Communication from the GPhC regarding Regulatory Concerns Regarding the Supply and Promotion of Weight-Management Medicines – Mounjaro®, Wegovy® and Related GLP-1 Therapies
The GPhC has recently provided strategic guidance and regulatory clarity concerning the ongoing concerns around the supply, prescribing practices, and promotional activities related to GLP-1 receptor agonists, particularly Mounjaro®, Wegovy®, and other weight-management medicines—especially where private prescriptions are involved.
As part of their continued collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Advertising Standards Authority (ASA), they are observing an increasing number of compliance issues that may pose risks both to patient safety and to the professional standing of pharmacy service providers.
Key Areas of Concern:
- Unauthorised Promotional Messaging: Communications—via email, social media, and websites—are encouraging patients to request switches between GLP-1 therapies (e.g., from Mounjaro® to Wegovy®), often without alignment to formulary guidance, licensing restrictions, or clinical appropriateness.
- Inappropriate Clinical Advice: Patients are being advised on treatment switches that do not conform to good prescribing practice, relevant product SmPCs, or the MHRA’s GLP-1 guidance, including the need for clinical oversight during such transitions.
- Bulk Supply and Inadequate Monitoring: they have seen evidence of patients being supplied with extended courses of treatment without adequate clinical review. This is contrary to best practice, which requires ongoing monitoring and regular clinical reassessment.
- Customer Service Failures: A pattern of delayed or unsatisfactory responses to patient complaints—particularly refund requests—is emerging. This contravenes the GPhC’s standards for patient-centred care and risk management.
Regulatory Obligations and Best Practice
It is imperative to remember the following:
- Promotion of Prescription-Only Medicines (POMs) to the public remains strictly prohibited, as outlined in the MHRA’s Blue Guide and reinforced by the ASA’s CAP Enforcement Notices. Only the consultation service may be promoted—not the medicines themselves.
- Prescribing decisions—whether by pharmacist independent prescribers or via third-party prescriber models—must align with:
- National and local formulary guidelines
- The Summary of Product Characteristics (SmPC) for each product
- The MHRA’s guidance on GLP-1 therapy switching
- Pharmacy service models involving multiple stakeholders (e.g., third-party prescribers, external suppliers) must demonstrate integrated governance frameworks, including:
- Clear roles and responsibilities
- Robust due diligence on third-party providers
- Policies to identify and mitigate inappropriate or high-risk medicine requests (e.g., multiple concurrent orders)
- Pharmacies must maintain an effective complaints handling process, as per Standard 1.4 of the GPhC standards. This includes providing timely, appropriate responses and a clear escalation pathway.
Enforcement and Inspections
The GPhC has begun targeted inspections, prioritising those pharmacies generating high volumes of complaints or where non-compliance is suspected. Failure to meet regulatory expectations may lead to enforcement action against owners, superintendent pharmacists, individual prescribers, and pharmacy technicians.
Recommendations:
- Audit your current promotional content across digital and physical channels.
- Review and align prescribing protocols with MHRA guidance and local formularies.
- Engage with third-party service providers to validate their clinical governance processes.
- Strengthen complaints handling and documentation procedures.
PCL can support you with reviewing your compliance frameworks, operational risk exposure, or third-party governance models and assist with initiating a formal gap analysis aligned with MHRA and GPhC requirements. Please contact us for more information on how we can help.