Online pharmacies in England, Scotland and Wales are required to follow updated guidance from the General Pharmaceutical Council (GPhC), after concerns that prescription-only medicines (POM) for weight loss are being inappropriately supplied.
On 4 February 2025, the GPhC published ‘Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet’, which provides updated standards on how the prescription of weight loss drugs should be administered.
The GPhC guidance provides information on creating an effective risk assessment to ‘safeguard the health, safety and wellbeing of patients and the public.’ Risk assessments are especially important for medications:
- Liable to misuse
- That require ongoing monitoring
- Labelled with a black triangle
- At a higher risk of serious harm if taken in overdose
The guidance contains standards on how monitoring should take place, ensuring registration with an appropriate regulator, such as the Care Quality Commission, and ensuring compliance with data protection laws.
One of the key updates is that weight loss POMs are now unable to be prescribed by online pharmacies based purely on online questionnaires or photos. Instead, it is necessary to access the patient’s clinical records or talk to the patient’s GP/regular prescriber to help prevent people giving false information. The prescriber also needs to verify the patient’s weight, height and/or body mass index.
To ensure compliance with these updates, the GPhC will conduct inspections and write to pharmacies.
Weight loss POMs have been a concern in recent years to several regulatory affairs bodies, as overdosing on medicines such as Ozempic, Wegovy (semaglutide) and Saxenda (liraglutide) can cause severe hypoglycaemia and may require hospitalisation. The US Food and Drug Administration (FDA) has reported adverse effects of compounded semaglutide products and cautioned that they ‘do not undergo FDA premarket review and so pose a higher risk to patients.’ Since 2021, the Advertising Standards Authority (ASA) has also been actively monitoring this issue, stressing that weight loss POMs should only be administered by a healthcare professional.
These extra safeguarding measures on weight loss POMs may have repercussions for the clinical trial process for weight loss drugs, changes to advertising standards and stricter post-market surveillance, and could also affect the availability of these drugs on the market.
Regulatory affairs professionals can stay updated by reviewing guidance from relevant organisations, such as the GPhC, ASA and the FDA.
