Health Service Focus

The importance of reporting adverse drug reactions

The MHRA has launched a new awareness campaign to ensure health professionals and the public are aware of the longrunning ‘Yellow Card’ scheme, which can act as an early warning system to report adverse reactions and side effects to drugs. NHE talked to Mick Foy, group manager at the MHRA’s Vigilance and Risk Management of Medicines division.

The Yellow Card scheme is nearly 50 years old, having been introduced in 1964 after the thalidomide scandal. The basic idea remains the same – a way for members of the public and health professionals to fl ag adverse drug reactions, and to provide new information on side effects.

Mick Foy, group manager at the MHRA’s Vigilance and Risk Management of Medicines division, admitted that public awareness is currently “quite low”, with estimations that only around 8% of people know of it. Awareness among health professionals is much higher, he said, but engagement with the scheme is not always as high as it should be.

The MHRA is trying to raise awareness and engagement with a fresh campaign, tailored to different groups.

Foy told us: “We’re planning a phased and sustainable campaign. In the past we’ve perhaps focused on one group and then stood back to see what happens.

“But now we’ve tried to come up with a strategy that’s a little more sustained. Patients and healthcare professionals hopefully will be hearing similar messages but in a different context over a longer period of time.

“The Yellow Card scheme is receiving as many if not more reports than we’ve ever received, but we recognise that levels of reporting are still quite low overall and under-reporting is a factor. Whilst we are getting 26,000 reports a year roughly – and last year’s figures were higher than the year before, with lots coming from the pharmaceutical industry – we want to get the message out that people should be reporting directly to the MHRA.

“That applies to certain groups, particularly general practice, since the numbers of reports coming from those groups has declined.”

2006 was the peak year for public reports into the scheme, at 3,584, but by 2012 the number stood at 1,789.

Foy said: “There’s a couple of reasons for the public decline: when we were getting numbers around the 3,000 mark, that was a time of high campaigning – we had posters in pharmacies and leaflets in GP surgeries and so on.”

He said 2006 and the years just after were a time of high public concern and interest in drugs issues, thanks to factors like the introduction of HPV vaccination for all 12 to 13-year-old girls in 2008, concerns over pandemic flu and so on.

The MHRA’s current priority with the scheme is to better integrate it with GP and hospital systems, and is trialling new ways of doing this with Cerner at a hospital in Newcastle.

Foy said: “We’re trying to facilitate Yellow Card reporting by giving them the functionality to send us a Yellow Card easily from the system the healthcare professionals are actually using.”

Foy suggested it would be optimistic to look at the declining trends in public and GP reporting and assume there are actually fewer adverse reactions and side effects occurring.

He said: “Medicines are always going to cause side effects. We’re interested in the new ones and the most serious etc.

“Members of the public are stimulated to report adverse drug reactions when there’s news coverage of a particular issue and they say ‘oh yes, I’ve experienced that’ and fill one of those forms in.

“That’s good because it embeds a reporting culture – they’ve reported once, hopefully they’ll remember it next time and know what to do.

“But it’s impossible to say really that there are fewer side effects happening.

“We say the same thing when we get more reports – it may be there are more people reporting, rather than more actual incidents of adverse drug reactions.”

Impact on the NHS

Adverse drug reactions are estimated to cost the NHS around £466m and account for 1 in 16 hospital bed admissions, and 4% of hospital bed capacity.

Foy said: “The impact on the NHS is remarkable: a lot of extended hospital stays, admissions to hospitals, and the drug tariff because you often treat a reaction with another treatment.”

Safety issues the Yellow Card scheme has helped identify

• Serious haemorrhages from bloodthinning drug dabigatran (Pradaxa) and the need to closely monitor kidney function
• Interaction between grapefruit juice and a particular brand of Amlodipine for blood pressure
• Seizures with the anti-smoking medicine Zyban when taken with other medicines
• Alopecia (hair loss) in women taking the Yasmin contraceptive pill

Widespread support for the campaign

Howard Duff, director of the Royal Pharmaceutical Society, said: “The Royal Pharmaceutical Society is proud to partner with the MHRA and the Yellow Card Scheme campaign to work towards safer medicines and more informed patients. The reporting of adverse events is a huge opportunity for pharmacists to take a lead in reducing adverse drug reactions, and I am sure our members will respond to this campaign.”

Mike Holden, chief executive of the National Pharmacy Association, said: “Community pharmacies are well placed to promote and support patient safety and discuss any adverse reactions patients are experiencing.” Mike Johnson, Marketing Manager at Rowlands Pharmacy, said: “The MHRA’s Yellow Card scheme campaign highlights that customers can use pharmacies to report their concerns about the medicines they are taking. The Yellow Card scheme helps identify potential safety factors that ultimately help to make taking medicines even safer.”

Dr June Raine, the MHRA’s director for the Risk Management and Vigilance of Medicines, said: “It’s vital that pharmacists, GPs and the public use the Yellow Card Scheme to report any suspected adverse drug reactions from their patients, in particular if it is a serious or previously unknown side-effect from a medicine or vaccine.

“We realise healthcare professionals have heavy workloads and we greatly appreciate their support for the Yellow Card Scheme. But we need them to use the scheme more frequently and report even when they are not sure a side-effect has been caused by a medicine. Identifying a new risk could have a major impact on the clinical management of patients.”