I EDITORIALS I
Drug information for patients S.M. MACLEOD,* MD, PH D, FRCP[C]
There is growing debate on the question of how much supplementary information on medication should be provided to patients. In the United States the Food and Drug Administration presently requires provision of a "patient package insert" to all patients receiving oral contraceptives, estrogens or intrauterine contraceptive devices. The Drug Regulation Reform Act, which is under study in the United States, would greatly extend the requirement for patient package inserts. In Canada the health protection branch of the Department of National Health and Welfare has not yet demanded the provision of supplementary drug information to patients. However, initiative in this area was passed to the Canadian Pharmaceutical Association (CPA), which, in July 1977, formed a project committee on supplementary drug information. The chairman, Dr. J.G. Nairn, of the faculty of pharmacy at the University of Toronto, initially contacted 43 groups of individuals throughout Canada and solicited their opinions on the provision of drug information to patients. However, the Canadian Medical Association (CMA) was the only medical organization approached. The remainder of those contacted were pharmacists, representatives of other paramedical groups and lobbyists for consumer rights.' During the first 15 months of the project the committee was without medical representation, although a draft proposal was released in June 1978' and a final proposal completed in April 1979. Since October 1978 Dr. N.P. DaSylva, director of medical services for the CMA, has been a member of the project committee. Arrangements have also recently been made for physicians from the CMA and the College of Family Physicians of Canada to review supplementary information sheets as they are prepared by the CPA. The committee's proposal endorses the provision * Director, pediatrics, professor, pediatrics,
division of clinical pharmacology, department of Hospital for Sick Children, Toronto; associate departments of pharmacology, medicine and University of Toronto
Reprint requests to: Dr. SM. MacLeod, Director, Division of clinical pharmacology, Department of pediatrics, Hospital for Sick Children, 555 University Ave., Toronto, Ont. M5G 1X8
of supplementary information on medication to patients and consumers as a complement to the patient-physician or the patient-pharmacist dialogue. In general, the committee believed that supplementary information should be given for all medications, whether prescription or over-the-counter, although it would be the physician's prerogative to request that such information be withheld for prescription items. It was proposed that the CPA develop supplementary informatio.i sheets that would be submitted for approval to an expert committee of physicians, pharmacists and consumers. No allowance was made for input from the manufacturers of the medications in question. Final approval of the supplementary information sheets would be sought from the health protection branch. Dr. Nairn has suggested that preparation of supplementary information sheets should begin immediately and that they should be introduced at a rate of approximately six per month. In Canada one such patient package insert is available; it was prepared for oral contraceptive agents by the health protection branch in consultation with a special committee of nongovernment advisers. The resulting information sheet was introduced without further discussion with practising family physicians, nonacademic obstetricians or the relevant pharmaceutical companies. With this precedent in mind the medical profession should be wary of the initiative now taken by the CPA. It should be clear from the performance of the special project committee that little effort will be made to involve medical groups in the preparation of information sheets or to solicit the opinion of medical practitioners concerning the likely impact of supplementary drug information on the doctor-patient relationship. More cautious groups with greater medical input have repeatedly pointed out the hazards of hasty adoption of the principle of increased drug information for patients. The idea of informing patients about their medications is laudable; however, it should be apparent that there is no method available for the design and use of patient information sheets that can assure benefit without the possibility of harm to a significant proportion of patients. Drug information sheets, unless carefully worded and designed, may discourage apCMA JOURNAL/OCTOBER 20, 1979/VOL. 121
+-For prescribing information see page 1107
1043
propriate use. The American Society for Clinical Pharmacology and Therapeutics, in its official response to the United States' Drug Regulation Reform Act, suggested that "patient package inserts should be included only when an actual document has been thoroughly tested and as a result of such tests has been shown to have benefits that outweigh its hazards".2 Joubert and Lasagna3'4 have demonstrated that some patients demand additional information about their medication. Younger and better educated patients show greater interest in the provision of material from nonphysician sources, while elderly and more poorly educated patients depend more on advice from the physician. Reading and comprehension of the supplementary information sheet present another problem.5 The readability of the information sheet used in the United States on estrogens was recently reviewed by Pyrczak.6 He found that 9th- to 10th-grade reading ability was required and therefore suggested that signifcant improvements in its readability were needed if it was to serve the purpose for which it was intended. Such studies indicate some of the problems that arise with the general introduction of supplementary information on medications. There are many more questions that have not yet been answered:7.8 * Who should assume responsibility for a drug information program? Should there be any government intervention? * How can input from practising physicians be assured? * What are the hidden costs of a patient package insert? Won't the introduction of a system leading to extensive patient-pharmacist consultation ultimately require increased dispensing or consultation fees from the pharmacist? * Are modern graduates in pharmacy adequately trained to offer valid consultation on the drug and the disorder it is designed to correct? * Is it possible to design patient package inserts that will be meaningful to the older, less affluent and more poorly educated members of the population? * Do patient package inserts carry a significant risk of harm to a proportion of patients through worsening of compliance with therapeutic regimens? * Should the patient package insert discuss such discretionary matters as usual drug dosage and indications? Is there a demonstrated need for a significant proportion of patients to have greater access to information about drugs? It is clear that the people who are most insistent on having such information are those who already have access to and are familiar with considerable educational resources. Books on drugs, including the "Compendium of Pharmaceuticals and Specialties",9 are available in many public libraries in Canada and can therefore be consulted by any patient.
1044 CMA JOURNAL/OCTOBER 20, 1979/VOL. 121
The most widely used book in the public libraries in New York is the "Physicians' Desk Reference",1 which circulates approximately once every 15 minutes. This suggests that affluent, well educated patients are not entirely without drug information. It is questionable whether it is practical to involve patients implicitly in the risk-benefit decision that must be made in every therapeutic equation. In the United States the Food and Drug Administration has required that all patients be provided with a statement regarding the proper use of estrogens and a warning of the potential dangers and relative risks. The emphasis in these guidelines is on possible hazard, not on therapeutic benefit, and it is unlikely that many patients will be able to use the information in deciding whether the risks of estrogen therapy are acceptable.'1 The need for supplementary drug information directed toward the patient is controversial. Undoubtedly there are some situations in which such information will prove beneficial. The main issues at the moment are the method and degree of implementation. In Canada the medical profession is standing quietly aside while pharmacists are introducing a new and important factor into the doctor-patient relationship. The provision of supplementary information *on medications has implications for all physicians. To the extent that this new factor may well lead to a significant deterioration in health care for some patients it should not be ignored. References 1. NAIRN JG (chmn): Draft Proposal for Supplementary information on Medication, project committee on supplementary drug information, Canadian Pharmaceutical Association, Toronto, June 1978 2. WARDELL W, HAYES AH: Statement of the American Society for Clinical Pharmacology and Therapeutics on the Drug Regulation Reform Act of 1978 (HRI 1611). Presented to the subcommittee on health and environment of the Committee on Interstate and Foreign Commerce, Washington, June 27, 1978 3. JOUBERT P, LASAGNA L: Patient package inserts. 1. Nature, notions, and needs. Clin Pharmacol Ther 18: 507, 1975 4. Idem: Patient package inserts. 2. Toward a rational patient package insert. Ibid, p 663 5. Licuoiu 5: A quantitative assessment of the readability of PPI's. Drug intell Cliii Pharmacy 12: 712, 1978 6. PYRCZAK F: Application of Some Principles of Readability Research in the Preparation of Patient Package inserts, department of pharmacology and toxicology, Center for the Study of Drug Development, Rochester, NY, 1978 7. DORSEY R: The patient package insert: is it safe and effective? JAMA 238: 1936, 1977 8. Patient package inserts (E). Br Med 1 2: 586, 1978 9. ROTENBERG
GN,
HUGHES
FN
(eds):
Compendium
of
Pharmaceuticals and Specialties, 14th ed, Canadian Pharmaceutical Association, Toronto, 1979 10. HUFF BB (ed): Physicians' Desk Reference, 33rd ed, Medical Economics, Oradell, NJ, 1979 I I. LANDAU RL: What You Should Know A bout Estrogens: or the Perils of Pauline, department of pharmacology and toxicology, Center for the Study of Drug Development, Rochester, NY, 1978
Drug information for patients S.M. MACLEOD,* MD, PH D, FRCP[C]
There is growing debate on the question of how much supplementary information on medication should be provided to patients. In the United States the Food and Drug Administration presently requires provision of a "patient package insert" to all patients receiving oral contraceptives, estrogens or intrauterine contraceptive devices. The Drug Regulation Reform Act, which is under study in the United States, would greatly extend the requirement for patient package inserts. In Canada the health protection branch of the Department of National Health and Welfare has not yet demanded the provision of supplementary drug information to patients. However, initiative in this area was passed to the Canadian Pharmaceutical Association (CPA), which, in July 1977, formed a project committee on supplementary drug information. The chairman, Dr. J.G. Nairn, of the faculty of pharmacy at the University of Toronto, initially contacted 43 groups of individuals throughout Canada and solicited their opinions on the provision of drug information to patients. However, the Canadian Medical Association (CMA) was the only medical organization approached. The remainder of those contacted were pharmacists, representatives of other paramedical groups and lobbyists for consumer rights.' During the first 15 months of the project the committee was without medical representation, although a draft proposal was released in June 1978' and a final proposal completed in April 1979. Since October 1978 Dr. N.P. DaSylva, director of medical services for the CMA, has been a member of the project committee. Arrangements have also recently been made for physicians from the CMA and the College of Family Physicians of Canada to review supplementary information sheets as they are prepared by the CPA. The committee's proposal endorses the provision * Director, pediatrics, professor, pediatrics,
division of clinical pharmacology, department of Hospital for Sick Children, Toronto; associate departments of pharmacology, medicine and University of Toronto
Reprint requests to: Dr. SM. MacLeod, Director, Division of clinical pharmacology, Department of pediatrics, Hospital for Sick Children, 555 University Ave., Toronto, Ont. M5G 1X8
of supplementary information on medication to patients and consumers as a complement to the patient-physician or the patient-pharmacist dialogue. In general, the committee believed that supplementary information should be given for all medications, whether prescription or over-the-counter, although it would be the physician's prerogative to request that such information be withheld for prescription items. It was proposed that the CPA develop supplementary informatio.i sheets that would be submitted for approval to an expert committee of physicians, pharmacists and consumers. No allowance was made for input from the manufacturers of the medications in question. Final approval of the supplementary information sheets would be sought from the health protection branch. Dr. Nairn has suggested that preparation of supplementary information sheets should begin immediately and that they should be introduced at a rate of approximately six per month. In Canada one such patient package insert is available; it was prepared for oral contraceptive agents by the health protection branch in consultation with a special committee of nongovernment advisers. The resulting information sheet was introduced without further discussion with practising family physicians, nonacademic obstetricians or the relevant pharmaceutical companies. With this precedent in mind the medical profession should be wary of the initiative now taken by the CPA. It should be clear from the performance of the special project committee that little effort will be made to involve medical groups in the preparation of information sheets or to solicit the opinion of medical practitioners concerning the likely impact of supplementary drug information on the doctor-patient relationship. More cautious groups with greater medical input have repeatedly pointed out the hazards of hasty adoption of the principle of increased drug information for patients. The idea of informing patients about their medications is laudable; however, it should be apparent that there is no method available for the design and use of patient information sheets that can assure benefit without the possibility of harm to a significant proportion of patients. Drug information sheets, unless carefully worded and designed, may discourage apCMA JOURNAL/OCTOBER 20, 1979/VOL. 121
+-For prescribing information see page 1107
1043
propriate use. The American Society for Clinical Pharmacology and Therapeutics, in its official response to the United States' Drug Regulation Reform Act, suggested that "patient package inserts should be included only when an actual document has been thoroughly tested and as a result of such tests has been shown to have benefits that outweigh its hazards".2 Joubert and Lasagna3'4 have demonstrated that some patients demand additional information about their medication. Younger and better educated patients show greater interest in the provision of material from nonphysician sources, while elderly and more poorly educated patients depend more on advice from the physician. Reading and comprehension of the supplementary information sheet present another problem.5 The readability of the information sheet used in the United States on estrogens was recently reviewed by Pyrczak.6 He found that 9th- to 10th-grade reading ability was required and therefore suggested that signifcant improvements in its readability were needed if it was to serve the purpose for which it was intended. Such studies indicate some of the problems that arise with the general introduction of supplementary information on medications. There are many more questions that have not yet been answered:7.8 * Who should assume responsibility for a drug information program? Should there be any government intervention? * How can input from practising physicians be assured? * What are the hidden costs of a patient package insert? Won't the introduction of a system leading to extensive patient-pharmacist consultation ultimately require increased dispensing or consultation fees from the pharmacist? * Are modern graduates in pharmacy adequately trained to offer valid consultation on the drug and the disorder it is designed to correct? * Is it possible to design patient package inserts that will be meaningful to the older, less affluent and more poorly educated members of the population? * Do patient package inserts carry a significant risk of harm to a proportion of patients through worsening of compliance with therapeutic regimens? * Should the patient package insert discuss such discretionary matters as usual drug dosage and indications? Is there a demonstrated need for a significant proportion of patients to have greater access to information about drugs? It is clear that the people who are most insistent on having such information are those who already have access to and are familiar with considerable educational resources. Books on drugs, including the "Compendium of Pharmaceuticals and Specialties",9 are available in many public libraries in Canada and can therefore be consulted by any patient.
1044 CMA JOURNAL/OCTOBER 20, 1979/VOL. 121
The most widely used book in the public libraries in New York is the "Physicians' Desk Reference",1 which circulates approximately once every 15 minutes. This suggests that affluent, well educated patients are not entirely without drug information. It is questionable whether it is practical to involve patients implicitly in the risk-benefit decision that must be made in every therapeutic equation. In the United States the Food and Drug Administration has required that all patients be provided with a statement regarding the proper use of estrogens and a warning of the potential dangers and relative risks. The emphasis in these guidelines is on possible hazard, not on therapeutic benefit, and it is unlikely that many patients will be able to use the information in deciding whether the risks of estrogen therapy are acceptable.'1 The need for supplementary drug information directed toward the patient is controversial. Undoubtedly there are some situations in which such information will prove beneficial. The main issues at the moment are the method and degree of implementation. In Canada the medical profession is standing quietly aside while pharmacists are introducing a new and important factor into the doctor-patient relationship. The provision of supplementary information *on medications has implications for all physicians. To the extent that this new factor may well lead to a significant deterioration in health care for some patients it should not be ignored. References 1. NAIRN JG (chmn): Draft Proposal for Supplementary information on Medication, project committee on supplementary drug information, Canadian Pharmaceutical Association, Toronto, June 1978 2. WARDELL W, HAYES AH: Statement of the American Society for Clinical Pharmacology and Therapeutics on the Drug Regulation Reform Act of 1978 (HRI 1611). Presented to the subcommittee on health and environment of the Committee on Interstate and Foreign Commerce, Washington, June 27, 1978 3. JOUBERT P, LASAGNA L: Patient package inserts. 1. Nature, notions, and needs. Clin Pharmacol Ther 18: 507, 1975 4. Idem: Patient package inserts. 2. Toward a rational patient package insert. Ibid, p 663 5. Licuoiu 5: A quantitative assessment of the readability of PPI's. Drug intell Cliii Pharmacy 12: 712, 1978 6. PYRCZAK F: Application of Some Principles of Readability Research in the Preparation of Patient Package inserts, department of pharmacology and toxicology, Center for the Study of Drug Development, Rochester, NY, 1978 7. DORSEY R: The patient package insert: is it safe and effective? JAMA 238: 1936, 1977 8. Patient package inserts (E). Br Med 1 2: 586, 1978 9. ROTENBERG
GN,
HUGHES
FN
(eds):
Compendium
of
Pharmaceuticals and Specialties, 14th ed, Canadian Pharmaceutical Association, Toronto, 1979 10. HUFF BB (ed): Physicians' Desk Reference, 33rd ed, Medical Economics, Oradell, NJ, 1979 I I. LANDAU RL: What You Should Know A bout Estrogens: or the Perils of Pauline, department of pharmacology and toxicology, Center for the Study of Drug Development, Rochester, NY, 1978
