Which is a disadvantage of the FDA Adverse Event Reporting System (FAERS)? A. Reported adverse effects...

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

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

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.

Solutions

Expert Solution

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

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

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

Explanation: The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. Pharmacovigilance is intended to assess risk-benefit and recognize and further investigate any serious AEs, with the options of updating the product’s labeling information, restricting use of the drug, communicating new safety information to the public, or investigating whether the drug should be removed from the market.

Nightingale answered 1 year ago

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