Reporting adverse drug reactions, medical device incidents and other patient safety incidents
Early, routine reporting of adverse reactions, incidents and near misses involving medicines and devices can allow performance and systems issues to be investigated, problems rectified and lessons learned.17 You must make reports in accordance with your employer or contracting body’s local clinical governance procedures.18
You should anonymise or code the information or seek consent, if practicable, or see our confidentiality guidance for more advice.
You must also make sure dangerous occurrences and accidents are reported to the Health and Safety Executive in accordance with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013, and that local procedures for reporting and learning from similar issues are followed.
You must inform the MHRA about:
- serious suspected adverse reactions to all medicines and all reactions to products marked with a Black Triangle in the BNF and elsewhere using the Yellow Card Scheme.19
- adverse incidents involving medical devices, including those caused by human error that put, or have the potential to put, the safety of patients, healthcare professionals or others at risk.20 These incidents should also be reported to the medical device liaison officer within your organisation.
The MHRA collects data on licensed and unlicensed prescription-only, pharmacy and over-the-counter medicines.
Further guidance on reporting is available from the MHRA: Reporting Adverse Incidents. Incidents involving medical devices in England and Wales should be reported to MHRA reporting adverse incidents. In Northern Ireland they should be reported to Northern Ireland Adverse Incident Centre; and in Scotland to Health Facilities Scotland online incident reporting.
You should provide patients with information about how they can report suspected side effects directly to the MHRA.
You should also:
- check that all serious patient safety incidents are reported to the National Reporting and Learning System (in England and Wales), especially if such incidents are not automatically reported through clinical governance arrangements where you work
- where appropriate, inform the patient’s general practitioner, the pharmacy that supplied the medicine, the local controlled drugs accountable officer and the medicines manufacturers of relevant adverse drug reactions and patient safety incidents.
You should respond to requests from the Drug Safety Research Unit for prescription-event monitoring data and information for studies on specific safety or pharmacovigilance issues.