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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.

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.

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.

As the pharmacist's clinical role expands he is confronted with legal questions concerning actual or proposed activities. A number of papers have appeared in the literature of pharmacy which address the potential legal liability of the pharmacist who engages in clinical activity but most are written in terms of general principles of law with few specific circumstances addressed. In this article, legal questions raised by clinical pharmacists in the course of their everyday practices are evaluated and discussed. Among the issues presented are use of an FDA-approved drug for an unapproved use, informed consent in administration of unapproved drugs, the role of the pharmacist in managing hypertensive patients visiting a hospital-based clinic, the legality of a pharmacist administering injectible drugs, the legality of permitting Pharm.D. students to draw blood, and the application of the Federal Food, Drug and Cosmetic Act to the preparation of aluminum hydroxide cookies for dialysis patients. The specific questions are answered and the legal standard of care expected of pharmacists performing clinical functions is discussed. While no cases have been decided yet concerning newer clinical activities, some precedent can be found in past cases. Approaches to handling these questions should be of value in addressing future legal issues presented as pharmacists further seek to better utilize their knowledge.

In exercising source selection of drug products, the pharmacist may be subject to liability based on (1) the premise of negligence in selecting the source, i.e., breach of duty to exercise due care, or (2) breach of warranty, most probably in the form of breach of implied warranty of merchantability or of breach of warranty of sale by description. The pharmacist's familiarity with drug recalls, compendial standards, manufacturer reputation and bioavailability problems are discussed as these relate to his liability. Increased responsibility for source selection of drug products may increase the pharmacist's liability, but the extent of the liability in this area does not appear to be great.