Modern use of drugs in the treatment of diseases of children and newborns is increasingly based on off-label use of drugs. The lack of adequate formulations for the pediatric population, the lack of appropriate therapeutic parallels for the treatment of children's diseases and the small number of clinical trials involving the pediatric population have contributed to the mass use of these drugs. The use of these drugs implies extrapolation of doses and indications registered for adults to children, although it is known that the pharmacodynamics and pharmacokinetics of children and adults differ significantly. In the past two decades, many legislative and regulatory initiatives have been taken around the world to improve the use of drugs in children. However, children are still prescribed off-label and unlicensed drugs. The aim of this study was to present a review of the literature in which off-label and unlicensed use in the pediatric population was investigated. Literature was searched through the Google Scholar and Pub Med search engines and using the keywords off label drug, pediatric medicine, use in pediatrics, in the period from May to August 2019. Selected and presented in this article are studies published in the period from 1996 to 2015, which as a subject of research had the use of off-label and unlicensed drugs in the pediatric population. Medicines prescribed for children should be registered for use in the pediatric population and used in accordance with approved indications for children, whenever possible. It is necessary to take measures for more rational use of medicines in pediatrics, which include the collaboration of health workers in order to provide medicines for children that are proven to be effective, high quality and safe to use.

This study investigated the behavior of urban-living students related to the salty snacks consumption, and their contribution to salt daily intake. A cross-sectional survey on 1313 urban-living students (16–25 years, 61.4% university students and 38.6% high school students) used a pre-verified questionnaire created specifically for the study. The logistic regression analysis was performed to investigate the factors influencing snack consumption. The results of salt content and the snack consumption frequency were used to evaluate snack contribution to salt intake. All subjects consumed salty snacks, on average several times per week, more often at home and slightly more during periods of intensive studying, with 42% of the participants reporting to consume two or more packages per snacking occasion. Most of the participants consumed such products between main meals, but 10% of them took snacks immediately after the main meal. More high-school students than university students were in the “high snack group” (p < 0.05). The most frequently consumed salty snacks were those with the highest content of salt. Salt intake from snack products for a majority of participants ranged between 0.4 and 1 g/day. The research revealed younger age, home environment and significant contribution to salt intake as critical points in salty snack consumption among urban-living students important for the better understanding of their dietary habits.

Genetic counselling is a complex process that helps people to understand and adopt medical, psychological and genetic aspects of the disease and enable them to make an appropriate decision. In this framework, we revisited all the existing models for decision-making and suggested their use in the process of genetic counselling, which may lead to more equitable and more favourable outcomes. Also, Donabedian's (Structure-Process-Outcome) model for the development of key performance indicators was applied to assess the quality in the process of genetic counselling. Quality indicators at SPO model in the process of genetic counselling were proposed. The social, economic and humanistic outcomes have also been identified. All defined quality indicators together represent a framework for monitoring, evaluation and continuous improvement of the process of genetic counselling. Although the new medical services of genetic counselling tend to be developed as a powerful multidisciplinary field, the implementation of quality management model will certainly help the development of collaborative practice.

Objective. Continued Professional Development (CPD) is one of the most significant precursors to increased competency. Appropriate instruments and support are required for its implementation. This paper demonstrates the attitudes held by pharmacists on the impact of the competency framework on CPD, its acceptance among Serbian pharmacists and potential future application. Furthermore, the motivational impact of the competency framework on CPD as well as the relationship between certain demographic indicators and motivators of CPD are provided. Method. Research on the cross-sectional method throughout 2015-16 included pharmacists working in publicly-owned pharmacies. The survey was anonymous and voluntary. The questionnaires generated for this research contain demographic data on those surveyed and open-ended questions with multiple choice answers and applied a Likert-type scale. Statistical analysis was conducted by applying Microsoft Office 2003 and the Statistical Package for Social Sciences (SPSS) version 22. Results. Among the respondents, the female gender dominated, respondents who had not completed a speciality within their respective field, with an average age of 42 years, and an average of approx. 15 years of service. 26.12% of the respondents had prior experience with the competency framework. Most respondents were of the opinion that these instruments motivated them to actively manage their own PD, to set concrete PD objectives and to review their own competency. Over half intend to apply competency frameworks in future. The statistical Chi-square test indicates it is not possible to determine with certainty that there are differences in terms of motivation in managing PD and in PD goal setting between the groups of variables. Conclusion. The research indicates a positive attitude/opinion of pharmacists towards the competency framework and in recognising these instruments as supportive to CPD.

Background: Medicines dispensing is an error-prone activity, therefore potentially jeopardizing patient safety. This study aimed to assess the community pharmacists’ attitudes towards the causes of dispensing errors and preventive measures, as well as their practice in incidents reporting. Materials and Methods: A cross-sectional survey was performed by distributing an adopted and validated questionnaire to a nationwide sample of community pharmacists in Serbia. The questionnaire included sections related to the participants’ socio-demographic characteristics, their attitudes towards factors causing dispensing errors and corrective actions, as well as their practice in reporting. Statistical analyses were conducted using SPSS Statistics software ver. 21.0. The associations between categorical variables were analyzed using Chi-square test. Results: The study included 1,004 participants, mainly female (94.9%), with the mean age 40.9±9.9 years and mean work experience 14.3±10.0 years. More than a third of the participants (35.4%) indicated an increasing risk of dispensing errors. The main causes included illegible prescriber‘s handwriting (44.3%) and interruptions during dispensing (39.2%), while the major corrective actions were providing pharmacists with education in clinical pharmacy (71%) and reducing the interruptions during dispensing (63.9%). The majority of respondents (85.2%) stated that they routinely reported dispensing incidents. However, even 16.5% of them admitted to having fear sometimes or always. Additionally, only 58.1% of participants would use voluntary dispensing error reporting system. Conclusion: Serbian community pharmacists are aware of the existing risk in medicines dispensing and the corrective actions identified should be put into practice so as to manage them prospectively. Although the results indicate good practice in incidents reporting, conducting tailored educations and building of safety culture is necessary to improve patient safety.

Background and objectives: Pharmacotherapy literacy (PHTL) is an individual’s capacity to obtain, evaluate, calculate, and comprehend basic information about pharmacotherapy and pharmacy-related services necessary to make appropriate medication-related decisions, regardless of the mode of content delivery (e.g., written, oral, visual images and symbols). It is already proven that low PHTL of parents can cause serious problems in the treatment of a pediatric population. We aimed to identify the differences in parental PHTL levels, socio-demographic and health-related characteristics (chronic disease of a child, breastfeeding of a child, annual visits to a pediatrician, parental-self-estimation of health status) between rural and urban areas and to investigate the influence of living in rural areas on a low PHTL level. Materials and methods: Our study was cross-sectional with a validated 14-item instrument (“Parental pharmacotherapy literacy questionnaire—Serbian”), which assessed overall PHTL and its three domains of knowledge, understanding and numerical skills necessary for the safe use of medicines. We analyzed 250 parents of pre-school children (1–7 years old) in rural areas and 182 parents from urban areas in Serbia. Results: Every tenth parent from rural and every fourth parent from urban areas had the highest PHTL level or more than 85% correct answers. However, 51% and 28% of parents in rural and urban areas, respectively, had a low PHTL level (less than 65% correct answers), [Х2(1, n = 432) = 33.2; p < 0.001]. Parents from different areas statistically differed in age, education level, employment, breastfeeding and annual visits to pediatrician rate. Those from rural areas had almost twice the probability of low PHTL levels (ORa = 2.033; p = 0.003) than their urban counterparts, independently of other examined parental characteristics. Conclusions: Parents from rural areas have more difficulties to obtain, evaluate, calculate and comprehend basic information related to pharmacotherapy than parents from urban areas.

Background and objectives: Pharmaceutical literacy skills of parents are crucial for appropriate and safe medication use in pre-school children (ages 1–7 years). A recent study on pharmacotherapy literacy from Serbia showed that one in five parents have difficulty understanding common information about the use of medicines. Because antipyretics are considered to be the most frequently used group of over-the-counter (OTC) medications during the pre-school period, we aimed to: (i) examine parental practice and expectations in antipyretic medication use, and (ii) analyze associations of parental practice and expectations related to socio-economic status and pharmacotherapy literacy. Materials and methods: A cross-sectional survey using a self- report validated specific instrument was conducted with the parents of pre-school children in kindergartens in Belgrade, Serbia. Pharmacotherapy literacy refers to the knowledge and personal skills needed to meet the complex demands of medicine use in both healthcare and non-healthcare settings. A comprehensive literature review, expert-focus group consultation, and pre-testing were employed in 4-item multiple-choice test development to explore practice and expectations related to the use of OTC pediatric antipyretic medicines. Results: The final analytical cohort was comprised of 813 participants, the majority (63.3%) chose a medicine based on a physician’s suggestion and only 15.4% of parents reported they would follow the advice of a pharmacist. More than a half of parents (54.1%) would need advice about antipyretic medicine from a pharmacist, firstly in a simpler language. Parents satisfied with the information given by a pharmacist had higher pharmacotherapy literacy, compared to parents with lower levels (OR–0.718, 95%CI (0.597–0.865), p < 0.001). Men had a higher expectation of pharmacists to explain medicine use in a simpler language (OR–1.630, 95%CI (1.063–2.501), p = 0.025), as well as parents with three or more children (OR–2.527, 95%CI (1.43–4.459), p = 0.001). Parents with higher knowledge about medicine use were less likely to ask for simpler information (OR–0,707; 95%CI (0,583–0,856), p < 0,001). Conclusions: Our main finding is that practice in antipyretic OTC medicine use was associated with levels of parental pharmacotherapy literacy. The expectations of pharmacists were higher among parents with lower levels of pharmacotherapy literacy, who expected more information in a simpler and more precise language. This study highlighted the need for pharmacists to identify risks in parental practice and to provide information about medicines to parents of pre-school children in a simpler and more appropriate way.

Abstract Background Smoking rates in Serbian adults are among the highest in Europe. The objective of this study is to assess the prevalence of smoking and smoking-related behaviours of Belgrade University students depending on their sociodemographic characteristics and faculty group. Methods A cross-sectional study was carried out among 2,608 Belgrade University students (59.6% female) in 2015. A self-administered questionnaire was applied to the opportunity sample to collect the data describing students’ smoking habits and attitudes across all 30 faculties of the university. Results 30.5% of students reported smoking: 26.4% of medical, and 31.1% of non-medical ones. Smoking rate among female students was 31.2% vs. 29.5% among males. Age (p=0.001), relationship (<0.001) and employment status (p=0.002) had statistically significant influence on smoking status, while the differences in smoking status between genders (p=0.141) and medical and non-medical group of students (p=0.066) were not statistically significant. The highest percentage of students started smoking during high school (66.2%). As the most common reason to start smoking, respondents cited peer influence (36.5%). 44.3% of students who smoked unsuccessfully tried to quit smoking. Conclusion To combat high smoking prevalence among a younger population, the formal education of students about the adverse impacts of smoking should be integrated in all active anti-smoking programs. Medical students, as future healthcare professionals, can play an important role in smoking rates reduction among both younger and general populations, if properly trained and educated about smoking prevention and cessation techniques.

Background/Aim. Valid and reliable instruments were emphasized in the studies of pharmacotherapy literacy which is the capacity to obtain, evaluate, calculate, and comprehend basic information about pharmacotherapy and actions necessary to make appropriate medication-related decisions. The aims of this study were: to develop an instrument for assessment of pharmacotherapy health literacy among parents of pre-school children in Serbia (PTHL-SR) and to evaluate psychometric properties. Methods. This study was a four-stage methodological one, conducted from November 2015 to October 2016. The instrument content was established through qualitative and quantitative expert reviews in the first and second phase. Experts had to answer about the clarity and relevance of questions. The Content Validity Ratio (CVR) and index (CVI) were calculated based on the necessity and relevance of questions. Third phase was pre-testing of initial instrument to assess comprehensibility of questions. In the fourth phase, 300 parents completed questionnaire at several kindergartens in Belgrade, to determine questionnaire?s reliability through internal consistency, using the Cronbach?s alpha coefficient and correlation between classes. Results. The 14-items questionnaire was developed (initial PTHL-SR) and pre-tested on a pilot sample. It had 4 groups of questions about knowledge, understanding, numerical skills and access to medicines-related information. The Content Validity Ratio (CVR = 0.875) was significant and adequate (Lawshe CVR8 = 0.780). Conclusion. PTHL-SR is a reliable instrument for assessment of pharmacotherapy literacy among parents of pre-school children in Serbia and can be used for the evaluation of understanding, calculating and accessing medicines-related information.

Background/Aim. The protective effect of periconceptional folic acid supplementation in reducing the risk of neural tube defects (NTDs) and other adverse pregnancy outcomes has been scientifically confirmed. The present study aimed to assess knowledge, attitudes, and practice (KAP) of community pharmacists and pharmacy technicians with regards to counselling women of reproductive age on adequate folate intake. Methods. The cross-sectional study was conducted among the nationwide stratified sample of pharmacists and pharmacy technicians, practicing in both private and state-owned community pharmacies in Serbia. The detailed literature review, expert consultation and pre-testing were employed in the questionnaire development. The descriptive and inferential statistical analyses were performed using the SPSS software ver. 22. Results. Among 730 survey participants, 96.6% correctly identified types of deformities that could be prevented by folic acid and 77.0% recognized recommended dosage for women capable of becoming pregnant. However, fewer were able to recognize the optimal timing for folic acid supplementation (61.1%) and the proper dose for the NTD recurrence prevention (42.9 %). While 43.2% of pharmacy technicians thought that it was not their responsibility to provide a counselling concerning the measures for the prevention of congenital anomalies, only 4.7% of licensed pharmacists and none of the interns were of that opinion (?2 = 198.287; df = 4; p < 0.001). The majority of respondents (54.7%) reported provision of informative consultation concerning folic acid once a week, or few times a month, while only 10 stated to do so on a daily basis. In addition, based on self-report, only 36.7% of participants communicates information and advice regarding adequate folate status at their own initiative, while the rest addresses this topic only on the patients request, i.e., reactively. Conclusion. Although participants acknowledged the importance of their role in preconception health promotion, our findings revealed certain knowledge gaps as well as dominantly reactive counselling practice. Tailored educational interventions and professional support are needed to improve the engagement of community pharmacy personnel in this area of public health.

Access to orphan drugs (In EU regulation Orphan Drugs are refered as Orphan Medi- cinal Products (OMP)) is a key role in determining whether patients with rare diseases (RDs) will receive adequate and efficient treatment. The objective of this article is to identify differences in patient access to orphan drugs in 3 pharmaceutical markets: Serbia, Croatia and Macedonia. Patient access was defined: as the market access (availability) and affordability (financial accessibility). We analysed the legislative requirements for the authorisation process and made a cross country comparison. Retrospective cross-sectional analysis was done on drug lists in selected countries and a cross-comparison between the List of Orphan Drugs in Europe (LODE) for a six-month period (May 2014-October 2014). We included all 179 OMPs marketed in EU in our analysis, which had received market authorization in Croatia upon its membership in the EU. Total number of marketed drugs in Serbia was 59 (32.96%) drugs and in Macedonia 52 (29.05%) drugs. However, market authorization does not guarantee patient access to any given drug, so only 39.11% of OMPs could be accessed by Croatian patients (70 drugs).The number of refunded drugs in Serbia and Macedonia was smaller (32 and 20, respectively) which makes respectively, 17.88% and 11.17% of drugs on the LODE. The present study showed some variations between countries in selected indicators of availability and access to orphan drugs. Patients in Croatia had greater number of registered and refunded drugs, but in Serbia more than a half of registered OMPs could be refunded from National Health Insurance Fund. Macedonia had smaller number of inhabitants and also had the smaller number of patients from certain RDs which results in lower total number of OMPs. Acta Medica Medianae 2018;57(4):43-51. (OMP), affordability, availability, rare diseases, legislative requirements