Restricting channels of distribution for pharmaceuticals.
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Biomedical subjects
Publications and source records attributed to J L Fink.
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The incidence of drug-related liability claims is discussed, and data from a number of studies in this area are reviewed. Drug categories that appear to cause the greatest problems are hormones, anticoagulants, adrenal steroids, and antibiotics. Focusing attention on these categories may enable the pharmacist to function as a liability-reducing factor in the institutional setting.
Pharmacists often are called upon to adjust the number of dosage units dispensed pursuant to a prescription. Common examples are requests to dispense half or double the amount requested by the prescriber. In some cases, reductions in quantity may be dictated by the provisions of a prescription drug insurance program, either private or governmental. A review of the literature reveals very little information on the legality of such actions by pharmacists. Focusing on both the federal Food, Drug and Cosmetic Act and the federal Controlled Substances Act, a review of the law in this area is presented. Some states also have provisions, either in statutes or regulations, that address the issue. Specific examples are presented and discussed, with the goal being to clarify the law in this area with which the pharmacist must deal on a daily basis.
Following a brief review of the origin of antisubstitution and drug product selection laws, the legal basis of the hospital formulary system is compared with that of drug product selection. By understanding the differences in the two, the pharmacist can better understand application of the law in these areas to pharmacy practice.
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Liability issues of hospitals with contract-managed pharmaceutical services are discussed. The number of hospitals with pharmaceutical services operated by outside organizations is rapidly increasing. Because pharmacy personnel are employed by the contractor rather than the hospital, a hospital's liability for the actions of these employees is related to the specific agreement between the hospital and the contractor. Application of the doctrine of respondeat superior to these contractual arrangements and specific factors determining the degree of control that the hospital has over contracted employees are discussed. Hospitals contemplating the use of contract-managed pharmaceutical services should determine the exact nature of their liability for the actions of contracted employees.
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The potential for clinical pharmacy services to reduce the liability of institutions and the personnel who practice in them is presented. Several studies are reviewed that identify the characteristics of patients who are at a high risk of developing complications. Based on these data and data gathered on drug-related malpractice claims, pharmacists can concentrate their efforts on those patients who have the greatest liability implications to the institution. Pharmacists' efforts to reduce the liability of their institutions can also provide a justification for their clinical services.
A survey was undertaken using sample alumni of the University of South Carolina College of Pharmacy and the Philadelphia College of Pharmacy and Science to attempt to determine practice parameters of male and female pharmacists. The study included male and female graduates during an 18-year period from 1961 through 1978. Data are presented relating sex to practice interruptions and the characteristics exhibited thereof. The results disclosed that 126 (34.7%) of the female and 21 (8.4%) of the male practitioners had interrupted their practices at one time or another following graduation. Furthermore, 88.8% of all practice interruptions among females was found to be linked to familial obligations.
The potential for running afoul of the law by mislabeling a drug product at the time of dispensing is substantial. By understanding the law in this area, pharmacists can take steps to comply fully with the law and yet meet the needs of the patients they serve. State boards of pharmacy should acknowledge that they have an educational as well as a regulatory function and endeavor to educate their licensees of the law in this area.
In recent years hospitals have been creating materials management departments to effect cost controls and to increase efficiency. In some instances, it has been suggested that responsibility for maintenance of drug inventories should be shifted from the director of pharmacy to the director of materials management. Legal aspects of this shift in responsibility may preclude such changes. The Joint Commission on Accreditation of Hospitals' Standards clearly state that this responsibility is to rest with the pharmacy service. State law may also bear on the issue. Both state pharmacy acts and board of pharmacy regulations may contain provisions which are relevant to the issue. Pennsylvania law is used as an example of the points to be evaluated when considering the question. Clearly, this responsibility must continue to fall within the jurisdiction of the director of pharmacy.
Court cases in which the Standards of the Joint Commission on Accreditation of Hospitals have been introduced into evidence are reviewed to examine the various legal roles of the Standards and to consider some implications of this for the hospital and for the hospital pharmacist. Following a review of the Darling case, the role of the Standards in establishing a legal duty is examined with emphasis on a case involving medication handling where it was held that a hospital may be liable for damages resulting from failure to comply with JCAH Standards. The Standards have also been used to assist in creating a national standard of due care by abrogating the locality or community rule. Miscellaneous uses of the Standards are also discussed. The product institutional pharmacist will be thoroughly familiar with JCAH Standards applicable to activities related to medication handling and take steps to assure that every effort is made to comply with these requirements.
The legal implications of pharmacists serving as therapeutic consultants to other health professionals are discussed. The legal view of the consultant relationship and the relative liability exposure of the primary practitioner and the consultant are reviewed. The pharmacist's liability when serving as a therapeutic consultant is considered in light of the high standard of care that would probably be used in evaluating the pharmacist's performance. Other legal issues considered include potential criminal liability of the pharmacist, whether responses should be in writing, impact of charging for therapeutic consultation services, and coverage for such activities under professional liability insurance policies. By being aware of the legal implications in these areas, pharmacists may limit their liability exposure to an acceptable level.
The legality of state requirements that professionals participate in continuing professional education is discussed. The historical development of the requirement in pharmacy is reviewed, and the legal doctrine of police power is considered as the basis for legal requirements in this area. The need for a statutory basis for this condition is presented, and court cases wherein such requirements have been challenged are reviewed. There must be statutory authorization for imposing continuing education requirements for professionals, and the statute and regulations affecting the rule must not infringe on an individual's constitutional rights.