Operating across the UK, the Yellow Card Scheme (YCS) was established in 1964 following the thalidomide tragedy as part of a newly introduced system that monitored the safety of medicines by a body independent of the pharmaceutical industry. Today, it is run by the Medicines and Healthcare products Regulatory Agency (MHRA). The YCS was set up to collect, collate and investigate reports of suspected adverse drug reactions.
The YCS allows the MHRA to monitor the safety of all medicines and medical devices continuously over the entire product life. Through input from pharmacists, other healthcare professionals (HCPs) and the public, the YCS acts as an early warning system for the identification of previously unrecognised or suspected adverse drug reactions (ADRs) and enables the identification and refinement of risk factors that may affect the clinical management of patients. Since its inception, Yellow Card reporting has helped to identify numerous important safety issues.
Anyone can report via the Yellow Card website. You can also report suspected ADRs to medicines via:
- the free Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems (SystmOne®/Vision™/MiDatabank®)
- freephone: 0800 731 6789 (10am to 2pm Monday-Friday)
- forms in the British National Formulary (BNF), BNF for Children, MIMS, or Proprietary Association of Great Britain (PAGB) OTC Directory
- downloading forms from the Yellow Card website and sending them freepost to ‘Yellow Card’
- email to [email protected]
All medicines are covered by the YCS. Suspected ADRs that are associated with misuse, overdose, medication errors, unlicensed and off-label medicines use, defective medicines and suspected fake medicines are also reportable. For biologicals (including biosimilar medicines and vaccines) ADR reports should clearly state the brand name and the batch number of the suspected medicine. The YCS also covers radiographic contrast media, herbal medicines or homeopathic remedies, and medical devices used in healthcare for diagnosis, prevention, monitoring or treatment of illness or disability, as well as, safety concerns associated with e-cigarette products and their refills.
The reporting of suspected ADRs is voluntary. However, reporting is supported within the codes of practice of all HCPs, by their associations and their regulators; the Royal Pharmaceutical Society encourages, as a matter of best practice, the reporting of suspected ADRs under the YCS.
Underreporting is a common problem for all spontaneous ADR reporting schemes, such as the UK’s YCS. Pharmacists are in a unique position to identify and report suspected ADRs. Pharmacists are also well placed to inform the public about the YCS and can encourage patients to report all possible side effects that they may have experienced with medicines. Pharmacists have a professional responsibility to advise patients and carers on the reporting of any suspected side effects associated with their medicines, including vaccines and medicines available without a prescription, herbal medicines and complementary remedies.
The MHRA is are keen to encourage more Yellow Card reporting from pharmacists, who, in 2017, made up 29% of all suspected ADR reports received directly from HCPs. Every Yellow Card report is important as it can take very few reports to trigger action by the MHRA into a medicines safety issue.
As a minimum, a YCS report must include four pieces of information: 1) details about the patient, 2) the drug(s)/vaccine(s), 3) the adverse drug reaction they experienced, and, 4) details of the individual completing the report.
The MHRA encourages pharmacists, other HCPs and the public to report all suspected adverse drug reactions that are:
- associated with newer drugs and vaccines that are under additional monitoring i.e. those that display a black triangle (▼) in their Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC).
- serious, medically significant or result in harm (for established medicines, even if the ADR is well recognised).
Only a suspicion is needed to submit a Yellow Card report. If there is any doubt about whether to report a suspected ADR, a Yellow Card should be completed.
Any information provided to the YCS is kept safe, secure and confidential. The report will be entered into the MHRA’s safety database and analysed alongside reports from the pharmaceutical company and other information available worldwide. Where appropriate, the MHRA takes action to minimise risk and maximise benefit to patients which can include; changes or warnings in the product information or packaging; changes on how the medicine should be used; changes to the dose of the medicine; restricting the indications for use of a medicine; changes to the legal status of a medicine; removal of the medicine from the market.
Recognised effects can be found within the product information produced by pharmaceutical companies such as the SmPC and PIL supplied within a medicines packaging. The MHRA provides information about suspected ADRs received via the YCS through interactive Drug Analysis Profiles (iDAPs) which can be accessed from the YCS reporting website. The MHRA also produces a monthly bulletin called Drug Safety Update which includes the latest emerging news about medicines, including suspected ADRs.