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Misuse of an over-the-counter drug to treat urinary tract infection raises concern about reclassifying prescription drugs

A growing number of prescription medications, ranging from nicotine patches to nonsedating allergy medications, are being reclassified to over-the-counter (OTC) status. However, a new study shows that inappropriate use of an OTC drug to treat urinary tract infection (UTI), formerly available only by prescription, is common, as is substitution of the drug for a visit to the doctor. This finding bolsters the arguments of critics of drug reclassification, who are concerned that it will encourage improper self-diagnosis and self-medication. It also underscores the need to educate consumers about the proper use of these reclassified drugs, says Chih-Wen Shi, M.D., M.S.H.S., of the University of California, Los Angeles.

In a study supported by the Agency for Healthcare Research and Quality (National Research Service Award fellowship F32 HS11507), Dr. Shi and colleagues evaluated the use of an OTC urinary analgesic, phenazopyridine (pyridium), which is widely marketed for UTI via television commercials and women's magazines. They surveyed a random sample of 434 adult OTC pyridium purchasers in 31 Los Angeles pharmacies over a 5-month period. Survey questions addressed symptoms prompting use, prior history of UTI, prior prescription use of pyridium, concurrent therapy, medical contraindications, and other topics.

The researchers defined inappropriate use as having medical contraindications to pyridium or not having concurrent antibiotic and/or provider evaluation for urinary symptoms. Half (51 percent) of those surveyed used OTC pyridium inappropriately, and 38 percent substituted it for medical care. Inappropriate use was correlated with having little time to see a provider, receiving friend's or family's advice, having prior UTIs, having used prescription pyridium, and having back pain. Respondents with incorrect knowledge about pyridium's mode of action were twice as likely as those with correct knowledge to use it inappropriately or substitute it for medical care.

See "Usage patterns of over-the-counter phenazopyridine (pyridium)," by Dr. Shi, Steven M. Asch, M.D., M.P.H., Eve Fielder, Dr.P.H., and others, in the April 2003 Journal of General Internal Medicine 18, pp. 281-287.

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