S3 cannabidiol proposal


TGA scheduling delegate proposes pharmacist-only dispensing of low-dose cannabidiol

The Therapeutic Goods Administration (TGA) Joint scheduling committee is set to hear a delegate-initiated proposal to allow pharmacist-only supply of low dose cannabidiol products.

The move follows the conclusions of a TGA review that concluded S3 dispensing of cannabidiol presents a good safety and tolerability profile at the low dose range of under 60mg/day.

On the same day the review findings were released (24 April), the TGA announced its scheduling delegate had initiated a proposal to create a S3 listing for Cannabidiol in preparations for therapeutic use when:

  • the cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer; and
  • the maximum recommended daily dose is 60 mg or less of cannabidiol; and
  • in packs containing not more than 30 days’ supply; and
  • cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and
  • any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2 per cent or less of the total cannabinoid content of the preparation; and
  • for adults aged 18 years and over.

“In Australia, CBD is currently a Schedule 4 substance and therefore only available with a prescription. The access controls on CBD in Australia are notably more restrictive than comparable regulators. CBD is available as an over the counter product (for products without medicinal claims) in the UK and some US states,” the proposal states.

“It is proposed that down-scheduling to Schedule 3 is more appropriate than Schedule 2, as pharmacist advice is necessary to mitigate safety risks associated with CBD’s high potential for drug-drug interactions when used concomitantly with many other commonly prescribed drugs that are metabolised via CYP pathways”.

The review, which commenced in late 2019, was commissioned as the TGA said there were only limited published studies available on the safety profile of cannabidiol (CBD) at lower doses.

“Low dose cannabidiol for plant derived CBD or synthetic CBD which only contains the (-) CBD enantiomer would be suitable for consideration for down scheduling, potentially to Schedule 3, given that the conditions for which it is proposed for use require oversight by a healthcare professional and there remains the potential for drug-drug interactions,” the review concluded.

“Whilst there are some minor signals of adverse effects such as mild drowsiness and fatigue, this could be managed as for similar S3 medicines, such as requiring a label that indicates should not use if driving or operating machinery as for other medicines that can cause potential drowsiness.

Schedule 3 requires that both Product Information and Consumer Medicine Information is available. These documents could include information about drug-drug interactions. In addition, a S3 medicine requires interaction with a pharmacist that would further reduce any unintended drug-drug interactions”.

The consideration of down scheduling low dose CBD should only apply to people over 18 years of age, the report stated, finding there was “little evidence of use in children and therefore of its safety profile in this group”.

The review focused on safety, and did not look at the efficacy of low dose CBD in the management of specific conditions, the TGA said. The review also shied away from making specific recommendations about possible indications for low dose products.

 

Previous ‘A supply chain in distress.’
Next Research Roundup

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.

No Comment

Leave a reply