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.

BACKGROUND Effective use of over-the-counter (OTC) medications depends on purchasers' knowledge of their indications. This study examines consumer knowledge regarding the urinary tract analgesic phenazopyridine, which recently became available without prescription.METHOD We conducted a cross-sectional survey of a stratifi ed cluster random sample of purchasers of OTC phenazopyridine (N = 434) in 31 Los Angeles retail pharmacies. RESULTSThe response rate was 58%. Only 29% correctly characterized the likely cause of their symptoms, and only 57% correctly characterized the action of the drug. Worse consumer knowledge was associated with nonwhite race, fi rst-time use, and less contact with health providers.CONCLUSION Many consumers possess poor knowledge about phenazopyridine, potentially leading to undertreatment, especially in groups with worse access to care.

OBJECTIVES:Little is known about how the public uses formerly prescription medications that are available over-thecounter (OTC). This study examines whether consumers inappropriately use and substitute a recently widely distributed OTC urinary analgesic, phenazopyridine, for provider care. DESIGN/SETTING:We conducted a cross-sectional survey of a stratified cluster random sample of OTC phenazopyridine purchasers (N = 434) in 31 Los Angeles retail pharmacies over 5 months. Recruited by shelf advertisements, participants were 18 years or older who purchased a phenazopyridine product. Each completed a 25-item self-administered anonymous questionnaire. Inappropriate use was defined as 1) having medical contraindications to phenazopyridine, or 2) not having concurrent antibiotic and/or provider evaluation for the urinary symptoms. RESULTS:The survey response rate was 58%. Fifty-one percent of the respondents used OTC phenazopyridine inappropriately, and 38% substituted it for medical care. Multiple logistic regression analyses revealed that inappropriate use was correlated with having little time to see a provider (odds ratio [OR], 1.57; 95% confidence interval [95% CI], 1.26 to 1.96), receiving friend's or family's advice (OR, 1.25; 95% CI, 1.05 to 1.47), having prior urinary tract infections (OR, 0.49; 95% CI, 0.30 to 0.80), having used prescription phenazopyridine, (OR, 0.40; 95% CI, 0.25 to 0.63), and having back pain (OR, 0.34; 95% CI, 0.16 to 0.74). Similar correlates were found in those who substituted OTC phenazopyridine for provider care. Respondents with incorrect knowledge about phenazopyridine's mode of action had 1.9 times greater odds of inappropriate use and 2.2 times greater odds of substitution than those who had correct knowledge about this drug.CONCLUSION: Inappropriate use of OTC phenazopyridine appears common. Increasing the public's knowledge about reclassified drugs may help to mitigate this problem.KEY W OR DS: ph armacy; s urvey; over-the-counter; phenazopyridine. J GEN INTERN MED 2003;18:281±287.

Many prescription drugs have been converted to over-the-counter (OTC) status in recent years. Another drug that has been proposed for OTC status is a levonorgestrel-only emergency contraceptive pill. The debate surrounding OTC access to emergency contraceptive pills echoes issues encountered in previous reclassification processes and raises new challenges. This article discusses the emergency contraceptive pill, the evolution of its access options, and the context and implications of changing its status from a prescription to an OTC medication.

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