OTC management of heartburn

In addition to antacids and histamine-2 receptor antagonists (H2RAs), proton pump inhibitors (PPIs) for the relief of heartburn are now approved for over-the-counter (OTC) sale in Australian pharmacies.1 For heartburn sufferers, this means better access to more appropriate treatment options, without the need for a prescription.2 Up to 80% can now find an effective treatment regimen for their heartburn at a pharmacy.3

Pharmaceutical Society of Australia National Vice-President Shane Jackson says the benefits are that PPIs are extremely effective at relieving symptoms of reflux and indigestion.

"Having patients get access to OTC Somac, combined with advice from pharmacists, is appropriate."

Treatment options

Antacids, H₂RAs and PPIs are all heartburn treatments that reduce gastric acid in the stomach. They have all demonstrated effectiveness in reducing heartburn symptoms, though each class of drug exerts its symptom relief effect via different mechanisms. Thus each type of treatment will be more or less appropriate for particular groups of heartburn sufferers, depending on the frequency and severity of their symptoms.²

Antacids

Antacids relieve heartburn symptoms by neutralising gastric acid in the stomach. They offer fast acting, temporary relief of heartburn; however, symptoms often return quickly after antacid treatment (e.g. within one hour).⁴ This is because antacids do not treat the underlying cause of heartburn (i.e. excessive gastric acid production). Rather, they simply neutralise the acid that has already been produced by the stomach.

Antacids have long been available over the counter in Australia.⁵ They provide effective relief of mild heartburn symptoms, but are not effective in treating more severe or frequent heartburn (occurring ≥ two times per week).²

Histamine-2 receptor antagonists

H₂RAs act by blocking histamine receptors on the parietal cells of the stomach and, by doing so, blocking gastric acid secretion and reducing gastric acidity. By blocking acid secretion, they relieve heartburn symptoms. 

Similar to antacids, H₂RAs may provide adequate relief for patients with infrequent or mild heartburn, but patients with frequent heartburn symptoms (occurring ≥ two times per week) may require twice daily therapy if treated with H₂RA,² and drug tolerance may develop within a week.⁶

H₂RAs provide prompt symptom relief,⁷ but are less effective in the long-term management of frequent or moderate to severe heartburn symptoms, compared to PPIs.^3,8,9

Dr Jackson said, "H₂ antagonists have been available for three or four years without complications, and PPIs are possibly even safer if used for short courses."

Proton pump inhibitors

PPIs relieve heartburn symptoms by reducing the production of gastric acid in the stomach. That is, they resolve the underlying cause of heartburn. They block acid production by binding to enzymes in the stomach’s parietal cells, where gastric acid is produced, and in doing so provide greater and more prolonged symptom relief than either antacids or H₂RAs. In addition, they are more effective in healing erosive oesophagitis, a common complication of prolonged heartburn.²

Dr Jackson says that PPIs can induce headaches and diarrhoea on occasion, but overall are a very safe class of drug for short courses. He says that PPIs can be used for longer courses as long as their use is being monitored.

The only OTC PPI available for heartburn relief in Australia contains the active ingredient pantoprazole (20 mg per tablet), and is marketed under the brand name Somac Heartburn Relief.¹

Target populations for OTC PPIs

The release of PPI tablets for OTC sale enables pharmacists to offer heartburn therapy to a greater range of patients. In particular, it provides a new OTC treatment option for patients with frequent heartburn symptom (i.e. those patients who experience heartburn at least twice a week).² This may be a considerable proportion of the population, as data shows that up to 20% of Australians experience heartburn at least once a week.¹ Evidence also shows that a considerable proportion of heartburn sufferers (20%) do not bother to treat their condition. A further 50% use antacids as the sole means of treatment. Only 20% of heartburn sufferers use prescription medicines for treating their heartburn symptoms.⁵

Patients taking antacids may find their heartburn symptoms relapse very quickly after treatment (e.g. within an hour of taking antacids),⁴ as may those using H₂RAs (who will often require twice daily doses).² For frequent heartburn sufferers, PPIs are likely to offer more effective relief than either antacids or H₂RAs.² Pharmacists can offer Somac Heartburn Relief to patients who are currently self-medicating with antacids or H₂RAs.¹⁰ Patients who use prescription pantoprazole for heartburn may also benefit from the availability of Somac Heartburn Relief, as they may be able to use OTC medications when they run out of prescription medication.

Dr Jackson says OTC reflux medications such as Somac Heartburn Relief are extremely beneficial for those people who need quick and effective relief.

"It’s appropriate if patients need something to tide them over until they can see their GP, or perhaps people who are travelling" Dr Jackson said.

"Of course, if patients need ongoing medication it is less expensive for them to see their doctor as it is subsidised."

Somac has limited side effects, but there are some precautions pharmacists must be aware of when providing Somac Heartburn Relief. The tablets should not be used by children, or women who are pregnant or lactating, as safety has not been established in these populations.¹¹

Patients who continue to experience heartburn after taking Somac Heartburn Relief for 14 consecutive days should be referred to their doctor for clinical examination.¹ Patients with some "alarm" symptoms (e.g. severe symptoms, prolonged use of other heartburn relief medication) should also be referred to their doctor for thorough examination before Somac Heartburn Relief is provided.²

Somac Heartburn relief can be taken again by sufferers provided that previous use of the product provided good symptom relief. For example, if Somac Heartburn Relief relieves a person’s heartburn symptoms and then they experience the same type of symptoms, say a month later, then using Somac Heartburn Relief again is likely to be appropriate. As Somac Heartburn Relief is only available from a pharmacy, the pharmacist will provide advice to customers on if the product is suitable for them.¹ 

Dr Jackson says that while Somac Heartburn Relief can be used for multiple courses, it must be monitored.

"As long as it is used for the right purposes and people don’t confuse the symptoms with anything more serious, like chest pains."

It is important, in some cases, to refer patients to a GP.

For more information on acid reflux and heartburn and related investigations, treatments and supportive care, see Acid Reflux and Heartburn.

For more information on over-the-counter pantoprazole, see Somac Heartburn Relief.

References

1. Somac Heartburn Relief: Pharmacist Training Manual. Northryde, NSW: Nycomed Pty Ltd; 2008.
2. Armstrong D, Marchetti N. Pharmacist-specific guidelines for the medical management of GERD in adults. CPJ/RPC. 2008; 141(Suppl 1): S10-5.
3. van Zyl JH, de K Grundling H, van Rensburg CJ, Retief FJ, O’Keefe SJ, Theron I, et al. Efficacy and tolerability of 20 mg pantoprazole versus 300 mg 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. McPhee SJ, Tierney LM, Papadakis M (eds). Chapter 14: Alimentary tract: Diseases of the esophagus. Current Medical Diagnosis and Treatment (46th edition). New York: McGraw Hill; 2007: 582.
5. Bolin TD, Korman MG, Hansky J, Stanton R. Heartburn: Community perceptions. J Gastroenterol Hepatol. 2000; 15(1): 35-9.
6. Fackler WK, Ours TM, Vaezi MF, Richter JE. Long-term effect of H2RA therapy on nocturnal gastric acid breakthrough. Gastroenterology. 2002; 122(3): 625-32.
7. 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 
8. 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.
9. Dettmer A, Vogt R, Sielaff F, Lühmann R, Schneider A, Fischer R. Pantoprazole 20 mg is more effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Aliment Pharmacol Ther. 1998; 12(9): 865-72.
10. Pharmacy retail success with Somac Heartburn Relief [advertorial]. Aust J Pharmacy. 90: 2009; 43.
11. Somac Tablets [online]. MIMS. 16 July 2007 [cited 2 April 2009]. Available from URL: http://mims.hcn.net.au/
12. Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, et al. A population based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180(7): 713-8.