“Off-label prescribing” means that a medicine is being used in a way that is different to that described in the license for it, for example, using a medicine for a different illness to that stated in the license.1 Novo Nordisk acknowledges that all licensed prescribers have the choice to prescribe treatments outside of their intended purpose, or approved parameters of use, Novo Nordisk does not endorse this in any way. Novo Nordisk recommends all prescriptions are in line with a medicines approved Summary of Product Characteristics (SmPC).

We’ve been closely monitoring how our medicines are being portrayed in both mainstream and social media, and we share ongoing concerns that off-label promotion and use of our medicines is putting supply at risk for people living with diabetes in the UK.

Prescription only medicines should be used in line with their approved indication. Any decisions made regarding treatment options should always be made in consultation with a healthcare professional and require strict medical supervision.

While we are subject to strict regulations regarding promotion of our medicines — which includes how we talk about them publicly — we are continuing to take steps to ensure accurate information is available to support the responsible use of our medicines. This includes:

  • All healthcare professional (HCP) and educational materials for our medicines focus on the Medicines and Healthcare products Regulatory Agency (MHRA) approved indications only, in compliance with all applicable regulations.
  • We do not encourage off-label use of our medicines and actively discourage off-label prescriptions and promotion from HCPs and retailers.
  • We offer a comprehensive programme of clinical training to any HCP who utilises our medications as part of their clinical practice. This includes information around the specific indication, suitable patient population, dosing, administration, and follow-up.
  • In response to our current supply and demand situation, we are working closely with the Department of Health and Social Care on how HCPs should prescribe our medicines in line with local laws and regulations.
  • Collaborating with regulators and health authorities to take action against activity that violates relevant regulations and codes, such as promoting our medicines to the public.
  • We work to ensure reporters and external stakeholders have accurate information about our medicines and take reasonable measures to inform the press of misinformation and issue corrections.
  • Where Novo Nordisk is made aware of an illicit online offering for its medicines (e.g. selling without requiring prescription, counterfeit, or promoting off-label use to the public) on websites, marketplaces or social media, Novo Nordisk systematically assesses the best course of action, which can include attempting to remove these from the internet or further investigating them. 

 

1. Oxford University Hospitals. Unlicensed and “Off-label” medicines. https://www.ouh.nhs.uk/patient-guide/leaflets/files/72458unlicenced.pdf (accessed September, 2023).