NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Why should I report to the Yellow Card scheme?

Yellow Card Scotland has provided a summary of the importance and relevance to practice of reporting adverse drug reactions (ADRs) via the Yellow Card scheme.

KEY POINTS

  • As little as 2 or 3 reports of an ADR can generate a safety signal, so every report counts
  • Outcomes from safety reviews may include restrictions on use of a product or updates to product information
  • Risks identified via a Yellow Card are communicated via the MHRA Drug Safety Updates
  • Report an ADR to the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the App (visit the App store or Google play)

The value of the Yellow Card Scheme, the national system for reporting ADRs, has been demonstrated many times, and it has helped to identify numerous important safety issues, many of which were not recognised as being related to a particular medicine until we received information from Yellow Cards (see examples below).

Signal Detection

A safety signal may be generated from as little as 2 or 3 reports of an ADR. Each signal generated is investigated further by the MHRA. An impact analysis is undertaken considering the strength of the evidence and the seriousness of the ADR to prioritise the most urgent safety issues. Resulting actions may include updates to the product information, communication of risk in the Drug Safety Update or even restrictions on the use of the product. So please remember that every report counts, when you can, submit a Yellow Card report to contribute to the safer use of medicines.

Yellow Cards lead to changes in practice

Examples to show the impact of Yellow Card reporting are presented below:

Nexplanon®

What did you report?

Migration of the implant within the arm from the insertion site. Some reports included implants located within the vessels of the arm and the pulmonary artery.

What did we do?

These reports led to updated advice via the Drug Safety Update in June 2016 on correct insertion of the implant, including an amended diagram demonstrating the correct angle for insertion.

Gabapentin

What did you report? 

Respiratory depression with gabapentin, even without concomitant use of opioids. In the UK, there have been 50 Yellow Card reports of respiratory depression or dyspnoea associated with gabapentin between 19 February 1996 and 1 September 2017. Of these cases, 17 report opioids as co-suspect or concomitant medications.

What did we do?

This led to a European review of gabapentin. The review considered these reports along with other evidence, and the product information for gabapentin was amended to include warnings for severe respiratory depression. Dose adjustments may be necessary in patients considered to be at risk of respiratory depression.

Warfarin and miconazole oral gel

What did you report? 

The interaction between miconazole oral gel and warfarin is well established, but continues to be a problem. As of early 2018, there have been a total of 175 reports of this interaction, and 25 of these have been since a Drug Safety Update article on the topic in June 2016. The most common events reported have been:

  • increased INR (135 reports)
  • contusion (23 reports)
  • haematuria (19 reports)
  • fatal outcome (3 cases).

What did we do?

  • The prescribing information for over-the-counter (OTC) miconazole gel changed and is now contraindicated in patients taking warfarin.
  • There are also more prominent and explicit warnings within the patient information leaflet, the SPC and on the packaging of OTC miconazole oral gel.

Further examples of safety issues in which Yellow Card reporting has contributed, can be found here.

For information on training packages including e-learning modules, go to: http://www.yccscotland.scot.nhs.uk/Training/Pages/default.aspx

Sign up to the Drug Safety Update here: https://www.gov.uk/drug-safety-update/email-signup

 

Published 20/11/2018