Pharmacotherapy
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| Define pharmacoepidemiology | the study of the use and the effects of drugs in large numbers of people
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| what is the purpose of pharmacoepidemiology | to identify and quantify drug outcomes along with incidence rates and estimates of relative risk
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| what does pharmacoepidemiology provide info on? | health and cost outcomes, devices, and biologicals, particularly after their approval for clinical use
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| 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
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| what was the incidence of serious ADRs in hospital patients | 6.7%
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| What are type A ADR reactions | these are expected exaggerations of a drug's known pharmacologic effects.
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| 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
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| what is another name for type B rxns | hypersensitivity reactions
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| T or F. It is possible to detect all potential risks and benefit during premarketing studies for a drug? | F
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| who do clinicians report ADRs/ADEs tol? | the manufacturer or the Medwatch system of the FDA
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| T or F. Manufacturers don't have to report adverse events to the FDA | F
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| To which agency are ADEs in vaccines reported? | Vaccine Adverse Event Reporting System (VAERS) run by the FDA and CDC
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| 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
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| define therapeutics | the mode/method of healing any disease or injury
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| what is pharmacology | the study of the how chemical substances interact with living systems
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