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MHRA - spotlight on the decline in the number of Yellow Card reports

The Medicines and Healthcare products Regulatory Agency (MHRA) have announced that the number of reports of adverse drug reactions from healthcare professionals has declined after increasing for the previous 8 years.

Between 2009 and 2017, the number of reports the MHRA received from UK healthcare professionals doubled. However, in 2018, there was a significant decrease in reports from some healthcare professional groups.

It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported. Under-reporting coupled with a decline in reporting makes it especially important to report all suspicions of adverse drug reactions to the Yellow Card Scheme.

*The importance of ADR reporting cannot be overestimated. Research by the universities of Sheffield, Manchester and York concludes the following:
  • 66 million potentially clinically significant errors occur per year, 71% of these in primary care
  • Prescribing in primary care accounts for 33.9% of all potentially clinically significant errors
  • The estimated cost of avoidable ADRs are £98.5 million per year, consuming 181,626 bed-days, causing 712 deaths, and contributing to 1,708 deaths
  • Primary care ADRs leading to a hospital admission cost £83.7 million and causing 627 deaths
  • Secondary care ADRs leading to a longer hospital stay cost £14.8 million and caused 85 deaths and contributing to 1,081 deaths
[*Citation: Elliot RA, Camacho E, Campbell F, et al. Prevalence and economic burden of medication errors in the NHS England.]

Feature
Yellow Cards can be used for reporting suspected adverse drug reactions to medicines, vaccines, herbal or complementary products, whether for self-medication or prescribed. This includes suspected adverse drug reactions associated with misuse, overdose, or medication errors, or from use of unlicensed and off-label medicines.

The statistics show the decline by professional group::

Healthcare professional group Decrease in number of reports Decrease in 2018 compared with 2017
Hospital pharmacists –380 –11%
General practitioners (GPs) –280 –4%
Community pharmacists –226 –14%
Hospital doctors –161 –7%
Physicians –142 –46%
Nurses –122 –5%
Healthcare professionals in hospitals –53 –7%
What can healthcare professionals and their organisations do to raise awareness of the Yellow Card Scheme?
  • Download our animation and add it to the screens in your patients’ waiting area
  • Encourage dialogue regularly between your colleagues and patients, parents, and caregivers about the importance of reporting suspected adverse drug reactions to the Yellow Card Scheme and new Drug Safety Updates
  • Discuss suspected adverse drug reactions that you have reported and how you’ve kept up to date with emerging safety issues with Drug Safety Update in your professional re-validation, annual appraisals and for continuing professional development (CPD) purposes
  • Engage locally with your regional Yellow Card Centre or your local Medication Safety Officer (MSO) in England at your hospital trust
  • See the dedicated guidance on the Yellow Card Scheme for healthcare professionals including accredited CPD e-learning modules and downloadable materials to share on social media
  • Want to add the Yellow Card logo to supporting information on your website, intranet, e-mail signatures or screensavers? Get in touch with us.
Role of patients in reporting side effects and using the Yellow Card Scheme

The MHRA state that:
Patient reports, including those from parents and carers, now account for the highest reporting group compared to any specific group of healthcare professionals, for example compared to GPs or hospital pharmacists (see Figure 3 for a comparison).

Next time you are talking to your patients or even producing or providing health information for patients, remember to mention the potential for side effects and how to report them to the Yellow Card Scheme. Providing and discussing the Patient Information Leaflet that accompanies all licensed medicines forms an ideal basis for this discussion.

Every report counts, and a few minutes taken by you or your patient to report can make a lifetime of difference for others. Don’t delay, report today.

Article citation: Drug Safety Update volume 12, issue 10: May 2019: 4.

Sources
The Medicines and Healthcare products Regulatory Agency (MHRA)
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 22/05/19

MHRA information on ADR reports

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.