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Australia’s first authorised GP prescriber of medicinal cannabis says making it easier for doctors to prescribe would be a safer way to increase access.
The proposed changes, detailed recently by the Therapeutic Goods Administration (TGA), would see certain cannabidiol (CBD) products become available over the counter at pharmacies from June next year in a bid to ‘to allow greater access’ to consumers.
Since June 2015, CBD products – defined as containing at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis – have been considered a Schedule 4 (S4) prescription-only medicine.
However, under the new classification due to come into effect on 1 June 2021, patients aged 18 and over will be able to purchase packets containing up to 1800 mg of CBD (equivalent to 30 days’ supply of the maximum safe daily dosage) without a prescription.
The products would also need to include labels warning against use if pregnant or breastfeeding.
GP Dr Vicki Kotsirilos was Australia’s first authorised GP prescriber of medicinal cannabis. She told newsGP that while making CBD products more accessible would help meet community demand – some of which is currently being captured by the black market – she would prefer the process to be managed by a doctor.
‘The GP knows the patient well, their medical history, and is ideally suited to monitor the patient for clinical responses to the CBD product, watch for interactions with other medication and report any side effects to the Adverse Drug Reaction Advisory Committee,’ she said.
‘How can pharmacists be in a position to determine when it is appropriate to dispense CBD and monitor the clinical responses of CBD for these conditions?
‘A better system would be to provide our patients an S4 script without the need to make a SAS Catergory B application … through the TGA, which is still quite an onerous process.’
The TGA delegate responsible for recommending CBD’s down-scheduling did so despite the Advisory Committee on Medicines and Chemicals Scheduling finding the current scheduling ‘appropriate’.
‘The majority of the members on the committee were not persuaded that there is currently sufficient evidence to relax the access controls on cannabidiol … to the general sales levels or that cannabidiol meets the scheduling factors for Schedule 3,’ the TGA’s Notice of interim decisions to amend (or not amend) the current Poisons Standard states.
The advisory committee warned CBD is ‘likely to have interactions with many pharmaceuticals available for human use’, can have adverse reactions ‘including somnolence, decreased appetite, diarrhoea, fatigue and liver dysfunction’, and has the potential for misuse, particularly among children and adolescents.
A lack of approved indications would also prevent a pharmacist from being able to determine appropriate supply, the committee stated.
However, the TGA delegate attempted to mitigate these risks by not allowing any CBD products to be directly advertised to consumers, while limiting supply to pharmacy-only medicines entered on the Australian Register of Therapeutic Goods (ARTG).
Pharmaceutical Society of Australia (PSA) President Dr Chris Freeman responded to the interim decision by stating pharmacists would need to be ‘supported with the right information’ should the down-scheduling proceed.
‘It’s important to note that this was a delegate-initiated submission; the pharmacy profession did not ask for this down-scheduling of cannabidiol,’ he told AJP.
‘Whilst low-dose cannabidiol may be relatively safe at low doses, it is important that it has a therapeutic purpose and evidence behind the claims.
‘We would not want the pharmacy profession being set up to fail by allowing the availability of products through the Schedule 3 appendix M category that has little or no therapeutic benefit.’
According to the TGA, any CBD product registered on the ARTG would need to provide a full submission to support its intended use, including ‘data relating to the efficacy for any indications for the product’.
Dr Kotsirilos says any side effects to CBD-alone products are generally ‘mild and reversible’, but more ‘high-quality robust’ research into CBD is needed, and it is usually only indicated as a last-line treatment when all other proven safe therapies have failed.
‘Therapeutic effects of CBD are for analgesia, anti-inflammatory, anti-anxiety, anti-psychotic, anti-convulsant and to help reduce the psychoactive effects of THC [tetrahydrocannabinol] when combined in medicinal cannabis products,’ she said.
‘CBD-alone products contain no or negligible THC levels so do not cause the same side-effects as THC. CBD balances THC side effects when in a combined formula and has no psychoactive effects.
‘You can also continue to drive when using CBD-alone products, but not THC medicinal cannabis products.’
There are currently no CBD products on the ARTG, but the TGA had approved more than 61,000 SAS Category B applications for unapproved medicinal cannabis products as of 31 August 2020. The vast majority of these applications have occurred since 2016 and there are currently are 103 authorised prescribers across Australia.
Consultation on the decision remains open until 13 October, with a final decision expected on 25 November.
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