Good practice in prescribing and managing medicines and devices

Reporting adverse drug reactions medical device incidents and other patient safety incidents

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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 

23

Raising and acting on concerns about patient safety’ (2012) London, General Medical Council

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.

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You must use the Yellow Card Scheme26  to inform the MHRA about:

  1. serious suspected adverse reactions to a medicine
  2. all reactions to products marked with a Black Triangle in the BNF and elsewhere.
26

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.

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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 liaison officer within your organisation and the relevant national body:

  1. in England and Wales – MHRA reporting adverse incidents
  2. in Northern Ireland – Northern Ireland Adverse Incident Centre.
  3. in Scotland – Health Facilities Scotland online incident reporting
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You should give patients information about how they can report suspected side effects directly to the MHRA.

90

You should also check that all serious patient safety incidents are reported to the relevant national body, especially if such incidents are not automatically reported through clinical governance arrangements where you work.

  1. In England and Wales, it’s the National Reporting and Learning System.
  2. In Northern Ireland, it’s the Northern Ireland Regional Health and Social Care Board (HSCB) and the Northern Ireland Regional Public Health Agency.
  3. In Scotland, it’s Healthcare Improvement Scotland.
91

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.

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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.