Abstract and Introduction
Background: The aim of this study was to assess how US gastroenterologists perceive and utilize over-the-counter (OTC) and prescription medications for gastroesophageal reflux disease (GERD) and chronic constipation (CC).
Methods: A total of 3,600 randomly selected American Gastroenterological Association (AGA) members were mailed a 27-question survey that assessed their perceptions and use of OTC and prescription medications. The χ2 test and Student's t-test were utilized for bivariate analysis.
Results: A total of 830 gastroenterologists (23.1%) completed the survey. For the typical acid reflux patient, 50% of gastroenterologists recommended OTC proton pump inhibitors (PPIs), 13% recommended an OTC histamine2 receptor antagonist, whereas 33% recommended a prescription PPI. However, in the typical CC patient, 97% of gastroenterologists initially utilized OTC treatments. The vast majority of gastroenterologists felt that OTC brand name and store brand PPIs (76%) and polyethylene glycol (PEG 3350; 90%) were equally effective. Despite this, a minority "always" or "very often" directed their patients to purchase a store brand PPI (35%) or laxative (40%). In addition, gastroenterologists tended to underestimate the cost savings associated with store brand medicines and had limited knowledge regarding the regulation of store brands.
Conclusions: Among US gastroenterologists, OTC medications now dominate primary therapy of GERD and CC. Despite feeling that name brand and store brand PPIs and laxatives are equally effective, the majority of gastroenterologists recommend brand name medicines and underestimate the cost savings associated with store brands. In this age of accountable care, greater efforts to help physicians and patients to better utilize their health-care dollars is warranted.
Gastroesophageal reflux (GERD) and chronic constipation (CC) are common and bothersome gastrointestinal disorders. It has been estimated that in the United States, 20–30% of people experience GERD symptoms weekly and 15–27% of people report chronic constipation.[1,2] GERD and constipation are the number one and two leading diagnoses noted at ambulatory care visits for GI problems. GERD leads the direct annual medical costs for all digestive diseases at $12.1 billion with an additional $515 million in indirect medical costs. Medications are a significant portion of these costs. In 2004, there were ~64.6 million prescriptions written for GERD medications in the United States on an annual basis. Of the prescribed GERD medications, proton pump inhibitors (PPIs) accounted for >75% of prescriptions. In 2004, this exceeded $10 billion, with the majority of sales (>9.5 billion) for brand name products. In 2010, Nexium accounted for the most retail dollars (US$5.2 billion) of all branded drugs sold in the United States. In addition, constipation is associated with an estimated 1.57 billion in annual direct medical costs, including 178 million in prescription drug costs. Within the United States, the over-the-counter (OTC) market accounts for a significant proportion of the different drug classes utilized by physicians for treating both GERD and constipation. For GERD, the PPI market continues to evolve with a limited number of prescription options as well as numerous OTC medications including brand name (i.e., Prilosec OTC)and generic or "store brand" products (i.e., Target brand omeprazole). Prilosec OTC was the first brand name OTC PPI to be introduced in September of 2003. Subsequently, Prevacid 24HR, Zegerid OTC, and most recently Nexium 24HR have all been released OTC. The OTC generic equivalents of Prilosec, Prevacid, and Zegerid have also all been released and are available as store brands with the store brand of esomeprazole to become available in March of 2017. For constipation, the current classes that comprise the US OTC market include: fiber supplements, stool softeners, osmotic agents, and stimulant laxatives. Both brand name and store brands are available for each of the various laxative options.
OTC brand name and OTC store brand products contain the same active ingredient, but vary considerably in price. In this era of increased scrutiny of health-care expenditures, attention to cost effectiveness among physicians is a growing topic of discussion. Little is known about how US gastroenterologists consider and utilize prescription, OTC name brand, and store brand products for patients with GERD and CC. In addition, as the number of OTC options increases and payers increasingly implement medication coverage strategies that push providers and patients to OTC products, it will become increasingly important for stakeholders to understand the regulation of and difference between name brand and store brand OTC treatments. Therefore, the aim of this study was to assess how US gastroenterologists perceive and utilize prescription as well as name brand and store brand OTC medications for GERD and chronic constipation and to determine gastroenterologist's knowledge of the federal regulation of OTC medications. We hypothesize that US gastroenterologists may have preferential practices when prescribing OTCs and have little knowledge of the price differences between store brand OTC GI medications and brand name alternatives of the same medications.
Am J Gastroenterol. 2015;110(11):1516-1525. © 2015 Nature Publishing Group