The number of special access approvals has shot up by hundreds over the past few months
The TGA has released its latest data on the use of unapproved medicinal cannabis products in Australia.
Such products can be accessed through the Authorised Prescriber Scheme (AP), the Special Access Scheme (SAS) and through clinical trials.
When products in the Australian Register of Therapeutic Goods (ARTG) are found to not be clinically suitable, the SAS provides a pathway for prescribers to access unapproved products for individual patients on a case-by-case basis, explains the TGA.
Since 1992 – when the TGA received the first known unapproved medicinal cannabis SAS application – until 31 January 2019, the organisation has approved over 3500 SAS Category B applications.
The large majority of approvals have occurred since 2016, and the number has been rising significantly in the past few months.
Here is a breakdown of the number of SAS Category B approvals by month for the previous 12 months, as provided by the TGA:
Month | Number of SAS Category B approvals |
February 2018 | 37 |
March 2018 | 54 |
April 2018 | 89 |
May 2018 | 132 |
June 2018 | 146 |
July 2018 | 188 |
August 2018 | 229 |
September 2018 | 237 |
October 2018 | 331 |
November 2018 | 567 |
December 2018 | 491 |
January 2019 | 672 |
Prescribers who make SAS applications must specify for which indication they are intending to use the unapproved medicinal cannabis product.
To date, the TGA has approved SAS applications including, but not limited to, the following indications:
- Chemotherapy-induced nausea and vomiting
- Refractory paediatric epilepsy
- Palliative care indications
- Cancer pain
- Neuropathic pain
- Spasticity from neurological conditions, and
- Anorexia and wasting associated with chronic illness (such as cancer).
The TGA points out that approval under SAS does not necessarily mean the patient has accessed or continues to access treatment, as actual supply is a matter for the medical practitioner and their patient.
Sativex (nabiximols), an approved medicinal cannabis product included in the ARTG, is also available in Australia and its use is not included in the above statistics.
Australian patients may also be accessing unapproved medicinal cannabis products outside the SAS, via the Authorised Prescriber Scheme.
As of 31 January 2019, there were 54 Authorised Prescribers—medical practitioners who are approved to prescribe unapproved therapeutic goods for a particular condition or class of patients in their immediate care without further TGA approval.
PSA’s position statement on cannabis and cannabinoids for medicinal use, published in October, states that the organisation supports the use of cannabis for medicinal purposes where a medical practitioner has established that the potential therapeutic benefits outweigh the risks.
“The patient and/or carer must provide informed consent, and there must be appropriate medical oversight and ongoing monitoring of outcomes,” says the PSA.
However it adds: “PSA acknowledges that evidence on safety and efficacy of cannabis and cannabinoids for medicinal use is still limited and therefore the risk profile of individual substances is yet to be comprehensively established.
“PSA believes that a cannabinoid with low or no amounts of THC [delta-9-tetrahydrocannabinol, which is responsible for its psychoactive effects] and therefore minimal or no psychoactive properties should be considered proactively for inclusion in Schedule 4 of the Poisons Standard.”
The organisation does not support the recreational use of cannabis due to the potential for short- and long-term adverse effects.
“Pharmacists are committed to delivering services and care to reduce harms from substance use and substance use disorders,” says the PSA.
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