Reporting adverse drug reactions

Be sure to report any suspected adverse drug reaction to comply with GMC guidance

ALL UK clinicians should be familiar with The Yellow Card Scheme for collecting information on suspected adverse drug reactions (ADRs) to medicines. It is run by the Medicines and Healthcare Products Regulatory Agency (MHRA) and Commission on Human Medicines (CHM) and is used to collect data from health professionals and the general public on both licensed and unlicensed medicines.

No doubt diligence will vary when it comes to reporting ADRs to the scheme but all doctors should be aware that recent GMC guidance has confirmed that doing so is a matter of professional obligation.

In January of this year the GMC published Good practice in prescribing and managing medicines and devices which strengthened and broadened existing advice on prescribing medicines. Among other changes the guidance also reminded doctors that they “must” report any adverse incidents involving drugs and medical devices.

The guidance states: “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. You must make reports in accordance with your employer or contracting body’s local clinical governance procedures.”

Doctors are advised that they 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”. Healthcare staff must also report any adverse incident involving medical devices – including those caused by human error – that could compromise the safety of patients, healthcare professionals or others.

The guidance states that doctors should also check that 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 local clinical governance arrangements. In addition, doctors should (where appropriate) inform the patient’s GP, the pharmacy that supplied the medicine, the local controlled drugs accountable officer and the medicines manufacturers of relevant adverse drug reactions.

Dangerous occurrences and accidents must also be reported to the Health and Safety Executive in accordance with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 and local procedures for reporting and learning from similar issues must be followed.

Reports using the Yellow Card scheme can be made online or via post (FREEPOST Cards can be found in the BNF, MIMS, ABPI compendium or obtained by calling freephone 0800 731 6789).

Yellow Card reports do not include personal information about patients which could be used to identify an individual (such as name or address) but the MHRA does require the age and gender of the person who experienced the suspected ADR in order to investigate contributing factors. The GMC advises that in reporting any adverse incident doctors should anonymise or code the information, or seek consent if practicable.

ACTION Report any suspected adverse drug reaction to comply with GMC guidance.

 

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