Question

question 28

a pharmacy technician should identify that which of the following adverse events should be reported using the fdas medwatch program?

a patient who misses a dose of their blood pressure medication

a patient who experiences a serious adverse drug reaction to a newly approved medication

a pharmacist who makes a dispensing error

a medication that has expired in the pharmacy stock

Explanation:

Identify the purpose of FDA's MedWatch

Using the Adverse Event Reporting knowledge point
The FDA's MedWatch program is a voluntary reporting system designed for healthcare professionals and consumers to report serious adverse events, product quality problems, product use errors, or therapeutic inequities/failures associated with FDA-regulated medical products (such as medications, medical devices, cosmetics, and special foods).

Evaluate the given options

• Option 1: A patient missing a dose of blood pressure medication is a compliance issue, not an adverse event caused by the drug itself.
• Option 2: A serious adverse drug reaction to a newly approved medication is a classic example of what should be reported to MedWatch to help monitor post-market safety.
• Option 3: A dispensing error is a medication error that is typically handled through internal pharmacy quality assurance systems or dedicated error-reporting databases (like ISMP), rather than MedWatch (unless it is related to confusing product packaging/labeling).
• Option 4: Expired stock is an inventory management issue, not an adverse event.

Answer:

• A patient who misses a dose of their blood pressure medication
• A patient who experiences a serious adverse drug reaction to a newly approved medication (Correct answer)
• A pharmacist who makes a dispensing error
• A medication that has expired in the pharmacy stock