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Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS and Joint ACMS-ACCS meetings, June 2020
Scheduling of chemicals and poisons
3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)
3.2 Interim decision in relation to eletriptan
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Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to eletriptan as follows:
Schedule 4 - Amend Entry
Schedule 3 - New Entry
Appendix H - New Entry
Index - Amend Entry
In making this interim decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to eletriptan;
- The two public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate
The Committee recommended that the scheduling of eletriptan be down-scheduled from Schedule 4 to Schedule 3 and to create an Appendix H entry in the current Poisons Standard.
The Committee also recommended an implementation date of 1 February 2021.
Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters considered necessary to protect public health.
The reasons for the advice included:
a - the risks and benefits of the use of a substance:
- Frequent use may result in medication overuse headache;
- Possible cerebral vascular side effects associated with eletriptan as well as cardiovascular events;
- Dizziness and drowsiness;
- Risk concerning potential delay in seeking medical advice.
- Eletriptan provides effective treatment of acute migraine with or without aura;
- Established safety profile when used as directed;
- Timely access for patients with confirmed migraine diagnosis may improve patient outcomes.
b - the purposes for which a substance is to be used and the extent of use of a substance:
- Acute treatment of migraine headache with a stable well established pattern of migraine symptoms with or without aura.
c - the toxicity of a substance:
- Contraindications to use:
- Established coronary artery disease (including ischaemic heart disease (IHD));
- Signs and symptoms of IHD or Prinzmetal's angina;
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- Peripheral vascular disease;
- Basilar or hemiplegic migraine or 'atypical' headache;
- Using another triptan;
- Used an ergotamine type medication within 24 hours;
- Serious cardiac events, including some that have been fatal, have occurred following the use of other 5HT1 agonists;
- Interaction risk if used within 48 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, erythromycin, clarithromycin, amprenavir, ritonavir, indinavir, saquinavir, nelfinavir and nefazodone (specific to eletriptan).
- Adverse effects are typically mild in intensity and transient.
- Most common adverse effects dizziness, drowsiness and chest symptoms.
- Safety and efficacy not established in people <17 or > 65.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
- The recommended initial dose is 40 mg.
- The maximum single dose is 80 mg.
- The maximum daily dose should not exceed 160 mg.
- If a second dose is required, it should not be taken within 2 hours of the initial dose.
- The proposed Schedule 3 entry is for oral use in tablets containing 40mg or less per tablet and when in a pack containing not more than 2 dosage units.
e - the potential for abuse of a substance:
f - any other matters considered necessary to protect public health:
- Risk reduction can be further mitigated by pharmacist counselling and verification of diagnosis by a medical practitioner if required.
- Consideration of sufficient time for information to be developed by February 2021.
Reasons for the interim decision (including findings on material questions of fact)
I have made a decision to down-schedule eletriptan from Schedule 4 to Schedule 3 with a new Appendix H listing in the current Poisons Standard.
I have decided to include a pack size limit in the new Schedule 3 entry to mitigate the risks of medication overuse headache, unintentional and intentional overdose. I have made the Schedule 3 entry indication specific on the grounds that eletriptan is not effective for other types of headache. I note that this decision is consistent with the recent decisions to down-schedule sumatriptan, zolmitriptan, rizatriptan.
I find that the eletriptan satisfies the Schedule 3 scheduling factors on the basis that the risk profile of eletriptan is well defined and the risk factors for adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist. I am satisfied that the risk of adverse events, including cardiovascular events, can be minimised through pharmacist-consumer consultation. Pharmacists will exercise profession judgment on the migraine pattern of the presenting patient and if necessary, refer the patient for verification of diagnosis by a medical practitioner. Eletriptan is most effective when taken as soon as possible following onset of a migraine. I am of the view that down-scheduling of eletriptan to Schedule 3 would improve timely access for patients with migraine and therefore improve patient outcomes.
I consider the recent decisions to down-schedule sumatriptan, zolmitriptan, rizatriptan to Schedule 3 to be relevant to my deliberations on the basis that there is a therapeutic class effect associated with “triptans” or 5HT1 agonists. I have not identified any significant differences in eletriptan compared to sumatriptan, zolmitriptan, rizatriptan which would signal for it not to be down-scheduled to Schedule 3. I have considered that there is no evidence that any triptan is safer than another, although the response to each agent can vary considerably between patients. The same individual may also respond quite differently to different triptans. I have taken into account that unlike sumatriptan, zolmitriptan and rizatriptan, eletriptan is not a substrate of MAO-A, which in my view, is in favour eletriptan being made available in addition to other the triptans, especially in patients taking monoamine oxidase inhibitors (MAOIs).
I note that a number of peak heath organisations, including the Pharmacy Guild of Australia, Pharmaceutical Society of Australia and the Australian Medical Association were in support of a decision to down-schedule eletriptan to Schedule 3 of the Poisons Standard.
Having considered the matters set out in the guidelines for advertisements for medicines containing Schedule 3 substances, I am satisfied that there are no foreseeable potential impacts on public health that would preclude advertising eletriptan directly to consumers through the provision of an Appendix H listing.
I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters considered necessary to protect public health.
Proposed implementation date
1 February 2021