The thalidomide tragedy stimulated schemes worldwide to detect emerging problems with medicines that went undetected in clinical studies. Since 1964, the UK’s Yellow Card Scheme has received more than 800,000 reports of suspected Adverse Drug Reactions (ADRs). During 2015 alone, the Medicines and Healthcare products Regulatory Agency (MHRA) received nearly 40,000 suspected ADR reports on Yellow Cards.1 The scheme now also includes adverse incidents related to medical devices, counterfeit and defective medicines, and safety concerns associated with e-cigarettes.1 But there is a pressing need to increase the quality and quantity of Yellow Card reports — and nurses can help.
Over the years, the Yellow Card Scheme helped identify numerous safety concerns. For instance, based partly on Yellow Card data, the MHRA highlighted the increased risk of tuberculosis in patients taking tumour necrosis alpha inhibitors. The MHRA advised pretreatment screening for Mycobacterium tuberculosis and close monitoring for the infection during treatment. Based on Yellow Cards, the MHRA warned that patients taking warfarin should limit
or avoid drinking cranberry juice and that St John’s wort potentially reduces the efficacy of concurrent hormonal contraceptives.1
Nevertheless, under-reporting remains a big problem. For example, the British Journal of Clinical Pharmacology2 recently highlighted the dearth of Yellow Card reports for paternal, transmammary and transplacental ADRs in children less than two years of age. Moreover, important data is often missing. About one in seven (14.5%) Yellow Cards did not include the outcome, while less than one in 100 (0.8%) included the gestational age at birth. Vaccines made up 76% of the ADRs reported on Yellow Cards. The authors comment that: ‘With the exception of vaccinations, spontaneous reports alone are not currently generating the data required’.2
So, what can be done? Nurses are central to the success of the Yellow Card scheme: doctors completed 41% of Yellow Cards that covered suspected ADRs in children less than two years of age. Nurses completed 31%.2 You can stay up to date with the monthly Drug Safety Update (www.gov.uk/drug-safety-update) and the MHRA recently introduced a Yellow Card app, which is free to download from iTunes or the Google Play Store, to receive news and alerts for particular medicines as well as report suspected side effects. But, fundamentally healthcare professionals and patients need to submit more Yellow Cards. After all, when was the last time you filed a Yellow Card?
Mark Greener is a freelance medical writer
1. Greener M. Adverse drug reactions: Prescribing’s twilight zone. Prescriber. 2017; 28(1):27–31
2. Hawcutt DB, Russell N-J, Maqsood H et al. Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: Content and utility analysis. Br J Clin Pharmacol. 2016; 82(6):1601–12