Biomaterial Database

Food and Drug Administration's adverse drug reaction monitoring program. 1978

B Lee, and W M Turner

The adverse drug reaction monitoring program of the Division of Drug Experience within the FDA is described. Historical information on the development and activities of the current drug reaction monitoring program, and goals and objectives of the current program are discussed. Also presented are a brief description of the Voluntary Reporting System, intensive drug monitoring studies and special epidemiologic studies, and a workable definition of alert reports and examples of their previous role within the FDA. Pharmacists should participate actively in adverse drug reaction monitoring.

UI	MeSH Term	Description	Entries
D008991	Monitoring, Physiologic	The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine.	Patient Monitoring,Monitoring, Physiological,Physiologic Monitoring,Monitoring, Patient,Physiological Monitoring
D012042	Registries	The systems and processes involved in the establishment, support, management, and operation of registers, e.g., disease registers.	Parish Registers,Population Register,Parish Register,Population Registers,Register, Parish,Register, Population,Registers, Parish,Registers, Population,Registry
D004345	Drug Industry	That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.	Industries, Pharmaceutic,Industry, Drug,Industry, Pharmaceutic,Industry, Pharmaceutical,Pharmaceutical Industry,Drug Industries,Industries, Drug,Industries, Pharmaceutical,Pharmaceutic Industries,Pharmaceutic Industry,Pharmaceutical Industries
D004812	Epidemiologic Methods	Research techniques that focus on study designs and data gathering methods in human and animal populations.	Epidemiologic Method,Epidemiological Methods,Methods, Epidemiologic,Epidemiological Method,Method, Epidemiologic,Method, Epidemiological,Methods, Epidemiological
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
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