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 does the term 'unlabeled' mean in the context of adverse event reporting for marketed products?
Answer: The adverse event is not listed in the current approved prescribing information
An unlabeled (unexpected) adverse event is one not described in the current version of the approved prescribing information or Summary of Product Characteristics.
Which disproportionality analysis method calculates the Reporting Odds Ratio (ROR) for signal detection in spontaneous reporting databases?
Answer: Case/non-case method
The case/non-case method is the statistical approach used to calculate the Reporting Odds Ratio (ROR) in spontaneous reporting database signal detection.
Under EU GVP Module VI, what is the maximum time allowed to submit a follow-up ICSR after obtaining significant new information on a previously reported serious case?
Answer: 15 days
Under EU GVP Module VI, significant new information on a previously submitted serious ICSR must be submitted as a follow-up within 15 calendar days.
A medically unqualified consumer reports an ADR directly to a pharmaceutical company. What obligation does the company have regarding this report?
Answer: The report must be processed as a valid ICSR if the four minimum elements are present
Consumer reports must be processed as valid ICSRs when all four minimum elements are present, regardless of whether the reporter has medical qualifications.
What is the primary objective of a Risk Management Plan (RMP) in pharmacovigilance?
Answer: To describe the safety profile and outline measures to prevent or minimize risks and assess effectiveness of those measures
An RMP describes the safety profile of a product, identifies missing information, and outlines pharmacovigilance and risk minimization activities to manage identified and potential risks.
Which term describes an adverse drug reaction that is severe, potentially life-threatening, and requires immediate medical intervention but does not result in death or permanent injury?
Answer: Life-threatening adverse event
A life-threatening adverse event is one in which the patient is at immediate risk of death at the time of the reaction, which is a seriousness criterion under ICH E2A.
In pharmacovigilance, what is meant by 'important identified risk'?
Answer: A risk for which there is adequate evidence of an association with the use of a medicinal product and which is of significance for public health or risk-benefit assessment
An important identified risk is a confirmed safety concern with adequate evidence of association with the product that significantly impacts the risk-benefit profile.