Legal issues associated with formulary product-selection when there are two or more recognized drug therapies. 1988

F Z Liang, and R B Greenberg, and G F Hogan
Legislative and Regulatory Division, American Society of Hospital Pharmacists, Bethesda, MD 20814.

The legal issues associated with selecting drug products under the formulary system when there are two or more recognized drug therapies are discussed. The primary legal issue involved is whether a decision by a health-care provider to use a particular drug product can be viewed as "reasonable" under the circumstances when there are two or more recognized drug therapies for treating a patient. In the institutional setting, the physician diagnoses and prescribes drug products but authorizes, under the formulary system, the selection of alternative agents. Imposition of civil liability on health-care providers for a patient's drug-related injury based on a formulary decision has not yet occurred. Liability would most likely be based on negligence in such a case. The standard of care a medical provider will be measured against is what a "reasonable provider" would do under like circumstances. An institution's decision whether or not to routinely have available a particular drug product that is among several accepted therapies would probably not be viewed as negligent, so long as that decision was based on the objective clinical judgment of the medical staff operating under the formulary system. It is unlikely that a decision to use one of two (or more) drug products would be "negligent" if that decision was based on a current and objective evaluation of the medical literature and supported by a recognized segment of medical opinion.

UI MeSH Term Description Entries
D008318 Malpractice Failure of a professional person, a physician or lawyer, to render proper services through reprehensible ignorance or negligence or through criminal intent, especially when injury or loss follows. (Random House Unabridged Dictionary, 2d ed) Professional Negligence,Negligence,Negligence, Professional,Professional Negligences
D010606 Pharmacy and Therapeutics Committee An advisory group composed primarily of staff physicians and the pharmacist which serves as the communication link between the medical staff and the pharmacy department. Drug Committee,Formulary Committee,Therapeutics Committee,Committee, Drug,Committee, Formulary,Committee, Pharmacy,Committee, Therapeutics,Committees, Drug,Committees, Formulary,Committees, Pharmacy,Committees, Therapeutics,Drug Committees,Formulary Committees,Pharmacy Committee,Pharmacy Committees,Therapeutics Committees
D010607 Pharmacy Service, Hospital Hospital department responsible for the receiving, storing, and distribution of pharmaceutical supplies. Clinical Pharmacy Service,Hospital Pharmacy Service,Pharmacy Service, Clinical,Hospital Pharmaceutic Service,Hospital Pharmaceutical Service,Hospital Pharmacy Services,Pharmaceutic Service, Hospital,Pharmaceutical Service, Hospital,Service, Clinical Pharmacy,Service, Hospital Pharmaceutic,Service, Hospital Pharmaceutical,Service, Hospital Pharmacy,Clinical Pharmacy Services,Hospital Pharmaceutic Services,Hospital Pharmaceutical Services,Pharmaceutic Services, Hospital,Pharmaceutical Services, Hospital,Pharmacy Services, Clinical,Pharmacy Services, Hospital,Services, Clinical Pharmacy,Services, Hospital Pharmaceutic,Services, Hospital Pharmaceutical,Services, Hospital Pharmacy
D011307 Drug Prescriptions Directions written for the obtaining and use of DRUGS. Drug Prescribing,Drug Prescription,Drug Prescribings,Prescribing, Drug,Prescribings, Drug
D005572 Formularies, Hospital as Topic Works about formularies concerned with PHARMACEUTICAL PREPARATIONS prescribed in hospitals. Hospital Formularies as Topic
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D064420 Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. Drug-Related Side Effects and Adverse Reaction,Adverse Drug Event,Adverse Drug Reaction,Drug Side Effects,Drug Toxicity,Side Effects of Drugs,Toxicity, Drug,Adverse Drug Events,Adverse Drug Reactions,Drug Event, Adverse,Drug Events, Adverse,Drug Reaction, Adverse,Drug Reactions, Adverse,Drug Related Side Effects and Adverse Reaction,Drug Related Side Effects and Adverse Reactions,Drug Side Effect,Drug Toxicities,Effects, Drug Side,Reactions, Adverse Drug,Side Effect, Drug,Side Effects, Drug,Toxicities, Drug

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