Following the seventh global Medicines Safety Week, Phil Tregunno from the Medicines and Healthcare products Regulatory Agency (MHRA) discusses the importance of reporting patient harm from medicines and devices, even if it’s only suspected, and the ways you can help
Raising awareness of the MHRA’s Yellow Card scheme – the system that collects information on suspected adverse drug reactions to medicines – with patients is critical. And we know that you, as their GP, are crucial in helping us to inform them.
When a patient contacts you to discuss any unexpected reactions, we recognise that you are uniquely placed to signpost them to our app, website, or phone number as you consider their symptoms and determine whether the medication is the cause of their reaction.
It is also critical that we make reporting as easy as possible for you. Over the past two years, we’ve taken steps to integrate the reporting of adverse effects for medicines directly into your GP systems, with SystmOne, EMIS and Vision all supporting this function. And we are continuing to work on making reporting on all channels smoother, faster and more intuitive.
Why do reports matter?
Reports help us to monitor the safety of healthcare products once they are on the market. They have already helped us to identify numerous safety issues.
For example, a concerned about a potential interaction in a patient between HIV therapy cobicistat (prescribed by a GUM clinic) and an inhaler containing the corticosteroid fluticasone (prescribed by a GP) led to reviews at both national and European level.
These resulted in strengthened warnings about possible systemic corticosteroid adverse effects, including adrenal insufficiency, suppression or Cushing’s syndrome if a corticosteroid is co-administered with a HIV-treatment-boosting agent.
It is key to discuss the importance of reading the patient information leaflet with your patients and advise them on what to do if they experience problems with a healthcare product (they should talk to a healthcare professional and report the issue to us).
What should I report?
When it comes to Yellow Card reports, we need as much information as possible. Product brand names, batch numbers for vaccines and biologicals, medical history, concomitant medications, treatment dates, onset timing and duration all help us determine what factors are at play.
It is not just reactions involving prescribed medicines that need to be reported – you can also report suspected defective or fake medicines, adverse reactions to herbal or homeopathic medicines, any problems with medical devices (including apps, software and artificial intelligence) and even e-cigarettes and their refill liquids. If you have a suspicion, then reporting is key.
You can do this quickly and easily through any EMIS, SystmOne and Vision system or by using the Yellow Card app or website. Alternatively, you can signpost your patient to the app, website or freephone number so that they can report themselves.
For those medicines that have a black triangle symbol (▼), it is vitally important that you report all suspected adverse drug reactions if you think they may have occurred. With the Commission on Human Medicines (CHM), we intensively monitor the safety of all these products.
However, we are encouraging everyone to be vigilant about suspected adverse reactions to any health product, especially new, serious or rare reactions or those that may have a delayed onset, and report to us as soon as possible.
We can help
We’d encourage you to sign up to receive our drug safety updates or download the app from the Google Play Store or Apple App Store to get them directly to your phone so you can stay up to date with the latest in medicines and devices safety information.
Without accurate, timely data, monitoring is always going to be less effective. Every time you submit a report or support your patient to do so, you are helping to improve the safety of these products.
Phil Tregunno is deputy director of patient safety monitoring at the MHRA