The national system to collect reports of adverse drug reactions was devised in 1964 following the thalidomide disaster. This enabled doctors, dentists and coroners to send in reports of suspected adverse reactions to licensed drugs taken at the recommended dosage on postage-prepaid yellow cards.
Since the Yellow Card Scheme launched, the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Commission on Human Medicine (CHM) have collected over 500,000 forms, enabling them to evaluate the extent of reported problems and identify culpable drugs.
Prescription medicines, herbal remedies, OTC medicines, vaccines, blood products, medical devices and appliances are all included. All healthcare professionals can report, and patients are being encouraged to fill in a recently introduced, simple online form.
Reporting rate fall
A recent fall in the reporting rate suggests that much more needs to be done to ensure both the paper and online forms are used. While over 70 per cent of reports come from GPs, they should ensure that all healthcare staff are trained to complete forms when appropriate.
Posters available from the MHRA should be displayed in surgeries to encourage patients to report side-effects.
What to report
Any suspected reaction should be reported even if its causality is uncertain.
Answering questions on the yellow card form will reveal concurrent illness or other medication possibly contributing to the symptoms. All this information is useful in determining the safety of a drug under different conditions.
For instance, an adverse effect may only manifest itself as a drug interaction, or when the drug is used in a larger population. Or it may be delayed several years.
By reporting serious reactions the scale of the problem can be seen, and comparisons can be made of the incidence of reported side-effects in different drugs of the same group.
For example, yellow card data helped to establish that ibuprofen is the NSAID associated with the lowest incidence of GI bleeding while azapropazone has the highest incidence.
Renal impairment with ACE inhibitors was similarly established, as was the relative incidence of side-effects using different beta-blockers.
Reports are acknowledged with a reference number and you can ask details of previous reports.
If a specific problem is identified, the MHRA/CHM may: circulate warnings to doctors and pharmacists; publish their findings on the MHRA website or advise withdrawal of drugs from the market. They can also amend product licences or prescription status or request changes to the summary of product characteristics.
The system has been criticised on the grounds that side-effects may be wrongly labelled and could be entered under different headings.
For example parasuicide could be reported as 'non-accidental overdose'. This could lead to underestimating the frequency of an adverse reaction as in the recent case of certain antidepressants.
Also patients maybe concomitantly taking OTC medication which is unrecorded and could be implicated.
Action by GPs
The reporting rate has fluctuated over the years, and the recent fall in reports suggests that much more needs to be done.
While GPs are by far the most frequent yellow card users, they should ensure that forms and information is readily available for their staff, and should encourage patients to report themselves.
Connecting for Health could play a major role in capturing both primary and secondary care data for this purpose. Equally important for pharmacovigilance is information from other countries, to help fill the large gaps in our knowledge about the safety of drugs.
Dr Bainbridge is treasurer of the Dispensing Doctors' Association
What should be reported
- Any serious reactions that are life-threatening or resulted in death, disability or prolonged hospitalisation.
- All unusual or serious reactions to older, well-established drugs and to any vaccines.
- All suspected adverse drug reactions in children.
- All suspected side-effects with herbal products, drugs new to the UK market or in new formulations marked with a black triangle in MIMS, the Electronic Medicines Compendium (eMC), or listed on www.mhra.gov.uk
- Find the Yellow Card form at the back of MIMS or go to the MHRA website via www.yellowcard.gov.uk.