Over-the-Counter Antifungal Drug Misuse Associated with Patient-Diagnosed Vulvovaginal Candidiasis

Ferris DG, Nyirjesy P, Sobel JD, et al.

Editor Comments: The following article reinforces the need for improved counseling by pharmacists in the area of nonprescription medicines. The FDA certifies that all labeling of nonprescription medicines is easily understood by the public and thus is safe and effective when used as directed. The pharmacist can help ensure that the public actually reads and follows the directions properly, answer questions that may arise, and/or refer the patient to a physician. This article serves to remind faculty of the need to reinforce to our students the importance of proper patient counseling regarding nonprescription medicines. Self-Treatment of Vulvovaginal Candidiasis Prior to the last decade, vulvovaginal candidiasis was treated exclusively by a healthcare provider. The Food and Drug Administration (FDA) guidelines indicate that women who have previously been diagnosed by a clinician and those who read the product label are able to self-treat with these products. Method Ninety-five women in five states were recruited to participate in the study as they were purchasing over-the-counter products designed to treat vulvovaginal candidiasis. The time period was September 1997 through December 1999. Patients answered an in-depth survey; a complete clinical examination and laboratory tests were also performed. Results Only 32 (33.7%) made the correct diagnosis of vulvovaginal candidiasis. An additional 19 (20%) had vulvovaginal candidiasis plus another type of vaginitis, primarily coexisting bacterial vaginosis (18.9%). Fifty-one percent had a vaginal pH greater than or equal to 4.7, 30% had a positive sniff test, 36% had evidence of vulvovaginal candidiasis by the 10% potassium hydroxide test, 30% had evidence of vulvovaginal candidiasis by Gram stain, and 45% had a positive fungal culture. One woman had a positive test for C. trachomatis. Women who correctly self-diagnosed vulvovaginal candidiasis (including those with mixed infection) reported being no more certain of their diagnoses than women without vulvovaginal candidiasis (median Likert score 7; range 1 not certain—10 very certain). Women with a previous clinically based diagnosis of vulvovaginal candidiasis were not more accurate in self-diagnosis than women without a previous diagnosis of vulvovaginal candidiasis (chi square = 0.27, P = 0.6), and women who read the label were no more likely to have vulvovaginal candidiasis than women who did not (Fisher exact test, P = 0.39). Discussion Although it's purported to have the benefit of reduced healthcare costs and empowering women, self-treatment of vulvovaginal candidiasis in reality can be dangerous because women tend to misdiagnose, regardless of whether they report reading the label or having prior incidences of vulvovaginal candidiasis. Additionally, the delay in accurate diagnosis of the condition has the potential to be severe. One patient in the study actually required hospitalization for her condition, and that would have been delayed had she self-treated. The authors observe that while empowering women to self-treat may be financially lucrative for pharmaceutical companies, it may not be in the best financial or health interests of women. Obstet Gynecol 2002;99:419-25. Copyright © 2002 and published by Medical Economics Company at Montvale, NJ 07645-1742. All rights reserved. Return to Top