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Physician Utilization by Consumers of OTC Proton Pump Inhibitors

A. Mark Fendrick1, Michael Shaw2, Lisa Allgood3, Greg Allgood3, David Peura4
1University of Michigan, Ann Arbor, MI;
2Park Nicolet, St Louis, MN;
3Procter & Gamble Health Sciences Institute, Cincinnati, OH;
4University of Virginia, Charlottesville, VA.

Purpose: Decreased physician visits are anticipated after a prescription drug "switches" to over-the-counter (OTC) status. However, no decrease was observed after H2 receptor antagonists were approved for over-the-counter (OTC) use. The safety and efficacy of proton pump inhibitors have led to the evaluation of omeprazole (Prilosec) in the OTC setting. The proposed omeprazole OTC label provides specific recommendations to consumers on when to consult their doctor. This study was conducted to assess consumer compliance to label directions and to assess physician utilization.

Methods: To measure correct self-selection, compliance with label directions, and physician consultation by purchasers of OTC omeprazole in a naturalistic setting, more than 5,000 consumers were approached at 5 shopping malls in geographically distinct areas of the US, and asked if they had heartburn. Self-reported heartburn sufferers (n=1999) were shown the OTC omeprazole carton and were given the opportunity to purchase study medication at the intended market price. This self-selection population was provided a diary to document product usage and physician contact for heartburn. In addition, as part of an ongoing program, a representative population of over 30,000 OTC consumers was surveyed via mail and internet regarding physician utilization for heartburn.

Results: Of the 866 subjects who purchased study medication (91% of had > 2 heartburn episodes per week), 75% of subjects had contact with a physician (53%-prior to; 26%-during; 8%-soon after) about frequent heartburn. There were no gender, age, race, socioeconomic, or education differences between those who did/did not visit a physician. Importantly, of the subjects who had not consulted a physician prior to the study, 20% did so for the first time in association with the study. Of the 758 subjects who completed the study, only 1 took more than the recommended 14-day treatment regimen without consulting a physician and had recurrent heartburn. The physician consultation rate was corroborated by survey data in which consumers reported consultation rates between 41% and 68% for their frequent heartburn.

Conclusions: Consumers appropriately self-selected the OTC omeprazole product, used the product appropriately, and consulted their physicians for management of frequent heartburn. The rate of physician visits by consumers of OTC proton pump inhibitors in a naturalistic setting met or exceeded present experience. Thus, it is unlikely that the availability of OTC proton pump inhibitors will decrease physician utilization.


Fendrick, AM, M Shaw, L Allgood, G Allgood, D Peura. Physician Utilization by Consumers of OTC Proton Pump Inhibitors. Digestive Diseases Week, Orlando, Florida, May 2003.

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