Self-selection and use patterns of over-the-counter omeprazole for frequent heartburn.
OBJECTIVE
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.
Fendrick
A Mark
AM
Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA. amfen@umich.edu
Shaw
Michael
M
Schachtel
Bernard
B
Allgood
Lisa
L
Allgood
Greg
G
Grender
Julie
J
Peura
David
D
D000293:Adolescent; D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000008:administration & dosage; D003257:Consumer Product Safety; D004348:Drug Labeling; D005260:Female; D005500:Follow-Up Studies; D006356:Heartburn / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D009853:Omeprazole / Q000627:therapeutic use*; D010349:Patient Compliance; D010672:Phenytoin / Q000008:administration & dosage; D054328:Proton Pump Inhibitors; D017494:Proton Pumps / Q000008:administration & dosage; D012008:Recurrence; D012017:Referral and Consultation; D012651:Self Medication; D013997:Time Factors; D014481:United States / Q000453:epidemiology
D000897:Anti-Ulcer Agents; D000927:Anticonvulsants; D004366:Nonprescription Drugs; D054328:Proton Pump Inhibitors; D017494:Proton Pumps; D010672:Phenytoin; D009853:Omeprazole