Pharmacy and the Civil Law

Pharmacy and the Civil Law

Invitational Article Pharmacy and the Civil· Law James Clayton Simmons The American Trial Lawyers Association recently has stated its position that...

2MB Sizes 0 Downloads 83 Views

Invitational Article

Pharmacy and the Civil· Law

James Clayton Simmons

The American Trial Lawyers Association recently has stated its position that, "The interests of the patient-consumer must be paramount over those of the health care provider, the lawyer, or the insurance carrier." As an active trial lawyer experienced in the health professions, I view this position merely as a statement of what our civil law has always sought to accomplish: the provision of adequate remedies to people who might be injured through no fault of their own. Our court system of civil justice currently is playing a major role in dictating the rights, liabilities, duties and obligations of all health professionals, including pharmacists.

established as the minimum standard required of that practice through civil litigation. The impact of civil law, spearheaded by triql lawyers knowledgeable in the ways of medicine, is the single most influential force responsible for upgrading and maintaining the high standards of medicine that we know today. Numerous pharmacists have said to me over the past few years, "Plaintiffs' trial lawyers are now turning to pharmacy because they no longer want to attack the physician." There is an ever-increasing

Influence of Civil (Professional Liability) Litigation

As the pharmacist seeks ways to provide professional service commensurate with his educated capacity, civil litigation will playa profound and dramatic part in establishing the parameters- within which he will be expected to practice. Trial lawyers will represent plaintiffs in lawsuits against pharmacists, hospitals, pharmaceutical manufacturers and I tharmacies; this development will establish CIO"l standards of care and procedures that :ha be required of the profession as a whole. ane impact of civil litigation on the practice of medicine is evidence of the validity of this pos~tion. All the federal legislation enacted over the past 25 years has not had the upgrading effect on the practice of medicine that has come about through malpractice or professional liability litigation. Although most of the malpractice publicity was blown out of proportion, it still served to alter virtually all the procedures followed in hospitals, emergency rooms, operating rooms and physicians' offices. The record-keeping procedures in hospitals and medical practice, the various precautions of doublecheck, etc., are now a customary part of the everyday practice of medicine, after being

James Clayton Simmons, 8S Pharm, JD, is a pl?intiff's trial attorney specializing in medical and pharmaceutical liability as senior partner in the law firm of $immons and London in Atlanta, Georgia. He is also Adjunct Professor of Pharmacy Law, Mercer University School of Pharmacy, Atlanta, Georgia, and a professional lecturer on malpractice in the health professions.

awareness by pharmacy of the existence of civil responsibility dictated through the process of civil litigation. This awareness has resulted from pharmacists acquiring new roles. A look at the phases of pharmacy history is beneficial in seeing why the courts are playing such an influential role in pharmacy today. Phases of Pharmacy Phase. One. Phase One of pharmacy in the United States was that golden era where the pharmacist was known in the community as "Doc." Phase One began with the establishment of neighborhood pharmacies and lasted through the era of the pharmacist compounding chemicals and dispensing his own drug formulations. This period ended with industry taking over mass production of pharmaceuticals, thus eliminating that area of service from pharmacy at both the hospital and community levels. During Phase One, the public respected and admired the profession because it recognized the education and skills required of the pharmacist.

730

Early judicial case decisions relating to pharmacists who had erred in compounding or dispensing prescription medications clearly outlined the standards required of the pharmacist and the responsibility to his patron as being of the highest degree. During the early 1900s there were very few federal or state regulations dictating the method of a pharmacist's practice or his duty to the public. The civil law, then as now, dictated the standard of care and the liabilities of pharmacists and pharmacy as a profession. Phase Two. History's subsequent course indicates that the public's respect and admiration during Phase One was based on its knowledge and appreciation of the "service" provided by this member of the health professions. The health professions' and the pub.lic's demand for more and better drugs caused the onset of Phase Two and resulted in mass production by pharmaceutical manufacturers of pills, capsules and other forms of pharmaceuticals. The production capabilities of major pharmaceutical companies provided drug products at a fraction of the cost that would have been required had the individual pharmacist prepared each dosage unit. During the 1950s and 1960s, new pharmaceutical products were introduced to the market with such rapidity that it was difficult for the pharmacist to keep the products on his shelf in sufficient quantities to dispense prescriptions. The pharmacist of this era was caught in the middle of a dramatic change in the methods of providing health care to the American public. During Phase Two, pharmacists also began to sell non-health-related items. I attended pharmacy school and practiced in hospital, community and industrial pharmacy during that time. My contemporaries and I experienced a sense of dissatisfaction with our abundance of knowledge but a lack of opportunity to use it. Many of us searched for more satisfying and fulfilling ways to use our education . The educational requirements for pharmacists during Phase Two were increased through the participation and concern of universities and schools of pharmacy in the profession's future . Pharmacists could not understand why the educational community would so actively seek additional requirements for a degree at a time when the

Jo.urnal of the American Pharmaceutical Association

practice of pharmacy was becoming more of a physical routine with less provision of actual service. Regardless of the reasons, the increased educational requirements play an important role in the development of Phase Three, which we are now entering. In retrospect, the pharmacist could not identify his role in health care during Phase Two. His traditional role was taken over by the manufacturer on one hand and the fast service cut-rate store on the other. The increasing importance of hospital pharmacy and the ever-growing belief by the public that pharmacists attend college for five years to learn how to count and pour, added to his problem. Phase Three. Although Phase Two witnessed pharmacy becoming more of a physical routine, it did not see the void filled with professional service. Phase Three of pharmacy appears to be a time when service, such as that provided during Phase One, is returned to pharmacy practice. The alternative is the simple dispensing of prescription drugs at government-regulated prices. With simple dispensing, the only way to increase compensation would be to process more prescriptions with cost and profits being controlled by the bureaucracy. This situation presents the pharmacist, who can dispense only a certain number of prescriptions per day with no future. It would be impossible to increase his income to a level which justifies the education required to have a professional license to practice pharmacy. Why, one might ask, would a pharmacist spend so many years acquiring an education which would limit him so strictly in earning capacity? If pharmacy follows the non-service oriented route, it will die as a profeSSion through economic strangulation. Pharmacists are aware that a return to service is necessary for their future. In Phase Three we are witnessing a growing trend in the direction of providing service in the form of patient consultations, computerized patient information programming, patient profile systems, etc. You will note how casually we refer to the word "patient" when describing these services, rather than the word' 'customer," when speaking of a prescription. The "patient" is becoming an active part of pharmacy's new era. Pharmacy has tried to sell a professional image by developing the professional fee concept. Many pharmacists felt that merely charging a professional fee would cause them to be accepted as professionals, but the public could see no difference in the way

Vol. NS 17, No. 12, December 1977

prescriptions were dispensed. Where was and where is the professional service? There must be more than the charging of a professional fee in the mind's eye of the patrons served by the profession. Pharmacy cannot become a profession that renders a professional service by merely saying it is one. The rendering of service, even if sold in conjunction with a product, is what the public is beginning to look for and expect. The providing of service will increase the overall earning capacity of pharmacists by allowing the knowledge acquired through extensive pharmaceutical training to be sold for a profit. In other words, for pharmacy to become a profession in the sense of medicine or law, it must dispense knowledge for

I have never met a pharmacist who does not agree that he should be allowed to prescribe certain medications without the necessity of a written prescription order from a physician. profit in the form of service, rather than the mere dispensing of pills. The types of service to be performed will vary from what the law will allow to what the pharmacist is educationally prepared to do. II the evolution of pharmacy continues in this predictable direction, the next major horizon of opportunity could be the development of another class of pharmaceuticals which can be dispensed only at the direction of a pharmacist. I have never met a pharmacist who does not agree that he should be allowed to prescribe certain medications without the necessity of a written prescription order from a physician. If the public and bureaucracy are adequately informed concerning the pharmacist's qualifications, I see no reason why another class of drugs will not some day be made available for prescribing by pharmacists. The opportunities for service that would open up to the profession are countless. The Third Phase of pharmacy as a profession has resulted from the complicated process of evolution influenced dramatically by economic necessity, education, the pressures of commerce and bureaucracy, the pharmacist's desire to use his knowledge and the public's need for additional health care services. Today's pharmacist is caught in the unique position of being blessed with an

abundance of knowledge regarding the chemical reactions and pharmacological effects, dosage, clinical reactions and interactions of pharmaceutical products. During Phase Two, pharmacists were blessed with the same knowledge to a degree, but they were not provided with the opportunity to use it. The public did not expect the pharmacist to use this knowledge, nor was the public generally aware that the pharmacist possessed it. As that same public becomes aware of the pharmacist's education and ability, and as more pharmacists reach out in search of new ways to use it, the civil law will naturally keep up with pharmacists' assumption of responsibility and will dictate a corresponding assumption of liability. Phase Three finds the pharmacist somewhat between the rock and the hard place. He is damned if he provides affirmative information and advice to his patron, as this will lead to an increasing level of responsibility and liability. On the other hand, the pharmacist who does not provide this information will be damned because the public will demand that he live up to the civil responsibility and new standards created by his education and ability. As pharmacists seek to participate in health care services to their capability and assume the new responsibilities for which they are educationally equipped, new standards for the profession are being established. The best example today is the new standard being established in hospitals throughout the country requiring a patient profile and cross-check system to protect against overdoses, side effects or possible interactions the patient might suffer while institutionally confined. Pharmacists are creating trends and setting new standards by counseling their patrons about various prescribed medications. With pharmacists' assumption of responsibilities that have a direct bearing on which medications might be dispensed, pharmaceutical manufacturers are beginning to pay more attention to community and hospital pharmacists by educating them about the products they produce and market. Especially important to the manufacturer is. the question of bioequivalency / bioavailability, and whether one product is actually the same as another. As industry realizes that pharmacists may make the ultimate decision as to which medication is or is not dispensed, the pharmacist suddenly takes on a different status in the eyes of the manufacturer. Pharmacists' education does not

731