Biomaterial Database

Drug product selection and the law. 1979

J L Fink

Pharmacists are reported to be concerned about their liability exposure when engaging in drug product selection. A review of the elements of a suit for negligence is presented along with a brief application of those principles to a suit for negligence in drug product selection. The role of the manufacturer in assuring product integrity is emphasized. A liability suit also could be based on contract law principles, which are discussed. A few reasons that may explain why no suit has been successfully maintained in this area to date are presented. Finally, discussion of legislative provisions that attempt to contain the pharmacist's liability exposure are considered.

UI	MeSH Term	Description	Entries
D007880	Legislation, Drug	Laws concerned with manufacturing, dispensing, and marketing of drugs.	Drug Laws,Food, Drug and Cosmetic Act,Narcotic Laws,Drug Legislation,Drug Law,Law, Drug,Law, Narcotic,Laws, Drug,Laws, Narcotic,Narcotic Law
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
D010595	Pharmacists	Those persons legally qualified by education and training to engage in the practice of pharmacy.	Clinical Pharmacists,Community Pharmacists,Retail Pharmacists,Clinical Pharmacist,Community Pharmacist,Pharmacist,Pharmacist, Clinical,Pharmacist, Community,Pharmacist, Retail,Pharmacists, Clinical,Pharmacists, Community,Pharmacists, Retail,Retail Pharmacist
D011307	Drug Prescriptions	Directions written for the obtaining and use of DRUGS.	Drug Prescribing,Drug Prescription,Drug Prescribings,Prescribing, Drug,Prescribings, Drug
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D013810	Therapeutic Equivalency	The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.	Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.