Cvao.org

Self-medication with vaginal antifungal drugs:
physicians’ experiences and women’s
utilization patterns

Sinikka Sihvoa,b, Riitta Ahonenc, Heli Mikanderc and
Elina Hemminkia

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.
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 special-
ists 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 pre-
vious 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 spon-
taneous information and to have more informative advertisements on vaginal antifungal drugs.
Keywords. Miconazole, over-the-counter drugs, self-medication, vulvovaginal candidiasis.
clotrimazole) were released over-the-counter (OTC) in1991; these same drugs were released in the UK in 1992, Vaginal Candida infection, a common problem among and in Finland miconazole was released in 1993, women, has been regarded as a minor complaint suitable clotrimazole in 1994 and tioconazole in 1995.
for self-medication. It has been estimated that vaginal According to labelling, vaginal antifungal drugs should candidiasis affects ~75% of women during their lifetime, be used under the surveillance of a physician in the and ~40–50% of them have recurrent episodes.1 In case of a first infection, if it is the third infection during the USA, certain imidazole derivatives (miconazole and the past 6 months, if the woman is under 16 years old or if it is during the first trimester of pregnancy.2 Thecrucial point for appropriate self-medication is that Received 23 June 1999; Revised 15 October 1999; Accepted
the woman should be able to self-diagnose correctly.
26 October 1999.
Vulval and vaginal itching (pruritus) is the most common aStakes (National Research and Development Centre for symptom related to Candida. Other possible symptoms Welfare and Health), POB 220, 00531 Helsinki, bUniversity of (white, thick discharge, dysuria, vulval erythema and Helsinki, Department of Public Health, POB 41, FIN-00014 swelling) can be related to many vaginal infections other University of Helsinki and cUniversity of Kuopio, Departmentof Social Pharmacy, POB 1627, 70211 Kuopio, Finland.
than Candida (e.g. bacterial vaginosis, trichomoniasis, Family Practice—an international journal Chlamydia, gonococcal infection, herpes simplex or specialists in general practice (n = 288) in six of the allergies).1,3–5 It has been suggested that most vaginal 12 Finnish counties between June and September 1996.
symptoms are treated as Candida infection although The sample was selected from the national register of bacterial vaginosis is more common.6 In a 1996 survey, healthcare professionals by listing all physicians by zip- Finnish physicians held a positive view about the OTC codes and then picking every other physician. To make release of vaginal antifungal drugs and considered reminders possible, each respondent was asked to send miconazole to be suitable for self-medication,7 like their their name tag in a separate envelope. After a reminder, British colleagues in 1994.8 American physicians’ per- 351 questionnaires were returned, of which 10 were ex- ceptions about the reclassification of vaginal antifungal cluded because the physicians were no longer in clinical work or had changed to other specialties. The response The purpose of this study was to estimate the appro- rate was 77% for both GPs and gynaecologists. The priateness of self-medication with vaginal antifungal drugs mean age was 47.5 (SD 7.8) years among gynaecologists by examining women’s utilization patterns and physicians’ and 46.5 (6.4) years among GPs. In both groups, about observations of adverse events due to self-treatment.
The questionnaire included questions on opinions on OTC releases in general7 and more detailed questions about OTC vaginal antifungal drugs. The questions usedwere related to physicians’ experiences of problems due to patient self-medication with vaginal antifungal drugs: A sample of 20 out of 795 pharmacies in Finland was “Have you observed in your work any of the following picked from different areas to represent different clien- adverse events due to the use of OTC vaginal anticandida tele. All selected pharmacies agreed to participate. In drugs?” (i) No; (ii)Yes, sometimes; (iii) Yes, often; and each pharmacy, a questionnaire was given to consecutive (iv) Cannot remember (listing eight adverse effects, customers buying OTC vaginal antifungal drugs during see Table 3). Also: “Have any of the adverse effects October and December 1997. The woman filled in the ques- you have observed been clinically significant?” (i) No; tionnaire at home and mailed it to the researcher. Depend- (ii) Yes, which ones? The chi-square test was used in ing on the pharmacy’s size and location, each pharmacy statistical testing of differences in both data sets.
distributed 10–50 questionnaires. Altogether, 453 question-naires 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 The mean age of the women using vaginal antifungal from a health care professional; or (iv) at least two pre- drugs was 35 years (SD 11.1), ranging from 15 to 77 years.
vious treatment episodes during the previous 6 months The women came from all social classes (according to but no physician consultation during the past year. The education) and 66% of them were in a steady relationship.
symptom profile was determined with the following They had more often had two or more sexual partners question: “Have you had any of the following symptoms during the past year (20% versus 13%, P Ͻ 0.01) and had during the past 2 weeks?” (i) No; (ii)Yes, but not trouble- a higher lifetime incidence of sexually transmitted some; or (iii)Yes, troublesome (with a list of 12 symptoms diseases (STDs) than Finnish women in general10 (20% listed, see Table 2). The proportion of women having symptoms more likely to indicate infections other Miconazole products were purchased most often than Candida was defined according to the medical (44%), followed by clotrimazole-containing products literature.1,3,4 Structured questions were used to study (35%) and tioconazole (17%). Half (49%) of the women decision-making (“Was it easy to conclude what these had used antifungal drugs already during the previous symptoms result from?”) and healthcare-seeking (“If 6 months and 29% had had a vaginal Candida infection the product would not have been available without a diagnosed by a physician during the past year (Table 1).
prescription, would you have visited a doctor?” and Forty-four per cent of the women were classified as using “Which doctor would you have visited?”).
the drug against the recommendations: 14% had never The sexual health profile of antifungal drug users was had a physician-diagnosed Candida infection, 30% had studied by comparing them with Finnish women from a already used two or more treatments without contacting population-based survey, FINSEX-1992, which included a physician during the previous year, 3% were pregnant women aged 18–74 years (n = 1144).10 but had no professional recommendation for use, andtwo users were under 16 years of age.
Nearly all women had experienced vulvovaginal Anonymous questionnaires were sent to a random itching (Table 2). Stinging and increased discharge were sample of working-age gynaecologists (n = 169) and also common symptoms, but less often found to be Self-medication of vaginal Candida Frequency of vaginal Candida drug use and physician’s earlier diagnosis of Candida or STDs had no effect on women’s reports of symptoms requiring a physician’sevaluation. About a quarter (24%) had experienced symptoms for 2 days or less (open-ended question) and18% 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 Ͻ 0.05) and for those who had had symptoms for at least a week (22%, P Ͻ 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%).
a Two women did not give their age.
b “Don’t remember” responses (3%) not shown in the table.
Physicians’ observations of disadvantages of self-medicationGynaecologists more often than GPs reported seeing Proportion (%) of women having had symptoms during the adverse events due to self-medication with vaginal anti- previous 2 weeks (n = 299)a fungal drugs (95% versus 74%, P Ͻ 0.01). Unnecessaryuse and use for the wrong indications were the most commonly mentioned adverse events (Table 3). Private- sector gynaecologists reported adverse events mostoften. Both female GPs and female gynaecologists Symptoms likely to indicate Candida infection reported seeing adverse effects more often than their In the subsequent question that explored the sig- nificance of these adverse effects, 21% of all physicians stated that some of the disadvantages they had observedwere clinically significant. Problems were identified more often by gynaecologists than by GPs (30% versus 16%, P Ͻ 0.01), more often by female than male doctors Symptoms likely to indicate another infection (28% versus 15%, P Ͻ 0.01) and more often by private- sector physicians (45% versus 18%, P Ͻ 0.001). The most commonly mentioned clinically significant problemswere misdiagnosis and resultant delays in treatment (12%) and delay specifically in the treatment of STDs a Responses to a structured question, symptoms classified afterwards Our results show that most women using antifungal according to the literature (see Methods).
drugs had at some time had a vaginal Candida infection diagnosed by a physician and that they did not report anyproblems in self-diagnosing or self-medicating; a similar troublesome. Half of the women had symptoms that result was found previously among American college could be caused by infections other than Candida. A students.11 However, a notable number of women used quarter of the women (25%) had symptoms which called OTC drugs against the recommendations: many used for physician consultation. Women’s age, education and antifungal drugs for the third time in 6 months without Family Practice—an international journal Physicians’ experiences of adverse events due to self-medication with OTC vaginal antifungal drugs (%) Chi-square test, df = 2, ***P Ͻ 0.001, ns = not significant.
consulting a physician or without ever having had a et al.5 Candida albicans is the major causative pathogen physician-diagnosed Candida infection. Further, half of in candidiasis. However, infections increasingly are the women reported symptoms that are not typical of caused by non-albicans species. The 1- to 3-day Candida infection, but can indicate other infections. The imidazole regimens will suppress C.albicans, but may evaluation of the appropriateness of self-medication by create an imbalance of flora that facilitates an over- classifying symptoms based on the medical literature growth of non-albicans species against which imidazoles and women’s own reports is an imprecise method. There- fore, these results have to be taken only as suggestive.
The drawbacks found have to be weighed against the However, our results support earlier studies12 and case benefits resulting from better availability of treatments reports13 on problems with self-diagnosis. Ferris and and the current satisfaction of the women and physicians.
co-workers12 have shown that prior clinical diagnosis of To decrease the problems raised by these two surveys, vaginal candidiasis only moderately affects women’s more complete information should be provided for ability to diagnose vaginal Candida infection correctly.
women. Advertisements can maintain the erroneous belief On the other hand, one can question whether a woman among women that if you have some of the symptoms is likely always to be diagnosed correctly by a physician: listed in the advertisement, you have Candida. Women O’Dowd et al.6 have shown that only half of the women need information about all vaginal infections and their in the UK were given a vaginal examination when symptom profiles so that they can judge their risk of contacting their GP because of vaginal symptoms. Signs having an infection other than Candida. Pharmacy and symptoms have been shown to have poor predictive personnel should take more responsibility in preventing incorrect self-diagnosis or continuous use. The physician’s Taking into account the fact that most physicians role in making the correct diagnosis and providing considered antifungal agents suitable for OTC status,7 it information remains important since most vaginal anti- is surprising that they reported so many problems related fungal drug users have at some time consulted a to self-medication with these drugs. Their perceptions about unnecessary use gains support from the statisticson medicines, which show increased consumption ofvaginal imidazoles after OTC release.14 Many physicians in this study were worried about delayed treatment due to incorrect self-diagnosis, a result 1 Working Group of the British Society for Medical Mycology.
also found among American physicians.9 Some physicians Management of genital candidiasis. Br Med J 1995; 310: 1241–
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expressed their concern about the inefficacy of treat- 2 Pharmaca Fennica. Lääketietokeskus [Finnish Drug Compendium].
ments. This problem has been discussed by Horowitz Self-medication of vaginal Candida 3 Schaaf MV, Perez-Stable EJ, Borchardt K. The limited value of 9 Taylor CA, Lipsky MS. Physicians’ perceptions of the impact of the symptoms and signs in the diagnosis of vaginal infections. reclassification of vaginal antifungal agents. J Fam Pract 1994; Arch Intern Med 1990; 150: 1929–1933.
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4 Goode MA, Grauer K, Gums JG. Infectious vaginitis—selecting 10 Kontula O, Haavio-Mannila E (eds). Suomalainen seksi—tietoa therapy and preventing recurrence. Postgrad Med 1994; 96:
suomalaisten sukupuolielämän muutoksesta [FINSEX— Information about changes in the sexual life of Finnish people, 5 Horowitz BJ, Giaquinta D, Ito S. Evolving pathogens in vulvovaginal candidiasis: implications for patient care. J Clin 11 Lipsky MS, Taylor C. The use of over-the-counter antifungal Pharmacol 1992; 32: 248–255.
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6 O’Dowd TC, Parker S, Kelly A. Women’s experiences of general practitioner management of their vaginal symptoms. Br J Gen 12 Ferris DG, Dekle C, Litaker MS. Women’s use of over-the-counter Pract 1996; 46: 415–418.
antifungal medications for gynecologic symptoms. J Fam Pract 7 Sihvo S, Hemminki E, Ahonen R. Physician’s attitudes toward re- 1996; 42: 595–600.
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13 Kabongo ML. Problems with over-the-counter vaginal preparations.
8 Erwin J, Britten N, Jones R. General practitioners’ views on over the Am Fam Physician 1993; 48: 579.
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14 Finnish Statistics on Medicines 1997. National Agency for Medicines, Social Insurance Institution, Helsinki, 1998.

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