TaylorWessingEmployed to monitor the safety of medicines in clinical use, the Yellow Card Scheme has played a pivotal role in public health protection in the UK. Last year the scheme celebrated its 50th anniversary after being established in 1964, following the thalidomide disaster, to provide an early warning of possible hazards through the collection and monitoring of suspected adverse drug reactions (ADRs). To coincide with its 50th anniversary, last year a new single reporting website was launched to support increased reporting and awareness, as the Yellow Card Scheme was extended to include devices, counterfeits and defective medicines. Georgia Powell, Associate at BIA member Taylor Wessing, outlines the basics of the scheme below.

The Yellow Card Scheme is the UK system for monitoring the safety of healthcare products to ensure that they are acceptably safe for use by patients.  The Scheme was introduced in 1964 following the thalidomide disaster, and is run by the Commission on Human Medicines (CHM) and the Medicines and Healthcare Products Regulatory Agency (MHRA). A similar system, the “Black Triangle Scheme”, was introduced by the European Medicines Agency in Autumn 2013 in order to monitor medicines marketed in EU countries.

Reports to the Yellow Card Scheme can be made for all medicines – including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies – and medical devices available on the UK market.  The MHRA encourages health professionals, patients and carers to submit Yellow Card reports, alongside pharmaceutical companies who are subject to pharmacovigilance obligations, which require them to pass on reports that they receive about suspected side effects of their products.

The Scheme collects information on a range of suspected issues and problems, including adverse drug reactions (ADR) and side effects, medical device adverse incidents, defective medicines, and counterfeit and fake healthcare products.

Side effects and ADR

The MHRA encourages the reporting of all serious suspected ADR for established vaccines and medicines to the Yellow Card Scheme.  These products are labelled with an inverted black triangle symbol, to ensure that prescribers are aware of the need to monitor them carefully.

The Yellow Card Scheme acts as an early warning system for identifying previously unrecognised ADR, and as an important source of information on side effects.  Data from the reports are subjected to statistical analysis to identify drug-reaction combinations that meet defined criteria, which are then are assessed by a team of physicians, pharmacists and scientists to investigate the causal relationship and other possible risk factors. If an ADR is confirmed, the MHRA may require steps to be taken to minimise the risk and publicise the new information, for example by restricting the product indications, reducing the recommended doses, changing the duration of treatment, or by adding special warnings and precautions to the product literature.  In rare circumstances, a medicine may be withdrawn from the market if its risks are considered to outweigh its benefits. The MHRA also strives to alert clinicians and secondary information providers (such as the British National Formulary and clinical software suppliers) of new information on adverse reactions.

Medical device adverse incidents

The MHRA collects information on all adverse incidents involving the use of medical devices in the UK. This may include injuries caused by medical device failure or misuse, as well as wrong or delayed diagnoses or treatment of patients. Reports to the Scheme may result in an investigation being undertaken directly by the MHRA, or by the manufacturer on the Agency’s behalf.

Defective medicines

Yellow Card reports on quality issues with medicines are submitted to the Defective Medicines Report Centre.  If a defective medicine is considered to present a risk to public health, the company or manufacturer may be required to recall affected batches or – in the most serious cases – all batches from the market.  A drug alert notification may be issued to healthcare professionals, and other regulators and countries may be notified of a recall through the issue of a Rapid Alert notification.

Counterfeit or fake healthcare products

Reports of counterfeit or fake medicines or medical devices on the UK market are investigated in accordance with the Human Medicines Regulations 2012 and Consumer Protection Act 1987, and associated legislation.  The MHRA has powers to enter business and private property to seize suspected counterfeits, and can work with manufacturers to resolve potential issues and problems. Where necessary, the MHRA can also take formal enforcement action against individuals and organisations, which may result in civil injunctions, fines and often imprisonment.

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