WIDELY used proton pump inhibitor (PPI) esomeprazole has been recommended for relaxed scheduling by the Advisory Committee on Medicines Scheduling (ACMS), to enhance access under certain conditions.
The Committee decided that the product be scheduled S2 in oral preparations containing 20 mg or less of esomeprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply.
The basis of the decision rested on overseas data (UK and US) demonstrating the safety and effectiveness of 14 days’ therapy compared with just seven days together with the fact that the less effective H2RA alternative ranitidine which is already unscheduled (seven days’ supply) or S2 (14 days) can be subject to patient tolerance issues and is inferior in inhibition of food-stimulated acid secretion.
The use of 14 days’ therapy with esomeprazole has also been demonstrated to provide improved sleep quality, work productivity and functionality resulting from the effective relief of the symptoms of heartburn and acid reflux.
Access to a 14-day pack was also deemed to be more cost-effective than two seven day packs.
In other decisions, PDE5-inhibitors sildenafil and vardanafil for erectile dysfunction are to remain S4 for safety reasons, given that “pharmacies do not have adequate screening facilities to manage the risks associated with the use of these products”.
Similarly, the ACMS said the current scheduling of ibuprofen combined with paracetamol “remains appropriate”.