OTC Sildenafil Pharmacy Fail

Authorities have highlighted a high proportion of pharmacists inappropriately supplying erectile dysfunction medication sildenafil.

A Pharmacy Quality Audit Update issued by the country’s Medsafe regulator relates to audits undertaken in the first quarter of 2018, which have been introduced under a new risk-based framework currently being phased in. The document cites example of sildenafil supplied outside of guidelines, such as to patients with high blood pressure or other cardiovascular issues.

Some supplies were in quantities greater than the allowed maximum of 12 tablets, or in broken packs, and pharmacies were not always able to demonstrate that there was a system in place for recording consultations related to the resupply of the medication.

The issues were highlighted under a specific quality criterion which stated that medicines requiring supply by an accredited pharmacists should be “recorded, sold and labelled in accordance with regulatory and professional requirements”.

Of more than 70 pharmacies audited during the period, on either a pre-notified or unannounced basis, just 17% were found to have attained the required standard. Almost a third of the pharmacies (29%) were classified as having “high” or “critical” risk levels in this area, with Medsafe saying the significant level of non-compliance was concerning. “The pharmacy sector is encouraged to work towards significant improvement in this area, particularly in the supply of sildenafil,” the regulator advised.

Source:, Thursday 27 September 2018