Self-selection and use patterns of over-the-counter omeprazole for frequent heartburn.

Abstract

BACKGROUND AND AIMS:

The Food and Drug Administration approval and subsequent launch of over-the-counter (OTC) omeprazole raises the question whether consumers would use OTC omeprazole appropriately in a "real world" setting.

METHODS:

A 3-month observational study was conducted in an OTC setting to determine whether consumers could (1) correctly self-select to use omeprazole for frequent heartburn, (2) comply with a product label that calls for 14 consecutive days of once-daily dosing, and (3) use more than 14 doses of medication only under the advice of a physician. Consumers were interviewed at 5 shopping malls in geographically distinct areas of the United States and asked whether they had heartburn. Of the 1999 self-reported heartburn sufferers, 866 determined the product was appropriate for their condition and purchased the product; of these, 758 (88%) returned diaries documenting product usage and physician contact.

RESULTS:

OTC consumers accurately self-selected; more than 90% of participants had heartburn 2 or more days/week. Analysis of diary data showed a high degree of compliance to label use directions; only 3% of subjects took more than 14 doses without consulting a physician. After 3 months, 43% of subjects did not have recurrence of heartburn. Overall, 75% of subjects had contact with a physician about heartburn before, during, or soon after the study (26% contacted a physician during the 3-month study). Of the 758 subjects, only 1 subject took more than 14 tablets without consulting a physician and had recurrence of heartburn.

CONCLUSIONS:

Actual use data support that consumers accurately self-select if an OTC proton pump inhibitor is appropriate for use, comply with a 14-day regimen in the OTC setting, and appropriately seek physician involvement for longer-term management of frequent heartburn.

• Authors: A Mark Fendrick, Michael Shaw, Bernard Schachtel, Lisa Allgood, Greg Allgood, Julie Grender, David Peura
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 2 Issue 1 Pg. 17-21 (Jan 2004) ISSN: 1542-3565 [Print] United States
• PMID: 15017628 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Ulcer Agents
• Anticonvulsants
• Nonprescription Drugs
• Proton Pump Inhibitors
• Proton Pumps
• Phenytoin
• Omeprazole

Topics

• Adolescent
• Adult
• Anti-Ulcer Agents (therapeutic use)
• Anticonvulsants (administration & dosage)
• Consumer Product Safety
• Drug Labeling
• Female
• Follow-Up Studies
• Heartburn (drug therapy, epidemiology, psychology)
• Humans
• Interviews as Topic
• Male
• Middle Aged
• Nonprescription Drugs (therapeutic use)
• Omeprazole (therapeutic use)
• Patient Compliance
• Phenytoin (administration & dosage)
• Proton Pump Inhibitors
• Proton Pumps (administration & dosage)
• Recurrence
• Referral and Consultation
• Self Medication
• Time Factors
• United States (epidemiology)