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Focus on reporting to the MHRA’s yellow card scheme

21 March 2019

In this edition we have teamed up with the Medicines and Healthcare products Regulatory Agency (MHRA) to provide information about the Yellow Card Scheme and highlight the essential role the whole pharmacy team plays in reporting any suspected adverse drug reactions (ADR) to the scheme online or via the free app, and encouraging others to do the same.

What is the yellow card scheme?

The Yellow Card Scheme is an early warning system for the identification of previously unrecognised ADRs and enables the MHRA to identify risk factors, outcomes of the ADR and other issues that may affect clinical management; including the safer use of medicines to protect patients from avoidable harm. The value of the Scheme has been demonstrated many times and has helped identify numerous safety issues.

As a pharmacy professional you and your team are in a unique position to support patients by providing expert advice on the safe use of medicines, and to help prevent, identify and report suspected ADRs to the Yellow Card Scheme. You are also a key link to encourage patients, parents and carers to report any suspected side effects to medicines themselves.

There are clear expectations on professionals and pharmacy owners to report to the Yellow Card scheme. Our standards for pharmacy professionals say that professionals must speak up when they have concerns, and our standards for registered pharmacies state that we expect ‘concerns are raised when it is suspected that medicines or medical devices are not fit for purpose’.

 

 

MHRA figures

The MHRA’s statistics show that in the UK, 88% of pharmacists mention the Yellow Card Scheme as the place to report a suspected ADR. However, there is an unknown and variable level of under-reporting. 

In 2018, the pharmacy team accounted for 28% of all suspected ADR reports submitted to the Yellow Card Scheme by healthcare professionals. Yet last year, there was an overall 9% decrease in the reporting of suspected ADRs from the pharmacy sector compared to the previous year. This decrease in reporting was seen mainly from community, hospital and pre-registrant pharmacists as shown in the graph above (reporter qualifications are as reported on the Yellow Card).

The MHRA is looking to reverse this trend and we want to encourage the entire pharmacy team to report suspected ADRs to the Yellow Card Scheme.

Please report all suspected adverse drug reactions that are:

  • serious, medically significant or result in harm. Serious events are fatal, life-threatening, a congenital abnormality, disabling or incapacitating, or resulting in hospitalisation
  • associated with newer drugs and vaccines

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristic. The most up-to-date list of black triangle medicines is available at: www.mhra.gov.uk/blacktriangle

If you are in doubt whether to report a suspected adverse drug reaction, please complete a Yellow Card either online or via the app.

Support and resources to help encourage reporting