Improving Appropriate Use of Antifungal Medications: The Role of an Over-the-Counter Vaginal pH Self-Test DeviceReport as inadecuate

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Infectious Diseases in Obstetrics and Gynecology - Volume 11 2003, Issue 4, Pages 209-216

Professor Obstetrics and Gynecology, Keck School of Medicine of the University of Southern California, Women’s and Children’s Hospital, 1240 N. Mission Road, Room L1022, Los Angeles 90033, CA, USA

Private Practice Obstetrics and Gynecology Retired, Pasadena, CA, USA

FDA Regulatory Consultant, Washington, DC, USA

Statistical Consultant, Bethel, CT, USA

Private Practice Obstetrics and Gynecology, Monterey Park, CA, USA

Received 5 May 2003; Accepted 25 September 2003

Copyright © 2003 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Objectives: To determine whether patients can understand and use the vaginal pH device in the diagnosis ofvaginitis. To compare whether vaginal pH readings determined by patients and healthcare providers are similar.To determine whether vaginalpHcan reduce inappropriate over-the-counter OTC antifungal medication use andimprove the correct diagnosis of vaginitis.

Methods: One hundred and fifty-one women indicated their belief about the cause of their vaginal infection, readthe instructions of the vaginal pH device package insert, used the device and interpreted the findings. The patientinterpretations were compared with results obtained by healthcare providers, blinded to patient findings.

Results: Over 96% of patients stated that they could easily read the instructions, use the vaginal pH device andinterpret the readings. They obtained the same readings as healthcare professionals Kappa = 0.9. Restrictingthe use of OTC antifungal medications to those individuals with vaginitis symptoms and vaginal pH ≤ 4.5significantly reduced inappropriate use by approximately 50%, Fisher's exact test,p-value = 0.018. Conversely,seeking healthcare provider assessment with vaginal pH > 4.5, leads to correct diagnosis of vaginitis.

Conclusions: The vaginal pH device can be used as an OTC diagnostic tool by consumers when a vaginal infectionis suspected. Vaginal pH readings would direct patients whether to purchase an antifungal medication or seekprofessional diagnosis from a healthcare provider. Understanding and use of this vaginal pH device could reduceinappropriate use of OTC antifungal medications by approximately 50% and improve the correct diagnosis ofvaginitis.

Author: Subir Roy, James C. Caillouette, Joel S. Faden, Tapon Roy, and Diana E. Ramos



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