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Regulation is needed for off-label drugs

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Prescribers must explain options to patients Prescribers must explain medication options to patients

The GMC is currently revising its guidelines, in part to enable health professionals to prescribe off-label or unlicensed medicines on the basis of cost. While the council is thought to have stepped back from its original proposal to abandon the need to inform patients of what is happening, it is still taking a step too far.

Recently, health secretary Andrew Lansley suggested patient groups sue trusts if people suffer adverse reactions after being prescribed an off-label or unlicensed medicine. However, it is not for patients to regulate the system; also, it does not acknowledge that sometimes, prescribers have no choice but to prescribe in this way.

When a licensed treatment for a condition exists, the patient does - and should - have a choice. Recent research shows this often is not offered, nor is information about side effects of off-label medicines provided.

Last year, the European Alliance for Access to Safe Medicines (EAASM) published When is a Medicine not a Medicine, citing examples of use of unlicensed or off-label medicines which put cost before patient safety. Together with other stakeholders, we issued a Consensus Statement.

This re-stated that medicines should only be used off-label or unlicensed in the case of unmet medical need. It called for authorities to establish a framework to research and publish the number of adverse events related to unlicensed or off-label use of medicines; introduce a professional Code of Practice to govern mandatory reporting of adverse events related to unlicensed or off-label use of medicines; improve awareness so that patients know when they are prescribed these medicines, consent to this, and know how to ensure adverse events are reported.

The EAASM is campaigning for an amendment to be included in the current review of the EU Pharmacovigilance Directive. Cost should not be the key consideration in any treatment choice. Medicines used off-label or unlicensed must be brought into at least as stringent a regulatory environment as licensed medicines.

Jim Thomson, chair, European Alliance for Access to Safe Medicines

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