Mothers' Perceived Risks and Practices for Over Counter Medications of Children Under Five Years

Over the counter medications are drugs that are purchased without medical prescription. The use of these medications in children is usually initiated by parents. Using over counter medicine in developing countries found to be higher than in industrialized countries. Aim: Assess perceived risks and practices for over the counter medications among mothers of children under five years. Method: A descriptive cross-sectional study design. The study was conducted at Pediatric outpatient clinics of Tanta and Kafr-Elsheikh University Main Hospital. A convivence sample of 1000 mother of children under age 5 participated in the study. Tools: data was collected using three tools: Socio-demographic data questionnaire, Drug Use Health Belief Scale, and Over-the-Counter Medication Practices Questionnaire Results: the use of over the Counter medications was reported by all the participants in the study and 43.2% of mothers reported purchasing over the Counter for their children 3-4 times during this month. Most used medication were antipyretics to save the life of the child in cases of emergency (62.5%). 58.9% of the participants had unsatisfactory practice regarding over the counter medication use. A highly positive significant correlation (r=0.69 p=0.0001) was found between mothers' perceived risks and their reported practice. Conclusion : using over the Counter medications is common among the study participants and for different reasons. There is a over the counter medications. Recommendation: This research draw the attention to this serious problem. Strategies and educational program should be implemented to improve mothers' perception and practice about using over counter medications.


Introduction
Over-The-Counter (OTC) medications refers to medications that is taken without doctor consultation and a prescription. A culture of OTC medications in most countries began to emerge in the late 19 th century when the World Health Organization (WHO) permitted the conversion of various pharmaceuticals to non-prescription status to be supplied over the counter without any prescription to lessen the burden on healthcare professionals. (1) The prevalence of using OTC is high in most countries. For instance, In Australia, Trajanovska, (2009) found that 98.2% of the parents in their study purchased at least one OTC medicine for their children in 12 months. In the United Kingdom, studies reported that 66% of parents used OTC over 4 weeks (Kemper, 1999). Similarly, According to data from a populationbased survey in the United States, 54% of parents used OTC for children less than 13 months to treat cough and cold symptoms (Lokker, 2009). (2) Also, a recent study done in Palestine revealed that 91.9% of the parents used drugs without a physician's prescription (Ali, 2020). Figures appear to be similarly high for Egypt where OTC medications can easily be obtained from pharmacies. A cross-sectional study conducted by Zohour (2014) about maternal practices in giving oral medications to young children complaining of common illnesses reported that 70% of the children received OTC medications. (3) There is a wide range of OTC medications that the parents use. The most common medications purchased and used by the parents are cough and cold products, antipyretics, influenza drugs, and antibiotics. Theses OTC medications were promoted through radio, television, and print advertising in most countries. (4) In Egypt, the Egyptian health authorities published a decree with a precise description of over-the-counter medications at the end of 2015. Following revision and approval by health authorities, the decree also permitted pharmaceutical corporations to advertise their product directly to customers through a variety of media. Through various social media platforms, various pharmaceutical corporations began promoting their medicines to Egyptian consumers and people starts to use them for their children even with the risks that these medications have. (5) There are several risks reported in the literature regarding the usage of OTC. Poison due to using these medications has been reported in several pieces of research. This poison can happen due to several factors such as lack of supervision of the children by the parents, lack of child-resistant closure, and lack of parents' knowledge about the medication. (6) In addition, most Egyptian parents give OTC Antibiotics to their children. reported that there are high rates of antibiotic misuse in Egypt and 23.3% of the antibiotics purchased in the participating study pharmacies were without prescription. Misuse of antibiotics without a prescription might be associated with serious effects on resistance. Bacterial resistance can lead to a prolonged hospital stay and high morbidity and mortality rate. (7) Furthermore, studies also suggested that parents have poor knowledge about OTC. Many parents have difficulty understanding the indications and appropriate dosing of OTC medications. For instance, A crosssectional study conducted in Palestine showed that there is a lack of knowledge among parents about the appropriate dose of medications, a study evaluating the ability of the parents to give the correct OTC medication dose to their children reported that, 70% of the parents were not able to determine the correct dose of medication. (8) Another study done in Serbia showed that there is pharmacotherapy literacy among parents of preschool children and most of the parent has difficulty understanding information that is given either in written or spoken form about the use of medicines. (9) Additional concerns about using OTC medications include allergic reactions, drug interactions, and use of inappropriate medications for various diseases, side effects of some medications such as visual hallucinations, irritability, and sleepiness. If there is a great risk in using OTC medications, why parents are using them? And is it effective? In a systematic review research that examined the effectiveness of over-thecounter (OTC) cough medicines for acute cough in children, the researchers reported that there is no good evidence for or against the effectiveness of OTC cough medicines in acute cough. (10) So, despite the risks of using these medications and their unproven effectiveness, there are some factors reported in the literature that make parents decide to use OTC medications in managing their children's diseases such as accessibility, convenience, and time-saving. (11) In a qualitative study that aimed at investigating the situational and social factors that lead parents to use OTC medications, researchers reported that parents use it as a form of "social medication" to give they control over their children's behavior, to reduce the inconvenience to the parents of having a sick child, calming, and sedating the children. (12) Significance of the study Healthcare providers including pediatric nurses need to provide current evidence-based information to mothers regarding appropriate and safe medication used for their children. To do that, we must first determine the current OTC medicine practices of Egyptian mothers. The literature surrounding the types of medicines used, risks, and reasons for use is limited in Egypt. Therefore, the present study aimed to describe mothers' perceived risks and practices for over counter medications of children under five years. The data were collected using face-toface interviews. The following tools were used to collect the data. Tool I: Socio-demographic data of the mothers It includes age, marital status, educational level, residence area, work status, number of children, occupational status, monthly income, and causes of taking over-the-counter medication. Tool I I: Drug Use Health Belief Scale This tool assesses the mothers' perception of perceived susceptibility, severity, benefits, barriers, and their self-efficacy of using over counter medication. The scale were was developed by Erci and Cicek's (2017) (13) and consists of 28 items related to five domains which include: perceived susceptibility (6 items) determines the risks perceived by individuals related to using un-prescribed drugs, perceived severity (6 items) , the items indicates how the individual perceive the seriously dangerous of the outcomes of using OTC medicine, perceived barriers (6 items) determine the barriers perceived by the individual when he use OTC medicine, perceived benefits (4 items) perception about the benefits of using OTC medicine and self-efficacy (6 items) that determine the individuals self-belief. Each item on the scale is scored on a 5 points Likert type scale, ranging from 1 =strongly disagree to 5=strongly agree. The total scale scores are obtained by summing all the scores together. The maximum score on the scale is 28 and the minimum score is 140. The higher score indicates a higher level of health beliefs related to conscious and prescription drug use. the scale developed by Eric and Cicek (2017) (13) alpha of the scale of the current study was 0.89 Tool III: Over-the-Counter Medication Practices Questionnaire This questionnaire was developed by the researchers after reviewing the relevant literature.The questionnaire consists of 13 close-ended questions related to the most common over the counter medications wrong practices. The score of the questionnaire varied from 0-13. A score range from (0-7) indicates unsatisfactory practice, and a score of (8-13) indicates satisfactory scale was 0.90.

Tools Validity
The Perceived benefits, barriers, risks, and self-efficacy questionnaire was translated into Arabic by the researchers through a back translation procedure. To establish the validity of the questionnaire content, all the study questionnaires were reviewed item by item by a panel of experts in pediatric nursing and a physician. In addition, a pilot study was done with 10% of the study sample who had the same inclusion criteria as the subjects in this study to assess the reliability, readability, time needed, and culture congruence of all the study questionnaires. The results of the pilot study helped in refining the questionnaires and were not included in the analysis. Ethical consideration Permission to undertake this study was received from the Faculty of Nursing Institution of Ethical Research Committee, Tanta University was obtained with code number (93-9-2022). In addition, written informed consent was granted from the mothers who agreed to participate in the study. An initial interview was conducted with the mothers in a private room to inform them about the objectives and benefits of the study. Mothers were assured that their participation is voluntary, and they can withdraw from the study at any time without any risk.

Data analysis
The data was analyzed using SPSS version 24 for Windows. Following the normality check, descriptive statistics were employed to analyze the percentages, mean scores, and standard deviation of the descriptive demographic data (SD). Pearson correlation coefficient (r) was used to determine the relationship between the continuous variables. Inferential statistics such as ANOVA was used to determine the relationship between the socio-demographic variables age, educational level, marital, employment status, and monthly income. Statistical significance was set at p-value 0.05. (14) Results Table  (1) Illustrates sociodemographic characteristics of the studied mothers. The results indicated that slightly more than half (52.9%) of mothers were 30-40 years old. The majority (97.6%) of the mothers were married and 33.7% had secondary school certificates. Slightly more than half (52.9%) of the mothers had 3 -4 children, while 1.4% only had more than 4 children. Also, about half (50.8%) of the participants earn less than 1000 EGP per month, while 8.7% of them earn more than 5000 EGP per month. Three-quarters (75.9%) of participating mothers were housewives while 10.9% were working in the medical field. Table (2) Indicates the frequency of using OTC and source of medications, it was found that, 43.2% (n=432) of mothers reported purchasing OTC for their children 3-4 times during this month. Regarding the source of advice about the OTC medicine that they should purchase for their children, the most common source was the pharmacist 43.4% (n= 434), using the previous physician's prescription 43.9 %, (n= 439), and asking friends and relatives for prescriptions 12.7% (n=127) are next most common. Table (3): Shows reasons for using over counter medication. It was observed that the most common reasons indicated by the mothers for using OTC was to save the life of the child in the case of emergency (62.5%), the next common reason was effectiveness of the drug (40.7%), followed by the geographical location of the pharmacy near their house (29.5).

Discussion
Using over-the-counter medications for children is a commonly neglected problem in developed and undeveloped countries, especially in Egypt. There are scarce studies done in Egypt that investigated this problem and most of them were done in Upper Egypt and Alexandria and non were carried out in the Egypt Delta region (15) . The present study aimed to assess mothers' perceived risks and reported practices regarding over counter medications for children under five years.
All mothers in the present study frequently used OTC for their children and nearly half of them used OTC three to four times over the last month. This may be due to repeated chest infections and inflammatory conditions for this age group of children and maternal desires to manage repeated symptoms at home. Also children less than five years old are characterized by active movement and curiosity to discover their environment which increases the risks to acquire repeated infection. Our finding is in agreements with Younes (2011) (16) who reported that nearly one-quarter of their participated mothers used OTC medication at least once per week. The primary source of over-thecounter medication information in the current study was physicians followed by pharmacists then friends and relatives. These results matched with Alenazi K 2021 (17) who reported that the primary source of the parents' information about medication ranked as the follow 87.4% the physicians, 25.7% pharmacists, internet 22.2%, friends 8.6%, and relative 7.2%. The primary reason for utilizing over-the-counter medications, according to nearly two-thirds of the mothers, was to preserve their children's lives in emergencies. This finding is consistent with Younes 2011 (16) , who indicated that treating the child in severe situations, particularly at late hours of the night, was the primary reason for using OTC medications for children.
Regarding most common group of medication used, most of the mothers reported using antipyretic making it the most frequently used medications category followed by antitussive. This may be connected to the fact that fever and coughing are the most typical symptoms of illness among children under the age of five. These findings are consistent with those of Alenazi K 2021 (17) , Kasim K (2018) (15) who reported that 70% of their participants mothers gave OTC antipyretics to children under 5 years who complained of fever, and common cold.. Additionally, Suluhan (2016) (18) revealed that mothers administered antipyretics to their children without seeking medical advice. In this study, the mean scores of mothers' perceptions regarding perceived risks of over counter medications related to perceived susceptibility, severity, and selfefficacy were high while the mean perceived benefits and barriers were low. The presenting mean scores of mothers' perceived risk scale are arranged from the highest to lowest as follows perceived susceptibility (27.18), perceived severity (25.22), perceived self-efficacy(23.36), perceived barriers (9.39), and perceived benefits ( 8.36). These findings might be explained by the reason that mothers were more aware of the dangers of taking drugs without a prescription as a result of extensive media exposure. This finding in agreement with Alosaimi (2022) (19) who stated that the mean score for perceived risk scale domains ranked from the highest to the lowest were as follows: perceived susceptibility ( 1.56; 0.36), perceived severity (1.52;0.29) and self-efficacy (1.45;0.32). The present study evaluated that mothers practices regarding use of over counter medication and found that more than half of the participating mothers had unsatisfactory practice. The researcher's explanation is the majority of the studied mothers had Lower educational level and this may be lack knowledge about searching, finding, understanding and evaluating the medical information, as opposed to those with higher education levels. The results of the present study in accordance with Sezer T (2022) (20) , Pavyde (2015) (21) and Yu (2014) (22) who show that individuals with higher education levels used medication more appropriately than those with lower education levels. The present study evaluated over counter in relation to their sociodemographic characteristics (age, residence, education, marital status, monthly income). It was observed that, there were highly statistical significant practices and their socio-demographic data P=0.0001, with exception of age which represents statistical significant difference only P=0.016. The finding in accordance the Suluhan( 2016) (18) and Barutcu (2017) (23) who reported that that mothers with lower educational levels exhibit behaviors of using medication without prescriptions and improper storage of unused medicine. The finding of the present study indicated that the age of more than half of the participated mothers was ranged between thirty to forty years old and had three to four children. This indicates that their experience with age and maternal hood might have a role in increasing their frequency usage of medication for their children without medical description. This finding was in agreement with the study conducted by Alenazi K 2021 (17) who found that most of the parents were more than thirty years of age and had more than five children. Regarding job type, three quarter of mothers were housewife and the eductional level of the majority was precollege education. The monthly income less than one thousand EGP. From the researcher point of view, all of the previous factors had the main impact on the prevalence of maternal self-medication behavior in Egypt especially in rural areas. The present finding congruent with Castro A (2022) (24) who stated that the prevalence of self-medication was 49.6% related to many factors such as age, having two or more children, children, medium educational level, unemployment and socioeconomic level. In the same line other study conducted by Alosaimi (2022) (19) who suggested that education and job type influence OTC medication use. However findings reported by Sharma (2006) (25) contradict with the present results who observed that increased mothers self-medication for their children was associated with higher education level and socioeconomic status. Also Zaki and Albarraq (2014) (26) stated that the high prevalence of well-educated mothers in their study might help mothers to conduct internet searches and gain knowledge regarding over counter drug use.

Conclusion
Based on the results of this study, it can be concluded that using OTC medications is common among the study participants and for different reasons. There is a relationship the practices of using the OTC medications. The practices of using OTC were related to the participants' socio-demographic background.

Recommendations
Public education programs should be organized regarding the use of over counter medication. Mothers' awareness should be raised regarding benefits and barriers of over counter medication through mass media. Health regulation polices should be made to regulate mothers use of over counter medication and decrease adverse effect of it.