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Effectiveness of patient drug record plans : An evaluation Waller, Ronald Henry 1972

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EFFECTIVENESS OF PATIENT DRUG RECORD PLANS (AN EVALUATION) by RONALD HENRY WALLER B.S. (Pharm.), University of British Columbia, 1968 A THESIS SUBMITTED IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE in the Division of Clinical Pharmacy of the Faculty of Pharmaceutical Sciences We accept this thesis as conforming tp the required standard THE UNIVERSITY OF BRITISH COLUMBIA April , 1972 In presenting t h i s thesis i n p a r t i a l f u l f i l m e n t of the requirements for an advanced, degree at the University of B r i t i s h Columbia, I agree that the Library s h a l l make It f r e e l y available for reference and study. I further agree that permission for extensive copying of t h i s thesis for scholarly purposes may be granted by the Head of my Department or by h i s representatives. It i s understood that copying or publication of t h i s thesis for f i n a n c i a l gain s h a l l not be allowed without my written permission. Department of Clinical Pharmacy in the Faculty of Pharmaceutical Sciences, The University of B r i t i s h Columbia Vancouver 8, Canada ^ t e March 20, 1972 i EFFECTIVENESS OF PATIENT DRUG RECORD PLANS (A'N EVALUATION) by R.'H. WALLER ABSTRACT •An evaluation was undertaken to determine the effectiveness of fpatient record plans which had been in use i n two community pharmacies for periods of 6 and 9 years. A retrospective study of potential tetracycline interactions demonstrated that, numerically, the non-prescription drugs represented the greatest potential danger. A l -though i n the past, non-prescription medications were not routinely recorded, i t i s concluded that both prescribed and non-prescribed drugs should be entered on patient record charts and screened for potential interactions. The routine recording and screening of patient allergies and disease states on the patient record plan was shown to be of value in several instances in one pharmacy. A comparison of drug sensitivities 'flagged' on pharmacy records and physician's records showed that the pharmacist often had on record more allergies than did the physician. Using the patient record plan to determine the theoretical time of the last dose of an antibiotic, two surveys were undertaken to determine i f a written reinforcement of verbal instructions and patient involvement in a follow-up interview could help improve self-administration habits in ambulatory patients. It was found that more patients did in fact, follow, their dosage regimen and fewer patients discontinued their course of therapy without j u s t i f i c a t i o n . Seventeen steps were defined i n a i i dispensing procedure used i n one of the pharmacies operating with a patient record plan. These could be further divided into those fun-ctions which could be performed by a non-professional assistant and those which were to be done only by a pharmacist. The time requiredfifor the individual pharmacist to perform a l l 17 steps was compared to the time required for a (pharmacist and non-professional assistant) team to do the same functions. Pharmacist time per prescription appeared to be reduced 40 to 50% by the team approach. Signature of Supervisor; s. ACKNOWLEDGEMENTS The author wishes to express his gratitude to Dr. J.N. Hlynka for his enthusiastic encouragement and guidance throughout the preparation of this thesis. In addition, the co-operation and assistance of phar-macists Ben Gant and John Dyck i s greatly appreciated. The financial assistance of the Geigy Scholarship i s greatfully acknowledged. Wendy Waller not only deserves special thanks as the typist for this thesis, but sincere appreciation i s also extended for her excep-tional understanding as a wife. She was a mother to four sons, and s t i l l provided the author with the needed encouragement to continue his studies, It i s only f i t t i n g then, that this thesis be dedicated to an excellent typist, mother and wife - Mrs. Wendy Waller. iv TABLE OF CONTENTS Pao£ ABSTRACT 1 ACKNOWLEDGEMENTS i i i TABLE OF CONTENTS iv LIST OF TABLES v LIST OF FIGURES vi LIST OF APPENDICES vii INTRODUCTION 1 LITERATURE SURVEY 5 A. Patient Record Plans 5 B. Drug Interaction Information 11 - Significance of Drug Interactions 14 C. Drug Sensitive Conditions and Patient Record Plans 19 D. Drug Administration and Patient Record Plans 24 E. Pharmacist Time and Patient Record Plans 31 1. The Non-Professional Assistant's Role 31 2. The Cost of Patient Record Plans 33 STATEMENT OF PROBLEM 38 EXPERIMENTAL METHODS 39 A. General 39 B. Drug Interactions 40 C. Drug Sensitive Conditions and Patient Record Plans 44 1. Comparison with Previous Data 45 2. Comparison with Physicians Data 46 3. Effectiveness of the Patient Record Plan 48 D. Drug Administration 48 1. Effectiveness of Single Instructions 49 2. Effectiveness of Multiple Instructions 51 E. Pharmacist Time 53 RESULTS AND DISCUSSION 57 A. Drug Interactions 57 B. Drug Sensitive Conditions 63 C. Drug Administration 74 D. Pharmacist Time 81 SUMMARY AND CONCLUSIONS 87 APPENDICES 90 BIBLIOGRAPHY 92 V LIST OF TABLES Table Page I. INCIDENCE OF POTENTIAL TETRACYCLINE INTERACTIONS AS RELATED TO PRESCRIPTION-ONLY AND NON-PRESCRI-PTION DRUGS. 59 II. NATURE OF POTENTIAL TETRACYCLINE INTERACTION WITH PRESCRIPTION-ONLY AND NON-PRESCRIPTION DRUGS. 61 III. INCIDENCE OF DRUG SENSITIVE CONDITIONS AS RE-PORTED ON PATIENT RECORD PLANS. 65 IV. REPORTED DRUG SENSITIVE CONDITIONS ACCORDING TO SEX AND AGE. 67 V. COMPARISON OF REPORTED RESULTS WITH PREVIOUS STUDIES ACCORDING TO SPECIFIC DRUG GROUP SEN-SITIVITIES 69 VI. REPORTED DRUG SENSITIVE CONDITIONS AS RELATED TO DISEASE STATES. 70 VII. COMPARISON OF PHARMACY AND PHYSICIAN RECORDS AS RELATED TO DRUG SENSITIVE CONDITIONS. 72 VIII. ACCURACY OF SELF-MEDICATION REGIMEN BY PATIENTS RECEIVING (a.) SINGLE OR (b.) MULTIPLE PHARMACY INSTRUCTIONS. 76 IX. REASON FOR PATIENTS NOT COMPLETING ANTIBIOTIC THERAPY. 79 X. DISPENSING FUNCTIONS AS RELATED TO PHARMACIST AND NON-PROFESSIONAL ASSISTANT RESPONSIBILITIES, 82 XI. DISPENSING TIME REQUIRED USING A PATIENT RECORD PLAN FOR (a.) AN INDIVIDUAL PHARMACIST AND (b.) A PHARMACIST - NON-PROFESSIONAL ASSISTANT TEAM APPROACH. 84 vi LIST OF FIGURES Fi gure Page 1. DRUG ALLERGY MEMORANDUM. 47 2. PHARMACIST FOLLOW-UP INTERVIEW FORM. 50 3. PATIENT INFORMATION NOTE. 52 vii L IST OF APPENDICES FAMILY RECORD CHART FOR PRESCRIPTIONS PHARMACY X. PATIENT RECORD CHART - PHARMACY Y. INTRODUCTION One of the most dramatic changes affecting the futuresof pharm-aceutical practice i s the emerging concept of c l i n i c a l pharmacy. There are numerous ways in which c l i n i c a l pharmacy may be defined. Perhaps the most comphrensive has been presented by Tyler. "Clin i c a l pharmacy i s that division of pharmacy which deals with patient care with particular emphasis on drug therapy. In practice i t i s patient orientated and includes not only the dispensing of required medication but also advising the patient on the proper use of a l l medications, both pre-scribed and patient selected. It also u t i l i z e s the pharmacist as an information source for members of the medical and other health professions on a l l matters pertaining to drugs and their dosage forms" (1). Furthermore, the practitioners of the c l i n i c a l concept should not be classed as a new rank of pharmacists as Hlynka explains, "Clin i c a l pharmacy i s a concept of education and practice and a l l pharmacists - whether they practice in the hospital or the community - are, or should be clinicians" (2). In other words, there must be an upgrading of the pharmacists functions so that a l l pharmacists may claim their c l i n i c a l role on the health team. The literature leaves l i t t l e doubt that at the present time c l i n i c a l pharmacy i s more hospital, than community based (2 - 11). C l i n i c a l l y -oriented community pharmacists, however, are now beginning to present their approaches to patient-oriented practice, These include White, (12) Chiles (13), Dyck (14), and Gant (15) to mention just four of the leaders. - 2 -The common link between these men i s that they were a l l pioneers i n the development of a patient record plan before their other c l i n i c a l programs;; began to be developed. They do not share a t r a i t which i s too common in community pharmacies - a t r a i t that has been aptly described by Franke as, ", , . fear they would lose some prescription business" (16). What are the main c r i t e r i a of c l i n i c a l pharmacy i n the community? The four authors mentioned earlier (12 - 15) have the following con-viction: that they treat patients, not customers, Plein (3) has summarized similar convictions in projecting progressive services ex-pected of a community pharmacist. They are as follows: "1. Prepares and maintains medication records for patients, l i s t i n g medications dispensed on prescription and medications the patient buys for selfrmedication, and l i s t i n g also any a l -1 lergies or drug reactions reported by the patient or by his physician. Before f i l l i n g a pre-scription the pharmacist refers to the patients medication record and checks for possibility of drug interactions and other therapeutic income patabilities of the new drug with medication the patient i s receiving on previous prescription by the same or another prescribed. Before advising the patient on O-T-C medication, the pharmacist re^ fers to the patients medication record so that he is aware of the medication that the patient i s re-ceiving and can prevent the patient from self-medicating with a drug that may interfere with his prescribed regimen or may augment his disease (E.G., a cold remedy containing an adrenergic agent i n a patient receiving antiHtiypertension medication or a patient who i s receiving tetracycline and who wants to buy an antacid). 2. Discuss with the patient how his medication i s to be taken and i f necessary caution him regarding possible side effects. - 3 -3. Refer the patient to the physician when he asks advice on O-T-C medications for a condition that the pharmacist feels warrents a physicians attention. 4. Serves as a resourse person for physicians, den-tis t s , and nurses by answering questions on drug efficacy and on possible drug reactions and inter-actions . 5. Advises patients on use of prescription adjuncts and other health needs. 6. Participates i n public health education programmes" (3). Certain tools are required, however, in order to enable effective execution of these services. A complete up-to-date drug information library i s necessary (13). A self-imposed regimen of continuing pro-fessional education i s essential (17). Perhaps the newest and most contentious tool i s a properly maintained and u t i l i z e d patient record plan, A patient record plan, which i s a medication summary, may be kept for an individual patient or for a family. It is primarily a chronological l i s t of those medications purchased in a pharmacy by the patient or family. This l i s t should include both prescribed and s e l f -selected medications. A record system alone is not a guarantee of success in c l i n i c a l pharmacy. To be truly effective, a pharmacist must use the information from the patient record plan to promote better drug u t i l i z a t i o n . Although the patient record plan i s gaining wider acceptance and interest by pharmacists, i t s ultimate potential is s t i l l unknown. Many questions relating to i t s effectiveness and economy in operation must be answered. How valuable is i t i n detecting potential drug interactions, allergies, and other drug sensitivities? How can i t be used to promote more effective self-administration of the drugs by the ambulant patient? How can the pharmacist ju s t i f y the - 4 -additional time required to use the plan i n influencing the above? The studies presented here were performed in an attempt to identify the strengths and weaknesses of existing patient record plans and to provide answers to the above questions relating to the plans' ef-fectiveness i n promoting better drug therapy i n the ambulatory patient. - 5 -LITERATURE SURVEY A. PATIENT RECORD PLANS A r t i c l e s about p r e s c r i p t i o n record plans have been common i n the American l i t e r a t u r e s i n c e 1964 (13,14); although Eugene White o r i g i n a t e d h i s f a m i l y medication records i n A p r i l , 1960 (12). Var-ious kinds of records o f p r e s c r i p t i o n medication have t r a d i t i o n a l l y been maintained by pharmacists. This has o f t e n been l i m i t e d t o the f i l i n g of the o r i g i n a l p r e s c r i p t i o n order. By law, t h i s i s a l l that i s r e q u i r e d i n most Canadian provinces as provided under the Food and Drugs Act (18). What i s new about the i d e a i s the r e a l i z a t i o n t h a t , i n modern pharmaceutical p r a c t i c e , the medication i s so potent and the p o s s i b i l i t y of drug i n t e r a c t i o n s and t h e r a p e u t i c i n c o m p a t a b i l i t i e s i s so gre a t , that the o l d time records are inadequate. These l a t t e r r e c o r d s , which give only the name o f the p a t i e n t , p r e s c r i p t i o n num-ber and the amount charged, provided l i t t l e p r o t e c t i o n f o r the phar-macist and c e r t a i n l y inadequate p r o t e c t i o n f o r the p a t i e n t (19). Two e x c e l l e n t reviews about the types o f p a t i e n t record plans i n use are by Kane on American plans (20), and by Ligon on Canadian plans (14), An e x c e l l e n t guide to a s s i s t i n the establishment o f a p a t i e n t record p l a n a l s o has been prepared by the Pharmaceutical A s s o c i a t i o n of B r i t i s h Columbia (21). However, i t s d i s t r i b u t i o n to pharmacists i n the province i s on a request b a s i s only at the present time. Some o f the designations being attached to such p a t i e n t record plans i n c l u d e : p r e s c r i p t i o n r e c o r d s , f a m i l y record cards, f a m i l y pre-s c r i p t i o n record systems, p a t i e n t medication record systems, i n d i v i d u a l medication summary f i l e ( 1 9), to mention j u s t a few. For the pur-poses of t h i s t h e s i s , the term " p a t i e n t record p l a n s " w i l l be used - 6 -in place of the above terms. A l l sizes and shapes of cards are used depending on the need of the particular pharmacy i n i t i a t i n g the record plan. One pharmacist (22) has suggested a wallet sized record card that would be carried by the patient from physician to physician or from pharmacy to pharmacy. This could be an answer to the problem of starting a patient record plan in highly transient locations. Those pharmacies wishing to record more detailed information use larger cards (14,20), while those concerned with the speed of operation use a smaller form. A recent a r t i c l e by McQueen and Segal (23) suggests that even-tually a l l pharmacists w i l l have a connecting terminal to a central computer containing information on patient medication and on drug inter-action information. Whichever method is chosen, according to one pharm-acist, "... the important thing is to start a family record system going, and i f you want to have a good system by next year, you must start today" (14). Several authors have gone to great detail i n enumerating the po-tential benefits of the patient record plan. These include the following: 1. The prevention of potential drug interactions, C15, 22, 24 - 26), 2. The prevention of patient exposure to drugs to which a patient i s allergic or to which he has a sensitivity (12 - 14, 21, 27), 3. Prevention of exposure to drugs which are contraindicated i n a particular disease (13, 26, 28), or physiological state (29), 4. Control of drug abuse and duplication (13, 14, 19, 21), 5. Assist i n advising and consulting patients on the proper drug u t i l i z a t i o n (12, 13, 21, 30 - 34), - 7 -6. A s s i s t i n drug r e c a l l s (19, 21), 7. Help improve physician-pharmacist r e -l a t i o n s (21), 8. Increases p a t i e n t l o y a l t y to one pharmacy (14,21) 9. Basis f o r preparing income tax (19) or t h i r d p a r t y insurance r e c e i p t s (21), 10. Pharmacy s t a f f time saved i n the p r e p a r a t i o n of number 9 above, renewing p r e s c r i p t i o n s when the p r e s c r i p t i o n number i s l o s t , o r i n preparing a drug resume f o r a p h y s i c i a n on one p a t i e n t (14) , 11. A v a l u a b l e source of i n f o r m a t i o n on the p a t i e n t , h i s f a m i l y , h i s p h y s i c i a n s , h i s p l a c e of employ ment, h i s phone number at home and at work, h i s group insurance number, w e l f a r e number, o r D.V.A. number, and even h i s c r e d i t r a t i n g , i f d e s i r e d (14), 12. May provide s p e c i f i c i n f o r m a t i o n concerning dosage and renewal a u t h o r i t y w i t h renewal i n t e r v a l s (14, 19). Perhaps a futureeuse of the p r e s c r i p t i o n record plan w i l l be i t s i n c l u s i o n i n medication h i s t o r i e s upon h o s p i t a l admission as suggested by Yakimets (35). and McHale and Canada (36). One of the f u t u r e economic i m p l i c a t i o n s of the plans i n use could be f o r b e t t e r c o n t r o l and guidance i n the management of thirds-party drug insurance programs (19). The p o p u l a r i t y of the v a r i o u s p r e s c r i p t i o n record plans i s r e f l e c t ted by the f a c t that i n the 1971 survey of Canadian pharmacies, 156 of 402 r e p o r t i n g pharmacies (38.8%) use a p a t i e n t record plan (37). In a d d i t i o n , at l e a s t one p r o v i n c e , A l b e r t a , i s planning to r e v i s e t h e i r standards of p r a c t i c e r e g u l a t i o n s to i n c l u d e the n e c e s s i t y of a pharm-a c i s t to m a i n t a i n an i n d i v i d u a l o r f a m i l y p r e s c r i p t i o n drug p r o f i l e system (38). Even some American boardsof pharmacies are expanding r e g -u l a t i o n s i n t h i s d i r e c t i o n . For example, the Michigan Pharmacy Act now defines the p r a c t i c e of pharmacy i n the f o l l o w i n g manner: - 8 -". . . The interpretation of the prescription order; compounding, dispensing or selling of drugs and devices, whether dispensed on a pre-scription, or sold, on or given directly to the ultimate consumer and the proper and safe storage and distribution of drugs and devices, 'the maintenance of proper records therefore'* and the responsibility for advising as re-quired as to the contents, therapeutic values, hazards, and uses of such a r t i c l e s " (39). (* Internal quotation marks added by the author) In addition the Michigan Board of Pharmacy has revised one of i t s rules about service i n hospitals as follows: "Interpreting a medication order for prescri-ption drugs includes a review by the pharmacist of the complete drug regimen of the patient to prevent a drug interaction with the drug ordered, to prevent a drug-food interaction, and to prevent a drug-patient interaction" (39). In the province of British Columbia, an amendment was proposed to the standards of practice bylaw i n 1971 to include a family record plan under the l i s t of recommended equipment (40). The Canadian Pharmac-eutical Association Commission on Pharmaceutical Services has recom^ mended the following: "That the keeping of patient medication records, on a regular basis, be recognized as an intergal part of prescription service to the public" (19). Also, at the national l e v e l , a special committee of the Canadian Pharma-ceutical Association at the 1971 convention recommended: "That provincial associations consider the i n -clusion of family record systems in their stan-dards of practice regulations, thereby making the keeping of family records by community pharmacies mandatory" (41). - 9 -The evidence to date strongly suggests that record plans are being accepted for their potential and w i l l be placed in more and more phar-macies in the future possibly i n a l l Canadian pharmacies. It is wise to consider the words of caution expressed by Knapp and his associates: " patient record system is v i t a l the re-cord system alone i s not a guarantee... It must be used conscientiously and thoroughly every time i t is called for, despite the time and despite the expense. The pharmacist is a professional person for whom the ultimate goal is successful treatment of the patient. But we also believe that pharmacists Cand record plans)* w i l l be judged by their ac-complishments and not be their potential" (17). (* Internal brackets added by the author.) In Canada, the concept of keeping a system of records in this manner is relatively new and the diffusion of new ideas i s relatively slow when traditional methods of operation must be replaced. The following three factors have been implicated as reasons for the slow spread of usage of patient record plans. F i r s t l y , the expense involved i n setting up, maintaining, and u t i l i z i n g the records in a busy prescription department; Secondly, the hesitancy of the pharmacist to question prescriptions unless there was an obvious error; Thirdly, the lack of understanding of the real pur-pose of the system and the manner i n which i t would be used to best advan-tage (19). It is hoped that the last two of these can be overcome by educational programs through the profession and through the Faculties of Pharmacy in Canada. Many potential advantages of patient record plans have been pro-jected but very few authors have tested the v a l i d i t y of many of the claims they have made for the patient record plans. Many testimonials - 10 -have been presented, like Gant (15), Taciuk (24), Chiles (24) and others (13); but no studies could be found that would indicate the incidence of interactions detected by record plana, or how many exposures to a l -lergic drugs had been prevented. The cost of operating a record plan, and the increased staff requirements, are often presented as arguments against the use of patient record plans. Are these objections valid? Some general comments on cost of operation are presented i n the article by Ligon in March 1971 (13), as well as data from case studies in the report of the Commission on Pharmaceutical Services (42). However, no actual time study surveys of this problem could be found. Another question, which apparently has not been evaluated, relates to the effect of the patient record plan in promoting better drug usage or self-administration by the ambulatory patient. The future acceptance of the patient record plan, with respect to effectiveness and cost, would appear to depend largely on the answers to questions such as these. - 11 -B. DRUG INTERACTION INFORMATION Probably one of the most useful aspects of the patient record plan Is Its potential for detecting undesirable drug Interactions. Chiles (25) has said that an effective job of detecting drug interactions cannot be accomplished without two prerequisites. F i r s t , there must be a know-ledge, by the pharmacist, of the many interactions; which for the com-munity pharmacist includes a knowledge of non-prescription drug inter-actions, as well as prescription drug interactions. He must understand the theoretical basis of these interactions. Secondly, there must be an alphabetical patient record card system for a l l prescriptions f i l l e d , and a l l non-prescription drugs purchased over-the-counter, Being familiar with the review arti c l e s , such, as those by Hartshorn (43), and having the necessary reference texts in the pharmacy library i s not enough to make the knowledge of drug interactions useful. It i s impossible to remember a l l the possible interactions; and d i f f i c u l t to find factual information when the pharmacist is busy f i l l i n g prescriptions, talking on the telephone to physicians, or consulting with patients in the pharmacy. It i s necessary as well to have an easy-to-use handbook on drug interactions that can be used quickly to screen a l l new medication orders with those drugs the patient i s currently, orLhas recently been taking. In an attempt to f u l l f i l the needs of the busy pharmacy practitioner, Gant and Waller (44) prepared the 'Drug Interaction Index1, Of the two main sections in this reference, one section is devoted to l i s t i n g drugs alphabetically on the f i r s t column of the page. A second column l i s t s a l l - 12 -o f those drugs I n a l p h a b e t i c a l order which may i n t e r a c t w i t h the f i r s t drug. A t h i r d column b r i e f l y described the p o t e n t i a l r e s u l t o f the i n t e r a c t i o n . F i n a l l y , a f o u r t h column gives the reader an accurate guide to the second s e c t i o n o f the book which contains more d e t a i l about the p o t e n t i a l r e s u l t of the i n t e r a c t i o n and the proposed mechanism. This reference makes no attempt to evaluate c l i n i c a l s i g n i f i c a n c e ; and can serve best as a screening mechanism f o r the busy p r a c t i t i o n e r . The "Drug I n t e r a c t i o n Index" i s updated by p e r i o d i c supplements which are based on both review a r t i c l e s , l i k e Hartshorn, (43) or on o r i g i n a l papers. This type of reference i s probably best described as a "primary" screening reference f o r drug i n t e r a c t i o n s . The busy pharmacist i n h o s p i t a l s , o r i n community pharmacies, can q u i c k l y review a p a t i e n t r e c -ord card and the new drug o r d e r s ; and cross check these f o r p o t e n t i a l i n t e r a c t i o n s i n the "Drug I n t e r a c t i o n Index". Once a p o t e n t i a l I n t e r a c t i o n has been detected, the pharmacist must evaluate i t s p o t e n t i a l dangers. Many drugs which i n t e r a c t are used t o -gether and o f t e n w i t h no problem,(43). What i s important i s t h a t the pharmacist and the p h y s i c i a n r e a l i z e that there i s a p o t e n t i a l f o r an i n t e r a c t i o n and the p o s s i b l e a l t e r a t i o n o f e f f e c t . Very seldom does the s i t u a t i o n a r i s e where two drugs cannot be used together. I n d i s c r e t i o n i n communication can change the pharmacist from a v a l u a b l e member of the h e a l t h team to an "ignorant p e s t " as Hartshorn has so a p t l y d escribed him (45). Fear of becoming the "Ignorant p e s t " has prevented many pharmacy p r a c t i t i o n e r s from becoming more ag r e s s i v e i n t h e i r use of drug i n t e r -a c t i o n i n f o r m a t i o n . To f u r t h e r a s s i s t the pharmacist i n assuming t h i s new r o l e o f monitoring drug i n t e r a c t i o n s , two books have been p u b l i s h e d - 13 -r e c e n t l y (46, 47). The f i r s t i s a p i l o t p r o j e c t c a l l e d " E v a l u a t i o n of Drug I n t e r a c t i o n s " (46). I t i s an attempt to b r i d g e the gap between r e c o g n i z i n g the e x i s t e n c e of an i n t e r a c t i o n and p r o v i d i n g a s a t i s f a c t o r y s o l u t i o n to the problem. This approach hopes to h e l p p h y s i c i a n s and pharmacists to decide between complete discontinuence of one o r the other of the drug therapies Involved; o r to make a simple change i n choice of drugs w i t h respect to one or both of the therapies i n v o l v e d ; o r to u t i l i z e the same drugs but adju s t o r modify the dosage schedule to one or both of the pharmaceuticals i n v o l v e d ; or to continue both drugs at the same dosage regimen but under much, c l o s e r monitoring o f the p a t i e n t (46). This p r o j e c t a l s o w i l l provide two s e c t i o n s . One s e c t i o n provides b r i e f monographs of s p e c i f i c drug i n t e r a c t i o n s ; and the other s e c t i o n o f f e r s chapters w i t h d e t a i l o f background i n f o r m a t i o n such as pharmacol-ogy, biopharmaceutics and t h e r a p e u t i c s . A l l of t h i s i n f o r m a t i o n w i l l h elp the p r a c t i t i o n e r to b e t t e r understand the various i n t e r a c t i o n s , The above p r o j e c t covers only ten such i n t e r a c t i o n s , and i s pres-e n t l y u s e f u l f o r only those t e n . However, a s i m i l a r book by Hansten (47) i s very thorough i n covering 11 t h e r a p e u t i c c a t e g o r i e s of drug-drug i n t e r a c t i o n s , and twe n t y - f i v e s e c t i o n s on drug-laboratory t e s t i n t e r a c t i o n s . This p u b l i c a t i o n does not go i n t o as much d e t a i l as the previous t e x t . However, at the present time i t i s the most comphrensive reference on the subje c t of e v a l u a t i o n of drug i n t e r a c t i o n s . These two books could be considered as "secondary" review references s i n c e they are too d e t a i l e d f o r p r e l i m i n a r y s c r e e n i n g , but are best used when e v a l u a t i o n i s r e -qu i r e d i n making a p r o f e s s i o n a l d e c i s i o n about a p o t e n t i a l i n t e r a c t i o n . A c c o r d i n g l y , i t i s now p o s s i b l e f o r a pharmacist to have a "primary" - 14 -screening reference and a "secondary" review reference f o r monitoring drug i n t e r a c t i o n s . Significance of Drug Interactions Now that reference m a t e r i a l i s becoming a v a i l a b l e on drug i n t e r -a c t i o n s and more community pharmacists are monitoring drug usage w i t h the a i d o f a p a t i e n t record p l a n ; the importance of e v a l u a t i n g p o t e n t i a l drug i n t e r a c t i o n s i n the community s e t t i n g and the e f f e c t i v e n e s s of the p a t i e n t card system i n monitoring the same should r e c e i v e more a t t e n t i o n . I t should be r e a l i z e d t h a t drug i n t e r a c t i o n s can be very s e r i o u s and i n f a c t deaths have been a t t r i b u t e d to combined drug therapy r e s u l t i n g i n unintended i n t e r a c t i o n s (43, 46). Many l e s s dramatic but c l i n i c a l l y s i g n i f i c a n t drug i n t e r a c t i o n s a l s o have been reported (A3). There i s no way of e s t i m a t i n g how o f t e n drug i n t e r a c t i o n s have c o n t r i b u t e d to i n -creased t o x i c i t y or decreased t h e r a p e u t i c e f f i c a c y . However, s e v e r a l authors (26, 43, 46). have pointed to the p o s s i b l e c o r r e l a t i o n i n the s i g n i f i c a n t i n c r e a s e of adverse e f f e c t s i n p a t i e n t s using more than one drug. U n f o r t u n a t e l y , only very dramatic e f f e c t s of a drug, o r drug com-b i n a t i o n , are u s u a l l y p e r c e i v e d ; and undoubtedly many c l i n i c a l l y s i g -n i f i c a n t i n t e r a c t i o n s have been overlooked. Although i n f o r m a t i o n on the number of p a t i e n t s i n v o l v e d i n drug i n t e r a c t i o n s i s l i m i t e d , there i s no shortage of r e p o r t s on p o t e n t i a l drug combinations that may be i n v o l v e d . Long l i s t s o o f p o t e n t i a l drug i n t e r a c t i o n s have been provided (43, 44, 48) which to some extent rep-resents an o v e r r e a c t i o n to the problem. Many of these r e p o r t s are based on i n s u f f i c i e n t data, l i m i t e d numbers of p a t i e n t s , o r animal data alone (43). I f the pharmacist i s to make a u s e f u l c o n t r i b u t i o n i n screening - 15 -potential interactions, he must become familiar with the limitations of c l i n i c a l and s c i e n t i f i c evidence as presented in the literature. Tet-racycline, for example, has been l i s t e d as a potential interactant with many drugs. If the pharmacist was to alert the physician everytime he learned of a patient taking tetracycline and one of these drugs, he would soon lose the respect of his colleague. Many other factors, which determine the significance of the potential interaction, must be consid-ered f i r s t . The following presentation of tetracycline and some potential drug interactions suggest some such factors which must be considered in screening drug interactions. (a) Tetracycline Interactions With Calcium, Aluminum and/or Magnesium Containing Preparations. Well established c l i n i c a l data has shown that there i s a reduction i n tetracycline blood levels when aluminum hydroxide gel, or magnesium-aluminum hydroxide gel, or milk of magnesia i s given concurrently with tetracyclines (49 - 53). The mechanism previously had been attributed to chelation of the cations by the tetracycline (51). However, a pH effect on the dissolution of the tetracycline is also proposed now since an antacid (sodium bicar-bonate) , containing no divalent or trivalent cations has been shown to impair absorption of the tetracyclines (54). Eight ounces of pasturized milk and four ounces of cottage cheese have also been cited to reduce significantly the absorption of tetracycline (55). Although the mechanism i s not agreed upon, the above are inter-actions that could conceivably result i n inadequate therapy, suboptimal response, or relapse (55, 56). - 16 -(b) T e t r a c y c l i n e I n t e r a c t i o n s With Iron Products. In a recent study, plasma l e v e l s of the t e t r a c y c l i n e s reached only 10 to 15% of t h e i r expected v a l u e when an i r o n supplement was given o r a l l y a t the same time as the t e t r a c y c l i n e , ( 5 7 ) . This i n t e r a c t i o n i s not l i s t e d I n Hansten's book (47). However, t n l i g h t o f the recent evidence (57), i t should be considered a s i g n i f i c a n t i n t e r a c t i o n . Cc) T e t r a c y c l i n e I n t e r a c t i o n s With P e n i c i l l i n s . The b a c t e r i o s t a t i c e f f e c t o f t e t r a c y c l i n e has been shown to an-tagonize the b a c t e r i c i d a l a c t i v i t y of p e n i c i l l i n s , C 5 8 , 59), Since pen-i c i l l i n s act by i n h i b i t i n g c e l l w a l l s y n t h e s i s , and the t e t r a c y c l i n e s i n h i b i t p r o t e i n s y n t h e s i s , there i s a p o t e n t i a l r i s k to usi n g both. Clin^-i c a l l y , the antagonism has only been shown to occur under s p e c i f i c con-d i t i o n s of dose and order of therapy (59). This probably p l a y s a minor r o l e i n c l i n i c a l medicine depending on these r e l a t e d f a c t o r s . One author (56) suggests t h a t , i f the two must be used together, the f o l -lowing p o i n t s should be observed. The p r e s c r i b e r should be sure adequate amounts of each agent are gi v e n ; antagonism i s most l i k e l y when b a r e l y s u f f i c i e n t amounts o f each are given. Secondly,hhe should begin admin-i s t r a t i o n of the p e n i c i l l i n a t l e a s t a few hours before the t e t r a c y c l i n e . (d) T e t r a c y c l i n e I n t e r a c t i o n s With Anticoagulants ( O r a l ) . O r a l t e t r a c y c l i n e could enhance the e f f e c t of o r a l a n t i c o a g u l a n t s due to impaired v i t a m i n K production by suppressing organisms i n the gas^-t r o i n t e s t i n a l t r a c t . This may be only s i g n i f i c a n t when d i a t a r y i n t a k e o f v i t a m i n K i s d e f i c i e n t (56). However, c a u t i o n must be e x e r c i s e d to ensure - 17 -that no b l e e d i n g tendencies a r i s e when t e t r a c y c l i n e i s administered o r a l l y to p a t i e n t s s t a b a l i z e d on o r a l a n t i c o a g u l a n t s . Ce) T e t r a c y c l i n e I n t e r a c t i o n With R i b o f l a v i n . Hartshorn (60) r e p o r t s that r i b o f l a v i n may decrease a n t i b i o t i c a c t i v i t y based on a study by F o s t e r (61). This i s most l i k e l y not a c l i n i c a l l y s i g n i f i c a n t i n t e r a c t i o n s i n c e only the one study can be found to support a p o t e n t i a l i n t e r a c t i o n and i t i s u n c l e a r what mech-anism i s i n v o l v e d . ( f ) T e t r a c y c l i n e I n t e r a c t i o n With C i t r i c A c i d . C i t r i c a c i d has been shown i n a c l i n i c a l t r i a l to enhance the ab-s o r p t i o n of t e t r a c y c l i n e h y d r o c h l o r i d e (62). A p o s s i b l e mechanism i s tha t c i t r a t e s may ch e l a t e metal ions i n the g a s t r o i n t e s t i n a l t r a c t (62). This i s a b e n e f i c i a l i n t e r a c t i o n t h a t could be used to enhance e f f e c t -iveness of t e t r a c y c l i n e therapy. ( I n s t r u c t p a t i e n t s to take t e t r a c y c l i n e w i t h f r u i t j u i c e s ) . C g ) T e t r a c y c l i n e I n t e r a c t i o n With Chymotrypsin ( O r a l ) . When chymotrypsin and t e t r a c y c l i n e were administered together o r a l l y , there was a great i n c r e a s e i n t e t r a c y c l i n e b l o o d l e v e l over t e t r a c y c l i n e given alone (63). This i s another b e n e f i c i a l i n t e r a c t i o n , but no mechanism has been proposed. (h) T e t r a c y c l i n e I n t e r a c t i o n s With Urine A c i d i f i e r s . Hartshorn (60) reports that at a u r i n e pH of 5.5 o r l e s s , there i s an enhanced a n t i b i o t i c a c t i v i t y s i n c e t e t r a c y c l i n e w i l l be excreted l e s s - 18 -r a p i d l y i n an a c i d u r i n e . Again t h i s could be of value when t e t r a c y c l i n e s are r e q u i r e d to t r e a t kidney i n f e c t i o n s . L i k e w i s e , u r i n e a l k a l i n i z e r s w i l l enhance the r a t e of e x c r e t i o n and decrease t e t r a c y c l i n e e f f e c t i v e n e s s . The above co n s i d e r a t i o n s must be recognized before i n i t i a t i n g any a c t i o n on a p o t e n t i a l i n t e r a c t i o n w i t h t e t r a c y c l i n e . Pharmacists i n h o s p i t a l s u s u a l l y can i n f l u e n c e f a c t o r s , such as dosage regimen i n com-bined therapy. However, pharmacists d e a l i n g w i t h ambulatory p a t i e n t s do not have such c o n t r o l . T h e i r screening problem becomes more complicated i n that they must a l s o be a l e r t e d to i n t e r a c t i o n s of drugs s e l f - s e l e c t e d by the p a t i e n t . Are such n o n - p r e s c r i p t i o n s e l e c t i o n s a s i g n i f i c a n t p o t e n t i a l problem? Should the recording of these drugs on p a t i e n t record plans be as c r i t i c a l as recording p r e s c r i p t i o n - o n l y medications? Block and Lamy C64) have reviewed many of the dangers of n o n - p r e s c r i p t i o n drug s e l f - m e d i c a t i o n and t h e i r p o t e n t i a l i n t e r a c t i o n s . They conclude t h a t , s i n c e the p h y s i c i a n i n most instances i s unaware of the p a t i e n t s s e l e c t i o n of n o n - p r e s c r i p t i o n drugs, the burden f o r preventing n o n - p r e s c r i p t i o n drug i n t e r a c t i o n s r e s t s s o l e l y w i t h the pharmacist and h i s proper u t i l -i z a t i o n of the p a t i e n t record p l a n . How w e l l does t h i s system serve i t s purpose? Many have claimed i t can work (15, 25, 64) but no r e p o r t s of e f f e c t i v e n e s s have been w r i t t e n . - 19 -C. DRUG SENSITIVE CONDITIONS AND PATIENT RECORD PLANS. The prevention of medical problems i s as important in health care as the treatment of existing problems. Therefore, when a patient has had an allergic reaction at one time to a drug i t i s essential that a l l health professionals be aware of this before prescribing, dispensing, or admin-istering any medication to this patient. Furthermore, many patients have specific diseases in which certain medications are contraindicated. For the purposes of this study, both drug allergies and these specific disease states w i l l be referred to as "drug sensitive conditions". Drug sensitivities have been reported In 10 to 15% of the people of the United States in one study (65). Another investigator (66) re-ported 20% of people who were questioned had drug allergies. Another survey (36,) i n a hospital showed as many as 25% of the patients admitted to hospitals reported drug hypersensitivities. The higher percentages were found when pharmacists conducted the interview of the patient. A mail-in survey conducted by a community pharmacist (13) showed that 9% of his patients who responded to the questionnaire had previous drug allergies or idiosyncracies. The low percentage in the latter could reflect that many patients were not familiar with exactly what should be classed as an allergy or idiosyncracy; or they had forgotten the name of the offending agent. A pharmacist interviewer could define these terms, and obtain more positive responses. However, i t would be expected that those patients who were aware of their allergy to drugs would be motivated to reply to the survey. A comparison of the pharmacists' hospital admission interviews (36), the respiratory disease patients (67) and the mailed-in question-naires (13) are as follows: - 20 -MAIL IN RESPIRATORY DISEASE HOSPITAL INTERVIEW Chiles PATIENTS McHale (13) Meyer (67) (36) Total patients with allergies 311 142 50 Causative Agents 1. Penicillins 186 78 24 (percentage) (59) (55) (48) 2. Sulfonamides 43 19 9 (percentage) (14) (13) (18) 3. A.S.A. 12 17 4 (percentage) (4) (12) (8) 4. Morphine, Codeine, Meperidine 20 5 7 (percentage) (6) (4) (14) 5. Tetracyclines 7 3 3 (percentage) (2) (2) (6) 6. Other drugs and chemicals 12 20 20 One book (67) reports their are 100 to 300 fatal reactions to pen-i c i l l i n alone i n the United States each year. They estimate from 10 to 15 million people have been, or s t i l l are, hypersensitive. Drug sen-s i t i v i t i e s are reported to occur most frequently i n the third decade of l i f e , and i n females more than in males (67). Unless a pharmacist main-tains a patient record plan, i t is extremely d i f f i c u l t for him to pre-vent further exposure of patients to those drugs which have caused problems in the past. Chiles states, "In order to prevent allergic reactions i t i s nec-essary not only to get the data on the card but also the card must be pulled before each prescription i s f i l l e d . In this way not only allergies but other problems can be averted" (13). - 21 -One o f the other problems which can be averted i s when a p a t i e n t has a p a r t i c u l a r disease o r p r e - e x i s t i n g c o n d i t i o n i n which c e r t a i n drugs are c o n t r a i n d i c a t e d . For example, p a t i e n t s w i t h glaucoma should not use any drugs which have a n t i c h o l i n e r g i c p r o p e r t i e s , ( 1 3 ) . The presence of glaucoma i n a p a t i e n t could be flagged at the top of the p a t i e n t record card j u s t l i k e an a l l e r g y . I f not f l a g g e d , t h i s disease may be i n -d i c a t e d by the f a c t t h a t the p a t i e n t i s using m i o t i c drugs l i k e p i l o c a r -p i n e , o r phospholine i o d i d e ( 1 3 ) . Hypertensive p a t i e n t s should not be given drugs which would aggravate t h i s c o n d i t i o n such as pseudoephedrine or phenylephrine ( 1 3 ) . D i a b e t i c s should be cautioned to avoid high sugar content cough syrups or to avoid unnecessary i n j e s t i o n of s a l i c y l a t e s ( 1 3 ) . Pregnancy i s a c o n d i t i o n i n which many drugs are c o n t r a i n d i c a t e d , espec-i a l l y headache t a b l e t s c o n t a i n i n g ergotamine ( 1 3 ) . P e p t i c u l c e r p a t i e n t s are to avoid many drugs and foods. A l c o h o l , c a f f e i n e d r i n k s , pepper and other s p i c e s are j u s t a few foods ( 2 8 ) . Drugs l i k e c o r t i c o s t e r o i d s , indomethacin : and s a l i c y l a t e s are c o n t r a i n d i c a t e d i n p e p t i c u l c e r p a t i e n t s ( 1 3 , 2 8 ) . U s u a l l y antacids are used i n l a r g e amounts by these p a t i e n t s , whether on p r e s c r i p t i o n o r purchased over-the-counter. The pharmacist must be aware o f t h i s when these p a t i e n t s are given o r a l t e t r a c y c l i n e f o r i n f e c t i o n ( 2 8 ) . The concurrent use of antacids and t e t r a c y c l i n e s w i l l impair t e t r a c y c l i n e absorption and could delay o r prevent the e r a d i c a t i o n of the i n f e c t i o n ( 2 8 ) . To make the most of the p a t i e n t record p l a n there must be a w e l l designed card c o n t a i n i n g the necessary i n f o r m a t i o n about drug s e n s i t i v i t i e s and p r e - e x i s t i n g disease s t a t e s . The problem of g e t t i n g t h i s i n f o r m a t i o n from p a t i e n t s i s o f t e n a d i f f i c u l t t a s k ; and a time consuming one both i n the h o s p i t a l ' s o u t - p a t i e n t c l i n i c ( 3 3 i 35, 3 6 ) , and i n community pharm-- 22 -a c i e s (13, 27). In the community s e t t i n g some pharmacists o b t a i n t h i s data from a q u e s t i o n n a i r e mailed out to the p a t i e n t (13, 14) or from i n -the-store i n t e r v i e w s (14, 21). The h o s p i t a l pharmacist (26) has an ad-vantage i n that he has access to the p a t i e n t s current disease s t a t e s and medication c h a r t ; w h i l e the community pharmacist u s u a l l y has no access to the d iagnosis or the p h y s i c i a n s o u t - p a t i e n t chart (30, 34). Even though the p o t e n t i a l use of the record card i n the area of prevention of a l l e r g i c r e a c t i o n s to medication o r w i t h h o l d i n g products c o n t r a i n d i c a t e d i n pre-e x i s t i n g disease s t a t e s i s w e l l p u b l i c i z e d (12, 13, 20, 21, 27, 28, 34), no r e p o r t s have shown the i n c i d e n c e of i t s use i n t h i s area, or i t s f u t u r e p o t e n t i a l to the community pharmacist contemplating the use of the p a t -i e n t s record card system. I f the community pharmacist i s to keep pace w i t h the s e r v i c e s o f -f e r e d by the h o s p i t a l pharmacist, i t would appear t h a t a mechanism of p r o v i d i n g the community pharmacist w i t h more data on the p a t i e n t s present disease s t a t e must be considered to make the record p l a n more u s e f u l i n preventing p o t e n t i a l drug^-disease i n t e r a c t i o n (28). In other words, the c l i n i c a l pharmacist i n the community must be more d i s e a s e - o r i e n t e d as w e l l as being more p a t i e n t and drug-oriented. One step toward s o l v i n g t h i s problem has been presented i n the Canadian Pharmaceutical J o u r n a l of November (23) by McQueen and Segal i n t h e i r a r t i c l e on " P a t i e n t Oriented Drug I n t e r a c t i o n Communication System". The i n t r o d u c t i o n of the computer i n t o t h i s area w i l l h o p e f u l l y help s o l v e many of the problems i n t h i s area of p a t i e n t i n f o r m a t i o n . The p a t i e n t record p l a n may be a v a l u a b l e t o o l i n the prevention of - 23 -adverse drug e f f e c t s due to drug s e n s i t i v i t i e s and diseases i n which c e r t a i n medications are c o n t r a i n d i c a t e d . However, there are questions which cannot be answered s o l e l y from the l i t e r a t u r e . How w e l l does the a l l e r g y i n f o r m a t i o n on the p r e s c r i p t i o n record plans compare to a l l e r g y data c o l l e c t e d by other researchers?(67, 36)? How w e l l does t h i s i n f o r -mation on drug s e n s i t i v i t i e s compare to the same i n f o r m a t i o n on a phy-s i c i a n s o u t - p a t i e n t record? Has a p a t i e n t record p l a n been e f f e c t i v e i n i n f l u e n c i n g drug therapy because of t h i s flagged i n f o r m a t i o n on a l l e r g i e s and diseases? - 24 -D. DRUG ADMINISTRATION AND PATIENT RECORD PLANS The responsibility of a patient for his prescribed medication differs depending on whether he i s hospitalized or is an out-patient. The med-ication program for a patient i n the hospital i s handled by the physician, pharmacist, and nurse. The physician prescribed, the pharmacist dis-penses and the nurse administers the medication to the patient at the correct time in the prescribed dosage. The nurse i s also able to ob-serve the effects of the drug and report any adverse effects to the phy-sician. The medication may be continued or stopped at the discression of the physician who sees the patient one or more times a day. Drug dosage can easily be altered from dose to dose without involving a de-cision by the patient. From the patients chart the physician can see the total drug program of the patient at any one time and can prevent therapeutic incompatabilities or contraindications. Thus, the hospital-ized patient is relieved of responsibility for controlling his drug therapy program - i t is done for him (69). What of the patients outside the hospital? Depending upon his socio-economic (69) standing or his mobility in the community, he may or may not normally v i s i t one family physician who has an intimate knowledge of the patient, his family, and the environment in which he l i v e s . Even though the patient may be v i s i t i n g only one c l i n i c of doctors on a reg-ular basis, he i s not necessarily seen by the same physician at each v i s i t . Thus, there could be created a lack of continuity i n his drug therapy pro-gram. One of the main problems i n treating an out-patient i s that he must be relied upon to take his medication correctly. The patients con-dition may be adversely affected i f the physician's medication directions - 25 -are not followed exactly. The physician may lose confidence i n an other-wise effective therapeutic agent because the patient i s not following his directions. It i s proposed by some (69) that each patient required more detailed instructions on how and when to take his medication or he may be more apt to misunderstand instruction, forget to take a dose or even discontinue taking the drug. The patient may not be cognizant of what his illness i s or why he i s taking his medication. In a busy physician's office there is not always sufficient time to help a l l patients to understand their medication. Hence, some patients are forced to act on their own i n i t -iatives. Various investigators have studied the problem of self-medication by out-patients (69 - 73). The frequency of misuse in these studies ranged from 20% to 90% of the patients misusing one or more of their med-ications. These past studies have a l l been conducted within out-patient departments of teaching hospitals. Latiolais and Berry (69) found that 77 (42.8%) of 180 out-patients sampled misused at least one of their medications. Of this group, 8 patients (10.4%) were actually misusing their medication in such a manner that i t was very detrimental to their health. The most frequent type of misuse was either overdosage or under-dosage (69). The reason for over-dosages was that many psychiatric pa-tients were included in this study who tended to exceed recommended doses. The second most frequent misuse in this study (69) was omission of one or more dosages. This is the chief type of misuse reported in other l i t -erature (70). The two main reasons given in the literature for misuse are the following: 1. The patient thought he was cured and stopped taking the drug before he was supposed to; - 26 -2. the patient did not understand his instructions. The latter was the more prevelant excuse in the studies by Latiolais and Berry (69) and by Tuttle (70). In the study by Latiolais and Berry (69) they compared the effect of information received from the physician or from the pharmacist, on the incidence of medication errors by the patient. They concluded that the more information the physician gave about the use of the medication, the less l i k e l y the patient was to misuse i t . This coincides with the findings of others lik e Curtis (71). The pharmacists instructions in this one study (69) seemed to have l i t t l e effect on the patients misusing his medication. They explain the lack of effectiveness of the pharmacist by the fact that, i n the study, the insteuctions were given i n a crowded waiting room with noise&and distractions around. They also showed that fewer than one in five patients knew when to stop taking their medications. They often did not know whether the drug was for an acute ailment or a cronic i l l n e s s . By not knowing when to stop, the patient i s more li k e l y to discontinue the drug prematurely; especially the short term drugs such as antibiotics (69). These same authors have suggested the need for more investigation. One area they suggest i s the effect of the pharmacists instructions on a patient. They recommend: "... i t is evident that someone must take more time with these patients to explain how to take medicines properly. Physicians and pharmacists must review their traditional prescribing and dispensing procedures to see how these can be modified to help this type of out-patient u t i l i z e potent medication safely. Steps must be taken to solve this problem of misuse of medication by out-patients" (69). - 27 -In other words, a way must be found by pharmacists to improve the e f f e c t i v e n e s s of t h e i r communications to p a t i e n t s on the use of medication. As demonstrated i n many of these s t u d i e s , the problem i s not only one o f proper i n s t r u c t i o n s by the p h y s i c i a n and pharmacist, but a l s o one of proper understanding and compliance to the i n s t r u c t i o n s by the p a t i e n t . To achieve gr e a t e r c o n t r o l of drug use i n s o c i e t y there has to be an i n -crease i n p r o f e s s i o n a l - p a t i e n t contact. As physicians cannot spend much more time i n t h i s s e r v i c e , the pharmacist should assume t h i s r e s p o n s i b i l i t y f o r the p a t i e n t using h i s medication c o r r e c t l y . T u t t l e (30), found that an extremely s m a l l percentage of the p a t i e n t ' s c l i n i c time w i t h the p h y s i c i a n i s spent on i n f o r m a t i o n and query w i t h regard to the drug therapy being i n i t i a t e d . Almost a l l of the b r i e f time a v a i l a b l e must be spent on: " 1. p h y s i c a l examination, 2. q u e s t i o n i n g of the p a t i e n t regarding background to h i s c o n d i t i o n and sym-ptoms observed, 3. r e q u i s i t i o n i n g the r e q u i r e d l a b o r a t o r y t e s t s and r e f e r r a l s , 4. entry making i n t o the medical record of i n f o r m a t i o n obtained i n the appointment, 5. reassurance of the p a t i e n t by the p h y s i c i a n , 6. the b a s i c w r i t i n g of the p r e s c r i p t i o n once the course of treatment has been decided upon" (30). She found that s u f f i c i e n t time i s not a v a i l a b l e f o r a complete explan-a t i o n of s e l f - a d m i n i s t r a t i o n of the drugs, and a l l of the d e s i r a b l e pre-cautionary i n f o r m a t i o n , even i f the p h y s i c i a n has t h i s i n f o r m a t i o n at hand. - 28 -Several a r t i c l e s have s t a t e d that the use of a p r e s c r i p t i o n record p l a n has a pla c e i n c o n t r o l l i n g misuse of medications (12, 14, 30). The guide published by the Pharmaceutical A s s o c i a t i o n o f the Province of B r i t i s h Columbia on "Family Record P l a n s " s t a t e d that the pl a n a s s i s t s the pharmacist t o , " l e a r n of abuse o f p r e s c r i b e d drugs!'overdose, under-dose, e t c . " (21). Dyck (14) p o i n t s out that h i s Family Record System has proved v a l u a b l e i n s i t u a t i o n s where p a t i e n t s are exceeding doses w i t h drug abuse tendancies, or have made i n c o r r e c t assumptions, o r m i s i n t e r p r e t e d the p h y s i c i a n s advice (14). This i s a l s o claimed by C h i l e s (13). P l e i n (3) s t a t e d that the c l i n i c a l pharmacist i n a community pharmacy maintains , medication records and discusses w i t h the p a t i e n t how h i s medications are to be taken. Smith says that using a p a t i e n t p r o f i l e w i l l , as he puts I t , "guarantee the p a t i e n t the best drugs are used and used c o r r e c t l y " ( 4 ) . T u t t l e (30) claims t h a t s t u d i e s are under way i n h o s p i t a l o u t - p a t i e n t departments to determine how the pharmacist can c o n t r i b u t e more f u l l y to h e a l t h care w i t h p a t i e n t drug p r o f i l e s and p a t i e n t follow-ups to ensure that the p a t i e n t i s p r o p e r l y o b t a i n i n g and using h i s medication. She a l s o has prepared a l i s t of p a t i e n t i n s t r u c t i o n s to be i n c l u d e d w i t h the pre-s c r i p t i o n . These three i n c h by f i v e inch cards, c a l l e d "medi^notes" f o r 118 drugs, are used to r e i n f o r c e p h y s i c i a n and pharmacist i n s t r u c t i o n s to the p a t i e n t . Fox, (74) McGee, (32) Smith., (33) and Vreugdenhil (31) a l s o proposed w r i t t e n reinforcement of a u x i l l i a r y d i r e c t i o n . As y e t , most o f the suggestions are not fol l o w e d up i n t h e l l i t e r a t u r e and t h e i r e f f e c t -iveness has not been reported upon. One home follow-up which was pro-posed was that of White (12). He c a l l e d i t a "Pharmacotherapy Home Follow-up", o r "P.H.F.". This i s a plan whereby the p a t i e n t i s p e r s o n a l l y contacted at home - by phone - to determine whether he i s t a k i n g h i s - 29 -medication p r o p e r l y ; and whether he i s experiencing any adverse r e a c t i o n s or i n t e r a c t i o n s . He can a l s o a s c e r t a i n whether c e r t a i n medications have been taken as p r e s c r i b e d . I t i s suggested that t h i s method w i l l p rovide c l o s e r drug s u r v e i l l a n c e . He claims the P.H.F. w i l l reduce the c a l l s to the already overtaxed p h y s i c i a n w i t h respect to h i s p r e s c r i p t i o n s . I t w i l l a l s o encourage the p a t i e n t to t h i n k of the pharmacist f i r s t on questions concerning h i s medication. U n f o r t u n a t e l y , Mr. White does not report on how s u c c e s s f u l t h i s approach has been i n reducing the misuse of medication. I f the P.H.F. phonecalls are conducted by a pharmacist there w i l l be another increase on the pharmacists time, i n a d d i t i o n to h i s time monitoring the p a t i e n t s drugs on the p a t i e n t record p l a n . P a t i e n t contact and communication w i l l be hard to e s t a b l i s h s i n c e the pharmacist w i l l not know when the p a t i e n t i s at home o r at work. The time he phones may not be convenient f o r the p a t i e n t . Therefore, i t seems reasonable that an a l t e r n a t e approach could be suggested, so as to put the onus on the p a t i e n t to contact the pharmacist at the completion of a dosage regimen, o r at the f i r s t s i g n of a drug r e l a t e d problem. B e l l a f i o r e (34) supports t h i s proposal by suggesting t h a t the p u b l i c w i l l have to be educated about drugs i n order to e n l i s t i t s co-operation w i t h the e f f o r t s that the pharmacist i s attempting on i t s b e h a l f . Perhaps by i n v o l v i n g the p a t i e n t on t h i s type of follow-up program, he w i l l be more motivated to f o l l o w the d i r e c t i o n s of h i s p h y s i c i a n and pharmacist; w i t h the end r e s u l t p f b e t t e r medication u t i l i z a t i o n and b e t t e r p a t i e n t care. Evidence i n the l i t e r a t u r e i n d i c a t e s that o u t - p a t i e n t drug usage could be improved i f the pharmacist could spendtwnore time p r o p e r l y i n s t r u c t i n g h i s p a t i e n t s on p r e s c r i p t i o n usage. A form o f p a t i e n t follow-up has been - 30 -suggested (12) as well as a written reinforcement to verbal i n s t r -uctions (30). If these approaches are used i n a community setting, how effective w i l l they be? How can the prescription record plan be used in a patient follow-up to improve drug utilization? - 31 -E. PHARMACIST TIME AND THE PATIENT RECORD PLAN 1. The Non-Professional A s s i s t a n t ' s Role. One of the most p r o f e s s i o n a l i n n o v a t i o n s i n the modern p r a c t i c e o f pharmacy, the p a t i e n t record p l a n , i s meeting an o b s t a c l e i n implemen-t a t i o n s i m i l a r to that encountered by other innovations - i n c r e a s i n g the demands on pharmacists' time and paperwork l o a d . The other main o b s t a c l e to implementation i s cost of maintenance i n terms of p r o f e s s i o n a l and non- p r o f e s s i o n a l involvement. The Commission on Pharmaceutical S e r v i c e s (75) i n d i c a t e d that they t h i n k there i s at l e a s t a p a r t i a l s o l u t i o n to t h i s problem by the use of non - p r o f e s s i o n a l a s s i s t a n t s i n some dispensary f u n c t i o n s . They b e l i e v e that the c o n s u l t a t i v e f u n c t i o n s are among the most important p r o f e s s i o n a l r e s p o n s i b i l i t i e s i n the current r o l e s t r u c t u r e and th a t the use of p r o p e r l y t r a i n e d and supervised n o n - p r o f e s s i o n a l a s s i s t a n t s i n the r o u t i n e c l e r i c a l and t e c h n i c a l f u n c t i o n s represents an e f f e c t i v e mechanism by which e x t r a time can be made a v a i l a b l e f o r p r o f e s s i o n a l development of these f u n c t i o n s . They a l s o made reference to the present pharmacist time u t i l i z a t i o n . The Commission i n d i c a t e d that there i s concern, both w i t h i n the p r o f e s s i o n and amongst h e a l t h care planners g e n e r a l l y , that pharmacists are under u t i l i z e d i n t h e i r p r o f e s s i o n a l and h e a l t h r e l a t e d r e s p o n s i b i l i t i e s , The Commission report says, " The Royal Commission on Health S e r v i c e s , and Harley Committee, and the Committee on the Healing A r t s a l l have commented on the f a c t t h a t , although t r a i n e d as p r o f e s s i o n a l s , community pharmacists spend a s i g n i f i c a n t p r o p o r t i o n of t h e i r time on duties unrelated to t h e i r p r o f e s s i o n a l r o l e " (76). - 32 -The l a t t e r quotation r e f l e c t s the concern that the pharmacist i s not performing up to h i s c a p a b i l i t i e s ; w h i l e i n the former comments, the Commission suggested that the pharmacist can r e l i e v e much of h i s non - p r o f e s s i o n a l work loa d by the use of a s s i s t a n t s i n the dispensary. Another task f o r c e report i n 1969 f o r the American Pharmaceutical Assoc-i a t i o n (68) agrees w i t h the above comments. T h e i r f i n d i n g s show th a t the average American pharmacist may be unusual, i f not unique, among u n i v e r s i t y -educated p r o f e s s i o n s i n the p r o p o r t i o n of h i s e f f o r t s i n v e s t e d i n fun-c t i o n s perhaps not demanding a p r o f e s s i o n a l l e v e l o f knowledge and s k i l l . While t h i s question has never been completely evaluated, i t c l e a r l y has generated recent i n t e r e s t i n r e d e f i n i n g and r e i n f o r c i n g the pharmacists p r o f e s s i o n a l f u n c t i o n ; and c o n s i d e r i n g , on the other hand, whether a subordinate a u x i l l i a r y could be more e f f e c t i v e l y u t i l i z e d (68). In both c o u n t r i e s , the pharmacy planners have suggested the pharmacist has to be-come more e f f i c i e n t i n h i s p r o f e s s i o n a l r o l e , perhaps by e n r o l l i n g the non-p r o f e s s i o n a l a s s i s t a n t . Franke (77) found that experience i n numerous pharmacies ( m i l i t a r y , h o s p i t a l and others) has demonstrated that i n d i v -i d u a l s without formal pharmacy education can e f f e c t i v e l y undertake many of the r o u t i n e a c t i v i t i e s of pharmacists, under the s u p e r v i s i o n of a l i -cenced pharmacist. As e a r l y as 1968, Americans (78) have gone so f a r as to recommend th a t J u n i o r Colleges and other e d u c a t i o n a l i n s t i t u t i o n s de-velop a pharmacist-aid c u r r i c u l u m f o r the t r a i n i n g o f n o n - p r o f e s s i o n a l a s s i s t a n t s i n pharmacy. G r a d u a l l y , pharmacists are beginning to accept pharmacy t e c h n i c i a n s ' or n o n - p r o f e s s i o n a l a s s i s t a n t s ' (N.P.A.) p a r t i c i p a t i o n i n the dispensing f u n c t i o n ; thus a l l o w i n g pharmacist to move Into more meaningful and c h a l -lenging r o l e s , where t h e i c a b i l i t y to make judgements and d e c i s i o n s as^ sures f o r them a good f u t u r e i n the main stream o f h e a l t h care. The use - 33 -of pharmacy t e c h n i c i a n s o r a s s i s t a n t s has been w r i t t e n about i n Great B r i t a i n (79) s i n c e the 18th century. A recent survey (80) on the use of pharmacy t e c h n i c i a n s i n American h o s p i t a l s forsees that a m a j o r i t y of the b a s i c dispensing process could e v e n t u a l l y be conducted w i t h proper super-v i s i o n by t r a i n e d h o s p i t a l pharmacy t e c h n i c i a n s . P r o f e s s i o n a l organ-i z a t i o n s have been c a r e f u l to s e t down guide l i n e s f o r the u t i l i z a t i o n s o f n o n - p r o f e s s i o n a l a s s i s t a n t s i n h o s p i t a l s (68) and i n community pharm-acies (81). There i s uniform agreement th a t i t i s the pharmacist who must maintain r e s p o n s i b i l i t y throughout f o r i n v o l v i n g a n o n - p r o f e s s i o n a l i n the p r a c t i c e o f pharmacy, without d i m i n i s h i n g the e f f e c t i v e n e s s and s a f e t y of pharmaceutical s e r v i c e s to the p a t i e n t . The use of non-pro-f e s s i o n a l a s s i s t a n t s i n the community pharmacy has become more popular w i t h the wide acceptance of the p a t i e n t record p l ans• The use of the a s s i s t a n t t o perform many of the no n - p r o f e s s i o n a l f u n c t i o n s has^permitted the pharmacist to monitor p a t i e n t records and to spend more time i n con s u l -t a t i o n w i t h the p a t i e n t (14). 2. The Cost of P a t i e n t Record P l a n s . Many pharmacists^would s t i l l seem to oppose the use o f a p a t i e n t r e -cord p l a n on the grounds that they do not have enough time, o r th a t there i s too much i n i t i a l c o s t , o r th a t they cannot a f f o r d to h i r e more s t a f f . What then i s the cost of operating a p a t i e n t record plan i n a Canadian pharmacy? A recent a r t i c l e (14) surveyed s e v e r a l Canadian pharmacies to get opinions on the cost o f o p e r a t i o n . One Ontario pharmacist, Vernon C h i l e s , s a i d that the cost depends on many v a r i a b l e s , such as whether the cards are entered by an a s s i s t a n t o r a pharmacist. W i l l a new o r p a r t -- 34 -time s t a f f member be r e q u i r e d to implement a p a t i e n t record plan? What type of equipment i s r e q u i r e d to meet the needs of the i n d i v i d u a l pharmacy? How much data i s to go i n t o the cards? In h i s p a r t i c u l a r s t o r e , he claims that one f u l l time r e c e p t i o n i s t , and h a l f of a pharm-a c i s t ' s s a l a r y i s r e q u i r e d to maintain the record p l a n . This would amount to about 18 cents per p r e s c r i p t i o n . The cost of m a i n t a i n i n g m a t e r i a l s i s only about $60.00 per year (14). Mr. Gant (82) has i n d i c a t e d the i n i t i a l cost of s e t t i n g up I s minimal. He f e l t a pharmacist could begin w i t h a thousand cards plus a one drawer f i l e f o r l e s s than $50.00. Annual main-tenance of m a t e r i a l would be about the same cost o r l e s s . These costs however, are o f f s e t by economic advantages such as: 1. Time saved due to having names, phone numbers and insurance data on the p a t i e n t s cards. 2. Time saved i n not having t o l o c a t e l o s t p r e s c r i p t i o n numbers. 3. Time saved i n not having to w r i t e r e c e i p t s each time. 4. Saving of at l e a s t $200.00 a year i n cost of p r i n t i n g r e c e i p t forms (14). 5. P a t i e n t s appreciate the improved s e r v i c e that f a m i l y record cards p r o v i d e . There--f o r e , they are more l i k e l y to get a l l of t h e i r p r e s c r i p t i o n s at one pharmacy. This advantage, alone, more than covers the cost of m a i n t a i n i n g a p a t i e n t record plan (14). Another Kelowna pharmacist, John Dyck, (83) a l s o agrees that the cost o f m a t e r i a l , and l a y personnel r e q u i r e d by a p a t i e n t record plan are e a s i l y o f f s e t by other cost saving f a c t o r s and by the complete nature of v a l -uable i n f o r m a t i o n a v a i l a b l e i n a few seconds. Mr. Dyck s a i d , " I t i s a - 35 -pharmacist time-saver, and t h i s i s a money-saver" (14). Only b r i e f reports c o u l d be found i n the l i t e r a t u r e of a c t u a l l t i m e - s t u d i e s of e n t r i e s on p r e s c r i p t i o n record p l a n s , or how the use of a n o n - p r o f e s s i o n a l a s s i s t a n t could i n c r e a s e the e f f i c i e n c y o f f i l l i n g p r e s c r i p t i o n s i n a pharmacy using a p a t i e n t record p l a n . Pharmacist Doug Cowan (14) i s promoting one system o f cards and claims that the average time spent r e -cording on the card i s anywhere between one-half a minute and a f u l l min-ute. The Commission on Pharmaceutical Services (42) presented data from case s t u d i e s i n 27 pharmacies i n Ontario to examine the expense p a t t e r n of d i f f e r e n t types of p r a c t i c e . The study was based on i n t e r v i e w s w i t h the owner o r manager, and a q u e s t i o n n a i r e which they completed. They q u a n t i t a t e d costs of m a i n t a i n i n g a record card by f i n d i n g the amount of time spent by pharmacist and c l e r i c a l a s s i s t a n t , and m u l t i p l y i n g i t by t h e i r h o u r l y wage. M a t e r i a l and equipment costs were found t o be i n -s i g n i f i c a n t and were not i n c l u d e d . They found t h a t n o n - p r e s c r i p t i o n medications were not r o u t i n e l y compiled on the r e c o r d s , and the cost of t h e i r i n c l u s i o n was not added to the study. They found t h a t costs mea-sured as time spent, a s s o c i a t e d w i t h the maintenance of p a t i e n t r e c o r d s , were d i f f i c u l t to i s o l a t e s i n c e the p r e p a r a t i o n , use, and e n t e r i n g of i n -formation on cards was an i n t e r g a l p a r t of the dispensing procedure. In some pharmacies they discovered that c e r t a i n tasks r e l a t i n g to the cards were delegated to c l e r i c a l s t a f f and that t h i s c o n s t i t u t e d such a l a r g e part of t h e i r d u t i e s that i t could be q u a n t i f i e d . As a r e s u l t , the costs i n c u r r e d by non-professionals could be measured w i t h more accuracy than costs a l l o c a t e d to pharmacists, to whom the reviewing of a p a t i e n t ' s r e -cord card was a s m a l l p a r t of the time taken to dispense a p r e s c r i p t i o n (42). - 36 -They found that by using c l e r i c a l s t a f f expenses o n l y , the average cost per p r e s c r i p t i o n f o r m a i n t a i n i n g the p r e s c r i p t i o n record card was 3.9 cents (0.5 - 7.0}cents on a cost range). However, i f the pharmacist's s a l a r y were i n c l u d e d i n the cost of maintenance the average value was 7.0 cents (cost range 2.0 - 15.1 c e n t s ) . In pharmacies w i t h h i g h p r e s c r i p t i o n volume, the costs per p r e s c r i p t i o n tended to be lower. They found that those pharmacists who d i d not u t i l i z e c l e r i c a l s t a f f i n the dispensary would not maintain records because they feared the amount of time to maintain records would be excessive (42). This study does not d e f i n e which f u n c t i o n s were performed by the a s s i s t a n t o r how the costs were d i v i d e d when the pharmacist's time was i n c l u d e d . The same commission (84), i n another survey, reported on the average time r e q u i r e d to dispense a r e g u l a r o r a n a r c o t i c - c o n t r o l l e d drug pre-s c r i p t i o n . A new r e g u l a r p r e s c r i p t i o n took from 6.16 minutes to 7.45 minutes when annual s a l e s volumes were over $200,00 or under $80,000 r e s p e c t i v e l y . A renewed r e g u l a r p r e s c r i p t i o n was 7.39 minutes to 8.94 minutes, and a n a r c o t i c and c o n t r o l l e d drug was 7.90 minutes to 9.55 minutes f o r the above mentioned s a l e s volume groups. Those p r e s c r i p t i o n s r e -q u i r i n g n a r c o t i c r e g i s t e r entry took approximately 17% longer to f i l l . This i n c r e a s e d time f o r recording of n a r c o t i c s and c o n t r o l l e d drugs represented 2 t o 10 cents per p r e s c r i p t i o n . This cost of r e c o r d i n g time compares w e l l w i t h the cost of time f o r rec o r d i n g on a p a t i e n t record card i n the p r e v i o u s l y mentioned study (42). The Commission on Pharmaceutical Services sums up i t s o p i n i o n on the keeping o f p a t i e n t record plans as f o l l o w s : " . . . the expense l e v e l i s not p r o h i b i t i v e and should not deter pharmacists from adopting - 37 -this system. It is our impression that the use of non-professional assistants is essential to making a patient record system efficient and economical" (85). The questions that have yet to be answered are: 1. How much pharmacist time can be saved when a no n - p r o f e s s i o n a l a s s i s t a n t i s u t i l i z e d ? and 2. I s there an economic advantage to t h i s approach? - 38 -STATEMENT OF PROBLEM The f u t u r e acceptance o f the p a t i e n t record p l a n as an i n t e g r a l t o o l i n promoting b e t t e r and s a f e r use of drugs by the ambulant p a t i e n t w i l l l a r g e l y depend on how e f f e c t i v e they are and how much demand they p l a c e on the pharmacist's time. Such p a t i e n t record plans have been i n use i n two B r i t i s h Columbia community pharmacies f o r approximately s i x to nine years. The o b j e c t i v e s of the present study are to evaluate the effect-r iveness and economy o f these plans according t o : 1. the importance o f r e c o r d i n g n o n - p r e s c r i p t i o n drugs as w e l l as p r e s c r i p t i o n drugs i n i d e n t i f y i n g p o t e n t i a l drug i n t e r a c t i o n s ; 2. a l e r t i n g the pharmacist of p o s s i b l e c o n t r a i n d i c a t e d drug usage depending on a l l e r g i e s and/or disease s t a t e s ; 3. a s s i s t i n g the pharmacist i n i n f l u e n c i n g the ambulatory p a t i e n t to f o l l o w p r e s c r i b e d d i r e c t i o n s f o r drug admin-i s t r a t i o n ; and 4. the p o t e n t i a l c o n t r i b u t i o n of the no n - p r o f e s s i o n a l a s s i s -tant to the pharmacist i n the dispensing of drug products and drug i n f o r m a t i o n . - 39 -EXPERIMENTAL METHODS A. GENERAL The geographic area chosen f o r conducting t h i s research was a sm a l l c i t y i n the i n t e r i o r o f B r i t i s h Columbia. The l a b o r a t o r y s e t t i n g s used i n the study were two community pharmacies s i t u a t e d i n t h i s c i t y , phar-macy X and pharmacy Y. Pharmacy X was a c l i n i c pharmacy s i t u a t e d i n a medical b u i l d i n g w h i l e pharmacy Y was a community pharmacy w i t h a phy-s i c a l emphasis on the dispensary, and a sm a l l e r f r o n t s t o r e area w i t h p r o f e s s i o n a l products p r i m a r i l y . The common fe a t u r e which q u a l i f i e d each of these pharmacies was the f a c t that both had had a p a t i e n t record plan i n continuous o p e r a t i o n f o r at l e a s t s i x y e a r s . The o b j e c t i v e s of the present study were p a r t i a l l y r e t r o s p e c t i v e and p a r t i a l l y dependant upon e x i s t i n g o p e r a t i n g procedures i n a pharmacy having a record p l a n i n operation f o r a l l of i t s p a t i e n t s . The above requirements could best be f u l f i l l e d by these two pharmacies at the time of t h i s study. One r e t r o s p e c t i v e e v a l u a t i o n of the p a t i e n t r e c o r d p l a n was r e l a t e d to determining i t s e f f e c t i v e n e s s i n i d e n t i f y i n g p o t e n t i a l drug i n t e r s a c t i o n between p r e s c r i b e d drugs, and between p r e s c r i b e d drugs w i t h non-p r e s c r i p t i o n medications. The second r e t r o s p e c t i v e study was conducted to determine the r o l e of the p a t i e n t record p l a n i n i n f l u e n c i n g the therapy of those p a t i e n t s having a reported drug s e n s i t i v e c o n d i t i o n . These pharmacies and t h e i r p a t i e n t record plans were a l s o s e l e c t e d t o p r o j e c t the usefulness o f such systems i n i n f l u e n c i n g ambulatory p a t i e n t - 40 -s e l f - a d m i n i s t r a t i o n of t h e i r p r e s c r i b e d medications. A p a t i e n t f o l l o w -up program using the record plan was developed. One f u r t h e r a c c e s s i b l e t f a c t o r was the saving i n pharmacists time i n maintaining an o p e r a t i n g p a t i e n t recordsplan when he employed a non - p r o f e s s i o n a l a s s i s t a n t (N.P.A.) i n the p r e s c r i p t i o n f i l l i n g procedure. B. DRUG INTERACTIONS The o b j e c t i v e s of t h i s aspect were t o review past p a t i e n t record cards i n order to i d e n t i f y p o t e n t i a l drug i n t e r a c t i o n s between "pres-c r i p t i o n - o n l y " medications; and between " p r e s c r i p t i o n - o n l y " drugs and " n o n - p r e s c r i p t i o n " drugs. T e t r a c y c l i n e and i t s analogues were s e l e c t e d as the major drugs of s u r v e i l l a n c e i n t h i s r e t r o s p e c t i v e study due to the f a c t that t e t r a c y c l i n e i n t e r a c t i o n s have been e x t e n s i v e l y reviewed i n the l i t e r a t u r e (see l i t e r a t u r e survey pp. 14 - 19). W e l l documented i n t e r a c t i o n s are reported w i t h both " p r e s c r i p t i o n - o n l y " and "non-pres-c r i p t i o n " medications. T e t r a c y c l i n e s are used o f t e n enough i n ambulatory p a t i e n t s t o have a la r g e p a t i e n t sample. They are used by a l l age groups and socioeconomic c l a s s e s of p a t i e n t s . They are used mainly f o r acute c o n d i t i o n s and f o r s p e c i f i c periods of time, and o f t e n they are given to p a t i e n t s r e c e i v i n g other medication e i t h e r on p r e s c r i p t i o n or over-ther counter (O.T.C). Therefore, i t was a n t i c i p a t e d that the t e t r a c y c l i n e drugs would serve as a prototype i n determining the o b j e c t i v e s of t h i s study. The " p r e s c r i p t i o n - o n l y " i n t e r a c t a n t s surveyed i n t h i s study were p e n i c i l l i n , i t s analogs and the coumarin a n t i c o a g u l a n t s . The "non-pre-s c r i p t i o n " i n t e r a c t a n t s were the d i v a l e n t and t r i v a l e n t c a t i o n - c o n t a i n i n g preparations such as a n t a c i d suspensions, l a x a t i v e s and i r o n c o n t a i n i n g - 41 -supplements. I n order t o avoid any tendancy t o unfavorably compare the records of the two pharmacies, the i n t e r a c t i o n study was performed i n one pharmacy onl y . T h i s pharmacy had maintained, over the past n i n e y e a r s , some form of p a t i e n t r e c o r d p l a n . P r i o r t o 1968, the p l a n p r i m a r i l y was a record of p r e s c r i p t i o n purchases and no attempt was made by the pharmacist t o monitor f o r p o t e n t i a l i n t e r a c t i o n s a t the time a new p r e s c r i p t i o n was f i l l e d . The medication was u s u a l l y entered on the p a t i e n t s c h a r t by non-pharmacists at the end of the day o r the next day. I t would seem l i k e l y t h a t the p o t e n t i a l i n t e r a c t i o n s found on these charts would not have been detected by the pharmacist. The second system, i n i t i a t e d i n 1968, was used more than the previous charts t o monitor f o r p o t e n t i a l drug i n t e r -a c t i o n s . P r e s c r i p t i o n s were entered by the pharmacist each time a drug was ordered and previous medications were q u i c k l y checked f o r p o t e n t i a l i n t e r a c -t i o n s . During t h i s second p e r i o d of recorded medication i t was assumed, t h e r e f o r e , t h a t the pharmacist used the p a t i e n t r e c o r d chart c o r r e c t l y , and prevented the reported p o t e n t i a l i n t e r a c t i o n s t h a t were detected i n t h i s p e r i o d of the survey. (For example: a p a t i e n t may have had a p r e s c r i b e d a n t a c i d on May 3, 1968 and on May 5, 1968 r e c e i v e d a t e t r a c y c l i n e p r e s c r i p t i o n . I t i s assumed t h a t the pharmacist would have detected t h i s p o t e n t i a l i n t e r -a c t i o n and he would have, i n s t r u c t e d the p a t i e n t on how t o minimize the e f f e c t of the a n t a c i d when t a k i n g a dose of t e t r a c y c l i n e ) . On these two r e c o r d system approaches i n pharmacy Y, a t o t a l of 10,935 p a t i e n t s charts were a v a i l a b l e . A random numbers t a b l e was used t o draw samples from both systems and a t o t a l of 1,758 charts were drawn f o r the survey. Each f a m i l y c h a r t was then read by the researcher and the - 42 -f o l l o w i n g data recorded: P a t i e n t s name, o r f a m i l y name. Payment plan - p r i v a t e , o r t h i r d party (Welfare o r Dept. of Vetrans A f f a i r s (DVA). T o t a l d u r a t i o n ( i n months) that the f a m i l y had been on the p a t i e n t record c h a r t . T o t a l number of p r e s c r i p t i o n s on the c h a r t . The date and q u a n t i t y of each t e t r a c y c l i n e p r e s c r i p t i o n . I f a t e t r a c y c l i n e p r e s c r i p t i o n was recorded a check was made f o r : ( i ) P e n i c i l l i n p r e s c r i p t i o n s ( i i ) Coumarin anticoa g u l a n t p r e s c r i p t i o n s ( I i i ) N o n - p r e s c r i p t i o n product c o n t a i n i n g a d i v a l e n t o r t r i v a l e n t c a t i o n I f any of the above products were recorded on the chart a check f o r a p o t e n t i a l i n t e r -a c t i o n was then i n v e s t i g a t e d . The parameters- used to determine i f a p o t e n t i a l i n t e r a c t i o n could have occurred were as f o l l o w s : using the dosage i n f o r m a t i o n and the qu a n t i t y p r e s c r i b e d on the p a t i e n t s chart f o r both, the t e t r a c y c l i n e and the i n t e r a c t i n g agent, a usage i n t e r v a l f o r each could be p l o t t e d on a calender. A p o t e n t i a l i n t e r a c t i o n was reported when both o f the drugs i f taken as d i r e c t e d could be used on the same day. Example 1. A p a t i e n t r e c e i v e d a p r e s c r i p t i o n f o r a t e t r a c y c l i n e on June 6, 1967 and took 4 doses per day f o r 6 days. He a l s o r e c e i v e d a p r e s c r i p t i o n on June 7, 1967 f o r 12 ounces of Maalox w i t h one teaspoonful every hour, prn. then a p o t e n t i a l I n t e r a c t i o n was reported. - 43 -Example 2. A p r e s c r i p t i o n f o r p e n i c i l l i n was ordered on March 4, 1968 f o r 5 days supply. On March 6, 1968, another p r e s c r i p t i o n f o r t e t r a c y c l i n e was given to t h i s p a t i e n t . Again, t h i s i s reported as a p o t e n t i a l i n t e r a c t i o n . There i s no way that the i n v e s t i g a t o r could determine i f the p a t i e n t had been i n s t r u c t e d to d i s c o n t i n u e the f i r s t a n t i b i o t i c before the second was s t a r t e d . Whenever p o s s i b l e , the researcher a l s o recorded whether two phy-s i c i a n s orders were r e s p o n s i b l e f o r the p o t e n t i a l i n t e r a c t i o n reported. In a r e t r o s p e c t i v e study of t h i s nature, no attempt was made to determine the c l i n i c a l s i g n i f i c a n c e o f any of the reported p o t e n t i a l i n t e r a c t i o n s . The p o t e n t i a l s i g n i f i c a n c e must be based only on the e v a l u a t i o n presented i n the l i t e r a t u r e survey (pg. 14). The i n c i d e n c e of the t e t r a c y c l i n e and " n o n - p r e s c r i p t i o n " drug i n t e r a c t i o n s was of p a r t i c u l a r i n t e r e s t . Although t h i s pharmacy used the p a t i e n t record c a r d , the p a t i e n t s who d i d notlhave t h i r d - p a r t y payment of t h e i r " n o n - p r e s c r i p t i o n " drugs seldom had these medications recorded on t h e i r p a t i e n t record card. In order to make a comparison between the o v e r a l l i n c i d e n c e of p o t e n t i a l drug i n t e r a c t i o n s w i t h t e t r a c y c l i n e and those i n t e r a c t i o n s caused by a n o n - p r e s c r i p t i o n drug, the f o l l o w i n g approach was used. Two groups of p a t i e n t s were Included i n the survey. The group having some form of t h i r d p a r ty payment plan (Welfare p a t i e n t s and D.V.A. p a t i e n t s ) were c a l l e d "Group A". Group A p a t i e n t s , f o r b i l l i n g purposes, had n o n - p r e s c r i p t i o n drugs i n c l u d e d on a p r e s c r i p t i o n form; and these med^ -i c a t i o n s were then recorded on the record c h a r t . Consequently, these p a t i e n t s had a h i g her number of n o n - p r e s c r i p t i o n drug e n t r i e s on t h e i r - 44 -p a t i e n t record c h a r t . The second group o f p a t i e n t s were a l l those fam-i l i e s and p a t i e n t s not i n c l u d e d i n the "Group A" segment o f the p o p u l a t i o n . These were p r i m a r i l y p r i v a t e payment p a t i e n t s and u s u a l l y had very few nota t i o n s made o f t h e i r n o n - p r e s c r i p t i o n medication purchases. "Group A" p a t i e n t s represented a t o t a l of 284 p a t i e n t record charts out of the 1,758 charts sampled. The number o f p o t e n t i a l i n t e r a c t i o n s found i n t h i s group, w i t h the l a r g e r number of n o n - p r e s c r i p t i o n drugs on t h e i r c h a r t s , were compared t o the o v e r a l l p o p u l a t i o n on the b a s i s of t e t r a c y c l i n e i n t e r a c t i o n s w i t h n o n - p r e s c r i p t i o n drugs. C. DRUG SENSITIVE CONDITIONS The e f f e c t i v e n e s s of the p r e s c r i p t i o n record p l a n was a l s o to be evaluated w i t h respect to i t s r o l e i n i d e n t i f i c a t i o n o f drug s e n s i t i v e c o n d i t i o n s . * This Information was r o u t i n e l y flagged on 5,000 p a t i e n t s charts i n a prominent p o s i t i o n f o r easy reference by the pharmacist each time an entry i s made on the p a t i e n t record c h a r t . The reasons f o r monitoring f o r drug s e n s i t i v e c o n d i t i o n s was o u t l i n e d i n the l i t e r a t u r e survey (pg. 19). Three main o b j e c t i v e s had been considered f o r t h i s p o r t i o n of the study as f o l l o w s : 1. i t was r e q u i r e d t o compare the data regarding d r u g - s e n s i t i v e c o n d i t i o n s , which was t a b u l a t e d on the p a t i e n t r e c o r d plans i n the two separate pharmacies w i t h the l i t e r a t u r e data as shown i n the l i t e r a t u r e survey (pg. 20). * Drug a l l e r g i e s and recorded disease s t a t e s . - 45 -2. i t was of i n t e r e s t to compare the " a l l e r g y " i n f o r m a t i o n flagged on a pharmacy medication chart to that i n f o r m a t i o n flagged on a p r i -vate p h y s i c i a n ' s p a t i e n t c h a r t . This part of the study was i n c l u d e d because o f the com-p a r a t i v e e f f i c i e n c y w i t h which t h i s i n f o r -mation i s gathered by pharmacists i n h o s p i t a l s e t t i n g s (43, 86),and 3. i t was e s s e n t i a l to determine the e f f e c t i v e n e s s of the p r e s c r i p t i o n record p l a n i n preventing p a t i e n t s from r e c e i v i n g c o n t r a i n d i c a t e d med-i c a t i o n . 1. Comparison With Previous Data. This study was conducted i n both the above mentioned pharmacies. Appendices I and I I gives i l l u s t r a t i o n s of the two types of p r e s c r i p t i o n record cards maintained i n the two pharmacies surveyed. F i v e thousand cards, r e p r e s e n t i n g approximately h a l f of the a c t i v e f a m i l y charts i n these pharmacies, were sampled to determine the p o t e n t i a l i n c i d e n c e o f drug s e n s i t i v e c o n d i t i o n s . Those charts surveyed i n pharmacy X were p a t i e n t s l i s t e d under the alphabet from A to F and from M to R i n c l u s i v e . Pharmacy Y p a t i e n t s were from G to L and from S to Z i n c l u s i v e . The f o l l o w i n g method was used i n the e v a l u a t i o n . I f a drug s e n s i t i v e c o n d i t i o n was flagged on the chart then f u r -ther data was c o l l e c t e d from the i n f o r m a t i o n entered on the chart as f o l l o w s : 1. the sex of the p a t i e n t w i t h the drug s e n s i t i v e c o n d i t i o n ; 2. the age, 21 y r s . o r over f o r a d u l t s or c h i l d r e n s ages, i f a v a i l a b l e ; 3. the fa m i l y ' s l a s t name; - 46 -4. the number of members of the f a m i l y ; 5. the i n i t i a l entry date on the pre-s c r i p t i o n record p l a n ; 6. the t o t a l number of months on the pre-s c r i p t i o n record p l a n ; 7. the t o t a l number of p r e s c r i p t i o n s f o r the f a m i l y ; 8. the number of drug s e n s i t i v e c o n d i t i o n s per p a t i e n t ; and 9. the type of drug s e n s i t i v e c o n d i t i o n . - a l l e r g y to what drug ( p e n i c i l l i n ) - disease s t a t e as flagged ( d i a b e t i c ) The r e s u l t s from t h i s data could then be t a b u l a t e d and compared to previous f i n d i n g s on the in c i d e n c e of drug s e n s i t i v e c o n d i t i o n s . 2. Comparison With P h y s i c i a n ' s Data. A f u r t h e r procedure was undertaken to determine i f t h i s i n f o r m a t i o n d u p l i c a t e d o r was d i f f e r e n t from s i m i l a r i n f o r m a t i o n which i s flagged on phy s i c i a n ' s records. Twenty-five p a t i e n t s were a r b i t r a r i l y chosen from the above l i s t i n pharmacy X. These names were then given to the c l i n i c ' s records department. The s t a f f of t h i s department p u l l e d the charts f o r these same twenty-five p a t i e n t s , and the comparison o f flagged a l l e r g y i n f o r m a t i o n was t a b u l a t e d . The reviewer performed a follow-up to t h i s comparison study i n an attempt to determine the a u t h e n t i c i t y of the drug s e n s i t i v i t y flagged on - 47 -the pharmacy's records. A memorandum was prepared (see F i g . 1) FIGURE NO. 1 DRUG ALLERGY MEMORANDUM To C l i n i c Re. P a t i e n t Address Our records show th a t t h i s p a t i e n t has reported t o us th a t he/she i s s e n s i t i v e to or a l l e r g i c t o the f o l l o w i n g medication. This i n f o r m a t i o n may be of value t o you when p r e s c r i b i n g medication f o r the above p a t i e n t . .Pharmacy per. PHARMACIST This was then attached t o the ou t s i d e of the p h y s i c i a n ' s p a t i e n t c h a r t f o r h i s f u t u r e use i n determining the v a l i d i t y of the drug s e n s i t i v e c o n d i t i o n . - 48 -3. E f f e c t i v e n e s s of the P a t i e n t Record P l a n . One o f the above pharmacies performed an a d d i t i o n a l f u n c t i o n w i t h p a t i e n t record p l a n s . Comments were recorded i n the r i g h t hand column, whenever a pharmacist used the flagged i n f o r m a t i o n on the p a t i e n t record card to prevent a p a t i e n t from r e c e i v i n g a drug c o n t r a i n d i c a t e d i n t h i s drug s e n s i t i v e c o n d i t i o n . In reviewing the charts i n t h i s pharmacy, the researcher t a b u l a t e d the number of comments entered on the p a t i e n t ' s r e c o r d , which would i n d i c a t e that the flagged i n f o r m a t i o n had been u s e f u l i n pre-venting a p o s s i b l e adverse r e a c t i o n . (For example, i f the pharmacists wrote, " a l l e r g i c r e a c t i o n prevented" next to a p r e s c r i p t i o n f o r a pen-i c i l l i n s e n s i t i v i t y , o r i f the pharmacist wrote, " p a t i e n t (with glaucoma) advised not to purchase a n t i h i s t a m i n e - c o n t a i n i n g cough remedy"). These comments were t a b u l a t e d from approximately h a l f of the p a t i e n t records i n t h i s pharmacy and do not represent the t o t a l number of times when t h i s f l a g g e d p a t i e n t i n f o r m a t i o n i s u t i l i z e d . This r e p r e s e n t a t i o n , i t was f e l t , would be adequate f o r the o b j e c t i v e of the study. D. DRUG ADMINISTRATION The o b j e c t i v e of t h i s aspect o f the study was to determine the e f f e c t -iveness of the pharmacist using a p r e s c r i p t i o n record p l a n i n i n s t r u c t i n g p a t i e n t s on the proper s e l f - a d m i n i s t r a t i o n of p r e s c r i b e d medication. The p a t i e n t record p l a n gives the pharmacist a means of f l a g g i n g " t h e o r e t i c a l -f i n i s h " dates, and c o n t a c t i n g the p a t i e n t i n a follow-up survey to de-termine i f p a t i e n t s are using t h e i r p r e s c r i b e d drugs as i n s t r u c t e d , - 49 -A n t i b i o t i c s were chosen f o r t h i s study s i n c e w i t h these drugs i t i s q u i t e c r i t i c a l that the p a t i e n t complete h i s p r e s c r i b e d medication. A n t i b i o t i c s are almost always given f o r a d e f i n i t e time p e r i o d and s p e c i f i c dosage schedule. Therefore, i t was q u i t e easy to c a l c u l a t e the time when the l a s t dose should be taken by the p a t i e n t , and to enter t h a t i n f o r m a t i o n on the p a t i e n t r e c o r d c a r d . Two approaches were used i n t h i s study. The f i r s t was t o determine the e f f i c i e n c y of s e l f - m e d i c a t i o n by the p a t i e n t through an unannounced pharmacy check a f t e r the medication was t h e o r e t i c a l l y f i n i s h e d . The second approach represented a s i m i l a r check, but the p a t i e n t was f o r -warned of the follow-up contact. Both approaches were evaluated i n one of the two pharmacies i n c l u d e d i n the o v e r a l l study. 1. E f f e c t i v e n e s s of S i n g l e I n s t r u c t i o n s . F i f t y p a t i e n t s ' charts were flagged f o r t h e o r e t i c a l time f o r l a s t dose. These p a t i e n t s would normally be i n s t r u c t e d by the p h y s i c i a n s i n t h i s community to take t h e i r p r e s c r i p t i o n u n t i l f i n i s h e d and a l s o on an empty stomach, (onefohour before o r two hours a f t e r meals). Furthermore, i n the pharmacy the pharmacists reminded the p a t i e n t s that these a n t i b i o t i c s should be taken u n t i l f i n i s h e d and to take each dose on an empty stomach. Using the flagged f i n i s h - d a t e on the p r e s c r i p t i o n record card, a pharm-a c i s t made an unannounced v i s i t to the p a t i e n t s home on t h i s date to de-termine i f the medication had been used as d i r e c t e d . At no time was the p a t i e n t a l e r t e d beforehand that the pharmacist would be v i s i t i n g them concerning t h e i r p r e s c r i p t i o n . I f the i n t e r v i e w e r was able to contact the p a t i e n t , he asked to see the p r e s c r i p t i o n c o n t a i n e r . I f any doses were - 50 -l e f t , he would count them and record the number of doses missed. The pat-i e n t was asked questions to determine why doses were omitted; i f the drug was taken on an empty stomach; and i n the case of t e t r a c y c l i n e , i f a n t a c i d s , i r o n products, and m i l k were avoided (as i n s t r u c t e d by the pharmacist at the time of d i s p e n s i n g ) . The p a t i e n t s were a l s o asked about any apparent s i d e a f f e c t s to t h e i r therapy. (See F i g 2 f o r i n t e r v i e w sheet) FIGURE NO. 2 PHARMACIST FOLLOW-UP INTERVIEW FORM P a t i e n t Address T h e o r e t i c a l time f o r l a s t dose 1. Ask to see p r e s c r i p t i o n c o n t a i n e r . - Number of doses l e f t - I f a l l gone - time of l a s t dose - F i n i s h e d too e a r l y ? 2. I f not a l l gone, why not? 3. How many doses missed? When? Why?, 4. Taken w i t h meals at a l l ? Taken always 1 hour before or 2 hours a f t e r meals 5, T e t r a c y c l i n e p r e s c r i p t i o n s . Antacids or l a x a t i v e s ? Iron preparations? M i l k ? D a i r y products? 6, Any s i d e e f f e c t s ? - 51 -Since the pharmacist could not t e l l i f the p a t i e n t took h i s s t a r t i n g dose at once or waited u n t i l one hour before h i s next meal; i t was decided that an allowance of plus or minus one dose would be accepted as evidence of a p a t i e n t f o l l o w i n g the c o r r e c t schedule. These parameters- would i n -d i c a t e the p a t i e n t was o b t a i n i n g maximum b e n e f i t from h i s medication as intended by the p h y s i c i a n . Those p a t i e n t s w i t h more than one dose l e f t past the t h e o r e t i c a l f i n i s h time, i n c l u d i n g those who missed doses and those who stopped too e a r l y , were considered to have misused t h e i r a n t i -b i o t i c . (For example: a p r e s c r i p t i o n f i l l e d at 1:00 p.m. on the 17th of August f o r 28 t e t r a c y c l i n e at four doses per day should be a l l completed by noon August 24th, plus or minus one dose). This approach was expected to i n d i c a t e how w e l l p a t i e n t s f o l l o w e d extensive v e r b a l d i r e c t i o n s r e c e i v e d from phys i c i a n s as w e l l as pharmacists. 2. The E f f e c t i v e n e s s of M u l t i p l e I n s t r u c t i o n s . In the second p o r t i o n of t h i s study ( a l s o i n pharmacy X) 50 ad-d i t i o n a l p a t i e n t s w i t h a n t i b i o t i c s p r e s c r i p t i o n s had t h e i r p a t i e n t record card flagged as t o t h e o r e t i c a l f i n i s h time. This time, however, the p a t i e n t s were asked to p a r t i c i p a t e i n a survey of a n t i b i o t i c s and were given a note requesting t h e i r p a r t i c i p a t i o n . (See F i g . 3 on f o l l o w i n g page) - 52 -FIGURE NO. 3 PATIENT INFORMATION NOTE  IMPORTANT NOTICE This prescription contains an ANTIBIOTIC. It is particularly important that this medication be taken as directed. It i s also important that antibiotics be taken u n t i l they are ALL USED UP. To assist your pharmacist in a survey of ANTIBIOTICS, would you please contact this pharm-acy by phone (phone number) when you have taken your last dose of this medication OR i f you stop taking this prescription for any reason. Thank you for your assistance in this survey. Pharmacy Name Address Phone Number The patient was not alerted to the intent of the follow-up i n -terview, that i s , to determine the number of doses l e f t at the theor-e t i c a l finish time. When the patients contacted the pharmacy as re-quested, they were interviewed by a pharmacist to determine: the time of the last dose; or i f any were l e f t , how many; any side effects; and patient comments on the effects of their medication. The purpose of this project was to obtain the sameiinformation as before about usage, with two additional modifications introduced. F i r s t , the patient was involved i n his own follow-up program. The onus was put on him to become involved in his own treatment program. It was hoped he - 53 -would then understand and f o l l o w the v e r b a l i n s t r u c t i o n s b e t t e r because o f the personal involvement. Second, v e r b a l i n s t r u c t i o n s about the use o f h i s a n t i b i o t i c drug were r e i n f o r c e d w i t h w r i t t e n i n s t r u c t i o n s (as suggested by T u t t l e (30)) given t o the p a t i e n t w i t h h i s p r e s c r i p t i o n (see F i g . 3 ). I t was expected that the w r i t t e n reinforcement would help the p a t i e n t understand h i s d i r e c t i o n s b e t t e r and promote proper u t i l i z a t i o n . The r e s u l t s obtained i n t h i s approach could then be compared to the r e s u l t s obtained i n the follow-up v i s i t s to p a t i e n t s r e c e i v i n g only v e r b a l i n -s t r u c t i o n from the pharmacist. E. PHARMACIST TIME One of the main c r i t i c i s m s , (see l i t e r a t u r e survey pp. 30 r- 37) of the p a t i e n t record p l a n , as a means of r e c o r d i n g p a t i e n t s medication purchases, i s the i n c r e a s e i n work load on the pharmacist w i t h the ad-d i t i o n of more paper work. Two methods of reducing p r o f e s s i o n a l time involvement have been suggested - n o n - p r o f e s s i o n a l a s s i s t a n t s , and e l e c -t r o n i c data p r o c e s s i n g . The most recent of these i s the use of e l e c -t r o n i c data processing, (E.D.P.) (23, 87, 88), which i s not yet com-p l e t e l y adapted to community p r a c t i c e . However, the second approach has been used e x t e n s i v e l y i n many co u n t r i e s (79, 80), and g u i d l i n e s are pre-pared to a s s i s t pharmacists i n a s s i g n i n g work schedules (68) f o r the use of n o n - p r o f e s s i o n a l a s s i s t a n c e . The purpose of t h i s p o r t i o n of the study was to i d e n t i f y how a pharmacist's time, when using a p r e s c r i p t i o n record p l a n , can be more - 54 -e f f i c i e n t l y used by the employment of a n o n - p r o f e s s i o n a l a s s i s t a n t i n the p r e s c r i p t i o n f i l l i n g process. I t was of i n t e r e s t to determine the e f f e c t of employing aunon-professional a s s i s t a n t i n reducing pharmacist-time per p r e s c r i p t i o n i n the f i l l i n g process. The approach used was t o determine pharmacist-time r e q u i r e d i n pharmacy X which had an e s t a b l i s h e d p a t i e n t record p l a n . This time was then compared to the time r e q u i r e d f o r the pharmacist to f i l l the p r e s c r i p t i o n s w i t h the a i d of a n o n - p r o f e s s i o n a l a s s i s t a n t . For the purposes of a t i m i n g study, 17 steps were i d e n t i f i e d i n the p r e s c r i p t i o n f i l l i n g y - p r o c e d u r e . On the b a s i s of the g u i d e l i n e s es-t a b l i s h e d by the B.C. Pharmaceutical A s s o c i a t i o n (68) these 17 steps were f u r t h e r d i v i d e d i n t o those which could be performed by aanon-profes-s i o n a l a s s i s t a n t w i t h d i r e c t pharmacist s u p e r v i s i o n , and those d u t i e s which should be performed by the pharmacist as f o l l o w s : Pharmacist Non-Professional A s s i s t a n t A. 1. Receipt of p r e s c r i p t i o n from p a t i e n t . 2. I n t e r p r e t a t i o n and i d -e n t i f i c a t i o n . 3. C a l c u l a t e p r i c e . B 4. P u l l p a t i e n t card or type new card. 5. Stamp p r e s c r i p t i o n number on p r e s c r i p t i o n , daysheet, p a t i e n t record c a r d . 6. Name and p r i c e entered on daysheet. 7. Date and p r i c e entered on p a t i e n t record card. 8. Type l a b e l . C. 9. S e l e c t medication and c o n t a i n e r . 10. Count or pour med-i c a t i o n . 11. Package & a f f i x l a b e l . 12. F i n a l check of pre-s c r i p t i o n . Return medication to stock. - 55 -Pharmacist Non-Professional A s s i s t a n t Make entry on p a t i e n t record card. Check p a t i e n t record card f o r a l l e r g i e s . 'Drug I n t e r a c t i o n Index' (44) checked f o r p o s s i b l e drug i n t e r a c t i o n s w i t h previous medication. Give p r e s c r i p t i o n to p a t i e n t , advise on proper use, answer any questions concerning the p r e s c r -i p t i o n ^ a n d other med-i c a t i o n s . 16. Wrap medication, r i n g up s a l e , as cash o r charge. When necessary type new charge card. 17. R e f i l e p a t i e n t record card and p r e s c r i p t i o n . C r i t e r i a were e s t a b l i s h e d to s e l e c t which p r e s c r i p t i o n s would be timed, and which procedures would not be i n c l u d e d . Only newly w r i t t e n p r e s c r i p t i o n s brought i n t o the pharmacy by the p a t i e n t were i n c l u d e d . The p a t i e n t had to w a i t f o r i t to be f i l l e d , and was not aware that h i s pre-s c r i p t i o n was being timed. However, i t i s important to note t h a t the pre p a r a t i o n of a new p r e s c r i p t i o n record card was a l s o i n c l u d e d i n the timi n g s i n c e t h i s i s a r e g u l a r p a r t of ma i n t a i n i n g p r e s c r i p t i o n record p l a n s . I t can be seen from the previous o u t l i n e o f steps that the non-p r o f e s s i o n a l a s s i s t a n t can p o t e n t i a l l y perform many of the mechanical as-r pects of the process and thus enable the pharmacist to spend time w i t h the p a t i e n t as w e l l as to monitor the p a t i e n t s record c h a r t . I n the f i r s t s e t of timings the pharmacist performed a l l 17 steps completely by hi m s e l f f o r 15 p a t i e n t s having only one p r e s c r i p t i o n . Other p a t i e n t s having more than one p r e s c r i p t i o n were a l s o timed, but they were D. 13. 14. 15. E. - 56 -i n the m i n o r i t y . In the second p a r t o f the study, the n o n - p r o f e s s i o n a l a s s i s t a n t performed segments B and E of the process w h i l e the pharmacist performed segments A,C, and D. Each of the f i v e segments was timed s e p a r a t e l y . An a d d i t i o n a l 15 p a t i e n t s , w i t h one p r e s c r i p t i o n , were timed as w e l l as s e v e r a l p a t i e n t s w i t h two p r e s c r i p t i o n s , i n order to compare w i t h those timed w i t h the pharmacist doing a l l 17 s t e p s . A comparison of the above timings was expected t o i n d i c a t e the p o t e n t i a l value o f a pharmacist and n o n - p r o f e s s i o n a l a s s i s t a n t team i n the dispensing procedure. This e v a l u a t i o n was conducted us i n g the normal r o u t i n e i n a pharmacy w i t h a p a t i e n t record p l a n , and no compar-i s o n was done w i t h a pharmacy not using a p r e s c r i p t i o n record plan s i n c e t h i s researcher was not f a m i l i a r w i t h the r o u t i n e used i n such a pharmacy. Therefore, such a comparison would have b i a s I n favor o f the pharmacy w i t h the p a t i e n t record p l a n . - 57 -RESULTS AND DISCUSSION The f o l l o w i n g s t u d i e s were performed i n an attempt to i d e n t i f y the strengths and weaknesses of e x i s t i n g p a t i e n t record plans w i t h respect to promoting b e t t e r drug therapy i n the ambulatory p a t i e n t - and not to qu a n t i t a t e the s i g n i f i c a n c e of these f a c t o r s . A c c o r d i n g l y , no s t a t i s t i c a l a n a l y s i s of the r e s u l t s are presented f o r each area i n v e s t i g a t e d . I n -stead, the r e l a t i v e importance o f the v a r i a b l e s i d e n t i f i e d are p r o j e c t e d as percentages f o r i n t e r p r e t a t i o n purposes, w i t h the i n t e n t i o n t h a t each of these should be s t u d i e d i n d i v i d u a l l y and i n more d e t a i l i n the f u t u r e . A. DRUG INTERACTIONS The e f f e c t i v e n e s s of the p a t i e n t record plan i n monitoring i n t e r -a c t i o n s was determined by reviewing 1,758 c h a r t s . These record plans p r i n c i p a l l y represented a record of p r e s c r i p t i o n drugs which p a t i e n t s r e c e i v e d from one of the two pharmacies i n t h i s study. However, one segment of the popul a t i o n surveyed, "Group A" due to t h i r d - p a r t y -payment reasons, had both p r e s c r i p t i o n and n o n - p r e s c r i p t i o n drugs recorded. The only p o t e n t i a l i n t e r a c t i o n s which were evaluated i n t h i s study were those between t e t r a c y c l i n e and other p r e s c r i p t i o n - o n l y or n o n - p r e s c r i p t i o n medications. The t e t r a c y c l i n e s were a r b i t r a r i l y s e l e c t e d as examples because of t h e i r popular use and the inci d e n c e of l i t e r a t u r e r e p o rts about i n t e r a c t i o n s f o r t h i s group of a n t i b i o t i c s . ( - 58 -The p r e s c r i p t i o n - o n l y drugs surveyed as i n t e r a c t a n t s were the coumarin anticoagulants and the p e n i c i l l i n s . The n o n - p r e s c r i p t i o n i n t e r a c t a n t s were d i v a l e n t and t r i v a l e n t c a t i o n c o n t a i n i n g drugs such as a n t a c i d s , l a x a t i v e s and i r o n p r e p a r a t i o n s . The t o t a l p o t e n t i a l i n t e r a c t i o n s were recorded as w e l l as those s p e c i f i c a l l y f o r n o n - p r e s c r i p t i o n drugs w i t h p a t i e n t s i n Group A. The above charts represented 30,149 p r e s c r i p t i o n s , 955 of which were s p e c i f i c a l l y f o r a t e t r a c y c l i n e . For the purposes of t h i s study, any of the above p r e s c r i p t i o n - o n l y o r n o n - p r e s c r i p t i o n i n t e r a c t a n t s , which could have been administered on the same day as the t e t r a c y c l i n e , was r e -corded as a p o t e n t i a l i n t e r a c t i o n . The number of p o t e n t i a l i n t e r a c t i o n s w i t h a t e t r a c y c l i n e as r e l a t e d to prescriptions-only and n o n - p r e s c r i p t i o n drugs are presented i n Table 1. - 59 -TABLE I INCIDENCE OF POTENTIAL TETRACYCLINE INTERACTIONS1 AS RELATED TO PRESCRIPTION-ONLY2 AND NON-PRESCRIPTION DRUGS 3 Population Surveyed General Group A Group A as a % of General Number of Tetracycline Prescriptions Surveyed 955 261 27% Total Number of Inter-actions 56 41 73% Number of Non-Prescr-iption Drug Interactions 37 30 81% 1. As reported in the literature (44) and administered on the same day as tetracycline. 2. Penicillins or coumarin anticoagulants. 3. Divalent and trivalent cation containing products. 4. Represents primarily a record of prescription-only drugs, 5. Represents a segment of the general population with both prescr-iption-only and non-prescription drugs recorded. - 60 -Of the 955 p r e s c r i p t i o n s f o r a t e t r a c y c l i n e there was a p o t e n t i a l i n t e r -a c t i o n i n 56 cases. I t was i n t e r e s t i n g t o t note that 37 of the 56 p o t e n t i a l i n t e r a c t i o n s (approximately 66%) were due to n o n - p r e s c r i p t i o n drugs. This confirms the importance o f r e c o r d i n g , on the p a t i e n t record c h a r t , n o n - p r e s c r i p t i o n drugs as w e l l as p r e s c r i b e d medication. This percentage would l i k e l y be gre a t e r i f both p r e s c r i b e d and non-prescribed drugs had been recorded f o r the general p o p u l a t i o n . This observation i s supported by the f a c t t h a t , i n Table I , 41 of 56 (approximately 73% of a l l the i n t e r a c t i o n s ) were detected i n the records of p a t i e n t s i n "Group A", who were i s o l a t e d because of the r o u t i n e r e c o r d i n g of both n o n - p r e s c r i p t i o n and p r e s c r i p t i o n drugs. More s i g n i f i c a n t l y , of the 37 i n t e r a c t i o n s due to the n o n - p r e s c r i p t i o n drugs i n the general p o p u l a t i o n , 30 (approx-imately 81%) were detected i n p a t i e n t s charts from "Group A". A f u r t h e r breakdown of the number of i n t e r a c t i o n s according to the nature of the I n t e r a c t a n t i s i n Table I I . - 61 -TABLE I I NATURE OF POTENTIAL TETRACYCLINE INTERACTION^WTTH PRESCRIPTION-ONLY AND NON-PRESCRIPTION DRUGS Popu l a t i o n Surveyed Drug I n t e r a c t a n t General Group A" P res c r i p t i o n - o n l y - P e n i c i l l i n - Coumarin Anticoagulants 14 5 8 3 TOTAL 19 11 Non-P res c r i p t i o n - D i v a l e n t and T r i v a l e n t c a t i o n s - Antacids and L a x a t i v e s - I r o n Preparations 26 11 23 7 TOTAL 37 30 1. As reporte d i n the l i t e r a t u r e (44) and administered on the same day as t e t r a c y c l i n e . 2. Represents p r i m a r i l y a record of p r e s c r i p t i o n - o n l y drugs. 3. Represents a segment of the general p o p u l a t i o n w i t h both p r e s c r i p t i o n -only and n o n - p r e s c r i p t i o n drugs recorded. - 62 -I t must be r e a l i z e d t h a t , i n a r e t r o s p e c t i v e study o f t h i s nature there i s no way of t e l l i n g how o f t e n these p o t e n t i a l problems could have caused c l i n i c a l l y s i g n i f i c a n t changes i n the p a t i e n t s therapy. However, the po-t e n t i a l r i s k s are w e l l documented (43, 44, 46, 47) and the p a t i e n t record p l a n presents the means of d e t e c t i n g p o s s i b l e i n t e r a c t i o n s before they might occur. An attempt was made, whenever p o s s i b l e , t o determine the cause f o r the p o t e n t i a l t e t r a c y c l i n e i n t e r a c t i o n w i t h the p r e s c r i p t i o n -only drugs i n Table I I . In 3 of the 14 p o t e n t i a l p e n i c i l l i n i n t e r a c t i o n s , there were two doctors ordering f o r the same p a t i e n t . Furthermore, 3 of the 5 p o t e n t i a l coumarin i n t e r a c t i o n s were the r e s u l t of two ph y s i c i a n s ordering f o r the same p a t i e n t . This i s a d d i t i o n a l evidence o f the need f o r a pharmacist to monitor p a t i e n t s records f o r p o t e n t i a l i n t e r a c t i o n s , s i n c e not a l l p r e s c r i p t i o n s f o r a p a t i e n t are r e c e i v e d from one p h y s i c i a n . For the n o n - p r e s c r i p t i o n drug i n t e r a c t i o n s , at l e a s t 10 of the 37 p o t e n t i a l problems were the r e s u l t s of two p h y s i c i a n s o r d e r s . I t i s recognized that complete re c o r d i n g o f a l l non-prescribed drug purchases would be i d e a l i s t i c . Several f a c t o r s which prevent the phar-macist from keeping a complete record are as f o l l o w s : p a t i e n t s do not purchase a l l t h e i r n o n - p r e s c r i p t i o n medications i n pharmacies; p a t i e n t s do not always purchase a l l t h e i r pharmaceuticals i n one pharmacy; p a t i e n t s may not even purchase these h e a l t h products i n the same community, ( f o r example - m a i l order purchasessfrom c a t a l o g u e s ) ; p r e s c r i b e d medications may a l s o be s u p p l i e d from o u t s i d e the community, ( f o r example - m a i l order pharmacies). Even though there i s a problem of t r a n s i e n c y when the pharmacist attempts to maintain a complete drug r e c o r d , every e f f o r t must be made by the pharmacist and the p a t i e n t to e s t a b l i s h as complete a record as p o s s i b l e . - 63 -W i t h i n the parameters;•• o f t h i s study, w i t h respect to p o t e n t i a l t e t r a c y c l i n e i n t e r a c t i o n s , i t can be seen that the n o n - p r e s c r i p t i o n drugs do represent, n u m e r i c a l l y , a l a r g e r p o t e n t i a l problem w i t h i n t e r a c t i o n s than do the p r e s c r i p t i o n - o n l y medications. This more than j u s t i f i e s t h e i r i n c l u s i o n on the p a t i e n t s record p l a n , whether purchased on p r e s c r i p t i o n o r i n the "front-shop" area o f a pharmacy. Furthermore, not only should they be recorded on the c h a r t , but a l s o the pharmacist must make use of t h i s i n f o r m a t i o n whenever s e l l i n g o r dispensing any medication i n order to prevent p o s s i b l e t h e r a p e u t i c misadventure. B. DRUG SENSITIVE CONDITIONS Drug s e n s i t i v e p a t i e n t s , f o r the purposes of t h i s study, are i n -t e r p r e t e d as those p a t i e n t s who have a reported drug a l l e r g y o r who may have a disease i n which c e r t a i n medications are c o n t r a i n d i c a t e d , o r which should be used w i t h some degree o f c a u t i o n . I t i s important to r e a l i z e t h a t many p a t i e n t s do have a l l e r g i e s to drugs, and a l l h e a l t h p r o f e s s i o n a l s must be aware of e x a c t l y which drugs a p a t i e n t can or cannot r e c e i v e . The purpose o f t h i s study i s t h r e e - f o l d . 1. To compare the data regarding drug s e n s i t i v e p a t i e n t s , which was t a b u l a t e d on the p a t i e n t record plans i n two separate pharmacies, w i t h previous i n f o r m a t i o n on drug a l l e r g i e s from the l i t e r a t u r e . 2. To compare the a l l e r g y i n f o r m a t i o n recorded on a pharmacy record chart to a p h y s i c i a n ' s p a t i e n t c h a r t . - 64 -3. To demonstrate the effectiveness of the patient record plan in preventing drug sen-si t i v e patients from receiving contraindicated medication. 1. Comparison With Previous Data In the survey 5,000 patients record charts were checked and this represented 15,500 patients. The incidence of patients with one or more drug sensitive conditions is shown in Table III. - 65 -TABLE III INCIDENCE OF DRUG SENSITIVE CONDITIONS AS REPORTED ON PATIENT RECORD PLANS2 Number of Drug Sensitive Conditions Per Patient Number of Patients one 452 two 65 three 28 four 4 3 greater than five 3 TOTAL 554 1. Reported drug allergies, sensitivities or disease states i n which certain medications may be. contraindicated. 2. As determined from a survey of 5,000 patient record cards. 3. One each with 6,9, and 11 reported drug sensitive conditions. - 66 -Only 554 patients (approximately 4%) had reported at least one drug sensitive condition on their record chart, which Is low In comparison to other reports (13, 36, 65, 67). McHale, (36) reported as many as 25% of patients had drug hypersensitivities. Two reasons may be postulated for the lower figure In the present study. 1. Children are Included In this data and they have fewer drug sensitivities (67). 2. The data i s collected on the patient record plan only at the i n i t i a l interview with the patient. Many of these families have been on the plan for more than six years. Unless the patient volunteers new allergy information to the pharmacy, this w i l l not appear on the record chart. This demonstrates that pharmacists must endeavor to keep their information up-dated for maximum value. Table IV seems to substantiate the fact that children have fewer drug sensitive conditions. - 67 -TABLE IV REPORTED DRUG SENSITIVE CONDITIONS ACCORDING TO SEX AND AGE Sex Number of P a t i e n t s (Percentage o f T o t a l ) Females 337 (61) Males 211 (38) Not I n d i c a t e d 6 ( 1) Age 0 - 5 years 14 ( 2 ) 6 - 10 years 42 ( 8) 11 - 15 years 28 ( 5) 16 - 20 years 28 ( 5 ) Age not given 7 ( 1 ) Over 21 years 435 (79) 1. As determined from a survey of 5,000 p a t i e n t record cards. - 68 -Table IV shows that about 80% of the drug s e n s i t i v e c o n d i t i o n s reported were i n p a t i e n t s over 21 years of age. I t al s o would seem to support others (67) i n demonstrating that females have more drug s e n s i t i v e c o n d i t i o n s than males. The r e l a t i o n s h i p of s e n s i t i v i t i e s to s p e c i f i c drug groups a l s o compares w e l l w i t h the r e s u l t s of previous s t u d i e s as shown i n Table V. - 69 -TABLE V COMPARISON OF REPORTED RESULTS 1 WITH PREVIOUS STUDIES ACCORDING TO SPECIFIC DRUG GROUP SENSITIVITIES Reported Results Other Studies C h i l e s ( 1 3 ) Meyler ( 6 7 ) McHale ( 3 6 ) T o t a l p a t i e n t s w i t h drug s e n s i t i v i t i e s 5 5 4 311 142 50 Causative Agent P e n i c i l l i n (% of p a t i e n t s ) 284 ( 5 1 ) 186 ( 5 9 ) 78 ( 5 5 ) 2A ( A 8 ) Sulfonamides (% of p a t i e n t s ) 9 3 ( 1 7 ) 43 ( 1 4 ) 19 ( 1 3 ) 9 ( 1 8 ) S a l i c y l a t e s (% of p a t i e n t s ) 54 ( 1 0 ) 12 ( A ) 17 ( 1 2 ) A ( 8 ) Opiates (morphine, codeine, meper-i d i n e ) (% of p a t i e n t s ) 54 ( 1 0 ) 20 ( 6 ) 5 ( A ) 7 ( I A ) T e t r a c y c l i n e (% of p a t i e n t s ) 28 ( 5 ) 7 ( 2 ) 3 ( 2 ) 3 ( 6 ) S e n s i t i v i t i e s to other drugs and chemicals 192 12 20 20 1, As determined from a survey of 5,000 p a t i e n t record cards. - 70 -Table VI represents the relationship of recorded drug sensitive conditions according to reported disease states. TABLE VI REPORTED DRUG SENSITIVE CONDITIONS AS RELATED TO DISEASE STATES Disease Total Number Specifically Noted Diabetis Mellitus 9 Epilepsy 4 Glaucoma 3 Peptic Ulcer 2 Asthma 2 Other 3 TOTAL 23 1. As determined from 5,000 patient record charts. - 71 -I t was somewhat s u p r i s i n g t h a t only 23 of the 5,000 charts had a reported disease s t a t e entered on the card. In c o n s i d e r i n g the common nature of the above di s e a s e s , i t seems reasonable to assume that such disease s t a t e s are not r o u t i n e l y recorded on the p a t i e n t record plans surveyed. One reason f o r t h i s may be that only when a disease was s p e c i f i c a l l y entered at" the top of the p a t i e n t s chart was i t recorded i n the survey r e s u l t s . Many of these c o n d i t i o n s would be obvious to the pharmacist from the p a t i e n t s previous medications. For example: D i a b e t i c - I n s u l i n or tolbutamide; E p i l e p t i c - D i l a n t i n ; V Glaucoma - P i l o c a r p i n e eyedrops;/ P e p t i c U l c e r - Donnatol pl u s a n t a c i d s ; . Asthma - I s u p r e l mistometers. This aspect of study appeared to show q u i t e w e l l the p o t e n t i a l o f p a t i e n t record plans i n i d e n t i f y i n g and preventing drug s e n s i t i v e c o n d i t i o n problems. I t becomes apparent that the value of t h i s procedure i s pro-p o r t i o n a l to the extent of u t i l i z a t i o n by the pharmacist. 2. Comparison With P h y s i c i a n s Data. Twenty-five p a t i e n t s charts w i t h known drug s e n s i t i v i t i e s from the above study were compared to s i m i l a r data on p h y s i c i a n ' s charts f o r the same 25 p a t i e n t s . This was done to determine how the pharmacist i n f o r -mation compared to that of the p h y s i c i a n as r e l a t e d to t h i s problem of drug therapy. - 72 -TABLE VII COMPARISON OF PHARMACY AND PHYSICIAN RECORDS AS RELATED TO DRUG SENSITIVE CONDITIONS1 Information Source Pharmacy Physician 2 Total number of patient charts 25 25 Number of drug sensitive conditions 32 10 1. Drug allergies or sensitivities only i n this table. 2. Twenty-five charts identified i n part with recorded drug sensitive conditions compared to physician medical records. - 73 -The results of Table VII would appear to support recent claims in the literature (36, 86) that pharmacists may generate better information in this respect. An important qualification must be considered i n keeping the above data i n perspective. It must be conceded from the reports of others (89) that not a l l reported allergies are true drug sen-s i t i v i t i e s ; and perhaps a method of determining which allergies are important should be devised. It would appear that a co-operative ap-proach may be the best in this respect. Such an approach was impl-emented i n the c l i n i c of this study i n the following manner. A memorandum (Figure 1) was attached to the physicians' patient record with the pharmacy's data on drug sensitive conditions. The doctor would then be able to consider the significance of the pharmacy's information i n his future drug therapy for the patient. This exchange of patient infor-mation would be d i f f i c u l t between physicians and pharmacists who are not i n a group practice setting, such as c l i n i c pharmacies or group practice health centers. The important factor at present is that a l l pharmacists should be aware of the possibility that the physicians records about patient sensitivities may not be complete. 3. Effectiveness of the Patient Record Plan In Drug Sensitive Conditions. 0 One of the pharmacies not only recorded the presence of a drug sen-s i t i v e condition, but also frequently noted the use of the information in influencing therapy. These notations were reviewed in this respect according to such effectiveness. On three occasions the prescribed drug was witheId because i t was contralndicated in the patients disease state. - 74 -On 25 other occasions a prescribed drug was witheld or changed because of a reported drug allergy. Since such notations were not standard pro-cedure, i t can be assumed the above examples represent only a token of the pharmacist's potential contribution i n this area. It has been shown that the patient record plan would appear to be an effective tool for identifying patients with drug sensitive conditions and preventing further exposure to contraindicated medications. Further-more, i t would appear that this tool would be made more effective when integrated with physicians records. It has also been demonstrated that such information recorded by the pharmacist can be valuable in advising the patient with respect to potential problems. C. DRUG ADMINISTRATION It has been recognized that the value of the physicians' and pharm-r acist's instructions to the patient with respect to correct self-admin-istration of drugs is only effective i f the patient understands fu l l y and follows these instructions. Such effectiveness was evaluated in a study under two approaches u t i l i z i n g patient record plans. Originally, the f i r s t approach was intended to demonstrate good patient self-administration habits, since they received excellent instructions from both the phy-sicians and pharmacists in this c l i n i c . The research was then going to be conducted in a setting where patients did not receive extensive verbal i n -structions. However, due to the poor results found in this f i r s t approach, a second study was designed to see i f patient self-administration habits could be improved under the same system. - 75 -1. S i n g l e I n s t r u c t i o n s . In the f i r s t approach, f i f t y p a t i e n t s who r e c e i v e d a p r e s c r i p t i o n f o r an a n t i b i o t i c were given v e r b a l i n s t r u c t i o n s by the pharmacist on how t o p r o p e r l y use the medication, and to complete the dosage schedule. According to the dosage schedule, the t h e o r e t i c a l l a s t dose time was c a l -c u l a t e d (see experimental method, pg. 49). This i n f o r m a t i o n was then flagged on the p a t i e n t s record c a r d ; and without p r e a l e r t i n g the p a t i e n t , the pharmacist v i s i t e d the home on the day the l a s t dose should have been taken and requested t o see the p r e s c r i p t i o n c o n t a i n e r . This permitted the researcher to determine how c l o s e l y the p a t i e n t f o l l o w e d the pre-s c r i b e d dosage regimen. Other questions about s i d e e f f e c t s and r e s u l t s of therapy were a l s o asked, (see Figure 2, pg. 50) Column No. 1 (Group No. 1) i n Table V I I I shows the r e s u l t s of these i n t e r v i e w s . - 76 -i TABLE V I I I ACCURACY OF SELF-MEDICATION REGIMEN BY PATIENTS RECEIVING (a) SINGLE OR (b) MULTIPLE PHARMACY INSTRUCTIONS1 Types of P a t i e n t s 2 Group I Group 2 T o t a l P a t i e n t s Participating;-; 20 29 T o t a l P a t i e n t s W i t h i n P l u s or Minus One Dose^>^ 4 15 (% of t o t a l ) (20) T o t a l P a t i e n t s Completing Therapy 13 26 (% of t o t a l ) (65) (90) 1. (a) S i n g l e i n s t r u c t i o n s represents 50 p a t i e n t s who r e c e i v e d v e r b a l i n s t r u c t i o n s from the pharmacist and were contacted i n the home by an unannounced follow-up v i s i t . (b) Represents 50 p a t i e n t s r e c e i v i n g m u l t i p l e forms of i n s t r u c t i o n - v e r b a l i n s t r u c t i o n s from the pharmacist as b e f o r e , w r i t t e n r e -inforcement of these i n s t r u c t i o n s , andemotivation of the p a t i e n t by a s k i n g him t o i n i t i a t e the follow-up i n t e r v i e w . 2. Group 1 p a t i e n t s were those r e c e i v i n g s i n g l e i n s t r u c t i o n s . -Group 2 p a t i e n t s were those r e c e i v i n g the m u l t i p l e i n s t r u c t i o n s . 3. The schedule was determined by c a l c u l a t i n g the t h e o r e t i c a l time f o r the l a s t dose w i t h i n p l u s or minus one dose. 4. In the e n t i r e two groups only one p a t i e n t f i n i s h e d too e a r l y , t h i s was because only 18 doses were given when 24 doses were r e q u i r e d according t o the d i r e c t i o n s . - 77 -Of the 50 p a t i e n t s surveyed, only 20 could be contacted by personal unannounced v i s i t a t i o n s . Of these, only 4 p a t i e n t s (20%) appeared to use t h e i r a n t i b i o t i c according to the p h y s i c i a n s and pharmacists i n s t r -u c t i o n s , w i t h i n the c r i t e r i a of t h i s study. Only 13 of the 20 p a t i e n t s contacted e v e n t u a l l y completed t h e i r a n t i b i o t i c medication. This r a t h e r poor s e l f - a d m i n i s t r a t i o n record was s u p r i s i n g s i n c e i t was a p o l i c y of both the p h y s i c i a n s and the pharmacists i n the survey c l i n i c to i n s t r u c t the p a t i e n t on the importance of f o l l o w i n g the p r e s c r i b e d dosage regimen. These r e s u l t s would seem to support the importance of p a t i e n t s not only r e c e i v i n g proper i n s t r u c t i o n s , b u t , a l s o understanding and f o l l o w i n g the same. 2. M u l t i p l e I n s t r u c t i o n s . The second approach used i n t h i s study was designed t h e r e f o r e , to see i f an a d d i t i o n a l mechanism could be added to improve p a t i e n t understanding and h i s f o l l o w i n g of i n s t r u c t i o n s . F i f t y a d d i t i o n a l p a t i e n t s on a n t i -b i o t i c s were s e l e c t e d using the p a t i e n t record plans as p r e v i o u s l y i n d i c -ated w i t h two m o d i f i c a t i o n s . F i r s t , a w r i t t e n note was added to the v e r b a l i n s t r u c t i o n s - (see experimental method). The second m o d i f i c a t i o n was to i n c l u d e a request of the p a t i e n t to phone the pharmacist when the l a s t dose was taken (see F i g , No, 3, pg. 52 of experimental method) The r e s u l t s of 29 responses are shown i n Column 2 (Group 2) of Table V I I I . In t h i s case 15 (approximately 50%) were w i t h i n the permitted dosage v a r i a n c e ac-cording to the c r i t e r i a e s t a b l i s h e d f o r the study. Even more s i g n i f i c a n t perhaps, was the f a c t that 26 of the 29 (approximately 90%) f i n i s h e d t h e i r p r e s c r i b e d therapy. There seems to be an improvement i n the s e l f - a d m i n i s -- 78 -tration in the two groups responding from 13 of 20 (65%) in Group 1 to 26 of 29 (90%) i n Group 2 eventually completing their therapy. These comparative results suggest that some form of pharmacist follow-up, as suggested by White (7) and Tuttle (30) would help improve drug administration. Needless to say time i s a deterrent in a pharmacist visitation or a telephone campaign to reach patients about their drug therapy. The approach used i n this study would seem to be more efficient since the onus was placed on the patient to telephone the pharmacy. His chart was quickly pulled from the f i l e , and this was used to check whether or not the patient had completed the schedule according to his directions. This follow-up program involved only a few seconds per c a l l and often other problems about the drug therapy were discussed with the patient. In a few instances, the patient was even referred to his family physician for further counselling. Those patients not following their schedule to completion were questioned about the reasons. Their replies for each of the two groups are summarized in Table IX. - 79 -TABLE IX REASON FOR PATIENTS NOT COMPLETING ANTIBIOTIC THERAPY Number of Patients 1 2 Reason Group 1 Group 2 1. Severe stomach distress 2 2. Headache 1 3. Felt better, therefore stopped 2 4. Fear of monilial overgrowth 1 5. Took only when he needed them 1 6. Told to stop by a second physician 1. Group 1 patients received only single instructions, 2. Group 2 patients received multiple instructions as described in Table VIII - 80 -The above r e s u l t s r e f l e c t the importance of a follow-up i n t e r v i e w w i t h p a t i e n t s i n Group 2. The three p a t i e n t s not completing t h e i r therapy In t h i s group d i d not f o r f a i r l y v a l i d reasons. Those i n Group 1 appeared to stop forramore questionable reasons. Some i n t e r e s t i n g a t t i t u d e s were i d e n t i f i e d upon d e t a i l e d d i s c u s -s i o n w i t h the two groups. Several p a t i e n t s i n Group 1, who f a i l e d to f i n i s h on time, misunderstood the v e r b a l i n s t r u c t i o n s . This d i d not seem to occur when w r i t t e n i n s t r u c t i o n s were given to the p a t i e n t s i n Group 2. Others i n Group 1, who had more than 2 doses remaining, could not r e -member miss i n g any doses, even though as many as 6 had been missed. Again Group 2 p a t i e n t s could u s u a l l y account f o r missed doses, eventhough they d i d not attempt to catch up to t h e i r schedule. Those p a t i e n t s who were t a k i n g a t e t r a c y c l i n e drug were s p e c i f i c a l l y t o l d v e r b a l l y to avoid t a k i n g any dose w i t h meals, a n t a c i d s , m i l k or i r o n c o n t a i n i n g products. I t was d i s a p p o i n t i n g to f i n d that two of 20 p a t i e n t s t a k i n g t e t r a c y c l i n e had taken i t w i t h m i l k , three p a t i e n t s used an an-t a c i d c o n c u r r e n t l y , and one p a t i e n t took an i r o n supplement at the same time. Four p a t i e n t s would admit that they had taken t e t r a c y c l i n e w i t h t h e i r meals at l e a s t once a day. These p a t i e n t s were a l l i n Group 1 and w r i t t e n i n s t r u c t i o n s , as suggested p r e v i o u s l y , should be r o u t i n e l y used by pharmacists t o r e i n f o r c e these v e r b a l d i r e c t i o n s . Proper drug u t i l i z a t i o n i n a n t i b i o t i c therapy can o f t e n be the d i f f e r e n c e between success and f a i l u r e i n e r r a d i c a t i n g an i n f e c t i o n . The pharmacist has a r e s p o n s i b i l i t y to ensure that the p a t i e n t understands a l l h i s d i r e c t i o n s and uses the p r e s c r i p t i o n as intended. The r e s u l t s presented here seem to show how one form of pharmacist follow-up contact w i t h the p a t i e n t may help improve drug u t i l i z a t i o n w i t h a n t i b i o t i c s . One important t o o l used i n t h i s - 81 -follow-up contact i s the p a t i e n t record p l a n . The f e a s i b i l i t y of such follow-up i n t e r v i e w s , the time r e q u i r e d , and the a l t e r n a t e methods of i n i t i a t i n g such follow-up i n t e r v i e w s would d i f f e r according to the par-t i c u l a r pharmacy o p e r a t i o n . These f a c t o r s would r e q u i r e f u r t h e r e v a l u a t i o n . E, PHARMACIST TIME In previous aspects of the current research emphasis was placed on determining how the pharmacists might promote more e f f e c t i v e drug therapy through the use o f p a t i e n t record plans. The second major q u e s t i o n , which should be answered before the f e a s i b i l i t y of p a t i e n t record plans are accepted i n p r a c t i c e i s one of economics. How can the pharmacist modify h i s present p r o f e s s i o n a l r o u t i n e to j u s t i f y the time r e q u i r e d to main-t a i n such records? In .ah : attempt t o answer t h i s q u e s t i o n , a study was conducted r e l a t i v e to the use of a n o n - p r o f e s s i o n a l a s s i s t a n t i n a pharmacy. The dispensing procedures i n the pharmacy (pharmacy X) were adapted to the f u n c t i o n s which must be performed by a pharmacist, and those which might be done by a n o n - p r o f e s s i o n a l a s s i s t a n t under the super-v i s i o n of the pharmacist. These 17 steps are presented i n Table X. - 82 -TABLE X DISPENSING FUNCTIONS1 AS RELATED TO PHARMACIST AND NON-PROFESSIONAL ASSISTANT RESPONSIBILITIES Function Responsibility Pharmacist Non-Professional Assistant" D. 1. Receipt of prescription from patient. 2. Interpretation & identification, 3. Calculate price. 9. Select medication & container, 10. Count or pour medication. 11. Package and affix label. 12. Final check of prescription. Return medication to stock, 13. Make entry on patient record card. 14. Check patient record card for allergies. 'Drug Interaction Index' (44) checked for pos-sible drug interactions with previous medication. 15. Give prescription to patient advise on proper use, answer any questions concerning the prescription & other medications. Pull patient card or type new card. Stamp prescription number on prescription, daysheet, patient record card. Name and price entered on daysheet. Date and price entered on patient record card. Type label. 16, 1.7. Wrap medication, ring up sale, as cash or charge. When nec-essary type new charge card. Refile patient record card Si prescription. 1. Seventeen functions defined in dispensing process of a prescription i n one pharmacy. 2. Functions which must be performed by a pharmacist. 3. Functions which may be done by a non-professional assistant under the supervision of a pharmacist. - 83 -To evaluate the p o t e n t i a l of a non - p r o f e s s i o n a l a s s i s t a n t i n a s s i s t i n g the pharmacist i n dispensing the f o l l o w i n g approach was used. 1. I n d i v i d u a l Time. The time r e q u i r e d f o r the pharmacist to perform a l l 17 of the above steps alone was determined f o r 15 p a t i e n t s r e c e i v i n g one p r e s c r i p t i o n . This i n d i v i d u a l time requirement was f u r t h e r evaluated f o r f i v e p a t i e n t s r e c e i v i n g two p r e s c r i p t i o n s . 2. Team Time. The time segments were evaluated f o r the same numbers of p a t i e n t s as above when the non - p r o f e s s i o n a l a s s i s t a n t s and pharmacist performed the dispensing procedures as a team on a co-operative b a s i s as shown i n Table X. The r e s u l t s of the comparative times r e q u i r e d i n the two approaches represented i n Table X I . - 84 -TABLE XI DISPENSING TIME REQUIRED USING A PATIENT RECORD PLAN1 FOR (a) AN INDIVIDUAL PHARMACIST2 AND (b) A PHARMACIST - NON-PROFESSIONAL ASSISTANT TEAM3 APPROACH Dispensing Time (Minutes) Individual Team Pharmacist Pharmacist Non-Professional Asst. One prescription per patient 6.8 4.1 3.4 (Range) (5.1 - 11.0) (2.5 - 6.8) (1.9 - 5.2) Two prescriptions per patient 10.7 5.4 4.5 (Range) (7.9 - 13.9) (4.2 - 5.9) (3.5 - 5.8) 1. See Table X for detailed procedure for each member of the team. 2. Time for pharmacist dispensing a l l 17 steps. 3. Time for pharmacist and non-professional assistant team following a l l 17 steps. 4. Average time for 15 patients with one prescription and five patients with two prescriptions. - 85 -In f i l l i n g one prescription the apparent pharmacist time required was reduced from 6.8 minutes to 4.1 using the team approach. This represents an approximate saving in pharmacist time of 40%. Since the non-professional assistants functions (D and E in Table X) were performed while the pharmacist was doing C and D for the same patient or starting function A for the next patient (see Table X), hense, the max-imum team time spent on a prescription normally was no more than the pharmacist's total team-time. On the other hand, the summation of the times for individual members was greater than when the individual pharmacist performed a l l of the steps (7.15 minutes vs 6.8 minutes). It i s interesting to note that the pharmacist total time of 4.1 minutes for the one prescription represented 66 seconds, 98 seconds, and 79 seconds for functions A, C, and D respectively (see Table X for details). The 3.4 minutes required by the non-professional assistant was made up of 117 seconds and 84 seconds respectively for functions B and E. In f i l l i n g two prescriptions per patient, the pharmacist time was reduced from 10.7 minutes to 5.4 minutes with the team approach. This represents an approximate saving of 50% of pharmacist time. It would appear the efficiency of the team increases as the number of prescriptions f i l l e d per patient increases. Pharmacist time for two prescriptions for functions A, C and D were 104 seconds, 137 seconds and 81 seconds respectively. The non-professional assistants time for functions B and E of this approach were 175 seconds and 97 seconds. The total time that the pharmacist alone; and the team approach required - 86 -in dispensing prescriptions and using a patient record plan compare favourably to those times previously reported (84) (see literature survey pg. 33 - 36) for the pharmacist alone. The important feature of the above results, however, is the apparent professional time saved in dis-pensing, when aided by a non-professional assistant in the mechanical functions. This saving would appear to jus t i f y the pharmacist's In-volvement In the consultation aspects related to the patient record plan which require professional judgement. Furthermore, the team approach to dispensing would appear to be as economically favorable to a pharmacy operation as when the pharmacist performs a l l the dispensing functions alone. The 40% or 50% saving per prescription on pharmacist time with the team approach, as indicated i n these results should account for the cost of involvement of a non-professional member. In summary, the above results of a team approach to dispensing, and while using the patient record plan, represents one method in which the pharmacist can promote better drug therapy through the use of such a plan without increasing the overall cost of dispensing. - 87 -SUMMARY AND CONCLUSIONS A patient record plan, which i s a medication summary, i s maintained in many community pharmacies for an individual patient or a family. This summary should include both prescribed and self-selected medications, dispensed or sold for that patient or family. Studies using patient record plans, which have been used in two community pharmacies for six and nine years, have supported the effectiveness of such plans in identifying and preventing potential problems related to drug use at the ambulatory patient level. Several aspects of these studies further showed how the plans may be used to a greater advantage than at present in this respect. These studies concentrated on the influence of patient record plans with respect to drug interactions; drug sensitive conditions, self-admin-istration of drugs by patients, and pharmacist time in dispensing, Some of the features include: 1. Patient record plan format i s conducive to surveillance of potential interactions between prescribed and non-prescription drugs. 2. The patient record plans surveyed show that primarily prescription-only drugs are recorded, Using tetracycline analogues and reviewing the records of patients for which both prescription-only and nonr-prescription drugs were regularly entered, i t appeared that more potential inter-actions occurred with non-prescription drugs than with prescription drugs. - 88 -3. It i s concluded that, in maintaining a patient record plan, a pharmacist should record non-prescription as well as prescription-only drugs, hence screen both for potential interactions. 4. Drug sensitive conditions such as allergies and disease states were found to be recorded regularly on the patient record plans reviewed. Although there was no indication as to how such recording prevented contraindicated therapy in most cases, several excellent examples of the pharmacist's contribution i n this area were identified. 5. Drug sensitive conditions noted in a select group of patients were greater i n number than those recorded for the same patients on physicians charts. A method of transferring information from the former to the latter i s suggested to provide a comprehensive record of drug s e n s i t i v i t i e s . 6. The use of the patient record plan in determining theoretical last dose time of a prescription has been shown to influence the accuracy of prescribed self-medication regimen for a patient. Patients receiving only verbal instructions before using apprescription did not appear to follow such regimen as well as did those patients who received verbal and written instructions as well as follow-up interview after the dosage schedule was finished. 7. A procedure for placing the responsibility of i n i t i a t i n g the follow-up interview on the patient i s described. 8. Functions required in the dispensing procedure with the ef-fective use of a patient record plan were described. The time required for the individual pharmacist to perform a l l 17 steps was compared to the time required for a pharmacist and a non-professional assistant in doing the same functions. Pharmacist time per prescription appeared to be reduced approximately 40 to 50% by the team approach, thereby absorbing the cost of the non-professional assistant's involvement i n the dispensing procedure. APPENDIX I FAMILY RECORD CHART FOR PRESCRIPTIONS PHARMACY X ; L SURNAME CHILDREN'S NAMES BIRTH DATES HUSBAND' S NAME WIFE'S NAME . ..... ADDRESS , ......... I CITY TELEPHONE ...... ....... PLACE OF EMPLOYMENT ALLERGIES, ETC. (IF ANY) , PHYSICIANS' NAMES o cn i DATE NUMBER PRICE FOR DR. REP. NAME OF DRUG QTY. COMMENTS APPENDIX I I FAMILY RECORD CHART - PHARMACY Y FAMILY ...... PHONE...... ADDRESS , DATE PR] [CE PRESCRIPTION MEDICATION I Day/Mo./Yr. $ c Number R f l . DOCTOR PATIENT Ph.C. Quantity D e s c r i p t i o n Strength Dosage - 92 -BIBLIOGRAPHY 1. T y l e r , V.E., Am. J . Pharm. 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