Question 1:
Safety data is only collected during the later phases of the clinical development program for a medical product.
True or False?
Answer: False
Safety data collection is NOT limited to the later phases of the clinical development program, but are collected throughout the lifecycle of FDA-regulated products.
Question 2:
Health care providers are required to report all adverse drug events.
True or False?
Answer: False
Reporting of adverse drug reactions is voluntary for health care providers, but is required for manufacturers. However, it is important for health care providers to report ADRs to support safe medication use.
Question 3:
The frequency of experiencing adverse drug event X for a given drug can be determined through spontaneous reporting systems.
True or False?
Answer: False
FDA does not receive reports for every adverse event because it is a voluntary system.
• Frequency cannot be determined because we do not know the total number
of people experiencing an ADR (numerator) or the total number of people receiving the drug (denominator).
• The FDA Adverse Event Reporting System (FAERS) has limitations, e.g. time on market can influence the number of reports, and reports can increase due to publicity (when an adverse event with a drug is reported in the news).
Question 4:
A safety signal could be:
A. A new, previously unknown, adverse event
B. A new drug interaction
C. An observed change in quantity, severity, or in the affected population of a known adverse event
D. All of the above
Answer: D (All of the above)
Illustrations of safety signals include (1) new unlabeled adverse events, (2) an observed increase in a labeled event (already listed in the package insert) or a greater severity or specificity of a labeled event, (3) an unrecognized drug-drug interaction, or (4) a newly identified at-risk population (e.g. patients with kidney disease).
Presented by the PhRMA Foundation Safe and Effective Prescribing Project
For more information, please call 202-572-7756
