Family Practice Vol. 17, No. 2, 145-149
© Oxford University Press 2000
Self-medication with vaginal antifungal drugs: physicians' experiences and women's utilization patterns
a Stakes (National Research and Development Centre for Welfare and Health), POB 220, 00531 Helsinki,
b University of Helsinki, Department of Public Health, POB 41, FIN-00014 University of Helsinki and
c University of Kuopio, Department of Social Pharmacy, POB 1627, 70211 Kuopio, Finland.
Sihvo S, Ahonen R, Mikander H and Hemminki E. Self-medication with vaginal antifungal drugs: physicians' experiences and women's utilization patterns. Family Practice 2000; 17: 145–149.
Received 23 June 1999; Revised 15 October 1999; Accepted 26 October 1999.
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Abstract |
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Background. In many countries, vaginal antifungal drugs have been released on over-the-counter (OTC) markets, yet little is known about women's management of their symptoms.
Objectives. The aim of this study was to judge the appropriateness of self-medication with vaginal antifungal drugs by examining utilization patterns and physicians' experiences of women's self-medication.
Methods. An anonymous questionnaire survey was carried out in 20 pharmacies in Finland of women buying OTC vaginal antifungal drugs in 1997. Out of the 453 questionnaires distributed, 299 (66%) were returned. A survey of a random sample of gynaecologists (n = 169) and specialists in general practice (n = 288) was carried out in 1996. The response rate was 77%.
Results. Nearly all women had used vaginal antifungal drugs previously, 49% during the previous 6 months. Most women did not report any difficulties with treatment, but 44% of women used the drug against recommendations. Half of the women had symptoms that are more likely to be related to infections other than Candida. Physicians had observed several disadvantages of self-treatment, with unnecessary use and use for the wrong indications being the most often reported. In all, 31% of gynaecologists and 16% of GPs reported that these adverse events had been clinically significant, with delay in the treatment of other infections being the most common problem.
Conclusion. The results raise concerns about inappropriate use and women's ability to self-diagnose correctly. Because vaginal antifungal drugs are likely to remain on OTC markets, two ways to address these concerns are for physicians and pharmacy personnel to provide spontaneous information and to have more informative advertisements on vaginal antifungal drugs.
Keywords. Miconazole, over-the-counter drugs, self-medication, vulvovaginal candidiasis.
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Introduction |
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Vaginal Candida infection, a common problem among women, has been regarded as a minor complaint suitable for self-medication. It has been estimated that vaginal candidiasis affects ~75% of women during their lifetime, and ~40–50% of them have recurrent episodes.1 In the USA, certain imidazole derivatives (miconazole and clotrimazole) were released over-the-counter (OTC) in 1991; these same drugs were released in the UK in 1992, and in Finland miconazole was released in 1993, clotrimazole in 1994 and tioconazole in 1995.
According to labelling, vaginal antifungal drugs should be used under the surveillance of a physician in the case of a first infection, if it is the third infection during the past 6 months, if the woman is under 16 years old or if it is during the first trimester of pregnancy.2 The crucial point for appropriate self-medication is that the woman should be able to self-diagnose correctly. Vulval and vaginal itching (pruritus) is the most common symptom related to Candida. Other possible symptoms (white, thick discharge, dysuria, vulval erythema and swelling) can be related to many vaginal infections other than Candida (e.g. bacterial vaginosis, trichomoniasis, Chlamydia, gonococcal infection, herpes simplex or allergies).1,3–5 It has been suggested that most vaginal symptoms are treated as Candida infection although bacterial vaginosis is more common.6 In a 1996 survey, Finnish physicians held a positive view about the OTC release of vaginal antifungal drugs and considered miconazole to be suitable for self-medication,7 like their British colleagues in 1994.8 American physicians' perceptions about the reclassification of vaginal antifungal agents were mixed.9
The purpose of this study was to estimate the appropriateness of self-medication with vaginal antifungal drugs by examining women's utilization patterns and physicians' observations of adverse events due to self-treatment.
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Methods |
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Survey of users
A sample of 20 out of 795 pharmacies in Finland was picked from different areas to represent different clientele. All selected pharmacies agreed to participate. In each pharmacy, a questionnaire was given to consecutive customers buying OTC vaginal antifungal drugs during October and December 1997. The woman filled in the questionnaire at home and mailed it to the researcher. Depending on the pharmacy's size and location, each pharmacy distributed 10–50 questionnaires. Altogether, 453 questionnaires were distributed and 299 (66%) were returned.
The criteria for possible inappropriate self-medication were defined as follows: (i) never had a physician-diagnosed Candida infection; (ii) age under 16 years; (iii) used during pregnancy without recommendation from a health care professional; or (iv) at least two previous treatment episodes during the previous 6 months but no physician consultation during the past year. The symptom profile was determined with the following question: "Have you had any of the following symptoms during the past 2 weeks?" (i) No; (ii)Yes, but not troublesome; or (iii)Yes, troublesome (with a list of 12 symptoms listed, see Table 2
). The proportion of women having symptoms more likely to indicate infections other than Candida was defined according to the medical literature.1,3,4 Structured questions were used to study decision-making ("Was it easy to conclude what these symptoms result from?") and healthcare-seeking ("If the product would not have been available without a prescription, would you have visited a doctor?" and "Which doctor would you have visited?").
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The sexual health profile of antifungal drug users was studied by comparing them with Finnish women from a population-based survey, FINSEX-1992, which included women aged 18–74 years (n = 1144).10
Physicians' survey
Anonymous questionnaires were sent to a random sample of working-age gynaecologists (n = 169) and specialists in general practice (n = 288) in six of the 12 Finnish counties between June and September 1996. The sample was selected from the national register of healthcare professionals by listing all physicians by zipcodes and then picking every other physician. To make reminders possible, each respondent was asked to send their name tag in a separate envelope. After a reminder, 351 questionnaires were returned, of which 10 were excluded because the physicians were no longer in clinical work or had changed to other specialties. The response rate was 77% for both GPs and gynaecologists. The mean age was 47.5 (SD 7.8) years among gynaecologists and 46.5 (6.4) years among GPs. In both groups, about half of the physicians were women.
The questionnaire included questions on opinions on OTC releases in general7 and more detailed questions about OTC vaginal antifungal drugs. The questions used were related to physicians' experiences of problems due to patient self-medication with vaginal antifungal drugs: "Have you observed in your work any of the following adverse events due to the use of OTC vaginal anticandida drugs?" (i) No; (ii)Yes, sometimes; (iii) Yes, often; and (iv) Cannot remember (listing eight adverse effects, see Table 3). Also: "Have any of the adverse effects you have observed been clinically significant?" (i) No; (ii) Yes, which ones? The chi-square test was used in statistical testing of differences in both data sets.
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Results |
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Use of vaginal antifungal drugs
The mean age of the women using vaginal antifungal drugs was 35 years (SD 11.1), ranging from 15 to 77 years. The women came from all social classes (according to education) and 66% of them were in a steady relationship. They had more often had two or more sexual partners during the past year (20% versus 13%, P < 0.01) and had a higher lifetime incidence of sexually transmitted diseases (STDs) than Finnish women in general10 (20% versus 11%, P < 0.001).
Miconazole products were purchased most often (44%), followed by clotrimazole-containing products (35%) and tioconazole (17%). Half (49%) of the women had used antifungal drugs already during the previous 6 months and 29% had had a vaginal Candida infection diagnosed by a physician during the past year (Table 1). Forty-four per cent of the women were classified as using the drug against the recommendations: 14% had never had a physician-diagnosed Candida infection, 30% had already used two or more treatments without contacting a physician during the previous year, 3% were pregnant but had no professional recommendation for use, and two users were under 16 years of age.
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Nearly all women had experienced vulvovaginal itching (Table 2
). Stinging and increased discharge were also common symptoms, but less often found to be troublesome. Half of the women had symptoms that could be caused by infections other than Candida. A quarter of the women (25%) had symptoms which called for physician consultation. Women's age, education and earlier diagnosis of Candida or STDs had no effect on women's reports of symptoms requiring a physician's evaluation. About a quarter (24%) had experienced symptoms for 2 days or less (open-ended question) and 18% for a week or more before buying the drug. The majority (79%) of women said that it is easy to determine the causes of their symptoms, 12% found it difficult and 10% could not say. Self-diagnosis was more difficult for those women who had never visited a physician due to vaginal symptoms (21%, P < 0.05) and for those who had had symptoms for at least a week (22%, P < 0.01). Nearly half (46%) of the women stated that they would have contacted a physician immediately if antifungal drugs had not been available OTC. Another 49% would have waited for a couple of days to see whether the symptoms would ameliorate by themselves before contacting a physician, and only 4% would not have contacted a physician or could not answer the question. Most women would have contacted a GP in a public health centre (46%) or a private gynaecologist (45%).
Physicians' observations of disadvantages of self-medication
Gynaecologists more often than GPs reported seeing adverse events due to self-medication with vaginal antifungal drugs (95% versus 74%, P < 0.01). Unnecessary use and use for the wrong indications were the most commonly mentioned adverse events (Table 3). Private-sector gynaecologists reported adverse events most often. Both female GPs and female gynaecologists reported seeing adverse effects more often than their male colleagues.
In the subsequent question that explored the significance of these adverse effects, 21% of all physicians stated that some of the disadvantages they had observed were clinically significant. Problems were identified more often by gynaecologists than by GPs (30% versus 16%, P < 0.01), more often by female than male doctors (28% versus 15%, P < 0.01) and more often by private-sector physicians (45% versus 18%, P < 0.001). The most commonly mentioned clinically significant problems were misdiagnosis and resultant delays in treatment (12%) and delay specifically in the treatment of STDs (8%).
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Discussion |
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Our results show that most women using antifungal drugs had at some time had a vaginal Candida infection diagnosed by a physician and that they did not report any problems in self-diagnosing or self-medicating; a similar result was found previously among American college students.11 However, a notable number of women used OTC drugs against the recommendations: many used antifungal drugs for the third time in 6 months without consulting a physician or without ever having had a physician-diagnosed Candida infection. Further, half of the women reported symptoms that are not typical of Candida infection, but can indicate other infections. The evaluation of the appropriateness of self-medication by classifying symptoms based on the medical literature and women's own reports is an imprecise method. Therefore, these results have to be taken only as suggestive. However, our results support earlier studies12 and case reports13 on problems with self-diagnosis. Ferris and co-workers12 have shown that prior clinical diagnosis of vaginal candidiasis only moderately affects women's ability to diagnose vaginal Candida infection correctly. On the other hand, one can question whether a woman is likely always to be diagnosed correctly by a physician: O'Dowd et al.6 have shown that only half of the women in the UK were given a vaginal examination when contacting their GP because of vaginal symptoms. Signs and symptoms have been shown to have poor predictive value in defining vaginal infection.3
Taking into account the fact that most physicians considered antifungal agents suitable for OTC status,7 it is surprising that they reported so many problems related to self-medication with these drugs. Their perceptions about unnecessary use gains support from the statistics on medicines, which show increased consumption of vaginal imidazoles after OTC release.14
Many physicians in this study were worried about delayed treatment due to incorrect self-diagnosis, a result also found among American physicians.9 Some physicians expressed their concern about the inefficacy of treatments. This problem has been discussed by Horowitz et al.5 Candida albicans is the major causative pathogen in candidiasis. However, infections increasingly are caused by non-albicans species. The 1- to 3-day imidazole regimens will suppress C.albicans, but may create an imbalance of flora that facilitates an overgrowth of non-albicans species against which imidazoles are ineffective.
The drawbacks found have to be weighed against the benefits resulting from better availability of treatments and the current satisfaction of the women and physicians. To decrease the problems raised by these two surveys, more complete information should be provided for women. Advertisements can maintain the erroneous belief among women that if you have some of the symptoms listed in the advertisement, you have Candida. Women need information about all vaginal infections and their symptom profiles so that they can judge their risk of having an infection other than Candida. Pharmacy personnel should take more responsibility in preventing incorrect self-diagnosis or continuous use. The physician's role in making the correct diagnosis and providing information remains important since most vaginal antifungal drug users have at some time consulted a physician due to these symptoms.
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References |
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1 Working Group of the British Society for Medical Mycology. Management of genital candidiasis. Br Med J 1995; 310: 1241– 1244.
2 Pharmaca Fennica. Lääketietokeskus [Finnish Drug Compendium]. 1998.
3 Schaaf MV, Perez-Stable EJ, Borchardt K. The limited value of symptoms and signs in the diagnosis of vaginal infections. Arch Intern Med 1990; 150: 1929–1933.[Abstract]
4 Goode MA, Grauer K, Gums JG. Infectious vaginitis—selecting therapy and preventing recurrence. Postgrad Med 1994; 96: 85–98.
5 Horowitz BJ, Giaquinta D, Ito S. Evolving pathogens in vulvovaginal candidiasis: implications for patient care. J Clin Pharmacol 1992; 32: 248–255.[Abstract]
6 O'Dowd TC, Parker S, Kelly A. Women's experiences of general practitioner management of their vaginal symptoms. Br J Gen Pract 1996; 46: 415–418.[ISI][Medline]
7 Sihvo S, Hemminki E, Ahonen R. Physician's attitudes toward reclassifying drugs as over-the-counter. Med Care 1999; 37: 518–525.[ISI][Medline]
8
Erwin J, Britten N, Jones R. General practitioners' views on over the counter sales by community pharmacists. Br Med J 1996; 312: 617–618.
9 Taylor CA, Lipsky MS. Physicians' perceptions of the impact of the reclassification of vaginal antifungal agents. J Fam Pract 1994; 38: 157–160.[ISI][Medline]
10 Kontula O, Haavio-Mannila E (eds). Suomalainen seksi—tietoa suomalaisten sukupuolielämän muutoksesta [FINSEX—Information about changes in the sexual life of Finnish people, in Finnish], WSOY, Helsinki, 1993.
11 Lipsky MS, Taylor C. The use of over-the-counter antifungal vaginitis preparations by college students. Fam Med 1996; 28: 493–495.[Medline]
12 Ferris DG, Dekle C, Litaker MS. Women's use of over-the-counter antifungal medications for gynecologic symptoms. J Fam Pract 1996; 42: 595–600.[ISI][Medline]
13 Kabongo ML. Problems with over-the-counter vaginal preparations. Am Fam Physician 1993; 48: 579.
14 Finnish Statistics on Medicines 1997. National Agency for Medicines, Social Insurance Institution, Helsinki, 1998.
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