Prevalence and Determinants of Self-Medication Among Pregnant Women at an Antenatal Clinic at Soba Teaching Hospital, Sudan: A Cross-Sectional Analysis

Introduction

In recent years, self-medication has become a significant aspect of the healthcare system [1] and has become a common health practice worldwide [2]. Self-medication is defined by the World Health Organization as “the selection and use of medicines by individuals to treat self-diagnosed illnesses or symptoms” [3]. While self-medication offers advantages, such as time-saving and reduced pressure on healthcare facilities, improper self-medication can lead to exaggerated illnesses and wasted medical resources [1].

Self-medication is notably high among pregnant women, especially in developing countries [4]. This population often resorts to prescription-only medications, non-prescription drugs, and herbal remedies, due to the ease of accessibility to medicines [5,6]. Based on the literature, the prevalence of self-medication among pregnant women varies globally, ranging from 2.2% to 72.4% [5]. Worldwide, more than 200 million women become pregnant yearly, and most of them were found to use at least 1 medicine during their pregnancy [7,8]. An Ethiopian study revealed a prevalence of practicing self-medication of 69.7% during current pregnancy [9]. In other studies, pregnant women reported considerable levels of using high-risk medications during pregnancy, at 59% in France and 21% in the Netherlands [8]. Despite its commonality, self-medication among this population represents a challenge because of the accompanied possible risks to the woman and fetus [10], including the significant risks of abortion, prematurity, birth defects, and even death [2,11].

Limited data on drug safety among pregnant women exist due to ethical, legal, and practical concerns hindering medical research on this population [7]. Earlier studies in Africa may not have thoroughly explored the extent of self-medication among pregnant women [11–13]. A recent survey revealed that approximately 50% of women in Africa use self-medication during pregnancy [14]. A Sudanese cross-sectional study highlighted inadequate knowledge of pregnant women regarding medications, with analgesics and antibiotics being the most used drug classes [14,15]. Beside the notable lack of studies on drug use among pregnant women in Sudan, Sudan as a county has unique healthcare challenges hindering the extrapolating of findings from other countries. The health system in Sudan is fragile, with restricted healthcare services and more lenient pharmaceutical regulations, in addition to the inconsistency in the level of care between urban and rural areas. This study not only bridges a gap in local data but also sheds light on self-medication practices, potentially guiding international strategies for addressing these challenges in similar contexts. This study aimed to evaluate self-medication in pregnant women attending antenatal clinics at Soba Teaching Hospital, Sudan.

Material and Methods

STUDY DESIGN AND SETTING:

This study adhered to the ethical guidelines of the 1975 Declaration of Helsinki. Ethical approval (FPEC-23-2022) was obtained from the Ethics Committee of the Faculty of Pharmacy, University of Khartoum. Additional permission was obtained from Soba University Hospital before conducting the study. Each participant provided written informed consent to be included in the study. Confidentiality was ensured throughout the study. A facility-based cross-sectional study was conducted using an interviewer-administered semi-structured questionnaire to pregnant women who visited the antenatal clinic in Soba University Hospital, a tertiary hospital in Khartoum state, Sudan. The study was conducted between September and November 2022.

STUDY POPULATION AND SAMPLING PROCEDURE:

The target population included all pregnant women who attended the antenatal clinic at Soba University during the study period and were willing to participate. Pregnant women with communication challenges due to physical or psychological problems and those unwilling to give consent were excluded from the study.

The sample size for the study was 230 participants, which was calculated using the single population proportion formula for the prevalence of self-medication practice, which was 73.1% (P=0.73) [13], with a 95% confidence interval, margin of error of 5% (d=0.05), and 5% contingency for nonresponse rate. Based on the reports from the statistical department at Soba University Hospital, the approximate average number of pregnant women attending antenatal clinics is 950 per month (N= 950). The participants were selected using a simple random sampling technique

DATA COLLECTION TOOL:

Data were collected using a pre-tested semi-structured interviewer-administered questionnaire. In this study, a total of 25 questions were used and separated into 4 parts. Part 1 included demographic and clinical information (12 items), such as age, education, employment position, family income, health insurance, residence, and comorbidities and obstetric information, such as gravidity, parity, history and reasons for abortion, and gestational age. All of these items were rated on a binary and 3-point scale. Part 2 gathered information on self-medication (1 item). Part 3 collected information on sources to obtain the product, source of recommendations, common illness or symptoms that necessitate self-medication, and most commonly used medications and herbal medicine. The questionnaire included open-ended and multiple-choice questions. The last part collected information about the reasons for self-medication, which were assessed on binary scale (7 items).

The questionnaire was prepared in the English language and included all related variables. It was then expressed in the Arabic language to the participants during the interview, and then the responses were back-translated to English to ensure consistency of meaning. The questionnaire was developed and validated by the authors based on previous studies [6,9,14,15] and was modified to achieve the study objectives. Furthermore, the validity and reliability of the tool were tested by conducting a pre-test with 15 pregnant women (these data were excluded from the study). Further, slight amendments were made after piloting and revising with experts in the field. Subsequently, the Cronbach alpha was measured as 0.71, which indicated good validity and reliability of the instrument.

DATA ANALYSIS:

Data were analyzed using the Statistical Package for Social Sciences for Windows, Version 24.0 (IBM Corp, Armonk, NY, USA). Descriptive statistics, including frequencies and percentages, were used to summarize study variables and evaluate the distribution of responses. The chi-square test was used to test associations between independent variables. A binary logistic regression model was used to evaluate the relationship between self-medication practice and explanatory variables. All variables were included in the final multiple regression model, regardless of their P values in the unadjusted analysis, and the model’s adequacy was assessed with the Hosmer and Lemeshow test. Both crude odds ratios and adjusted odds ratios were reported, along with a 95% confidence interval (95% CI). A P value of <0.05 was deemed statistically significant in the final model.

Results

SOCIO-DEMOGRAPHIC CHARACTERISTICS OF THE STUDIED POPULATION:

Of the 230 pregnant women included in this study, all responded to the questionnaire (acceptance rate 100%). As shown in Table 1, most (38.7%) were in the 25 to 30-year age group, 65.7% were unemployed, and nearly half of the participants (45.7%) had attended college. Only 27.8% of the respondents had health insurance. Asthma and diabetes mellitus were the most common comorbid diseases and were reported by 10% and 6.1% of participants, respectively (Table 1).

OBSTETRIC INFORMATION OF THE STUDIED POPULATION:

Among the study population, 67% of participants were multigravida, with 40% having more than 1 child. A total of 32.6% of pregnant women had a history of abortion, and, of them, 58.7% of these cases were attributed to unknown causes. At the time of the study, 39.1% of the participants were in the second trimester (13 to 24 weeks; Table 2).

PREVALENCE AND TYPES OF SELF-MEDICATION PRACTICE:

Of the 230 pregnant women interviewed, 184 (80%) practiced self-medication during their current pregnancy (Table 3). Among the population practicing self-medication (n=184), 44.6% used pharmaceutical products, 22.8% used on herbal remedies, and 32.6% used both (Table 4). Regarding the source of products and recommendations among the population practicing self-medication, pharmacies were the primary source of products for self-medication (44.6%), with 43.5% of participants relying on pharmacies for recommendations (Table 4).

COMMON ILLNESSES/SYMPTOMS AND REASONS FOR SELF-MEDICATION:

Among the pregnant women practicing self-medication, 49.5% used it to treat nausea, and 46.2% used it for heartburn (Table 5). Beliefs in the safety of medications (40%), expensive doctor visit fees (28.1%), and belief in the ability to self-medicate (21%) were the main drivers for practicing self-medication (Table 5).

PHARMACEUTICAL PRODUCTS AND HERBAL REMEDIES USED FOR SELF-MEDICATION:

As presented in Table 6, among pregnant women practicing self-medication, analgesic medications were the most commonly used among pharmaceutical products (32.6%), followed by anti-emetic medications (27.7%) and antibiotics (17.9%), while peppermint and citrus fruits were the most used among herbal remedies (19.6% and 17.4%, respectively).

FACTORS ASSOCIATED WITH THE SELF-MEDICATION PRACTICE:

The chi-square test did not establish significant relationships between socio-demographic characteristics and the practice of self-medication (Table 7). At the bivariate level, no socio-demographic characteristics were found to be statistically significantly related to self-medication practices among pregnant women. In the multivariate model, the data fit the model adequately, with no significant differences between the observed and predicted values (Hosmer and Lemeshow test=0.752). Additionally, none of the socio-demographic characteristics were identified as significant predictors of self-medication practices. The complete logistic regression results for self-medication practices are presented in Table 8.

Discussion

In this study, we found that 80% of pregnant women practiced self-medication, with at least 1 pharmaceutical and/or herbal medicine used during their current pregnancy. Self-medication practice was identified by the World Health Organization definition as the use of drugs without professional supervision for self-diagnosed conditions, as well as the unsupervised use of prescribed drugs for chronic or recurrent conditions [1,3]. This prevalence aligns with similar studies in Nigeria (85%) [10], Ghana (65.4%) [2], and the Republic of the Congo (59.9%) [16], but is higher than rates reported in Jordan (33.1%) [5], Ethiopia (36%) [17], Iran (25.8%) [18], and Mexico (21.9%) [19]. In Pakistan, 37.9% of the studied population was found to use over-the-counter drugs during their current pregnancy [20]. In the present study, the reasons for self-medication practice among pregnant women included beliefs in medication safety (40.2%), expensive doctor visit fees (28.3%), belief in the ability to self-medicate (26.1%), previous disease/drug experience (22.8%), and the availability of medicines at home (20.1%). To the best of our knowledge, these reasons have been recorded in almost all previous studies that took place in developing countries but with different rates. In Jordan, pregnant women resort to self-medication for 2 main reasons: their belief that ailments were simple and because they already experienced the same condition before [5]. In Pakistan, the main drivers of using over-the-counter drugs were the high fees of doctor visits, to save time, the accessibility of medications, and their perceptions of their sufficient knowledge regarding the illness and medications [20]. In Nigeria, the Republic of the Congo, and Ethiopia, participants justified the use by saying their ailments were minor, they had prior use of the drug, and they had financial constraints [10,17,21]. In another Ethiopian study, patients justified the use by the high accessibility of the medicine and the simplicity of the medical condition [4].

Pregnancy is characterized by significant physiological changes resulting in various symptoms, such as nausea and vomiting, heartburn, and backache. These ailments often cause pregnant women to resort to self-medication [22]. As in the present study, nausea (49.5%) heartburn (46.2%), and backache (29.9%) were the most common symptoms for self-treatment. However, in the Republic of the Congo, urinary tract infections, malaria, and typhoid fever were mentioned, in addition to the common cold [12]. This should be taken under consideration, as both malaria and urinary tract infections should be diagnosed in a clinical setting. Also, this finding highlighted the problem of easy access to medicines without prescription, which could result from the improper dispensing practices and the non-strict healthcare regulations. In Tanzania, malaria, followed by morning sickness and headaches, were conditions that could lead pregnant women to seek self-medication practice [23]. In Pakistan, 60% of the pregnant women studied practiced self-medication to treat headaches [20]. In Jordan, 80% of pregnant women surveyed used self-medication to treat headaches and joint pain [5].

In our study, the most frequently used class of medications was analgesics, consistent with findings in Jordan [5], Ghana [2], and Pakistan [20]. In Tanzania, anti-emetics came first, followed by anti-malaria and analgesics [23]. In Ethiopia, antibiotics were the most common drug class, followed by analgesics [4]. Our study results highlight the importance of analgesics and herbal remedies as common self-medication choices.

The findings of our study revealed that patients primarily relied on self-initiative, pharmacists, and relatives for information on self-medication. In Pakistan, most participants depended on their own initiative, and the rest gained information from their husbands and pharmacists [20]. In Jordan, they also depended mainly on their own information and previous experience to treat themselves [5]. In Mexico, more than half (59.4%) received recommendations from their relatives and friends [19]. However, it is important to note that in a previous Sudanese study, awareness of pregnant women regarding medicines in general and what to avoid during pregnancy was incorrect in a considerable portion of participants [15].

In the present study, pharmacies were identified as the primary source of products used for self-medication during pregnancy. This finding is advantageous as it ensures proper storage of medications and provides access to professional guidance from pharmacists. However, it also underscores a potential issue with the irrational dispensing of certain medications, particularly when participants rely primarily on “self-initiative” for recommendations. In many countries, including Sudan, acquiring medications from community pharmacies is not a process governed by strict rules. This makes community pharmacies a convenient source of medications, as shown in our findings.

In Jordan, pharmacies were considered the main source; however, about one-fourth of participants relied on left-over medications at home [5]. In Ethiopia, patients were found to depend on pharmacies, herbal shops, and leftover medications [17] in addition to family, friends, and neighbors [4]. Using leftover medicines represents a serious issue, storage conditions cannot be guaranteed, and people can use them incorrectly or for a wrong diagnosis.

Notably, 22.8% of participants in the present study relied solely on herbal remedies for self-medication. The main obstacle to using such remedies is that most lack studies proving their safety and efficacy, especially in special populations, such as pregnant women (24). This type of practice is common especially in Africa [22]. A Sudanese review study named several plants that are widely used but should be avoided during pregnancy, including Abrus precatorius and Achyranthes aspera, due to their abortifacient effect, Chamaemelum nobile (with high dosages) and Cimicifuga racemose, as they induce uterus contractions, and Ruta graveolens and Trigonella foenum-graecum, due to their teratogenic effects [24].

In Tanzania, the preference for herbal remedies was very clear, with almost 25% of the studied population relying on them for self-medication [23]. In Jordan, 32.14% were using herbs to treat pain and cough. There was a general perception among them that herbal remedies are safer [5]. There are many concerns regarding the safety of herbal products, as they can include toxic or unsuitable ingredients, be contaminated, or interact with other drugs [22].

In the present study, statistical tests did not establish significant relationships between socio-demographic characteristics and the prevalence of self-medication, contrasting with findings in Nigeria that revealed a significant relationship between the patient’s age and their practice of self-medication (P<0.05) [10]. In Iran, there were significant relationships between self-medication and the educational level and residence of pregnant women (P=0.05) [17]. In Tanzania, self-medication was found to be affected significantly by patient occupation (P=0.01), gestation age (P<0.01), and education (P<0.01) [23]. In Mexico, patient level of education, alcohol intake, and smoking were associated significantly with self-medication [19]. In Ethiopia, patient ages of less than 35 years, living in rural areas, and history of using the same medications were predictors of self-medication [4]. While in Jordan, the obstetric information including gestational age of 28 weeks and more and gravidity of 4 and more significantly affected self-medication practice [5].

These study findings may necessitate the implementation of targeted educational programs to increase awareness of self-medication among this specific population, the development of guidelines for safe medication practices, and the improvement of access to professional medical advice. Furthermore, we will propose policy measures to strengthen regulatory oversight of medications and herbal remedies used during pregnancy.

Despite the significance of this study, it had several limitations. The study was a questionnaire-based study conducted in an antenatal clinic and, therefore, it may not be representative of the population who attended other healthcare facilities. Data regarding exposure to pharmaceutical products and herbal remedies were collected relying on the women’s recall from their entire pregnancy duration; therefore, there is a possibility of recall bias leading to underestimation of medicine use among this special population. This limitation could be addressed by more intensive studies involving longitudinal studies to track self-medication practices over time, qualitative research targeting reasons behind self-medication choices, and studies to assess the effectiveness of educational interventions to the general population, pregnant women, and healthcare providers. We also recommend research into safety studies covering the specific risks associated with commonly used medications and herbal remedies in the context of pregnancy.

Conclusions

The findings from this study showed that the prevalence of self-medication reported by pregnant women attending an antenatal clinic in Sudan was high and included approved drugs and herbal medicines, mainly from pharmacies, and was driven by the perception that all medications supplied by pharmacies are safe. Thus, we strongly recommend conducting various strategies to improve awareness about the risks of inappropriate self-medication, including educational campaigns for all women of reproductive age and healthcare providers training. Also, we recommend that stakeholders in Sudan implement comprehensive regulatory measures to effectively control and reduce self-medication practices among pregnant women.