ? Custodial staff must be trained to protect themselves & prevent contamination 2. Storage ? Must be stored separately from other products ? Many have sufficient vapour pressure to allow volatilization at room temperature ? Storage should be under negative pressure     233 Topic  Information in USP 797 3. Room Specifications ? Air changes should be 12 per hour to remove contaminants ? Access should be limited where drugs are stored and prepped ? Room should be physically separated and be under slightly negative pressure to prevent hazardous drugs from leaving area (min. 0.01 inches of water) ? ISO class 5 to be placed in an ISO class 7 area ? 100% of air vented through HEPA filter outside from BSC 4. Personal Protective Equipment ? Appropriate chemotherapy gloves should be worn receiving, stocking, distributing, manipulating and disposing ? PPE: gowns, gloves, masks, eye protection, shoe covers, hair covers 5. Administrative& other ? Those with reproductive capability must confirm in writing that they understand the risks associated with handling hazardous drugs ? Environmental sampling should take place as a benchmark and every 6 months thereafter to ensure containment ? Sampling should take place inside working area of BSC, counter tops where finished products are placed, areas adjacent to BSC to include the floor, & patient areas where products are dispensed. ? Cyclophosphamide >1 ng/cm2 found to cause human uptake and this should be documented, identified &contained. Possible corrective actions include more training, thorough cleaning and re-assessment of engineering controls    234 Appendix B-Resources For Environmental Assessment Phase    235    236     237 Protocol for Analysis Wipe Tests for Surface Contamination   The protocol for chemical analysis utilized in this thesis work was described in Hon et al., 2011 and based on work by Chu and Barnjak, 2005.  The chemical analysis was done using high-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) with the electrospray ionization in the positive-ion mode.  The system components were a Waters Acquity Ultra-Performance Liquid Chromatography (UPLC) liquid chromatograph, a Waters Micromass Quattro Premier XE tandem mass spectrometer and an Acquity UPLC BEH (ethylene bridged hybrid) C18 1.7, 2.1 x 100mm column (Waters Corporation, Milford Massachusetts).  The mass spectrometer was operated in the multiple-reaction monitoring mode.  The HPLC mobile phase was 0.2% formic acid in a 1:1 methanol and deionized water.  The samples were analyzed in batches and limits of detection were obtained for each of the analytical batches and contamination levels were reported in nanograms per wipe (ng/wipe).  In all batches, the limit of detection was determined on the basis of the average value for a laboratory blank plus three standard deviations.  All analysis was carried out at the University of British Columbia School of Population and Public Health laboratory (formerly School of Environmental Health).          238 Table B1:  Full Wipe Test Results For Phase 1: Environmental Assessment (n=61) Values in ng/cm2 CYCLOPHOSPHAMIDE      Site # #1 #2 #3 #4 #5 Biosafety Cabinet 0.001592274 0.001781325 0.001603959 0.03974136 0.001781325 Chair 0.008808929 0.511484149 0.007522519 0.001781325 0.000814319 Marking Pen 0.006674129 0.030909888 not tested 57.9548 9.154157921 Transport Box not tested 0.000662499 0.049197469 0.025329329 0.000901249 Outside of Transport Box not tested not tested not tested not tested 0.015253249 Doorknob Inside 0.004123438 0.001781325 0.004997619 0.030693039 0.001781325 Doorknob Outside 0.004123438 0.001781325 0.002210799 0.015014149 0.004349739 Receiving Cart 0.036222539 0.001781325 not tested 0.001781325 0.001781325 Checking Counter not tested 0.005096949 0.002172479 not tested not tested Cart in Chemo Room 0.006213699 0.001781325 0.000680669 0.001781325 not tested Receiving Counter 0.012875879 0.001781325 not tested 0.001781325 0.001781325 Beside Chemo Sink 0.008019219 0.001781325 0.003646879 0.001781325 0.000901249 Chemo Tray not tested 0.001781325 0.001356069 0.023603919 0.001781325 Pass Through not tested not tested 0.003269489 0.001781325 not tested Staging Counter not tested not tested 0.000788999 not tested not tested Checking Counter Adjacent not tested not tested 0.002883609 not tested not tested Counter Above Chemo Storage not tested not tested 0.002776959 not tested not tested Service Counter 0.001781325 not tested not tested not tested 0.001781325 Counter near computer in chemo 0.001781325 not tested not tested not tested not tested Fridge Inside pharmacy 0.001781325 not tested not tested not tested not tested METHOTREXATE      Site # #1 #2 #3 #4 #5 Biosafety Cabinet 0.001437593 0.00012053 0.003450968 0.001719275 0.000236393 Chair 0.00012053 0.00012053 0.000277343 0.005307368 0.003102893 Marking Pen 0.00045159 0.00045159 not tested 0.00871054 0.263974868 Transport Box not tested 0.00012053 0.002945918 0.018870397 0.064725818 Outside of Transport Box not tested not tested not tested not tested 0.003648893 Doorknob Inside 0.001021165 0.000279003 0.001226547 0.000877943 0.003217172 Doorknob Outside 0.000420818 0.000279003 0.001842693 0.00012053 0.008446512 Receiving Cart 0.001949468 0.00012053 not tested 0.001519493 0.002440868 Checking Counter not tested 0.00012053 0.003034643 not tested not tested Cart in Chemo Room 0.003833168 0.00012053 0.00012053 0.003848675 not tested Receiving Counter 0.00012053 0.00012053 not tested 0.00012053 0.00012053 Beside Chemo Sink 0.001662818 0.00012053 0.003737618 0.00012053 0.008139743 Chemo Tray not tested 0.00012053 0.00012053 0.00012053 0.00012053 Pass Through not tested not tested 0.001601393 0.00012053 not tested Staging Counter not tested not tested 0.000768743 not tested not tested METHOTREXATE        239 Site # #1 #2 #3 #4 #5 Checking Counter Adjacent not tested not tested 0.003034643 not tested not tested Counter Above Chemo Storage not tested not tested 0.00012053 not tested not tested Service Counter 0.00012053 not tested not tested not tested 0.000789218 Counter near computer in chemo 0.00012053 not tested not tested not tested not tested Fridge Inside pharmacy 0.000168143 not tested not tested not tested not tested    240 Appendix C- Employee Questionnaire      241        242         243       244      245        246 Raw Data for Employee Questionnaire (Coded) Participant Code 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 1 5 2 19 0 0 0 5 3,7 1 2 5 4 0 2,3 1,2,3,4 3 2 1,2,3,4 2,3 2 2 5 1 20 0 0 0 12.50 1,2,3,4,6 0 2 6 3 0 1,3 1,2,3,4 3 2 1,2,3,4 2,3,4 4 3 5 1 15 0 0 0 28 2 0 2 4 3 0 2 1,2,3,4 4 2 2 3 4 4 5 2 23 0 0 0 8 7 1 2 5 4 0 1,3 1,2,3,4 4 4 1,3 1,2,3,4 2 5 5 1 0.25 0 0 0 2 3 1 2 5 3 1 na na 4 5 4 6 1 6 5 1 3 0 0 0 20 1,2,3,4,6 0 2 5 3 0 1 1,2,3,4 4 5 1,3,4 6 5 7 5 1 15 0 0 0 20 2,3,4,6 0 2 4 3 0 1,3 1,2,3,4 4 5 1,2,3,4 99 3 8 5 1 31 0 0 0 25 1,2,3 0 2 6 3 0 3 2,3,4 4 5 3 4 2 9 5 1 12 0 0 0 12 1,2,3,4,6 0 2 5 3 0 1,2 1,2,3,4 99 5 1,2,4 2,3,4,5 1 10 5 2 23 0 0 0 18 7 0 1 5 4 0 3 1,2,3,4 99 2 1 3 2 11 5 2 16 0 0 1     1 2 4 4 0 2 2,3,4 99 4 1,3,4 3 1 12 3 1 11 0 0 0 30 2 0 2 4 3 0 2 2,3 99 5 1,2,4 1,2,3   13 3 1 1 0 0 0 16 2,4,7 0 1 2 4 1 na na 2 5 2,3,4 2,3 2 14 3 1 5 0 0 0 75 1,2,3,4,6 0 1 2 3 0 1,2 1,2,3,4 1 1 1,2,3,4 1,2,4,5 1 15 3 1 40 0 0 0 30 1,2,3,4,6 0 2 6 3 1 na na 99 2 3,4 1,2,4,5 1 16 3 1 7 0 0 0 15 2 0 1 4 3 0 2 1,2,3,4 99 2 2,3,4 1,2,4,5 2 17 3 2 2 0 0 0 35 7 0 2 6 4 1 na na 4 5 4 6 1 22 3 1 12 0 0 0 15 1,2,3,6 0 1 4 3 0 2 1,2,3,4 3 2 3 1,2,4,5 3 23 3 1 11 0 0 0 30 1,2,3,4,6 0 2 4 3 0 2 1,2,3,4 3 1 4 1,2 3 24 3 1 2 0 0 0 8 1,2,4 0 2 3 3 0 1,2 1,2,3,4 2 2 2,4 2 2 25 3 1 3 0 1 0 150 1,2,3,6 1 2 4 3 0 1,2,3 1,2,3,4 2 2 1,2,3,4 1,2,3,4 2 26 3 1 23 0 1 0 150 1,2,3,4,6 0 2 5 3 1     2 1 3 1,2 2 27 3 1 9 0 0 0 3 2 0 2 6 3 0 1,2 1,2,3,4 3 1 3 2 1 28 3 1 3 0 0 0 150 1,2,3,4,6 1 2 2 3 0 1,2 1,2,3,4 2 2 2,3,4 1,2 1 29 3 1 9 0 0 0 2.5 99 0 2 5 4 0 2 1,2,3,4 99 2 1,2,3,4 1,2,3,4,5 1 18 2 2 30 0 0 1   na na 1 6 4 0 2 1,2,3,4 3 2 1,2,4 1,2,4 2 19 2 2 35 0 0 0 8 3,7 1 2 6 4 1 na na 99 2 1 3 2 20 2 1 13 0 0 0 30 2,3 0 2 6 3 1 na na 4 2 1,3,4 1,2,3,4,5 2 60 2 1 9 0 0 0 10 2,3,4,6 0 2 3 3 0 1,3 1,2,3,4 2 2 4 1,2,3,4,5 3 61 2 1 3 0 0 0 20 1,2,3,4 0 2 2 3 0 1,2 2,3,4 2 2 4 1 3 62 2 2 10 0 0 0 40 3,6 0 2 6 4 0 2 2,3,4 99 2 3 1,2,3 2      247 Participant Code 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 2 1 40 0 0 0 25 3,7 0 2 7 4 0 2 99 4 3 1,3 1,2,3 2 30 1 1 2 0 0 0 52 1,2,4,6 0 2 2 3   na na   3 1,2,3,4 1 4 31 1 1 27 0 0 0   2 0 2 6 3 0 1,2,99 2,3,4 99 5 1,2,3,4 1,3 1 32 1 1 5 0 0 0 15 2,3,4 0 2 3 3 1 na na 99 4 1,3,4 2 5 33 1 2 29 0 0 0 60 3,4 0 1 6 4 1 na na 4 3 1,2,3,4 3 3 34 1 1 4 0 0 0 40 2,99 0 2 3 3 0 1,2 1,2,3,4 4 2 1,2,3,4 6 4 35 1 2 35 0 0 0 100 1,3 1 2 6 4 0 2 1,2,3,4 3 1 3 3,4 2 36 1 2 18 0 0 0 80 3,7 0 2 5 4 0 2,3 3,4 99 4 1,3,4 2 2 37 1 99 8 0 0 1 na na na 2 5 3 1 na na 4 3 1,2,3,4 2,99 2 38 1 2 26 1 0 0 2 1,3,4 na 2 5 4 0 3 4 4 4 1,2,3,4,99 6 1 39 1 1 5 0 1 0 na 2 0 2 5 3 0 2 2,3,4 99 3 1,2,3,4 6 2 40 1 2 5 0 0 0 na 2,3,7 1 1 3 4 1 na na 4 5 1,3,4 2 2 41 1 1 25 0 0 0 2 3,7 na 2 5 3 0 2,3 1,2,3,4 99 2 1,4 1,2,3 1 42 1 2 8 0 0 0 na 2,3,4,6,7 1 1 5 5 1 na na 4 3 3 6 2 43 1 1 30 0 0 1 na na na 2 6 3 0 2,3,99 3,4 na na 4 3 3 44 1 1 2 0 0 0 40 1,2 0 2 2 3 0 1 1,2,3,4 99 2 1,2,3,4 6 2 45 1 1 4 0 0 0 na 7 na 2 4 3 1 na na 4 3 1,3,4 6 3 46 4 1 20 0 0 0 2 2,4,6 0 2 5 3 0 1,2 1,2,3,4 99 2 1,3,4 6 2 47 4 2 16 0 0 1 na na na 3 5 4 1 na na 4 5 1,2,3,4 2,3 3 48 4 1 10 0 0 0 10 2 0 2 6 3 0 1,2,99 1,2,3,4,99 99 2 1,2,3,4 1,2,4,5 2 49 4 1 23 0 0 0 12 2 0 2 5 3 0 2,3 1,2,3,4 99 3 1,2,3,4 1,2,3,4 5 50 4 2 25 0 0 0 1 7 1 2 5 4 0 1,2,3,99 1,2,3,4 3 1 2,4 1,2,3,4,5 1 51 4 1 11 0 0 0 2 2,4 0 2 6 3 0 2 2,3,4 3 5 3,4 2 3 52 4 2 33 0 0 1 na na na 2 6 4 0 3 1,2,3,4 99 1 3,4 1,2,3,4,5 1 53 4 2 30 0 0 1 na na na 2 6 5 0 2 1,2,3,4 99 4 99 1,2,4,5, 1 54 4 2 19 0 0 0 1 1,7 0 2 5 4 0 2 1,2,3,4 3 2 3,4 1,2,3 2 55 4 1 27 0 0 0 na 2,4,6 1 2 6 3 0 2 1,2,3,4 99 2 1,3,4 1,2,4,5 1 56 4 2 1.5 0 0 0 0.5 7 0 2 3 4 0 1 1,2,3 4 4 4 1 2 57 4 1 21 0 0 0 10 2 0 2 5 3 0 2 1,2,3,4 3 2 3,4 2,4 1 58 4 2 25 0 1 0 1 99 1 2 6 5 0 1,2,3 1,2,3,4 99 1 2 1,2,4 1 59 4 1 9 0 0 0 na 2,4 0 1 4 3 0 2,3,4 99 2 1,3,4 1,2 3 2   248    Participant Code 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 1 1 2 2 2 1 1 0 0 0 0 2 2 1 1 5 1 5 1 5 2 4 2 2 1 1 1 0 0 0 0 1 1 1 1 5 1 5 1 5 3 2 2 3 2 1 1 0 0 0 1 2 2 1 1 5 1 5 1 5 4 1 2 3 3 1 1 0 0 0 2 2 2 1 1 5 1 5 1 5 5 2 2 2 2 1 1 2 2 2 0 2 2 1 1 5 1 5 1 5 6 4 3 2 2 1 2 1 1 1 0 2 2 1 1 5 4 5 1 5 7 3 3 2 2 1 1 0 0 2 3 2 2 1 1 5 2 5 1 5 8 2 2 2 2 1 1 0 0 0 0 2 2 1 1 5 5 5 1 5 9 1 2 2 2 2 1 0 0 0 0 2 2 1 1 5 1 5 1 5 10 2 2 2 2 1 1 0 0 0 0 2 2 1   5 5 5 1 4 11 3 5 5 3 1 1 0 0 0 1 4 3 1 1 5 4 5 5 5 12         1 1 0 0 0 0 1 1 1 1 1 1 1 1 5 13 2 1 2 5 1 1 0 0 0 0 5 1 1 1 1 1 5   5 14 1 1 1 1 1 1 0 0 0 0 1 1 1 1 1 1 1 1 5 15 3 2 2 2 1 1 0 0 0 0 2 2 1 1 1 5 1 1 5 16 2 2 2 1 1 1 0 0 0 0 1 1 1 1 1 1 1 1 5 17 1 2 1 3 1 1 0 2 0 0 3 3 1 1 1 1 5 1 5 22 1 2 2 1 1 1 0 0 0 0 1 1 1 1 1 1 1 1 5 23 3 1 1 1 1 2 0 0 0 0 1 1 1 1 1 5 1 1 5 24 2 2 2 2 1 1 0 0 0 0 1 1 1 1 1 5 1 1 5 25 2 2 2 2 1 1 0 0 0 0 1 1 1 1 1 1 1 1 5 26 2 2 2 2 1 1 0 0 0 0 2 2 1 1 1 5 1 1 5 27 1 1 1 2 2 1 0 0 0 0 1 1 1 1 1 1 5 1 5 28 2 2 2 2 1 3 0 0 0 0 1 1 2 2 1 5 1 1 5 29 4 2 2 1 3 1 1 0 0 0 0                 18 2 2 1 2 1 1 0 0 0 0 2 1 1 1 1 1 5 1 5 19 1 5 1 3 1 1 0 0 0 0 2 2 na na na na na na 5 20 1 1 1 2 1 1 0 0 0 0 1 1 1 1 1 1 5 1 5 60 3 2 3 1 1 3 0 0 0 0 1 1 1 1 1 1 5 1 5 61 3 2 2 2 1 1 0 0 0 0 1 1 1 1 1 1 5 1 5 62 1 1 2 5 1 1 0 0 0 0 2 2 na na na na na na 5   249    Participant Code 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 21 3 2 2 2 2 1 0 0 0 0 2 2 na na na na na na 5 30 3 2 2 3 1 1 0 0 0 0 2 2 1 1 5 1 5 1 5 31 1 1 2 2 1 1 0 0 0 0 1 1 1 1 4 1 4 1 1 32 5 4 2 2 1 1 0 0 0 0 2 2 1 1 5 1 5 1 4 33 2 4 2 5 1 1 0 0 0 0 2 2 na na na na na na 2 34 4 3 2 2 1 1 0 0 0 0 2 1 1 1 5 1 5 1 5 35 2 2 2 1 1 1 0 0 0 0 2 1 1 2 5 1 5 1 5 36 1 2 2 3 3 1 0 0 0 0 3 3 na na na na na na na 37 5 3 2 4 1 1 0 0 0 1 4 5 na na na na na na na 38 3 3 3 2 1 1 0 0 3 3 5 5 1 1 4 1 5 1 5 39 2 3 5 2 1 1 0 0 0 0 1 2 1 1 5 1 5 1 5 40 3 2 2 4 1 1 0 3 0 0 1 2 1 1 5 1 5 1 5 41 2 2 2 2 1 1 0 0 0 0 1 1 1 5 5 1 5 1 5 42 2 2 2 5 1 1 0 0 0 0 3 2 1 3 5 2 5 2 1 43 4 2 2 2 1 1 0 0 0 0 2 2 1 1 4 1 5 1 5 44 2 3 2 3 1 1 0 0 0 0 2 2 1 1 5 1 5 1 5 45 3 4 3 3 1 3 1 0 2 0 2 2 1 2 2 1 5 1 3 46 2 2 2 2 1 1 0 0 0 0 1 1 1 1 5 5 1 1 5 47 2 2 5 5 1 1 0 0 0 0 4 5 na na na na na na na 48 2 3 3 1 1 1 0 0 0 0 1 1 1 1 5 1 5 1 5 49 2 2 2 2 1 1 0 0 0 0 2 2 1 1 5 1 4 1 5 50 1 2 2 2 1 1 0 0 0 0 2 1 1 1 5 1 5 1 5 51 3 5 3 2 1 3 0 0 0 0 2 2 1 1 5 5 1 1 5 52 1 1 5 2 1 1 0 0 0 0 2 2 na na na na na na na 53 3 5 5 5 1 1 0 0 0 0 2 2 na na na na na na na 54 2 1 1 2 1 1 0 0 0 2 2 1 1 1 5 1 5 1 5 55 2 2 2 99 1 na 0 0 0 0 1 1 1 1 5 5 1 1 5 56 3 3 3 3 1 1 0 0 0 0 2 2 na na na na na na na 57 1 1 1 1 1 2 0 0 0 0 1 1 1 1 5 1 5 1 5 58 2 2 1 2 1 1 0 0 0 0 1 1 na na na na na na na 59 2 2 2 2 2 1 0 0 0 0 2 1 1 1 5 1 1 1 5   250 Appendix D: Summary of Focus Group Results Table D1: Summary of Coding Frame Information For Phase 3: Focus Group Sessions Question Posed by Investigator Thematic Category Specific Ideas From Focus Groups (proportion of focus groups discussed) 1.  What are your thoughts on working with cytotoxic drugs? 1. Personal Health 1. Concerns about health and past handling practices  (3/5)  2. Musculoskeletal injuries from preparation of cytotoxic drugs (2/5)  3. Absence of health monitoring program (2/5) 2. Safety In the workplace 4. Current practices in place protective against exposure (3/5)  5. Individual practices differ as they pertain to working safely with cytotoxic drugs (3/5) 2. What are your thoughts on the findings from the environmental assessment? 3. Hypothesizing source of worksite surface contamination 6. Housekeeping practices responsible for surface contamination (2/5)  7. Improper use of personal protective equipment responsible for surface contamination (4/5)  8. Product comes contaminated from manufacturer and leads to contamination in worksite (2/5) 4. Variable practices in place for safe handling. 9. Individuals follow different work procedures that may or may not be enforced (3/5) 5. What level is harmful? 10. Until amount of contamination on surface is shown to have a health impact, people will not be concerned (2/5) 3.  What are your thoughts on the findings from the employee questionnaire? 6. Variable practices in place for training and the use of personal protective equipment. 11. Training across the organization for safe handling of cytotoxic drugs had not been standardized (4/5)  12. Inconsistent use of respiratory protection when carrying out work with cytotoxic drugs (4/5) 4.  Are there barriers to working 7. Limited time and resources 13. Heavy workload and limited time prevents working safely with cytotoxic drugs (2/5)   251 safely with cytotoxic drugs?  14. Changes in resourcing and availability of funding prevents working safely with cytotoxic drugs (2/5)  15. Ability to work  safely limited by physical space and design of worksite (2/5) 8. Physical demands of job 16. Preparation of cytotoxic drugs leads to musculoskeletal injuries (2/5)  9. Relationships between health care providers  17. Relationships with oncology patient services barrier to working safely (2/5)  18. Relationships between personnel within pharmacy department barrier to working safely (1/5) 10. Complacency and individual technique 19. Not all co-workers following safe work practices when handling cytotoxic drugs (3/5) 5. What are some strategies that could be used to promote working safely with cytotoxic drugs? 11. Standardized protocols and policies 20. Safe work procedures  for working with cytotoxic drugs consistent across organization (3/5)  12. Standardized training and education 21. All worksites should have the same training and orientation for working safely with cytotoxic drugs (5/5)  22. Standard training and response for cleaning up cytotoxic drug spills (3/5) 13. Increased supervision 23. Supervision to include follow up to ensure safe work practices are taking place when working with cytotoxic drugs (3/5) TOTAL 13 23          252 Appendix E-Safety Initiatives Protocol for Receiving Hazardous Drugs    253 Protocol for Checking Hazardous Drugs  254 Protocol for Spill Clean Up        255 Introduction to Working Safely With Hazardous Drugs         256    257    258    259    260 Participant Evaluation of Safety Initiatives                      261 Appendix F: Final Worksite Assessment Tool      262     

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