Post-Marketing Surveillance Flashcards

A Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU) might require which of the following?

Answer: Patient enrollment in a registry before the drug can be dispensed

ETASU can require patient enrollment in registries, certification of pharmacies or prescribers, and laboratory testing before dispensing to ensure safe use.

In the context of post-marketing safety reporting timelines, a 15-day 'alert report' is required for adverse events that are:

Answer: Serious, unexpected, and there is a reasonable possibility of drug causality

Under FDA and ICH E2A guidelines, expedited 15-day reporting applies to serious, unexpected adverse events where there is a reasonable possibility the drug caused the event.

Which post-marketing surveillance tool uses large healthcare databases (claims, EHR) to detect safety signals through automated algorithms?

Answer: Active surveillance via the Sentinel System

The FDA's Sentinel System actively queries large electronic health databases using pre-specified algorithms to detect safety signals without relying on voluntary reports.

When a post-marketing safety update reveals a new contraindication for a drug, the regulatory pathway most commonly used to change the US label is:

Answer: Changes Being Effected immediately (CBE-0)

Adding or strengthening a contraindication qualifies for a CBE-0 supplement, allowing the label change to be implemented immediately while the supplement is pending FDA review.

The Medical Dictionary for Regulatory Activities (MedDRA) is used in post-marketing surveillance primarily to:

Answer: Standardize the coding and terminology of adverse events across regulatory submissions

MedDRA provides a standardized, hierarchical medical terminology used globally to code adverse events, diagnoses, and medical history in regulatory submissions.

In a signal evaluation process, which of the following outputs would trigger immediate regulatory action without waiting for further data?

Answer: A cluster of fatal cardiac events with a strong temporal relationship to a recently approved drug

A cluster of fatal events with strong temporal association represents an urgent safety signal that warrants immediate regulatory action such as label update, Dear Healthcare Provider letter, or market withdrawal.

Which ICH guideline specifically addresses the format and content of Periodic Benefit-Risk Evaluation Reports (PBRERs)?

Answer: ICH E2C(R2)

ICH E2C(R2) defines the structure and content requirements for PBRERs, which replaced Periodic Safety Update Reports (PSURs) as the harmonized post-marketing periodic safety report.