Adverse drug reaction classification and pharmacovigilance and reporting concepts tested on USMLE Step 1.
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- What does a Type A adverse drug reaction (ADR) mean?
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Augmented: an exaggerated, dose-dependent effect predictable from the drug's known pharmacology.- What does a Type B adverse drug reaction (ADR) mean?
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Bizarre: an unpredictable, non-dose-related reaction, often immune-mediated (idiosyncratic).- What does a Type C adverse drug reaction (ADR) mean?
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Chronic: a reaction related to cumulative dose over long-term therapy, such as NSAID-induced peptic ulceration.- What does a Type D adverse drug reaction (ADR) mean?
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Delayed: a reaction that appears sometime after drug exposure, such as teratogenesis or carcinogenesis.- What does a Type E adverse drug reaction (ADR) mean?
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End-of-use: a reaction that occurs upon drug withdrawal, such as opioid withdrawal or beta-blocker rebound tachycardia.- Give an example of a Type A (dose-dependent) adverse drug reaction.
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Bradycardia caused by a beta blocker.- Give an example of a Type B (idiosyncratic) adverse drug reaction.
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Anaphylaxis after penicillin administration.- Which type of adverse drug reaction, A or B, accounts for the majority of all adverse drug reactions?
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Type A (dose-dependent, predictable reactions).- What is the purpose of the Naranjo Adverse Drug Reaction Probability Scale?
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To estimate the likelihood that a specific drug caused an observed adverse event, using a scored questionnaire.- What does FAERS stand for?
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FDA Adverse Event Reporting System.- What is MedWatch?
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The FDA's voluntary safety information and adverse event reporting program for healthcare professionals and consumers.- What is a Phase IV clinical trial?
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Post-marketing surveillance conducted after a drug is approved, to detect rare or long-term adverse effects in the general population.- What is the Weber effect in pharmacovigilance?
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The observation that adverse drug reaction reporting typically peaks in the second year after a drug reaches the market, then declines.- What is a black box warning?
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The FDA's strictest drug labeling warning, highlighting a serious or life-threatening risk associated with the medication.- What is the main limitation of spontaneous adverse event reporting systems?
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Significant underreporting, since only a small fraction of actual adverse events are ever submitted.
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