Question 73

Shingrix given subcutaneously instead of IM should be reported to MedWatch.

MedWatch is the FDA's program for reporting adverse events and medication errors, making it the appropriate channel for reporting the administration of Shingrix via the incorrect route.

A) OSHA

OSHA, the Occupational Safety and Health Administration, is primarily concerned with workplace safety and health regulations. It does not handle medication error reports or adverse event reporting related to vaccines, making it an incorrect option in this context.

B) iPLEDGE

iPLEDGE is a program designed specifically for the safe distribution of certain medications, such as isotretinoin, and is not relevant for reporting vaccine administration errors. Thus, it is not the correct choice for reporting the subcutaneous administration of Shingrix.

C) MedWatch

MedWatch serves as the FDA's reporting system for adverse events and medication errors, including issues related to the administration of vaccines. Reporting the incorrect administration route of Shingrix to MedWatch ensures that the information is documented for patient safety and regulatory oversight, confirming it as the correct answer.

D) ISMP VERP

The ISMP (Institute for Safe Medication Practices) VERP (Vaccination Error Reporting Program) is focused on reporting vaccination errors but is not the primary federal reporting system. While it may collect such reports, MedWatch is the formal channel for reporting errors to the FDA, making ISMP VERP less appropriate in this specific case.

Conclusion

MedWatch is the definitive reporting system for adverse events and medication errors regulated by the FDA, including the incorrect administration route of Shingrix. The other options, while relevant to various aspects of health and safety, do not pertain directly to the reporting of vaccine-related errors, confirming MedWatch as the correct choice.