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 ensure performance and systems issues are investigated, problems rectified and lessons learned.23 You must make reports in accordance with your employer or contracting body’s local clinical governance procedures.25
You should anonymise or code the information, or seek consent, if practicable. If necessary, see our explanatory guidance ‘Confidentiality: good practice in handling patient information’ (2017) for more advice.
You must use the Yellow Card Scheme26, 27 to inform the MHRA about:
- serious suspected adverse reactions to a medicine
- any suspected adverse reactions to products marked with a Black Triangle symbol (▼).28
You must 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’ 1995. You must follow local procedures for reporting and learning from similar issues.
The MHRA provides guidance for healthcare professionals, patients and the public on reporting adverse incidents with medicines and medical devices to the Yellow Card scheme.
New medicines and vaccines that are under additional monitoring may be marked with an inverted black triangle symbol (▼). The symbol appears in the British National Formulary (BNF), summaries of product characteristics, patient information leaflets and elsewhere.
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 must be reported to the medical device safety lead in your organisation (if there is one) and the relevant national body:
- in England and Wales – MHRA reporting adverse incidents
- in Northern Ireland – Northern Ireland Adverse Incident Centre.
- in Scotland – Health Facilities Scotland online incident reporting
You should give patients information about how they can report suspected side effects directly to the MHRA.
You should also check that patient safety incidents are reported to the relevant national body or system, especially if such incidents are not automatically reported through clinical governance arrangements where you work. For instance:
- In England and Wales, patient safety incidents are reported to the National Reporting and Learning System (NRLS), or its replacement, the Learn from patient safety events (LFPSE) service.29
- In Northern Ireland, serious adverse incidents are reported to the Regional Health and Social Care Board (HSCB) and the Regional Public Health Agency.30
- In Scotland, significant adverse event reviews commissioned by NHS boards for a category one adverse event should be reported to Healthcare Improvement Scotland.31
The LFPSE service was launched in July 2021 and will eventually replace the NRLS. During the transition period professionals will need to identify which system their organisation is using to report incidents. Further information on the LFPSE service is available on NHS England and Improvement’s website.
The Health and Social Care Board provides detailed guidance in its procedure for the reporting and follow-up of serious adverse incidents in Northern Ireland.
Where appropriate, you should also report relevant adverse drug reactions and patient safety incidents to the patient’s GP, the pharmacy that supplied the medicine, the local controlled drugs accountable officer and the medicine manufacturers.
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.