1- INTRODUCTION

Micronutrients are considered as one of the major groups of nutrients the body needs. A deficiency in such nutrients may result in the disruption of the normal functioning of the body and the occurrence of various diseases in people (1). Micronutrient deficiencies especially iron and vitamin A and vitamin D, are common nutritional problems in children under two years of age. Today, food safety is one of the national and international priority programs; and in the meantime, special attention has been given to food security, especially in the sustainable development goals (SDGs). Micronutrient deficiencies form an important global health issue in many countries worldwide, especially in developing countries (2). According to the World Health Organization’s (WHO) recommendations and the guidelines issued by Iranian Ministry of health and Medical Education, the use of vitamin supplements containing vitamins A and D, multivitamin drops or iron supplements for children are essential(3). Based on the new health care services provided for children, children under two years of age should take iron supplements and supplements containing vitamins A and D. Evaluating the dosage recommended for infants is, then, one of the main functions of a health system. (4) In this study, more than 98% of subjects receiving the healthcare services at government health centers in Qom province were children under two years of age living in this province,  and  some children for some reasons (such as  oral and dental complications, gastrointestinal complications, family or physician-induced demand, forgiving to give the child’s supplements on the part of the family,  having  supplement intolerances, etc.) have not taken supplements (5),  which may lead to wasting  the financial resources allocated to the provision of  this service. It is considerable that 4% of financial resources are allocated to rural health insurance and the family physician program for providing the supplements and 11% to the health system transformation plan in the field of health and distributing supplements containing vitamins A and D, multivitamins or iron drops among all infants at the specified time provided in the instructions and   providing parents with necessary training on how to use these micronutrients for children (6). However, no comprehensive study has been conducted, so far, to assess the relationship between the use of supplements and possible wastage of these supplements. In this study, in addition to examining the demographic factors related to infants and families, factors such as availability, geographical distribution, required financial resources, allocated financial resources, appropriate or  inappropriate  use of supplements in infants, financial burden of Inappropriate use of supplements, and the wasted financial resources were evaluated; moreover, this study may offer an opportunity to conduct further studies on the causes for wasting the financial resources allocated to other sectors. According Budget distribution guidelines, in total, 27,894,511,309 Rials (11% of the financial resources of Iran's health system transformation plan) are allocated to programs providing the supplements for Qom city and its suburban parts; and 3,276,503,597 Rials (4 % of the financial resources of Iran's health system transformation plan) are allocated to the health services for villages and cities with populations less than 20,000 (7).

Accordingly, due to limited health care resources, this study attempted to investigate the financial burden of inappropriate use of supplements in children under two years of age, receiving the health care services at government health centers in Qom province in 2019.

2- MATERIALS AND METHODS

2-1. Study design and population

The study population consisted of children under two years of age living in urban, suburban and rural areas of Qom province. Proportional stratified sampling was used for selecting the participants from among the cases whose data were provided in the Integrated Health System (SIB) and the Statistical Centre of Iran (SCI) as well as Civil Registration Office of Qom province. The sample size was determined per group. The participants were divided into three groups: (1) those living in urban and rural areas with populations of less than 20,000 (n=90, population= 100,000 people), (2) those living suburbs and low-income areas (n=353, population= 390,000 people), and (3) those living in Qom city (n=777, population= 859,000 people). According to data obtained from the SIB, the sample size per group was calculated using the simple random sampling.

2-2. Methods

In the next step, using the drug information system of the Food and Drug Organization, Ministry of Health & Medical Education, the dose of supplement drops was obtained  and also using the system announcing the dose and conditions of drugs confirmed  by  Iran’s Health Insurance Organization,  the dose  of supplement drops  existing in  Iran’s  pharmaceutical market  was obtained; afterwards, the weighted average price of each supplement was to be determined, since due to a sharp rise in inflation in 2019 and the restrictions of drug manufacturing and distribution for drug companies,  the price of goods and services, including drugs, had increased by several times during this year. Determination method of the weighted average price of each supplement (was used based on the number and price of each drop based on which  the weighted average price of iron supplementation was 34.880 Rials and supplements containing vitamins A and D or multivitamin were 35.536 Rials.

2-3. Measuring tools: Validity and reliability

The study tool was questionnaire. This questionnaire consisted of two parts; the first part dealt with generic questions on the demographic characteristics of the participants including their personal and family-related characteristics; and the second part dealt with the questions on access to supplements containing vitamins A and D, supplementation with iron or multivitamins when receiving health care services and appropriate or inappropriate use of these supplements and factors affecting it. 10% of the questionnaires were reviewed by the researcher in order to confirm their validity and reliability. The validity of the questionnaire was examined by the panel of experts based on their opinions and knowledge of the field. Cronbach's alpha was used to assess its reliability. Cronbach's alpha was 0.76 for a sample size of 30.

2-4. Ethical consideration

This study was approved by the ethical committee of Iran University of Medical Sciences (IR.IUMS.REC.1398.738).

2-5. Data Analyses

The obtained data were entered into statistical software. After selecting the subjects and obtaining their individual characteristics as well as the geographical information about their place of residence, a standardized questionnaire included information on the age of the mother and the infant, parental education level, the level of household income, healthcare services provided by government health centers, the usage status of supplements containing vitamins A and D, the usage status of supplementation with iron or multivitamins, dose of each supplement assessed by a trained person in the field of nutrition, etc. All statistical analysis were performed using SPSS 23. The Pearson Chi-square test and independent-samples t- test were used to test the research hypotheses. The independent-samples t-test was used to examine the association between the age of the mother and the infant and the adequate intakes of iron supplementation and supplements containing vitamins A and D or multivitamins.

3- RESULTS

The study participants comprised of 1, 220 children under two years old living in Qom province.  Out of 1, 220 participants, 576 were boys (47.2%), and 644 girls (52.8%). Regarding the place of residence, 777 subjects (63.7%) lived in Qom city, 353 subjects (28.9%) lived in the suburbs and low-income areas and 90 subjects (7.4%) lived in in urban and rural areas with populations of less than 20,000.  Regarding parental education level, 856 mothers (70.16%) and 1,175 fathers (96.31%) had a high school diploma or less. The results of this study demonstrated that 64.3% of children had access to iron supplementation distributed by Government Health Centers. Access to supplements containing vitamins A and D or multivitamins compared to iron supplementation was slightly better provided, since 77.7% of children had access to these supplements. Moreover, our results revealed that 61.3% of these children did not receive iron supplementation or did not fully use it. Regarding supplements containing vitamins A and D or multivitamin, 40.2%.of children did not receive them or did not fully use them. Regarding the mother's occupational status, 94.4% of mothers were housewives.

In this study, children ranged from 0 to 24 months in age; the highest frequency (23.2%) was in age group of 21-24 months. The mothers’ age ranged from 13 to 54 years, the highest frequency of which was in the age group of 26-30 years (30.5%).  Regarding the level of household income, 39.9% of the families had incomes below 15 million Rials, 52% of them had incomes between 15-30 million Rials, 7.6% had incomes between 30-45 million Rials, and 0.5% had incomes greater than 45 million Rials per month. (Table 1)

The results of independent-samples t-test showed that there was a significant association between age of the infant and the adequate intakes of iron supplementation (p=0.026) and supplements containing vitamin A and D or multivitamin (p = 0.001), but no significant correlation was found between maternal age and adequate intake of iron and vitamins A-D or multivitamin supplementation (Table 2).

According to the results of the tests performed, a significant associations was observed between place of residence and adequate intake of iron supplementation. (P = 0.000), so that the children living in urban and rural areas with populations less than 20,000, the suburbs and Qom received the adequate intake of iron supplementation. Similarly, there was a significant association between place of residence and adequate intake of supplements containing vitamins A and D or multivitamin (p=0.020). (Table 3)

Moreover, no statistically significant association was observed between maternal education level and the adequate intake of supplements containing vitamins A and D or multivitamins (p=0.217). Likewise, there was no significant relationship between maternal education level and the adequate intake of iron supplementation (p =0.131). A significant association was, however, observed between the father's education level and the adequate intake of supplements containing vitamins A and D or multivitamin (p=0.041), while there was no significant relationship between the father's education level and the adequate intake of iron supplementation (p= 0.104). No statistically significant association was found between household income level and the adequate intakes of iron supplementation (p=0.240) and the supplements containing vitamins A and D or multivitamins (p=0.325). Additionally, there was no significant association between maternal occupation and the adequate intakes of iron supplementation (p=0.497) and supplements containing vitamins A and D or multivitamins (p=0.329). (Table 4).

Based on the data obtained from demographic information as well as the calculation of the costs of the wastage of supplements provided to 0-24-month-old children using the weighted average, the following results were obtained as shown in Table 5:

- 161 of the subjects living in Qom city (38.2% of all), did not fully take iron supplementation, which wasted 38.15% of the financial resources, equal to 67,388,160 Rials.

- 136 of the subjects living in the low-income suburban parts of Qom city, (46.9% of all) did not fully take iron supplementation, which wasted 46.90% of the financial resources, equal to 56,924,160 Rials.

- 16 of the subjects, living in rural areas (21.9% of all) did not take iron supplementation fully, which wasted 21.92 % of the financial resources, equal to 6, 696, 960 Rials.

- 120 of the subjects living in Qom city (22.5% of all) did not fully take supplements containing vitamins A and D or multivitamins, which wasted 22.47% of the financial resources, equal to 102,343,680 Rials.

- 88 of the subjects living in the low-income suburban parts of Qom city (26.51% of all) did not fully take supplements containing vitamins A and D or multivitamins, which wasted 26.51% of the financial resources, equal to 75,052,032 Rials.

- 10 subjects living in rural areas (12.2% of all) did not fully take supplements containing vitamins A and D or multivitamins, which wasted 12.20% of the financial resources, equal to 8,528,640 Rials. (Table5).

4- DISCUSSION

Micronutrient deficiencies, especially in regard to iron and vitamin A and vitamin D, form an important global health issue, and consumption of these supplements has been recommended by healthcare systems (2). There are different views about the consumption of these micronutrients, so that some believe that dietary modifications (especially in children) and the modified food pyramid for family can reduce the micronutrient deficiency (11). Some studies and supplemental programs for children in developed countries recommend different methods of enriching infant cereals or the use of MMPs (12) (13) in order to provide household food security and children's health (14). In the same line, some scientific research studies considering the adverse effects of supplements and the need for caution in giving them to a child recommend for providing the nutrients and diets containing a variety of different foods instead of dietary supplements (12). Despite, in the supplements providing program for children aged 0-24 months, according to national programs and recommendations of the World Health Organization, iron, vitamin A and vitamin D supplements should be given to a child daily to reduce the micronutrient deficiencies (6).  The present study, thus, investigated the financial burden of inappropriate use of supplements in children under two years of age receiving the healthcare services at government health centers in Qom province during 2018. Among 948 subjects (77%) living in Qom province, 218 cases (23%) did not fully take supplements containing vitamins A and D or multivitamins; and caused a loss of 185,924,352 Rials out of 808,515,072 Rials allocated to the supplements providing program for children. Likewise, amongst 785 subjects (64.3%) living in Qom province, 313 cases (39.87 %) did not fully take iron supplementation; and caused a loss of 131,009,280 Rials out of 328,569,600 Rials allocated to this program (Table 5).

Finally, according to the obtained data, the total financial burden of inappropriate use of supplements in children under two years of age living in Qom province was 8,615,324,009 Rials out of 31,171,014,906 Rials allocated to the program (27.87%) (Table 5).

The findings revealed that 23% of children receiving supplements containing vitamins A and D or multivitamin did not take them fully and wasted the financial resources allocated to this service in Qom province. This is consistent with the results of a study conducted by Dr. Kermani at Milad Hospital, suggesting that only 70% of people had fully taken the supplements containing vitamins A and D. In addition, 42% of clients in his study did not have access to supplements containing vitamins A and D, which was higher than the data obtained from our study, but the results are consistent with our findings (17). Moreover we found that 39.87% of children did not fully take the iron supplementations, which wasted 39.87% of financial resources. According to studies conducted in this regard, especially Masoudpour’s study in Rafsanjan city this result can be related to the side effects of the use of iron supplementation observed by those receiving this service (18). Previous studies have shown that adequate intake of iron supplementation in people living in Rafsanjan (18), Ardabil (8); Gorgan (19) and Yasuj (20) was found to be about 50%. In the present study, it was approximately 60%, which was consistent with the results obtained from studies conducted in other cities.

Furthermore, our results revealed no significant association between the adequate intakes of   vitamins A and vitamin D and iron supplements and maternal education level  (p = 0.131) and (p = 0.217), respectively. These findings are also consistent with the results of studies in Ardabil (8) and Milad Hospital in Tehran (17). Moreover, in this study, no significant relationship was observed between the adequate intake of iron supplementation and father's education level (p = 0.104), but there was a relationship between  adequate intake of  supplements containing   vitamins A and D  and father's education level (p=0.041). Our results showed that there was a significant association between the age of the child and adequate intakes of iron supplementation (p = 0.026) and supplements containing vitamins A and D (p = 0.001). In addition, no significant association was observed between the maternal age and the adequate intakes of iron supplementation (p = 0.140) as well as supplements containing vitamins A and D (p = 0.428). However, the results obtained from the study conducted in Rafsanjan showed a significant relationship between maternal age and adequate intake of iron supplementation (p = 0.000) (18). Moreover, the present study showed that there was no significant association between the maternal occupation and the adequate intakes of iron supplementation and supplements containing vitamins A and D (p=0.513). (Table 4)

The present study also investigated the financial burden of inappropriate use of supplements in children under two years of age receiving the healthcare services at government health centers in Qom Province during 2018 and the results revealed that only 64.3% of children under 2 years of age living in Qom Province had access to iron drops and 77.7% of them had access to vitamin drops and only 38.69% of children under 2 years received the iron supplementation and 59.84% of them received supplements containing  vitamins A and D or multivitamin adequately. Further in this study, the rate of the wasted financial resources in the supplements providing program for children was about 27/87%, which due to the overhead costs of the mentioned chain, the real value will be much more than this amount. (Table5)

According to some studies, a maximum of 10% wastage in financial resources allocated to family physician program (related to delivering quality health services) is acceptable in Iran's health system transformation plan (6). The rate of wastage found in the present study is not, however, acceptable; and the parameters related to the health service providers, the recipient of services and distributor of the supplements must then be evaluated.

5- CONCLUSION

Considering the significant percentage of wastage in resources allocated to providing supplements for children under two years of age, it is necessary to design and implement educational interventions for mothers of under two-year-old children and more precisely monitor the allocation of resources in this field.

6- Acknowledgment

This research was supported by grant No 15697-48-2-98 by Iran University of medical sciences.