A committee has ruled against Viagra going OTC, saying the pharmacy setting is not equipped to provide medical diagnosis for underlying conditions of ED
The Advisory Committee on Medicines Scheduling (ACMS) has again ruled that the entry for sildenafil remain in Schedule 4 of the Poisons Standard.
An application had been proposed by the sponsor to create a new Schedule 3 entry for sildenafil (Viagra) in divided preparations for oral use containing 50 mg of sildenafil per dosage unit, in packs of not more than eight dosage units.
The applicant argued that amending the schedule would help reach men with erectile dysfunction (ED) who do not seek help from their doctor about their condition.
It will also direct men away from the unregulated supply of imported ED medicines, they argued.
The supply of Schedule 3 sildenafil would be contingent on the sponsor making CPD accredited training available to pharmacists, and providing a patient assessment tool to facilitate screening and counselling by the pharmacist, according to the application.
However the ACMS has ruled that the medicine stay prescription only.
“ED is an independent risk factor of cardiovascular disease,” says the committee in outlining the reasons for its advice.
“Risk of ED treatment without medical diagnosis or treatment of any underlying serious medical conditions (such as cardiovascular disease and diabetes) outweighs [the] benefit of making sildenafil available as a Schedule 3 medicine.”
The ACMS said that diagnostic tools such as ECG and other cardiac testing are not possible for use in a pharmacy setting, and added that sildenafil has a significant adverse effect profile that requires monitoring and oversight by a medical professional.
“There is no evidence that the patient will consult with their GP at the advice of their pharmacist. There is no evidence that the benefits of improved access for consumers are greatly outweighed by the risk of improper diagnosis or treatment of ED or associated risk factors by a pharmacist,” the committee found.
Meanwhile the UK’s move to launch OTC Viagra in March this year has been lauded by health professionals as “a great public health opportunity”.
This is because erectile dysfunction conversations are “picking up”, say pharmacists.