Pharmacy Daily | CBD scheduling a big step forward

PLANS to down-schedule cannabidiol (CBD) to Pharmacist-Only preparations will be "a major step forward for the profession of pharmacy," former Pharmacy Guild of Australia National President, Kos Sclavos, believes.

Welcoming the interim scheduling decision announced by the Therapeutic Goods Administration (TGA) yesterday (PD breaking news), Sclavos told Pharmacy Daily that "this decision will see pharmacists play a key role in the management of patients using medicinal cannabis".

The measure, with a proposed implementation date of 01 Feb 2021, will mean medicinal cannabis can be provided by a pharmacist, in accordance with additional supply requirements specified in Appendix M of the Standard.

Currently cannabidiol in preparations for therapeutic use is under S4 or S8 in various jurisdictions, with most products only available through the Special Access Scheme (SAS).

The proposed new entry in S3 specifies "cannabidiol in oral, oral mucosal and sublingual formulations for therapeutic use" when either plant derived, or if synthetic contains only the CBD enantiomer in daily doses of 60mg.

In the Therapeutic Goods Administration (TGA) and the notice of interim decisions to amend (or not amend) the current Poisons Standard, the delegate of the Secretary of the Department of Health, noted that a proposal to exempt CBD from scheduling had been rejected.

"I am not satisfied that CBD can be supplied at the general sales level, with reasonable safety, and without any access to health professional advice," the delegate said.

"The external evaluation report found that whilst CBD has low toxicity, adverse events and drug interactions are possible.

"On that basis, it is my firm view that CBD is unsuitable for general sales.

"Due to uncertainty of adverse effects, the effects of longer term use and the potential for drug interactions, I find that the risks cannot be managed with packaging and labelling in the absence of pharmacist advice."

Data from the TGA released earlier this month revealed more than 61,000 SAS Category B applications for unapproved medicinal cannabis product were approved up 31 Aug.