Post-Marketing Surveillance Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Post-Marketing Surveillance flashcards as text
Which of the following best defines a 'cohort event monitoring' study in post-marketing surveillance?
Answer: A prospective follow-up of a defined group of patients exposed to a specific drug to capture all medical events
Cohort event monitoring prospectively follows an exposed cohort, capturing all events regardless of suspected causality to identify safety signals.
The Benefit-Risk Balance (BRB) assessment in post-marketing surveillance weighs which two primary factors?
Answer: Clinical benefits of treatment against known and potential risks
The BRB assessment compares the clinical benefits of a drug (efficacy, patient outcomes) to its risks (adverse effects, misuse potential) to justify continued marketing.
In pharmacovigilance, a 'labeled' adverse event is one that:
Answer: Is already described in the product's current approved labeling
A labeled adverse event is one already listed in the approved product label; unlabeled (unexpected) events require expedited reporting.
Which of the following signal detection methods compares the observed-to-expected ratio of drug-event combinations in spontaneous reporting databases?
Answer: Proportional Reporting Ratio (PRR)
The PRR is a disproportionality analysis method that compares how frequently a drug-event pair appears relative to all other drugs reporting that event.
A pharmacovigilance professional receives an adverse event report where the patient outcome is listed as 'not recovered/not resolved.' How should the case be classified?
Answer: Serious, because ongoing harm qualifies as a serious outcome under ICH E2A
Under ICH E2A criteria, 'not recovered/not resolved' signifies persistent harm and must be considered when evaluating seriousness, which can qualify a case as serious.
What is the primary purpose of a Drug Utilization Study (DUS) in the post-marketing setting?
Answer: To evaluate how a drug is prescribed, dispensed, and used in real-world practice
A DUS describes patterns of drug use in a population, including prescribing practices, patient demographics, and deviations from approved labeling.
Which type of post-marketing study is MOST appropriate for detecting rare adverse events that occur in fewer than 1 in 10,000 patients?
Answer: Large simple safety trials or large-scale database studies
Large simple safety trials and database studies enroll or analyze tens of thousands of patients, giving adequate statistical power to detect rare adverse events.