OTC PPI will result in more effective patient treatment

The first non-prescription proton pump inhibitor (PPI) has been approved for over-the-counter sale in Australian pharmacies.1 In order to be available over-the-counter, medication must meet diagnostic and safety criteria.6 The medication, a 20mg dose of pantoprazole, is indicated for the symptomatic relief of heartburn and other symptoms of gastro-oesophageal reflux disease (GORD).2 In numerous clinical trials, it has been demonstrated to offer more effective treatment of heartburn symptoms than currently available over-the-counter therapies (i.e. H2 receptor antagonists).3-5

While making medications available without prescription raises concerns about safety and efficacy, it also has the potential to reduce the cost of healthcare and increase accessibility to consumers.^6,7 In the case of heartburn treatments, antacids and H₂RA ranitidine are already available over-the-counter in Australian pharmacies and supermarkets.⁸ Considering these circumstances, a more effective medicine, available over-the-counter in pharmacies, may actually increase the number of patients consulting a health professional about their heartburn symptoms, by increasing contact with pharmacists.

According to Dr Sanjay Nandurkar, the accessibility of over-the-counter heartburn relief such as Somac Heartburn Relief would lead to more effective patient treatment.

"Because more effective medications can be used sooner, we should see an improvement in QOL," Dr Nandurkar said.

"The majority of the heartburn sufferers do not have any serious underlying pathology. The risk of Barrett’s oesophagus is small and cancer is very remote (if the high prevalence is taken into account). In the majority, there are no erosions or ulcerations and symptom control is the main objective."

Heartburn is the most common symptom of GORD and some 40% of adults experience symptoms of GORD at least once a month.⁹ The Gastroenterological Society of Australia estimates that 15–20% of the adult population experience heartburn at least once a week.¹⁰ However, the majority of heartburn sufferers do not treat their symptoms with prescription medicines. An Australian study reported that only 20% of heartburn sufferers used prescription medicines to treat their symptoms.⁸ Around half of those who reported heartburn used antacid therapy and a further 20% did not treat their symptoms at all.⁸ This indicates that many individuals treat heartburn as a trivial condition, despite the significant negative impact it can have on an individual’s daily life.

Heartburn sufferers who do not consult a doctor, either leave their condition untreated or self-diagnose and medicate using over-the-counter therapies, either antacids or H₂ receptor antagonists.⁷ These medications can provide temporary relief of the symptoms of heartburn, but are not as effective as PPIs and antacids do not treat the underlying cause of heartburn – they do not reduce the production of gastric acid.⁹

PPIs target H⁺/K⁺-ATPase, an enzyme in the stomach’s parietal cells, which is responsible for the production of gastric acid.¹¹ By binding to this enzyme, PPIs suppress acid release and provide long-lasting relief from heartburn symptoms, which is clinically superior to the relief offered by H₂RAs.^3-5

PPIs have been previously used in the treatment of heartburn in larger doses on prescription only.¹¹ Heartburn is usually diagnosed based on symptoms and their effect on the patient’s daily life, without the need for medical investigations (e.g. endoscopy).¹² Thus, the diagnostic criteria make heartburn a suitable condition for pharmacy, as well as general practitioner, diagnosis.^6,12

Dr Nandurkar said while perhaps not all aspects can be dealt with in a pharmacy setting such as elderly patients or patients with recurring symptoms for which caveats are installed, simple and straightforward cases can be handled by the pharmacist.

"Some aspects can be managed at pharmacy level; other aspects by their GP. This would improve liaising between pharmacists and GPs," he said.

The newly approved over-the-counter form of this medicine is a 20mg daily dose of pantoprazole (Somac Heartburn Relief), administered for 7–14 days. This is half the standard prescription dose. The 20mg dose has been shown to relieve heartburn symptoms in up to 80% of patients after 14 days treatment.³ Three clinical trials have been conducted, comparing 20mg pantoprazole once daily, with 300mg ranitidine, a H₂RA also available over-the-counter in Australia. Each of the trials found pantoprazole treatment to be more effective than ranitidine treatment.^3-5

The medication at this dose induces only limited side effects, but there are some precautions which must be taken. The use of the medication is contraindicated in children, pregnant women and lactating women. In addition, patients who continue to experience symptoms after 14 days of use, and those with a range of warning signs (e.g. severe symptoms, prolonged use of other heartburn relief medication), should be referred to a doctor for thorough assessment.¹

Pharmacists are now in an excellent position to provide more effective non-prescription treatment. They are also in a better position to refer heartburn patients requiring medical assessment to a general practitioner.

Dr Nandurkar said there were also other "intangible" benefits.

"Obesity and smoking are significant risk factors for reflux disease. Pharmacists can perhaps take time to explain some weight loss strategies and available options to wean them off smoking," he said.

This in turn could help other areas such as cardiovascular protection, stroke prevention and the like."

Dr Nandurkar said he believed accessibility to over-the-counter Somac Heartburn Relief would benefit consumers in terms of their treatment choices, and they should talk to their pharmacist.

The following tool can be used to identify whether treatment with this new form of heartburn relief is appropriate.

More information 

For more information on acid reflux and heartburn and related investigations, treatments and supportive care, click here.

References

1. Somac Heartburn Relief: Pharmacist Training Manual. Nycomed Pty Ltd; 2008.
2. Somac Heartburn Relief Tablets (Pantoprazole) Product Information. North Ryde, NSW: Nycomed Pty Ltd; 2008.
3. van Zyl JH, de K Grundling H, van Rensburg CJ, Retief FJ, O’Keefe SJ, Theron I, et al. Efficacy and tolerability of 20mg pantoprazole versus 300mg ranitidine in patients with mild reflux-oesophagitis: A randomized, double-blind, parallel and multicentre study. Eur J Gastroenterol Hepatol. 2000; 12(2):197-202.
4. van Zyl JH, van Rensburg C, Vieweg W, Fischer R. Efficacy and safety of pantoprazole versus ranitidine in the treatment of patients with symptomatic gastroesophageal reflux disease. Digestion. 2004; 70(1): 61-9.
5. Dettmer A, Vogt R, Sielaff F, Lühmann R, Schneider A, Fischer R. Pantoprazole 20mg is more effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Aliment Pharmacol Ther. 1998; 12(9): 865-72.
6. Aronson JK. Over-the-counter medicines. Br J Clin Pharmacol. 2004; 58(3): 231-4.
7. Mansfield JE, Callahan D. Benefits of over-the counter heartburn medication to consumers and the health care system [online]. The Neilson Company. 7 December 2008 [cited 2 April 2009]. Available from URL: http://www.chpa-info.org/ media/ resources/ r_5333.pdf
8. Bolin TD, Korman MG, Hansky J, Stanton R. Heartburn: Community perceptions. J Gastroenterol Hepatol. 2000; 15(1): 35-9.
9. Fass R, Sontag SJ, Traxler B, Sostek M. Treatment of patients with persistent heartburn symptoms: A double blind randomized trial. Clin Gastroenterol Hepatol. 2006; 4(1): 50-6.
10. Digestive Health Foundation. Gastro-oesophageal disease in adults: Guidelines for clinicians [online]. Gastroenterological Society of Australia. 2 July 2008 [cited 2 April 2009]. Available from URL: http://www.gesa.org.au/ pdf/ RefluxDisease4Ed08.pdf 
11. Somac Tablets [online]. MIMS. 16 July 2007 [cited 2 April 2009]. Available from URL: http://mims.hcn.net.au/
12. Armstrong D, Marchetti N. Pharmacist-specific guidelines for the medical management of GERD in adults. Can Pharm J. 2008; 141(Suppl 1): S10-15.