News

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‘Growing concerns’ spark TGA cannabis consultation

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The Therapeutic Goods Administration (TGA) will investigate whether medicinal cannabis regulations are adequate and appropriate in response to ‘increasing public and professional concern’ over safety risks, particularly for unapproved high-strength products.
 
The TGA has announced it will open public consultation on 11 August in a bid to understand if existing arrangements ‘provide adequate oversight for the more than 1000 unapproved products currently supplied in Australia’.
 
It linked concerns with the ‘rapid growth’ in products being used in Australia, as approvals through the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme skyrocket, largely fuelled by telehealth.
 
Those came under particular scrutiny in May in an ABC 7.30 program which found one doctor had reportedly issued 17,000 scripts in six months, while a pharmacist allegedly dispensed 959,000 products in a year.
 
As the TGA embarks on its consultation and ‘significant regulatory reform consideration’, it says three key issues have so far been raised:

• Whether there is appropriate regulatory oversight of unapproved medicinal cannabis products being accessed via the SAS and AP schemes
• The safety risks associated with unapproved medicinal cannabis products, particularly those products containing tetrahydrocannabinol (THC)
• The growing number of product-specific telehealth services prescribing unapproved medicinal cannabis through vertically integrated direct-to-consumer business models

Melbourne GP Associate Professor Vicki Kotsirilos, who was one of the original GP prescribers of medicinal cannabis, said she welcomes the move to open the regulations up to public scrutiny, particularly given the popularity of high-strength THC products.
 
She noted that Category 5 dried THC products account for the highest number of scripts according to TGA data, and that they are mostly dispensed to the 18–44-year-old age group purportedly to treat chronic pain and anxiety.
 
‘The problem is we know that THC can also cause and contribute to further anxiety and trigger psychotic events,’ Associate Professor Kotsirilos told newsGP.
 
‘Also, there is an addictive quality and it can cause cannabis use disorder in such high doses. So therefore, the high use of THC products can actually compound the problem.
  
‘When medicinal cannabis became available in 2016 for patients, this was never the intent.
 
‘These products were used for patients in exceptional circumstances such as patients undergoing cancer therapies and in palliative care, eg for nausea and vomiting during chemotherapy to improve quality of life.’
 
In May, the Australian Health Practitioner Regulation Agency (AHPRA) said seven practitioners appeared to have used the SAS to issue at least 1500 prescriptions for Category 5 medicinal cannabis products in six months.
 
‘The dried herb THC products are now being inappropriately overprescribed,’ Associate Professor Kotsirilos said.
 
‘I don’t think it is your average GP who is contributing to these figures.’
 

Melbourne GP Associate Professor Vicki Kotsirilos.

As well as noting concerns over safety risks for unapproved medicinal cannabis products, the TGA announcement highlights the rise of ‘vertically integrated’ companies supplying products direct to consumers.
 
However, it noted that trend is out of its remit as the therapeutic goods regulator and will not form part of the consultation.
 
‘Access to medicinal cannabis products is governed by complex arrangements,’ it states.
 
‘Legal access to medicinal cannabis products is facilitated by the TGA, while prescribing and dispensing is regulated by AHPRA, the Medical Board of Australia, the Pharmacy Board of Australia, and relevant state and territory legislation.’

A TGA spokesperson told newsGP the consultation will be open for eight weeks to allow ‘sufficient time for all stakeholders to provide input’.
 
‘The purpose of the consultation is to gather information from a range of stakeholders seeking their knowledge, experiences and observations of the use of unapproved medicinal cannabis products in Australia,’ they said.

Last month, AHPRA released new guidelines for medical practitioners who prescribe medicinal cannabis.
 
It said prescribers should be ‘as careful and diligent’ when prescribing medicinal cannabis as they are with other drugs of dependence.
 
It also highlighted concerns over emergency department presentations showing medicinal cannabis-induced psychosis as well as ‘evidence of over-servicing and ethical grey areas around single-purpose dispensaries’.
  
The TGA says the information from the consultation ‘will inform options for regulatory reforms to ensure appropriate regulatory oversight and market controls’, but warned further consultations may be required.
 
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medicinal cannabis TGA Vicki Kotsirilos

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