Prevalence and factor associated with over-the-counter use of antifungal agents’, in Mwanza City, Tanzania

Abstract

Background: Misuse of antifungal agents both in clinics and agriculture has been associated with the increased trend of antifungal resistance. In Tanzania, there is limited information regarding the magnitude of antifungal obtained over the counter. This study was therefore, conducted to determine the extent of over the counter (OTC) antifungal use and factors associated to it. Methods: This was a cross-sectional study involving patients buying antifungal agents from community pharmacies between May and July 2015 in Mwanza city, Tanzania. Data were collected by the investigator using interview guided questionnaire. Results: A total of 270 patients were enrolled and interviewed. The mean age was 30±12 years. Majority of patients (59.6%) were females. Of the 270 patients, 188 (69.3%) had dermatophytes. A total of 150 (55.6%, 95%CI 49.6-61) obtained antifungal OTC. Of 150 patients who received antifungal agents OTC, 64 (42.3%) received more than one antifungal agents compared to only 9.2% (11/120) of those with prescription (p<0.001). Clotrimazole was the commonly prescribed antifungal agent while fluconazole was mostly obtained OTC. On univariate analysis, increase in age was found to be associated with the tendency of obtaining antifungal agents over the counter (OR 1.03, 95% CI 1.008-1.05, P<0.006). Having skin fungal infections was the only predictor of obtaining antifungal agents OTC (OR 3.36, 95% CI 2.34-4.81, P<0.001). Conclusion: In Mwanza City, patients receive multiple antifungal agents over the counter and the practice is significantly more for those with skin fungal infections. There is a need for the advocacy on appropriate use of antifungal agent reduce the associated impact of resistance development. © 2017, National Institute for Medical Research. All rights reserved.

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Tanzania Journal of Health Research Doi: http://dx.doi.org/10.4314/thrb.v19i1.8
Volume 19, Number 1, January 2017
1
Prevalence and factors associated with over-the-counter use of antifungal
agents in Mwanza City, Tanzania
MARTHA F. MUSHI1*, BENEDICTOR MASEWA2, MARY JANDE2, MARIAM M. MIRAMBO1, STEPHEN E. MSHANA1.
1Department of Microbiology and Immunology, Weill Bugando School of Medicine, P. O. Box 1464, Mwanza,
Tanzania
2Department of Clinical Pharmacology, Weill Bugando School of Medicine, P.O. Box 1464, Mwanza, Tanzania
Abstract
Background: Misuse of antifungal agents both in clinics and agriculture has been associated with the increased
trend of antifungal resistance. In Tanzania, there is limited information regarding the magnitude of antifungal
obtained over the counter. This study was therefore, conducted to determine the extent of over the counter
(OTC) antifungal use and factors associated to it.
Methods: This was a cross-sectional study involving patients buying antifungal agents from community
pharmacies between May and July 2015 in Mwanza city, Tanzania. Data were collected by the investigator using
interview guided questionnaire.
Results: A total of 270 patients were enrolled and interviewed. The mean age was 30±12 years. Majority of
patients (59.6%) were females. Of the 270 patients, 188 (69.3%) had dermatophytes. A total of 150 (55.6%, 95%CI
49.6-61) obtained antifungal OTC. Of 150 patients who received antifungal agents OTC, 64 (42.3%) received
more than one antifungal agents compared to only 9.2% (11/120) of those with prescription (p<0.001).
Clotrimazole was the commonly prescribed antifungal agent while fluconazole was mostly obtained OTC. On
univariate analysis, increase in age was found to be associated with the tendency of obtaining antifungal agents
over the counter (OR 1.03, 95% CI 1.008-1.05, P<0.006). Having skin fungal infections was the only predictor of
obtaining antifungal agents OTC (OR 3.36, 95% CI 2.34-4.81, P<0.001).
Conclusion: In Mwanza City, patients receive multiple antifungal agents over the counter and the practice is
significantly more for those with skin fungal infections. There is a need for the advocacy on appropriate use of
antifungal agent to reduce the associated impact of resistance development.
Keywords: Over the counter, dispensing, antifungal agents, Tanzania
Introduction
Invasive life threatening fungal infections have dramatically increased in the past three decades
(Hudson, 2001; Sundriyal et al., 2006). The increased of fungal infections has been linked to increase
use of the broad spectrum antibiotics, anticancer therapy and increase in prevalence of
immunocompromised infections such as acquired immune deficiency syndrome (AIDS) (White et al.,
1998). The phenomenon of switching of some antifungal agents from only prescription to over-the-
counter (OTC), has provided conducive environment to the misuse of the antifungal agents (Lipsky &
Waters, 1999). The misuse has been implicated in the rise of antifungal resistant strains as the result
of selective pressure (Stephenson, 1997; Hudson, 2001). Nevertheless the trends of opportunistic
fungal infections have been observed to increase in recent decades from 18% (Mayanja et al., 1999,
Matee et al., 2000) to above 60% (Nweze & Ogbonnaya, 2011; Kwamin et al., 2013; dos Santos Abrantes
et al., 2014), which has resulted in the increase use of antifungal agents.
Over-the-counter drugs are the medicines that an individual can buy without a prescription.
Most often, they include pain relievers, allergy medicine, or various types of heartburn relief
medications. Generally, over-the-counter medicines are less potentially dangerous than prescription
medicines. Self-medication, including the use of over-the-counter (OTC) medicines is a global
* Correspondence E-mail: mushimartha@gmail.com

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phenomenon of public health concern (Bennadi, 2013; Schmiedl et al., 2014). High levels of self-
medication practices with over-the-counter medicines and complementary and alternative
medications have been reported in Australia, United States and Germany (Bradley & Blenkinsopp,
1996; Eisenberg et al., 1998; Hanlon et al., 2001; Beitz et al., 2004; Goh et al., 2004; MacLennan et al.,
2006). In a multi-centre study in six Latin American countries, a relatively high percentage of
prescribed medicines were being dispensed without medical prescription and this was attributed to
lack of access to medical care (DURG, 1997).
Over the counter medications has the advantage of reducing health care cost. However, in
addition to the fact that OTC and self-medication are the potential contributors to human pathogen
resistance to antimicrobials, the adverse consequences of such practices may result in greater
probability of inappropriate, incorrect, or undue therapy, missed diagnosis, delays in appropriate
treatment, adverse drug reactions and increased morbidity (Lipsky & Water, 1999; Hersh et al., 2007;
Bennadi, 2013; Schmiedl et al., 2014). Worldwide studies on OTC antifungal uses are limited (Lipsky et
al., 2000; Sihvo et al., 2000; Schneider et al., 2013). In sub-Saharan Africa including Tanzania, there is
inadequate data regarding the OTC practices (Truter & Graz, 2014). According to the Tanzania national
policy on prescription of medicine, antibiotic and antifungal are prescribed drugs (Mnyika & Killewo,
1991). Therefore, this study was conducted to determine the magnitude of OTC and its associated
factors among patients with fungal infections in Mwanza City, Tanzania.
Materials and Methods
Study design
This cross sectional study was conducted in Mwanza City in north-western Tanzania, from May to July
2015 and involved community pharmacies. A total of 27 randomly selected community pharmacies out
of 57 were visited. In each pharmacy the first ten patients enquiring antifungal agents were recruited
into the study. The study excluded all patients’ relatives/friends who visited the pharmacy to purchase
antifungal agents and patients below 18 years of age.
Data collection
Data were collected through face-to-face interview using a guided questionnaire. Then, each enrolled
patient was privately interviewed to obtain demographic and necessary information’s such as type of
infections, prescription status, type of antifungal dispensed, number of antifungal dispensed and
previous history of antifungal use. The diagnoses were obtained from the prescriptions. For patients
without prescriptions the clinical pharmacist made the diagnosis; in case of the inconclusive diagnosis,
a medical doctor was consulted.
Ethical considerations
Ethical clearance was granted by the joint Catholic University of Health and Allied Science/Bugando
Medical Centre Research Ethics and Review Committee. Permission to conduct the study was sought
from all community pharmacies administrations. All patients were requested to sign the written
informed consent before recruitment. All patients’ data were kept as confidential.
Data analysis
In this study patients were cauterized into those who obtained antifungal agents without prescription
(OTC group) and those with prescriptions (prescriptions group). The data were entered and cleaned
using Microsoft Excel software and analysed using STATA Version 11. Age as continuous variable was
summarized using mean ± standard deviations. Categorical variables were summarized in proportions.
Step-wise logistic regression analysis was done to determine factors associated with habit of

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43%
25%
16%
11% 5%
Tinea corporis
Tinea pedis
Tinea capitis
Tinea unguium
Tinea cruris
obtaining antifungal agents over the counter. A p-value of less than 0.05 was considered as
statistically significant at the 95% confidence interval.
Results
Patient demographic characteristics
A total of 270 patients with fungal diseases were enrolled. The mean age of patients was 30±12 years
and females accounted for the majority of patients (n=161; 59.63%). Only 27 (10%) patients had a
history of previous antifungal use (Table 1).
Table 1: Demographic characteristics and history of antifungal use and prescription status
Variable
Response
Frequency
Percentage
Sex
Male
109
40.4
Female
161
59.6
Prior antifungal use
No
243
90.0
Yes
27
10.0
Prescription status
No
150
55.6
Yes
120
44.4
Fungal diseases
The commonest fungal diseases were dermatophytoses 188(69.63%). Tinea corporis 43% (81/188),
tinea pedis 25% (47/188) and tinea capitis 16% (30/188) were the common dermatophytes observed
(Figure 1).
Figure 1: Distribution of dermatophytes among patients
Other fungal infections included vulvo-vaginal candidiasis 55 (20.37%), oral candidiasis 19 (7.04%) and
systemic candidiasis 8 (2.96%). In the current study systemic candidiasis was referred to the fungal
infections involving blood stream and meninges. Most of the patients with dermatophytes either
received fluconazole 46 (24.47%) or the combination of fluconazole+clotrimazole 22 (11.7%), while for
vulvo-vaginal candidiasis most of the patients received clotrimazole 52 (94.55%). All patients with oral
candidiasis received nystatin (Table 2). Other antifungal drugs dispensed included Itraconazole
capsules, Miconazole cream, Tioconazole, Salicylic acid and Benzoic acid.

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Table 2: Antifungal drugs dispensed in relation to diseases
Disease
Clot
Fluc/clot
Fluc
Nystatin
Griseofulvin
Ketoconazole
Others
Dermatophytes (188)
17(9.04%)
22(11.7%)
46(24.47%)
0(0%)
30(15.96%)
24(12.77%)
49(26.04%)
Vulvo-vaginal
candidiasis (55)
52(94.55%)
1(1.82%)
0(0%)
0(0%)
1(1.82%)
0(0%)
1(1.82%)
Systemic candidiasis (8)
0(0%)
1(12.5%)
3(37.5%)
0(0%)
0(0%)
4(50%)
0(0%)
Oral candidiasis (19)
0(0%)
0(0%)
0(0%)
19(100%)
0(0%)
0(0%)
0(0%)
Total (270)
69(25.56%)
24(8.89%)
49(18.15%)
19(7.04%)
31(11.48%)
28(10.37%)
50(18.52%)
Key: Clot= clotrimazole; Fluc/Clot= fluconazole+clotrimazole; Fluc= fluconazole
Antifungal agents dispensed
Of the 270 patients, the majority 150 (55.5%) obtained antifungal agents over the counter (OTC) while
120 (44.5%) obtained antifungal agents with prescription. The average number of antifungal dispensed
per patients was 1.27 (270/343). The commonest class of antifungal dispensed was azoles, given either
singly 148 (54.8%), in combination of two azoles 69 (25.6%) or azole with other type of antifungal
agent 7 (2.6%). Of 293 azoles dispensed, 197 (64%) was given OTC. The commonest specific azole agent
prescribed was clotrimazole whereas fluconazole was commonly obtained over the counter. Nystatin
was most often prescribed than being obtained OTC (94.7% vs. 5.3%, 95%CI 0.90-0.99, p<0.001).
Clotrimazole, fluconazole, ketoconazole and griseofulvin were commonly obtained OTC (Table 3). Out
of 150 patients who received antifungal agents OTC, 64 (42.3%) received more than one antifungal
agents compared to only 9.2% (11/120) of those with prescription (p<0.001).
Table 3: Common antifungal agents dispensed in relation to OTC and prescription status
Antifungal agent
Prescription
Over the counter
Frequency
Percentage
Frequency
Percentage
Nystatin (19)
18
94.7
1
5.3
Clotrimazole (103)
48
46.6
55
55.3
Fluconazole (104)
36
34.6
68
65.4
Ketoconazole (60)
13
21.7
47
78.3
Griseofulvin (31)
4
12.9
27
87.1
Others (26)
9
34.6
17
65.3
Total (270)
120
44.5
150
55.5
Predictors of OTC
The mean age of patients with prescription was 27.4±12.6 years while the mean age of patients
obtained antifungal agents OTC was 31.3±10.4 years p=0.006. On univariate analysis, as the age
increased by one year there was 3% chance of obtaining antifungal over the counter (OR 1.03, 95% CI
1.008-1.05, P<0.007). More males (65.4%) than females (49%) obtained antifungal OTC (OR 1.9 95% CI
1.17-3.1, p=0.01). All 27 patients with history of prior-use of antifungal agents were in the group of the
OTC. Having skin fungal infections was the predictor of obtaining antifungal agents OTC (OR 3.36, 95%
CI 2.34-4.81, P<0.001) (Table 4).

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Table 4: Factors associated with over-the-counter (OTC) practices
Variable
Response
Univariate
Multivariate
OTC (%)
OR (95%CI)
P-value
OR (95%CI)
P-value
Age
-
31±10
1.03(1.01-1.05)
0.006
1.01(0.98-1.04)
0.384
Sex
Female (161)
79(49)
1
Male (109)
71(65.4)
1.9(1.17-3.1)
0.01
0.94(0.51-1.7)
0.869
Diagnosis
None skin infections (82)
14(17.1)
1
Skin infections (188)
136(72.3)
12.7(6.5-24.5)
<0.001
3.36(2.34-4.81)
<0.001
Discussion
Availability of the antimicrobial agents OTC has been associated with the constant exposure of the
pathogens to antimicrobial pressure which results to the increased antimicrobial resistance (Hudson,
2001). In the current study over half of the patients received antifungal agents OTC. The observed OTC
practice is higher than that reported in a study in Jordan (Yousef et al., 2008). Self-medication has
been described to be common in low-and-middle income countries (Greenhalgh, 1987; Van der Geest,
1987, 1990; Bezold, 1990) where health services are inadequate and poverty is common (Van der
Geest & Hardon, 1990). The common drawbacks of self-medication is the delay of making definitive
diagnosis that can lead to delay in obtaining appropriate therapy, use of suboptimal therapy and
misuse of the antifungal agents which include inappropriate combination of antifungal agents (Ferris
et al., 2002; Francis et al., 2005). In the current study, four in every ten patients who received
antifungal OTC had combination of topical and systemic antifungal agents. This is associated with the
alter of the normal microbial flora and change the pattern of fungal infections (Hudson, 2001).
In the current study all patients with previous use of antifungal agents received drug OTC. The
fact that most of the patients with prior history of antifungal use tended to obtain the subsequent
doses OTC has also been reported elsewhere (Wood & Brass, 2001). According to Ferris et al. (1996)
only about one-third of patients with previous diagnosis of fungal infections could accurately
diagnose a recurrent fungal infection; therefore, in about two third the subsequent treatment is
inappropriate.
Azole agents are the major antifungal drugs used in the treatment of fungal infections
worldwide. The emergence of azole resistant strains of fungi poses a great challenge in managing
these fungal diseases (Bader et al., 2013; Mushi et al., 2016). In this study about two-thirds of the
patients received azole antifungal agents OTC. The observed prevalence in our study is much higher
than that reported previously by Mathema et al. (2001). The difference could be explained by the poor
health seeking behaviour and lack of skin specialists in our setting. The use of topical antifungal
agents is advocated to be under physician supervision to avoid suboptimal dosage and recurrence
(Sutcliffe, 1998). In the current study having dermatophytes was found as predictor of obtaining
antifungal agents OTC.
In conclusion, over the counter antifungal agent dispensing is high in Mwanza City and most
of patients get combination antifungal therapy. Having skin fungal infections was found to predict the
OTC practice. There is a need of re-enforcing the policy of antifungal prescription in Tanzania so as to
reduce the consequence of antifungal misuse.
Acknowledgements
We would like to acknowledge the support obtained from all pharmacists and patients participated in
this study. This study was supported by research grant from Catholic University of Health and Allied
Sciences to MFM.

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Conflict of interest
Authors declare no competing interests.
Author’s contributions
MFM, BM, MMM designed the study, BM and MJ collected the data, MFM and SEM analysed the data,
MFM and SEM drafted the first manuscript, SEM critically reviewed the manuscript. All authors
approved the final version of the manuscript.
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