Question

Which is a disadvantage of the FDA Adverse Event Reporting System (FAERS)?

A. Reported adverse effects can remove the product from the market.

B. Reports received from the manufacturers are forwarded to the FDA to be added to its computerized database.

C. The reporting system can restrict the use of a drug in specific populations if found unsafe.

D. The nurse should examine the incidence of adverse effects that occur over and above that caused by a placebo.

Answer 1

Answer: The correct answer is option B

FAERS is the database that contains the adverse event of drugs, medical error, and lack of quality complaints from the consumer, health care professional, and manufacturer. If the report gets from any person to the manufacturer then they have to report to the FDA. But they can also manipulate the report by the manufacturer before reporting to FDA. This is one of the disadvantages of FAERS.

The other options are wrong because restriction of the unsafe drug, remove from the market and repeated examination of the product will helps to prevent from any adverse effects and maintain safeness to the consumers.