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Medicines watchdog launches campaign to urge pharmacists, GPs and the public to report side-effects through vital drug safety warning system

1 February 2013

 
 
Medicines and Healthcare products Regulatory Agency (MHRA)

Press release

The Medicines and Healthcare products Regulatory Agency (MHRA) is today launching a public health campaign in partnership with pharmacy organisations to highlight the need for the public to report any suspected side effects from medicines through the Yellow Card Scheme.

The Yellow Card Scheme – was introduced in 1964 following the Thalidomide tragedy and has proved to be a successful system for the early detection of emerging safety issues with medicines. It acts as an early warning system for identifying previously unrecognised adverse drug reactions, but also provides valuable information on recognised side effects. This allows the MHRA to identify and refine understanding of potential safety issues that may affect the treatment of patients. It is used to update prescribing advice for health professionals.

Healthcare professionals and the public can report side effects on a voluntary basis and there is a legal obligation for pharmaceutical companies to do so. While the MHRA appreciates the ongoing support of GPs, pharmacists and the public for the scheme, figures show that reports from members of the public have declined from a high of 3,584 in 2006 to 1,789 in 2012. GP reporting has fallen steadily over a nine-year period from 5,578 in 2003 to 3,511 in 2012.

The MHRA’s campaign to raise awareness of the Yellow Card Scheme aims to ensure health professionals recognise the importance of reporting adverse reactions and to increase public awareness of the scheme. It has been developed with and supported by the National Pharmacy Association, the Royal Pharmaceutical Society, the Company Chemist Association, the Association of Independent Pharmacies and Royal College of GPs.

Yellow Cards are being distributed to pharmacies and materials to help health professionals to recognise the importance of reporting adverse reactions using the Yellow Card Scheme are being rolled out throughout February.  A promotional video to encourage the public to report adverse drug reactions to the MHRA is also being shown in 339 Rowlands pharmacies across the UK.


“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."

Dr June Raine MHRA’s Director for the Risk Management and Vigilance of Medicines

The value of the Yellow Card scheme has been demonstrated many times and it has helped to identify numerous important low-risk safety issues over the years, including:

  • Serious haemorrhages from blood-thinning 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.

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.

“Patients and the public can also give a different and extremely useful insight into suspected side-effects and we are very keen to receive Yellow Cards directly from them too. Our promotional video shows that Yellow Cards can be submitted easily by patients and healthcare professionals through the website at www.mhra.gov.uk/yellowcard

Dr Hilary Jones, television doctor, said:

“GPs, pharmacists and other healthcare professionals are in a unique position to report suspected adverse drug reactions through the Yellow Card Scheme because they are often the first healthcare professional a patient comes into contact with.

“I support the MHRA’s Yellow Card Scheme and I want to see GPs and other healthcare professionals using it and encouraging their patients to use it.”

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.”

Notes to Editor

  1. Spokespeople are available for interview bids, please contact the MHRA press office on 020 3080 7651 07770 446 189 (out of hours) or email press.office@mhra.gsi.gov.uk

  2. The promotional video that is being shown at 339 Rowlands pharmacy shops can be viewed here: Yellow Card video (Link to YouTube)

  3. Adverse drug reactions place a significant burden on the NHS estimated to be as much as £466 million through hospital admissions. Studies have shown that adverse drug reactions account for 1 in 16 hospital admissions, and for 4% of hospital bed capacity.  (ref: Pirmohamed M et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 329;15-19)

  4. The MHRA collects adverse drug reaction reports through the Yellow Card Scheme in the UK from unlicensed and licensed medicines including: prescription medicines; vaccines; over the counter medicines; herbal and other complementary remedies;

  5. The number of reports received via the Yellow Card Scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons, as this scheme is associated with an unknown and variable level of under-reporting.  ADR reporting rates may be influenced by the seriousness of reactions, their ease of recognition, extent of use of a particular drug and promotion and publicity about a drug.
      
  6. It is important to note that a report of an adverse drug reaction does not necessarily mean that it was caused by the drug. Other factors such as the underlying disease or other medicines may contribute to suspected adverse reactions.   

  7. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk


Contacts

Press Office: +44 20 3080 7651
e-mail: press.office@mhra.gsi.gov.uk
Out-of-hours: +44 7770 446 189


Further information