Adverse Drug Reaction Reporting 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 Adverse Drug Reaction Reporting flashcards as text
What regulatory action follows confirmation of a new serious safety signal for a marketed product?
Answer: Label update, risk communication, or other risk minimization measures depending on signal strength
Confirmed safety signals typically result in label updates, Dear Healthcare Professional letters, REMS implementation, or other risk minimization measures proportional to the risk.
Which ICH guideline specifically addresses pharmacovigilance planning and the content of PSURs?
Answer: ICH E2C(R2)
ICH E2C(R2) provides guidance on the structure and content of Periodic Benefit-Risk Evaluation Reports (PBRERs), which are the international equivalent of PSURs.
A sponsor receives an IND safety report for a fatal SAE from an investigator on Day 1. By which day must the FDA receive the expedited report?
Answer: Day 7
Fatal or life-threatening unexpected SUSARs in IND studies must be reported to the FDA within 7 calendar days of the sponsor's initial receipt under 21 CFR 312.32(c).
What is 'medication error' in the context of pharmacovigilance reporting?
Answer: An unintended error in prescribing, dispensing, or administration of a drug that may or may not cause patient harm
A medication error is an unintended failure in the drug treatment process that may or may not lead to patient harm and is reportable when it results in an adverse outcome.
Which source of ADR data typically has the highest rate of underreporting, estimated at capturing only 1–10% of actual reactions?
Answer: Spontaneous reporting systems
Spontaneous reporting systems are subject to significant underreporting, estimated to capture only 1–10% of actual ADRs due to factors like uncertainty about causality and lack of awareness of reporting obligations.
In the context of aggregate safety reporting, what is a 'data lock point' (DLP)?
Answer: The specific date up to which all relevant safety data are included in a periodic safety report
The data lock point is the specific calendar date up to which all safety information is collected and included in a periodic safety report such as a PSUR or PBRER.
Which federal regulation requires US pharmaceutical companies to establish and maintain records of adverse drug experience information received from any source?
Answer: 21 CFR 314.81 (NDA post-marketing reports)
21 CFR 314.81 requires NDA holders to maintain records of and submit post-marketing safety reports, including all adverse drug experience information received from any source.