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Independents' Day

Warning on GMC off-label prescribing guidance

By Lilian Anekwe

Changes to prescribing guidance under consultation by the GMC would place patient safety at risk and could compromise GPs, drug companies have warned.

The Association of the British Pharmaceutical Industry is unhappy at proposals GPs could use an unlicensed or off-label medicine in preference to licensed drugs if they 'are satisfied, on the basis of authoritative clinical guidance, that it is as safe and effective as a licensed alternative'.

The GMC consultation on its Good Practice in Prescribing guidelines, which ended last month, added that it 'may not be necessary to draw the patient's attention to the licensing status of the medicine', as along as GPs were satisfied there was sufficient clinical guidance to support their decision.

But the ABPI claimed the proposed changes would cause conflict 'between clinical and NHS budgetary responsibilities at a time when doctors are being asked to play an enhanced role in resource management with financial rewards for success'.

It argued the changes would 'increase the risk to patient safety by undermining the medicines regulatory process'.

The GMC has proposed changes to the prescribing of unlicensed medicines

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