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The drug formulary approval process in select Canadian hospitals D’Sa, Mel Matthew 1994

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T H E D R U G F O R M U L A R Y A P P R O V A L PROCESS IN S E L E C T C A N A D I A N  HOSPITALS  by  M E L M A T T H E W D'SA B.Sc. (Pharm), The University of British Columbia, 1991  A THESIS SUBMITTED I N P A R T I A L F U L F I L L M E N T O F T H E R E Q U I R E M E N T S FOR T H E D E G R E E O F M A S T E R O F SCIENCE in T H E F A C U L T Y O F G R A D U A T E STUDIES The Faculty of Pharmaceutical Sciences Division of Pharmacy Administration  We accept this thesis as conforming to the required standard.  T H E UNIVERSITY O F BRITISH C O L U M B I A  December 1994  © Mel Matthew D'Sa, 1994  In presenting this thesis in partial fulfillment of the requirements for an advanced degree at the University of British Columbia, I agree that the Library shall make it freely available for reference and study. I further agree that permission for extensive copying of this thesis for scholarly purposes may be granted by the head of my department or by his or her representatives. It is understood that copying or publication of this thesis for financial gain shall not be allowed without my written permission.  Division of Pharmacy Administration in the Faculty of Pharmaceutical Sciences The University of British Columbia Vancouver, B C , Canada  Date: December 30,1994  ABSTRACT One of the many responsibilities of the profession of pharmacy is to serve as a gatekeeper for pharmaceuticals. In contemporary hospital practice one way that pharmacy fulfills this responsibility is through its involvement i n the multidisciplinary pharmacy and therapeutics (P&T) committee.  By using a  formulary system, a P & T committee generates a drug formulary. In essence, a drug formulary is a restricted drug list that reflects the current clinical judgement of the medical staff. It also represents a list of drugs approved for use within a hospital. However, research in the literature has identified various influences of a political, organizational, societal, legal, professional, and economic nature that have the potential to impact on the drug formulary approval process. The attitudes and opinions of key clinical decision makers such as pharmacy directors and P & T committee chairs concerning the drug formulary approval process have not been documented in the Canadian literature. This study reports the results of a national mail survey conducted to examine the attitudes and opinions of select hospital pharmacy directors and P & T committee chairs with respect to the current and future drug formulary approval process. A l s o obtained was information concerning demographic and organizational aspects of a large number of hospitals. The hypothesis tested is that pharmacy directors and P & T committee chairs do not believe that the drug formulary approval process will demonstrably change in the next five to ten years. Also, identified items in the literature are not expected to have significant influence o n the future process. It appears that the drug formulary approval process in Canadian hospitals is a function of many underlying influences. change.  The actual process itself is not expected to  However, various influences, especially those of an economic nature, are  expected to significantly impact the future process.  Findings have implications for  health care professionals, hospitals, hospital P & T committees,  governments,  party payers, drug companies, and pharmaceutical industry analysts.  third-  iii TABLE OF CONTENTS  Abstract  .  ii  Table of Contents  iii  List of Tables  v  List of Appendices  viii  Acknowledgements  ix  CHAPTER ONE: INTRODUCTION  1  Background  1  The Diffusion Process  1  The A d o p t i o n Process  2  The D r u g Formulary  4  The Formulary System  5  The Pharmacy and Therapeutics Committee..:  6  C H A P T E R T W O : REVIEW O F T H E LITERATURE  8  Potential Influences on the Drug Formulary Approval Process  8  Political Influences  8  Organizational Influences  10  Societal Influences  12  Legal Influences  15  Professional Influences  16  Economic Influences  24  Statement of the Problem  30  TABLE OF CONTENTS  (Continued)  CHAPTER THREE: METHODS  32  Study Sample  32  Data Collection  32  Data Analysis  37  Assumptions  38  C H A P T E R FOUR:  RESULTS  41  C H A P T E R FIVE: DISCUSSION  71  The Pharmacy and Therapeutics Committee  72  The D r u g Formulary  75  Pharmacy Directors: The Drug Formulary Approval Process  78  P & T Committee Chairs: The Drug Formulary Approval Process  96  Future Directions  102  Limitations  103  C H A P T E R SIX: C O N C L U S I O N  105  Addendum  107  REFERENCES  109  Appendix 1: Research Certificate  130  Appendix 2: Survey Instrument  132  Appendix 3: Follow-up Covering Letters  139  Appendix 4: Item Influence on the D r u g Formulary A p p r o v a l Process  142  LIST O F T A B L E S  Table  Page  1  Characteristics of Survey Respondents  42  2  Survey Respondents by Hospital Bed Size  43  3  Survey Respondents by Province/Territory  45  4  Type of Hospital by Hospital Bed Size  46  5  Teaching Program by Hospital Bed Size  47  6  T w o Year Hospital Actual Versus Budgeted Expenditures by Hospital Bed Size  7  48  Level of Pharmacy Clinical Services Provided to the Majority  of Hospital Beds by Hospital Bed Size  49  8  P & T Committee Membership by Staff Title  50  9  P & T Committee Size Characteristics by Hospital Bed Size  51  10  Responsibilities of P & T Committee as Reported by Pharmacy Directors  52  LIST O F T A B L E S (Continued)  Table  11  Page  Responsibilities of P & T Committee as Reported by P & T Committee Chairs  12  53  Organizational Reporting Relationships of P & T Committee  by Hospital Bed Size  54  13  P & T Committee Chairperson by Hospital Bed Size  55  14  P & T Committee Secretary by Hospital Bed Size  56  15  Frequency of P & T Committee Meetings by Hospital Bed Size  57  16  Degree of Drug Formulary Control by Hospital Bed Size as Reported by Pharmacy Directors  17  58  Degree of D r u g Formulary Control by Hospital Bed Size as Reported by P & T Committee Chairs  59  18  Year of Last Drug Formulary Updating by Hospital Bed Size  60  19  Characteristics of Drug Formulary Additions and Deletions Over Past T w o Years  61  LIST O F T A B L E S (Continued)  Table  Page  20  Committees Involved with the Drug Formulary A p p r o v a l Process.....62  21  Opinions on Future P & T Committee Appointments as Reported by Pharmacy Directors  22  Opinions o n Future P & T Committee Appointments as Reported by P & T Committee Chairs  23  63  64  Wilcoxon Matched-Pairs Signed-Rank Test of Items Influencing Current and Future Drug Formulary Approval Process as Reported by Pharmacy Directors and P & T Committee Chairs  66  viii LIST O F A P P E N D I C E S  Appendix  1  Page  University of British Columbia Behavioural Sciences Screening Committee for Research and Other Studies Involving H u m a n Subjects Certificate  2  130  The D r u g Formulary Approval Process in Canadian Hospitals Survey Instrument  132  3  Follow-up Covering Letters  139  4  Item Influence on the Drug Formulary Approval Process  142  ACKNOWLEDGEMENTS Gratitude is extended to my Master's degree supervisor M r . D a v i d H i l l for his initial suggestion of the graduate program at U B C as well as his ongoing encouragement and invaluable advice. Appreciation is also extended to the rest of my supervisory committee including Dr. Helen Burt, Dr. Peter Jewesson, M r . Ron McKerrow, Dr. A l a n Mitchell, and Dr. Joseph Tan for their time and attention to this work. The external review of this work by Dr. D a v i d Fielding and Dr. James Orr is acknowledged. The financial assistance provided by the Merck Frosst Pharmacy Postgraduate Fellowship is gratefully acknowledged. This work is dedicated to my mother, father, brother, and sister. Without their support this course of studies would not have been possible.  1 CHAPTER ONE  INTRODUCTION  Background N e w drugs are developed for many reasons. They may be developed to replace existing drugs, to complement existing drugs in multidrug treatment protocols, to treat emerging health problems or medical conditions, to treat previously untreatable health problems or medical conditions, to create or gain market share, or for any combination of these reasons.  The existence of thousands  of drugs on the Canadian market necessitates a rational and organized approach to drug selection by potential users such as hospitals. The cost, efficacy, and safety of a drug are among the primary criteria considered in determining whether a new drug will be accepted for use within a hospital. The acceptance process for new drugs in contemporary practice involves a form of technology diffusion and, ultimately, the adoption of the drugs from industry by prescribing physicians and hospitals. The diffusion process. The process by which a new technology is introduced and adopted by users is complex. Rogers (1962) refers to the overall process as the diffusion of an innovation, with diffusion being defined as the spread of a new concept, product, or service from an innovation source to its ultimate adopter. For a new technology a sequence of events occurs over a given time period. This sequence includes the initial innovation or discovery stage, subsequent communication of the existence of a technology through a social system of adopters, and then the ultimate adoption or rejection of the new technology. Innovation starts the diffusion process.  New drugs are continually being  discovered or developed by the pharmaceutical industry. Communication is essential to spread information about the existence of a new drug among potential adopters. In the case of new drugs approved for the Canadian market by the federal  2 government's Health Protection Branch, the traditional means of disseminating new drug information to the medical and pharmacy staff of a hospital is usually via sales representatives (Iteen & Decker, 1993). In addition, advertising and industrysponsored educational events are also important communication vehicles.  Ideally,  the diffusion process leads to ultimate adoption. However, Rogers (1962) states that rejection, the decision not to adopt an innovation, may result. Potential adopters may question the need for certain new drugs, while other adopters may be content with existing drugs and choose not to adopt. The adoption process. Whereas the diffusion process is thought to occur among potential adopters, the adoption process is more of an individualized process. The adoption process is defined as the mental process from first hearing about an innovation to actual use in practice (Rogers, 1962). For a potential adopter engaged in the adoption process a series of events occurs. These include initial exposure to a new technology, gathering of information leading to an interest in that new technology, evaluation of it, and finally, adoption or rejection of the new technology.  A new drug sometimes creates its own perceived need in the eyes of  potential adopters. Evaluation is critical as it determines the fate of a new drug. W h e n viewed as a technological innovation originating from a pharmaceutical manufacturer to eventual acceptance by hospitals, a new drug can be characterized by a number of important attributes (Rogers, 1962). Adoption of a new drug is greatly influenced by its relative advantage or superiority over existing drugs. The degree to which a drug is consistent with existing community values is termed compatibility. For example, the introduction of oral contraceptives in a country that prohibits any form of birth control would not demonstrate compatibility. Complexity, another important attribute, refers to a drug's ease of use, such as its method of administration or frequency of dosing. The attribute of trialability is the degree to which a drug may be tried on a limited basis. New drugs have a greater chance of being adopted if end users can experiment with them on a  3 small scale before deciding to adopt them. Finally, observability refers to how visible the beneficial features of a drug are to its users. Drugs with clear and observable therapeutic effects will diffuse quickly among hospitals. With respect to the diffusion process of new drugs in hospitals there are various structural, procedural, and outcome considerations that are identifiable.  As  new drugs are introduced in countries, they diffuse into different areas where they inevitably become localized in various organized health care settings. Individual hospitals serve as unique social systems. Rogers (1983) defines a social system as a group of functionally differentiated individuals collectively engaged in problemsolving behaviour. Within each hospital there are functionally differentiated individuals involved in the evaluation of new drugs. Participants i n the hospital social system include pharmacists, pharmacy directors, physicians, other medical staff, associated health care personnel, hospital pharmacy and therapeutics (P&T) committees or drugs and therapeutics committees (D&T), and various other hospital  committees.  Social system adopters such as hospitals can be classified by the speed with which they accept a new technology.  According to Rogers (1983) this classification  displays a bell curve distribution in which distinct groups are described as: innovators (approximately 2.5% of the population of adopters), early adopters (13.5%), early majority (34.0%), late majority (34.0%), and laggards (16.0%). Regardless of the relative speed of new drug acceptance displayed by hospitals, social systems in hospitals are involved with various processes. Some processes that must be dealt with on an ongoing basis include the drug technology adoption process, the formulary system, health care issues in general, and various social programs such as drug benefit programs that affect the manner in which social systems operate. The outcomes of these various processes include a drug formulary (a compilation of local technology-assessment activities as well as a restricted drug list), treatment outcomes, and health status outcomes.  Diffusion theory provides the underlying conceptual framework for this investigation into the Canadian hospital drug formulary approval process. Specifically, this study involves an examination of the attitudes and opinions of key participants within the hospital social system engaged in the adoption or approval process of new drugs. Attitudes and opinions to be examined relate to perceived items thought to influence the new drug formulary approval process. There has been limited experience with other studies that examine or explain the drug formulary approval process in hospitals. A study by Coleman, Katz, and Menzel (1966) serves as one of the first analyses of the diffusion of a new drug. However, the study is limited in scope since only one new drug, in the community pharmacy setting versus the hospital pharmacy setting, was analyzed. In Canada new technologies contribute to increases in the cost of health care. The widespread adoption of some new technologies generally precedes the availability of hard evidence of their effectiveness (Feeny, 1986). Furthermore, premature diffusion is altogether too common and can adversely affect both health and health care costs. Mathisen (1992) states the following: W i t h each new technological innovation there is an accompanying rush to embrace it. Enthusiastic advocates report early successes i n the lay press. Expectations by the public run high and often drive demand for the technology before it has been subjected to rigorous evaluation to determine efficacy, safety, cost, and appropriate indications for use. (p. 4) One method that has evolved as a means of evaluating new drugs is the concept of the drug formulary. The drug formulary. New drugs introduced to hospitals are subject to a screening process that should include an evaluation of attributes such as relative advantage, compatibility, complexity, trialability, and observability. If a new drug is approved for use it is then added to a hospital's drug formulary. A drug formulary as defined by the American Society of Hospital Pharmacists (ASHP) is a continually  5 revised compilation of pharmaceuticals (plus important ancillary information) that reflects the clinical judgement of an institution's medical and pharmacy staff (ASHP, 1986a). Contemporary treatment of patients is based on the safe and effective use of drugs. Thus, the multiplicity of available drugs makes it imperative that an organized and sound program of drug selection and drug usage be developed to ensure that patients receive the best medication (Linkewich & Prevoznik, 1979). One such drug selection program or evaluation process that ultimately generates a restricted hospital drug list is known as the formulary system ( A S H P , 1988). The formulary system.  Contemporary formulary systems have existed since  1936 when the importance of establishing formal liaison between the hospital pharmacist and the medical staff was formally recognized in the literature. In 1936 a document entitled Minimum  Standard for Hospital Pharmacies was endorsed by  the American College of Surgeons and published (Francke, Latiolais, Francke & H o , 1964). In an attempt to ensure the quality of drug-use while controlling its cost, the professional staff of an institution, working through a P & T committee, evaluates, appraises, and selects from among many drug entities those it considers most beneficial for patient care. The formulary system provides detailed guidelines for the procuring, prescribing, dispensing, and administering of drugs ( A S H P , 1986a); policies for the dissemination, maintenance, and comprehensive review of formulary drugs (ASHP, 1983); protocols for the procurement, storage, distribution, and safe use of formulary drugs (ASHP, 1980); and active surveillance mechanisms to regularly monitor compliance with these standards and to intercede where indicated (Spector, Park, Johnson & Vesell, 1988). A n effective formulary system does not allow non-formulary drugs to be routinely available from the pharmacy (Hoffmann, 1984). "Although the use of a formulary is not a guarantee of highquality medical care, the achievement of rational prescribing, effective utilization review, or control of drug costs is difficult if not impossible without it" (Garrison, 1979, p. 506).  The Pharmacy and Therapeutics committee.  The hospital formulary system  is administered through a P & T committee that is comprised of appointed pharmacists, physicians, nurses, and others as appropriate. It is a policyrecommending body to the medical staff and hospital administration o n matters related to the therapeutic use of drugs (ASHP, 1992b). The committee has an advisory responsibility in the implementation of policies regarding evaluation, selection, and therapeutic use of new and existing drugs in hospitals (ASHP, 1986b). W h e n a drug is authorized for use in a hospital, pharmacists, physicians, and others will generally monitor its use and may develop drug utilization evaluation criteria to monitor the appropriateness of its use (Iteen & Decker, 1993). Guidelines for the evaluation of new drugs for hospital formularies have been clearly described in the literature ( A S H P , 1981). The P & T committee also has an educational responsibility to develop programs to meet the needs of nurses, pharmacists, physicians, and other health care personnel for complete and current knowledge on matters related to drugs and drug-use (ASHP, 1986b, 1992b). The committee's influence is greatest at the time a new drug is being considered for formulary listing (Hochla & Tuason, 1992). The traditional P & T committee is in itself a sub-committee that usually reports to the Medical Advisory Committee of the hospital (ASHP, 1992b). In some hospitals, ancillary committees that report directly to P & T committee are also involved in the drug formulary approval process, such as an antimicrobial sub-committee (Detorres & White, 1984). Local practice patterns will dictate individual hospital P & T committee structures and reporting relationships.  The  modern P & T committee has been described as an integral component of the quality assurance process in hospitals (Herfindal, 1989). Features of the organization and operation of the P & T committee have been described in the literature (Linkewich & Prevoznik, 1979; A S H P , 1981, 1986b, 1992a, 1992b).  7 Recommended changes to patient care practices involving drugs are conveyed by practitioners in the hospital to the P & T committee for appraisal. Consequently, the speed of formulary assessment will depend on the interest in a drug and the urgency expressed by the professional staff for procurement of that drug, combined with the nature and outcome of a P & T committee's evaluation process. P & T committees as final decision makers hold a great degree of power. Indeed, P & T committee activities have been described as sacred within an institution (Green, 1986). The outcome of its decisions have a significant bearing on the prescribing practices of physicians, the services required of other health care personnel, financial outlays by a hospital, and ultimately on patient care outcomes. Excessive haste in approving new drugs for use may lead to overuse by physicians, added drug costs, and a higher risk of adverse drug reactions. Demand for ancillary services such as laboratory tests, changing patterns of usage, and inservice education requirements may also be influenced by formulary approval of new drugs. Delays in formulary approval may deny patients new drugs essential for optimal therapy and thus may make patients more susceptible to adverse patient care outcomes.  Compounding these situations is the observation that a significant  number of medications are heavily marketed by pharmaceutical companies despite questionable usefulness (Hochla & Tuason, 1992). In the past five years close to 100 new drugs have been approved for the Canadian market by Health Canada ("Chemical Pursuit," 1994). The number of new chemical entities approved increased from 9 in 1988 to 28 i n 1992.  More  importantly, the pharmaceutical industry is at work on more than 300 new drugs to fight disease including 124 for cancer, 86 for heart disease, 88 for acquired immune deficiency syndrome, 42 for arthritis, 19 for Alzheimer's disease, and 6 for Parkinson's disease (Anonymous, 1994). Many of these new and potentially costly drugs will likely be subject to formulary assessments by Canadian hospital P & T committees.  8 CHAPTER TWO  REVIEW O F T H E L I T E R A T U R E  Potential influences on the drug formulary approval process In general, the literature examining the Canadian drug formulary approval process is sparse. Noticeably absent are studies examining this process with respect to its current state or its future direction. In recent years hospital practice as well as pharmacy practice has undergone significant changes.  Research i n the literature has  identified emerging items (many external to hospital and pharmacy practices) that may potentially influence the drug formulary approval process.  Items are thought  to originate from the following areas of influence: political, organizational, societal, legal, professional, and economic (Hepler, 1988; Manasse, 1989b; Shane, 1992). Political influences.  Political influences at the federal, provincial, and local  levels impact the hospital drug formulary approval process. Australia has set a precedent by requiring mandatory economic assessments before new drugs are allowed to be marketed (Bloom, 1992). These assessments are used to assist regulatory agencies in setting and justifying prices. Canada's Patented Medicine Prices Review Board (PMPRB) created in 1987 has a surveillance role over new drugs. PMPRB's mandate is to ensure that the prices of patented and new medicines are not excessive. Its pricing policy requires that new drug prices fall within the range of prices for other drugs used to treat the same condition. Prices for new drugs are limited to the median of the prices charged for those drugs in other industrialized countries. Since the inception of P M P R B , the prices of patented drugs in Canada have increased on average by 2.9% per year, which is below the average increase in the consumer price index of 4.2% per year (PMPRB, 1993). Prior to the creation of the P M P R B , the prices of all medicines increased at an annual rate of 7.5%, while the consumer price index increased at an annual rate of 4.2%.  9 Drugs are important to Canada's health care system with all ten provinces and two territories having drug benefit programs that subsidize the cost of drugs for their residents as part of provincial health insurance programs (Detsky, 1993). It has been noted that the role of government in health care development is increasing (Frankenfeld, 1993). Proposed mandatory drug assessment attempts such as provincial guidelines for the economic analysis of new drugs have the potential to influence the drug formulary approval process in hospitals (Ontario Ministry of Health, 1991). Currently in the community setting certain provincial governments are ceasing to pay for medications deemed to be ineffective, unnecessary, or not costeffective (Pharmacare, 1994). Proposed inter-provincial committees may allocate more decision-making power to provincial governments (Detsky, 1993). This will be of benefit to provincial hospitals by eliminating redundancies arising from simultaneous evaluations of new drugs by numerous hospital P & T committees. There is growing evidence in the literature that other hospital committees (Chang & Shane, 1993; Iteen & Decker, 1993), task forces (Hayman & Crane, 1993), and patient-centered clinical teams (Taylor, 1993) are also involved in the hospital drug formulary approval process. Strategic planning and sound policies dealing with the increasing number and cost of biotechnology products are important to the financial well-being of many hospitals, especially smaller hospitals.  The  establishment of biotechnology committees as adjuncts to P & T committees will foster greater acceptance of decisions that may be necessary in the future (Akinwande et al., 1993). The sheer number of biotechnology-derived products expected to become available in the next few years is justification for the creation of adjunct P & T committees. With regard to new drugs, there are several inherent implications, including (a) drug approval, surveillance, and regulatory processes; (b) manufacturers' image, influence, and impact; (c) professional group stature and credibility; and (d) impact and influence of professional organizations (Manasse, 1989b) that directly influence  10 political agenda setting, political decision making, and public policy development. The role of government is to develop policies that will provide incentives for stakeholders, such as health care professionals and manufacturers, in a manner that is congruent with the goals of government (Anderson et a l , 1990). In so doing government will maintain its position in the approval process of new drugs. Organizational influences. Hospitals are rapidly moving away from being compartmentalized, hierarchical structures (McAllister, 1993). Advocates consider traditional hospital organizational structures to be obsolete and have turned to team-based structures that use philosophies such as patient-centered care (Hamilton, 1992; Sherer, 1993). "Patient-centered care is advanced manufacturing technology combined with old-fashioned customer service, a concept that allows hospitals to improve productivity by re-engineering the basic practices of health care delivery" (Troup, 1992, p. 24). Zellmer (1993b) states that in response to economic pressures, hospital management is striving for greater efficiency.  H e suggests the elevation of  the status of the pharmacy department in order to lead efforts to utilize new drugs more wisely. Four reasons why this should be done are: 1. The optimal use of pharmaceuticals in patient care requires a concentrated focus by the pharmacy department. 2. The transformation of pharmacy into a patient-focused profession requires a sense of unity among pharmacists. 3. The improvement of a hospital's overall competitiveness requires a pharmacy team effort. 4. The effective cost control of pharmaceuticals requires leadership by the pharmacy department, (p. 2450) The diffusion theory of Rogers provides for the observation that not all hospitals are at the same stage in the adoption of new organizational strategies. Innovator-type hospitals usually adopt organizational strategies before the vast  11 majority of hospitals. It is expected that as innovator-type hospitals adopt patient care strategies the early majority and late majority-type hospitals will follow. A s technology provides greater options in the care of patients, hospitals will continue to be confronted with difficult choices (Hochla & Tuason, 1992). The application of technology such as computers to health care as decision support tools is potentially pervasive, and promises to alter many tasks. Austin (1989) states that information systems support strategic planning, cost control, and evaluation of new technologies.  Furthermore, Austin states that information technology will have the  greatest impact on direct patient care in the decade ahead. Management may also benefit from executive information systems (Williams, 1991; Simpson, 1992). Advances in computer technology and software applicable to hospital pharmacy have assisted in the development of efficiencies previously unattainable (Baker, Grussing & Stewart, 1992). A computer-based support system for formulary decisions (FDSS) has been described in the literature (Senthilkumaran, Shatz & Kalies, 1987). FDSS requires P & T committee members to convert subjective opinions to numerical data that permit comparisons among drugs. A s an extension to FDSS, a system incorporating an expert system (RXPERT) has been developed and has been described i n the literature (Greer, 1992). Other demonstrations of applied technology include: the use of a computer-based system for maintaining and printing a hospital formulary (Sateren, Sudds & Tyler, 1987), the use of a hospitalwide computer system to ensure the safety of patients with respect to investigational drugs (Iteen & Ceppaglia, 1992), and the use of expert systems that automatically gather data, evaluate patient care, and perform drug-use evaluation and adverse drug monitoring (Shorttliffe, 1987; Morrell, Wasilauskas & Winslow, 1993; Grasela, Walawander, Kennedy & Jolson, 1993). As a warning of the limitations of the present "Information Revolution", Verity (1994) writes the following: We must learn the limitations of our tools as well as their power.  Even in its  most advanced state, the computer is not, and never can be, a panacea for  12 human problems or a substitute for our own, uniquely human judgement, (p. 18) Societal influences.  Drugs have been in use as long as there have been  human beings, but only in this century d i d drug research and innovation progress exponentially (Adams, 1983). Manasse (1989b) states the following: Society has granted itself the right to safe and effective new drugs through the establishment of laws, regulations, and sanctions pertaining to drug innovators and manufacturers. Society expects and has a right to safe and effective drug therapy. Society is not typically in a position to evaluate the various dimensions of appropriate drug therapy and must therefore rely heavily on the integrity and care of health professionals,  (p. 1141)  The health management literature has drawn attention to hospitalized patients.  The actions of patients have been found to aid in the following ways:  promotion of the quality of care, reduction of the cost of care, and promotion of their o w n satisfaction (MacStravic, 1988). Thinking of the patient as a customer elicits objections to the commercialization of an essential human service (Piper, 1986). Treating patients as guests risks focusing on amenities and ignoring the reality that hospitals are not hotels. Furthermore, MacStravic states that patients as partners incorporates a perspective in the care experience; elevation of their status above customers or guests in that patients become active participants rather than passive recipients. Historically, a majority of hospitals centered operations on meeting the needs of departments and disciplines rather than the needs of patients.  A new focus on  patients and their rights will revamp old systems so that patients are placed foremost on hospital agendas (Sherer, 1993). According to Sherer, patient-centered care has helped to reduce staff turnover, employee error and length of stay averages, waiting time for patient registration, processing time by the lab and pharmacy, and  13 in some cases hospital costs. Improved delivery systems to the satisfaction of patients, physicians, and staff have also been reported. The Joint Commission on Accreditation of Healthcare Organizations ( J C A H O ) serves as an appropriate gauge in determining the current direction of hospitals. Since 1951 the J C A H O has strived to enhance the quality of health care by establishing contemporary standards, evaluating health care organizations, rendering accreditation decisions, and providing educational and consultative support to health care professionals (Nadzam, 1991). In the past the J C A H O assessed the capability to provide good care by reviewing organizational structure and process, and this approach was sufficient when financial constraints were few. The focus of today's J C A H O is on variations in quality and value of patient care. Its agenda is grounded on the basis that patient outcomes are influenced by all activities of a hospital. In 1990 the J C A H O added a new requirement to its accreditation standards. Hospitals must have a mechanism in place to receive and respond to patient complaints concerning the quality of care received (Charters, 1993). The importance of patients to a hospital has made those involved in health care more aware of patient outcomes.  This area is important because many  researchers are seeking to precisely determine the outcomes produced by the enormous amount of resources being expended on health care. Interest i n improving health outcome evaluation is increasing as a result of the need to balance the costs and benefits of new medical technologies (Coons & Kaplan, 1993). Research is being undertaken to assess the quality and accuracy of outcomes measurement (Linder, 1992), although a useful broad-scale measurement system will not be available until the end of the century (Bergman, 1993). The outcomes management movement has challenged health care professionals to expand their perspective and to take increased responsibility for patients' health (Gouveia, 1992). The pharmacy literature contains articles dealing with continuous quality improvement (Gitlow & Melby, 1991), quality assurance (Angaran, 1991), quality of  14 life assessments and measures (Enright & Flagstad, 1991; MacKeigan & Pathak, 1992; Coons & Kaplan, 1993), management of patient outcomes (Gouveia, 1992), and the cost-effectiveness of pharmacists and their effect on health care outcomes (Bjornson et al., 1993). The latter study found that pharmacists have an effect on health care outcomes, which translates into an economic savings to the health care system and ultimately to society. As pharmacists increase their knowledge of health status measurement, their ability to make positive contributions to patients' health will increase (Gouveia, Bungay, Massaro & Ware, 1991). Society has entrusted pharmacists to help restore patients to better health. The measurement and management of patient outcomes will establish a foundation for health care practice by providing gauges of contributions to patients' health-related quality of life (Gouveia, 1992). Early thoughts on pharmacy and patient care were first described by Smith (1967) who forecasted that the future of hospital pharmacy would be in the patient care area. The J C A H O has placed emphasis on patient-centered practice (Ente, 1989). Societal needs for drugs and drug-related services have been discussed in the literature (Brodie, Parish & Poston, 1980). "Pharmacy will prosper by serving the needs of society best" (Hepler, 1985, p. 1306). Progressive changes have been observed at the local level. For example, in a move to become more accountable to the people it serves, Riverview Hospital, a large British Columbia psychiatric facility has stated that management will meet with patients every two weeks to discuss patient issues. The hospital has also passed a charter of patients' rights and patients are welcome on nearly all hospital committees and task forces (Wigod, 1994). A n investigation at this hospital yielded, among many other recommendations, that a mental health advocate be appointed to support people both inside and outside of the hospital who are the recipients of hospital services.  15 A societal perspective of patients' care may not be universally accepted. In a perspective from the pharmaceutical industry (Mossinghoff, 1988), "The patient's attending physician must retain the authority in determining the patient's drug therapy" (p. 1065). In addition, the importance and influence of drug company marketing has been clearly pointed out in the literature (Townsend, 1987; Hillman, 1991). However, there has also been recognition from the pharmaceutical industry as to the value of society's expectations.  The annual report of Merck U S A Inc. (1994),  a major pharmaceutical company, states the following: In addition to discovering valuable new medicines-which, in our industry, remains the cornerstone of success-society increasingly expects pharmaceutical companies to take greater responsibility for managing health care costs, for optimizing delivery of their products, for demonstrating their value, and, ultimately, for improving people's health, (p. 2) Patient-centered care has evolved from the need to look at the patient from a societal perspective as opposed to solely a hospital perspective. One of the assumptions of patient-centered care is that patients will be taking on a more active role i n the hospital setting. Judging by the growing attention given to patients in the health and health management literature, it is reasoned that the societal perspective of patients will become prominent in the future. Legal influences.  Although legal issues impacting the drug formulary  approval process were addressed in the seventies, the health literature has been silent in this area. P & T committee actions have sometimes been opposed vigorously by drug manufacturers, and hospitals have had to devote considerable resources to defend P & T committee decisions.  Manufacturers have attempted to  prove that P & T committees were legally responsible for approving new drugs that were, in effect, inferior to other drugs (Talley, 1978). More so in the United States than in Canada, legal challenges and questions of potential liability are emerging, as organizations and employers assume a more  16 active role in defining health care benefits (Enright, 1992). Liability issues emerge when there is a threat of not providing enough care according to Enright. W i t h the proliferation of many new drugs, P & T committees may be faced with increased risk of legal challenges or litigation resulting from a decision of whether or not to approve an expensive drug. With biotechnology-derived drugs for example, many of which carry high price tags, there is no other therapeutic alternative. For high risk or expensive products it is critical to develop hospital policies for patient selection and monitoring as well as methods for implementing these policies.  By not monitoring new drug therapies, not only are patients at risk  but hospitals as well as nurses, pharmacists, and physicians may be subject to potential legal repercussions (Chase, 1991). Effective use of new drugs extends beyond their approved indications. This may lead to adverse drug experiences, drug misadventures, liability, or medication errors from the use of unapproved indications, thus heightening the need for a well organized program for preventing and monitoring medication misadventure (Zellmer, 1993a). Professional influences.  With regard to professional responsibilities the  words of Brodie (1967) exemplify long-held beliefs about the role of pharmacy: Drug-use control is the keystone to pharmaceutical service. It transcends all individual functions of pharmacy, yet it is the composite of all. Drug-use control provides a purpose, it gives a direction, it recognizes need and fulfillment in the patient-pharmacist relationship, it is the basic ingredient which underlies the essentiality of pharmacy and its service,  (p. 65)  Hepler and Strand (1990) describe the pharmacist's initial role in the twentieth century as traditional, since the pharmacist's function was procuring, preparing, and evaluating drug products. As the preparation of pharmaceuticals was gradually taken over by the pharmaceutical industry, the pharmacist's professional role was reduced. Brodie's concept of drug-use control was  17 instrumental in the next evolutionary phase of pharmacy from a purely distributive to a clinical profession (Penna, 1990). Contributions to the literature sparked great interest in the future role of pharmacists in clinical pharmacy (Godwin, 1968; Bouchard, 1969; Francke, 1969). The clinical pharmacy movement attempted to realize the concept of the pharmacist as a therapeutic advisor (Hepler, 1987). Evidence for this is provided by the publication of over 300 articles between 1974 and 1984 dealing with clinical pharmacy services (Hatoum, Catizone, Hutchinson & Purohit, 1986). Roles of clinical pharmacists include effective reduction of drug costs, drug therapy monitoring with documentation, patient drug counseling, drug usage review, drug cost reduction, drug therapy management, adverse drug detection and prevention, pharmacokinetics, and drug information (McLeod, 1976; McKenney & Wasserman, 1979; Abramowitz, N o l d & Hatfield, 1982; Packer, Mahoney, Rich & Jeffrey, 1986; Hatoum, Hutchinson, Witte & Newby, 1988; Strand, Cipolle & Morley, 1988; Strand, Morley, Cipolle, Ramsey & Lamsam, 1990; Deady, Lepinski & Abramowitz, 1991). Guidelines as to the role of the clinical pharmacist have been published in the literature (ASHP, 1989). The Canadian Society of Hospital Pharmacists (CSHP) has published guidelines on levels of clinical services that can be provided by a hospital's pharmacy department:  Level I-Drug order review, Level II-Selective  patient pharmacotherapy monitoring, Level Ill-Comprehensive patient pharmacotherapy monitoring, and Level IV-Decentralized concurrent monitoring (CSHP, 1990). Hepler (1987) maintains that, "Clinical pharmacy is but one of pharmacy's many experiments, one that brought it full circle back to the patient care arena" (p. 383). Today, hospital pharmacists are finding themselves in the midst of an evolutionary stage in pharmacy; a transition point between the clinical movement that began in the late sixties, and pharmaceutical care, which is pharmacy's mission for the nineties (Penna, 1990). Articles in the pharmacy and health care literature  18 have emerged regarding the provision of pharmaceutical care in terms of patient outcomes (Strand, 1990), responsibilities of pharmacists in reducing the costs of pharmaceutical care (Hopefl, 1992), improvement of quality of care and reduction of medication cost (Lobas, Lepinski & Abramowitz, 1992), and levels of pharmaceutical care based on the needs of patients (Smith & Benderev, 1991; Strand, Cipolle, Morley & Perrier, 1991). Hospital pharmacists are striving to increase their visibility as health care professionals who have the knowledge, ability, and authority to influence patient care (Raiford, Clark & Anderson, 1991). Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes are (a) curing of a disease, (b) eliminating or reducing a patient's symptomatology, (c) arresting or slowing a disease process, or (d) preventing a disease or symptomatology (Hepler & Strand, 1990). Under pharmaceutical care pharmacists make drug selection, dosage and dosage interval decisions, and share accountability for the effects drugs produce in patients (Penna, 1990; Hepler & Strand, 1990). Zellmer (1993a) describes the diffusion of pharmaceutical care as a new innovation. H e states that pharmacists, with a well-organized effort, can change the fundamental nature of pharmacy practice. Pharmacy societies have endorsed pharmaceutical care by issuing mission statements to their members (CSHP, 1992; A S H P , 1993). Guidelines have been published to aid pharmacists in the provision of pharmaceutical care (Strand, Cipolle & Morley, 1992). Some innovator-type hospitals have described their experiences in the literature of incorporating a pharmaceutical care practice model in their respective hospital (Lee & Ray, 1993). One fundamental principle embodied by pharmaceutical care is the existence of a covenantal relationship between the patient and the pharmacist. C a n conflicts arise between a patient care philosophy and the principles and policies of drug therapy as governed by P & T committee formularies? Pharmaceutical care advocates  19 believe that pharmacists should have influence in the drug selection process (Penna, 1990). Others believe that the greatest limitation of drug-use evaluation by P & T committees is that it has become the end, not the means, of examining the quality of drug-use. Drug-use evaluation skirts around issues in pharmaceutical care, including strong patient focus and accountability for the provision of services based upon a unique body of knowledge (Enright & Flagstad, 1991). Pharmaceutical care can be viewed as an internal force and philosophy that will contribute to the future status of pharmaceutical services.  Shifts in hospital  philosophy towards patient care outcomes will reinforce the value of the pharmaceutical care philosophy. Historically, Brodie's (1967) concept of drug-use control was widely adopted and used by the pharmacy profession (Smith & Benderev, 1991). This preoccupation with the drugs themselves caused many pharmacists to overlook patient care. The results of a study that reported that ten minutes per day was spent in contact with patients by pharmacists (Ried, West & Martin, 1991) likely applies to many hospital pharmacies in North America. Hepler (1988) states that sponsors of new therapeutic modalities and new drug delivery systems will have to choose a distribution channel that will optimize penetration into the marketplace. The profession of pharmacy will have to decide if it can increase its value to society by controlling the use of drugs or grant control to others, e.g., radioactive drugs are controlled by the nuclear medicine department in many hospitals.  Pharmacy's alternative is to devote its resources and expertise to  patient care outcomes.  Pharmaceutical care directs pharmacists to focus attention on  the patient rather than the drug. W i t h regard to formularies and P & T committees, many formulary-related decisions are intuitive. A new drug is chosen because its pharmacotherapeutic contribution is essential, or because it is less costly than similar agents judged to be equally effective and safe (Schumacher, 1991). However, P & T committees are increasingly called upon to weigh numerous criteria in their decisions, such as  20 pharmacotherapeutics, economics, and quality of life outcomes.  These criteria have  contributed to external pressure to re-evaluate the current drug formulary approval process. Concern has been expressed in the literature by detractors of formularies, formulary systems, and P & T committees, who have challenged the conventional wisdom about the role of formularies and P & T committees.  Rucker and Visconti  (1978) raised many troubling questions about the ability of formularies to discriminate between superior and marginal drugs. Others spoke of an urgent need to consider formulary structure based on study results that cast serious doubts on whether formularies were prepared adequately or introduced appropriately (Plumridge, Stoelwinder & Berbatis, 1984). "Committees that simply place new drugs on formularies and do not consider the broader issues of physician education, drug-use review, cost containment, selection of therapeutic equivalents, and other mechanisms to improve prescribing are of little value" (Abramowitz, 1984b, p. 506). Zellmer (1986) stresses the importance of pharmacy directors to obtain deep and abiding medical staff support for the formulary system; failure to do so will result in staff pharmacists not enforcing P & T committee policy effectively.  Green  (1986) provides ample evidence to support his stance that the formulary system is a perpetuated deception. His criticisms concern three widely believed formulary system functions, namely: 1. Cost savings-formulary systems show significant savings for high-cost items such as antibiotics and enteral nutrition products, but there is minimal evidence of any economic benefits for attempts to limit the immediate availability of other drug classes or to institute across-the-board restrictions (Green, Chawla & Fong, 1985; Sloan, Gordon & Cocks, 1993). 2. Educational value-no studies have adequately evaluated the impact of education on altering prescriber compliance with the formulary. 3. Pharmacy's role as the drug controller-studies have proven that when P & T committee decisions requiring hours of time are not honoured or  21 enforced, or when hospitals grant non-formulary requests on a frequent basis, it may be asked who is really controlling drug-use. (p. 1537) Rucker and Schiff (1991) maintain that drug formularies cannot: 1. Determine whether a drug, versus diet or rest, is the therapy of choice. 2. Control for an inadequate or excessive quantity of medication. 3. Ensure that the most appropriate dosage or drug is ordered. 4. Eliminate prescribing an expensive preparation by ordering a cheaper alternative available from the formulary. 5. Negate ordering several prescriptions when fewer will suffice,  (p. 519)  Formulary performance may be weakened by ineffective procurement a n d / o r non-compliance by patients.  In addition, formularies have limited power to cope  with the inappropriate use of the most appropriate medication. Even marketing strategies by pharmaceutical firms and their representatives have been cited as a source for weakening the effectiveness of formularies (Davis, 1983; Hoffmann, 1984). Sometimes the cost-effectiveness appeal of formularies is illusory, since formularies when improperly designed merely displace costs by increasing the potential for less than optimal drug selection. Although studies have shown that drug formularies will save some money for some pharmacy departments, studies have also demonstrated that drug formularies lead to higher charges for other diagnostic and treatment services (Sloan, G o r d o n & Cocks, 1993). The influence of prescribing behavior without a formulary system has been documented in the literature (Ham, 1992). If any benefits are to be gained from formulary systems, hospitals must strengthen their enforcement of formulary restrictions and periodically evaluate the effectiveness of the system so that its merits can be documented (Green et al., 1985). The consistency of formulary decision-making is a problem if goals are not specified, screening criteria are not explicit, and the P & T committee does not adhere to appropriate decision-making protocols (Rucker, 1981).  22 One survey found that the role of the P & T committee as the final decision maker is significantly associated with limits on the availability of new drugs in health care organizations (Chinburapa & Larson, 1991). Various external parties to a hospital have a vested interest in the formulary approval process of a new drug. From the perspective of the pharmaceutical industry, a P & T committee with policies that limit the activities of firms or their representatives within a hospital may be viewed as a barrier to the acceptance of new drugs (Plumridge, 1984). Gouveia (1993) states that P & T committees should be restructured. Furthermore, i n response to the pressures imposed on hospitals by new high-cost drugs, P & T committee membership should be expanded to include an ethicist, patient, patient advocate, lawyer, social worker, payer, or any combination of the above.  P & T committees should use a representative form of government so that all  major medical staff constituencies are represented in deliberations that affect practice patterns and norms of professional behaviour (Pierpaoli, 1993). McAllister (1993) states that new standards should enable pharmacists to abandon procedures that consume excessive resources without offering a commensurate value in patient care. H e suggests the replacement of a P & T committee with a pharmacist who w o u l d chair a multidisciplinary group to develop and maintain medication-use policies and to oversee formulary maintenance-a similar concept to managed care. This committee would also review trends in patient outcomes and the impact of drug-use on hospital costs. There are those who offer supporting evidence for the use of formularies and P & T committees to assess new drugs. Abramowitz and Fletcher (1986) maintain that a formulary limits the use of ineffective or marginal drugs and those drugs with undesirable effects. When used effectively, a formulary is one of the most effective methods of ensuring rational drug therapy and controlling drug costs. A well-controlled formulary is significantly associated with a decrease in hospital drug expenditures (Hazlet & H u , 1992). Other benefits of hospital formularies include  23 improved control over drug inventory and drug-use, as well as a decrease in the duplication of similarly acting drugs (Rascati, 1992). Garrison (1979) states, "It is difficult to believe that nurses, pharmacists, and physicians serving on P & T committees w o u l d compromise a patient's treatment by failing to have the best agents available" (p. 507). Committees related to P & T committee functions have also been described. One successful example of a committee, other than P & T , involved in the formulary approval process can be found at the University of California Davis Medical Center (UCDMC).  The P & T committee at U C D M C is an active committee of the medical  staff and has successfully adopted many formulary management practices. T o date, its major concerns have been in restricting the formulary, controlling nonformulary drug use, and obtaining pharmaceutical agents at the best price possible using aggressive competitive bidding practices (Albertson et al., 1993). A s an adjunct to the P & T , a formal multidisciplinary clinical pharmacology consult service (CPCS) was established to coordinate clinical pharmacy services, educate health care providers, improve patient care, and provide formulary management and enforcement activities.  The C P C S is comprised of three clinical pharmacists, a full-  time clinical pharmacist coordinator, and three physician faculty members. Briefly, the C P C S is integral to the successful coordination of advanced formulary management.  It establishes consensus-based criteria for high risk and  expensive new drugs. These criteria are developed based on committee member experience and on the published literature, which are then approved by the P & T committee.  In this way the C P C S acts as a clinically responsive extension of the P & T  committee's formulary management activities.  It is critical that all clinical services  recognize that the authority of the CPCS to regulate the distribution of new drugs comes from the medical staff via the P & T committee.  The C P C S reports regularly to  the P & T committee about interventions taken by the service.  The feedback loop  allows for modification of the new consensus-based drug usage criteria as new data  24 and experience evolve. Members of the C P C S state that the acceptance of a formulary management system by the medical staff and active supervision and direction via the P & T committee are keys to success. Furthermore, the formulary management of high cost and high risk therapeutic agents via the C P C S is a logical extension of the role of the P & T committee. Formularies and P & T committees are prevalent in North American hospital pharmacy practice. In a 1982 survey of U.S. pharmaceutical services nearly 90% of all short-term hospitals had a generic substitution policy, implying that a formulary was i n place (Stolar, 1983). D'Sa, H i l l , and Stratton (1994), in a sample of 36 British Columbia hospitals, found that 100% of the respondents had a P & T committee with a drug formulary in place. Also, 25 respondents (69.4%) stated that the pharmacy department had a strong voice i n influencing formulary decisions. National survey results in 992 U.S. hospitals found that a well-controlled formulary was in place in 51.0% of the hospitals (Crawford & Myers, 1993). Rascati (1992), in a sample of 150 hospitals, found that 120 (96.2%) of 130 respondents had formularies i n place. C o m m o n roles of the formulary were to decrease costs (54.8%) and to provide appropriate drug therapy (37.1%) for patients. Nearly all respondents (96.9%) indicated they had a P & T committee comprised of nurses, pharmacists, physicians, and other hospital staff members. Economic influences.  There is heightened interest in the consideration of  economic value in the decision-making process with respect to new drug approvals. This interest is in response to the spiralling costs of health care and the resulting emphasis on cost containment (Draugalis, Bootman, Larson & M c G h a n , 1989). Historically, most new drugs have been integrated into clinical practice without a rigorous demonstration of their effectiveness or efficiency (Guyatt et a l , 1986). The health care system is routinely confronted with promising new drugs. The funding and subsequent adoption of any new drug therapy is being viewed with increasing scrutiny by health care decision makers. With the importance of cost containment  25 in today's health care environment, acceptance of a new drug can no longer be made on clinical grounds alone. Decisions must also be based on the expenditures associated with new drug therapies. Economic analysis provides guidance in determining to what extent a new drug should be adopted (Sheingold et al., 1992). The number of published studies that include economic evaluations of health care services, including new drugs, has dramatically increased in recent years; spurred by the large number of therapeutic and diagnostic technologies, their high costs, and the limited resources available to fund them (Weinstein, 1981; D r u m m o n d , 1987; Drummond, Stoddart, LaBelle & Cushman, 1987; Laupacis, Feeny, Detsky & Tugwell, 1992). With increasing pressure from hospitals, payers, pharmacists, and physicians, the pharmaceutical industry has started to evaluate and establish the value of each new drug, therapy, or treatment during initial clinical development and testing (Wilson, 1994). Furthermore, since the early sixties, the major objectives of clinical trials sponsored by drug companies have been to demonstrate not only the safety, but also the efficacy of investigational compounds (Boyer & Pathak, 1994). Today many clinical trials now include a third objective, which is to document the economic and humanistic value of a new drug. This objective may be achieved through the use of methods found in the new and rapidly developing discipline of pharmacoeconomics. Pharmacoeconomics is the natural progression of health economics into the area of drug-use assessment (Reid, 1994). Pharmacoeconomics uses the economic evaluation tools of cost-benefit, cost-effectiveness, cost-utility, or cost-minimization analyses to describe unique attributes of drugs in therapy versus treatment alternatives (Bootman, Larson, McGhan & Townsend, 1989; M c G h a n , 1993). Specific pharmacoeconomic guidelines, methods, and reviews are thoroughly documented in the economic and more recently the pharmacy literature (Weinstein & Stason, 1977; M c G h a n , Rowland & Bootman, 1978; Shepard & Thompson, 1979; Warner & Hutton, 1980; Bootman, M c G h a n & Schondelmeyer, 1982; Dao, 1983; Wagner, 1983;  26 Dao, 1985; Guyatt et al., 1986; Gagnon & Osterhaus, 1987; MacKeigan & Bootman, 1988; Detsky & Naglie, 1990; Lee & Sanchez, 1991; Freund & Dittus, 1992; Jolicoeur, Jones-Grizzle & Boyer, 1992; M c G h a n & Lewis, 1992; Udvarhelyi, Colditz, Rai & Epstein, 1992; Sanchez, 1994). The literature perspective most often taken is that of society, which represents all of the important outcomes an individual member of society could experience (Freund & Dittus, 1992). Pharmacoeconomic analyses represent valuable contributions to the formulary decision-making process (Skaer, 1993). Feeny (1986) remarks: The use of such tools is not a panacea, rather it can only help to inform decisions of the adoption and subsequent use of new drugs. Difficult social choices underlie such decisions and cannot and should not be avoided or obscured by the use of technical criteria, (p. 1) In hospitals, it is reasoned that some P & T committee members do not have the inclination, knowledge, time, or required expertise to interpret various pharmacoeconomic evaluations of new drugs. Many evaluations require training in the various pharmacoeconomic methods.  P & T members unfamiliar with these  methods will be at a disadvantage in deriving meaningful interpretations from these evaluations.  Subsequent decision-making activities may be weakened.  In most industrialized countries health care expenditures are i n large part publicly financed. In 1960, public expenditure on health care in Canada was 43% of the total expenditure on health care, and by 1982 it had grown to 74%. For comparative purposes, in the same time period, U.S. expenditures grew from 25% to 42% (Culyer, 1988). Continued growth of the pharmaceutical industry depends on the entrance of new, competitive, innovative products to the market, as well as the expanded sale of existing drug products (Manasse, 1989b). Drug therapy costs have sharply risen causing concern among hospital administrators, governments, and third party payers (Glazier & Berger, 1993). In spite of the best efforts of P & T committees, drug expenses keep spiralling upwards (Hayman & Crane, 1993).  27 There have been reports of successful methods to reduce drug costs resulting from P & T activities (Abramowitz, 1984a, 1984b; Weintraub, 1990; Hochla & Tuason, 1992). A personal computer-based physician inpatient ordering system that uses a problem-oriented approach to order implementation has been described. This system carries over 1,100 drug monographs and has been found to reduce drug charges by as much as 15.3% (Tierney, 1993). To expedite the formulary approval process a computer-based support system for formulary decisions has also been described. This menu-driven decision support system allows P & T committee members to convert subjective opinions to numerical data, thereby altering the mechanism to which the drug adoption process has traditionally occurred (Senthilkumaran et al., 1987). Gouveia (1993) states that many of what we have regarded as professional activities such as drug order screening, drug information, and drug cost reduction can be automated. A survey of 570 health care organizations reported that although formularies were reported as the established method of drug product management, nearly half of these organizations reported the use of new, formulary alternative approaches including (a) manufacturers' contracts, (b) incentives, such as discounts or usage rebates, and (c) exclusive or preferred status (Kreling & Mucha, 1992). The area of biotechnologically-derived drug products is a concern to some. The high cost of biotechnology drugs is a potential problem for hospitals with limited funding (Akinwande et a l , 1993). The proliferation of high-cost biotechnology products will make the application of rational drug-use policy in hospitals more important than ever (Herfindal, 1989). This category of medications is relatively new, has a seemingly immense patient population for both approved and non-approved uses, and acquisition costs that are substantially higher than those of any other drug category (Iteen & Decker, 1993). Furthermore, industry analysts estimate that the biotechnology-related drug products' market share of the  28 U.S. pharmaceutical market will increase from its current 4% to 33% ($60 billion plus) by the year 2000 (Bylinsky, 1991). The increased usage of high-cost biotechnology drugs has impacted tremendously on the hospital pharmacy drug budget (Lu & Chan, 1994). Indeed, L u and C h a n examined how to "squeeze out every last drop" of sargramostin ( G M CSF), a new biotechnology product (U.S. $160/vial), in order to save money for their hospital's drug budget. Others have described proactive ways such as the use of biotechnology sub-committees to face the challenges of biotechnology (Iteen & Decker, 1993). It is not a question of keeping these drugs off formularies; rather, it is a question of proper application of new technology in light of the experimental nature of many of their indications. Products under current trial or awaiting approval include thrombolytic agents, colony-stimulating factors, dismutases, erythropoietins, interferons, interleukins, monoclonal antibodies, peptides, tumor necrosis factor, and many vaccines (Starr, 1988). Biotechnology products differ markedly in composition, form, and action from those traditionally entering the market. Due in large part to expensive, new biotechnology drugs, much appears in the literature with respect to the choices among treatment alternatives (Birdwell & Pathak, 1989; Herfindal, 1989; Doolittle, 1991; Pierapaoli, 1993). In addition, the concept of cost control is expected to be important in the future. Cost control is a process with a strict set of managerial implications. It can be applied to a program, a department, a hospital, or the entire health care system (Arrington & Summerfield, 1986). Biotechnology drugs are likely to be potential targets for cost controls. From the perspective of an industry observer, Ryan (1993) offers the following reasons for rapidly escalating pharmacy costs: (a) pricing systems that recapture drug research, development, and market expenses; (b) widening use of newer, more expensive drugs in place of older, less expensive products; (c) increasing availability of new products and physicians' dependence on industry guidelines as a basis for product selection; and (d) treating of a single patient by multiple physicians, a  practice that may lead to duplicative medications and an increased incidence of adverse drug reactions.  Ryan's ultimate conclusion is that although the economic  costs of misusing expensive new drug products will be greater than at any time in the past, the rewards of the appropriate use of these products may be greater still. Thus, drugs can and will provide for longer, more productive lives and if they are appropriately used and monitored, should reduce overall health care costs. From the perspective of a hospital administrator, Shorb (1993) states that as cost-reduction pressures increase, hospital administrators will rely more on hospital pharmacists and expect them to work in greater partnership with members of the medical staff to assess and oversee the appropriate use of pharmaceuticals. H e cites the following as key activities to reduce drug costs while maintaining quality of care: (a) adopt and abide by a hospital formulary, (b) develop an effective P & T committee, (c) support group purchasing contracts, (d) decentralize pharmaceutical services, (e) increase the use of well-trained technicians, and (f) use new technology to develop improved delivery and dispensing systems. From the perspective of a hospital pharmacy director, Pierpaoli (1993) states that new drugs resulting from major advances in molecular biology and recombinant technology in the last half of the eighties can cost thousands of dollars per dose. Reasons that influence physicians' decisions to adopt a new treatment or abandon an existing one are only partially understood. A n informed public creates strong expectations for new drugs, often well before these advances have been thoroughly debated and challenged in the professional literature. W i t h respect to drugs, pharmacy departments are rightfully the nexus for bridging corporate and professional interests that exist in hospitals. From the perspective of a physician, Shulkin (1993) states that physicians have limited exposure to cost-saving initiatives during their training. Distrust between administrators and physicians is another barrier to physician involvement in reducing drug costs. Physicians view themselves as patient advocates and they  30 resist interventions to reduce costs if these efforts are perceived to have a negative impact on patient outcomes.  Physicians sometimes have the perception that drug  formularies take control away from the doctor by limiting patients' access to pharmaceutical innovations.  The most common avenue for physician  involvement in drug cost control has been the formulary. Hospitals and physicians are likely to be motivated to improve their prescribing practices if they are provided with information on the practice of their peers. From the perspective of an ethicist, Rothman (1993) states that it is critical that decisions restricting new drugs should be arrived at in as public a fashion as possible.  Covert rationing is inadvisable. Ethical questions involve the most  fundamental considerations of societal responsibility. Health care flourishes most when providers are open with their patients and their communities.  In an age of  educated patients and a diligent, informed press, there may not be any other choice. Perhaps the words of Herfindal (1989) are quite fitting to end this review: Society is approaching the point where the ability to pay for new and innovative technologies such as drugs is greatly out-paced by industry's ability to bring new products to market. To the extent that hospitals will be asked to self-finance these innovations, P & T committees are going to play a major role. (p. 2520) Statement of the problem Does criticism from the literature signal forthcoming changes in the drug formulary approval process in the hospital setting? Does pharmacy as a profession have to rethink concepts that have traditionally been thought of as sacred? H o w much time remains before P & T committees are either modified or eliminated? What changes, if any, will the drug formulary approval process in hospitals undergo in the next five to ten years? In contemporary hospital practice, the drug formulary approval process is carried out by P & T committees that have great influence on the fate of new drugs.  31 Research i n the literature has identified political, organizational, societal, legal, professional, and economic influences that have the potential to modify or change the future drug formulary approval process i n hospitals. Thus, the objective of this descriptive study is to survey opinions from pharmacy directors and P & T committee chairs about the current and expected future state of the drug formulary approval process in select Canadian hospitals.  A large amount of information with  respect to hospital demographic and organizational aspects will be gathered. The hypothesis being investigated is that pharmacy directors and P & T committee chairs are of the opinion that the drug formulary approval process in Canadian hospitals will not demonstrably change in the next five to ten years.  Also,  identified items in the literature are not expected to have significant influence on the future drug formulary approval process. The data collected will provide insight into the Canadian drug formulary approval process as well as justify the need for further studies that may have to be undertaken to critically assess the approval process.  The results of this study will provide information of interest to health care  professionals, hospitals, hospital P & T committees, governments, third-party payers, drug companies, pharmaceutical industry analysts, and others directly or indirectly involved or interested in the Canadian hospital drug formulary approval process.  32 CHAPTER THREE  METHODS  Study sample For this study entry criteria required that the hospital be an English-speaking public hospital in Canada, operate a pharmacy department, and have more than 100 beds. A national survey of Canadian hospital pharmacy services by Eli Lilly Canada Inc. found that the inclusion of hospitals with less than 100 beds noticeably skewed the averages and resulting observations (Canadian Hospital Pharmacy Annual Report, 1991). Neither the cause, the nature, nor how the skewed data affected the resulting observations was mentioned.  Subsequent annual surveys by Eli Lilly  Canada Inc. have excluded hospitals with less than 100 beds. Preliminary analyses of the potential sample revealed that many hospitals with less than 100 beds d i d not have a pharmacy department. Hence, the existence of a drug formulary or P & T committee may have been absent in these small hospitals.  Approximately 120 French-speaking hospitals which w o u l d have  otherwise met the inclusion criteria were excluded. This was due to workload and language considerations regarding the translation of the survey instrument as well as interpretation of survey responses. Using information from the Canadian Hospital Association Directory (1992), it was determined that 328 hospitals (31.1%) met the inclusion criteria out of a possible 1,054 Canadian hospitals. Data collection A mail survey was felt to be the most appropriate and effective research method for evaluating the drug formulary approval process in Canadian hospitals (Kerlinger, 1986). The somewhat geographically distant nature of the entire sample of Canadian hospitals precluded the use of other research methods.  For example,  telephone surveys or personal interviews with pharmacy directors and P & T  33 committee chairs were not considered to be feasible as these methods w o u l d have required an extraordinary amount of time and financial resources to conduct. A review of the pharmacy literature' was performed to identify specific items suitable for eliciting specific guidelines, standards, and other important aspects about the hospital drug formulary approval process.  American Hospitals, Hospital  A m o n g the journals reviewed were  Journal of Hospital Pharmacy, Canadian Journal of Hospital Hospital  Formulary,  Drug Intelligence and Clinical  Pharmacy,  Pharmacy, Hospitals,  Pharmacy, a n d Topics in Hospital Pharmacy Management. Information  from this literature was used to develop a structured mail survey. In September 1993 the preliminary survey was tested over the course of three weeks on those people considered to be experts on the drug formulary approval process.  Specifically, the survey was pilot tested on seven pharmacists, including  one pharmacy director and one assistant pharmacy director, in order to ensure face and content validity as well as clarity. The actual survey protocol was reviewed, approved and certified by the University of British Columbia Behavioural Sciences Screening Committee for Research and Other Studies Involving H u m a n Subjects (Appendix 1). In December 1993, a covering letter explaining the purpose of the written questionnaire and a four-page 27-item survey were mailed simultaneously to the pharmacy director and P & T committee chair of 328 hospitals (Appendix 2). Both groups received the same survey, although each group was instructed to complete the survey independently of the other. A follow-up survey was sent to nonresponders i n February 1994. To maximize the response rate, each survey was sent with a personally addressed letter and a stamped, self-addressed envelope (Dillman, 1972; Woodward, Chambers & Smith, 1982). Follow-up of non-responders consisted of a reminder letter with a copy of the survey mailed out in the same manner as in the initial mailing (Appendix 3). The inclusion of any type of gift or monetary inducement for completing the survey was deemed to be unnecessary and not  34 feasible.  Thus, no incentive was provided to potential survey respondents for  completing the mail survey, although requests for study results via publication reprints were acknowledged. The three part survey gathered data as follows: Part I-general hospital characteristics, Part II-hospital P & T committee and formulary characteristics and opinions on items affecting the current drug formulary approval process, and Part Ill-opinions on items affecting the future drug formulary approval process.  For the  drug formulary approval process questions in Parts II and III, respondents were presented with 28 items designed to be answered on a 5-point Likert-type rating scale (DeVellis, 1991). Respondents were asked to rate the influence of items as having "very strong", "strong", "moderate", "weak", or "no influence" on the drug formulary approval process. Responses were stratified by title (pharmacy director versus P & T committee chair) and by reported hospital bed size to optimize cell frequencies: 100-199, 200-299, 300-399,400-499, and >500 beds. This stratification scheme was similar to methods used by other researchers as described in the literature (Crawford & Myers, 1993; Plumridge, Stoelwinder & Rucker, 1993). The return rate of completed and acceptable surveys is crucial for data interpretation. Self-reporting of any activity is a possible bias that must be recognized (Isaac & Michael, 1981). One attempt to control for this bias was to stress to respondents the confidential nature in which the results would be handled. In addition, respondents were given the option of not identifying their hospital name as this survey question was labeled as optional. Confidentiality and anonymity were assured to all hospitals. The 28 "items" incorporated into this study's survey instrument were derived primarily from the work of Hepler (1988), Manasse (1989b), and Shane (1992), who have identified various influences affecting hospital and pharmacy practice. Specifically, influences of a political, organizational, societal, legal, professional, and economic nature were tested. Individual items were used in data collection to assist  35 in obtaining information suitable for testing the underlying influence thought to impact on the drug formulary approval process, as well as testing for correlation between the current and future drug formulary approval process.  Reasons for  specific item inclusion follow. Political decision making and public policy are sometimes closely related to the interests of the pharmaceutical industry, which are in turn related to the health status of the nation. A s Manasse (1989b) states, "Drugs can be a risky business in the political arena, particularly if they portend to create harm" (p. 1143). Important political measures thought to regulate or have the potential to regulate the approval and introduction of new drugs include "government assessment agencies", "provincial formularies", and "provincial P & T committees". Organizational structure and function have a bearing on the diffusion of new drugs from pharmaceutical manufacturers to ultimate adopters.  Foremost of these  organizational structures are "hospital P & T committees" whose role it is to evaluate new drugs. T o a lesser extent "hospital assessment committees" are sometimes involved in this process. The degree of "technology in drug development" is felt to influence adoption requirements. Many new drugs and emerging dosage forms require expertise and new services (Hepler, 1988). For example, certain biotechnology drugs have complex dosing regimens or monitoring characteristics. Actual "adoption by a leading hospital" or innovator-type hospital has been shown to influence the approval process of a new drug (Coleman et. al, 1967). The assistance of "computers/information systems" to facilitate drug formulary approval decision-making processes should be considered as it has been shown that computers can be used as formulary decision support tools (Senthilkumaran et al., 1987; Greer, 1992; Morrell, Wasilauskas & Winslow, 1994). The extent to which computers, expert systems, and artificial intelligence can be applied to the drug formulary decision-making process needs to be ascertained.  36 "Drugs in society are highly valued for their safety, efficacy, and easy access, with drugs deservedly gaining a prominent place among professionals and the lay public" (Manasse, 1989b, p. 1141). "Patients expect and have a right to safe and effective drug therapy" (Manasse, 1989b, p. 1144). "Patient request for a new drug" and "patient rights" within a hospital are items thought to have potential yet indirect influence on the drug formulary approval process.  Although a social value  underlies the existence of pharmaceutical manufacturers, i.e., to aid in the wellbeing of mankind, the extent and importance of "drug company marketing" has been well documented in the literature (Townsend, 1987). Manasse (1989b) states that, "Conventional marketing techniques are based on (a) the incidence of disease problems for which drugs are suitable treatment modalities, (b) the induced demand for the use of drugs as the treatment of choice, and (c) the increase i n portion of the competitor's market" (p. 1142). Thus, continued growth of the drug industry depends on the entrance of new, competitive drugs into the market. Legal issues affect the use of any drug. "Liability of a new drug" is an issue that health professional cannot ignore. It appears that an inherent liability or legal item is a consideration for the new drug formulary approval process (Manasse, 1989a). The extent to which pharmacy directors and P & T committee chairs are willing to expose the hospital and prescribing physicians to issues of liability or risk potential associated with the use of a new drug remains to be ascertained. Professional issues are related to the use of new drugs. "Drug-use" and "drug toxicity" are items felt to be important when considering a new drug for formulary inclusion. "Physician requests for a new drug" or "pharmacy requests for a new drug" actually initiates the process for evaluating the relative merits of a new drug through a "formulary system".  "Professional journal articles" and "pharmacy drug  evaluation reports" help i n the decision-making process by theoretically providing a non-biased opinion of a new drug.  "Outcome measurements", "pharmaceutical  care", and "quality assurance" are helpful to ensure the effectiveness and safety of  37 drug formulary" approval decisions in terms of positive outcomes for patient care (Shane, 1992). "The use of drugs has a substantial economic impact" (Manasse, 1989b, p. 1142). Under the Canadian health care system, "health care funding" is what ultimately drives the system and, indirectly, on a smaller scale, the drug formulary approval process.  "Financial management" in hospitals is critical for the survival of  many hospitals. It also determines if hospitals can afford to adopt new drugs. Sometimes a "new drug's acquisition cost" necessitates that "cost controls" be put into place. Only recently have "pharmacoeconomic evaluations" been formally recognized in the literature. Although still relatively new, various new drug evaluations are being considered by decision makers when deciding about a drug's "treatment cost versus alternatives". These brief item summaries were not included in the actual mail survey. Rather, respondents were presented with an alphabetical list of these items and were asked to rate each item's influence for the current and future drug formulary approval process in Canadian hospitals. Ratings were based on a five point scale. Also, respondents were asked to state any other items that they felt w o u l d have influence on the drug formulary approval process. Data analysis The required sample size (n) needed to be representative of the entire population of Canadian hospitals (N=1054) was 282 hospitals. This number was found using a table compiled by Krejcie and Morgan (1970) that presents the required sample size based upon the size of a given population. For this study, the total number of sampled hospitals based on study inclusion and exclusion criteria was 328 hospitals. Thus, this study requires an 86% (282/328) response rate to be generalizable to all 1054 Canadian hospitals. Responses were checked for completeness and data was categorized and analyzed using exploratory data techniques. Data was then coded for computer  38 analysis and tabulated using Microsoft E x c e l ® spreadsheet and S y s t a t ® statistical software.  For all statistical tests used, significance was defined as p<0.05 with the test  being two-tailed in nature. A statistician was consulted to verify the appropriateness of statistical tests used for data analysis. The ordinal nature of the underlying data obtained from the rating scale questions of Part II and III precluded the use of most types of parametric tests. In addition, the application of parametric tests to ordinal scale data causes any decisions about hypotheses to be doubtful (Siegel, 1956). For this reason nonparametric tests were chosen for data analysis. The non-parametric Wilcoxon matched-pairs signed-rank test was used to determine significance between the current and future drug formulary approval ratings for pharmacy directors and P & T committee chairs. Spearman rank correlation coefficient was used as a measure of association between current and future opinions.  The non-parametric Kolmogorov-Smirnov two-sample test was  used to determine significance between pharmacy directors and P & T committee chairs for both the current and future drug formulary approval process. Other powerful and possibly more useful statistical methods were not attempted due to time and workload considerations associated with this study. Ideally, factor analysis could have helped to reduce the actual number of items used in the mail survey. Factor analysis highlights those items found to be redundant in terms of accounting for the same influence (Kerlinger, 1986). Consequently a survey with fewer items could have been constructed, hence increasing the likelihood that respondents would complete a shorter rather than longer survey. Assumptions This study assumes that the drug formulary approval process is a proxy measure of drug technology adoption. However, it is important to realize that drug formulary approval does not necessarily imply usage within a hospital. It was also  39 assumed that pharmacy directors and P & T committee chairs surveyed were well versed i n their respective hospital's drug formulary approval process.  However,  occasionally the chair of a committee serves more as a figure head as opposed to an actively contributing member. Potential conflict of interest between P & T committee members or even hospitals themselves and pharmaceutical companies was not tested for. For example, the provision of research funding or other types of sponsoring activities by drug companies may influence the attitudes of potential adopters towards a new drug introduced by a sponsoring drug company. A n y relationships or mutual agreements existing between P & T committee members or hospitals and drug companies were not tested. P & T committee structure variables such as the length of time various appointed members had served on the committee were also not tested. The precise voting procedure or distribution of votes for new drug formulary inclusion was not ascertained among P & T committee members.  Long-standing senior P & T committee  members may possess a greater voice in determining the fate of new drugs as opposed to junior medical staff members. The influence, if any, of such situations needs to be acknowledged. Although French-speaking hospitals were excluded from the survey, Englishspeaking hospitals (7.8%) in the predominantly French-speaking province of Quebec who met the inclusion criteria were surveyed. Herein lies an important assumption.  The hospital practice environments of the Canadian provinces  surveyed were assumed for the most part to be homogeneous.  However, obvious  differences in language, i.e. French versus English, and to a certain degree cultural differences may potentially influence the practice environments in which certain hospitals operate.  Subsequent observations may be confounded by this assumption,  although only a small fraction of hospitals were from Quebec.  40 The existence of individual hospital ethical or pharmacoeconomic guidelines or standards with respect to new drugs was not determined. The relative strength of a pharmacy department's input into formulary and P & T committee issues was not tested. Finally, concerns of an emotional nature such as attitude towards completing the survey, respondent's state of mind, or lack of inclination to accurately complete the survey may have ultimately contributed to incomplete or inaccurate responses being provided by both pharmacy directors and P & T committee chairs.  41 CHAPTER THREE  RESULTS  Of the 328 identical surveys mailed to both pharmacy directors and P & T committee chairs, 233 (71.0%) were returned by pharmacy directors and 50 (15.2%) were returned by P & T committee chairs. U p o n review of the responses, there were five separate mergers between two hospitals and two separate mergers among three hospitals. This reduced the sample size by nine hospitals. Fourteen hospitals reported in the survey to have less than 100 beds and therefore were excluded. This further reduced the number of potential responses to 305 for pharmacy directors and P & T committee chairs. Eight surveys were received from pharmacy directors who also stated that they served as chair on a P & T committee and five responses were received from pharmacy directors who stated that they served as secretary o n a P & T committee. For the purposes of this study the responses from these thirteen pharmacy directors were considered as being representative of pharmacy directors only. Therefore the number of potential responses by P & T committee chairs was further reduced by 13 to 292. Twenty-six surveys from pharmacy directors were excluded from the analysis because they were blank (16 replies) or were duplicates (10 replies).  Seventeen  surveys from P & T committee chairs were excluded from the analysis because they were blank (8 replies) or were duplicates (9 replies). This left a total of 193 usable replies (63.3%) for pharmacy directors and 32 usable replies (10.9%) for P & T committee chairs. Table 1 reflects the characteristics of the sample size. Response rates for pharmacy directors from this study can be considered comparable if not higher than similar national surveys. The Canadian Hospital Pharmacy A n n u a l Report administered by Eli Lilly Canada Inc., which surveys Canadian hospital pharmacy services, has achieved national response rates ranging  42 from 42% to 50% between 1990 and 1993 (Canadian Hospital Pharmacy A n n u a l Report, 1990, 1991, 1992, 1993). Similarly, A S H P national surveys of U.S. hospital pharmacies have reported response rates ranging from 56% to 85% (Stolar, 1985; Raehl, Bond & Pitterle, 1992; Crawford & Myers, 1993).  Table 1 Characteristics of Survey Respondents  Pharmacy Directors Directors sampled Merged hospitals (-)  Sample Size 328 9  Excluded: <100beds(-)  P&T Committee Chairs Chairs sampled Merged hospitals (-)  Sample Size 328 9  Excluded: 14  <100beds(-)  14  Director as chair (-)  13  Potential responses  305  Potential responses  Surveys received  233  Surveys received  Excluded surveys:  292 50  Excluded surveys:  <100beds(-)  14  <100beds(-)  1  Blank (-)  16  Blank (-)  8  Duplicates (-)  10  Duplicates (-)  9  Total usable responses  193 (63.3%) Total usable responses  32 (11.0%)  Part I of the survey requested general hospital information. A wide distribution of responses based on hospital bed size was observed from analyzing the responses of pharmacy directors and P & T committee chairs (Table 2). The observed wide distribution was less pronounced than the actual distribution, which was skewed towards small hospitals having between 100 to 199 beds. A s reported by  43 pharmacy directors (n=193) the mean ± standard deviation (mean ± S D ) number of hospital beds was 379 ± 285 beds, and the median number was 300 beds. In terms of geographic distribution (Table 3), almost half of all pharmacy director and P & T committee chair respondents were from Ontario. Except for Prince Edward Island and Newfoundland, all other areas sampled had pharmacy director response rates greater than 50%. Response rates for P & T committee chairs ranged from 0% to 23.4%, with four provinces and one territory having a 0% response rate. Thus, i n large part, the responses to many survey questions reflect the experience of Ontario hospitals, which in turn is a reflection of the health care climate i n Ontario.  Table 2 Survey Respondents by Hospital Bed Size  Bed  Actual  Directors  Chairs  Size  Distribution  Responding  Responding  (n=328)  (n=193)  (n=32)  N o . (%)  N o . (%)  N o . (%)  100-199  125 (38.1)  55 (28.5)  5 (15.6)  200-299  68 (20.7)  37 (19.2)  8 (25.0)  300-399  56 (17.1)  35 (18.1)  2 (6.3)  400-499  29 (8.8)  21 (10.9)  8(25.0)  >500  50 (15.2)  45 (23.3)  9 (28.1)  Beginning with Table 4 and for all remaining tables, only survey responses from pharmacy directors will be presented and discussed unless otherwise explicitly stated. The disparity in response rates between pharmacy directors and P & T committee chairs permits only limited comparisons that would yield insight into the drug formulary approval process.  44 Table 4 shows that many of the survey responses received (43.5%) were from hospitals of a general and acute care type with some degree of chronic, extended care, or long term care. Some type of teaching program was reported to be offered to a combination of medical interns, nursing students, and pharmacy residents or students in 91.2% of responding hospitals (Table 5). The majority of pharmacy directors (46.6%) stated that their respective hospital's actual expenditures were within ± 2% of budgeted expenditures over the past two years (Table 6). M a n y hospitals with bed sizes greater than 500 reported being within ± 2% of budgeted expenditures. The last survey question of Part I requested respondents to rank the level of pharmacy clinical services provided to the majority of beds in the hospital, according to the rating scheme developed by the Canadian Society of Hospital Pharmacists (Table 7). Given that the provision of clinical services is generally dependent o n departmental education, staffing, and resources, 46.6% of respondents reported to be operating at Level II, which refers to selective patient pharmacotherapy monitoring. Small to moderate size hospitals (<400 beds) reported to be operating between Levels I to II, while larger hospitals (>400 beds) reported to be operating between Levels II to IV.  45  re  H-»  o  e»  o> eft G O  CM CO  CO  eft  co  co  tN  CO  o o  o o in  co  o o  O O O  LO  LO Os, CM  O o o  CN LO  rH  LO CO  00  o>  o o  o o  ON LO  O  rH  o  o o o, o o o  o  IN  CO  o >  rH  VO CM  IN  LO  LO  LO  rH  OS CM LO  co  IN  O O LO  CO CO  rH rH t-H  LO  LO  ON  rH  rH  CO  ON  vo  co  o o  rH  el "re  u  eft  o> eft G  a  O  Z  0  OH  (ft  CM CO  II G  01 rH  CO rH rH  rH  rH  O rH  VO rH  H,  o Z  Ol ~  Ci, re S  eft  00 CM  co H Gi  IN  IN CO  VO  O  LN  00 VO  VO IN VO  co  CM CO  LO CM  IN  IN  rH  LO rH  rH  CM  rH  rH  eft  re 0) o eft G 0  co OV  VO VO  a, eft  IN  LO  CO  tN  O  c5  o  01  JH  Eft  O u rH  H-*  eft Oi eft  0)  G  o re  o  S  o Z  CO  0  eft 01 J-  rH  vd LO  co CO LN  CO LO LO  rH rH  00  rH  O O O rH  J-l  re  rH  01 01  u  c  o Z  >  T3 <u a,  £ re  GO CM CO  CO  VO  LO  CM LO  CM  en  0  rH  cu Cft  H-»  G 01  G 0  D.  to 0)  eft 01  o> C/5  G re  rH  o  CO  H-< • rH  I-l rH  0»  H  U  G *> O u C  eft 0>  T3  > ,  r£>  G re  a G  O  u  rG eft rH  pa  re H-H rH  X, j-> re r *  eft  re CO  eft  re o  •rH  G re  G G -H  re 4-«  G  o  u  •8  G a  pa  Z  re O CO  re > O  Z  rH  re W o> U  •rH rH  0  T3  -t-> •rH rH rH  r2  H  G G  O <-rH  G  • rH rH  z  01  eft 01  •5 rG H-> rH  o  Z  46 Table 4 Type of Hospital by Hospital Bed Size (n=193)  Bed Size  A  B  100-199  26  18  4  1  1  3  1  -  1  200-299  19  13  3  1  1  -  -  -  -  300-399  15  9  5  5  1  -  -  -  -  400-499  10  4  4  1  1  1  -  -  -  >500  14  13  8  4  3  2  -  1  -  Total N o .  84  57  24  12  7  6  1  1  1  43.5  29.5  12.4  6.2  3.6  3.1  0.5  0.5  0.5  %  C  D  E  F  G  H  I  Note. Type of hospital:  A . General/acute care. B. General/acute care/chronic/extended care/long term care. C . General/acute care/chronic/extended care/long term care/rehabilitation. D . Chronic/extended care/long term care. E . Chronic/extended care/long term care/rehabilitation. F. General/acute care/rehabilitation. G . Rehabilitation. H . Chronic/extended care/long term care/other. I. Other.  Table 5 Teaching Program b y Hospital Bed Size (n=193)  Bed Size  A  100-199  7  200-299  B  C  D  E  F  G  H  4  16  5  12  4  4  3  11  12  6  3  4  1  -  -  300-399  8  11  6  8  -  -  1  1  400-499  11  7  1  2  -  -  -  -  >500  31  9  -  1  1  3  -  -  Total N o .  68  43  29  19  17  8  5  4  35.2  22.3  15.0  9.8  8.8  4.1  2.6  2.1  %  Note. Nature of hospital teaching programs: A . Medical interns, nursing students, and pharmacy residents/students. B. Nursing students and pharmacy residents/students. C . Nursing students. D . Medical interns and nursing students. E. N o teaching programs. F. Pharmacy residents/students. G . Medical interns and pharmacy residents/students. H . Medical interns.  48  Table 6 Two Year Hospital Actual Versus Budgeted Expenditures by Hospital Bed Size (n=193)  Bed  Over-budget  On-budget  Under-budget  No  Size  (> + 2%)  (± 2%)  (< - 2%)  Response  100-199  21  19  12  3  200-299  8  18  6  5  300-399  9  20  5  1  400-499  4  12  3  2  >500  13  21  7  4  Total No.  55  90  33  15  28.5  46.6  17.1  7.8  %  49  Table 7 Level of Pharmacy Clinical Services Provided tn the Majority of Hospital Rpds by Hospital Bed Size (n=1Q3)  Bed Size  Level I  Level II  Level III  100-199  24  19  2  -  10  200-299  16  16  4  -  1  300-399  11  18  5  1  -  400-499  4  13  1  2  1  >500  6  24  9  5  1  61  90  21  8  13  31.6  46.6  10.9  4.1  6.7  Total N o .  %  Level I V  N o Response  Note. Level of clinical service: I -D r u g order review. II- Selective patient pharmacotherapy monitoring. III-Comprehensive patient pharmacotherapy monitoring. I V - Decentralized concurrent monitoring.  Part II of the survey dealt with various aspects of the hospital's P & T committee and drug formulary. Respondents were also solicited for their opinions on items that influence the hospital's current drug formulary approval process. A l l 193 pharmacy directors and 32 P & T committee chair respondents stated that their hospital had a P & T committee in place. The director of pharmacy, nurses, physicians, and medical specialists served on more than 75% of P & T committees (Table 8). In addition to the pharmacy director, other pharmacists i n the hospital served on 57.5% of committees.  Table 9 shows that the overall mean ± S D number  50 of people on P & T committees was 9.4 ± 3.9 (range, 2-23). The mean number of people who served on P & T committees generally increased with hospital bed size.  Table 8 P & T Committee Membership by Staff Title (n=193)  Staff Title  No. P & T Committees  Representation (%)  Pharmacy director  190  98.5  Nurse  173  89.6  Physician (GP)  168  87.1  Medical specialist  155  80.3  Senior management  133  68.9  Other pharmacist  111  57.5  Surgeon  98  50.8  Clinical pharmacologist  28  14.5  Quality assurance staff  22  11.4  Pathologist  14  7.3  Laboratory technician  12  6.2  9  4.7  105  54.4  Finance staff Other  51 Table 9 P & T Committee Size Characteristics by Hospital Bed Size (n=193)  Bed  Mean  SD  M i n . No.  Max. N o .  Response  %  Size 100-199  7.4  2.9  3  16  28.5  200-299  9.0  2.7  4  15  19.2  300-399  9.5  4.0  2  18  18.1  400-499  10.6  4.5  4  20  10.9  >500  11.8  4.3  5  23  23.3  9.4  3.9  2  23  100.0  Overall  W h e n asked to indicate the responsibility of the hospital's P & T committee, both pharmacy directors and P & T committee chairs felt strongly that formulary drug approvals, drug-use review, and prescribing policies were the top three P & T committee responsibilities (Tables 10 and 11). Both groups felt that parenteral nutrition, drug handling/disposal, and purchasing decisions were minor P & T committee responsibilities. More than 90% of director respondents stated that their hospital's P & T committee reported directly to the hospital's medical advisory committee (Table 12). The P & T committee chair was most frequently a physician (Table 13), while the P & T committee secretary was most frequently the pharmacy director (Table 14). A s reported by pharmacy directors, 91.7% of P & T committees d i d record the minutes for P & T committee drug adoption and rejection decisions, while 5.7% d i d not record reasons, and the remaining 2.6% d i d not provide a response. P & T committee meetings were usually held on a monthly basis (Table 15). A number of respondents d i d indicate that P & T committee meetings were less frequent i n the summer months.  Table 10 Responsibilities of P&T Committee as Reported by Pharmacy Directors (n=193)  Identified Role  No. Pharmacy  %  Directors Formulary drug approval  191  99.0  Drug-use review  180  93.3  Prescribing policies  179  92.7  Restrictions on drug use  176  91.2  Therapeutic interchange  173  89.6  D r u g administration  167  86.5  ADR  160  82.9  Monitoring drug costs  160  82.9  P & T policy enforcement  148  76.7  Error reporting  142  73.6  Parenteral nutrition  95  49.2  D r u g handling/disposal  47  24.4  Purchasing decisions  35  18.1  monitoring  53 Table 11 Responsibilities of P&T Committee as Reported by P&T Committee Chairs (n=32)  Identified Role  No. P & T Committee  %  Chairs Drug-use review  32  100.0  Formulary drug approval  32  100.0  Prescribing policies  31  96.9  Monitoring drug costs  31  96.9  Restrictions o n drug use  30  93.8  ADR  monitoring  29  90.6  P & T policy enforcement  27  84.4  Error reporting  26  81.3  Therapeutic interchange  25  78.1  D r u g administration  24  75.0  Parenteral nutrition  23  71.9  D r u g handling/disposal  19  59.4  Purchasing decisions  19  59.4  Table 12 Organizational Reporting Relationships of P&T Committee by Hospital Bed Size (n=193)  Bed  Medical  Senior  Quality  No  Size  Advisory  Management  Assurance  Response  Nursing  Committee 100-199  51  1  -  2  1  200-299  36  1  -  -  -  300-399  33  1  1  -  -  400-499  19  2  -  -  -  >500  44  -  1  -  -  Total No.  183  5  2  2  1  %  94.8  2.6  1.0  1.0  0.5  Table 13 P&T Committee Chairperson by Hospital Bed Size (n=193)  Bed  Physician  Size  Pharmacy  Senior  No  Director  Management  Response  100-199  48  5  1  1  200-299  36  1  -  -  300-399  34  1  -  -  400-499  21  -  -  -  >500  44  1  -  -  Total No.  183  8  1  1  %  94.8  4.1  0.5  0.5  Table 14 P&T Committee Secretary by Hospital Bed Size (n=193)  Bed  Pharmacy  Secretarial  Other  Size  Director  Staff  Pharmacist  100-199  38  9  3  2  3  200-299  21  5  11  -  -  300-399  25  7  2  1  -  400-499  12  5  4  -  -  >500  32  6  6  1  -  Total No.  128  32  26  4  3  %  66.3  16.6  13.5  2.1  1.6  Physician  No Response  57  Table 15 Frequency of P&T Committee Meetings by Hospital Bed Size (n=193)  Bed Size  Monthly  Bimonthly  Quarterly  Semiannually  Other  100-199  21  14  18  1  1  200-299  20  9  7  1  -  300-399  26  2  6  1  -  15  3  3  -  -  >500  38  2  4  1  -  Total No.  120  30  38  4  1  %  62.2  15.5  19.7  2.1  0.5  400-499  '  W h e n asked about the existence of a hospital drug formulary, a majority of pharmacy directors reported that a formulary was in place 98.4% (190/193). Of the remaining three hospitals, one director stated that the formulary was in the process of being developed, while the remaining two directors stated that their hospital functioned without a formulary. Tables 16 and 17 describe the degree of drug formulary control as reported by pharmacy directors and P & T committee chairs respectively.  Asked how they would  rate this control on a 5-point rating scale in which 1 = "very tight control" and 5 = "very loose control", responding directors (97.9%) gave an overall median value of 2. Similarly responding. P & T committee chairs (93.8%) gave an overall median value of 2.  58 Table 16 Degree Of D r u g Formulary Control by Hospital Bed Size as Reported by Pharmacy Directors (n=193)  a  Bed  Very  Size  Tight  (2)  (3)  (4)  (1)  Very  No  Loose  Response  (5)  100-199  6  21  15  8  3  2  200-299  5  15  9  8  -  -  300-399  2  14  14  4  1  -  400-499  4  7  7  -  3  -  >500  6  24  9  4  -  2  23  81  54  24  7  4  11.9  42.0  28.0  12.4  3.6  2.1  Total N o .  %  Values reported on a scale of 1-5, where 1 = very tight control, and 5 = very loose control.  59 Table 17 Degree O f D r u g Formulary Control by Hospital Bed Size as Reported by P & T Committee Chairs (n=32)  Bed  Very  Size  Tight  a  (2)  (3)  (4)  (1)  No  Loose  Response  (5)  100-199  3  1  1  -  -  -  200-299  1  4  3  -  -  -  300-399  -  1  -  1  -  -  400-499  2  4  1  1  -  -  >500  5  1  1  -  -  2  Total N o .  11  11  6  2  -  2  34.3  34.3  18.8  6.3  -  6.3  %  a  Very  V a l u e s reported on a scale of 1-5, where 1 = very tight control, and 5 = very loose control.  Approximately 83.4% of pharmacy directors stated that their hospital's formulary had been updated within the past two years, with 5.2% mentioning that formulary updating is an ongoing process in their hospital (Table 18). Table 19 shows that over the past two years approximately 20.0 ± 11.5 drugs were added to the typical formulary (range, 0-60) and 25.3 ± 25.6 drugs were deleted from the typical formulary (range, 0-150).  60 Table 18 Year of Last D r u g Formulary Updating by Hospital Bed Size (n=193)  Bed  1994  1993  1992  1991  1990  1989  1988  1986  Ongoing  Size  No Response  100-199  4  33  6  4  1  -  -  1  3  3  200-299  4  21  6  2  1  -  1  -  2  -  300-399  1  25  6  1  -  -  -  -  1  1  400-499  4  8  6  1  -  -  -  -  1  1  >500  5  27  4  1  1  1  -  -  3  3  Total N o .  18  114  28  9  3  1  1  1  10  8  %  9.3  59.1  15.0  4.7  1.6  0.5  0.5  0.5  5.2  4.1  61 Table 19 Characteristics of D r u g Formulary D r u g Additions and Deletions Over Past T w o Years  Pharmacy Directors (n=193) Statistic  Additions  Deletions  Mean  20.0  25.3  SD  11.5  25.6  Range  0-60  0-150  Total N o .  168  169  % Response  87.0  87.6  Table 12 shows that 94.8% of P & T committees report directly to the medical advisory committee ( M A C ) . However, from Table 20 only 22.3% of respondents stated that the M A C was actively involved with the drug formulary approval process. Financial ranges reported for the M A C to grant final approval were from $5,000 per unit cost to $10,000 per treatment course. The observed discrepancy between Table 12 and Table 20 may be explained by the responses of some pharmacy directors who suggested that their hospital's M A C , when it came to drug formulary approval, only served to rubber-stamp P & T committee recommendations and were therefore not actively involved in the process.  62  Table 20 Committees Involved with the Drug Formulary Approval Process (n=193)  None M A C A M C  FC N R X A D R C C U H A P R C O T H PC  PE T P N  No.  122  43  14  4  2  1  1  1  1  1  1  1  1  %  63.2  22.3  7.3  2.1  1.0  0.5  0.5  0.5  0.5  0.5  0.5  0.5  0.5  Note.  Name of committees:  M A C = Medical Advisory Committee. A M C = Antimicrobial Committee. F C = Formulary Committee. N R X = Nursing Pharmacy Committee. A D R = Adverse Drug Reaction Committee. C C U = Critical Care Committee. H A = Health Administration Committee. O R C = Operating Room Committee. O T H = Other Committee. P C = Patient Care Committee. P E = Pharmacoeconomic Committee. T P N = Total Parenteral Nutrition Committee.  The last question of Part II dealt with the attitudes and opinions o n the influence of various items on the hospital's current drug formulary approval process with respect to breakthrough drugs, first-line drugs, or novel therapeutic drugs. This question was used to test for possible correlations between opinions on the current drug formulary approval process and views of the future drug formulary approval process.  Part III of the survey instrument first asked respondents which of the following, if any, would likely be appointed to a P & T committee i n the next five to ten years: ethicist, payer, lawyer, patient advocate, economist, social worker, other, or no other new appointees (Tables 21 and 22). Although 81.3% of pharmacy directors and 87.5% of P & T committee chairs sampled reported that no other new representatives w o u l d be appointed, a small percentage of pharmacy directors (8%) and P & T committee chairs (8-12%) felt that an ethicist, a patient advocate, or an economist could be appointed to serve on a P & T committee in the future.  Table 21 Opinions on Future P&T Committee Appointments as Reported by Pharmacy Directors (n=193)  None  Patient  Ethicist Economist  Other  Payer  Lawyer  Advocate  Social Worker  No.  157  17  16  15  5  4  1  1  %  81.3  8.8  8.3  7.8  2.6  2.1  0.5  0.5  64  Table 22 Opinions on Future P&T Committee Appointments as Reported by P&T Committee Chairs (n=32)  No One  Ethicist  Economist  Else No. %  Patient  Payer  Advocate  28  4  3  3  1  87.5  12.5  9.4  9.4  3.1  For both the current and the future drug formulary approval process, pharmacy directors and P & T committee chairs were asked to rate the influence of 28 items on a scale of 0-4, where 0 = "no influence", 1 = "weak influence", 2 = "moderate influence", 3 = "strong influence", and 4 = "very strong influence". The non-parametric Wilcoxon matched-pairs signed-rank test was used to determine significance between the current and future drug formulary approval process for pharmacy directors and P & T committee chairs. Results are presented i n Table 23. The critical z value based on a sample size of 193 was 1.96. For pharmacy directors 23 of 28 items differed significantly between the current and future drug formulary approval process. O f these 23 items 21 (91.3%) were expected to significantly increase in influence while 2 (8.7%) were expected to significantly decrease in influence in the future. For P & T committee chairs 11 of 28 items differed significantly between the current and future drug formulary approval process. A l l 11 (100%) items were expected to become significantly more influential in the future. The Spearman rank correlation coefficient calculated for the 23 items ranged from 0.35 to 0.94. The non-parametric Kolmogorov-Smirnov two-sample test was used to determine significance between pharmacy directors and P & T committee chairs for the current drug formulary approval process as well as for the future drug  65 formulary approval process.  With reference to the current drug formulary approval  process, the items of drug company marketing (p = 0.016) and quality assurance (p = 0.026) were significantly different between pharmacy directors and P & T committee chairs. N o item was found to be significantly different between pharmacy directors and P & T committee chairs for the future drug formulary approval process. Respondents were given the opportunity to add other items thought to influence the current or the future drug formulary approval process.  None of the  respondents provided further information. Finally, Appendix 4 provides a graphical description of each of the 28 items. Shown are how each item differs in rating between the current and future drug formulary approval process with respect to the number and percentage of pharmacy director respondents.  66 Table 23 Wilcoxon Matched-Pairs Signed-Rank Test of Items Between Current and Future Drug Formulary Approval Process as Reported by Pharmacy Directors (n=193> and P&T Committee Chairs (n=32)  a  Item Pharmacoeconomic  zobs  rs  P  r  2 s  (%)  medc  medf  evaluations  *  8.91  <0.00  0.42  17.6  3  3  1.19  0.23  0.81  65.6  3  3  Pharmacy directors  8.83  <0.00  0.52  27.0  3  4  P & T committee chairs*  3.94  <0.00  0.67  44.9  3  4  8.42  <0.00  0.55  30.3  1  2  2.68  0.01  0.68  46.2  1  2  Pharmacy directors*  8.32  <0.00  0.60  36.0  2  3  P & T committee chairs  1.00  0.32  0.78  60.8  3  3  8.23  <0.00  0.56  31.4  3  3  3.21  <0.00  0.71  50.4  3  3  Pharmacy directors P & T committee chairs Health care funding  Computers/information systems Pharmacy directors  •k  P & T committee chairs* Pharmaceutical care  Financial  management  Pharmacy directors P & T committee chairs  •k  Median influence as rated on a scale of 0-4 (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Note. z b s = observed z statistic, p = probability, r = Spearman correlation 0  s  coefficient, m e d = median rating for current drug formulary approval process, medf c  = median rating for future drug formulary approval process. *p<0.05.  67 Table 23 C o n t i n u e d  Item  zpbs  p  rs  r s (%)  rned  2  c  medf  Outcome measurements Pharmacy directors*  7.82  <0.00  0.55  30.3  3  3  P & T committee chairs  1.59  0.11  0.37  13.7  3  3  Pharmacy directors*  7.17  <0.00  0.51  26.0  3  4  P & T committee chairs*  3.87  <0.00  0.71  50.4  3  4  Pharmacy directors*  7.08  <0.00  0.37  13.7  1  3  P & T committee chairs*  2.35  0.02  0.68  46.2  2  2  Pharmacy directors*  7.24  <0.00  0.44  19.4  3  3  P & T committee chairs*  2.52  0.01  0.72  51.8  2  2  Pharmacy directors*  7.23  <0.00  0.55  30.3  2  2  P & T committee chairs*  2.33  0.02  0.35  12.3  2  2  Pharmacy directors*  7.21  <0.00  0.46  21.2  2  3  P & T committee chairs  0.98  0.33  0.39  15.2  2  3  Cost controls  Provincial P & T committee  Government assessment agencies  Technology i n drug development  Provincial formulary  "Median influence as rated on a scale of 0-4 (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Note. z  O D  s = observed z statistic, p = probability, r = Spearman correlation s  coefficient, m e d = median rating for current drug formulary approval process, medf c  = median rating for future drug formulary approval process. p<0.05.  68 Table 23 C o n t i n u e d  Item Treatment cost versus  zobs  P  rs  r  2 s  (%)  medc  medf  alternatives  Pharmacy directors*  7.10  <0.00  0.52  27.0  3  4  P & T committee chairs  2.11  0.03  0.66  43.6  3  4  7.04  <0.00  0.53  28.1  2  3  3.05  <0.00  0.74  54.8  3  3  Pharmacy directors*  6.44  <0.00  0.49  24.0  1  1  P & T committee chairs  1.43  0.15  0.57  32.5  1  1  Pharmacy directors  6.42  <0.00  0.66  43.6  1  2  P & T committee chairs  0.59  0.56  0.68  46.2  2  2  Pharmacy directors*  6.36  <0.00  0.60  36.0  3  3  P & T committee chairs  1.13  0.26  0.77  59.3  3  3  6.05  <0.00  0.56  31.4  3  3  2.33  0.02  0.67  44.9  3  4  Quality assurance Pharmacy directors P & T committee chairs  ~k  Patient request for a new drug  Patient rights  Pharmacy drug evaluation reports  N e w drug acquisition cost Pharmacy directors* P & T committee chairs  a  *  M e d i a n influence as rated on a scale of 0-4 (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong).  Note, zobs = observed z statistic, p = probability, r$ = Spearman correlation coefficient, medc = median rating for current drug formulary approval process, medf = median rating for future drug formulary approval process. *p<0.05.  69 Table 23 C o n t i n u e d  Item  z bs 0  p  r  r (%)  med  2  s  s  c  medf  Formulary system Pharmacy directors*  5.24  <0.00  0.61  37.2  3  3  P & T committee chairs  0.33  0.74  0.76  57.8  3  3  Pharmacy directors*  5.18  <0.00  0.68  46.2  2  3  P & T committee chairs  1.61  0.11  0.89  79.2  2  3  Pharmacy directors*  4.90  <0.00  0.69  47.6  3  3  P & T committee chairs  1.51  0.13  0.80  64.0  3  3  -4.23  <0.00  0.68  46.2  3  3  1.07  0.29  0.63  39.7  3  3  -3.12  <0.00  0.69  47.6  1  1  2.83  <0.00  0.62  38.4  1  1  Pharmacy directors*  2.34  0.02  0.75  56.3  3  3  P & T committee chairs  1.89  0.29  0.88  77.4  3  3  Hospital assessment committee  Liability of a new drug  Physician request for a drug Pharmacy directors* P & T committee chairs D r u g company marketing Pharmacy directors* P & T committee chairs* Professional journal articles  a  M e d i a n influence as rated on a scale of 0-4 (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong).  Note. z b s = observed z statistic, p = probability, r = Spearman correlation 0  s  coefficient, medc = median rating for current drug formulary approval process, medf = median rating for future drug formulary approval process. *p<0.05.  70 Table 23 C o n t i n u e d  medc  medf  75.7  2  2  0.94  88.4  2  2  0.11  0.68  46.2  3  3  -0.90  0.37  0.70  49.0  3  3  Pharmacy directors  1.17  0.24  0.78  60.8  3  3  P & T committee chairs  0.97  0.33  0.75  56.3  3  3  -0.58  0.56  0.74  54.8  3  3  0.90  0.37  0.77  59.3  3  3  -0.28  0.78  0.57  32.5  4  4  0.58  0.56  0.82  67.2  4  4  Item  zobs  P  rs  Pharmacy directors  1.82  0.07  0.87  P & T committee chairs  0.45  0.66  Pharmacy directors  -1.59  P & T committee chairs  r  2 s  <%)  A d o p t i o n by a leading hospital  Drug-use  D r u g toxicity  Pharmacy request for a new drug Pharmacy directors P & T committee chairs Hospital P & T committee Pharmacy directors P & T committee chairs  Median influence as rated on a scale of 0-4 (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Note. z b s = observed z statistic, p = probability, r = Spearman correlation 0  s  coefficient, m e d = median rating for current drug formulary approval process, medf c  = median rating for future drug formulary approval process. *p<0.05.  71 C H A P T E R FIVE  DISCUSSION  The results serve as a gauge of the current and predicted state of the drug formulary approval process in responding Canadian hospitals. The effect of the disparate response rates observed between pharmacy directors (63.3%) and P & T committee chairs (10.9%) must be considered when interpreting the results. The significance of the mail survey, with consideration of its source, may have contributed to a general lack of interest in completing the survey on the part of physician P & T committee chairs. Other considerations such as time constraints and lack of economic incentive may have also contributed to a low response rate on the part of physician P & T committee chairs. W h e n director respondents are compared to the universe of Canadian hospitals by geographic area, respondents from Ontario (43.5%) appear disproportionately i n the sample, while those from the Atlantic provinces are under-represented. O f the 328 hospitals sampled 46.3% were located in Ontario while 12.2% were located in the Atlantic provinces. The response rate of 63.3% for pharmacy directors was lower than the required rate of 86% to ensure generalizability of findings to all 1054 Canadian hospitals. Thus, generalizability of findings is limited.  ,  W h e n P & T committee chair respondents are compared to the universe of Canadian hospitals by geographic area, respondents from British Columbia (23.4%) appear disproportionately in the sample. Zero response rates were obtained for Manitoba, N e w Brunswick, Prince Edward Island, Newfoundland, and the Northwest Territories. Hence, generalizability of findings is also limited for P & T committee chairs.  72 The Pharmacy and Therapeutics committee A l l 193 pharmacy director respondents stated that their hospital had a P & T committee in place. Thus, the basic framework for a rational approach to drug therapy appears to be present in these Canadian hospitals. The pharmacy director was not represented on three of these P & T committees, indicating a strong belief among remaining respondents that the pharmacy director must be present on a P & T committee. In addition to the usual complement of nurses, physicians, medical specialists, and other pharmacists, 68.9% of responding committees also had representation from senior hospital administration. Stolar (1984) emphasizes that the P & T committee should be a committee of the hospital, not of the medical staff. Pierpaoli (1993) suggests that health care providers must realize that resources for new drug therapies are not the exclusive domain of a pharmacy department. Rather, it is a hospital-wide priority that demands the collective wisdom of the professional staff as well as administration. The diverse makeup of P & T committee appointed members-approximately twelve reported different staff titles with an additional 54.4% reported under the category of "other" suggests that Canadian hospital P & T committees have evolved into broad multidisciplinary committees. P & T committee organizational aspects such as the number of people appointed to a P & T committee (usually nine), the staff title of the P & T committee chair (usually a physician) and the P & T committee secretary (usually a pharmacy director), the P & T committee reporting relationship within a hospital (usually to M A C ) , and the frequency of P & T committee meetings (usually six times a year) were within published practices and standards (ASHP, 1984; Plumridge et al., 1984; A S H P , 1986b; Rascati, 1992; Plumridge et al., 1993). The results indicate that pharmacists serve as secretaries on 79.8% of the P & T committees.  This is important because observers believe that the pharmacy director  should serve as secretary, with responsibility for agenda preparation (Plumridge et.  73 al, 1993). The secretary and P & T committee chair, together with drug information pharmacists, if available, are the key personnel involved in agenda preparation and compilation of information for each meeting.  Because much of the leadership of  the P & T committee emanates from the secretary and P & T committee chair, these positions appear are critical for P & T committee success. A n effective hospital formulary system depends on an aggressive and concerned P & T committee. The director of pharmacy, as the committee secretary, must assume responsibility for organizing the activities of the committee. If the secretary is effective in this endeavour, the P & T committee can be decisive and will be willing to implement and support its decisions (Phelps & Godwin, 1978). The relatively strong importance of P & T committee responsibilities such as drug formulary approval, drug-use review, monitoring drug costs, and prescribing policies were similar to published findings (Plumridge et. al, 1993). These responsibilities reflect an important commitment to cost-effective and rational druguse, which is the basis for the existence of a P & T committee. The results indicate that responsibilities of a secondary nature such as purchasing decisions, and drug handling/disposal were not important for the P & T committee.  Abramowitz (1984a), Arrington and Summerfield (1986), and  H y n n i m a n (1992) maintain that P & T committees must play an important role in the actual purchasing process, although this was not observed in the sample. A m o n g the pharmacy director respondents, it was observed that 91.7% recorded reasons for P & T committee drug adoption and rejection, while 5.7% stated that reasons were not recorded. The recording of P & T committee minutes acts as a self-evaluation instrument and is crucial for a number of reasons (Quigley & Brown, 1981). It allows P & T committees to conduct retrospective studies to determine how effective it has been at evaluating and selecting drugs for formulary inclusion. It may uncover the reasons why a particular P & T committee may not be functioning effectively, such as lack of proper drug reviews or a few members  74 dominating the majority. Finally, the recording of such information w o u l d enable a large-scale retrospective study to be conducted. Hence more definitive statements could be made concerning the success of the P & T committee and the formulary system in the promotion of rational drug therapy. The results suggest that the majority of responding Canadian hospitals recognize the basic importance of recording P & T committee minutes. W i t h regard to the future, the question was asked as to which new disciplinary area might be added to the P & T committee in the next five to ten years. A small percentage of pharmacy directors (8%) and P & T committee chairs (8-12%) felt that an ethicist, a patient advocate, or an economist could be appointed to serve on a P & T committee in the next five to ten years. W h y an ethicist?  The dilemma  involved with the approval of costly biotechnology drugs in hospitals with limited resources requires critical thinking (Huber, 1989). McLean and Tierney (1994) state, "New drugs which might lead to economies to the health care system but not to the hospital itself, e.g., by decreasing length of stay, create a confusing ethical versus budget balancing exercise" (p. 179). A n ethicist could offer advice to help P & T committees in their deliberations concerning patients and their rights, both from an ethical and societal perspective. The use of an ethicist for new drug formulary approval decisions may still be premature as very few hospitals indicated that an ethicist was currently appointed to the P & T committee. W h y a patient advocate? The attention devoted to hospitalized patients based on evidence from the health management literature may require a support person to ensure that the rights of patients are not being ignored or overlooked. Several hospitals indicated that patient care advocates were appointed to the P & T committee. W h y an economist? There appears to be a need for those with expertise in understanding and interpreting various pharmacoeconomic analyses that promise to be an integral part of a P & T committee's formal evaluation process for new drugs.  75 A s such it is believed that many hospitals are still trying to grasp the relatively new area of pharmacoeconomic evaluations.  A n economist, trained in economic  principles and preferably decision analysis, could possibly offer useful advice to P & T committees in order to facilitate the use of pharmacoeconomic evaluations in the drug formulary approval process. Responses by pharmacy directors, and to a lesser degree P & T committee chairs, suggest that the structure and function of the P & T committees at these select Canadian hospitals appear to be comparable to that of other P & T committees as reported in the literature. Results also indicate that the P & T committee structure and function is not expected to significantly change in the next five to ten years. What about one of the primary products of its work, the hospital drug formulary? The drug formulary The prevalence and use of formularies was found to be widespread among Canadian hospitals surveyed, as 98.4% of respondents indicated that a formulary was in place. Regardless of hospital bed size many respondents (53.9%) stated there was tight to very tight control over the drug formulary in the hospital. P & T committee chairs (68.6%) expressed similar viewpoints.  Without a tight formulary,  many cost-containment methods cannot be attempted while others are made more difficult to implement (Abramowitz, 1984b). Furthermore, those with weak formularies must improve them by reducing the number of products and controlling the use of non-formulary agents. Strategies for establishing strong drug formularies have been clearly outlined in the literature (Abramowitz, 1984b). M a n y respondents (83.4%) indicated that their hospital's drug formulary was updated within the past two years, reflecting an ongoing interest in its maintenance. This was far better than experience elsewhere (43.0% as reported by Plumridge et. al, 1984) indicating that Canadian P & T committees place a high priority on maintaining a current formulary. In general, formulary functions were similar to those found in the literature (Rascati, 1992).  76 The success of a locally developed hospital formulary depends on the degree of consensus among doctors to follow the recommendations.  This in turn usually  depends on the extent to which local decision makers have been concerned with producing the recommended list of drugs. The recommendations must have the support of local doctors, not only in hospitals but also in surrounding general practices. One very important consequence of the circulation of a formulary is that it should lead to a uniformity of drug use throughout a district. This will simplify the continuation of drug treatment when patients are admitted to hospital (Turner, 1984). Continuous feedback, intervention, and review are required if a formulary is to continue to achieve its objectives of improving drug-use and reducing costs (Feely, Chan, Cocoman, Mulpeter & O'Connor, 1990). Other formulary models have been suggested. These include a national formulary developed by the government, a national formulary developed by a consortium of professional groups, a formulary developed by regional expert committees, or the modification of locally based formularies (Rucker & Visconti, 1979). The value of developing a national formulary for Canadian hospitals is difficult to ascertain due to the many barriers associated with this approach. One major barrier is geographical differences in microorganism flora resulting in different susceptibility patterns at different institutions.  This would therefore  require different antibiotics on formulary depending on the type of microorganism present (Taylor, 1994). Differing physician practices and patient mix may also impede attempts at formulary standardization. A n d although a national formulary developed by professional groups seems reasonable, coordination and controls that will maintain the integrity of the final selection process serve as limiting factors. Another strategy for improving formulary effectiveness may be found in the development of regional centers to provide technical assistance to local P & T committees.  These centers would monitor studies dealing with risks and benefits  related to drug use, assess their comparative significance, prepare drug monographs  77 upon request, and evaluate formularies voluntarily submitted for review (Rucker, 1981). Although conceivable, the question of who will pay for their existence and maintenance still needs to be answered. Rucker (1982) suggests that in order to strengthen local formulary performance, it seems essential that impediments to objective decision-making be overcome. General impediments cited are: the paucity of scientific studies stressing comparative drug evaluation, protracted diversity of opinions concerning the therapeutic properties of new drugs, unnecessary complexity and redundancy in drug nomenclature, the continued marketing and promotion of chemical agents whose therapeutic credentials are questionable on either an absolute or relative basis, sporadic or nonexistent data from post-marketing surveillance, and persistent efforts o n the part of certain manufacturers to influence the deliberations of P & T committees.  Rucker (1982) states the following:  Professional associations, third-party programs, and government agencies seem more impotent than active in pursuing problems of this type.  When  such impediments reside beyond the purview and influence of individual practitioners, sub-optimal results seem almost guaranteed, (p. 461) Impediments from the local level include: reluctance of administrators and practitioners to support quality assurance programs, pharmacists and physicians who exhibit more ignorance than familiarity with the formulary concept, the tendency of P & T committees to allow subjective elements to enter their appraisal of new drugs, lack of status accorded to professionals who serve on a P & T committee, record keeping procedures which make it difficult to determine reasons for drug adoption, and the common absence of pharmacy department resources sufficient to maximize the department's contribution to the needs of the hospital. The effect of change in hospital pharmacy has not gone unnoticed. Hepler (1993) offers the following observations with respect to change in hospital pharmacy:  78 It occurs in response to major forces beyond pharmacy's control, it probably will continue for the foreseeable future, and it is happening so rapidly that pharmacists in practice today retain divergent ideas, (p. 64) The following discussion describes one situation of change, specifically the influence of the various items on the current and future drug formulary approval process. Items are considered in the context of the formulary approval of breakthrough drugs, first-line drugs, or novel therapeutic drugs. The future was defined as a period of time over the next five to ten years. The extent to which various items influence the future drug formulary approval process in different Canadian hospitals is difficult to predict, although it is likely that these items will exert some degree of influence. Pharmacy directors: The drug formulary approval process Overall, pharmacy directors rated the organizational item of the hospital P & T committee as the item that most strongly influences the current drug formulary approval process. This item was uniformly rated the strongest by all respondents. N e w drug approvals in Canadian hospitals must be evaluated by hospital P & T committees.  The data affirms the very strong influence of a hospital's P & T  committee on the drug formulary approval process.  This influence is not expected  to significantly change in the next five to ten years as universally rated by all respondents.  Thus, it appears that the principal mechanism for the evaluation of  new drugs in hospitals will continue to be the P & T committee. T o what degree do pharmacy directors consider drug cost, efficacy, toxicity, and use as influencing the current drug formulary approval process?  Responding  directors indicated that all four items have a strong influence. Only drug cost and efficacy are predicted to become significantly more influential in the future. It is likely that as new, more efficacious drugs are brought to market, they will carry higher prices than the previous generation of drugs. This observation is strengthened by the fact that at one Canadian hospital (McLean & Tierney, 1994):  79 D r u g budgets are not increasing because of inflationary pressures, but rather because of new drugs on the market, usually more expensive than older agents, and some new agents which had no predecessors and broadened the pharmacotherapy spectrum. Moreover, recent developments in drug research had yielded agents which were bio-engineered and were extremely expensive, e.g., the colony growth factors, (p. 177) The items of drug toxicity and drug-use are important considerations when evaluating the attributes of any new drug. The importance of a drug's toxicity and use should be consistent over time. Hence no significant change is expected for the future drug formulary approval process. The results suggest that drug toxicity and drug-use will continue to have a strong to very strong influence on the drug formulary approval process. The formulary system was rated as having a strong influence for the current drug formulary approval process. For the future it was expected that this item will be significantly stronger. This reflects the importance and reliance of formulary systems as a means of controlling drug costs and use. The six economic items of cost controls, financial management, health care funding, new drug acquisition cost, pharmacoeconomic evaluations, and treatment cost versus alternatives are expected to have a strong to very strong influence on the future drug formulary approval process as reported universally by responding hospitals.  Cost controls currently have a strong influence on the drug formulary  approval process. This reflects a very strong belief in the importance of cost controls as a method of dealing with the prices of new drugs. The importance of cost controls has been described in the literature (Abramowitz, 1984b; Gagnon & Osterhaus, 1987). Hospitals previously reluctant to impose any controls whatsoever on drugs appear to be considering their options (Lumsdon, 1992). The use of ten different types of cost controls at the Ottawa General Hospital contributed to a 5% to 10% drug budget reduction without  80 alterations in patient care (McLean & Tierney, 1994). A s pharmacy's influence over the entire drug-use process expands, the methods for cost control are increased ( A S H P , 1992). Cost control can be enhanced by the use of alternative therapy, b i d purchasing, and prevention of inventory duplication (Plumridge et al., 1984), functions that the pharmacy directors surveyed ranked as the least important. Abramowitz (1984b) maintains that pharmacists should recognize that they are in a unique position to contain drug costs in hospitals since they combine unique expertise in purchasing, drug distribution, and therapeutics. Hospital administrators should recognize that hospital pharmacists are well suited and strategically positioned to be a part of the solution to the problems of rising drug costs and the increasing complexity of therapy (Pierpaoli, 1993). Therefore pharmacists should either engage in more active roles or be granted more active roles i n formulary management and P & T committee activities. Although the six economic items are expected to have strong to very strong influence on the future drug formulary approval process, there appears to be a discrepancy in the results. Only 8% of responding pharmacy directors indicated that an economist would be expected to be appointed to the P & T committee i n the future.  Do the majority of pharmacy directors believe that economic influences,  which will be more influential in the future, are to be handled without any assistance? The anomaly here is that Canadian directors foreshadow greater financial controls being imposed and yet do not believe that persons with financial expertise will be appointed to the P & T committee to a large extent. More than likely pharmacy directors believe that they are capable enough to handle future economic influences without external assistance. Further discussion is required on the subject of cost controls. Theoretically the concept of cost controls is beneficial to a hospital, as these controls help to moderate prices charged by suppliers. But at what resulting consequence must these  81 cost controls exact? Realistically, it would not be economical to spend several hundred thousand dollars in order to save a few thousand dollars on drug costs. Cost controls must be viewed with a rational and open perspective.  Although the  price of certain drug classes may appear to be exorbitantly high, when placed in proper perspective the difference is not as dramatic. For example, certain high cost drugs require minimal therapeutic monitoring and ancillary tests than do cheaper alternatives that may require expensive monitoring. Drug costs represent only 5% to 6% of a hospital's total budget. What must a hospital pay to achieve a minimal percentage reduction in drug costs? Specifically, the jeopardizing of patient care or the inadvertent creation of a "formulary-police" state may be the result of instituting cost controls that are too restrictive in nature. "Thus, the goal of formulary management should not necessarily be to decrease the drug budget alone but to also decrease the overall hospital costs and costs to society associated with specific diseases and conditions" (Crane, 1993, p.866). It is also worthwhile to note that those practicing in an health care organization have a vested interest in the hospital. Controlling the practices of a particular group, i.e. physicians, may lead to untoward reactions that may place strains on otherwise healthy professional relationships. According to Arrington and Summerfield (1986) controls on drug utilization present the greatest opportunity for savings but it is an opportunity which is perhaps the most complex.  Controlling drug utilization sometimes prevents the  use.of new drugs, whereas other techniques involve using new drugs more efficiently.  The key element in this process is the front-line physician. Generally  recognized items influencing a physician's drug-ordering behaviour include drug company marketing techniques, influential physicians, restrictive drug-ordering policies, or hospital based counter-detailing. The hospital setting is of significant importance in how these items affect prescribing. Furthermore, if the hospital is  82 also a research institution, then new and developing drug technologies will be of significant influence. In an editorial on drug costs, Somberg (1992), a physician, argues that the profits of pharmaceutical companies are substantial. The risks on capital are great and investment in drug research and development are higher than for any other industry. Developing price controls and new drug pricing policies will undermine the innovativeness of the pharmaceutical industry as a whole.  Rather, the best  approach lies in judicious pricing policies by industry, since some of the most profitable companies with the strongest research and development policies are the most sensible at pricing. Somberg concludes by stating that restrictions on the pharmaceutical industry may in fact be counterproductive to solving the problem of escalating health care costs. Eisenberg and Williams (1981) state that in the U.S.: Efforts to control medical costs have focused on physicians, whose decisions generate more than three quarters of all costs, and the hospital, where more than half of all health care dollars are spent,  (p. 2195)  Containing pharmacy expenses continues to be a priority for pharmacy directors. In the current economic climate many hospitals have established drug cost controls that would not have been acceptable to medical staffs a few years ago (Stolar, 1985). Pierpaoli (1993) and Zilz (1993) suggest that new drug proposals may have to be subject to the same financial scrutiny as capital expenses and new program initiatives. The results indicate that hospitals are serious about controlling new drug expenditures.  Implications for the pharmaceutical industry are  important. A s greater control is exerted over prescribing throughout the health care system, companies will be forced to become more competitive for a limited number of available health care dollars. Associated with cost controls is financial management which is also expected to have a significantly stronger influence on the future drug formulary approval  83 process.  Articles on financial management of benefit to practicing pharmacy  directors are prevalent in the pharmacy literature. It is anticipated that hospital finance departments will take more active roles in the financial management of hospital drug formularies. The pharmacy department plays an important role in response to financial pressures on the hospital. As Murdoch (1988) observes, "Pharmacists have an opportunity to make the transition from being 'formulary policeman' to a new role as trusted and valued contributors to management efforts in containing hospital operating costs" (p. 1). Health care funding is expected to play a significantly very strong role in the future. Global funding for hospitals, as determined by provincial government health care budgets, is sometimes a contentious issue. Hospitals sometimes are faced with the prospect of decreased funding in the face of a tougher economic climate. Economic pressures have recently forced Canadian provincial governments to curtail many programs and to limit health care budgets, with such measures accentuating the emphasis on cost containment at Canadian hospitals (Treleaven & Einarson, 1990). Hospitals must prepare well in advance for anticipated shortfalls of money and develop ways to manage through these difficult periods. With respect to new drug acquisition costs, Grossman (1992) questions how to assign prices for the next generation of new drugs. H e suggests that if a measurable improvement in the quality of life does not occur after an established drug is replaced with a newer drug, then the price of the new drug should be set at the same price level as that of the established drug. This suggestion seems reasonable. The results suggest that pharmacy directors believe new drug acquisition costs will have a significant influence on the future drug formulary approval process.  H o w new  drugs will be priced in the future remains to be ascertained. Napier and H o l z m a n (1992) point out that the hospital types with the highest non-salary pharmacy costs, teaching hospitals and hospitals with more than 500  84 beds, are more likely to use expensive therapies. Also, large hospitals are likely to maintain higher inventory levels to accommodate decentralized services. However, there will still be an important place for new drugs that provide a higher quality of care but at an increased cost (Drummond, Smith & Wells, 1988). Antimicrobials account for the greatest drug expenditure category in hospitals. The issue of new drug cost must be determined at each institution with consideration given to variations in acquisition and administration costs as well as coincident costs such as serum concentration determinations (DiPiro & Steele, 1987). For many antimicrobial drugs introduced in the past few years, lower acquisition costs have resulted in savings only after all components of the cost were considered. Therefore, P & T committees should focus solely on the issues of primary importance of efficacy, safety, and cost when selecting antimicrobial drugs. In identifying areas for potential cost reductions, it is imperative that pharmacy directors evaluate the benefits and costs of the entire drug-use process. The drug-use process as defined by ASFFP (1992c) is defined as a multiple step continuum that begins with the perception of a need for a drug and ends with an evaluation of the drug's effectiveness in the patient. The ultimate responsibility of the pharmacist is to ensure the safe and appropriate use of drugs at all points along this continuum. To this end A S H P (1992c) has formulated guidelines to help key decision makers with cost containment strategies for drug costs. Perhaps as P & T committees become increasingly familiar with pharmacoeconomic evaluations, there will be a greater reliance on these evaluations in the formulary decisionmaking process. For P & T committees it is important to recognize that drugs have played significant roles in declining death rates for poliomyelitis, tuberculosis, dysentery, meningitis, syphilis, and many other diseases. In addition, improvements in life expectancy and quality of life have occurred with the introduction of new drugs to treat various infections and health conditions such as diabetes mellitus, and  85 cardiovascular disease (Draugalis et al., 1989). Because prices of pharmaceuticals serve as easy targets, P & T committees may simply choose to approve less costly alternative drugs in an attempt to significantly save money. This strategy in the long run may not be viable. Furthermore, the literature has demonstrated that the least expensive alternative is not always the most economical. It will be important in the future to consider the overall impact of a new drug, through a pharmacoeconomic analysis, rather than consider drug costs alone.  In some  instances P & T committees may need to commission their o w n pharmacoeconomic and outcome studies based on published methodologies (Schrogie & Nash, 1994). In order to strike the most favorable balance between health care benefits and costs, it is necessary to subject new health care technologies (such as new drugs) to rigorous clinical and economic scrutiny before they become widely disseminated within the health care system (Guyatt et al., 1986). The expected increase in the quantity and quality of economic evaluations will require a commensurate increase in the training of users to understand and interpret the results of these evaluations appropriately. Pharmacoeconomic evaluations are expected to become significantly influential in the future.  Potential users include pharmaceutical manufacturers,  provincial formulary committees (which should look from the perspective of both the Ministry of Health and society), and hospital P & T committees.  Guidelines for  simplifying the technical nuances of the various methods of analysis are described in the literature (Draugalis, 1994; Sanchez & Lee, 1994), as well as the incorporation of pharmacoeconomic principles into hospital pharmacy practice (Gouveia & Bungay, 1994). It is essential that P & T committees appreciate that pharmacoeconomic evaluations have many uses. Reports can influence the following options in any drug formulary (Hatoum & Freeman, 1994): (a) inclusion or exclusion of newly introduced drugs, (b) inclusion, with restrictions, of newly introduced drugs, (c) removal of included drug therapies from the formulary, and (d) specific prescribing  86 practices within a hospital. It has been observed that it is highly embarrassing for pharmacy directors, who usually serve on a P & T committee, to admit to hospital administrators that they either are not familiar with or know how to meaningfully interpret the various pharmacoeconomic studies (Draugalis, 1994). It is doubtful that many pharmacy directors and P & T committees currently consider comprehensive pharmacoeconomic analyses in the drug formulary approval process. Only recently have detailed methods specific for hospital pharmacists been introduced in "the literature (Sanchez, 1994). The item of treatment costs versus alternatives is expected to have a very strong influence on the future drug formulary approval process.  P & T committees  will be faced with considering all the alternatives versus the treatment costs of a new drug under consideration. Drug companies may have to routinely demonstrate the relative economic efficiency of a new drug in terms of costs and other attributes versus other treatment alternatives. The professional items of outcome measurements, pharmaceutical care, pharmacy request for a new drug, physician request for a new drug, pharmacy drug evaluation reports, professional journal articles, and quality assurance were tested. Outcome measurements, pharmaceutical care, physician request for a new drug, pharmacy drug evaluation reports, and quality assurance were predicted to be significantly more influential in the future. Outcome measurements currently have a strong influence on the drug formulary approval process. It is expected that they will have a significantly stronger influence on the future drug formulary approval process.  W i t h respect to  outcome measurements, one reward to be gained from conducting drug therapy outcome analysis is that resulting formularies focus on promoting quality rather than simply being a tool to cut costs. New therapies will be chosen by their ability to prevent, control, or cure disease; eliminate or reduce symptoms; improve quality of life; decrease days lost from school or work; and provide safe, effective, rational, and  87 cost-effective treatment (Veal, 1993). Hospitals must attain an evolutionary point where all aspects of care are included and need to be presented and analyzed before a formulary decision is made. Pharmaceutical care was rated as having a moderate influence on the current drug formulary approval process, with it rising to a strong influence in the future. Although several large hospitals stated that they provide decentralized pharmacy clinical services (Level IV) to the majority of beds in the hospitals, larger hospitals tended to rate the influence of pharmaceutical care lower than that of smaller hospitals. There may exist a greater number of barriers to the provision of pharmaceutical care in larger hospitals as opposed to smaller hospitals. The latter group may have less bureaucratic barriers to contend with. The influence of requests by a pharmacy department for a new drug are not expected to significantly change in the future. However, it is expected that requests by physicians will significantly change in the future. Interestingly, it is expected that the requests made by physicians will have a weaker influence on the future drug formulary approval process. This was found to be universal among all the responding hospitals and may be attributable to increasing restrictions placed on the activities of pharmaceutical firms and their detailing to physicians. Shulkin (1993) observes that drug companies routinely give drug samples to physicians to give to their patients. Physicians believe that this practice saves their patients some money. These samples are used by pharmaceutical manufacturers to introduce new drugs that are often more costly than existing alternatives.  Further,  Shulkin maintains that no single approach to gaining physician involvement in pharmaceutical cost controls is likely to be effective.  Programs that offer a  combination of several methods, including the involvement of physician specialists in prescribing decisions, ongoing drug-use review, and educational efforts, will be the most likely to succeed.  88 Pharmacy drug evaluation reports are an excellent source of information for P & T committees evaluating the aspects of a new drug. It is expected that this item will significantly increase in influence for the future drug formulary approval process.  The literature suggests that well documented drug evaluation reports  should be prepared each time a drug is considered for formulary inclusion (Abramowitz, 1984b). The report should include a critical evaluation of clinical studies, since without a critical evaluation all new drugs will look advantageous to use. A literature search should be performed and the report should contain a cost comparison that identifies both the drug and non-drug costs associated with the use of similar formulary drugs. Lastly, the report should include the pharmacy department's recommendation for formulary inclusion, including suggested restrictions on prescribing. A s new drugs become available, P & T committees will rely increasingly on reports prepared by pharmacy departments to help them critically evaluate new drugs for formulary addition. Furthermore, pharmacy departments that prepare drug evaluation reports for P & T committees have the potential to influence formulary decisions (Majercik, M a y , Longe & Johnson, 1985). Thus, it appears that pharmacy directors realize the value of these reports and their potential to influence P & T committee decisions. Biotechnology promises to force pharmacists to play a pivotal role in decisions involving new biotechnological drugs (Stewart, 1989; Taylor, 1993). D r u g evaluation reports prepared by competent pharmacists with expertise in biotechnology drugs will be critical, and as more drugs become available, pharmacists will have to devote more time to their evaluation. Professional journal articles are used in the formulary decision-making process almost on a routine basis. At present they have a strong influence.  This  influence is not expected to significantly change in the future. A thorough, critical review of the pharmaceutical and medical literature is necessary for evaluating new  89 drugs proposed for formulary inclusion (ASHP, 1988). Results suggest that this is currently being done. Quality assurance holds a moderate current influence.  It is expected that this  item will have a strong influence i n the future. The patient is the ultimate consumer and should become actively involved in the quality assurance process (Nold, 1992). N o l d further states that quality assurance has received considerable attention from hospitals, pharmacists, and physicians since 1991. Those hospitals implementing effective quality assurance programs will fare better as health care systems are being restructured. A s pharmaceutical care becomes the accepted duty of the pharmacist, the need for pharmacists to obtain clinical privileges in the hospital setting will increase sharply (Hutchison, Wolfe, Padilla & Forrester, 1992). The J C A H O (1992) defines clinical privileges as "Permission to provide medical or other patient care services in the granting institution, within well-defined limits, based on the individual's professional license and his experience, competence, ability, and judgement" (p. 55). Hutchison et al. (1992) found that a clinical privileges program at a major medical center offers pharmacists the opportunity to provide pharmaceutical care, although a quality assurance plan is still essential for evaluation of patient care. A t first thought, the idea that pharmacists, through pharmaceutical care, should take responsibility for patient outcomes seems to conflict with the long held dictum that the physician has final responsibility over the patient.  However, there  is evidence that this is not the case (Strand, 1990; Hepler, 1991). Rather, pharmacists working in greater cooperation with physicians can achieve a higher level of control over a patient's outcome.  What remains to be seen is whether the pharmaceutical  care concept can be sold to other health care personnel including physicians, senior hospital administrators, governments, and patients. The following four organizational items were tested: adoption of a new drug by a leading hospital, computers/information systems, hospital assessment  90 committee, and technology in drug development.  Computers/information systems,  hospital assessment committee, and technology in drug development were predicted to be significantly more influential in the future. H a v i n g a lesser degree of influence than hospital P & T committees, hospital assessment committees are expected to play a strong role in the future drug formulary approval process. It is possible that new drugs may be treated like capital acquisitions in larger hospitals. It has been demonstrated that the development of a local formulary by a joint hospital assessment committee has resulted i n improved medical education for rotating physicians, reduced costs, and reduced drug company pressures (North, 1993). Smaller hospitals rated the adoption by a leading hospital item as having greater importance than larger hospitals. It is likely that larger hospitals view themselves as leading hospitals or innovator-types already, while smaller hospitals generally view themselves as early to late adopter-types who observe the behaviour of innovator-type hospitals. In this respect, adoption behaviour is not expected to significantly change in the future. The computers/information systems item was rated as having a weak influence.  However, in the future it is believed that this item will increase to a  moderate influence. It is expected that a variety of new linkages between pharmacy computer systems and databases both inside and outside the hospital will soon become standard (Nold, 1992). As management information systems and hospitalwide information systems are being implemented, usually in larger hospitals first, hospitals will utilize these systems for various formulary management purposes. The nursing literature has related the use of Executive Information Systems (EIS), similar to decision support systems. "EISs are becoming more prevalent in health care, even though they are coming to hospitals a little later than they d i d to other industries" (Simpson, 1992, p. 19). "It is reasonable that by the year 2000 computers  91 will be more integrated into the health care delivery process as they assist clinicians make decisions" (Dasta, 1992, p. 320). The diffusion of computer technology among health care organizations is expected to significantly increase in the future. This is as more applications of artificial intelligence and expert systems are tested and developed for health care as well as for hospital pharmacy. The lag time in which new applications are developed should decrease in the future as information systems support the evaluation of new drugs (Austin, 1989). However, a substantial effort is necessary to standardize computer related processes across hospitals in order to deal with important health concerns (Grasela et al., 1993). Dasta (1992) offers the following perspective as to where computers and their application to health care is heading: A s opposed to humans who may forget information, the computer will "remember" what it is told. Expert systems of this type must operate in collaboration with a human expert who can provide an important link between the potentially myopic considerations of the computer and the reality of the clinical environment. However, as systems become more "smarter", they can assist with much of the routine, nonjudgemental aspects of clinical pharmacy. For example, a properly designed pharmacy expert system should be able to handle routine tablet and capsule identification, respond to basic drug information requests, and produce intelligent literature searches with interpretive information beyond just a list of articles on the topic, (p. 319) The effect of technology in drug development cannot be overlooked. A s new drugs are introduced, it is expected that technology in drug development, such as in biotechnology, will engender new types of drugs and drug delivery systems directly influencing the future drug formulary approval process.  The results suggest that  technology in drug development will significantly influence the future drug  92 formulary approval process. Pierpaoli (1993) suggests that P & T committees must be equipped to monitor emerging new drugs as far in advance as possible. The political items of government assessment agencies, provincial formulary, and provincial P & T committee were tested. A l l three political items were predicted to be significantly more influential in the future. The data suggests that items of a political nature have a weak to moderate influence on the current drug formulary approval process.  The rather large  standard deviations indicate that these items were not universally rated among all respondents.  One possible reason for this is regionalization. For example, in British  Columbia, hospitals are divided according to different regional boundaries. Funding to hospitals is dependent on the region in which the hospital is located and not all hospitals receive equal funding. Consequently, the degree to which respondents rated the influence of various political items may be dependent on the funding they receive from their respective provincial governments. It does appear that government agencies, a provincial formulary, and a provincial P & T committee will have a moderate to strong influence on the future drug formulary approval process.  These items require regional, provincial or  national efforts which are not yet available (McLean & Tierney, 1994). A survey of community pharmacists (Canadian Pharmacy Services, 1992) found that 71% of pharmacists surveyed expected increasing pressure by government to control or reduce health care costs, which would have a strong impact on the future practice of pharmacy. One way government may exert control over new drugs is through the use of economic analyses. The use of pharmacoeconomic analyses as a criterion for government regulatory approval requires a substantial shift in the federal government's approach to drug regulation. The Patented Medicines Prices Review Board serves as a regulator of prices of newly approved drugs. However, there is no direct government effort to directly slow or limit the introduction of new drugs in Canada.  93 A n evaluation by the U.S. Office of Technology Assessment (1980) found two hypothetical positive effects of incorporating economic analyses into the government drug approval process.  First, manufacturers could formally  incorporate analyses such as cost-effectiveness, based on societal values, into their research, development, and marketing strategies. If governments used criteria such as reduced treatment costs, improved levels of health, and improved efficiency in disease prevention or treatment, then manufacturers could potentially develop new products or seek new markets where existing treatment or prevention measures are ineffective or inefficient.  This would theoretically result in the development of  cost-effective drugs. Second, if governments were able to accurately assess the costeffectiveness of a new drug, reduced expenditures may follow because ineffective drugs would be kept off the market entirely. By evaluating the cost-effectiveness of drugs in the market approval process, governments would be assessing a new drug very early i n the diffusion process. The U.S. Office of Technology Assessment (1980) found dissenting arguments put forth by consumer advocates, government employees, and pharmaceutical industry representatives for the argument that pharmacoeconomic analyses are appropriate to use in government new drug approval processes. First, the market approval process may be too early in the life of a new drug to evaluate its costeffectiveness. Sometimes the total benefits, costs, risks, and cost-effectiveness of new drugs that are used in the treatment of more than one medical problem may not be known for several years after the product's introduction (DiPiro & Steele, 1987). Second, the calculation of costs needed to assess the cost-effectiveness of a new drug is difficult to ascertain, because prices charged are dynamic and can vary substantially among geographical regions. Third, the use of economic analyses to evaluate new drugs would require extensive resources and substantial time.  Would  governments be prepared to accept this challenge? Lastly, by using an economic analysis as a criterion for the market approval process, governments may be  94 extending their role beyond the scope of responsibility. Usually choices based on economic criteria are left to be made by consumers, health care practitioners, hospital administrators, and third-party payers after a product has been marketed. Anderson et a l , (1990) provide a comprehensive examination of the role of government in the Canadian drug market. They suggest the following mandatory responsibilities of government:  (a) the health status of the population should be the  paramount concern of government when it is evaluating its role in the drug marketplace, (b) resources are limited and governments must make every effort to allocate these resources wisely, and (c) equitable access to effective health care services is a fundamental aspect of government's involvement i n health care. If feasibility considerations are overcome, government assessment agencies may be created and called upon to evaluate rapidly emerging new drugs. The ability of Canadian provinces to create and maintain provincial formularies and provincial P & T committees is still too early to predict. The societal items of drug company marketing, patient request for a new drug, and patient rights were tested. Drug company marketing was predicted to be significantly less influential i n the future, while the remaining two items were predicted to be significantly more influential in the future. It was assumed that respondents would complete the survey to the best of their ability in an honest fashion as possible. However, it must be acknowledged that respondents may have been unwilling to honestly accept or admit the degree to which they are influenced by the marketing efforts of drug companies.  The fact that  drug companies continually spend millions and millions of dollars on advertising must be recognized. Therefore caution is needed when interpreting these results. Directors rated drug company marketing as having a weak influence.  This  may reflect a concerted effort among hospitals to keep drug company marketing to an absolute minimum. A s for the future, it was uniformly stated that the influence of drug company marketing on the drug formulary approval process w o u l d  95 significantly decrease.  This is perhaps attributable to an even greater effort to limit  the activities of drug companies in hospitals, as well as any potential drug company activities that may influence physician prescribing behaviour towards new drugs for formulary consideration. The prospect of individual patients requesting a new drug for formulary approval seems rather remote (as suggested by the results), although the recognition of the rights of patients in a hospital is expected to become more important i n the future. This may take the form of a patient advocate or representative in the hospital who oversees, or attends to the concerns of, patients. A s alluded to earlier, pharmacy is undergoing a fundamental change in its mission-to a practice that promises to take responsibility for the outcome of drug therapy, pharmaceutical care. Advocates view this change as an opportunity to fill a societal need, thus bringing society and patients to the attention of health care practitioners (Schwartz, 1992). After all, changes from the eighties to the nineties display a shift from care for an inpatient episode of illness to care for the total episode of illness, regardless of the locus of care (Grossman, 1992). With respect to patient rights, the movement toward patient-centered care promotes the idea of forming teams to deal with the complex issues surrounding the use of biotechnology drugs (Taylor, 1993). For those conducting pharmacoeconomic analyses, the most appropriate viewpoint is that of society. The economic climate of the nineties, and likely the early part of the next century, will create the requirement that all participants i n the health care industry-the professions, governments, third-party payers, and patients-carefully assess the costs and benefits associated with new drugs and determine what society is prepared to pay (Reid, 1994). The legal item of liability of a new drug was tested. The importance of the liability potential of a new drug was felt to significantly increase in the future. Pierpaoli (1993) maintains that P & T committees must assume fiduciary  96 responsibility regarding new drugs. In so doing, they should act in the best interests of patients and the institution. The reaction of the pharmaceutical industry to the exclusion of new drugs from formularies should be considered (Plumridge et al., 1984). Threats of legal action, the organization of petitions, the distribution of information contradicting formulary decisions, and even the questioning of the integrity of P & T committees have been reported (Talley, 1978). Consequently, for fear of litigation, hospitals must consider the legal implications and possible repercussions of all new drugs forthcoming. For pharmacy directors 23 Of 28 items differed significantly between the current and future drug formulary approval process, as measured by the use of a Wilcoxon matched-pairs signed-rank test. Of these 23 items, 21 were predicted to be significantly more influential in the future. "Drug company marketing" and "physician request for a new drug" were predicted to be significantly less influential in the future. This could be due to increasing restrictions on the marketing activities of drug companies as well as physician prescribing practices. For pharmacy directors the manner in which the drug formulary approval process is conducted is not expected to demonstrably change in the next five to ten years. The influence of items particularly of an economic and professional nature is expected to significantly increase in influence in the next five to ten years. It would be useful for pharmacy directors to realize that the drug formulary approval process is functioning according to published guidelines and standards. It w o u l d be insightful, on a local hospital level, to determine how this process can be strengthened or made better. P & T committee chairs: The drug formulary approval process For the 32 P & T committee chair respondents, ratings were similar to the 193 pharmacy director respondents.  P & T committee chairs predicted that 11 items will  become significantly more important for the future drug formulary approval process. Due to the small sample size of the former group, a detailed analysis will  97 not be presented. Rather, general observations will be made. With respect to P & T committee chairs it was stressed by a number of respondents that P & T committee chairs were in effect just figure-heads and d i d not serve in an effective or useful capacity. Hence, another possible reason for the low response rate among P & T committee chairs. P & T committee chairs rated the organizational item of the hospital P & T committee as the item that most strongly influences the current drug formulary approval process. This observation was similar to that of pharmacy directors, again confirming the very strong influence of P & T committees on the approval process. This item is not expected to significantly change in the future. Results also suggest that the influence of the formulary system is expected to remain unchanged in the future, although it currently has a strong influence.  P & T committee chairs do not  believe that the formulary system will become as significantly stronger in influence as do pharmacy directors. Some physicians may view formulary systems as barriers to their prescribing practices. The results suggest that P & T committee chairs place greater emphasis on items of an economic nature than directors. P & T committee chairs ranked five of the six economic items as having the greatest influence after the item of a hospital's P & T committee.  These five economic items are expected to significantly influence  the future formulary approval process. Not rated as significantly influential was the economic item of pharmacoeconomic evaluations.  A lack of familiarity with the  term "pharmacoeconomic" may have been the reason for a lower rating for this item. Overall, from a physician's point of view, economic items will heavily influence the future drug formulary approval process. To what degree do P & T committee chairs consider drug cost, efficacy, toxicity, and use as influencing the drug formulary approval process? Responding P & T committee chairs indicated that all four items have a strong influence. Only drug cost was felt by respondents to be significantly more influential in the future. This  98 may indicate that drug cost will have a greater influence than drug efficacy or toxicity on formulary decision-making activities with respect to a new drug. Physicians as prescribers and as those responsible for patient care are expected to have concerns over drug toxicity as reflected in the high rating given for this item. Outcome measurements are expected to have strong influence in the future. The health management literature suggests P & T committees should seek changes in the formulary system by using an approach that is based on objective, measurable definitions of outcomes.  This is similar to how physicians diagnose and manage  medical conditions. Physicians observe signs (objective data) and symptoms (subjective data), establish a diagnosis and then define, implement, and monitor the treatment (Glazier & Berger, 1993). P & T committee chairs likely recognize that physicians request drugs for formulary inclusion more frequently than pharmacists. Physicians believe their new drug requests have a strong influence on the drug formulary approval process, although this is not expected to significantly change in the future. Results suggest that physicians recognize the value and importance of pharmacy drug evaluation reports as an aid in the formulary decision-making process. They consider it to have a strong influence at present and for the future. Similar to directors, P & T committee chairs consider professional journal articles to have a strong influence. Quality assurance was rated as having a strong influence at present and for the future. In a similar manner to directors, P & T committee chairs rated those items external to the drug formulary approval process such as government assessment agencies, provincial formularies, and provincial P & T committees as having a moderate influence o n the current drug formulary approval process.  D r u g company  marketing had the weakest influence on both the current and future drug formulary approval process as rated by P & T committee chairs.  99 Government assessment agencies were rated lower by P & T committee chairs compared to pharmacy directors. Government agencies are expected to have significantly more moderate influence in the future. P & T committee chairs predicted that provincial formularies and P & T formulary committees will have a moderate influence in the future. Differences in hospital funding may influence the views of physicians towards government, although this was not tested. The rating of the item of adoption by a leading hospital followed the same trend as observed for pharmacy directors. It is possible that P & T committee chairs of large hospitals view themselves as leaders or innovators, while P & T committee chairs of smaller hospitals generally observe and follow the actions of larger hospitals. Hospital assessment committees are expected to exert a significantly more stronger influence for the future. There seems to be a belief by physician respondents that assessment committees, either on a provincial or hospital level, will become significantly more influential in the future. Technology in drug development was considered to have a moderate influence on the current and future drug formulary approval process. A s opposed to pharmacy directors who felt that the influence of drug company marketing would significantly decrease in the future, P & T committee chairs predicted that the impact of such marketing would significantly increase in the future. Physicians are usually the recipients of drug company marketing efforts and expect such efforts to increase in the future. However, this item will still have weak influence overall. The possibility that P & T committee chairs have not indicated the true extent of drug company marketing on influencing their drug formulary decisions is an important point to consider. Although it is difficult to judge just how honestly P & T committee chairs have answered this question, one must recognize that this is a  100 sensitive issue. Physicians receiving grants, sponsorship, or other type of inducement from drug companies are not too likely to admit this fact. P & T committee chairs felt that patients have only a weak influence on the current drug formulary approval process. The autonomy of a physician may be felt to be unquestionable. Liability for a new drug is considered to have a strong influence on the current and future drug formulary approval process.  Since  physicians are sometimes viewed as being liable for their prescribing behaviour it would be expected that this item would hold prominence. For P & T committee chairs, 11 of 28 items differed significantly between the current and future drug formulary approval process as measured with the use of the Wilcoxon matched-pairs signed-rank test. A l l 11 items were predicted to be significantly more influential in the future. For P & T committee chairs, the drug formulary approval process and the manner in which it is conducted is not expected to demonstrably change in the next five to ten years. The influence of items particularly of an economic nature is expected to significantly increase in the future. The difference in ratings for the items of "drug company marketing", and "quality assurance" was found to be significantly different between pharmacy directors and P & T committee chairs for the current drug formulary approval process using the Kolmogorov-Smirnov two-sample test. Directors felt that "drug company marketing" was significantly more influential on the current drug formulary approval process than P & T committee chairs. P & T committee chairs felt that "quality assurance" was significantly more influential on the current drug formulary approval process. Some of the results discussed are based on statistical significance.  However,  sometimes statistical significance does not necessarily imply practical significance. This study has drawn attention to some of the many underlying items that may influence the drug formulary approval process.  A s is evident, the drug formulary  approval process will not change. The P & T committee will continue to be the  101 major source for new drug evaluations in hospitals. The magnitude of various items, especially those of an economic nature, influencing the drug formulary approval process will change in the next five to ten years as described by the results.  102 Future directions It is difficult to offer a conclusive statement about the drug formulary approval process in select Canadian hospitals based on the results of this study. It is equally difficult to offer definitive reasons for individual items that may influence new drug formulary approval patterns. However, it appears that there are a number of items considered to be statistically significant that will influence the future drug formulary approval process. The drug formulary approval process i n Canadian hospitals has not yet been thoroughly investigated.  A s suggested by Rucker and  Visconti (1979), it would be valuable to know the precise structure and process variables used by the best drug formularies in restricting their listings largely to superior pharmaceuticals. Future surveys may ensure that the drug formulary approval process is being undertaken in an efficient, organized, and rational manner. The existence and effectiveness of P & T committees and drug formularies in Canadian hospitals must be assessed in an ongoing manner. Some additional questions remain for consideration. Do high rates of adoption indicate some flaw in the drug formulary approval process?  Does the  rapid acceptance of new drugs by innovator-type hospitals place strains on health care budgets?  If so, are outcome measurement procedures in place to evaluate the  effects of rapid adoption of new drugs? D o conservative hospitals jeopardize the health of their patients by prolonging decisions on potentially beneficial drugs? Should pharmacoeconomic assessments be mandatory for the marketing of new drugs? A s hospitals move to higher levels of pharmaceutical care, how will this influence the approval process of new drugs by pharmacy and therapeutics committees?  A t what point will the prices of new drugs level off?  Will  governments be willing to accept greater responsibility for the regulation and approval of new drugs in Canada?  103 Limitations This study has several limitations. As described, the sample surveyed was limited to English-speaking public hospitals with 100 or more beds. The data should not be extrapolated to French-speaking hospitals nor to hospitals with fewer than 100 beds. It is quite likely that hospital practice environments differ to such an extent between English and French-speaking hospitals that valid generalizations cannot be inferred to any degree of certainty. The effect of the disparate response rates observed between pharmacy directors (63.3%) and P & T committee chairs (10.9%) must be considered when interpreting the results. Also, it must be acknowledged that director respondents from Ontario (43.5%) appear disproportionately in the sample, while those from the Atlantic provinces are significantly under-represented. Due to the less than required response rate obtained for pharmacy directors and P & T committee chairs, the generalizability of study findings is limited. As well, the possibility of nonresponder bias, which was not tested for, exists because the response rate was less than 100%. To collect the data, there was reliance on self-reporting by pharmacy directors and P & T committee chairs. Some respondents may have provided inaccurate information, e.g., provided approximations to objective questions.  The possibility  that the P & T committee chair and pharmacy director of the same hospital may have completed the survey jointly, in consultation with each other, or on behalf of one another was not tested for. Subtle differences in staff title position may confound the observations. For example, the P & T committee chair may serve as more of a figure-head rather than a member actively involved in the drug formulary approval process.  Responses from  such respondents may not be an accurate reflection of the drug formulary approval process and were not examined to specifically exclude this possibility.  104 W i t h respect to those who completed the survey, it is important to acknowledge that survey responses reflect the attitudes and opinions of P & T committee chairs and pharmacy directors. Other P & T committee appointed members may have completed the survey in a different manner, or viewed various aspects of the drug formulary approval process differently. This was not tested for. The data essentially represents a cross-section of responses at one point in time. T o have a consistency in responses to ensure a greater degree of internal validity, repeated surveys would be most appropriate. However, given the research time frame of this study, repeated surveys were not feasible. Intra-provincial differences that may potentially affect the hospital drug formulary approval process were not addressed or tested for. The influence of a national rating system such as that of the U.S. Food and Drug Administration, which does have influence over drug formulary decisions, was not tested (Sanborn, G o d w i n & Pessetto, 1991). W i t h respect to the actual survey itself, pre-testing among P & T committee chairs was not performed due to workload related reasons. Hence the extent to which P & T committee respondents experienced difficulty in interpreting various questions is unknown. However, it was felt that the testing of the survey instrument by experts within the pharmacy profession was sufficient, although it is acknowledged that the testing of content and construct validity is limited. A major portion of the survey involved the rating of various items. Advanced statistical tests such as factor analysis, which may have decreased the number of items required, were not performed. Additionally, factor analysis may have identified unnecessary survey items measuring the same influence.  This  w o u l d have resulted in fewer items being used for the survey instrument. Each hospital surveyed possesses its own unique drug formulary approval process. There is not one singularly correct process appropriate for all hospitals. Thus, the limitations and generalizability of this study must be acknowledged within the context of specific individual hospital practice patterns.  105 C H A P T E R SIX  CONCLUSION  This study investigated the drug formulary approval process in Canadian hospitals. This study showed that the concept of the hospital P & T committee and the hospital drug formulary has been widely accepted among the responding hospitals. This study also showed that the process for formulary evaluation of drugs will not demonstrably change in the next five to ten years. The P & T committee structure and organization and the role of a hospital's drug formulary will remain for the most part unchanged as currently stated by various hospital adopters of this process. This study has also demonstrated that what will change is the relative influence of various items on the actual drug formulary process. A s reported by pharmacy directors, the influence of 21 items is predicted to become significantly more stronger in the future. P & T committee chairs predicted that 11 items will become significantly more important in the future drug formulary approval process. Excluding the role of the P & T committee itself, it appears that items of an economic nature will have the greatest influence in the next five to ten years. These results have implications for governments, which are ultimately responsible for funding these processes.  In addition, drug manufacturers will likely have to change  the way they market new drugs. Proven therapeutic superiority and costeffectiveness of new drugs over available treatment alternatives will likely be mandatory. The fact that new drug therapies will be more expensive is expected to be true. It is also expected that economic analyses will become more common and their use by those involved in the drug formulary approval process will escalate.  106 The results provide a detailed but not exhaustive overview of the drug formulary approval process in Canadian hospitals. It is hoped that the findings will stimulate further studies that are more narrowly focused and more in-depth.  107 Addendum Although not specifically requested in the survey, the following are illustrative comments made by survey respondents with respect to the hospital drug formulary approval process. (on other committees besides P & T involved in formulary approval process): "...all P & T recommendations are approved by M A C , which are basically rubber stamped..." (on the future): "...no plan revealed to me..." "...no crystal ball here..." (on the actual survey): "...my apologies, this survey is too complex and time consuming..." "...don't feel I can complete this intelligently as I have been here a very short time and I am cynical already..." (on level of care): "...barely adequate, the level of care at this place is appalling. Pharmacy has never had any impact at this place and it is an uphill battle trying to get administration/medicine/nursing to see the need for change..." (on P & T meeting frequency): "...other than the meeting I chaired one month ago none were held for one year..." (on cost controls): "...with respect to cost controls and technology...while these are obviously related, I feel the cost is always a minor component in the evaluation for P & T when deciding on a formulary addition. The cost attracts a lot of attention and often leads to a more thorough review. So while more time is spent on the review, it is mainly focused on the correct guidelines for use to ensure appropriate use in patients rather than to reduce costs. A subtle difference. In  108 reality, the committee does not feel it has a mandate to admit a drug to formulary based on cost and it does not feel responsible for the drug budget, i.e., we add what is needed for offering the best patient care and are not going to deny therapy simply on a cost basis. It is still unclear who has the personal bravery to assume this role..."  109 REFERENCES  Abramowitz, P. W . (1984a). Controlling financial variables-purchasing, inventory control, and waste reduction. 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American Tournal of Hospital Pharmacy. 50(Suppl 4), SI2-14.  i  i  130  Appendix 1  J  L  132  Appendix 2  T H E F O R M U L A R Y A P P R O V A L PROCESS IN C A N A D I A N Position title of person completing this survey:  PART  I  HOSPITAL  1. Hospital name:  ;  INFORMATION  (optional)  •  2.  Hospital location:  3.  Total number of hospital beds:  4.  Indicate your type of hospital:  (state province only)  care/Long term care  ' General/Acute care  (check all that apply)  Rehabilitation  6.  Surgical  Pediatric  Psychiatric  (check all that apply)  Ambulatory care  Indicate if your hospital offers teaching programs to the following people, Medical interns .  Chronic/Extended  Other (specify)  5. Indicate the predominant services or specialties provided by your hospital: Medical  HOSPITALS  Nursing students  Other (specify) (yes/no)  Pharmacy residents or students  7. In the past 2 years hospital expenditures versus budgeted expenditures have been: Over-budget [>+2%] 8.  On-budget [within ± 2%]  (check one only)  Under-budget [<-2%]  According to the rating scheme developed by the Canadian Society of Hospital Pharmacist's Clinical Pharmacy Advisory Committee, what level of clinical services does the pharmacy department provide to the majority of beds in the hospital? (circle your level or leave blank if unknown) I - Drug order review  PART  II  II - Selective patient pharmacotherapy monitoring  CURRENT  HI - Comprehensive patient pharmacotherapy monitoring  IV - Decentralized concurrent monitoring  FORMULARY APPROVAL  PROCESS  1.  Does your hospital have a pharmacy and therapeutics committee [P&T]? (yes/no)  2.  Indicate the number of people from the following list who currently are appointed to serve on P&T.  If no, go to question 9  Pharmacy director  Clinical pharmacologist  Pathologist  Other pharmacist  Nurse  Laboratory technician  Medical specialist  Senior management  Other (specify)  Surgeon  Finance staff  Physician (GP)  Quality assurance staff  3. The role of your hospital s P&T includes:  TOTAL  (check all that apply)  Drug-use review  Drug administration  Therapeutic interchange  A D R monitoring  Formulary drug approval  Purchasing decisions  Prescribing policies  Restrictions on drug use  P&T policy enforcement  Parenteral nutrition  Monitoring drug costs  Other (specify)  Error reporting  Drug handling/disposal  4.  Who does P&T directly report to?  5.  Who is chair of P&T?  6.  Who is secretary of P&T? (indicate by staff title).  7.  Are reasons for P&T drug adoption or rejection recorded? (yes/no).  8.  How often are P&T meetings held? (check Monthly  9.  (state committee name or position title).  (indicate by position title)  Bimonthly  the most appropriate answer)  Quarterly  Biannually  Do you have a hospital formulary in place? (yes/no)  Annually  Other (specify)  If no, go to question 16  10. Describe the degree of formulary control with respect to drugs in your hospital, (circle one only) 1  2  3  4  5  Very tight control  11. When was the last updating of your hospital's formulary?  Very loose control  (month/year)  12. Approximately how many drugs have been added to formulary in the past 2 years?_ 13. Approximately how many drugs have been deleted from formulary in the past 2 years?_ 14. In your opinion, the formulary in your hospital functions: (rankfrom  1-most important to 3-least important)  To achieve or to maintain accreditation  To control drug-use  To change prescribing patterns  To facilitate inventory management  To include second-line alternatives in categories where needed To make a list of drugs available for use To ininimize therapeutic redundancy by excluding inferior preparations To maximize cost effectiveness and maximize benefits by excluding costly agents when possible without compromising patient care To specify drugs of choice as determined by relative safety and efficacy Other (specify)  15. Indicate the usual source of formulary inclusion drug requests, Individual physician request Medical staff department request Pharmacy department request Nursing request Drug company request Other (specify)  (rank from 1-most frequent to 5-least frequent)  16. Besides P&T, are there other committees involved with the formulary approval process? (yes/no) _ If yes, indicate the name of the committee, if pharmacy is represented on this committee, how long the committee has existed, and if the committee hasfinanciallimits (state dollar amount) that must be approved before drug approval.  17. Indicate what influence [VSI=very strong influence, SI=strong influence, MI=moderate influence, WI=weak influence, NI=no influence] the following items have on your hospital's current formulary approval process with respect to breakthrough drugs, first-line drugs, or novel therapeutic drugs, (select one influence per item or leave blank if unknown) Adoption by a leading hospital  VS1  Cbmputers/information systems  VSI  Cost controls  SI  MI  WI  NI  SI  MI  WI  NI  VSI  SI  llillliiilll  WI  NI  Drug company marketing  VSI  SI  MI  WI  NI  Drug toxicity  VSI  SI  lllllll!!!!!!!!!  WI  NI  Drug-use  VSI  SI  MI  WI  NI  Financial management  VSI  SI  ll^iiliiitiilliiili  WI  NI  Formulary system  VSI  SI  MI  WI  NI  Government assessment agencies  VSI  SI  MI  WI  NI  Healthcare funding  VSI  SI  MI  WI  NI  Hospital assessment committee  VSI  SI  MI  WI  1111111:11  Hospital P&T committee  VSI  SI  WI  .................NI  Liability of a new drug  VSI  SI  iisiiitiiiii  WI  llllilf  New drug acquisition cost  VSI  SI  Ml  WI  NI  Outcome measurements  VSI  SI  iiiiiiiiiiiii  WI  illlllli  Patient request for a new drug  VSI  SI  MI  Patient rights  VSI  SI  Pharmaceutical care  VSI  SI  Pliarmacoeconomic evaluations  VSI  Pharmacy drug evaluation reports  .......  ............I..........MI  WI  NI  iiliiii^illlllli  WI  iiiiiii  Ml  WI  NI  SI  MI  WI  NI  VSI  SI  MI  WI  NI  Pharmacy request for a drug  VSI  SI  MI  iiilllilliiilti!!  NI  Physician request for a drug  VSI  SI  MI  WI  NI  Professional journal articles  VSI  SI  WI  NI  Provincial formulary  VSI  SI  MI  WI  NI  Provincial P&T committee  VSI  SI  MI  llllllilllil  NI  Quality assurance  VSI  SI  MI  WI  NI  Technology in drug development  VSI  SI  MI  WI  NI  SI  MI  WI  NI  Treatment cost versus alternatives  Other (specify and indicate  VSI  influence level)  F A R T III 1.  APPROVAL  PROCESS  Besides current appointees, who is to be appointed to P&T in the next 5-10 years? (circle all Ethicist  2.  FUTURE FORMULARY  Payer  Lawyer  Patient advocate  Economist  Social worker  Other (specify)  1  that apply)  N o one else  Indicate what influence [VSI=very strong influence, SI=strong influence, MI=moderate influence, WI=weak influence, NI=no influence] the following items will have on your hospital's future formulary approval process in the next 5-10 years with respect to breakthrough drugs, first-line drugs, or novel therapeutic drugs, (select one influence per item or leave blank if unknown) Adoption by a leading hospital  VSI  SI  MI  WI  lllilllii  Computers/information systems  VSI  SI  MI  WI  Nl  Cost controls  VSI  SI  MI  WI  NI  Drug company marketing  VSI  SI  MI  WI  NI  Drug toxicity  VSI  SI  MI  WI  iiiiiii  Drug-use  VSI  SI  MI  WI  NI  Financial management  \S1  SI  iiiiiiiiiiiii  WI  NI  Formulary system  VSI  SI  MI  WI  NI  Government assessment agencies  VSI  SI  lllllliHlll  WI  NI  Healthcare funding  VSI  SI  MI  WI  NI  Hospital assessment committee  VSI  SI  iilliililii  WI  Nl  Hospital P&T committee  VSI  SI  MI  WI  Nl  Liability of a new drug  VSI  SI  MI  WI  NI  New drug acquisition cost  VSI  SI  MI  WI  Nl  Outcome measurements  VSI  SI  Ml  WI  NI  Patient request for a new drug  VSI  SI  MI  WI  Patient rights  VSI  SI  MI  WI  Pharmaceutical care  VSI  SI  MI  WI  NI  Pharmacoeconomic evaluations  VSI  SI  illllHBill  WI  NI  Pharmacy drug evaluation reports  VSI  SI  MI  WI  NI  Pharmacy request for a drug  VSI  SI  MI  WI  NI  Physician request for a drug  VSI  SI  MI  WI  NI  Professional journal articles  VSI  SI  MI  WI  NI  Provincial formulary  VSI  SI  MI  WI  NI  Provincial P&T committee  VSI  SI  MI  WI  llllllii  Quality assurance  VSI  SI  MI  WI  Nl  Technology in drug development  VSI  SI  MI  WI  NI  Treatment cost versus alternatives  VSI  SI  MI  WI  NI  ,,,,,,,.,,,M  111!!!!  Other (specify and indicate influence)  Thank-you for completing this survey. Questionnaires are to be mailed in the enclosed postage-paid envelope or faxed to (604) 822-3035 (Attn. Mr. D. Hill).  139  Appendix 3  142  Appendix 4  143 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Adoption by a leading hospital.  C  U  R  R  E  N  T  R  A  Item type: Political.  T  I  N  G  No, (%) Responses  F  U  T  U  R  E  No. (%) Responses  b  b  21 (11)  4  22 (11)  51 (26)  3  56 (29)  62 (32)  2  55 (28)  40 (21)  1  43 (22)  17(9)  0  11(6)  2(1)  No Response  6(3)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding.  144 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Computers/information systems.  C  U  R  R  E  N  T  R  A  Item type: Organizational.  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  0(0)  4  10 (5)  11(6)  3  49 (25)  30 (16)  2  44(23)  54 (28)  1  37 (19)  75 (39)  0  29 (15)  23 (12)  No Response  24 (12)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as deterrrdned with the use of the Wilcoxon matched-pairs signed-rank test.  145 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Cost controls.  C  U  R  R  E  N  Item type: Economic.  T  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  59 (31)  4  115 (60)  95 (49)  3  65 (34)  32 (17)  2  11 (6)  5(3)  1  1(1)  1(1)  0  0(0)  1(1)  No Response  1 (1)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  146 Pharmacy Director Rating of Current and Future Item I nfluence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Drug company marketing.  C  U  R  R  E  N  T  Item type: Societal.  R  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  No. (%) Responses b  2(1)  4  17(9)  3  18(9)  66 (34)  2  47 (24)  77(40)  1  85(44)  31 (16)  0  39 (20)  0 (0)  *  No Response  0(0)  4 (2)  a Rated influence (0 = none, 1 = weak, 2 - moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  147 Pharmacy Director Ratine of Current and Future Item Influence nn Drucr Formnbrv Approval Process in Canadian Hospitals (n=193)  a  Item: Drug toxicity.  C  U  R  R  E  N  Item type: Professional.  T  R  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  No. (%) Responses b  57 (30)  4  87 (45)  3  91 (47)  41 (21)  2  39 (20)  5(3).  1  3(2)  1(1)  0  1(1)  2(1)  No Response  2(1)  57 (30)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding.  148 Pharmacy Director Ratine of Current and Future Item Influence on Drue Formnlarv Approval Process in Canadian Hospitals (n=193)  a  Item: Drug use.  C  U  R  R  E  Item type: Professional.  N  T  R  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  No. (%) Responses b  47 (24)  4  101 (52)  3  87 (45)  34 (18)  2  43 (22)  2(1)  1  6(3)  0(0)  0  0(0)  9(5)  No Response  50 (26)  7(4)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding.  149 Pharmacy Director Rating of Current and Future Iterr» I n f l u e n c e on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Financial management.  C  U  R  N o . (%)  R b  E  N  T  Item type: Economic.  R  A  T  I  N  G  Responses  F  U  T  U  N o . (%)  b  R  E  *  Responses  34 (18)  4  91 (47)  3  90 (47)  50 (26)  2  16(8)  7(4)  1  2(1)  4(2)  0  1(1)  7 (4)  No Response  4 (2)  80 (41)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  150 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Formulary system.  C  U  R  R  E  N  T  No. (%) Responses b  Item type: Professional.  R  A  T  I  N  G  ,  F  U  T  U  R  E  *  No. (%) Responses b  41 (21)  4  91 (47)  3  80 (41)  38 (20)  2  26 (13)  6(3)  1  2(1)  4(2)  0  2(1)  13(7)  No Response  13 (7)  70 (36)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). ^Percentages are approximations due to rounding. *p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  151 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Government assessment agencies.  C  U  R  R  E  N  T  R  A  Item type: Political.  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  12.(6)  4  24 (12)  25 (13)  3  67 (35)  57 (30)  2  56 (29)  49 (25)  1  21 (11)  29 (15)  0  9(5)  21 (11)  No Response  16(9)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  152 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Health care funding.  C  U  R  R  E  N  T  Item type: Economic.  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  42 (22)  4  106 (55)  76(39)  3  69 (36)  45 (23)  2  9(5)  20 (10)  1  4(2)  5(3)  0  2(1)  5(3)  No Response  3(2)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  153 Pharmacy Director Rating of Current and Future Item I nfluence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Hospital assessment committee.  C  U  R  R  E  N  T  R  A  Item type: Organizational.  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses b  11(6)  4  32 (17)  3  50 (26)  25 (13)  2  36 (19)  16(8)  1  13(7)  51 (26)  0  19 (10)  58 (30)  No Response  55 (28)  20 (10)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  154 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Hospital P&T committee.  C  U  R  R  E  N  T  Item type: Organizational.  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  No. (%) Responses  b  b  127 (66)  4  123 (64)  55 (28)  3  58 (30)  5(3)  2  8(4)  3(2)  1  2(1)  2(1)  0  1(1)  1 (1)  No Response  1 (1)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding.  155 Pharmacy Director Rating of Current and Future Item Iniluence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  Item: Liability of a new drug.  C  U  R  R  E  N  T  Item type: Legal.  R  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  No. (%) Responses b  22 (11)  4  73 (38)  3  87 (45)  55 (28)  2  41 (21)  19 (10)  1  16(8)  5(3)  0  1(1)  No Response  13(7)  19(10)  *  35 (18)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). ^Percentages are approximations due to rounding. •k  p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  156 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: New drug acquisition cost.  C  U  R  R  E  N  T  Item type: Economic.  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  48 (25)  4  85(44)  99 (51)  3  82 (42)  35 (18)  2  22 (11)  9(5)  1  2(1)  0(0)  0  0(0)  2 (1)  No Response  2 (1)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  157 Pharmacy Director Rating of Current and Future Item In fluence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  Item type: Professional.  Item: Outcome measurements.  C  U  R  R  E  N  T  R  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  *  No. (%) Responses b  36 (19)  4  65 (34)  3  73 (38)  31 (16)  2  27 (14)  34 (18)  1  4(2)  13 (7)  0  3(2)  7(4)  No Response  7(4)  79 (41)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  158 Pharmacy Director Rating of Current and Future Item In!luence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Patient request for a new drug.  C  U  R  R  E  N  T  R  Item type: Societal.  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  No. (%) Responses b  0(0)  4  6(3)  3  24 (12)  32 (17)  2  43 (22)  77 (40)  1  81 (42)  70 (36)  0  35 (18)  8(4)  *  No  Response  2(1)  8(4)  a. Rated influence (0 = none, 1 = weak, 2 - moderate, 3 = strong, and 4 = very strong). b Percentages are approximations due to rounding. •k  p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  159 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Patient rights.  C  U  R  R  E  N  Item type: Societal.  T  R  A  T  I  N  G  No. (%) Responses b  1(1)  F  U  T  U  R  E  *  No. (%) Responses b  4  7(4)  25 (13)  3  32 (17)  57(30)  2  89 (46)  60 (31)  1  40 (21)  31 (16)  0  11 (6)  19 (10)  No Response  14 (7)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  160 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Pharmaceutical care.  C  U  R  R  E  N  T  Item type: Professional.  R  A  T  I  N  G  No. (%) Responses b  F  U  T  U  R  E  *  No. (%) Responses b  13 (7)  4  66 (34)  3  79 (41)  56 (29)  2  49 (25)  32 (17)  1  5(3)  10 (5)  0  3(2)  16(8)  No Response  10(5)  47 (24)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  161 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Pharmacoeconomic evaluations.  C  U  R  R  E  N  T  R  A  Item type: Economic.  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  29 (15)  4  94 (49)  84(44)  3  80 (41)  50 (26)  2  13 (7)  19 (10)  1  3(2)  4(2)  0  0(0)  7(4)  No Response  3(2)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding. •k  p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  162 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Pharmacy drug evaluation reports.  C  U  R  R  E  N  T  R  A  T  Item type: Professional.  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  36 (19)  4  64(33)  98 (51)  3  100 (52)  41 (21)  2  24 (12)  10(5)  1  2(1)  1(1)  0  1(1)  7(4)  No Response  2(1)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  163 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  Item: Pharmacy request for a new drug.  C  U  R  R  E  N  T  R  A  Item type: Professional.  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  No. (%) Responses  b  b  36 (19)  4  29 (15)  91 (47)  3  94 (49)  49 (25)  2  59 (31)  10 (5)  1  7(4)  4(2)  0  2(1)  3 (2)  No Response  2 (1)  *Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). ""Percentages are approximations due to rounding.  164 Pharmacv Director Rating of Current and Future Item I nfluence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Physician request for a new drug.  C  U  R  R  E  N  T  No. (%) Responses  R  Item type: Professional.  A  T  I  N  b  G  F  U  T  U  R  E  *  No. (%) Responses b  37 (19)  4  106 (55)  3  84(44)  41 (21)  2  62 (32)  2(1)  1  9(5)  2(1)  0  1(1)  5 (3)  No Response  4 (2)  33 (17)  a. Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). Percentages are approximations due to rounding. *p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  165 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Professional journal articles.  C  U  R  R  E  N  T  No. (%) Responses  R  Item type: Professional.  A  T  I  N  G  b  F  U  T  U  R  E  *  No. (%) Responses b  19 (10)  4  93 (48)  3  92 (48)  66 (34)  2  60 (31)  11 (6)  1  11(6)  2(1)  •0  0(0)  2(1)  No Response  5(3)  25 (13)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  166 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Provincial formulary.  C  U  R  R  E  N  T  Item type: Political.  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  *  No. (%) Responses  b  b  16(8)  4  39 (20)  33 (17)  3  62 (32)  47 (24)  2  50 (26)  54 (28)  1  21 (11)  34 (18)  0  10(5)  No Response  11(6)  9(5)  E  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  167 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Provincial P&T committee.  C  U  R  R  E  N  T  Item type: Political.  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  13(7)  4  34(18)  18 (9)  3  50 (26)  24 (12)  2  39 (20)  37 (19)  1  24 (12)  65 (34)  0  18 (9)  36 (19)  No Response  28 (15)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). ^Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  168 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Quality assurance.  C  U  R  R  E  N  T  Item type: Professional.  R  A  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  6(3)  4  21 (11)  45 (23)  3  67 (35)  62 (32)  2  68 (35)  45 (23)  1  12(6)  16(8)  0  7(4)  19 (10)  No Response  18(9)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  169 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Technology in drug development.  C  U  R  R  E  N  T  R  A  Item type: Organizational.  T  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  3(2)  4  22 (11)  36 (19)  3  54 (28)  73 (38)  2  77 (40)  45 (23)  1  21 (11)  14(7)  0  5(3)  22 (11)  No Response  14(7)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  170 Pharmacy Director Rating of Current and Future Item Influence on Drug Formulary Approval Process in Canadian Hospitals (n=193)  a  Item: Treatment cost versus alternatives.  C  U  R  R  E  N  T  R  A  T  Item type: Economic.  I  N  G  No. (%) Responses  F  U  T  U  R  E  *  No. (%) Responses  b  b  50 (26)  4  102 (53)  92 (48)  3  66 (34)  40 (21)  2  18(9)  8(4)  1  3(2)  1 (1)  0  0(0)  2(1)  No Response  4(2)  Rated influence (0 = none, 1 = weak, 2 = moderate, 3 = strong, and 4 = very strong). 'Percentages are approximations due to rounding. p<0.05 as determined with the use of the Wilcoxon matched-pairs signed-rank test.  

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