Question

A medication error resulting in serious patient harm has occurred in a hospital, and a root cause analysis is conducted. The results of the analysis indicate that similarity in generic name may have been involved. This should be reported to the____________.

Answer 1

Medication errors, particularly those due to similarities in generic names causing patient harm, must be reported to the U.S. FDA's MedWatch program, alongside local regulatory bodies and relevant hospital committees.

Step-by-step explanation:

A medication error resulting in serious patient harm has occurred in a hospital and a root cause analysis is conducted, revealing that similarity in generic name may have been involved in the incident. Such errors should be reported to the U.S. Food and Drug Administration (FDA), specifically to their MedWatch program, which is responsible for monitoring medication and device safety. In addition, local regulatory authorities and the hospital's patient safety and pharmacy and therapeutics committees should also be informed to undertake necessary action and prevent future occurrences.