Patient Safety & Quality AssuranceQuestion 79 of 100
A patient develops a severe rash days after starting a newly dispensed sulfonamide antibiotic, and the pharmacist decides to report it to the FDA. Which program should be used?
a.MedWatch, the FDA program for adverse events and product quality problems involving drugs and other medical products
b.VAERS, which collects reports of adverse events following vaccination
c.A DEA Form 106, used to report loss or theft of controlled substances
d.The manufacturer's product recall notification system
Explanation
MedWatch is the FDA's voluntary reporting pathway for suspected adverse drug reactions, medication errors and product defects, and reports from pharmacies help detect safety signals that clinical trials missed. VAERS is reserved for events after vaccines, DEA Form 106 covers controlled substance loss or theft, and a recall notification moves product off the shelf but is not a way to report a patient reaction.
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