Abstract

Off-label prescribing is the use of a medicinal product outside the conditions set out in the summary of product characteristics and should only be undertaken if there is no licensed alternative available to achieve the best outcome. New evidence that emerges after a licence has been prescribed does not necessarily mean there will be an application for the licence to be extended. Randomised controlled trials based on a homogenised population may not represent the complexities of an individual patient. Therefore, prescribers need to consider a definition of evidence-based prescribing that extends beyond best research evidence to incorporate clinical expertise and individual needs and perspectives of patients. Nurse prescribers should ensure that their competence and expertise to prescribe off-label is addressed to deliver true evidence-based prescribing. An audit of off-label prescribing by nurse prescribers is a potential wealth of evidence yet to be discovered.

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