United States
Hong KongMedWatch and reporting
MedWatch is the FDA program for voluntary reporting of adverse events and product problems. Manufacturer postmarketing reporting is separate and mandatory under 21 CFR 314.80.
Two reporting systems doing different jobs, and the exam distinguishes them.
MedWatch
The FDA program through which healthcare professionals, patients and consumers voluntarily report adverse events and product problems.
Voluntary is the operative word for a pharmacy: there is no obligation on an individual practitioner to file, and reporting is encouraged.
Manufacturer reporting is different
21 CFR 314.80 requires applicants to report adverse drug experiences on defined timescales. That is a regulatory obligation on the company rather than on a pharmacy, and confusing the two systems is the standard distractor: voluntary for the practitioner, mandatory for the manufacturer.
What gets reported to MedWatch
- Serious adverse events associated with a product
- Product quality problems, such as suspected contamination or defective packaging
- Therapeutic failure, where a product does not work as expected
- Medication errors involving a product's name, labeling or packaging
That last one is why MedWatch connects to the look-alike sound-alike material: a name causing errors is a product problem, not just a local one.
Internal reporting is separate again
A pharmacy's own event reporting system captures errors and near misses so the organization can find its system weaknesses. That is continuous quality improvement.
An error caused by local process goes there. A problem with the product itself goes to MedWatch as well.
The three, side by side
| System | Who reports | Mandatory? |
|---|---|---|
| Internal event reporting | Staff, to the organization | By policy |
| MedWatch | Practitioners, patients, consumers, to FDA | Voluntary |
| Postmarketing reporting, 21 CFR 314.80 | Manufacturers, to FDA | Mandatory |
Common questions
What is MedWatch?
The FDA program for voluntary reporting of adverse events and product problems.
Is MedWatch reporting mandatory?
Voluntary for practitioners. Manufacturer postmarketing reporting under 21 CFR 314.80 is mandatory.
What gets reported?
Serious adverse events, product quality problems, therapeutic failure, and errors involving naming, labeling or packaging.
How is internal reporting different?
It captures errors and near misses for the organization's own quality improvement.
What is the common confusion?
Treating voluntary practitioner reporting and mandatory manufacturer reporting as the same system.