Cannabis-based medicinal products: what we look at when we register and inspect

Page last updated: 12 May 2022

Our inspections will cover any specialist doctor, either in the NHS or an independent healthcare service, who intends to prescribe cannabis-based medicinal products.

For cannabis-based medicinal products, the prescribing doctor has responsibility for:

  • prescribing the medicine
  • overseeing a patient’s care and any follow-up treatment
  • continuing to monitor the effectiveness and side-effects of the prescribed medicine
  • keeping clear and accurate records of all medicines prescribed.

The provider should also regularly audit all prescribing of cannabis-based medicinal products by clinicians.

If your service intends to start prescribing and treating patients with cannabis-based medicinal products you must be able to demonstrate to us that you have assurances to deliver safe and effective care. Therefore, when we inspect, we will use the following specific key lines of enquiry (KLOEs) from our assessment framework for healthcare services.

Safe prescribing (KLOE S4)

Prescribing and clinical restrictions for cannabis-based medicinal products should be the same in NHS and independent services:

  • Only doctors who are on the General Medical Council (GMC) Specialist Register can prescribe unlicensed cannabis-based medicinal products, and they must work within the limits of their competence (non-medical prescribers cannot currently prescribe cannabis-based medicinal products).
  • Guidance from the GMC states that unlicensed medicines should not be used as first-line treatments to meet a patient’s needs.

Doctors on the GMC Specialist Register can prescribe cannabis-based medicinal products for a patient with an unmet clinical need on a named patient basis.

  • For NHS services this needs to be approved by the chair of their trust’s drug and therapeutic committee or the trust’s medical director.
  • For independent services prescribers should follow an equivalent but proportionate process, for example, through decisions from a clinical governance board or similar.

However, the decision to prescribe is ultimately for the prescribing clinician. This must be within their own area of practice and training (for example, physicians for adults should not be prescribing for children), and the decision must be based on sufficient knowledge of the patient and their previous medical history.

Informed consent (KLOE E6)

As with other unlicensed medicines, determining the most appropriate medicine or course of treatment to prescribe for a patient is a clinical decision. This decision should take into account:

  • the patient’s preferences and choices (or those of their parents or carers)
  • their clinical condition
  • the clinical evidence of efficacy and safety
  • the availability of licensed medicines.

Clinicians must also record details of discussions and give patients, or their parents or carers, sufficient information about the medicine to enable them to make an informed decision.

Because there is a lack of evidence on the long-term safety and effectiveness of cannabis-based medicinal products, clinicians will need to justify prescribing them.

Evidence of effectiveness (KLOE E1)

All prescribers should be satisfied that there is enough evidence or experience of using the medicine to demonstrate its safety and efficacy. Prescribers need to follow available clinical guidelines and principles for prescribing cannabis-based medicinal products, such as research evidence and guidance from professional, national, and international bodies.

Although the guidance provides recommendations for some treatment options with cannabis-based medicinal products, it is not a prescribing protocol, and the responsibility for the prescribing decision remains with the prescriber, in consultation with the patient or their parent or carer.

Where a prescriber takes a different approach from that set out in national guidance, clinicians and service providers need to provide a clear rationale to explain the decision to prescribe. A good practice example of this is shared clinical decision-making with a colleague who is another specialist with an appropriate scope of practice who does not have a pecuniary interest in making a positive decision to treat.