JUST over a half-century ago a 34-year-old research physician named Bill Inman left his job as medical adviser at ICI Pharmaceuticals to join the Department of Health. Britain was then waking up to the full extent of the thalidomide scandal. Thousands of babies had been born with deformed and missing limbs after their mothers had taken the drug, marketed to relieve nausea in pregnancy. A government committee on drug safety was formed to ensure such a disaster was never repeated. Its chair Sir Derrick Dunlop invited Bill Inman to develop an early warning procedure for adverse drug reactions.
Inman knew first-hand what it was like to live with disability. Just after finishing his pre-clinical studies at medical school – age 21 – he contracted polio and spent much of the next two years in an iron lung. Inman resumed his medical training on recovery but had to use a wheelchair for the rest of his life.
Joining the Department of Health in 1964 Inman was charged with developing a scheme that would adhere to key principles defined by Sir Derrick: spontaneity and speed, confidentiality and most importantly a commitment from healthcare professionals to report suspicions in the interest of protecting public health. Inman proposed supplying doctors and pharmacists with distinctive yellow postage-paid cards to report any side-effects occurring in newly licensed medicines. The Yellow Card scheme came fully into effect in 1970 and in the intervening years over 750,000 reports have been processed. Today the Yellow Card Scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Commission on Human Medicines. Most reports are now made online using the Yellow Card website or via FREEPOST cards found in the BNF, MIMS and ABPI compendium. The scheme has become a vital tool in monitoring the safety of all healthcare products in the UK. Yellow Cards can be used to report:
• suspected adverse drug reactions
• medical device incidents
• defective medicines
• suspected fake medicines.
Any medicine can cause side-effects or adverse drug reactions (ADRs). An ADR reported on a Yellow Card will be evaluated along with other sources of information such as clinical trial data, medical literature or data from other regulators. The reports are assessed by doctors, pharmacists and scientists, and the safety profile of the medicine is carefully evaluated including riskbenefit, as well as the side-effects of other medicines used to treat the same condition. Such investigations may result in safety alerts or other actions to protect public health.
Reports can be made for any medication either prescribed or over-the-counter, including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies. Most of the 25,000 ADR reports received each year are made by doctors, pharmacists or nurses but seven per cent come directly from patients and carers. Yellow Cards should be submitted for:
• ADRs that have caused death or a serious illness
• Any ADR, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary with a black triangle)
• Any ADR, however minor, if associated with a child (under 18 years of age) or in pregnancy.
Reports should not include personal information about patients which could be used to identify an individual (such as name or address) but the MHRA does require the age and gender of the person who experienced the suspected ADR in order to investigate contributing factors.
Yellow Cards are processed rapidly, according to tight timelines set out in legislation. Over the last five decades – despite its limitations – the system has established a proven track record in the identification of previously unrecognised safety hazards.
Only recently the Yellow Card scheme was extended to cover medical device adverse incidents. Such incidents could involve anything from contact lenses to condoms, heart valves to hospital beds, resuscitators, radiotherapy machines, surgical instruments, syringes, wheelchairs or walking frames. An ADR involving a medical device could, for example, include faulty brakes on a wheelchair or a batch of test strips for a blood glucose meter giving incorrect readings. Reports are made in the same way as for medications.
GPs are central to the success of the Yellow Card Scheme and it is part of a doctor’s routine duty of care to ensure they report ADRs. In its guidance Good practice in prescribing and managing medicines and devices the GMC reminds doctors that they “must” report such adverse incidents. The guidance states: “Early, routine reporting of adverse reactions, incidents and near misses involving medicines and devices can allow performance and systems issues to be investigated, problems rectified and lessons learned. You must make reports in accordance with your employer or contracting body’s local clinical governance procedures.”
Jim Killgore is publications editor at MDDUS
Making a report under the Yellow Card Scheme
There are two ways to report to the Yellow Card Scheme:
- The easiest way to report is online at www.yellowcard.mhra.gov.uk
- Complete a paper Yellow Card form which you can post to FREEPOST YELLOW CARD.
Yellow Cards can be found in the BNF, MIMS, ABPI Compendium or ordered by calling the Yellow Card Information Service freephone on 0800 731 6789