Guidance on the use of over-the-counter proton pump inhibitors for the treatment of GERD
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Objective The aim of this paper was to develop a guideline on the over-the-counter management of gastroesophageal reflux disease with proton pump inhibitors (i.e. omeprazole). Setting A meeting of internationally renowned gastroenterologists in January 2009, in Berlin, Germany. Methods An expert panel group of gastroenterologists convened to develop a consensus-based algorithm for pharmacists for over-the-counter (OTC) treatment with proton pump inhibitors (PPIs). Key considerations were the short-term safety and efficacy of PPIs, and the extent of the risk to the sufferer, owing to the treatment not being controlled by a physician. Main outcome measures A consensus-based treatment algorithm for the OTC management of gastroesophageal reflux disease and evidence-based guidance on the use of OTC PPIs. Results As defined by the treatment algorithm, the pharmacist should first confirm the diagnosis based on the presence of typical symptoms and secondly, as a result, rule out general practitioner referral. The third step focuses on the nature, severity and frequency of the symptoms—the patients who might have the highest benefit from a short course (14 days) of OTC PPIs are those with less than three episodes of heartburn and/or acid regurgitation per week. Patients who have three or more episodes per week can use the OTC PPIs but should also be encouraged to visit a physician, and those who already have a diagnostic work-up can use proton pump inhibitors as rescue treatment if they are known responders. Guidance for pharmacists, in the form of questions and answers, summarises the current published clinical experience with PPIs in terms of their efficacy and safety, and optimal treatment schedule. Conclusions Gastroesophageal reflux disease imposes a considerable burden on sufferers. Owing to their accepted efficacy and safety, PPIs are becoming popular as OTC options for the treatment of gastroesophageal reflux disease symptoms such as heartburn and acid regurgitation. Effective self-management of gastroesophageal reflux disease with OTC PPIs, e.g. omeprazole, could lead to lasting freedom from symptoms and improved quality of life for sufferers.
KeywordsGastroesophageal reflux disease GERD Guidance Omeprazole OTC drugs Pharmacist Proton pump inhibitors
The authors appreciate the editorial support for the preparation of this guidance provided by Ogilvy Heathworld, London, UK.
Funding was provided by Bayer Consumer Care AG, Basel, Switzerland.
Conflicts of interest
Gerald Holtmann has received research support, speaker’s fees, travel support or honoraria from Abbott, Ardeypharm, AstraZeneca, Bayer, J&J, Nycomed, and Steigerwald. Peter Malfertheiner has received research support and consulting fees from Abbott, AstraZeneca, Bayer Schering Pharma, Novartis, and Nycomed. Marc-André Bigard has been consultant for AstraZeneca, Bayer, Takeda, SanofiAventis and Speaker for AstraZeneca and Takeda. Roy Pounder has no conflicts of interest.
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