Adverse Drug Reaction Reporting
Drug Safety Update
Healthcare professionals have a professional responsibility to report suspected adverse drug reactions (ADRs)/side effects to the Medicines and Healthcare products Regulatory Agency (MHRA).
What to report:
- All suspected adverse drug reactions:
- In children (even if a medicine has been used off-label)
- In people aged over 65 years
- For new medicines (drugs and vaccines ) - identified by the black triangle ▼ symbol
- To biological medicines (such as blood products, antibodies and advanced therapies [such as gene and tissue therapy]) and vaccines
- Associated with rare or delayed drug effects
- Drug interactions
- Congenital abnormalities
- To complementary remedies, such as homeopathic and herbal products (licensed and unlicensed)
- All serious suspected adverse drug reactions for established vaccines and medicines, including unlicensed medicines, herbal remedies, and medicines used off-label
- Defective medicines (those that are not of an acceptable quality)
- Fake or counterfeit medicines or medical devices
- Adverse incident involving:
- All medical devices available on the UK market
- Nicotine-containing electronic cigarettes and refill containers (e-liquids)
ADRs that occur as a result of a medication error should be reported through the Trust’s reporting system – DATIX.
How to report:
- Through the Yellow Card Scheme using the electronic form at mhra.gov.uk/yellowcard
- By post. Paper copies are available:
- By downloading and printing out a form from mhra.gov.uk/yellowcard
- By writing to FREEPOST YELLOW CARD (no other address details necessary)
- By emailing email@example.com
- By calling the National Yellow Card Information Service on 0808 100 3352 (10am to 2pm Monday–Friday)
- In the back cover of the British National Formulary (BNF) and British National Formulary for Children (BNFc)
- Yellow Card Mobile App: download it from the Apple App Store or Google Play Store
IF IN DOUBT, STILL REPORT.
Patients and their carers can also report suspected adverse drug reactions to the MHRA. Reports can be submitted directly to the MHRA through the Yellow Card Scheme using the electronic form at mhra.gov.uk/yellowcard, by telephone on 0808 100 3352, or by downloading the Yellow Card form from mhra.gov.uk/yellowcard.
The Trust's Medicines Information centre can give information and advice on suspected ADRs. They can be contacted on extension 34217.