The serious birth defects caused by thalidomide in the 1960’s highlighted deficiencies in the way that new medicines were tested at the time and set in motion a series of changes to the regulation of medicines.
As part of this, the Yellow Card Scheme (YCS) was established in 1964 to ensure the routine monitoring of the safety of medicines was carried out by a body independent of the pharmaceutical industry. This role is performed by the UK medicines regulator, the MHRA.
The YCS is a way of monitoring the safety of medicines over the entire product life. It relies on the voluntary involvement of healthcare professionals and the public in submitting Yellow Card reports. Reports can be submitted in a variety of ways, many of which can be found on the Yellow Card website.
The YCS has helped identify numerous important safety issues on which the MHRA, as the regulator, takes action to minimise the risk and maximise the benefits of medicines to patients.
One of the drawbacks of YCS being a voluntary reporting system is that underreporting is a major problem. It is, therefore, crucial that everyone (healthcare professionals and patients) submit Yellow Card reports for all adverse drug reactions they come across.
Being a pharmacist, I was interested to note that in 2017, 29% of all suspected adverse drug reaction reports were submitted by pharmacists. While this is an increase on previous years there is still much more that pharmacists can do in identifying suspected adverse drug reactions, submitting Yellow Card reports and encouraging patients to submit reports.
Recently, The Royal Pharmaceutical Society and the ABPI Pharmacovigilance Expert Network worked together to produce a Quick Reference Guide and an Advice for Pharmacists document for pharmacists on the Yellow Card Scheme.
In developing these documents, I began to appreciate just how much value the MHRA places on every Yellow Card report it receives, each one of which can potentially prompt the MHRA to trigger an investigation into a reported safety issue.
In some cases, a small number of Yellow Card reports, taken together with other available information, can be sufficient to initiate an MHRA review.
So if you come across an adverse drug reaction in your working life, or as a patient, please take the time to report it – your single Yellow Card report could make all the difference to the safer use of medicines in future patient populations.
Dr Cable is a pharmacist with a PhD in Drug Delivery. Prior to commencing his PhD studies, Colin spent time in hospital pharmacy and in the pharmaceutical industry working in product development. On completion of his PhD, Colin joined the Royal Pharmaceutical Society (RPS) where he has remained ever since. He has had several roles in the RPS including a joint appointment with the RPS and the Western General Hospital in Edinburgh (2002-2008).
Currently Colin works as Assistant Chief Scientist at the RPS, a role which involves promoting pharmaceutical science, developing guidelines for pharmacists, promoting the pharmacy evidence base, responding to media enquiries and assisting in the development of RPS policy which is underpinned by pharmaceutical science.
Dr Cable was involved in the Handbook of Pharmaceutical Excipients from 1992 to 2017, initially as a member of the International Steering Committee and latterly as an editor. Colin was an honorary lecturer at Strathclyde University (2007 to 2011) and more recently has lectured pharmacy students as a visiting lecturer at King’s College London.