Clinical guidance for cannabis medicine prescribers
All cannabis medicines in Australia need to meet a quality standard to ensure they are free from contaminants and are manufactured to a consistent standard. However, high quality evidence on the efficacy of these medicines is still limited and with one exception, products currently available in Australia are not registered on the Australian Register of Therapeutic Goods (ARTG). Detailed evidence about the efficacy, safety and quality of a medicine is required for registration.
Unregistered medicines, including cannabis medicines, can be prescribed. However,information about dosing, side effects, adverse events and contraindications for their use is not readily available. For this reason, and to protect the safety of patients, unregistered medicines, including cannabis medicines, are treated as experimental drugs and require approval for use.
Practitioners have a responsibility to exercise caution when deciding to prescribe a novel product,and to fully inform and carefully monitor their patient.
As part of their application to prescribe an unregistered cannabis medicine, doctors need to describe what evidence-based treatments and registered medicines they have already tried.
They need to provide information about why they think it is appropriate to trial an unregistered medicine and how potential side effects and other risks will be monitored and managed. They are asked to provide scientific evidence supporting their application.
Sourcing the necessary information can be difficult. Research into how an unregistered cannabis medicine is absorbed, its effects on a person and how it interacts with other medicines may be absent or very limited. Early research may provide limited and sometimes contradictory results. It can be time-consuming and difficult for medical practitioners to research the literature and products available and to keep up with scientific developments.
Seeking expert advice
In NSW, expert clinical guidance and cannabis medicine prescribing advice for community general practitioners and rural clinicians is available via the John Hunter Hospital Pharmacy Department.
The service can assist with:
- understanding the latest evidence around cannabis medicines
- understanding the regulatory requirements for cannabis prescription
- considering tools to monitor a patient’s progress whilst using cannabis medicines
- provision of protocols to facilitate cannabis medicine prescribing.
The John Hunter Hospital Pharmacy Department can be contacted by email at HNELHD-JHHPharmacy@health.nsw.gov.au.
Public health practitioners working in metropolitan local health districts should consult their local medicines information services for clinical guidance and prescribing advice.
- Clinical trials
- Talking to your patient
- Prescribing pathways
- Information and support for prescribers
- Clinical guidelines
- Children and vulnerable people
Residential aged cared facilities