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Patients 'at risk' by weak control systems for reducing side-effects

18 April, 2001

The 'Yellow-Card' strategy to encourage health professionals report any suspected adverse reaction to 'new' drugs is failing and likely to put patients at risk, according to Drug and Therapeutics Bulletin (DTB). 

DTB also believes that the regulatory arrangements for the scheme, implemented by the Medicines Control Agency (MCA), need an urgent review.

Products are placed under black-triangle surveillance if they contain a new active substance not previously licensed for use in the UK. This involves including a black triangle on the Summary of Product Characteristics (SPC), a legal document which provides advice about the drug, including its unwanted effects and how these might be avoided.

Alongside this, the MCA and the Committee on Safety of Medicines run a scheme which encourages health professionals to use a Yellow Card to report any suspected adverse reaction for a black triangle drug.

In a survey of listed black triangle drugs, it was found that around a quarter of the SPCs accompanying these drugs did not display the expected black triangle. DTB also found that advice offered in the SPCs on avoiding unwanted effects in patients was often inconsistent, unclear and unhelpful. This therefore meant that adverse effects may be going unreported.

DTB asked individual companies for copies of printed SPCs for black-triangle medicines. Of the 163 SPCs obtained this way, 44 (27 per cent) did not display a black triangle.

Joe Collier, Editor of Drug and Therapeutics Bulletin said:

"Of particular concern in our survey findings is the weakness of the advice in the SPCs. While the information for prescribers can never be enough to cover all eventualities, it should be sufficient to offer workable and consistent advice for example to allow specialists and GPs to work together in managing risk.

"In this respect, SPCs often fail. The current arrangements need urgent review."