Use and predictors of over-the-counter medication among pregnant women visiting antenatal clinics in public health facilities in the Silte Zone, Central Ethiopia

doi:10.21203/rs.3.rs-3606700/v1

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Research Article

Use and predictors of over-the-counter medication among pregnant women visiting antenatal clinics in public health facilities in the Silte Zone, Central Ethiopia

https://doi.org/10.21203/rs.3.rs-3606700/v1

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Background

Self-medication with over-the-counter (OTC) drugs during pregnancy is a global problem that needs to be given significant attention due to the potential risks to both the mother and the foetus. However, data regarding the use and risk factors for OTC drugs during pregnancy are lacking in the study area. The purpose of this study was to assess OTC medications and predictors among pregnant women attending antenatal care (ANC) at selected public health facilities in the Silte Zone, Central Ethiopia.

Methods

An institution-based cross-sectional study was carried out from February 1st to 30th, 2023. A multistage sampling technique was used to select study participants. Data were collected by KoboTool box and analysed using SPSS (version 25). The association of independent variables with the dependent variable was determined using logistic regression analysis. To decide the presence and strength of an association, odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated. Findings were considered statistically significant when the p value was < 0.05.

Results

The prevalence of OTC medicine use was reported among 297 (55.2%) pregnant women during their current pregnancy. Age ≥ 35 (AOR = 12.6, 95% CI = 6.3–25.0), living in rural areas (AOR = 7.1, 95% CI = 4.1–12.3), not having health insurance (AOR = 17, 95% CI = 9, 9.3–31.3), having poor knowledge about the possible risks of OTC medication in the fetus (AOR = 4.6, 95% CI = 5.3–12.8), and attending fewer than four ANC visits (AOR = 9.5, 95% CI = 4.7–19.0) were predictors of OTC medicine use

Conclusion

This study revealed that a significant number of pregnant women used one or more OTC drugs. Pregnant women who are older, live in rural areas, lack health insurance, have less knowledge, and attend fewer ANC visits are more likely to use OTC drugs. Therefore, healthcare providers should offer advice to pregnant women about the safe use of OTC medications. This is especially important for older women who live in rural areas, have no health insurance, have low knowledge, and fail to frequently attend ANC visits.

Pregnancy

Use

predictors

OTC medicine

The World Health Organization (WHO) defines self-medication (SM) as the practice of patients or individuals utilizing medicines to treat diseases or symptoms that they have self-diagnosed on their own without consulting a healthcare provider (1–3). Self-medication comprises using OTC medications that do not require a prescription, using prescription medications irregularly, using medications that were left over from earlier prescriptions, and using herbal and traditional remedies (4, 5). In developing countries such as Ethiopia, the practice of self-medication is widespread due to resource shortages and restricted access to healthcare services (6, –7).

The 2018 meta-analysis study conducted in Ethiopia found that the average prevalence of OTC medicine was 44%, with a range of 12.5–78.1% (8). Using OTC medicine during pregnancy is becoming more common worldwide, particularly in developing countries, as a result of weak health care systems (9–11). Similarly, OTC during pregnancy is becoming more common in Ethiopia; reports of its prevalence range from 15.5–70% (8, 12, 13).

Pregnancy-related OTC is still a major health concern in clinical practice (14, 15). Pregnant women are typically excluded from clinical trials due to concerns about the safety of the developing baby or the mother, even though medications are frequently used throughout pregnancy in clinical practice (15, 16). This means that the safety of these drugs has not been completely determined. Therefore, it is best to avoid taking drugs when pregnant unless absolutely necessary (17). In spite of this, a significant proportion of pregnant women take OTC drugs (18). Generally, OTC drugs during pregnancy pose risks for the growing fetus as well as the mother. Among these are low birth weight, preterm delivery, breathing difficulties, toxicity to the fetus, and even death (15, 18, 19). In addition, OTC drug use during pregnancy has been associated with at least 10% of abnormalities occurring during birth (1).

The rate of OTC varies among populations and can be influenced by a wide range of factors, such as inadequate access to healthcare services, uncontrolled drug distribution, patient attitudes towards healthcare providers, socioeconomic factors, long wait times, costs of drugs, level of education, age, income, satisfaction, and beliefs about medication and disease (9, 12, 20–22). Pregnant women in developing countries, such as Ethiopia, are frequently unaware of the possible adverse effects of taking medication on themselves during pregnancy (7, 10, 23, 24). Although few studies have been performed on the practice of OTC during pregnancy, there has been little research on OTC among the general population in our environment (7, 8). Consequently, there is a scarcity of evidence in Ethiopia, particularly in the study area, where there has not been any study into pregnant women's usage of OTC medications. Therefore, this study explored the prevalence, reasons, and predictors of OTC medication use among pregnant women in the Silte Zone, Central Ethiopia, in an effort to raise awareness and promote safe drug use during pregnancy. An assessment of the practice and the factors influencing it will be useful for healthcare providers and relevant stakeholders in preventing potential risks caused by OTC during pregnancy. In addition, the results of the study will also improve health education programmes and help women realize the potential risks associated with using OTC drugs.

Study setting, population and sample size

An institution-based cross-sectional study carried out in public health facilities in the Silte Zone, Central Ethiopia. It is located 172 kilometres south of Addis Ababa, the capital of Ethiopia. The administrative centre of the zone is Werabe town. This zone consists of five town administrations, ten weredas, and 214 kebeles. The zone shares a common border on the south with the Halaba Zone, on the southwest with Hadiya, on the north with Gurage, and on the east with the region. The zone consists of a total population of approximately 1,007,660, with males at 498,792 (49.5%) and females at 508,868 (50.5%). According to the 2013 annual report of the Silte Zone’s health department, the zone has one comprehensive specialized hospital (namely, Werabe Comprehensive Specialized Hospital), three primary hospitals (Tora, Kibet, and Alemgebeya), 33 health centres, and 180 health posts. Additionally, there are 30 medium and 50 primary private clinics. The total number of women in the reproductive age group is projected at 277, 303. The study was carried out in five selected public health facilities in the Silte Zone. These are Worabe Comprehensive Specialized Hospital, Kibet Primary Hospital, Alicho Health Centre, Lera Health Centre, and Tora Gebaba Health Center. The study was carried out from February 1st to 30th, 2023.

The study included all pregnant women, regardless of gestational age, who visited the selected healthcare facilities for follow-up ANC visits during the study period. The study excluded women whose physical or mental health hindered them from providing information, such as those who were mute or mentally impaired, too sick to take part, or hard of hearing.

Using a single population proportion formula, the sample size was determined by taking into consideration the following assumptions: ; p = 0.69; a population distribution taken from a study on the prevalence of OTC use during pregnancy conducted in Harar, Ethiopia (17); d = 0.05 of marginal error at the 95% confidence level (Z = 1.96). A 10% nonresponse rate and a design effect of 1.5 were then added, resulting in a total sample size of 538. A multistage sampling method was used to select the study participants. Thirty percent of the ten districts (Silti, Lanfuro, and Alicho) were initially chosen. Three health centres were selected at random by using a lottery method in the Silti districts (Menaheriya), the Lanfuro district (Gebaba), and the Alicho district (Alicho health centre). Werabe Comprehensive Specialized Hospital (WCSH) and Kibet Primary Hospital (KPH) were chosen at random using simple random sampling for the five town administrations. As a result, the study included a total of five healthcare facilities. The average monthly estimated number of pregnant women who visited each antenatal clinic was recorded. According to the average monthly report of each healthcare facility, the average monthly ANC follow-up at Werabe Hospital, Kibet Primary Hospital, Alicho, Menaheriya, and Gebaba was 570, 360, 291, 301, and 289, respectively. These healthcare facilities provided a probability proportional to size sampling. Finally, a systematic random selection approach was used for selecting women from each health facility, with intervals of two, with the first participant selected by lottery as the starting point (Fig. 1).

Study variables

Dependent variable

The outcome measure for OTC medication use was whether the pregnant women had taken at least one kind of OTC medication during their current pregnancy. Either "Yes" or "No" was recorded for each response.

Independent variables

Sociodemographic characteristics (age, marital status, ethnicity, religion, educational status, income, occupation), obstetric factors, medical-related factors, behavioural related factors, condition of drug consumer, diseases that lead to use of OTC, knowledge and attitude about OTC medications.

Measurement

Herbs. Any part of a plant, including the wood, stems, bark, leaves, fruits, flowers, seeds, rhizomes, roots, and other components.

Herbal medicine is the use of any herb or combination of herbs used for the prevention and treatment of diseases (1).

Modern medicine. It is a medication that women take as prescribed by health care providers.

Knowledge about the risk of OTC. Eight questions were used to assess the level of knowledge of pregnant women regarding OTC. The average score was calculated, and it was divided into two categories: poor and good. Those who scored below the mean were considered to have poor knowledge, while those who scored above the mean were considered to have good knowledge.

Attitudes about the risk of OTC were measured by using six questions with a 5-point Likert scale.

Positive statements were scored in the following order: strongly agree = 5, agree = 4, neutral = 3, strongly disagree = 2, disagree = 1), and negative statements were scored in the opposite order. After calculating the mean of all participant responses, the mean score of each participant was dichotomized as having a positive or negative attitude. A positive attitude was considered when ≥ mean. A negative attitude was considered when < mean.

Current pregnancy. Mothers who were pregnant during the data collection period.

Data collection tool and procedure

The questionnaire was adapted to suit the current study after being developed based on relevant prior studies (16, 17). A face-to-face interview as well as a check of medical records were used for data collection. The questionnaire consists of sociodemographic characteristics, obstetric factors, and medical, behavioural, and medication-related factors. Eight BSc midwives were recruited for the data collection, and two BSc midwives participated in supervising the data collectors. The completed questionnaire was collected and signed by the supervisor after it was checked for any missing items and completeness. The woman’s pregnancy status was assessed by inquiring about her last menstrual period and confirming with a pregnancy test.

Data Quality Control

The questionnaire was initially written in English, then translated into the language of the area, and then converted back into English by experts to ensure consistency. These techniques were employed to maintain data quality. Before data collection, the questionnaire underwent a pretest on 5% of the sample size at the Tora Primary Hospital, and any adjustments that were needed for the local setting were made. Through proper application of validity criteria (content validity), the validity of the questionnaire was approved. A Cronbach's alpha score of 0.83 was obtained from the reliability test. Additionally, the investigators of this study provided training for the supervisors and data collectors for a day on the format and content of the questionnaire. The supervisors and investigators reviewed each completed questionnaire daily to ensure its accuracy, completeness, clarity, and consistency. Frequency distributions were also used to confirm the accuracy and consistency of the variables used in the data entry and analysis.

Data analysis methods

Data were collected by Kobo Toolbox and analysed using SPSS (version 25). To summarize the data, descriptive statistics, frequencies, and proportions were calculated. We used logistic regression analysis to identify the factors that influence OTC use. Initially, every independent variable was examined in a bivariate logistic regression analysis. After that, variables with a p value ≤ 0.25 in the bivariate logistic regression analysis were transferred to multivariable logistic regression. The odds ratio with a 95% confidence interval was used to assess the degree of association between the independent and dependent variables. The outcome of the model passed the Hosmer and Lemeshow goodness-of-fit test with a p value of 0.81, indicating that it was acceptable. Furthermore, multicollinearity was evaluated by measuring the variance inflation factor (VIF), and the results showed that the variables selected did not exhibit any multicollinearity. At a p value of 0.05 or below, the results were considered statistically significant.

Sociodemographic characteristics

The study involved 538 pregnant women, and the response rate was 100%. The mean (± SD) age was 30.5 ± 5.47. The majority of the respondents, 423 (78.6%), were in the age group of < 35 years. A total of 219 (40.7%), participants had never attended school. Three hundred eighty nine (72.9%) of the respondents were housewives. The average household income of more than half, 319 (59.3%), was between 2000 and 4500 ETB per month (Table 1).

Obstetric characteristics

Of the participants, 370 (68.8%) were multigravidas, and 418 (77.7%) were pregnant women in their second trimester. Of the participants, 432 (80.3%) had < 4 ANC follow-ups during the current pregnancy, and 84(15.6%) reported pregnancy-related problems from previous pregnancies (Table 2).

OTC medication use during pregnancy

The prevalence of OTC medication use during the current pregnancy was 55.2%. Among those who used OTC medication (297), 177 (59.6%) medicated themselves with herbal medicine, 79 (26.6%) used modern medicine, and 41(13.8%) used both modern and herbal medicine. The most frequent indication for taking OTC was morning sickness (19.5%). In addition, the most common reason for OTC use was the belief that the illness was not serious (40.4%). The most commonly used OTC drug type was antibiotics (20.2%). Of the total number of pregnant women, 327 (60.8%) had good knowledge regarding the possible risks associated with OTC medication, whereas 239(46%) had a negative attitude about those risks (Table 3).

Predictors of OTC medicine use

After controlling for possible confounders using the multivariate logistic regression analysis model, age ≥ 35 years (AOR = 12.6, 95% CI = 6.3–25.0), rural residency (AOR = 7.1, 95% CI = 4.1–12.3), absence of health insurance (AOR = 17, 95% CI = 9, 9.3–31.3), and attending fewer than four ANC visits (AOR = 9.5, 95% CI = 4.7–19.0) were predictors of OTC medicine use.

The odds of OTC medicine use during pregnancy were 7.1 times higher among pregnant women who resided in rural areas than among urban residents (AOR = 7.1, 95% CI = 4.1–12.3).

Similarly, the odds of OTC medicine were 9.5 times higher among pregnant women who had < 4 ANC visits than among those women who had ≥ 4 ANC visits (AOR = 9.5, 95% CI = 4.7–19.0).

Additionally, the odds of OTC medicine use were 12.6 times higher among those aged 35 and above than among those aged less than 35 (AOR = 12.6, 95% CI = 6.3–25.0).

Furthermore, pregnant women who had poor knowledge about the risks of OTC medicine to the fetus were 4.6 times more likely to practice OTC than those who had good knowledge (AOR = 4.6, 95% CI = 5.3–12.8) (Table 4).

Table 1

Sociodemographic characteristics of mothers (n = 538).
Variables	Frequency	Percent
Age in years
< 35	423	78.6
≥ 35	115	21.4
Residence
Rural	341	63.4
Urban	197	36.6
Marital status
Married	530	98.5
Unmarried	8	1.5
Religion
Muslim	493	91.6
Orthodox	21	4.0
Protestant	14	2.6
Catholic	10	1.8
Occupation
Housewife	389	72.3
Merchant	71	13.2
Government employee	29	5.4
Private employee	49	9.1
Ethnicity
Silte	385	71.6
Gurage	50	9.3
Amhara	36	6.7
Hadiya	31	5.8
Oromo	18	3.3
Kambata	18	3.3
Educational status of women
No formal education	219	40.7
Primary education	207	38.5
Secondary education	69	12.8
College and above	43	8.0
Monthly income in the Ethiopian birr
< 2000	110	20.4
2000–4500	319	59.3
> 4500	109	20.3
Distance from the health facility
< 5 km	244	45.4
≥ 5 km	294	54.6
Chronic illness
Yes	40	7.4
No	498	92.6
Health insurance
Yes	338	62.8
No	200	37.2

Table 2

Obstetric characteristics of the study participants, 2023 (n = 538).
Variables	Frequency	Percent
Number of ANC visit
< 4	432	80.3
≥ 4	106	19.7
Gestational period
First trimester	75	13.2
Second trimester Third trimester	370 93	68.8 17.3
Gravidity
Primigravida	120	22.3
Multigravida	418	77.7
Previous still birth
Yes	55	10.2
No	483	89.8
Previous pregnancy related complications
Yes	84	15.6
No	454	84.4

Table 3

OTC medicine practice during pregnancy, 2023 (n = 538).
Variables	Frequency	Percent
OTC medicine use during a current pregnancy
Yes	297	55.2
No	241	44.8
History of previous use of OTC
Yes	159	29.6
No	378	70.4
Type of medicine used
Herbal only	177	59.6
Modern only	79	26.6
Both herbal and modern	41	13.8
Reasons for OTC use
Disease not serious	120	40.4
Easily accessing medicines	90	30.3
Time saving	66	22.2
Long waiting time to receive health services	21	7.1
Common indications for OTC use
Morning sickness	58	19.5
Headache	49	16.5
Upper respiratory tract infections	46	15.5
Constipation	45	15.2
Cough and cold	33	11.1
Urinary tract infections	28	9.4
Heart burn	22	7.4
Dyspepsia	16	5.4
Sources of information about OTC medicine
Family and friends	86	29.0
Pharmacy/drug shop	61	20.5
Left-over medicines	53	17.8
Neighbours	50	17.2
Traditional healers	47	15.5
Class of medicine used
Antibiotics	60	20.2
Antiemetic	57	19.2
Herbs	45	15.2
Analgesics	43	14.5
Gastrointestinal medicines	37	12.5
Anthelmintic	30	10.1
Antimalarial	25	8.4
Knowledge about the risks of OTC medicine in the fetus
Poor knowledge	211	39.2
Good knowledge	327	60.8
Attitude about the risk of OTC to the fetus
Unfavourable attitude	239	44.0
Favourable attitude	299	56.0

Table 4

Predictors of OTC during pregnancy 2023(n = 538).
Variables	OTC medicine use		COR (95% CI)	AOR (95% CI)
Variables	Yes	No	COR (95% CI)	AOR (95% CI)
Residence
Rural	142	155	3(2.1–4.5) *	7.1(4.1–12.3)**
Urban	55	186	Reference	Reference
Age group
≥ 35	274	23	7.4(5.9–12.1)*	12.6(6.3–25.0)**
<35	149	92	Reference	Reference
The number of ANC visits
< 4	281	16	10.5(5.9–18.5)*	9.5(4.7–19.0)**
≥ 4	151	90	Reference	Reference
Health insurance
No	170	127	9.4(6.0-14.7)*	17(9.3–31.3)**
Yes	30	211	Reference	Reference
Knowledge about risks OTC medicine
Poor knowledge	136	161	1.87(1.3–2.7)*	4.6(5.3–12.8)**
Good knowledge	75	166	Reference	Reference

This study aimed to assess the rate and risk factors for OTC medication usage among pregnant women who visited antenatal clinics at selected public health facilities in the Silte Zone, Central Ethiopia. The overall prevalence of using OTC medications was reported to be 55.2%. A similar finding was reported from previous studies in Jimma (Ethiopia), Egypt, South Africa, and Pakistan, where OTC was practiced, which were 51%, 55%, 59.3%, and 55.3%, respectively (25–28). It is, however, less than the results from Harar-Ethiopia, Nigeria, Ghana, the United Kingdom, and the United States, which were 69.4%, 72.4%, 74.1%, 76.4%, and 82.5%, respectively (12, 29–32). Conversely, the obtained results from this study are higher than the findings from Wolaita, Nekemete Referral Hospital, Tigray, Indonesia, the Netherlands, Mexico, the United Arab Emirates, and Italy, which were 14.9%, 21.5%, 40.8%, 11.7%, 12.5%, 21.9%, 40%, and 43.9%, respectively (33–40). The disparities in the rate of OTC medication during pregnancy can be attributed to differences in the sociodemographic characteristics of the participants, the country's prescription drug regulation legislation, cultural beliefs and norms, and accessibility to healthcare provider and services.

Besides, in the current study, OTC medication use was more common among pregnant women who were 35 years of age or older. Our findings are consistent with studies conducted in Iran (20), Nekemete, Ethiopia (34), Indonesia (36), and Italy (40). However, this finding contradicts a study that was carried out in North Wollo (Ethiopia) (41) and Lebanese (42). A possible reason could be that older people may have a history of drug usage, and women who have taken over-the-counter medications in the past may have different drug practises than younger women.

Moreover, the current study's findings showed a significant association between using OTC medications and residing in a rural area. This finding is in accordance with different studies carried out in Iran (20), Jimma (25), Wollo (41), Gojjam (43), northern Uganda (44), and Kenya (45). Pregnant women in rural areas are more likely to take OTC drugs for a variety of reasons, including low awareness, scarce resources, trouble accessing healthcare services, and concerns about high payments.

Likewise, the results of this study showed that not having health insurance raises the likelihood of OTC medicine use. The reported result is consistent with the findings from Iran (20), Jimma (25), Tigray (35), Mizan (46) and, Lebanese (42). The study implies that community-wide community insurance is necessary because uninsured people have a higher rate of OTC medicine use and are unable to visit health care facilities. As insurance covers both visits and prescription drugs, this is done to enhance the likelihood of acquiring a prescription Moreover, compared to women who had more ANC visits, pregnant women in the current study who had fewer visits were more likely to use over-the-counter medication. This finding is consistent with studies from Gojjam (Ethiopia) (43) and Taif (47). This could be because repeated ANC visits to health facilities may enable mothers to have more information regarding unsafe use of OTC drugs during pregnancy. This finding sheds light on the importance of information and care given to women during antenatal clinic visits.

Furthermore, pregnant women were more likely to take OTC drugs if they were less knowledgeable about the potential hazards associated with using them. This is consistent with research done in Addis Ababa (24), Indonesia (36), and Italy (40). This might be likely because those who have knowledge of how to use OTC medications should see a healthcare provider before using them.

Strength of the study

The study's strengths included using the KoboTool box for data collection, choosing appropriate statistical tests and procedures to minimize biases and interpret the data, and obtaining enough samples using probability sampling techniques to properly represent the Silte Zone population.

Limitations of the studyThe study was affected by a number of challenges, including questioning technique variation, recall bias, and social desire bias. However, to address those problems, we neutralized interviewing practices, decreased the recall period, and trained data collectors. Furthermore, every participant gave their informed consent before any data were collected.

The results show that pregnant women in the study area commonly use OTC medications. Pregnant women who are older, lack health insurance, live in rural areas, have poor knowledge, and have a lower number of ANC visits are more likely to use OTC medications. Therefore, it is imperative that healthcare providers provide pregnant women with adequate counselling about the potential risks associated with OTC medication usage during pregnancy. This is particularly crucial for women who live in rural areas, are older, lack health insurance, have low knowledge, and attend ANC visits less frequently. The results of this study should encourage the establishment of appropriate interventions to lessen pregnant women's OTC use, as well as increased awareness among the ministry of health and healthcare professionals, particularly healthcare providers. Additional prospective longitudinal research is needed for a full understanding of their value to pregnant women.

ANC Antenatal Care

SM Self-Medication

OTC Over-The-Counter

SPSS Statistical Package for the Social Sciences

Acknowledgements

We would like to thank the Research and Review Ethical Board of Werabe University for allowing us to conduct this research. Additionally, we would like to thank mothers for sharing their experiences and views. Furthermore, we want to express our gratitude to the data collectors, supervisors, staff, and managers of the health facilities involved in this study.

Authors’ contributions

HM, MM, BA, MJ, and MA executed the research, participated in the data collection, and wrote the manuscript. HM, MM, and MJ were participating in the study design and conducting the statistical analysis. All authors read and approved the final manuscript.

Funding

Werabe University funded the research and it is open for the researchers to publish the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Ethics approval and consent to participate

The Declaration of Helsinki was strictly adhered to when conducting the research.The ethical clearance letter was provided by the Ethical and Review Board of Werabe University. Prior to starting the data collection, permission from the hospital administration was requested. Finally, signed agreement was requested once each participant (mother) who was recruited in the study throughout the data collection period was informed of the study's goals. The study's goal, procedures, potential risks, and benefits were presented to the participants. Participants were assured that choosing to participate in the study or withdrawing from it would not affect or risk their access to care. Every technique was employed to adhere to all relevant regulations and standards. We confirm that informed consent was obtained from all subjects and/or their legal guardian(s) if the participant’s age was less than 18 years.

Consent for publication

Not applicable.

Competing interests

The authors declare that there is no conflict of interest.

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No competing interests reported.

QuestionnaireusedforOTCassessment.docx.docx
Supplementary Material 1. Questionnaire used for OTC assessment

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Use and predictors of over-the-counter medication among pregnant women visiting antenatal clinics in public health facilities in the Silte Zone, Central Ethiopia

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Abstract

Background

Methods

Results

Conclusion

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Background

Methods

Study setting, population and sample size

Study variables

Dependent variable

Independent variables

Measurement

Data collection tool and procedure

Data Quality Control

Data analysis methods

Results

Sociodemographic characteristics

Obstetric characteristics

OTC medication use during pregnancy

Predictors of OTC medicine use

Discussion

Strength of the study

Conclusion and recommendation

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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