Writing on behalf of the Royal Australasian College of Physicians (RACP), Clinical Associate Professor Adrian Reynolds, Professor Jennifer Martin and Associate Professor Yvonne Bonomo wrote in their Perspective that “Australians’ acceptance of cannabis is higher than it has been for generations, for medicinal as well as recreational use.
“The pace and scale of the introduction of medicinal cannabis are unprecedented and have raised challenges for health professionals, not so much because of its known addictive and psychoactive properties, but because its introduction has not followed the usual research-based safety and effectiveness processes.
“While the RACP understands the community’s interest of cannabinoids as a therapeutic product, it emphasises that the usual regulatory processes designed to protect patients from serious harms are incomplete for medicinal cannabinoids, and that evidence of their effectiveness for many medical conditions is at present limited.”
In Australia, the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS) provides patient access to cannabis on compassionate grounds without the usual quality and safety data requirements.
The medicinal cannabis product cannabidiol is a promising but as yet sparsely researched treatment for paediatric epilepsy.
In their narrative review, Dr John Lawson, a paediatric neurologist and conjoint senior lecturer at the University of New South Wales, and colleagues at Sydney Children’s Hospital, Randwick wrote that the SAS “requires a case-by-case application to the TGA for approval, including clinical patient information, the proposed product and supplier”.
“To become an Authorised Prescriber, after local ethics committee approval, a medical practitioner must apply to the TGA to allow them to prescribe a specific medicine for patients with a specific indication, without subsequent approval required for individual patients,” they wrote.
“The prescribing medical practitioner has several responsibilities, including providing informed consent and a treatment plan and monitoring, and complying with reporting requirements including reporting any adverse event to the TGA. Once SAS or APS approval has been granted, the prescriber must arrange for the provision of the product with the supplier and local pharmacy and provides the patient with a prescription.”
In the case of paediatric epilepsy, “this means that general practitioners or paediatricians can only successfully apply via the SAS scheme with supporting documentation from a paediatric neurologist.”
Reynolds and colleagues emphasised that there needed to be a balance between compassion and careful assessment for patients for whom cannabis products might be beneficial.
“It is too early to form conclusions, and there are risks associated with liberalising access in the absence of standard regulatory requirements demonstrating quality, safety and efficacy,” they wrote. “Supporting patients to take an active part in their care requires us to provide them with evidence-based information about the treatment options available.”
This is a media release from the Medical Journal of Australia, which is a publication of the Australian Medical Association. The statements or opinions that are expressed in the MJA reflect the views of the authors and do not represent the official policy of the AMA or the MJA unless that is so stated.
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