Health and care regulators including the General Pharmaceutical Council (GPhC) have issued a joint statement on meeting regulatory standards during GLP-1 receptor agonists (GLP-1 RAs) shortages.
They said that they were ‘concerned’ to hear that people with type 2 diabetes were experiencing problems accessing GLP-1 Ras, amid widespread prescribing for weight loss purposes, in some cases off-label.
And they said that they recognised the ‘adverse impact’ of shortages and supply chain issues on patients, the public and wider health and care teams.
The statement was issued today by the GPhC, the Pharmaceutical Society of Northern Ireland, the General Medical Council and the Health and Care Professions Council.
They reminded health and care professionals that they ‘must meet relevant regulatory standards’ amid ‘challenging situations’, including the need to balance individual patient needs with wider public health and pressures, as well as limitations on available resources such as medicines shortages or other supply chain issues.
Health and care professionals must also be able to ‘account for their decisions’, including by ‘acting professionally at all times and providing person-centred care, using their knowledge and experience to make evidence-based decisions’, the statement said.
And the regulators stressed that it was ‘vital’ that registrants advise on, prescribe, supply, dispense or administer medicines ‘within the limits of their training, competence and scope of practice, regulatory standards and guidance and the law.’
They emphasised that prescribers were expected to take account of relevant national policy and guidance alongside profession-specific codes of conduct, standards and guidance.
In particular, they highlighted the Royal Pharmaceutical Society’s Prescribing Competency Framework, which outlines key competencies, including guidance around prescribing medicines that are unlicensed, off-label, or outside standard practice.
In particular, the regulators highlighted that prescribers need to assess the risks and benefits of a patient taking or not taking a medicine or treatment, as well as the need to consider the wider perspective including public health.
Prescribers were advised not to initiate new patients on GLP-1 RAs last year, amid ongoing shortages of the drugs.
And last month (27 June) the Department of Health and Social Care (DHSC) issued a Tier 3 (high impact) medicine supply notification for GLP-1 receptor agonists used in the management of type 2 diabetes.
It said that supply issues had been caused by an increase in demand for these products for licensed and off-label indications.
And it said that supply was not expected to return to normal until at least mid-2024.
Following that, Novo Nordisk – the manufacturer of several GLP-1 receptor agonists such as liraglutide and semaglutide – told The Pharmacist that it envisages intermittent supply shortages over the next 18 months, despite running factories 24/7 to increase production.
Pharmacists and GPs then stressed the need to protect remaining supplies for diabetes patients, while raising concerns about the impact of the shortage on practice and community pharmacy workload, as well as on patients.