3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)
3.4 Interim decision in relation to sildenafil
Interim decision
Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to sildenafil.
Materials considered
In making this interim decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to sildenafil;
- The five 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 sildenafil in the Poisons Standard remains appropriate.
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; (e) the potential for abuse 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:
- Risks
- Potential for incorrect diagnosis of erectile dysfunction (ED) by pharmacists. CVD risk and contraindications, adverse effects, misuse.
- Adverse events - the most serious of which are non-arteritic ischaemic optic neuropathy (NAION), priapism and interactions with nitrates and other drugs.
- Common adverse events include headache and flushing.
- Risk of lack of ongoing medical monitoring (under the current proposal).
- Benefits
- Effective treatment of ED.
b - the purposes for which a substance is to be used and the extent of use of a substance:
- Intended for use in men with ED aged 18 years or over, to assist in treatment of ED.
- ED affects up to 50% of men aged 40 to 70 years.
c - the toxicity of a substance:
- Sildenafil has a wide therapeutic index.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
- No Schedule 3 product at present.
e - the potential for abuse of a substance:
- Some evidence of off-label use (in the context of recreational substance use) and sourcing through internet purchases outside the medical system.
f - any other matters considered necessary to protect public health:
- All men with ED need thorough medical evaluation for its cause and ongoing monitoring.
- ED may be a symptom of more serious underlying conditions, which require ongoing medical monitoring (in addition to medical diagnosis).
- Sildenafil meets Schedule 4 factors, requiring medical intervention for monitoring of the condition.
Reasons for the interim decision (including findings on material questions of fact)
I have made an interim decision not to amend the current Poisons Standard in relation sildenafil, specifally not to down-schedule certain preparations of sildenafil from Schedule 4 to Schedule 3. My view is that the current scheduling of sildenafil is appropriate. The reasons for my decision are set out below.
Sildenafil is approved for the treatment of ED. ED can be a symptom of underlying conditions, which require medical practitioner diagnosis, ongoing monitoring and treatment. Having considered the Scheduling Policy Framework 2018 (SPF 2018), I find that the requirement for medical practitioner intervention is consistent with the Scheduling Factors under a Schedule 4 classification.
Sildenafil had been considered for down scheduling on two previous occasions, in 2017 and 2018. On both occasions, I found that sildenafil did not meet the Schedule 3 scheduling factors and that proposed education and checklist material was insufficient to mitigate the risk of down scheduling. In my view, the applicant has not presented, and I have not found, any new compelling clinical evidence to support the inclusion of sildenafil in Schedule 3.
I have considered the proposed risk mitigation strategies outlined in the Appendix M entry put forward by the applicant and found it did not systematically assess the risks associated with sildenafil use. I acknowledge that while pharmacists would not be making an initial decision as to whether treatment with sildenafil should be initiated. However, I have strong concerns that if down-scheduled there there is a risk of repeat supply without medical intervention and lack of follow up. I find that the potential for harm in the absence of medical practitioner oversight carries more weight than the benefit of increased patient access.
I have considered the views expressed in the public submissions and those of the applicant, suggesting that down-scheduling sildenafil to Schedule 3 would create ease of access, increase awareness of ED and enable early engagement with the healthcare system. However, no data has been provided to substantiate these claims or clearly articulate how these benefits would apply to men's health in general.
Having considered the need for medical practitioner oversight and the risks to consumers with the lack of patient follow up in a pharmacy setting, I am of the firm view that the current scheduling of sildenafil under Schedule 4 is appropriate.
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 purpose for which a substance is to be used and the and 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 that the Secretary considers necessary to protect public health.