The Law and Clinical Pharmacy JOSEPH 1. FINK 111. B.S.Phorm., J.D.
Philadelphia, Penn.
is being required of the practitioners of all health professions. Government is playing an ever-increasing role in the field of health care, and consumers of the services of health care providers and institutions are calling for more accountability. The body of knowledge related to health and disease is expanding at a rate that is unprecedented. The winds of change are strong; and pharmacy has been subjected to a call for more involvement with patient care, and pharmacists are being asked, “What can you contribute 8” I n order to discuss the law as it relates to clinical pharmacy, it is necessary to consider the origin of the concept of clinical pharmacy. Clinical pharmacy has been defined in numerous ways, and a widely accepted definition is lacking. One definition which seems to embody the philosophy of many practitioners in this field is: “Clinical pharmacy is a concept or a philosophy emphasizing the safe and appropriate use of drugs in patients. It places the emphasis of drugs on the patient not on the product. It is achieved only by interacting responsibly for drugs with all the health disciplines who are in
any way concerned with drugs.”’ Thus, clinical pharmacy is not really a “field” or “specialty,” but it is an attitude or a philosophy of professional practice. A number of authors have traced the recent history of However, the concept of the pharmacist acting as an advisor on proper drug use and accompanying physicians on ward rounds has been with us for ~ e n t u r i e s Moreover, .~ it has always been the responsibility of the pharmacist to utilize his knowledge to protect the patient from the potentially harmful substances which he is to consume or which are to be administered to him. To enhance this role, the professions of pharmacy and medicine were first legally required to be separate in the 1200’s,and this principle has been carried forward through time so that it is written into the statutes regulating the practice of pharmacy today. The pharmacist has both a n ethical and a legal responsibility to monitor the therapy of his patients in such a way as to prevent harmful drug-induced consequences. H e is to protect the patient from drug overdosages, either from incorrect selection of dosage strength o r dosage schedule, potential allergic reactions, and MR. FINKis Associate Professor of Pharmacy potential drug-drug or drug-food interAdministration at the Philadelphia College of Pharmacy and Science, 43rd Street and King- actions. The renowned pharmacologist sessing Mall, Philadelphia, Penn. 19104, and a John J. Abel recognized this when he remember of the Pennsylvania Bar. Presented at a Symposium on Clinical Pharma- marked that the physician “must often cology and the Law, held at the Fifth Annual rely upon the friendly hand of the profesMeeting of the American College of clinical sional pharmacist to correct his misPharmacology in Philadelphia, Penn., on May 1, takes. ”s 1976. HANGE
October, 1976
from the SAGE Social Science Collections. All Rights Reserved
605
FINE
The increasing trend toward specialization among practitioners of medicine has heightened the importance of the pharmacist’s clinical function, particularly with regard to monitoring the therapy of the patient who visits a multitude of specialists. If we visualize the specialty practitioners of internal medicine, dermatology, neurology, obstetrics, and other fields as being on the rim of a wheel with the patient located a t the hub, then the pharmacist would be located in the center as well, bearing the responsibility for assuring that the agents used by the various specialists do not produce untoward consequences in the patient. The practice of clinical pharmacy has many aspects. I n 1971, the Task Force on the Pharmacist’s Clinical Role issued its report.6 This group divided the clinical functions of the pharmacist into seven categories : (1) prescribing drugs, (2) dispensing and administering drugs, (3) documenting professional activities, (4) direct patient involvement, ( 5 ) reviewing drug utilization, (6) education, and (7) consultation. These, then, are the broad categories of activity which we must bear in mind when we discuss the clinical activities of pharmacists. A number of papers have been written concerning varying legal aspects of the practice of clinical Most of these have required that the author engage in ciystal ball gazing since the nature of the law is to decide cases in light of how cases have been decided in the past -the doctrine known as stare decisis. Because courts will follow precedent when deciding a n issue, whenever change occurs we must confront the problem that the courts will be called upon to decide cases for which there is no direct precedent. Until courts reach a decision about how a certain factual situation will be analyzed, attorneys can only speculate and engage in educated guessing concerning the outcome. The challenge is to apply 606
general legal principles to specific situations in order to anticipate the way that court, once it considers the situation, will decide the case. Perhaps a specific example will help to clarify what is meant. No court has ever been presented with a case wherein it is alleged that a pharmacist was negligent for failing to detect and prevent an adverse drug-drug interaction. Until such a case arises, attorneys can only speculate regarding the o u t ~ o m e . * I~n- ~many ~ situations involving the clinical activities of pharmacists, we must speculate concerning the impact of the law on the practitioners. However, the traditional rules serve us well, and their application may well prevent many potential legal entanglements. A noted authority in the application of legal principles to medical situations, Dr. Monroe E. Trout, has noted that the problem of legal actions based on inappropriate drug therapy is significant?8 He reports that a limited study of the malpractice problem f o r the Secretary’s Commission on Medical Malpractice identified that 22 per cent of closed malpractice claims were for failure to diagnose and 78 per cent were for improper treatment. Of the group attributable to improper therapy, 11 per cent were drug related, 6 per cent were the result of an error in therapy, and 2 per cent were due to injection site injuries. Thus, the scope of the problem is such that health professionals involved in proper and appropriate drug use should take steps to assure that drugs are appropriately used more frequently. A number of courts have ruled that the physician and the pharmacist are both liable in situations where the patient suffers a n adverse reaction which defendants should have warned the patient about. In one case, the patient was not told about the necessity of a drug-free interval every six months while consuming methyserThe Journal of Clinical Pharmacology
CLINICAL PHARMACOLOGY A N D THE LAW
gide.l9 Another case was brought to court when neither the physician nor the pharmacist informed the patient of the importance of limiting exposure to the sun while using methoxsalen.20 I n both of these cases, one of which was settled out of court and the other which resulted in a jury verdict, the liability was shared by the physician who prescribed the medication and the pharmacist who dispensed it. Since the courts seem to regard the pharmacist and the physician as both being responsible for preventable adverse drug reactions, the practitioners of the two professions of medicine and pharmacy would be well advised to communicate more frequently with regard to the medication being used by their patients. This advice will grow in importance as time passes and as drug knowledge expands. You are probably familiar with the paper which appeared in the Journal of Medical Education during 1973, which compared the number of lecture hours devoted to various pharmacological topics in the medical and pharmacy curricula of a major university.21 The pharmacy students received over three times as much instruction in pharmacology as did the medical students. As subleties of therapy become recognized, increasing attention will be focused on the need for expertise in the field of therapeutics. The knowledge explosion in medicine and pharmacy will make this so. Physicians can no longer be expected to keep up in all fields. It just is not humanly possible. The practitioner of clinical pharmacy stands ready to help. Let us turn our attention to the legal duties which practitioners owe to patients. One basic legal duty imposed on health professionals is that they practice in a nonnegligent fashion. A discussion of the elements of a legal action for negligence has been presented elsewhere22 and will not be considered in depth here. However, October, 1976
one aspect of negligence is of particular interest with regard to the activities of clinical pharmacists and clinical pharmacologists. Is there legal duty in some situations to obtain and use the services of a consultant ? When one realizes that he is confronted with a situation where his knowledge in the field is less than optimal, he should seek consultation in order to not be deemed to have acted negligently. Certainly, many instances related to drug therapy come to mind where consultation would be of clear benefit to the patient as well as the primary practitioner. The former would benefit from improved care, and benefit would inure to the latter in the form of reduced liability exposure as well as an informal type of continuing education. However, the fact that a consultation was made is not finally determinative on the question of legal liability. The consultant bears some potential legal liability, but not necessarily all. One who selects a consultant may still be deemed to have acted negligently if the consultant he selected was unskilled or unknowledgeable in the field in question. Hence, one must use due care in selecting the practitioner with whom he will be consulting. Beyond that, the primary practitioner still retains primary responsibility for the patient’s welfare. Should the consultant provide erroneous information, liability of the primary practitioner could be established on the basis of negligence in selection of the consultant, as already mentioned, or on the basis of negligence in using the information provided by the consultant. I n the latter situation, it would have to be established that the primary practitioner was negligent in not knowing that the information or suggestions of the consultant were erroneous. The best advice with regard to the use of consultants is twofold: select your consultants well and maintain your inde607
FINK
pendent judgment on behalf of the patient, even in light of the consultant’s supposedly greater expertise. We can reach several conclusions on the basis of this discussion of the law and clinical pharmacy. First, as pharmacists shift their orientation from the product to the patient, new responsibilities will fall on their shoulders. The law will expect them to perform in a nonnegligent fashion, but there is little legal precedent for the pharmacist to rely on when he attempts to evaluate how a court will view his actions. Guidance can be elicited from general principles of law, but their specific applications to a factual situation will be subject to speculation until some cases are decided in this area. Second, the pharmacist and the physician are increasingly finding themselves in the same boat with regard to malpractice claims. Increased communication concerning the therapy of patients will bring to bear the expertise of both groups in an effort to not only enhance patient care but to reduce potential liability exposure. The clinically oriented pharmacist is here to stay, and this will be regarded as a positive step for both pharmacy and medicine.
References 1. Parker, P. F.: The hospital pharmacist in
2. 3.
4.
5. 608
the clinical setting. I: The hospital pharmacist’s viewpoint. Paper presented at the Second Annual Midyear Clinical Meeting of the American Society of Hospital Pharmacists, December 4, 1967 (unpublished). Francke, G. N.: Evolvement of “Clinical Pharmacy.” Drug Intelligence and Clinical Pharmacy 3 :348 (1969). Wertheimer, A. I., and Knoben, J. E.: The past and potential of clinical pharmacy. The Apothecary 86:lO (Feb. 1974). Koup, J. R.: Letter: Deja vu: we have all been here before. Drug Intelligence and Clinical Pharmacy 7 :191 (1973). Cowen, D. L.: The colonial and revolutionary heritage of pharmacy i n America. VI:
The separation of pharmacy from medicine. The Pennsylvania Pharmacist 57 :7 (March 1976). 6. “Report of the Task Force on the Pharmacist’s Clinical Role”. J . Amer. Pharm. Assoo. NSll:482 (1971). 7. Bernzweig, E. P.: The pharmacist of the future: a lawyer’s view. J . Amer. Pharm. Assoo. NSS :591 (1968). 8. Steeves, R. F., and Patterson, F. T.: Legal responsibility of the hospital pharmacist for rational drug therapy. Amer. J . Hospital Pharmacy 26 :404 (1969). 9. Matte, P. J.: The community pharmacistprescriptions, proprietaries and legal problems. J . Amer. Pharm. Assoc. NSlO: 448 (1970). 10. Willig, 8. H.: Legal considerations for the pharmacist undertaking new drug consultation responsibilities. Food, Drug and Cosmetic Law Journal 25:444 (1970). 11. Barker, K N., and Valentino, J. G.: On a political and legal foundation for clinical pharmacy practice. J . Amer. Pharm. Assoc. NS12 :202 (1972). 12. DeMarco, C. T.: The legal basis for clinical pharmacy practice. Amer. J . Hospital Pharmacy 30:1067 (1973). 13. Roberts, C.: The pharmacist, the law and clinical activity. Presented at the Fourteenth Annual Continuing Education Seminar of the University of Pittsburgh School of Pharmacy, May 15 and 16, 1973 (unpublished). 14. Fink, J. L.: Some legal issues presented in clinical pharmacy practice. Drug Intel& gence and Clin. Pharm. 10:444 (1976). 15. Fink, J. L.: Liability aspects of patient medication records. J. Amer. Pharm. Assoc. NS15:496 (1975). 16. Roberts, C.: Beware the family record system. Chain Store Age 46:74 (Aug. 1970). 17. Reed, E. A.: Legal implications of the patient medication profile. J . Legal Ye&cine 4:41 (April 1976). 18. Trout, M. E.: The malpractice crisis today, I1: Medical-legal implications of prescribing. Hospital Formulary 11 :89 (1976). 19. Mahafey ‘us. Sandoz, Inc., Kansas Sedgwick City Dist. Ct., Case No. C-20275 (May 1974). 20. Tonnesson vs. Paul B. Elder Company (Cal. Super. Ct., Santa Clara Co., Docket No. 286356, March 8, 1974). 21. Csaky, T. Z.: Clinical pharmacy and pharmacology: friends or foes? J . Yea. Educ. 48:905 (1973). 22. Fink, J. L.: Interdisciplinary health care: some legal aspects. Amer. J. Pharm. 147: 45 (1975). The Journal of Clinical Pharmacology
Philadelphia, Penn.
is being required of the practitioners of all health professions. Government is playing an ever-increasing role in the field of health care, and consumers of the services of health care providers and institutions are calling for more accountability. The body of knowledge related to health and disease is expanding at a rate that is unprecedented. The winds of change are strong; and pharmacy has been subjected to a call for more involvement with patient care, and pharmacists are being asked, “What can you contribute 8” I n order to discuss the law as it relates to clinical pharmacy, it is necessary to consider the origin of the concept of clinical pharmacy. Clinical pharmacy has been defined in numerous ways, and a widely accepted definition is lacking. One definition which seems to embody the philosophy of many practitioners in this field is: “Clinical pharmacy is a concept or a philosophy emphasizing the safe and appropriate use of drugs in patients. It places the emphasis of drugs on the patient not on the product. It is achieved only by interacting responsibly for drugs with all the health disciplines who are in
any way concerned with drugs.”’ Thus, clinical pharmacy is not really a “field” or “specialty,” but it is an attitude or a philosophy of professional practice. A number of authors have traced the recent history of However, the concept of the pharmacist acting as an advisor on proper drug use and accompanying physicians on ward rounds has been with us for ~ e n t u r i e s Moreover, .~ it has always been the responsibility of the pharmacist to utilize his knowledge to protect the patient from the potentially harmful substances which he is to consume or which are to be administered to him. To enhance this role, the professions of pharmacy and medicine were first legally required to be separate in the 1200’s,and this principle has been carried forward through time so that it is written into the statutes regulating the practice of pharmacy today. The pharmacist has both a n ethical and a legal responsibility to monitor the therapy of his patients in such a way as to prevent harmful drug-induced consequences. H e is to protect the patient from drug overdosages, either from incorrect selection of dosage strength o r dosage schedule, potential allergic reactions, and MR. FINKis Associate Professor of Pharmacy potential drug-drug or drug-food interAdministration at the Philadelphia College of Pharmacy and Science, 43rd Street and King- actions. The renowned pharmacologist sessing Mall, Philadelphia, Penn. 19104, and a John J. Abel recognized this when he remember of the Pennsylvania Bar. Presented at a Symposium on Clinical Pharma- marked that the physician “must often cology and the Law, held at the Fifth Annual rely upon the friendly hand of the profesMeeting of the American College of clinical sional pharmacist to correct his misPharmacology in Philadelphia, Penn., on May 1, takes. ”s 1976. HANGE
October, 1976
from the SAGE Social Science Collections. All Rights Reserved
605
FINE
The increasing trend toward specialization among practitioners of medicine has heightened the importance of the pharmacist’s clinical function, particularly with regard to monitoring the therapy of the patient who visits a multitude of specialists. If we visualize the specialty practitioners of internal medicine, dermatology, neurology, obstetrics, and other fields as being on the rim of a wheel with the patient located a t the hub, then the pharmacist would be located in the center as well, bearing the responsibility for assuring that the agents used by the various specialists do not produce untoward consequences in the patient. The practice of clinical pharmacy has many aspects. I n 1971, the Task Force on the Pharmacist’s Clinical Role issued its report.6 This group divided the clinical functions of the pharmacist into seven categories : (1) prescribing drugs, (2) dispensing and administering drugs, (3) documenting professional activities, (4) direct patient involvement, ( 5 ) reviewing drug utilization, (6) education, and (7) consultation. These, then, are the broad categories of activity which we must bear in mind when we discuss the clinical activities of pharmacists. A number of papers have been written concerning varying legal aspects of the practice of clinical Most of these have required that the author engage in ciystal ball gazing since the nature of the law is to decide cases in light of how cases have been decided in the past -the doctrine known as stare decisis. Because courts will follow precedent when deciding a n issue, whenever change occurs we must confront the problem that the courts will be called upon to decide cases for which there is no direct precedent. Until courts reach a decision about how a certain factual situation will be analyzed, attorneys can only speculate and engage in educated guessing concerning the outcome. The challenge is to apply 606
general legal principles to specific situations in order to anticipate the way that court, once it considers the situation, will decide the case. Perhaps a specific example will help to clarify what is meant. No court has ever been presented with a case wherein it is alleged that a pharmacist was negligent for failing to detect and prevent an adverse drug-drug interaction. Until such a case arises, attorneys can only speculate regarding the o u t ~ o m e . * I~n- ~many ~ situations involving the clinical activities of pharmacists, we must speculate concerning the impact of the law on the practitioners. However, the traditional rules serve us well, and their application may well prevent many potential legal entanglements. A noted authority in the application of legal principles to medical situations, Dr. Monroe E. Trout, has noted that the problem of legal actions based on inappropriate drug therapy is significant?8 He reports that a limited study of the malpractice problem f o r the Secretary’s Commission on Medical Malpractice identified that 22 per cent of closed malpractice claims were for failure to diagnose and 78 per cent were for improper treatment. Of the group attributable to improper therapy, 11 per cent were drug related, 6 per cent were the result of an error in therapy, and 2 per cent were due to injection site injuries. Thus, the scope of the problem is such that health professionals involved in proper and appropriate drug use should take steps to assure that drugs are appropriately used more frequently. A number of courts have ruled that the physician and the pharmacist are both liable in situations where the patient suffers a n adverse reaction which defendants should have warned the patient about. In one case, the patient was not told about the necessity of a drug-free interval every six months while consuming methyserThe Journal of Clinical Pharmacology
CLINICAL PHARMACOLOGY A N D THE LAW
gide.l9 Another case was brought to court when neither the physician nor the pharmacist informed the patient of the importance of limiting exposure to the sun while using methoxsalen.20 I n both of these cases, one of which was settled out of court and the other which resulted in a jury verdict, the liability was shared by the physician who prescribed the medication and the pharmacist who dispensed it. Since the courts seem to regard the pharmacist and the physician as both being responsible for preventable adverse drug reactions, the practitioners of the two professions of medicine and pharmacy would be well advised to communicate more frequently with regard to the medication being used by their patients. This advice will grow in importance as time passes and as drug knowledge expands. You are probably familiar with the paper which appeared in the Journal of Medical Education during 1973, which compared the number of lecture hours devoted to various pharmacological topics in the medical and pharmacy curricula of a major university.21 The pharmacy students received over three times as much instruction in pharmacology as did the medical students. As subleties of therapy become recognized, increasing attention will be focused on the need for expertise in the field of therapeutics. The knowledge explosion in medicine and pharmacy will make this so. Physicians can no longer be expected to keep up in all fields. It just is not humanly possible. The practitioner of clinical pharmacy stands ready to help. Let us turn our attention to the legal duties which practitioners owe to patients. One basic legal duty imposed on health professionals is that they practice in a nonnegligent fashion. A discussion of the elements of a legal action for negligence has been presented elsewhere22 and will not be considered in depth here. However, October, 1976
one aspect of negligence is of particular interest with regard to the activities of clinical pharmacists and clinical pharmacologists. Is there legal duty in some situations to obtain and use the services of a consultant ? When one realizes that he is confronted with a situation where his knowledge in the field is less than optimal, he should seek consultation in order to not be deemed to have acted negligently. Certainly, many instances related to drug therapy come to mind where consultation would be of clear benefit to the patient as well as the primary practitioner. The former would benefit from improved care, and benefit would inure to the latter in the form of reduced liability exposure as well as an informal type of continuing education. However, the fact that a consultation was made is not finally determinative on the question of legal liability. The consultant bears some potential legal liability, but not necessarily all. One who selects a consultant may still be deemed to have acted negligently if the consultant he selected was unskilled or unknowledgeable in the field in question. Hence, one must use due care in selecting the practitioner with whom he will be consulting. Beyond that, the primary practitioner still retains primary responsibility for the patient’s welfare. Should the consultant provide erroneous information, liability of the primary practitioner could be established on the basis of negligence in selection of the consultant, as already mentioned, or on the basis of negligence in using the information provided by the consultant. I n the latter situation, it would have to be established that the primary practitioner was negligent in not knowing that the information or suggestions of the consultant were erroneous. The best advice with regard to the use of consultants is twofold: select your consultants well and maintain your inde607
FINK
pendent judgment on behalf of the patient, even in light of the consultant’s supposedly greater expertise. We can reach several conclusions on the basis of this discussion of the law and clinical pharmacy. First, as pharmacists shift their orientation from the product to the patient, new responsibilities will fall on their shoulders. The law will expect them to perform in a nonnegligent fashion, but there is little legal precedent for the pharmacist to rely on when he attempts to evaluate how a court will view his actions. Guidance can be elicited from general principles of law, but their specific applications to a factual situation will be subject to speculation until some cases are decided in this area. Second, the pharmacist and the physician are increasingly finding themselves in the same boat with regard to malpractice claims. Increased communication concerning the therapy of patients will bring to bear the expertise of both groups in an effort to not only enhance patient care but to reduce potential liability exposure. The clinically oriented pharmacist is here to stay, and this will be regarded as a positive step for both pharmacy and medicine.
References 1. Parker, P. F.: The hospital pharmacist in
2. 3.
4.
5. 608
the clinical setting. I: The hospital pharmacist’s viewpoint. Paper presented at the Second Annual Midyear Clinical Meeting of the American Society of Hospital Pharmacists, December 4, 1967 (unpublished). Francke, G. N.: Evolvement of “Clinical Pharmacy.” Drug Intelligence and Clinical Pharmacy 3 :348 (1969). Wertheimer, A. I., and Knoben, J. E.: The past and potential of clinical pharmacy. The Apothecary 86:lO (Feb. 1974). Koup, J. R.: Letter: Deja vu: we have all been here before. Drug Intelligence and Clinical Pharmacy 7 :191 (1973). Cowen, D. L.: The colonial and revolutionary heritage of pharmacy i n America. VI:
The separation of pharmacy from medicine. The Pennsylvania Pharmacist 57 :7 (March 1976). 6. “Report of the Task Force on the Pharmacist’s Clinical Role”. J . Amer. Pharm. Assoo. NSll:482 (1971). 7. Bernzweig, E. P.: The pharmacist of the future: a lawyer’s view. J . Amer. Pharm. Assoo. NSS :591 (1968). 8. Steeves, R. F., and Patterson, F. T.: Legal responsibility of the hospital pharmacist for rational drug therapy. Amer. J . Hospital Pharmacy 26 :404 (1969). 9. Matte, P. J.: The community pharmacistprescriptions, proprietaries and legal problems. J . Amer. Pharm. Assoc. NSlO: 448 (1970). 10. Willig, 8. H.: Legal considerations for the pharmacist undertaking new drug consultation responsibilities. Food, Drug and Cosmetic Law Journal 25:444 (1970). 11. Barker, K N., and Valentino, J. G.: On a political and legal foundation for clinical pharmacy practice. J . Amer. Pharm. Assoc. NS12 :202 (1972). 12. DeMarco, C. T.: The legal basis for clinical pharmacy practice. Amer. J . Hospital Pharmacy 30:1067 (1973). 13. Roberts, C.: The pharmacist, the law and clinical activity. Presented at the Fourteenth Annual Continuing Education Seminar of the University of Pittsburgh School of Pharmacy, May 15 and 16, 1973 (unpublished). 14. Fink, J. L.: Some legal issues presented in clinical pharmacy practice. Drug Intel& gence and Clin. Pharm. 10:444 (1976). 15. Fink, J. L.: Liability aspects of patient medication records. J. Amer. Pharm. Assoc. NS15:496 (1975). 16. Roberts, C.: Beware the family record system. Chain Store Age 46:74 (Aug. 1970). 17. Reed, E. A.: Legal implications of the patient medication profile. J . Legal Ye&cine 4:41 (April 1976). 18. Trout, M. E.: The malpractice crisis today, I1: Medical-legal implications of prescribing. Hospital Formulary 11 :89 (1976). 19. Mahafey ‘us. Sandoz, Inc., Kansas Sedgwick City Dist. Ct., Case No. C-20275 (May 1974). 20. Tonnesson vs. Paul B. Elder Company (Cal. Super. Ct., Santa Clara Co., Docket No. 286356, March 8, 1974). 21. Csaky, T. Z.: Clinical pharmacy and pharmacology: friends or foes? J . Yea. Educ. 48:905 (1973). 22. Fink, J. L.: Interdisciplinary health care: some legal aspects. Amer. J. Pharm. 147: 45 (1975). The Journal of Clinical Pharmacology
