Adverse event reporting
Please do not discuss safety issues or adverse events associated with pharmaceutical products or devices on the Medthority platform or our social channels. If you, your patient, or someone you know has possibly experienced an adverse event while taking any medication, you must report it to the relevant medical authority in your country or territory.
What is an adverse event?
An adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product or not.
Reporting adverse events
Users in the USA should report adverse events to the U.S. Food and Drug Administration (FDA).
Users in the UK should report adverse events to the Medicines & Healthcare products Regulatory Agency (MHRA).
Users in the European Union (EU) should report adverse events to their national pharmacovigilance system or directly to the sponsor or manufacturer.
If you’re located outside the USA, UK, or EU, please report adverse events to your local regulatory authority. You may find local reporting instructions in the product’s Summary of Product Characteristics (SmPC) or Patient Information Leaflet (PIL). For a global overview of national pharmacovigilance systems, visit the World Health Organization (WHO) Programme for International Drug Monitoring.
Medication errors and product quality complaints
In addition to adverse events, healthcare professionals may also need to report medication errors or product quality complaints.
In the USA, healthcare professionals can report:
- Medication errors (e.g., incorrect dosage, administration route, or patient)
- Product quality complaints (e.g., packaging defects, contamination, or therapeutic failure)
These reports can be submitted via the FDA's Adverse Event Reporting System (FAERS).
In other countries or territories, please refer to your national regulatory authority for guidance on reporting medication errors or product quality issues. These may be handled separately or as part of adverse event reporting.
Medthority content and reporting policy
Medthority reserves the right (but is not obligated) to:
- Remove any user-generated content that includes personally identifiable information and/or information relating to adverse events
- Report any adverse event mentioned on the Medthority platform or social channels to the relevant medical authority
