Question

A pharmacy technician is made aware of a Patient Safety Event (formerly known as a dispensing incident) and therefore must immediately notify _________ who in turn must electronically report the Patient Safety Event __________ as he or she is now known as __________.

Answer 1

A pharmacy technician must notify the pharmacist, acting as a pharmacovigilance officer, of any Patient Safety Event, who in turn must report the event to the FDA as per MedWatch program guidelines for ongoing drug safety and risk management.

Step-by-step explanation:

When a pharmacy technician becomes aware of a Patient Safety Event, which refers to an incident related to dispensing medication that could affect patient safety, the technician must promptly notify the pharmacist-on-duty. This is a critical step in the reporting process, as the pharmacist, also known as a pharmacovigilance officer in this context, is required to electronically report the event to the FDA. This reporting is mandated under the purview of programs like MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Reporting directly contributes to the post-marketing surveillance of drugs and is essential for ongoing patient safety and risk management.

According to the FDA's regulations, the sponsor (often the pharmaceutical company) must report any unexpected serious and fatal adverse drug events within 15 days. Other adverse events are to be reported on a quarterly basis. Such measures are a part of a comprehensive pharmacovigilance system tasked with evaluating the long-term safety of medications following their initial market approval. By assuring that these events are reported, pharmacovigilance systems aid in protecting public health and ensuring that the benefits of a drug continue to outweigh the risks during its lifespan on the market.