Misuse of Over-the-Counter Anti-Candida Medications Associated With Patient Self-Diagnosis

Gilles R. G. Monif, MD


Infect Med. 2003;20(2) 


Vulvovaginal candidiasis is a distressing condition that warrants rapid and effective resolution. The decision by the FDA to give antifungal medications over-the-counter (OTC) status had ample justification in terms of the potential for rapidly terminating symptoms, reducing health care costs, and empowering women in achieving these goals. However, an erroneous diagnosis often eliminates these potential benefits: relief of symptoms may be minimal or transient, the return for the health care dollar expended may be negated, and a more serious condition may be left undiagnosed.

Ferris and colleagues (Obstet Gynecol. 2002;99:419-425) evaluated 95 women by means of clinical examinations and laboratory tests. The women had self-diagnosed vulvovaginal candidiasis and had purchased OTC antifungal medications. Analysis of the results included an individual check for a history of vulvovaginal candidiasis and reading of the OTC package insert before use. Only 33.7% of the women correctly self-diagnosed vulvovaginal candidiasis. Women with a previous clinical diagnosis of vulvovaginal candidiasis were not more accurate in making a self-diagnosis of vulvovaginal candidiasis than women without a previous diagnosis. Similarly, whether a woman read the package insert had little significance in the accuracy of self-diagnosis. Fifty-one percent of these women required a physician-prescribed medication to terminate symptoms and their cause.

Allen-Davis and associates (Obstet Gynecol. 2002;99:18-22) looked at a different aspect of essentially the same problem. The investigators analyzed telephone and office management of vulvovaginal complaints in terms of the accuracy of a diagnosis of vulvovaginitis. The study population consisted of 253 women who first had telephone interviews conducted by nurses and then a clinical examination conducted by a physician, nurse midwife, or physician assistant. Statistical analysis demonstrated not only disagreement between the examining nurses and physicians about the major common causes of vaginitis but also disagreement between the telephone nurses and practitioners concerning the need for an office visit. The authors infer that office-based phone triage is flawed. The investigators conclude that self-diagnosis, at least for vulvovaginal candidiasis, is accurate in approximately one third of cases. The net result is that women bear an unnecessary erroneous diagnosis more often than should be tolerated. In theory, erroneous diagnosis erodes much of the cost savings and efficiency that could be gained by self- diagnosis or phone management.

To compound the issue, most practitioners who deal with infectious vulvovaginal disease have abandoned the microscopic examination (wet mount preparations) of vaginal secretions.

The concept of OTC self-medication has strong validity and is likely here to stay. There is no quick fix to this current dilemma in the area of vulvovaginal candidiasis. However, the following are steps that can be taken.

  • In view of evolving data, the FDA needs to reexamine the tenets used to make their decision to give some antifungal medications OTC status.

  • The FDA Women's Advisory advocates and the various medical disciplines that provide the bulk of women's health care need to correct the existing educational/information deficits that contribute to this problem.

If the problem is not corrected, this ready access to antifungal medications will continue to be associated with misuse of a woman's health care dollar and with delay in the diagnosis of the underlying cause of her symptoms.


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