United States
Hong KongAdverse event reporting
Postmarketing reporting of adverse drug experiences is required of applicants under 21 CFR 314.80. Practitioner and consumer reporting through MedWatch is voluntary.
Two systems, one of them mandatory and one not, and the exam distinguishes which is which.
The mandatory side
Postmarketing reporting of adverse drug experiences sits at 21 CFR 314.80. It obliges applicants - the companies holding the approval - to report adverse experiences to FDA on defined timescales.
This is a regulatory obligation on the manufacturer, not on a pharmacy or an individual practitioner.
The voluntary side
MedWatch is the FDA program through which healthcare professionals, patients and consumers may report adverse events and product problems.
Postmarketing surveillance depends heavily on practitioner reporting, because a manufacturer only learns about an event if someone tells it. Underreporting is a recognized weakness of the system, which is why reporting is encouraged even though it is not compelled.
Why postmarketing surveillance exists at all
Clinical trials involve a limited number of patients over a limited period. Rare adverse effects, and effects appearing only after long exposure or in populations not studied, emerge once a drug is in wide use.
The reporting system is how that becomes visible.
What connects to it downstream
- Labeling changes, where new information affects warnings
- Recalls, where a product problem is identified
- REMS, where risk management is added or modified
- Withdrawal, in the extreme case
What a technician contributes
Recognizing that something is reportable, escalating it, and recording accurately. The clinical assessment and the filing decision are not the technician's.
Keep the three systems apart
Internal event reporting for local errors and near misses. MedWatch for adverse events and product problems, voluntarily. Postmarketing reporting under 314.80, mandatorily, by the manufacturer.
Common questions
Who must report adverse drug experiences to FDA?
Applicants, under 21 CFR 314.80. Practitioner reporting through MedWatch is voluntary.
Is MedWatch mandatory?
No, it is voluntary - and postmarketing surveillance depends on it.
Why does postmarketing surveillance exist?
Trials are limited in size and duration; rare and long-term effects emerge in wide use.
What can result from it?
Labeling changes, recalls, REMS requirements, or withdrawal.
What does a technician do?
Recognize, escalate and record accurately. The assessment and filing are not theirs.