1.4 Calcifediol monohydrate

1 Final decisions made pursuant to regulation 42ZCZR - proposals referred to the November 209 Advisory Committee on Medicines Schedule (ACMS #28)

1.4. Final decision in relation to calcifediol monohydrate

Final decision

Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to calcifediol as follows:

Reasons for the final decision (including findings on material questions of fact)

I confirm the reasons for my final decision to create a new Schedule 4 entry for calcifediol for human internal use with a concentration cut-off of 10 micrograms or less calcifediol per recommended daily dose, are as detailed in my interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the submission received before the second closing date in response for the call for further submissions published on 6 February 2020 under regulation 42ZCZP of the Regulations. As the public submission reiterated a view consistent with a pre-meeting submission supporting access to calcifediol under Schedule 3, it has not be material to my decision.

Summary of public submissions on the interim decision

In response to the interim decision, one submission opposing the interim decision was received.

The main points opposing the proposed amendment were:

• Considering its use is consistent with the purpose of calciferol, but more useful in specific circumstances, it would be appropriate to enable sponsors to make applications for the S3 Pharmacist Only category that is equivalent in dose to the Vitamin D entry in Schedule 3:

  VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.

• For calcifediol, this could mean an equivalent dose of around 60-70 micrograms on a weekly basis could be considered for Schedule 3, pending appropriate evaluation through the registration process, to ensure that health professionals have the tools available to allow patients to access appropriate medicines without the need for managing prescriptions on an ongoing basis unless a higher dose was indicated.
• In summary, we propose that it would be appropriate to allow the gradation of access to calcifediol in an equivalent manner to colecalciferol.

Date of effect of the decision

1 June 2020