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UK's ABPI rejects GMC off-label suggestions

The ABPI has responded to the GMC's consultation on prescribing off-label drugs

Prescribing off-label drugs when a licensed alternative exists increases risks to patients and threatens the development of new medicines, the Association of the British Pharmaceutical Industry (ABPI) has said in response to the General Medical Council's (GMC) consultation on the matter.

The GMC is proposing to allow doctors to prescribe drugs off-label when there is a licensed alternative, as this "does not interfere with their [doctors'] ethical considerations," in an attempt to make off-label use clearer to its members.

However, the ABPI said that even if doctors believe it is the right thing to do, off-label prescribing will continue to put patients at risk, because of a lack of safety data for non-approved uses for drugs.

It said: "ABPI recommends that the GMC maintains unchanged its existing guidance (2008) on the use of off-label and unlicensed medicines, which emphasises that while doctors should make 'good use of the resources available' this does not extend to prescribing a medicine outside the terms of its licence, unless the doctor is satisfied that it would better serve the patient's needs than a licensed alternative.

"The existing guidance does not imply that cost can be an acceptable consideration in choosing an unlicensed medicine when there is a licensed alternative that meets the same clinical need."

6th June 2011


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