1 Final decisions made pursuant to regulation 42ZCZR - proposals referred to the November 209 Advisory Committee on Medicines Schedule (ACMS #28)
Note
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1.2. Final decision in relation to Zolmitriptan
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to vary the interim decision and amend the current Poisons Standard in relation to zolmitriptan as follows:
Schedule 4 - Amend Entry
ZOLMITRIPTAN except when included in Schedule 3.
Schedule 3 - New Entry
ZOLMITRIPTAN when in divided oral preparations containing 2.5 milligrams or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.
Appendix H - New Entry
ZOLMITRIPTAN
Index - Amend Entry
ZOLMITRIPTAN
Schedule 4
Schedule 3
Appendix H
Reasons for the final decision (including findings on material questions of fact)
I confirm the reasons for my final decision to create a Schedule 3 entry for zolmitriptan are as detailed in my interim decision. I have decided to vary the interim decision to take into account dosage units and the specific indication for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms. I consider the indication specific wording of the entry would support the quality use of zolmitriptan under a Schedule 3 classification. I also affirm my interim decision to create an Appendix H entry for zolmitriptan. In making my final decision, I have taken into account the material detailed in the interim decision and the two submissions received before the second closing date in response to the call for further submissions published on 6 February 2020 under regulation 42ZCZP of the Regulations.
While I note the public submission expressing the view that if one triptan is suitable for down-scheduling then it is appropriate for all triptans to be down-scheduled at the same time, this consideration has not been material to my decision. The triptans are listed individually in the Poisons Standard and this current application is for sumatriptan only. As per the requirements SPF 2018, each individual substance must be assessed against the Scheduling Factors on their own merits.
Summary of public submissions on the interim decision
In response to the interim decision, two (2) submissions were received. Both submissions supported the interim decision.
The main points provided in support of the interim decision were:
- The submissions provided by industry stakeholders supported the proposed amendments and inclusion within Appendix H.
- One submission agreed the access controls in place for a Schedule 3 medicine are appropriate and sufficient to mitigate the risk of misuse of zolmitriptan.
- Both submissions noted that the implementation date of February 2021, was decided by the delegate to allow the opportunity for sponsors to adhere to regulatory change and the opportunity to align labelling requirements to be developed and for the development of education and training material to be provided to pharmacists.
Additional comment:
- One submission expressed a view that if one triptan is suitable for down-scheduling then it would be appropriate for all of the triptans to be down-scheduled at the same time in the absence of evidence that there is a particular reason why one particular triptan does not meet the scheduling criteria.
- An implementation date of February 2021 was recommended to the Delegate to consider for any future triptan scheduling applications.
Date of effect of the decision
1 February 2021