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Legal Blotter: Drug reclassification questions
drug reclassification questions Over the last several years, the AMERICAN PHARMACEUTICAL ASSOCIATION st aff and committees have discussed the need for professional supervision and guidance in t he use of at least some drugs currently available for self-medication . In t he last 18 months, the APHA proposal st arted to take definite shape and has become the primary topic of discussion among pharmacists and, perhaps, drug manufact urers. T he broad outlines APHA advanced have served their intended purposes-promoting and encouraging discussion of the concept of reclassification . As a result of these discussions, professional introspection, questions, questionnaires, resolutions and other factors, many of the uncertainties and unknowns are being clarified. APHA has stated many times that it welcomes the ideas, comments and questions of pharmacists and others on its reclassification proposal ; we stand ready and willing to supply any pharmacist with the information he needs to make an intelligent and informed decision . Where answers or guidelines are not available, our staff and committees will work to obtain t he necessary data. The first public stir on t he APHA reclassification proposal came when APHA House of Delegates Chairman Calvin Berger appeared before a U.S. Senate subcommittee on August 23, 1963. However, it is important t o note that as early as 1960 the report of the APHA committee on legislation st at edThe committee is concerned about the unsupervised distribution and dispensing of drugs by non-qualified persons, all of which frequently occurs in non-licensed establishments. The committee further feels that this improper handling of drugs in an uncontrolled manner of distribution is inimical to public health and welfare and can most effectively be curbed by amendment of the federal Food , Drug and Cosmetic Act to incorporate the following principles1. It appears that there is an intermediate category of drugs which either were formerly under the prescription legend or which contain one or more drugs which by themselves are prescription legend drugs. All of these drugs must have their 30
distribution supervised by registered pharmacists or by the practitioner himself who is licensed by law to prescribe such drugs . .. Recognizing that it will take time and work from all state associations and close co-ordination of all pharmacy groups, the committee recommends that APhA take the necessary implementing action to accomplish the incorporation of the above principles into the federal Food , Drug and Cosmetic Act.
T he members of the 1960 APHA committee on legislation who participated in the deliberation leading up to the quoted report were Joseph Cohen, then secretary of the Maryland Pharmaceutical Association and currently director of professional services for NARD; P.H. Costello, then secretary of the National Association of Boards of Pharmacy; Raymond J. Dauphinais, then director of the APHA legal division; John E. Donaldson, then associated with a pharmacy chain; F. Royce Franzoni, a community pharmacist; Milton Heller, a pharmacist-attorney in private practice; Paul A. Pumpian, secretary of the Wisconsin Board of Pharmacy, and Hugo H. Schaefer, APHA Councilor. Subsequent committee reports carry additional references which show that the reclassification concept has been under active consideration within APHA for nearly five years. With this mat erial as background, we present some of t he questions pharmacists have asked along with summary answers which APHA has given from time to time. Q- Does APhA propose to eliminate selfmedication?
A-No. APHA's reclassification proposal seeks to make self-medication safer in the interest of public health and safety. Speaking before t he annual meeting of the Wisconsin Pharmaceutical Association on September 9, 1963, AP HA Executive Director William S. Apple spoke to this point specifically when he statedNow it is ... obvious that all . drugs cannot be placed on prescription
Journal of the AMERICAN PHARMACEUTICA L ASSOCIATION
order only status. Any effort to make all drugs available only upon pre· scription order would be unwise, un· workable and unnecessary. History itself shows us that self·medication ... are integral and necessary parts of civilized life. Q- Will pharmacists assume greater liability risks?
A.- From t he letters and questionnaires, we know that some pharmacists have established informal working agreements to govern the usual prescription renewal problem. In other cases, physicians utilize the "prn " or " ad lib" renewal instructions. In both cases, the pharmacists concerned must exercise professional judgmen t and discretion. The APHA proposal begins with the basic premise that pharmacists are competent authorities and have the necessary expertise to assume the responsibility for drug distribution. In our judgment, the pharmacist will have more responsibility but will not increase his liability. The liability will be no greater under the classifications as proposed by APHA than it is presently, but pharmacists will have greater exposure to potential liability. When a pharmacist exercises his judgment in advising the patron on the proper use of a drug for self-medication or in renewing a prescription order which a physician has marked with a "prn," he must use due care. That is, he must not be negligent. Under the reclassification proposal, the pharmacist would be faced with many more opportunities to exercise his professional judgment and discretion, but the risk would be no greater with each decision. This additional exposure is an insurable risk which can be taken care of reasonably by malpractice insurance. Harold L. Marquis, professor of science and law at Temple University, has discussed t he question of the pharmacist's liability un der reclassification in a paper which was first presented at the 1964 annual meeting of the Pennsylvania Pharmaceutical Association and later widely repUblished. He concluded that he didn't believe that the reclassification plans would increase the pharmacist's liability very much and didn 't believe the liability
question should be given much weight in deciding whether or not to support the proposal. Michael F. Markel, the noted food and drug attorney APHA has retained to assist with the technical aspects of the program, has advised that the liability question is insignifican t. Q-Why isn't the present category of OTC drugs adequate?
A-There seems to be a popular misconception that the law recognizes classes of drug products for self-medication. Most frequently mentioned are "proprietaries" and "over-the-counter" drugs as two separate categories. The federal law makes no such distinction. Presently, the federal law distinguishes between drugs which may be utilized only under the supervision of a qualified prescriber and drugs which may be distributed by anyone unless a specific state law is to the contrary. Under the federal law, OTC's, proprietaries, patent medicines, home remedies, ethicals and all similar drugs are clustered into the same grouping. The federal law provides the strict control of prescription only over certain drugs and provides for no control over the place or manner of distribution of all other drugs. For example, if a drug is removed from the prescription-only category-that is, released for OTC sale-then, at the given hour specified, that drug which heretofore required a prescription order may be distributed in any retail outlet. This is one anomaly the APHA proposal seeks to rectify. Q-Can manufacturers obviate the problem by controlling their drug distribution?
A-About 15 years ago, this was an effective and workable concept but reliance on this voluntary mechanism today is unrealistic. One factor which is quite significant here is the rapid change to mass merchandising and selfservice which we have experienced since 1950. Before these modern merchandising concepts caught on with supermarkets, pharmacies and other outlets, personal service was the rule and most drug products were distributed under the supervision of a pharmacist. Supermarkets and other non-pharmacy stores were not significant outlets for the wide variety of drugs which we find everywhere today. Furthermore, there was a fairly definite dichotomy in drug manufacturers 15 years ago. Prescription drug manufacturers distributed prescriptionlegend drugs and "ethicals" or OTC's and proprietary manufacturers distributed those drugs and household items widely promoted to the public. There was little overlapping. The corporate structures have all but obliterated any such distinction today. One corporate complex may have one subsidiary whose
name appears on the prescription-legend drugs, another subsidiary whose name appears on the OTC labels and a third subsidiary whose name appears on the proprietaries. In the current situation, we find that manufacturers have been forced, in many cases, to permit drugs to be sold in unsupervised outlets because such outlets can legally carry the items. Some products were finding their way into non-pharmacy outlets through diversion and clandestine arrangements. Mass merchandising and self-service and, by comparison, gigantic merchandising establishments in the food, drug and even soft-goods lines have become a way of life for most Americans. OTC's which once had the benefit of supervised distribution now find their way to the public without the necessary safeguard of professional counsel. Once upon a time manufacturers intended to keep certain products exclusively in pharmacies so that purchasers could have the benefit of the professional services of a pharmacist; but this intention, if it still exists, is no longer adequate to protect the pUblic. Reliance on the manufacturer's distribution pattern to protect the public safety is an anachronism. Such controlled distribution has utterly collapsed, yet there is even more reason to require such professional guidance and supervision in the use of many contemporary self-medication products. The products for self-medication are more potent and have a greater capacity for harm and misuse than preparations for selfmedication of several years ago. Q-Can a pharmacist provide professional counsel on drug use without "counter prescribing?"
A-There is a difference between providing guidance to assist a patron to select a given drug and prescribing a drug for a patient. With self-medication, the patient diagnoses his own minor ailment and prescribes for himself. The medical profession has long recognized the right of self-medication. The pharmacist will, however, assure himself that the patient has not overlooked warning signals of serious disease and is resorting to self-medication only for relief of a minor ailment. Pharmacists today routinely recommend given medicaments on the request of the patient. What's good for this head cold, this cough, athlete's foot and others are quite common questions and we respond to them. A pharmacist is not a diagnostician and should never attempt to diagnose any condition. A pharmacist can and should assist patrons to select the proper drug for self-medication once the diagnosis has been made just as a pharmacist assists the physician selecting a drug for a given diagnosis.
medI-Q Answers (Answers to MedI-Quiz on page 6)
1. 2. 3. 4. 5.
(B ) (A) (B) (B) (D) Barbital is excreted essentially unchanged in the urine 6. (C) 7. (C) 8. (B) Trade names are Syntetrin and Velacycline
9. 10. 11. 12.
(B) (A) (D ) (A) demethylchlortetracycline (Declomycin) (B) fluorouracil (C) mercaptopurine (Purinethol) (D ) triethylene melamine (E ) vincristine (Oncovin) (F ) pentaerythritol tetranitrate (Peritrate et al) (G) ethylenediamine tetraacetic acid (H) hexachlorophene (trade name for) (I) 2-pyridine aldoxime methochloride (pralidoxime chloride; Proto pam chloride) (]) dihydrotachysterol (Hytakerol) (K) decamethonium bromide (Syncurine) (L) isoflurophate (diisopropyl fluorophosphate; Floropryl) (M) dihydroergotamine (N) idoxuridine (Dendrid, Herplex, Stoxil) (0) radio-iodinated serum albumin (P) para-aminobenzoic acid (Q) phenolsulfonphthalein (R) sulfaethidole (sulfaethylthiadiazo 1e)
Pharmaceutical R&D Opportunity for Pharmaceutical Research man with Ph.D. in Pharmacy or closely related discipline. Challenging work involves basic drug dosage design research, including the opportunity to participate in Bio-Pharmaceutic team studies. Also involves individual responsibility for new product development of new ethical drugs as well as combinations of older drug substances. Hospital or industrial formulation experience desirable but not mandatory. Send complete resume to Donald G. Duncan, Personnel Mgr.
The Wm. S. Merrell Company Division of Richardson-Merrell Inc.
Cincinnati, Ohio 45215
An equal opportunity employer ~
Vol. NS5, No.1, January 1965
31
This chewable tablet is about to be crushed by a special hardness-testing machine. It is one way to make sure that our chewable tablets are neither too hard nor too soft. This simple device tells an important story. For instance, it can help determine whether a tablet is hard enough to withstand the rigors of packaging and handling. It also plays a leading role in cases in which the hardness factor could influence a tablet's therapeutic activity. 0 Hardness testing is just one aspect of an elaborate program at Eli Lilly and Company to insure the highest quality in our finished products. Eli Lilly and Company. Indianapolis 6, Indiana, U.S.A.
500101
distribution supervised by registered pharmacists or by the practitioner himself who is licensed by law to prescribe such drugs . .. Recognizing that it will take time and work from all state associations and close co-ordination of all pharmacy groups, the committee recommends that APhA take the necessary implementing action to accomplish the incorporation of the above principles into the federal Food , Drug and Cosmetic Act.
T he members of the 1960 APHA committee on legislation who participated in the deliberation leading up to the quoted report were Joseph Cohen, then secretary of the Maryland Pharmaceutical Association and currently director of professional services for NARD; P.H. Costello, then secretary of the National Association of Boards of Pharmacy; Raymond J. Dauphinais, then director of the APHA legal division; John E. Donaldson, then associated with a pharmacy chain; F. Royce Franzoni, a community pharmacist; Milton Heller, a pharmacist-attorney in private practice; Paul A. Pumpian, secretary of the Wisconsin Board of Pharmacy, and Hugo H. Schaefer, APHA Councilor. Subsequent committee reports carry additional references which show that the reclassification concept has been under active consideration within APHA for nearly five years. With this mat erial as background, we present some of t he questions pharmacists have asked along with summary answers which APHA has given from time to time. Q- Does APhA propose to eliminate selfmedication?
A-No. APHA's reclassification proposal seeks to make self-medication safer in the interest of public health and safety. Speaking before t he annual meeting of the Wisconsin Pharmaceutical Association on September 9, 1963, AP HA Executive Director William S. Apple spoke to this point specifically when he statedNow it is ... obvious that all . drugs cannot be placed on prescription
Journal of the AMERICAN PHARMACEUTICA L ASSOCIATION
order only status. Any effort to make all drugs available only upon pre· scription order would be unwise, un· workable and unnecessary. History itself shows us that self·medication ... are integral and necessary parts of civilized life. Q- Will pharmacists assume greater liability risks?
A.- From t he letters and questionnaires, we know that some pharmacists have established informal working agreements to govern the usual prescription renewal problem. In other cases, physicians utilize the "prn " or " ad lib" renewal instructions. In both cases, the pharmacists concerned must exercise professional judgmen t and discretion. The APHA proposal begins with the basic premise that pharmacists are competent authorities and have the necessary expertise to assume the responsibility for drug distribution. In our judgment, the pharmacist will have more responsibility but will not increase his liability. The liability will be no greater under the classifications as proposed by APHA than it is presently, but pharmacists will have greater exposure to potential liability. When a pharmacist exercises his judgment in advising the patron on the proper use of a drug for self-medication or in renewing a prescription order which a physician has marked with a "prn," he must use due care. That is, he must not be negligent. Under the reclassification proposal, the pharmacist would be faced with many more opportunities to exercise his professional judgment and discretion, but the risk would be no greater with each decision. This additional exposure is an insurable risk which can be taken care of reasonably by malpractice insurance. Harold L. Marquis, professor of science and law at Temple University, has discussed t he question of the pharmacist's liability un der reclassification in a paper which was first presented at the 1964 annual meeting of the Pennsylvania Pharmaceutical Association and later widely repUblished. He concluded that he didn't believe that the reclassification plans would increase the pharmacist's liability very much and didn 't believe the liability
question should be given much weight in deciding whether or not to support the proposal. Michael F. Markel, the noted food and drug attorney APHA has retained to assist with the technical aspects of the program, has advised that the liability question is insignifican t. Q-Why isn't the present category of OTC drugs adequate?
A-There seems to be a popular misconception that the law recognizes classes of drug products for self-medication. Most frequently mentioned are "proprietaries" and "over-the-counter" drugs as two separate categories. The federal law makes no such distinction. Presently, the federal law distinguishes between drugs which may be utilized only under the supervision of a qualified prescriber and drugs which may be distributed by anyone unless a specific state law is to the contrary. Under the federal law, OTC's, proprietaries, patent medicines, home remedies, ethicals and all similar drugs are clustered into the same grouping. The federal law provides the strict control of prescription only over certain drugs and provides for no control over the place or manner of distribution of all other drugs. For example, if a drug is removed from the prescription-only category-that is, released for OTC sale-then, at the given hour specified, that drug which heretofore required a prescription order may be distributed in any retail outlet. This is one anomaly the APHA proposal seeks to rectify. Q-Can manufacturers obviate the problem by controlling their drug distribution?
A-About 15 years ago, this was an effective and workable concept but reliance on this voluntary mechanism today is unrealistic. One factor which is quite significant here is the rapid change to mass merchandising and selfservice which we have experienced since 1950. Before these modern merchandising concepts caught on with supermarkets, pharmacies and other outlets, personal service was the rule and most drug products were distributed under the supervision of a pharmacist. Supermarkets and other non-pharmacy stores were not significant outlets for the wide variety of drugs which we find everywhere today. Furthermore, there was a fairly definite dichotomy in drug manufacturers 15 years ago. Prescription drug manufacturers distributed prescriptionlegend drugs and "ethicals" or OTC's and proprietary manufacturers distributed those drugs and household items widely promoted to the public. There was little overlapping. The corporate structures have all but obliterated any such distinction today. One corporate complex may have one subsidiary whose
name appears on the prescription-legend drugs, another subsidiary whose name appears on the OTC labels and a third subsidiary whose name appears on the proprietaries. In the current situation, we find that manufacturers have been forced, in many cases, to permit drugs to be sold in unsupervised outlets because such outlets can legally carry the items. Some products were finding their way into non-pharmacy outlets through diversion and clandestine arrangements. Mass merchandising and self-service and, by comparison, gigantic merchandising establishments in the food, drug and even soft-goods lines have become a way of life for most Americans. OTC's which once had the benefit of supervised distribution now find their way to the public without the necessary safeguard of professional counsel. Once upon a time manufacturers intended to keep certain products exclusively in pharmacies so that purchasers could have the benefit of the professional services of a pharmacist; but this intention, if it still exists, is no longer adequate to protect the pUblic. Reliance on the manufacturer's distribution pattern to protect the public safety is an anachronism. Such controlled distribution has utterly collapsed, yet there is even more reason to require such professional guidance and supervision in the use of many contemporary self-medication products. The products for self-medication are more potent and have a greater capacity for harm and misuse than preparations for selfmedication of several years ago. Q-Can a pharmacist provide professional counsel on drug use without "counter prescribing?"
A-There is a difference between providing guidance to assist a patron to select a given drug and prescribing a drug for a patient. With self-medication, the patient diagnoses his own minor ailment and prescribes for himself. The medical profession has long recognized the right of self-medication. The pharmacist will, however, assure himself that the patient has not overlooked warning signals of serious disease and is resorting to self-medication only for relief of a minor ailment. Pharmacists today routinely recommend given medicaments on the request of the patient. What's good for this head cold, this cough, athlete's foot and others are quite common questions and we respond to them. A pharmacist is not a diagnostician and should never attempt to diagnose any condition. A pharmacist can and should assist patrons to select the proper drug for self-medication once the diagnosis has been made just as a pharmacist assists the physician selecting a drug for a given diagnosis.
medI-Q Answers (Answers to MedI-Quiz on page 6)
1. 2. 3. 4. 5.
(B ) (A) (B) (B) (D) Barbital is excreted essentially unchanged in the urine 6. (C) 7. (C) 8. (B) Trade names are Syntetrin and Velacycline
9. 10. 11. 12.
(B) (A) (D ) (A) demethylchlortetracycline (Declomycin) (B) fluorouracil (C) mercaptopurine (Purinethol) (D ) triethylene melamine (E ) vincristine (Oncovin) (F ) pentaerythritol tetranitrate (Peritrate et al) (G) ethylenediamine tetraacetic acid (H) hexachlorophene (trade name for) (I) 2-pyridine aldoxime methochloride (pralidoxime chloride; Proto pam chloride) (]) dihydrotachysterol (Hytakerol) (K) decamethonium bromide (Syncurine) (L) isoflurophate (diisopropyl fluorophosphate; Floropryl) (M) dihydroergotamine (N) idoxuridine (Dendrid, Herplex, Stoxil) (0) radio-iodinated serum albumin (P) para-aminobenzoic acid (Q) phenolsulfonphthalein (R) sulfaethidole (sulfaethylthiadiazo 1e)
Pharmaceutical R&D Opportunity for Pharmaceutical Research man with Ph.D. in Pharmacy or closely related discipline. Challenging work involves basic drug dosage design research, including the opportunity to participate in Bio-Pharmaceutic team studies. Also involves individual responsibility for new product development of new ethical drugs as well as combinations of older drug substances. Hospital or industrial formulation experience desirable but not mandatory. Send complete resume to Donald G. Duncan, Personnel Mgr.
The Wm. S. Merrell Company Division of Richardson-Merrell Inc.
Cincinnati, Ohio 45215
An equal opportunity employer ~
Vol. NS5, No.1, January 1965
31
This chewable tablet is about to be crushed by a special hardness-testing machine. It is one way to make sure that our chewable tablets are neither too hard nor too soft. This simple device tells an important story. For instance, it can help determine whether a tablet is hard enough to withstand the rigors of packaging and handling. It also plays a leading role in cases in which the hardness factor could influence a tablet's therapeutic activity. 0 Hardness testing is just one aspect of an elaborate program at Eli Lilly and Company to insure the highest quality in our finished products. Eli Lilly and Company. Indianapolis 6, Indiana, U.S.A.
500101