Histamine2-receptor antagonists (H2RAs) are popular examples, although they may be supplanted by OTC proton pump inhibitors (PPIs).
In this study, researchers from the United States examined the extent that over-the-counter (OTC) histamine2-receptor antagonists (H2RAs) are substituted for physician care. They also examined whether consumers engaged in off-label use of these medications.
The team surveyed 1116 adult OTC H2RA consumers from 20 Los Angeles pharmacies.
They defined off-label use by the FDA warning label (e.g., bloody stools, dysphagia).
Substitution was defined by intent to use H2RA instead of going to a physician.
|34% of consumers substituted over-the-counter histamine2-receptor antagonists for physician care.|
|American Journal of Gastroenterology|
The researchers found that 46% of the consumers engaged in off-label use of OTC H2RAs.
They established that off-label use was associated with lower income, substitution for physician care, prior gastrointestinal disease, and past prescription H2RA use.
Overall, 34% substituted OTC H2RA use for physician care, of these, 54% met the criteria for off-label use.
The team found that substitution was associated with lack of health insurance, lack of time to see a physician, the belief that OTC H2RA was cheaper than clinic visits, and nonwhite race.
Dr Chih-Wen Shi and colleagues concluded, "Almost one-half of adult consumers reported using OTC H2RAs in a manner inconsistent with FDA labeling, and this off-label use was associated with substitution for physician care".
"Traditionally vulnerable populations were more prone to off-label use and to substituting H2RAs for physician care".
"Further studies are needed to assess patient outcomes, identify remedies, and explore implications for the reclassification of PPIs".