The Yellow Card scheme – improving medicine safety

I’ve recently had the pleasure of acting as RPS spokesperson for the MHRA Yellow Card Scheme, which acts as an early warning system for the identification of previously unrecognised drug reactions.

Before a medicine is granted a licence so that it can be made available in the UK, it must pass strict tests and checks to ensure that it is acceptably safe and effective. However, all medicines can cause side effects. Some may be mild, while others can be very serious. Some side effects may not yet be known which is why it’s important for people to report to the Yellow Card Scheme. Adverse Drug Reactions have a major impact on public health. The cost to the NHS through hospital admissions is estimated by MHRA to be £466 million.

Community Pharmacists are well placed to make a major contribution to the reporting and reduction of Adverse Drug Reactions. They have an important role in managing the patient pathway through their unique interaction with patients, providing expert advice on safe use of medicines and in identifying and advising on potential side effects. Pharmacists can help promote patient safety by informing patients about the Yellow Card Scheme and encouraging them to report directly as well as reporting ADRs themselves.

 It is particularly important to report reactions that:  

  • Are Serious
  • Are Not mentioned in the Patient Information Leaflet (PIL) or Summary of medicinal Products Characteristics (SmPC)
  • Related to medicines under additional monitoring (▼)
  • to herbal, homeopathic and complementary remedies (not sure we want to put these in)
  • occur in children or the elderly

 Even if you’re not sure a side effect was caused by a medicine, you should report it anyway.

 Yellow Card reports are evaluated alongside other information and evidence on medicine safety to determine whether any regulatory action is required to allow medicines to be used more safely and effectively. This can include restrictions in use, reclassification, refinement of dose instructions or the introduction of specific warnings of side-effects in product information.

If you are a patient and worried about a symptom that you think may be a side effect:

  1. Check the Patient Information Leaflet (PIL) supplied with the medicine. This lists the known side effects and advises you what to do.
  2. Talk to your doctor or pharmacist.
  3. Tell MHRA about your experience by reporting it to the Yellow Card Scheme.

The easiest and quickest way to report ADRs online is at http://www.mhra.gov.uk/yellowcard.  Yellow Card forms are available in the BNF, MIMS or by contacting the MHRA (e-mailing pharmacovigilance@mhra.gsi.gov.uk), or by telephoning: 0800 731 6789.

If you are a pharmacist, we recommend you check out this learning module which has been developed by MHRA and CPPE for pharmacists to find out more and this can also contribute to your continuing professional development. http://www.cppe.ac.uk/