Cannabis-based medicinal products

If you intend to provide a regulated activity, you must register with CQC for the regulated activity of Treatment of disease, disorder or injury. To register as a provider or a manager, we must be satisfied that you will meet the requirements of the regulations and that you will continue to comply with them once you are registered.

The legal requirements for registration with CQC apply to all NHS and independent organisations, although some independent doctors are exempt from CQC registration.

If you make a change to your existing service, such as offering cannabis-based products for medicinal use (CBPMs), or if you intend to prescribe these medicines remotely through an online consultation, you must update your statement of purpose and notify us in writing within 28 days of the change. This enables us to check that your prescribing meets the legal requirements.

What we look at when we register and inspect

Our inspections will cover registered services, either in the NHS or the independent sector, that intend to prescribe CBPMs.

If your service intends to start prescribing and treating patients with CBPMs you must be able to demonstrate to us that you have assurances to deliver safe and effective care.

Initiating CBPMs

Guidance from the GMC states that unlicensed medicines should not be used as first-line treatments to meet a patient’s needs.

Care providers must have a process to scrutinise and ratify the decision to initiate a CBPM. This is to ensure that it is a patient-centred and appropriate decision, and that an unmet clinical need has been established.

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

Role of the multi-disciplinary team

To ensure an effective process to scrutinise prescribing, our expectations are:

• Services must ensure that their processes allow for a minimum of 2 GMC specialist registered doctors to participate in the multi-disciplinary team to scrutinise and ratify prescribing decisions. This could be in person or asynchronously.
• The prescribing GMC specialist must be a specialist in the clinical specialism for which they are treating the patient.
• Any other specialist who reviews prescribing as part of the multi-disciplinary team must assure themselves that they have appropriate knowledge of the clinical specialism that they are being asked to review.
• The decision to prescribe must be based on sufficient knowledge of the patient and their previous medical history.
• Providers must have oversight of this process to ensure that they are meeting all the above requirements. Records should be effective and auditable to enable the multi-disciplinary team to operate.

This will mitigate the risks around inappropriate prescribing and will help to ensure that patients’ unmet clinical needs are being addressed.

Oversight of ongoing prescribing

The Misuse of Drugs Regulations 2001 make it clear that prescribing of CBPMs needs to be carried out by, or under the direction of, a GMC-registered specialist. We have seen examples of services that delegate care entirely to non-specialists with no ongoing practical involvement from the specialist. Services must be able to provide evidence that specialists have ongoing oversight of patients under their care and have practical involvement that is determined by the needs of the individual patient.

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

Informed consent

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 sufficient information about the medicine to patients, or their parents or carers, 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

All prescribers should be satisfied that there is enough evidence or experience of using the medicine to demonstrate its safety and efficacy.

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.

Our assessment framework includes additional details about what we look at when we inspect.