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GPhC stops short of discouraging off-label prescribing of GLP-1 RAs


GPhC stops short of discouraging off-label prescribing of GLP-1 RAs

By Neil Trainis

The General Pharmaceutical Council and other health regulators have today urged health and care professionals to act within the limits of their training, competence, scope of practice, regulation and the law when faced with shortages of GLP-1 receptor agonists – but stopped short of discouraging off-label prescribing of the products.

In a joint statement, the GPhC, Pharmaceutical Society of Northern Ireland, General Medical Council, Health and Care Professions Council and Nursing and Midwifery Council said they were aware the products were being “widely prescribed for weight loss purposes and in some cases prescribed off-label.”

But unlike the Medicines and Healthcare products Regulatory Agency, who just two days ago said supply issues were partly being driven by off-label prescribing and warned “off-label use of these agents for the management of obesity is strongly discouraged,” the five regulators said health and care professionals must meet “relevant regulatory standards” and “be able to account for their decisions.”

The regulators said that when it came to prescribing medicines that are unlicensed, off-label or outside standard practice, the Royal Pharmaceutical Society’s competency framework for all prescribers should be applied “to reflect different areas of practice or situations.”

The framework says unlicensed and off-label medicines can be prescribed “where legally permitted” and if appropriate safeguards” are followed.

The regulators said: “We know that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.

“Health and care professionals must meet relevant regulatory standards in these circumstances, and they should be able to account for their decisions. This includes acting professionally at all times and providing person-centred care, using their knowledge and experience to make evidence-based decisions.”

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