Call for comment on October deadline for Melatonin Pharmacist Only downscheduling, as doctors back S3 decision
The Therapeutic Goods Administration has issued a call for further public submissions on its interim decision to reschedule melatonin products.
The latest call wants submissions to specifically address the suitability of the current 1 October date for the rescheduling to occur.
In June, the TGA’s Scheduling committee released its interim decision to down-schedule modified release melatonin formulations from Schedule 4 to Schedule 3, with restrictions on age and pack size.
“The risk profile of melatonin is well defined and the adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist,” the TGA delegate said.
“I have not identified any compelling evidence, which establishes that melatonin can be safety supplied to consumers, by a pharmacist, outside the current approved indications”.
The S3 move has been backed by most pharmacy groups, and by the Australian Medical Association (AMA). Although PSA expressed concerns about a lack of consultation regarding training and support for pharmacists.
The Pharmacy Guild of Australia welcomed the decision in its submission: “Melatonin is a safe medicine used for the treatment of insomnia. Patients with primary insomnia will benefit from access to a proven, ARTG-registered product with a better safety profile than alternative prescription-only products such as benzodiazepines, Z-rugs or other Schedule 3 products such as promethazine or doxylamine”.
“We believe that the proposal fits all the criteria for a Schedule 3 medicine. In addition it will harmonise
with New Zealand where melatonin has recently been downscheduled”.
The decision was also supported by the Australian Medical Association (AMA)
“AMA members agree that melatonin offers a safer alternative to benzodiazepines or sedating anti-depressants for sleep conditions. Often individuals may use over the counter antihistamines to treat insomnia, despite limited evidence that it is effective.”
“Alternatively, Australians are purchasing stronger melatonin products from overseas suppliers and this can create a safety risk if the country of origin does not have the same or better standards or regulation as Australia”.
“Dosage and labelling requirements will be important for this change. For example, it must be
communicated to patients that there is limited evidence for the long-term efficacy of melatonin
use and sleep hygiene practices should be considered before melatonin is used.”.
PSA expressed some concerns about the decision and lack of consultation
“In the absence of any discussion with PSA regarding this S3/Appendix M proposal for melatonin and
the apparent lack of preparatory work on an appropriate pharmacist training package, PSA urgently
seeks the opportunity to collaboratively work with the applicant, consistent with the Appendix M
requirements outlined in the Scheduling handbook,” PSA said in its submission.
“PSA is also aware that there is a reasonable market in compounded melatonin, including higher
strength products. Thus, it may be necessary to consider these additional implications”.
The Society of Hospital Pharmacists of Australia (SHPA) said it “supports the down-scheduling of Melatonin, however a maximum quantity should be included”.
A review of the submissions already received on the decision has concluded that: “none have addressed the matter of the proposed date of effect of the proposed down-scheduling of 1 October 2020”.
“Therefore, the Delegate has decided to exercise the power… to publish a second notice for public submissions inviting interested persons to make submissions in relation to the 10 June 2020 interim decision’s proposed date of effect of 1 October 2020”.
The closing date for submissions on the proposed date of effect of the proposed down scheduling is 28 August 2020.