The Pharmaceutical Journal
Vol 268 No 7200 p781-786
1 June 2002

This article
Reprint
Photocopy

Branch Representatives' meeting summary

Call for better ADR reporting for unlicensed use of medicines

The meeting endorsed a motion that pharmacists should be encouraged to use the formal reporting system for adverse drug reactions for drugs that are unlicensed or being used outside their licence.

KATHRYN MARSH (British Pharmaceutical Students Association) said that drugs were often used without proper licensing approval in areas such as palliative care, oncology and paediatrics. In the absence of safety information obtained from clinical trials, a high rate of unforeseen ADRs might be expected.

Indeed, she added, a Derbyshire Children's Hospital pilot study had found a 3 per cent rate of adverse events for licensed medicines and a figure double that for unlicensed and off-label medicines.

The yellow card reporting scheme had been proved effective, but many people did not realise that it could be used for unlicensed or off-label drugs. A greater amount of information on adverse events to unlicensed medicines would allow a more rational use of these drugs and improve patient safety.

CATHERINE WALKER (BPSA), seconding, said that all patients deserved the right to medicines for which there was adequate data available to guarantee safety.

ANTHONY COX (Birmingham), who introduced himself as a regional adverse drug reaction pharmacist, said that more than half the drugs used in paediatrics were used in unlicensed ways. The yellow card scheme welcomed reports relating to unlicensed medicines or licensed products used in unlicensed indications. If people were failing to report such data, then they misunderstood the scheme.

The Medicines Control Agency had changed the ADR reporting criteria for children recently so that any suspected reaction, no matter how trivial, should be reported. This was purely because little information was available. Reporting by pharmacists was of high quality but was sadly in decline. Because pharmacists were the experts in medicines, a higher proportion of reports would be welcomed.

Dr ANDREW HERSOM (Hull) said that he applauded the spirit of the motion but felt that the word "drugs" was not specific enough. Herbal products, vitamins, etc, also had potential for adverse effects.