- Email: [email protected]
Problems Involved in Drug Reclassification
uring the past few years, the desirability of creating a new category of drugs which would be under intermediary level of professional control has been subjected to considerable discussion and debate. At present, physicians provide professional supervision for prescription-legend drugs and the laity largely medicate themselves with over-the-counter drugs. The new category (the third class) would be dispensed or sold by a pharmacist at his professional discretion and at the request of the patient. Such a plan can only be justified if public health and safety will be enhanced and suoh enhancement must be demonstrated not by logic hut by the collection and analysis of case histories of patrons injured by improper self-medication. The number of case histories reported might be only a random sampling which suffers from an inherent liability-many cases may be settled "off-the-record" by anxious insurance carriers or others to avoid adverse publicity (a common pradice and important consideration in many areas of liability today). Nevertheless, comprehensive study should be initiated, despite its difficulty and limitation. The results would be invaluable in testing any proposed reclassification plan and arriving at a judgment on a particular plan's effectiveness in reducing the number of injuries or extent of harm. This article evaluates the implications of some of the ways in which drugs might be reclassified and attempts to clarify some of the issues which have arisen in discussions of the concept. Perhaps this article will help correct some of the misconceptions and provide a climate for intelligent discussion and debate of the merits of reclassification. Although a reclassification plan could be adopted at either the federal
D
170
or state level, it would seem that ultimately some standards would have to be set at the federal level or there would be confusion and conflict over the classification and · labeling of drugs. These might not be too serious if only drugs in the over-the-counter category were placed in the reclassiIf prescription drugs fied group. were included in a reclassification scheme, a change in the .federal law would be required since the federal law is the controlling law. One approach to reclassification might be for a state to attempt reclassification on a limited and somewhat experi,m ental scale and then expand the system if its experience so warranted. That reclassification would result in increased inspection powers over the community pharmacy would not be true at the state level as the states already have very broad inspection powers. At the federal level, however, some pressure might be exerted to grant FDA the same power to inspect records on the reclassified drugs as it has under the Drug Abuse Control Amendments of 1965. Record inspection ,b y FDA, however, is not likely because reclassified drugs are not near ly as dangerous nor as likely to be abused as the depressant and stimulant drugs and prescription drug records (other than those covered by the 1965 amendments) are not subject under the general inspection powers of FDA. Some have expressed the fear that drug reclassification might result in federal licensing of community pharmacies. It is unlikely that this would occur. Under the 1962 amendments to the Food, Drug and Cosmetic Act drug manufacturers must register with FDA hut they are not required to obtain a license to manufacture drugs. However, hefore the 1962 amendments were passed, drug manufactur-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
ers were neither required to register nor to obtain a license in many states. Since community pharmacies are licensed at the state level, it seems unlikely that any proposed drug reclassification plan would require the federal licensing of community pharmacies. Although there are many possible variations in reclassification plans, there are only a few bask programs. The entire spectrum ranging from very little to almost complete control over drugs is found among these plans. The legal problems increase as the control over drugs increases but this is not an unusual or illogical phenomenon as legal liability in most areas increases as responsibility increases. If one wants to minimize legal liability, he should seek to decrease his responsibility. Such a minimization obviously is not feasible if the pharmacist wants to retain or increase his professional status in the community. The responsibilities o.f the pharmacist are increasing as our knowledge about drugs increases. We :h ave seen several drugs (e.g., gelsemium, folic acid and ipecac) that were formerly o-t-e placed in the prescription-only category in recent years as know ledge increased about their adverse effects. Even though we may learn that a certain o-t-c drug has more serious adverse effects than we formerly had thought, it may not be placed in a prescription-only category because these effects may not be regarded as serious enough to warrant the change. Under these circumstances, the pharmacist should exercise more care in dispensing it in the o-t-c category. dispensed in licensed pharmacies
One plan .for controlling reclassified drugs would be simply to require that they be dispensed only in licensed pharmacies. This plan, however, does not satisfy the element of increased
Harold L. Marquis, assistant professor of law at Emory University school of law~ has been interested in pharmacy law for several years. After earning his BA from the University of Iowa in 1954, he was called to active duty in the Air Force where he taught military law at Officers' Candidate School. He entered law school at the University of Iowa in 1'957 where he received his JD in 1960. From 1960 to 1962, he was a patent attorney with Dow Corning Corporation. After obtaining his LLM degree from the University of Michigan in 1962, he joined the faculty of Temple University where he taught courses in both pharmacy and law schools. Marquis joined the Emory faculty in 1965. He has been admitted to the Iowa and Michigan bars and is a registered patent attorney.
professional control of drugs implicit in reclassification. Furthermore, it could be attacked as ibeing motivated primarily by the economic interests of the pharmacy profession. These two factors should preclude serious considIt probably eration of this plan. would not result in any significant increase in legal liability for injuries sustained from such drugs since there would only be a minimal increase in the responsibility of the pharmacist.
the potential liability would not he as great as the liability is now when a pharmacist assists a patron in selecting a remedy. Since there have been very few cases holding the phar'm acist liable under these circumstances, it is logical to predict that there would not be many cases under this reclassification plan. The inherent toxicity of the reclassified drugs might create some increase in liability.
dispensed by licensed pharmacist
Merely reclassifying drugs would not insure their being properly dispensed and used. To be effective a plan must impose an obligation on the pharmacist to exercise greater control over the dispensing of these drugs, A reclassification plan might require the pharmacist to warn patrons about the contraindications, side effects and other hazards of the drug and to give some explanation of the therapeutic benefits and limitations of the drug. Obviously, he would not be required to warn a patron when he refused to dispense the drug because he felt it was :being used improperly. The oral explanation would be required because patrons might need a more personal warning than those printed on the labels which many may not even read. Yet the explanation should not be a substitute for hut only a supplement to the patron's reading the label carefully. Perhaps if more readable labels were written, they would be a more satisfactory aid in limiting drug abuses .of over-the-counter remedies. One of the major problems in this plan would be the difficulty of enforcing the requirements although potential civil liability would be an important factor in obtaining compliance. Drugs should be carefully screened before they are added to the reclassified group. Periodic re-evaluation to
Increased professional control of drugs could be provided by requiring that the reclassified drugs be "dispensed by a licensed pharmacist" or someone under his supervision, but it would be difficult to demonstrate that such an arrangement would safeguard the public health significantly unless the person under supervision was also qualified by training to handle this task (e.g.~ an advanced phaffilacy student or intern) . It would not be feasible to train pharmacy clerks to assume a large degree of responsibility for the sale of these -d rugs. Ordinary clerks should be allowed to perform only nondiscretionary duties with the reclassified drugs such as packaging and receiving payment. This plan would not result in increased protection of public health unless the pharmacist, either by law or by a code of ethics, was duty-bound to warn patrons of the drug's dangers and to make inquiries about the physical condition of patients in some cases. I.f the law required reclassified drugs to be dispensed personally by a pharmacist and a drug were sold by a clerk to a patient who was injured from it, a case of negligence would ibe established against the pharmacist. Although this increased professional responsibility probably would result in some increase in liability for injuries,
duty to warn
determine what drugs should be removed and what warning changes are needed must be undertaken to insure that the plan is realistic. It could be effective only if the number of drugs maintained in the classification were relatively few. A reclassification plan requiring personal warnings would increase the possibilities of liability but not as much as many think. The courts would be likely to hold that a pharmacist was negligent if he failed to warn a patron about a drug or if the warning did not meet all of the requirements of the reclassification plan. It would be difficult for an injured patron to prove that the explanation had not been given to him if the pharmacist gave these warnings regularly and routinely. He would have to prove not only that he was injured but also that the injuries were caused by the failure to warn. duty to inquire
A reclassification plan might require the pharmacist to inquire about a patron's condition and to give him any appropriate warning or advice on the basis of the inquiry before the drug could be dispensed. This obligation might be imposed only when certain drugs were dispensed or if there were reason to suspect that the patron was using a drug improperly or that he shouldn't use it at all. Such a plan might impinge upon the praotice of medicine. When the pharmacist is required to make certain inquiries, he can hardly avoid assisting the patron in diagnosing his illness and selecting a remedy. Yet this practice is not too much different from the present one. Pharmacists today question patrons buying drugs for selfmedication to determine whether there is any indication of a serious disease and if the patron should be examVol. NS7, No.4, April 1967
171
Reclassification drug plans impose greater responsibilities upon the pharmacist to warn the public of possible adverse effects in drugs dispensed at his professional discretion.
ined by a physician. Even in the absence of a reclassification plan, the pharmacist today may have some obligation to warn a patron about selfmedication. A reclassification plan would probably encourage patrons to seek the help of their pharmacist in diagnosing minor ailments to a much greater extent than they do now but it does not pose the legal issue of what constitutes the "unauthorized practice of medicine." It could, however, precipitate a jurisdictional dispute between physicians and pharmacists. If this type of plan were adopted, some alterations in pharmacy curriculums would be necessary because the pharmacist would have to evaluate the medication he is recommending or dispensing. The pharmacist would need to learn more about the therapeutics and conditions for which people commonly self-medicate, to understand the complete pharmacology of the drugs dispensed and to develop an ability to recognize mistaken self-medication by the patron. These new responsibilities would increase the possibilities of liability. A pharmacist would be negligent if he failed to inquire about a customer's condition when there was a duty to do so. It would be simple to make this determination if the duty to inquire were required every time a drug were dispensed. If it were imposed only if there were reason to suspect some misuse of the drug, then the question of negligence would hinge on the facts. Suppose the pharmacist does ask some questions of the patron, but fails to ask the pertinent questions and the patron is injured. Whether this is 172
negligence or not depends on all the facts of the particular case. The pharmacist certainly would not be expeoted to obtain the patron's complete medical history. He would he negligent only if he failed to ask the routine questions that should be asked of every patron purchasing this drug. The pharmacist cannot normally ibe expected to ask whether the patron has some rather unusual condition which might pose problems with this medication. If the pharmacist asks a question of ,t he patron and the patron either lies or fails to give a complete and honest answer, the patron would not be able to recover for injuries as the pharmacist would not be negligent. Suppose the pharmacist does obtain the pertinent information from the patron but the patron is injured by the drug. A question might he raised as to whether an adequate warning had been given. The question of liability under these circumstances would be litigated on the basis of either negligence or a breach of implied warranty of fitness theory. Whether the pharmacist was negligent or not would be determined by standards of the reasonably prudent pharmacist under the circumstances. The critical issue
is-what warnings reasonably should have been given on the basis of the information obtained from the patron? The implied warranty of fitness for a particular purpose is imposed by law where the pharmacist, at the time of dispensing, knows the particular purpose for which the drug is required. The essential aspect of this warranty is that the patron relies on the pharma-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
cist's skill or judgment to seleot the drug. If the patron insists on a partkular drug, he is not relying on the pharmacist's skill and judgment. In those states that have adopted the Uniform Commercial Code, this warranty can arise with drugs dispensed under their proprietary names when the patron relies on the pharmacist's selection. Liability for breach of warranty is strict liability and is not based on fault as is liability in negligence. Thus, if there is an implied warranty of fitness for a particular purpose and the patron is injured because the drug is not so fit, the pharmacist is liable. From a practical standpoint the manufacturer has the primary liability if a drug is not fit because normally a pharmacist would not recommend a product for a purpose not indicated on its label. He would bear the loss if he did so. Since, under these circumstances, the pharmacist is not likely to make such recommendations his liability under this plan would not increase as much as many fear. Any increase would be due to the greater role the phaf'macist would assume in assisting patrons in self-medication with all over-the-counter drugs. The increased professional responsibilities under this plan probably would stimulate patrons to seek the pharmacist's advice more frequently with over-thecounter drugs not covered by the reclassification. duty not to dispense
A reclassification plan might go beyond requiring a pharmacist to warn a patron and impose an obligation on him not to dispense a drug to a patron when he believes it is not in the best interest of the patron to use the drug. This type of plan is not foreign to the pharmacist as he presently has an obligation not to dispense exempt narcotics to an individual who has oibservaJble indications of addiction. There may be other situations under existing law and ethics where the phannacist has a duty not to dispense drugs. If the pharmacist is neither arbitrary nor capricious, he probably would not incur any legal liability by his refusal to dispense. The pharmacist's liability in those cases 'w here he did dispense would probably be increased. Any liability would most likely !be based upon finding that the pharmacist was negligent. The pharmacist would not be an insurer that the patron would not be injured iby the drug hut he would have to exercise due care in deciding whether he should dispense the drug to a patron. The phalTIlacist's liability might also be hased on an implied warranty of fitness for a particular purpose. The courts might hold that the pharmacist's failure to exercise his
right to refuse to dispense under a reclassification plan should be consid~ ered in deciding whether there was an implied fitness warranty. However, this would probably not be a very important faotor in finding such a warranty. A serious problem of "pharmacy shopping" could arise if the obligation not to dispense were imposed on the pharmacist. Sensible patrons would not try another pharmacy if the pharmacist satisfactorily explained his reasons for refusing to dispense a drug. The pharmacist might be tempted to forego his ethical standards if he knew the patrons he refused were obtaining the drugs elsewhere. A patron might be able to obtain the drug from another pharmacist because that pharmacist had lower standards or did not know certain facts about the patient that were known by the first pharmacist. Requiring pharmacies to keep records of the dispensing of such drugs would only disclose the more flagrant abuses because considerable professional discretion would be involved in most cases. However, it would be a monumental task to examine in a meaningful way the records of all pharmacies in a given area. One approach to this problem would be to require the names of patrons who have been refused certain drugs to he circulated immediately to all pharmacies in the area through an infonnation exchange. The government inspector would probably circulate the names of chronic abusers as
state inspectors now do the names of exempt narcotic abusers. Once a patron has been turned down it might be rather difficult to obtain his name. The procedure followed when exempt narcotics are purchased could be adopted. Patrons then would have to identify themselves and sign a register before obtaining the drug. The plan could be regarded as successful if a majority of the refused patrons did not buy the drug elsewhere. A substantial number of injuries would have been prevented even though there were a large number of violations. Of course these violations could be decreased by rigorous enforcement of the law.
recent leg islation
nurse programs, coordinated home oare programs and the like) . Finally, in the outside circle, we have identified the various professional disciplines that contribute to the total care of the chronically ill patient; together they make up the chronic disease control' "team" in the community. Thus we have attempted to condense .and translate into a simple graphic presentation all the basic elements of chronic disease community programs at the community level; one way to view this is as focusing required professional skills through appropriate types of care down to adequately evaluated patient needs. This process applies to the whole range of chronic diseases. The measure of a community's readiness to cope with contemporary health problems is the extent to which this process is carried out wisely and efficiently, bringing to the chronically ill patient and his family the needed material and paramedical services at the right time and in the right place and at the right cost. •
(continued from page 169)
basic research, the field application of public health methods rather than laboratory study) . In what might be called the bull'seye of this chart ,a re the patient and his family. Public health, like the legendary "old family doctor," is concerned with the total patient and his total environment, the most vital element of which is his family. The patient and his family share a multiplicity of needs, which we have categorized in the surrounding space as physical, social, economic and emotional. The next circle can be thought of as the area of diagnosis and decisions; this is the stage at which the chronically ill patient is evaluated, reevaluated and finally referred to a suitable source of care and treatment. All communities should possess the sources named in the next circleinpatient care ( as in a hospital or nursing home) , outpatient care (clinics) and home care ( visiting
conclusion
Although ,there are certainly many variations of reclassification plans, the analysis of the basic plans would not be changed significantly by most of the variations. The basic question that must be answered about drug reclassification is-will reclassification
result in increased protection of public health? The proposed study to determine the number of injuries and to analyze the case histories of patrons injured by improper use of over-the-counter drugs should shed considerable light on drug reclassification and on the merits of various plans. Such a study should also be helpful in deciding what drugs should be placed in any reThe concern classification group. about drug reclassification should ibe
directed to this area and not to bhe issues of economic well-being of the pharmacist and the legal liability implica
173
D
170
or state level, it would seem that ultimately some standards would have to be set at the federal level or there would be confusion and conflict over the classification and · labeling of drugs. These might not be too serious if only drugs in the over-the-counter category were placed in the reclassiIf prescription drugs fied group. were included in a reclassification scheme, a change in the .federal law would be required since the federal law is the controlling law. One approach to reclassification might be for a state to attempt reclassification on a limited and somewhat experi,m ental scale and then expand the system if its experience so warranted. That reclassification would result in increased inspection powers over the community pharmacy would not be true at the state level as the states already have very broad inspection powers. At the federal level, however, some pressure might be exerted to grant FDA the same power to inspect records on the reclassified drugs as it has under the Drug Abuse Control Amendments of 1965. Record inspection ,b y FDA, however, is not likely because reclassified drugs are not near ly as dangerous nor as likely to be abused as the depressant and stimulant drugs and prescription drug records (other than those covered by the 1965 amendments) are not subject under the general inspection powers of FDA. Some have expressed the fear that drug reclassification might result in federal licensing of community pharmacies. It is unlikely that this would occur. Under the 1962 amendments to the Food, Drug and Cosmetic Act drug manufacturers must register with FDA hut they are not required to obtain a license to manufacture drugs. However, hefore the 1962 amendments were passed, drug manufactur-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
ers were neither required to register nor to obtain a license in many states. Since community pharmacies are licensed at the state level, it seems unlikely that any proposed drug reclassification plan would require the federal licensing of community pharmacies. Although there are many possible variations in reclassification plans, there are only a few bask programs. The entire spectrum ranging from very little to almost complete control over drugs is found among these plans. The legal problems increase as the control over drugs increases but this is not an unusual or illogical phenomenon as legal liability in most areas increases as responsibility increases. If one wants to minimize legal liability, he should seek to decrease his responsibility. Such a minimization obviously is not feasible if the pharmacist wants to retain or increase his professional status in the community. The responsibilities o.f the pharmacist are increasing as our knowledge about drugs increases. We :h ave seen several drugs (e.g., gelsemium, folic acid and ipecac) that were formerly o-t-e placed in the prescription-only category in recent years as know ledge increased about their adverse effects. Even though we may learn that a certain o-t-c drug has more serious adverse effects than we formerly had thought, it may not be placed in a prescription-only category because these effects may not be regarded as serious enough to warrant the change. Under these circumstances, the pharmacist should exercise more care in dispensing it in the o-t-c category. dispensed in licensed pharmacies
One plan .for controlling reclassified drugs would be simply to require that they be dispensed only in licensed pharmacies. This plan, however, does not satisfy the element of increased
Harold L. Marquis, assistant professor of law at Emory University school of law~ has been interested in pharmacy law for several years. After earning his BA from the University of Iowa in 1954, he was called to active duty in the Air Force where he taught military law at Officers' Candidate School. He entered law school at the University of Iowa in 1'957 where he received his JD in 1960. From 1960 to 1962, he was a patent attorney with Dow Corning Corporation. After obtaining his LLM degree from the University of Michigan in 1962, he joined the faculty of Temple University where he taught courses in both pharmacy and law schools. Marquis joined the Emory faculty in 1965. He has been admitted to the Iowa and Michigan bars and is a registered patent attorney.
professional control of drugs implicit in reclassification. Furthermore, it could be attacked as ibeing motivated primarily by the economic interests of the pharmacy profession. These two factors should preclude serious considIt probably eration of this plan. would not result in any significant increase in legal liability for injuries sustained from such drugs since there would only be a minimal increase in the responsibility of the pharmacist.
the potential liability would not he as great as the liability is now when a pharmacist assists a patron in selecting a remedy. Since there have been very few cases holding the phar'm acist liable under these circumstances, it is logical to predict that there would not be many cases under this reclassification plan. The inherent toxicity of the reclassified drugs might create some increase in liability.
dispensed by licensed pharmacist
Merely reclassifying drugs would not insure their being properly dispensed and used. To be effective a plan must impose an obligation on the pharmacist to exercise greater control over the dispensing of these drugs, A reclassification plan might require the pharmacist to warn patrons about the contraindications, side effects and other hazards of the drug and to give some explanation of the therapeutic benefits and limitations of the drug. Obviously, he would not be required to warn a patron when he refused to dispense the drug because he felt it was :being used improperly. The oral explanation would be required because patrons might need a more personal warning than those printed on the labels which many may not even read. Yet the explanation should not be a substitute for hut only a supplement to the patron's reading the label carefully. Perhaps if more readable labels were written, they would be a more satisfactory aid in limiting drug abuses .of over-the-counter remedies. One of the major problems in this plan would be the difficulty of enforcing the requirements although potential civil liability would be an important factor in obtaining compliance. Drugs should be carefully screened before they are added to the reclassified group. Periodic re-evaluation to
Increased professional control of drugs could be provided by requiring that the reclassified drugs be "dispensed by a licensed pharmacist" or someone under his supervision, but it would be difficult to demonstrate that such an arrangement would safeguard the public health significantly unless the person under supervision was also qualified by training to handle this task (e.g.~ an advanced phaffilacy student or intern) . It would not be feasible to train pharmacy clerks to assume a large degree of responsibility for the sale of these -d rugs. Ordinary clerks should be allowed to perform only nondiscretionary duties with the reclassified drugs such as packaging and receiving payment. This plan would not result in increased protection of public health unless the pharmacist, either by law or by a code of ethics, was duty-bound to warn patrons of the drug's dangers and to make inquiries about the physical condition of patients in some cases. I.f the law required reclassified drugs to be dispensed personally by a pharmacist and a drug were sold by a clerk to a patient who was injured from it, a case of negligence would ibe established against the pharmacist. Although this increased professional responsibility probably would result in some increase in liability for injuries,
duty to warn
determine what drugs should be removed and what warning changes are needed must be undertaken to insure that the plan is realistic. It could be effective only if the number of drugs maintained in the classification were relatively few. A reclassification plan requiring personal warnings would increase the possibilities of liability but not as much as many think. The courts would be likely to hold that a pharmacist was negligent if he failed to warn a patron about a drug or if the warning did not meet all of the requirements of the reclassification plan. It would be difficult for an injured patron to prove that the explanation had not been given to him if the pharmacist gave these warnings regularly and routinely. He would have to prove not only that he was injured but also that the injuries were caused by the failure to warn. duty to inquire
A reclassification plan might require the pharmacist to inquire about a patron's condition and to give him any appropriate warning or advice on the basis of the inquiry before the drug could be dispensed. This obligation might be imposed only when certain drugs were dispensed or if there were reason to suspect that the patron was using a drug improperly or that he shouldn't use it at all. Such a plan might impinge upon the praotice of medicine. When the pharmacist is required to make certain inquiries, he can hardly avoid assisting the patron in diagnosing his illness and selecting a remedy. Yet this practice is not too much different from the present one. Pharmacists today question patrons buying drugs for selfmedication to determine whether there is any indication of a serious disease and if the patron should be examVol. NS7, No.4, April 1967
171
Reclassification drug plans impose greater responsibilities upon the pharmacist to warn the public of possible adverse effects in drugs dispensed at his professional discretion.
ined by a physician. Even in the absence of a reclassification plan, the pharmacist today may have some obligation to warn a patron about selfmedication. A reclassification plan would probably encourage patrons to seek the help of their pharmacist in diagnosing minor ailments to a much greater extent than they do now but it does not pose the legal issue of what constitutes the "unauthorized practice of medicine." It could, however, precipitate a jurisdictional dispute between physicians and pharmacists. If this type of plan were adopted, some alterations in pharmacy curriculums would be necessary because the pharmacist would have to evaluate the medication he is recommending or dispensing. The pharmacist would need to learn more about the therapeutics and conditions for which people commonly self-medicate, to understand the complete pharmacology of the drugs dispensed and to develop an ability to recognize mistaken self-medication by the patron. These new responsibilities would increase the possibilities of liability. A pharmacist would be negligent if he failed to inquire about a customer's condition when there was a duty to do so. It would be simple to make this determination if the duty to inquire were required every time a drug were dispensed. If it were imposed only if there were reason to suspect some misuse of the drug, then the question of negligence would hinge on the facts. Suppose the pharmacist does ask some questions of the patron, but fails to ask the pertinent questions and the patron is injured. Whether this is 172
negligence or not depends on all the facts of the particular case. The pharmacist certainly would not be expeoted to obtain the patron's complete medical history. He would he negligent only if he failed to ask the routine questions that should be asked of every patron purchasing this drug. The pharmacist cannot normally ibe expected to ask whether the patron has some rather unusual condition which might pose problems with this medication. If the pharmacist asks a question of ,t he patron and the patron either lies or fails to give a complete and honest answer, the patron would not be able to recover for injuries as the pharmacist would not be negligent. Suppose the pharmacist does obtain the pertinent information from the patron but the patron is injured by the drug. A question might he raised as to whether an adequate warning had been given. The question of liability under these circumstances would be litigated on the basis of either negligence or a breach of implied warranty of fitness theory. Whether the pharmacist was negligent or not would be determined by standards of the reasonably prudent pharmacist under the circumstances. The critical issue
is-what warnings reasonably should have been given on the basis of the information obtained from the patron? The implied warranty of fitness for a particular purpose is imposed by law where the pharmacist, at the time of dispensing, knows the particular purpose for which the drug is required. The essential aspect of this warranty is that the patron relies on the pharma-
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
cist's skill or judgment to seleot the drug. If the patron insists on a partkular drug, he is not relying on the pharmacist's skill and judgment. In those states that have adopted the Uniform Commercial Code, this warranty can arise with drugs dispensed under their proprietary names when the patron relies on the pharmacist's selection. Liability for breach of warranty is strict liability and is not based on fault as is liability in negligence. Thus, if there is an implied warranty of fitness for a particular purpose and the patron is injured because the drug is not so fit, the pharmacist is liable. From a practical standpoint the manufacturer has the primary liability if a drug is not fit because normally a pharmacist would not recommend a product for a purpose not indicated on its label. He would bear the loss if he did so. Since, under these circumstances, the pharmacist is not likely to make such recommendations his liability under this plan would not increase as much as many fear. Any increase would be due to the greater role the phaf'macist would assume in assisting patrons in self-medication with all over-the-counter drugs. The increased professional responsibilities under this plan probably would stimulate patrons to seek the pharmacist's advice more frequently with over-thecounter drugs not covered by the reclassification. duty not to dispense
A reclassification plan might go beyond requiring a pharmacist to warn a patron and impose an obligation on him not to dispense a drug to a patron when he believes it is not in the best interest of the patron to use the drug. This type of plan is not foreign to the pharmacist as he presently has an obligation not to dispense exempt narcotics to an individual who has oibservaJble indications of addiction. There may be other situations under existing law and ethics where the phannacist has a duty not to dispense drugs. If the pharmacist is neither arbitrary nor capricious, he probably would not incur any legal liability by his refusal to dispense. The pharmacist's liability in those cases 'w here he did dispense would probably be increased. Any liability would most likely !be based upon finding that the pharmacist was negligent. The pharmacist would not be an insurer that the patron would not be injured iby the drug hut he would have to exercise due care in deciding whether he should dispense the drug to a patron. The phalTIlacist's liability might also be hased on an implied warranty of fitness for a particular purpose. The courts might hold that the pharmacist's failure to exercise his
right to refuse to dispense under a reclassification plan should be consid~ ered in deciding whether there was an implied fitness warranty. However, this would probably not be a very important faotor in finding such a warranty. A serious problem of "pharmacy shopping" could arise if the obligation not to dispense were imposed on the pharmacist. Sensible patrons would not try another pharmacy if the pharmacist satisfactorily explained his reasons for refusing to dispense a drug. The pharmacist might be tempted to forego his ethical standards if he knew the patrons he refused were obtaining the drugs elsewhere. A patron might be able to obtain the drug from another pharmacist because that pharmacist had lower standards or did not know certain facts about the patient that were known by the first pharmacist. Requiring pharmacies to keep records of the dispensing of such drugs would only disclose the more flagrant abuses because considerable professional discretion would be involved in most cases. However, it would be a monumental task to examine in a meaningful way the records of all pharmacies in a given area. One approach to this problem would be to require the names of patrons who have been refused certain drugs to he circulated immediately to all pharmacies in the area through an infonnation exchange. The government inspector would probably circulate the names of chronic abusers as
state inspectors now do the names of exempt narcotic abusers. Once a patron has been turned down it might be rather difficult to obtain his name. The procedure followed when exempt narcotics are purchased could be adopted. Patrons then would have to identify themselves and sign a register before obtaining the drug. The plan could be regarded as successful if a majority of the refused patrons did not buy the drug elsewhere. A substantial number of injuries would have been prevented even though there were a large number of violations. Of course these violations could be decreased by rigorous enforcement of the law.
recent leg islation
nurse programs, coordinated home oare programs and the like) . Finally, in the outside circle, we have identified the various professional disciplines that contribute to the total care of the chronically ill patient; together they make up the chronic disease control' "team" in the community. Thus we have attempted to condense .and translate into a simple graphic presentation all the basic elements of chronic disease community programs at the community level; one way to view this is as focusing required professional skills through appropriate types of care down to adequately evaluated patient needs. This process applies to the whole range of chronic diseases. The measure of a community's readiness to cope with contemporary health problems is the extent to which this process is carried out wisely and efficiently, bringing to the chronically ill patient and his family the needed material and paramedical services at the right time and in the right place and at the right cost. •
(continued from page 169)
basic research, the field application of public health methods rather than laboratory study) . In what might be called the bull'seye of this chart ,a re the patient and his family. Public health, like the legendary "old family doctor," is concerned with the total patient and his total environment, the most vital element of which is his family. The patient and his family share a multiplicity of needs, which we have categorized in the surrounding space as physical, social, economic and emotional. The next circle can be thought of as the area of diagnosis and decisions; this is the stage at which the chronically ill patient is evaluated, reevaluated and finally referred to a suitable source of care and treatment. All communities should possess the sources named in the next circleinpatient care ( as in a hospital or nursing home) , outpatient care (clinics) and home care ( visiting
conclusion
Although ,there are certainly many variations of reclassification plans, the analysis of the basic plans would not be changed significantly by most of the variations. The basic question that must be answered about drug reclassification is-will reclassification
result in increased protection of public health? The proposed study to determine the number of injuries and to analyze the case histories of patrons injured by improper use of over-the-counter drugs should shed considerable light on drug reclassification and on the merits of various plans. Such a study should also be helpful in deciding what drugs should be placed in any reThe concern classification group. about drug reclassification should ibe
directed to this area and not to bhe issues of economic well-being of the pharmacist and the legal liability implica
173