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Define pharmacoepidemiology the study of the use and the effects of drugs in large numbers of people
what is the purpose of pharmacoepidemiology to identify and quantify drug outcomes along with incidence rates and estimates of relative risk
what does pharmacoepidemiology provide info on? health and cost outcomes, devices, and biologicals, particularly after their approval for clinical use
T or F . ADRs are based on doses not normally used in humans F. ADRs are based on the effects of a drug that occurs at doses used in humans
what was the incidence of serious ADRs in hospital patients 6.7%
What are type A ADR reactions these are expected exaggerations of a drug's known pharmacologic effects.
what are type B ADRs these are idiosyncratic and tend to be unrelated to the known pharmacologic action of a drug eg. thalidomide's teratogenic effects
what is another name for type B rxns hypersensitivity reactions
T or F. It is possible to detect all potential risks and benefit during premarketing studies for a drug? F
who do clinicians report ADRs/ADEs tol? the manufacturer or the Medwatch system of the FDA
T or F. Manufacturers don't have to report adverse events to the FDA F
To which agency are ADEs in vaccines reported? Vaccine Adverse Event Reporting System (VAERS) run by the FDA and CDC
Which three other organizations does the FDA have an agreement regarding reporting ADEs Kaiser Permanente, the VA, and the Centers for Education and Research on Therapeutics
define therapeutics the mode/method of healing any disease or injury
what is pharmacology the study of the how chemical substances interact with living systems
Created by: coolnuh