Adverse Reaction Surveillance

Almost all drugs have adverse effects associated with their use; these range in severity from mild inconveniences to severe morbidity and death. Some adverse ef fects are extensions of the drug's pharmacological effect and are predictable, for example, orthostatic hypotension with some antihypertensive agents, arrhythmias with certain cardioactive drugs, and electrolyte imbalance with diuretics. Other adverse effects are not predictable and may occur rarely or be delayed for months or years before the association is recognized. Examples of such reactions are aplastic anemia associated with chloramphenicol and clear cell carcinoma of the uterus in offspring of women treated with diethylstilbestrol during pregnancy. Postmarketing surveillance programs and adverse reaction reporting systems may detect such events. The best defense against devastating adverse actions is still the vigilance and suspicion of the physician.

^ Study Questions

1. The primary consideration in all clinical trials is to

(A) Determine the safety of the drug

(B) Determine the efficacy of the drug

(C) Ensure that there is no risk to the subject

(D) Provide for the welfare of the subject

2. To conduct reliable clinical trials with a potential new drug, it is necessary to establish a dose level that toxicity first appears. This is commonly determined in

(A) Phase I Studies

(B) Phase II Studies

(C) Phase III Studies (d) Phase IV Studies 3. The history of pharmacology includes a long list of heroes. The person considered to be the founder of American pharmacology is

(A) Claude Bernard

(B) Rudolph Bucheim

(C) John Jacob Abel

(D) Oswald Schmeideberg

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  • demsas gebre
    What is Adverse reaction surveillance in pharmacology?
    3 years ago

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