Rx-to-OTC Switch for PPIs Linked to Reduced PCP Visits for GERD

Omeprazole became available OTC in 2003
Omeprazole became available OTC in 2003

The over-the-counter (OTC) availability of proton pump inhibitors (PPIs) was associated with a significant decrease in the rate of primary care physician (PCP) visits for gastroesophageal reflux disease (GERD) in the U.S.  Findings from this study were published in The Journal of Clinical Pharmacology.

In 2003, the Food and Drug Administration (FDA) approved the Rx-to-OTC switch for PPIs. Using data from the National Ambulatory Medical Care Survey, researchers aimed to investigate whether having an effective OTC option for self-care of GERD would change the frequency of PCP visits for this condition.

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Analysis of the data showed that from 1993 to 2003 there was almost a 3-fold increase in physician visits for GERD. However after 2003 (when omeprazole became available OTC), visits for GERD plateaued then remained stable from 2004–2012.

Interestingly, the incidence of esophageal cancer, gastric cancer, and hospitalizations for upper GI hemorrhage did not differ in the time periods before and after 2003, indicating self-management was not associated with an increase in possible adverse consequences of misdiagnosis or inappropriate therapy of heartburn.

While more studies are needed to confirm the results of this study, the findings do suggest that an Rx-to-OTC conversion for drugs that treat common medical conditions could potentially have a profound effect on outpatient healthcare utilization.  

The authors do note several limitations to their study, one being that "the temporal relationship between the Rx-to-OTC switch of omeprazole and changes in physician visit rates for GERD is associative and does not prove causality."

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