To London, to celebrate 50 years of the Yellow Card scheme. The scheme, which was started by the erstwhile Committee on Safety of Drugs (CSD), and is now run by the Medicines and Healthcare products Regulatory Agency (MHRA), allows health professionals and patients to report suspected adverse drug reactions to medicines, either manually, on a yellow coloured card, or online.
I am medically of age with the Yellow Cards, having entered medical school in 1964. The first handout we received at the start of materia medica (i.e. clinical pharmacology) was a “yellow peril,” the fourth in the CSD’s “Adverse Reactions Series,” an A4 sheet of paper from which we learned that chloramphenicol caused agranulocytosis and should not be used except in Haemophilus influenzae meningitis and typhoid. I became fascinated by therapeutics and pharmacovigilance.
Over the years I have watched the Yellow Card scheme grow and mature, and it was an honour to be invited to take part (with about 80 others) in a one day symposium on the future of the scheme—one event in the 50th anniversary celebrations.
Each of the four sessions included three talks, questions and answers, and round table discussions.
1. Should Yellow Card reporting be statutorily mandated? The virtually unanimous view was that it should not, although the General Medical Council’s Good Practice guidance states that doctors “must inform the MHRA about serious suspected adverse reactions to all medicines and all reactions to [Black Triangle] products,” which, given the gloss that “must” implies “an overriding duty or principle,” suggests that they think it should.
2. How to improve reporting? Suggested incentives and reminders included making Yellow Card reporting part of appraisal and revalidation, adding it to the Quality and Outcomes Framework (QOF), offering prizes and awards, putting the Yellow Card logo on prescription forms, and praising contributions by feedback. Feedback methods included journal articles (perhaps “Yellow Card of the Week” in The BMJ?), and the use of social media and apps. Education was considered vital, and the roles of clinical pharmacologists and clinical pharmacists, working in tandem where possible, were stressed. Everyone agreed that reporting should be simplified.
3. How to use the data? Suggestions included analysis by time of onset of the reaction and searching susceptibility markers, such as age and genetic variants. It wasn’t clear what proportion of all adverse events ought to be reported in an ideal system, but under 10%—the current rate—is clearly unacceptable.
4. The role of patients. Patient reporting has proved highly successful. Everything should be done to encourage it.
Since many different groups are paying increasing attention to patient safety (i.e. avoiding unsafety), communication across the groups is essential. The Yellow Card scheme could act as a focus for the activities of the disparate groups. Perhaps a single body should have oversight of it all?
The first minister of state for life sciences, in his keynote address, launched a new simplified electronic reporting scheme. The MHRA also joined the Sign up to Safety campaign, to play its part in reducing avoidable harms in the NHS.
The meeting was run by June Raine with military efficiency. The proceedings were recorded. Rapporteurs took notes. A report will eventually appear.
So, happy birthday, Yellow Cards! Here’s to the next 50 years.
Jeffrey Aronson is a clinical pharmacologist, working in the Centre for Evidence Based Medicine in Oxford’s Nuffield Department of Primary Care Health Sciences, and president emeritus of the British Pharmacological Society.
Competing interests: Jeffrey is the editor of several books dealing with adverse drug reactions, including Meyler’s Side Effects of Drugs: the International Encyclopedia of Adverse Drug Reactions and Interactions and (with John Talbot) Stephens’ Detection and Evaluation of Adverse Drug Reactions: Principles and Practice.