S3 esomeprazole to go S2


woman with indigestion

The Schedule 3 entry for proton-pump inhibitor esomeprazole is set to be deleted from 1 February 2018

The TGA delegate has made an interim decision to downschedule the PPI to Pharmacy Only, where it appears in oral preparations containing 20mg or less per dosage unit in packs containing 14 days’ or less supply.

A general application was made to amend the Poisons Standard, and five submissions sent in – two in support of the proposal, and three opposed.

Esomprazole which is currently S4 will remain so, though that entry will be amended to reflect the new status of OTC preparations.

The reasoning behind the proposal was that increasing the pack size of S2 esomeprazole from seven to 14 days’ supply would improve access to PPI therapy, the recommended initial therapy for frequent heartburn sufferers.

This would align Australia’s standard with the experience of other countries such as the US and UK.

The applicant pointed out that ranitidine is already available from pharmacy for self-selection in 14-day packs, and that tolerance can develop with the drug class.

They said that histamine 2 receptor antagonists such as ranitidine are inferior in the inhibition of food stimulated acid secretion.

“In fact, only 15% of gastro-oesophageal reflux disease (GORD) patients treated with H2RAs achieve complete symptom relief. Of note, an Australian-based population study shows that a significant number of frequent heartburn sufferers are not satisfied with their treatment outcomes on H2RAs,” the application states.

They cited a study valuating the efficacy and quality of life impact of a daily dose esomeprazole 20mg, which “clearly demonstrated that at this strength and dosing frequency, there are significant benefits regarding relief/reduction of both the frequency and severity of heartburn and acid regurgitation”.

An improved QOL outcome was also reported.

The applicant also cited another Australian study which showed 61% of consumers who bought S3 esomeprazole needed treatment for longer than seven days and had to go back to a pharmacy to obtain more.

The main points in submissions opposing the downschedule were that the Pharmacist Only schedule meant pharmacists had the chance to consider whether a 14-day course was appropriate, and to recommend referral if any red flags appear.

It was also highlighted that “the long term use of proton pump inhibitors (PPIs) is one of the top 5 tests, treatments or procedures which should be questioned by GPs and their patients”.

“That statement is based on the evidence that a high proportion of patients are kept on maximal doses long term, and adverse effects of long term use include increased risk of gastrointestinal infection (incl. Clostridium difficile), community acquired pneumonia, osteoporotic fractures, interstitial nephritis, and nutritional deficiencies, particularly in the elderly or immunocompromised.”

The delegate decided to support the downschedule on the grounds that esomeprazole is a safe and effective first line treatment for the common symptoms of GORD and heartburn; that a 14-day supply better reflects the likely course needed; and on the grounds of the drug’s safety and efficacy data.

“The majority of adverse events are mild and transient in nature,” it said. “Esomeprazole has low toxicity when used for 14 days’ treatment at a dose of 20 mg per day. The risks are primarily associated with longer term use.”

The earliest possible implementation date, 1 February 2018, was set for the schedule change.

However an Australian study just published in the Journal of Clinical Pharmacy and Therapeutics calls for PPIs to be the focus of deprescribing programs.

“We have had a gutful: the need for deprescribing proton pump inhibitors” concluded that PPIs are overused worldwide.

“Proton pump inhibitor use in Australia increased between 2002 and 2010 and then gradually decreased. Estimates of the extent of inappropriate use in the international literature had a wide variation (11-84%),” the authors wrote.

“There appeared to be little change in the extent of appropriate PPI use reported through 34 international studies from 2000 to 2016.”

PPIs are being overprescribed in both hospital and community settings, they wrote.

“This may make patients more susceptible to a range of adverse effects. Interventions that have shown promise include regular medication reviews, facilitated by electronic prompts, and ongoing education of both health professionals and consumers.”

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