Change of schedule

Weekly-dose vitamin D products will be advertised from midway through the year following a decision that should enhance patient compliance

Among the recommendations from the November meeting of the Advisory Committee on Medicines Scheduling are to create a new Appendix H entry for Vitamin D.

“Access for high-risk consumers to a once-weekly dose of Vitamin D from a pharmacist for effective ongoing supplementation is likely to be beneficial and safe,” the committee advised.

“The compliance benefits, low-risk nature of the product and safeguards inherent in Schedule 3 mean the benefits of advertising the availability of this product exceed any potential risks”.

The application had stated that “while pharmacists may be aware of the compliance benefits of once weekly vitamin D, they would only have limited opportunity of discussing this with consumers”.

The committee advised that Vitamin D be entered in Appendix H of the Poisons Standard, with an implementation date of 1 June 2017.

 “Vitamin D is relatively safe and it is difficult to overdose on a Schedule 3 preparation, particularly if given under medical supervision through a pharmacist. The benefits include that some consumers find convenience in the Schedule 3 once-a-week dosage regime,” the committee said.

The committee felt the scheduling may lead to improved adherence to supplementation, particularly for long term regular treatment, and may be beneficial particularly for those with more severe deficiency or at higher risk (e.g. aged care residents, those with limited sun exposure, obese people and those with malabsorption conditions).

The committee also agreed to an amended S2 entry for paracetamol compounded with caffeine.

The proposal will see the existing Schedule 2 entry be amended for paracetamol when compounded with caffeine on grounds of boosting consumer convenience and self-care choices, as well as “evidence of a small incremental analgesic effect compared to single ingredient paracetamol (although whether this is clinically relevant is unknown), and evidence of faster onset of analgesia with smaller pack size to mitigate risk”.

Meanwhile, a series of adjustments to the scheduling of cannabis were recommended at a joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling.

The decision lowered the cut-off for total cannabinoids appropriate for hemp seed oil to be exempt from Schedules 8 and 9 from 50 mg/kg to 20mg/kg.

It also added to the cannabis entries regarding the hemp seed oil exception the advice :

“when labelled with either of the following warning statements:

  • Not for internal use; or
  • Not to be taken.”

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