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
A pharmacovigilance team discovers that a drug's real-world use pattern includes widespread off-label prescribing to pregnant women. What is the MOST appropriate post-marketing surveillance response?
Answer: Establish a pregnancy registry to prospectively collect safety data in this exposed population
A pregnancy registry is the gold-standard active surveillance method for collecting prospective, real-world safety data on drug exposure during pregnancy.
Under the FDA Safety Reporting Final Rule (21 CFR 314.81), when must an IND safety report be submitted to the FDA for a serious, unexpected, suspected adverse reaction?
Answer: Within 7 calendar days if fatal/life-threatening; within 15 calendar days for others
Fatal or life-threatening serious unexpected suspected adverse reactions require a 7-day IND safety report; all other serious unexpected suspected reactions require a 15-day report.
What distinguishes a 'medication error' from an 'adverse drug reaction' in post-marketing pharmacovigilance?
Answer: A medication error involves preventable deviation from intended drug use; an ADR occurs with normal use
Medication errors are preventable events involving incorrect use (wrong dose, wrong patient, wrong route), whereas ADRs occur as unintended effects during normal, correct use.
A pharmacovigilance scientist is performing a Bayesian data mining analysis on a spontaneous reporting database. Which metric is specifically associated with this Bayesian approach?
Answer: Information Component (IC)
The Information Component (IC) is a Bayesian disproportionality metric used by the WHO Uppsala Monitoring Centre in VigiBase to detect drug-event associations.
Which of the following represents a key limitation of spontaneous adverse event reporting systems in post-marketing surveillance?
Answer: They systematically underestimate adverse event rates due to underreporting
Spontaneous reporting systems suffer from significant underreporting, with estimates suggesting only 1–10% of adverse events are ever reported, making incidence rate calculations unreliable.
The International Birth Defects Information Systems (IBIS) and pregnancy exposure registries are most important for which aspect of post-marketing surveillance?
Answer: Detecting teratogenic effects of drugs by tracking fetal outcomes after maternal exposure
Pregnancy registries and IBIS systematically collect and analyze data on fetal outcomes (birth defects, miscarriage, premature delivery) following drug exposure during pregnancy.
A drug approved under accelerated approval has a confirmed efficacy endpoint that was used as a surrogate. Post-marketing confirmatory trials fail to show clinical benefit. What is the likely regulatory outcome?
Answer: The FDA may withdraw approval using expedited withdrawal procedures
Under the accelerated approval pathway, if confirmatory trials fail to verify clinical benefit, the FDA can withdraw approval through an expedited process without the standard hearing procedures.