S3 sildenafil rejected

THE Therapeutic Goods Administration’s (TGA’s) Advisory Committee on Medicines Scheduling (ACMS) has knocked back an application to make erectile dysfunction drug sildenafil available over-the-counter as a pharmacistonly medicine.

The ACMS said sildenafil did not satisfactorily meet the criteria for a Schedule 3 medicine because erectile dysfunction is a symptom with an underlying cause that requires diagnosis by a doctor.

The anonymous application had argued that easier access to the drug would encourage more men to seek treatment and lead to earlier and more frequent interaction with health professionals.

It also claimed that making it pharmacist-only would “destigmatise” erectile dysfunction and raise awareness of its association with diabetes and cardiovascular disease.

However the TGA’s committee said “the use of sildenafil at established therapeutic dosage levels may mask the symptoms or delay diagnosis of cardiovascular disease, [which] cannot be diagnosed by a pharmacist”.

It’s the second time the ACMS has rejected an application to downschedule sildenafil.

The committee also rejected an application to increase the pack size for S3 paracetamol/ ibuprofen combinations to 50 dosage units, saying a larger pack could potentially see consumers delay seeking further advice from a health practitioner and encourage off-label treatment of chronic pain.