A THIRD attempt to push for sildenafil to be down-scheduled is set to be rejected due to the risks to consumers and the "lack of patient follow up in a pharmacy setting".
Recommendations of the Advisory Committee on Medicines Scheduling (ACMS) published in the Therapeutic Goods Administration (TGA) notice of interim decisions to amend (or not amend) the current Poisons Standard, flagged risks around the potential for incorrect diagnosis by pharmacists, misuse and adverse events.
Outlining the reasons for rejecting the application for sildenafil to be down-scheduled, a delegate of the Secretary of the Department of Health noted that erectile dysfunction can be a symptom of underlying conditions, which require medical practitioner diagnosis, ongoing monitoring and treatment.
"Sildenafil had been considered for down scheduling on two previous occasions, in 2017 and 2018," the delegate said.
"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 S3.
"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 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.
"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 S4 is appropriate."
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