Pharmacists say TGA decision to leave vardenafil and sildenafil S4 is a missed opportunity for them to better help the 60% of Australian men aged over 45 years who have experienced erectile dysfunction.
On Saturday 16th September the Australian College of Pharmacy held their “Pharmacy Controversies” half day CPD seminar in Brisbane.
In a presentation about managing risk in the treatment of erectile dysfunction, Dr Brett MacFarlane from the Australian College of Pharmacy informed the audience of the 15th September announcement of the interim decision by the TGA Scheduling Delegate to leave both vardenafil and sildenafil as S4, following recent applications by their respective sponsors for down scheduling to S3.
The TGA’s reasons to not down schedule PDE5 inhibitors to S3 included:
- increased evidence for the link between erectile dysfunction and cardiovascular disease
- concern the supply of PDE5 inhibitors by pharmacists without prescription would increase the risk of improper diagnosis or treatment
- concern that men with erectile dysfunction would not tell a pharmacist about their contraindications for treatment and
- lack of screening by pharmacy would lead to worsened health outcomes due to the possibility of men never going to a doctor for assessment.
The non-prescription supply of sildenafil by specially trained pharmacists, using a screening tool, has been in place in New Zealand since 2014.
Pharmacy owners from New Zealand attending the College seminar were surprised at the TGA decision. They told the audience that their erectile dysfunction service was professionally satisfying and well received by their patients.
They said that many of their patients were not new to sildenafil therapy when purchasing it without prescription for the first time, and that they had already been assessed by a doctor for risk.
Dr MacFarlane lamented the TGA decision saying that it was a missed opportunity for pharmacists, who are the most accessible of health professionals, to engage with men about erectile dysfunction.
This would mean more men with risk factors for cardiovascular disease and other risks would be referred to a doctor for assessment, particularly those men who may not be aware of their own risks.
Presentation of a theoretical case study of a man with risk factors, requesting treatment for erectile dysfunction from a pharmacist, resulted in the vast majority of pharmacists in attendance electing to not treat the patient with a PDE5 inhibitor without prescription, if they were available, and instead refer him to a doctor.
Dr MacFarlane said the response indicated the conservative approach pharmacists take to medicine risk, and should help to alleviate the concerns of the TGA that men would not be referred to a doctor.
He could see a case for Australian pharmacists using a similar protocol to New Zealand which requires that patients be repeatedly monitored by pharmacists to address risk factors that may arise and require referral.
He said pharmacists should undertake comprehensive training in erectile dysfunction and identifying risk, before they could deliver a similar service.
Given the New Zealand situation of non-prescription supply of sildenafil and the Australian situation of continued supply of some medicines by pharmacists and allied health prescribing in some states, College President Georgina Twomey believes there is a place in the Australian regulatory environment for ensuring patient safety as well as enabling increased access to medicines.