Domain 2:

Safety and Quality: Adverse Drug Reactions

Reporting ADRs is an important strand of evidence that you can provide within Domain 2 of your annual appraisal process.

The Yellow Card Scheme for monitoring adverse drug reactions (ADRs) has been a cornerstone of UK pharmacovigilance for 50 years. It has been responsible for detecting many rare but serious ADRs that only come to light after new drugs have been launched onto the market. The numbers of reports has been stable over the last few years but the proportion being sent by hospital doctors and general practitioners has steadily fallen over the last 13 years. Studies over many years have indicated that only a small fraction of even the most serious adverse events are ever reported.

Reporting ADRs is also an important strand of evidence that you can provide within Domain 2 of your annual appraisal process:

Domain 2 - Safety and Quality

Contribute to and comply with systems to protect patients

22. You must take part in systems of quality assurance and quality improvement to promote patient safety. This includes:

  1. taking part in regular reviews and audits of your own work and that of your team, responding constructively to the outcomes, taking steps to address any problems and carrying out further training where necessary
  2. regularly reflecting on your standards of practice and the care you provide
  3. reviewing patient feedback where it is available.

23. To help keep patients safe you must:

  1. contribute to confidential inquiries
  2. contribute to adverse event recognition
  3. report adverse incidents involving medical devices that put or have the potential to put the safety of a patient, or another person, at risk
  4. report suspected adverse drug reactions
  5. respond to requests from organisations monitoring public health. When providing information for these purposes you should still respect patients’ confidentiality.

Taken from http://www.gmc-uk.org/guidance/good_medical_practice/systems_protect.asp

We would encourage all appraisees to consider reporting serious ADRs to any drug or any ADR to newer agents under intensive surveillance. Most clinicians can expect to see a few each year. We would also ask that appraisers consider asking about evidence of ADR reporting when addressing the sub-domain above during the appraisal process.

Sending a Yellow Card report using online reporting is quick and simple and makes a major contribution to improving the safety of medicines use in the UK.

Further information about what and how to report is available on the Yellow Card Centre Scotland website.

Some examples of the impact of reporting ADRs via the Yellow Card Scheme can be seen here.




This page was last updated on: 28/11/2017