AACMC meeting 3, 14 September 2017

The Australian Advisory Council on the Medicinal Use of Cannabis met on Thursday 14 September 2017 in Sydney for its third meeting.

The meeting was chaired by Professor James Angus AO.

In addition to receiving briefings on the progress of the regulatory scheme for the cultivation, production and manufacture of medicinal cannabis in Australia, members discussed three main issues:

• The development of clinical guidance documents and discussion of evidence reviews around the use of medicinal cannabis for five major groups of conditions (epilepsy, chronic non-cancer pain, multiple sclerosis, palliative care and chemotherapy-induced nausea and vomiting
• Medical practitioner experiences in prescribing medicinal cannabis
• Opportunities for aligning state, territory and Commonwealth activity.

Clinical guidance and evidence reviews

The Council reviewed the draft reviews of evidence for the use of medicinal cannabis for epilepsy, multiple sclerosis, chemotherapy-induced nausea and vomiting, palliative care and chronic non-cancer pain. The clinical guidance documents are being developed in consultation with clinician and patient groups and using international evidence from these reviews and are expected to be available at the end of 2017.

The Council noted that draft evidence reviews are under assessment for academic publishing, and will be made more generally available following that process. The Therapeutic Goods Administration has recently made available the annotated bibliographies used for these evidence reviews for epilepsy, multiple sclerosis, and chemotherapy-induced nausea and vomiting, and will shortly make available the bibliographies available for the other two groups of conditions.

These bibliographies can be found here: Access to medicinal cannabis products: Review of clinical evidence for medicinal cannabis and cannabis products

The Council discussed the current disconnect between the views of the wider community around the efficacy of medicinal cannabis and those of much of the medical profession. The development and publishing of guidance documents on the evidence base is therefore a crucial element to providing information to the medical community, patient groups and government on the rationale for the use of medicinal cannabis.

Medical practitioner experiences

The Council discussed case studies from a clinician member outlining their personal experiences in the first 11 applications to prescribe medicinal cannabis under NSW and Commonwealth rules.

These case studies demonstrated the need to carefully outline the indications for which medicinal cannabis is being prescribed, the formulation and dosages of such prescriptions, and the medical literature supporting that decision. The member stated that the timelines of Commonwealth and State responses to requests to prescribe had improved significantly, and in line with the growing sophistication of the applications and understanding of the available supporting evidence – with that growth being both on the part of the government assessors as well as the prescribing doctor.

The Council discussed aspects of medicinal cannabis prescribing and use which were ancillary to the prescribing process, but introduced access constraints, including the need to import some products not available in Australia, the requirement to refrigerate some products while still maintaining schedule 8 medicine security controls (i.e. stored in a locked safe in a refrigerator securely fixed to the premises), and state-based requirements for pharmacists and nurses to store, handle and administer the medicinal cannabis products.

Aligning the jurisdictions

The Council noted ongoing work being conducted to align the jurisdictions, with working groups in place with representatives from all states and territories in three specialist areas: law enforcement, cultivation and production, and patient access.

The Council discussed ongoing concerns by some members of the public around the complexity of Commonwealth and state and territory processes in accessing medicinal cannabis. The Council and members agreed to a number of initiatives to address cross-jurisdictional challenges, including:

• Establishing a national collection of data relating to medicinal cannabis adverse events
• Collating current and past clinical trials from across Australia to help identify research gaps
• Reviewing the functionality and use of the Special Access Category B form, and
• Working with medical professional organisations to improve information flows.

Next meeting

The Council agreed to meet again in November 2017.