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

Summary A number of risk behaviours, such as smoking, overweight, excessive alcohol intake, insufficient physical activity, excessive and frequent intake of salt, reduced fruit and vegetable intake, increased fat intake, which constitute living habits of an individual can influence the occurrence of hypertension and hyperglycaemia. The changing of these lifestyles can reduce the risk of developing prehypertension and prediabetes. The survey was conducted at student’s campuses. The respondents were subjected to the height, weight, blood glucose and blood pressure. Respondents filled in previously created questionnaire that was approved by the Ethics Committee for Biomedical Research Faculty of Pharmacy, University of Belgrade. The percentage of respondents with a glucose value above the reference value was 14.6% (n=19), 2.4% (n=3) had values greater than 7 mmol/L without being diagnosed with diabetes, and accordingly, 2.4% (n=3) had elevated HbA1c values (above 42 mmol/mol or 6.0%). The percentage of respondents with elevated systolic and diastolic blood pressure was 14.9% and 7.4% respectively. Regarding calculated risk scores, they showed parallel increase with increas-ing of BMI (HPS), systolic and diastolic pressure (OHS), and glucose concentration (OPS). When analysing all the factors that could cause the later development of diabetes, which is associated with hypertension as well, it is observed that the student population is very much exposed to those factors. The results of this study cannot be representative for the general population of students, but they can provide recommendations for further research.

Parental health literacy plays an important role in children’s health. Experiences from pharmacy practice show that is necessary to check if parents understand instructions about use of medicines for children. This study aimed to assess pharmacotherapy literacy of parents of pre-school children and to examine association of parental pharmacotherapy literacy level with parent’s socio-demographic characteristics. The study was cross-sectional, conducted among parents of pre-school children (1–7 years of age), in kindergartens in several municipalities of Belgrade, Serbia, during regular parents meetings, from May to October 2016. Functional health literacy was measured by the Serbian version of the Short Test of Functional Health Literacy in Adults (S-TOFHLA). Parental pharmacotherapy literacy was assessed with newly constructed PTHL-SR questionnaire with good psychometric characteristics (Parental pharmacotherapy literacy questionnaire—Serbian). Overall, 813 parents participated in the study, mostly females (81.30%), between 30 to 40 years of age (70.85%) with two children (56.70%). Almost all of our study participants (99%) had adequate health literacy as assessed by S-TOFHLA. Mean score on PTHL-SR was 72.83% (standard deviation was 13.37), with better results among females than males (72% of women were in the group of highest PTHL-SR results). Our study showed that many parents (76.5%) knew the appropriate usage of non-prescription medicine for children, 57.2% parents were able to correctly calculate the dose of oral syrup for a child, and only 43.3% were able to interpret non-prescription dosage information written on the package. The majority of parents (61.3%) would make a dosage to child based on age and not on their weight. Every fifth parent with adequate functional health literacy measured by S-TOFHLA test, achieved the lowest results measured by PTHL-SR. Higher performance of the PTHL-SR was significantly correlated with education (p < 0.001), female sex (p < 0.001), married parents and those living in common-law (p < 0.001), older parents (p < 0.05) and parents who have more children (p < 0.05), and are non-smokers (p < 0.05). These results provide evidence that limitations in understanding common information about use of medicines are widespread among parents of pre-school children and encourage efforts for further investigation. PTHL-SR questionnaire may be a useful tool for identification of parents who need more instructions and assistance from healthcare providers, above all in providing better communication, written or spoken at community pharmacy settings.

Introduction: Due to the nature of work in pharmacies pharmacists may occur job burnout, which can affect the quality of health services. It is necessary to use validated instruments to test the burnout. One type of instrument is Shirom-Melamed Burnout Questionnaire (SMBQ). Objective: The primary objectives of this work are: cultural adaptation and assessment metric characteristics of SMBQ in a population of pharmacists in Serbia. Alternative objective is evaluate the degree of burnout in the pharmacist population. Methods: For comparison Maslach Burnout Inventory (MBI) was used. All licensed pharmacists have received an email by the Pharmaceutical Chamber of Serbia, with a link for accessing the questionnaires. The questionnaires were completed by 514 pharmacists. Results and Discussion: Professional translators carried out the translation using translation steps like forward translation and backward translation. Were calculated following metric characteristics: α reliability coefficient Cronbach and associates; β the reliability of the first principal component; ψ1 representativeness; h1 the homogeneity (the average correlation of scale items), extent of curvature, horizontal (Skewness) and vertical (Kurtosis). Correlations between subscales are examined. Latent structure SMBQ (maximumlikelihud extraction) is examined. To select a number of factors, the method of parallel analysis was used. For calculation number of latent factors the Hull method was applied. Concurrent validity was examined by correlating the results of the questionnaire SMBQ and MBI. To confirm a one factor solution of the scale, factor analysis was used. Conclusion: All methods show that it is best to keep only one factor. SMBQ satisfies theoretical statistical criteria of reliability and validity and can be used to estimate job burnout at pharmacist population.

Objective: The aim of the research was to determine the frequency and severity of the burnout syndrome among the university educated professionals, working in pharmaceutical companies, related to burnout categories and to determine the connection between this concept and assertiveness. Method: The research was conducted by a cross-sectional study, on a suitable appropriate sample during 2016, and it included 75 university educated professionals, working in pharmaceutical industry in Serbia. The instruments used in the study included the trustworthy and reliable scales, as follows: Maslach Burnout Inventory Human Service Survey and Rathus Assertiveness Schedule. Results: The obtained results revealed the highest levels of burnout in 14% of the respondents, accompanied by high scores on the subscale of Emotional Exhaustion and Depersonalization, as well as the low scores on the Personal Accomplishment subscale. A cross-sectional analysis of socio-demographic determinants of our respondents in relation to the burnout syndrome has shown statistically significant differences in regards to line of business (χ2 = 10.834; p <0.05), gender (χ2 = 11.935; p <0.05), marital status (χ2 = 18.787; p <0.05), number of children in the family (χ2 = 17.142; p <0.05), age (p = 0.020), length of service (p = 0.018), length of service in the profession (p = 0.041) and working full-time while attending postgraduate school (χ2 = 19.910; p <0.01). An analysis of the results of our study has shown statistically significant differences in regards to the levels of assertiveness and the degree of burnout (p = 0.003). Conclusion: A burnout syndrome was more common in older female respondents whose average age is 41 years old or who has 15 years of service in profession in average, who worked full-time while attending postgraduate school, and who possessed lower levels of assertiveness.

Access to orphan drugs (In EU regulation Orphan Drugs are refered as Orphan Medicinal 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.

ABSTRACT Emergency contraception (EC) in Serbia is available in two products: Levonorgestel, which has nonprescription status, and Ulipristal acetate, which is a prescription-only medicine. Considering their dispensing statuses, gynecologists and pharmacists are health care professionals (HCPs) with the widest impact on EC use. Yet little is known about their beliefs and practices regarding these medicines. We surveyed 166 gynecologists (during October 2012—October 2013) and 452 community pharmacists (during January–April 2014). Results showed significant differences between these two groups, suggesting that provision of EC to users may be inconsistent. Gynecologists were more convinced than pharmacists that EC would reduce the abortion rate (86% versus 53%, p < .001). However, they were more concerned than pharmacists that easy access to EC would cause less regular contraceptive use (66% versus 29%, p < .001) and risky sexual behaviors, including initiating sexual activity at a younger age (37% versus 19%, p < .001) and having more sexual partners (33% versus 12%, p < .001). Additionally, more pharmacists than gynecologists (12% versus 2%, p < .001) said they would not provide EC to anyone under any circumstance, even to victims of sexual assault. These results indicated a need for reevaluating and establishing official guidelines for dispensing practices.

The study aimed to examine the external validity of the Folate Food Frequency Questionnaire (F-FFQ) designed for assessing the folate intake in Serbian women of reproductive age. The F-FFQ was tested against repeated 24 h dietary recalls and correspondent nutritional biomarkers (red blood cells (RBC) and serum folate concentrations) using the method of triads. In a cross sectional study, 503 women aged 18–49 years completed dietary questionnaires and representative validation subsample (n = 50) provided fasting blood samples for biomarker analyses. Correlation coefficients were calculated between each of the dietary methods and three pair-wise correlations were applied for the calculation of validity coefficients. Correlation coefficients observed between F-FFQ and three 24 h recalls were r = 0.56 (p < 0.001) and r = 0.57 (p < 0.001) for total sample and validation group, respectively. Bland–Altman plot and cross-classification analyses indicated good agreement between methods. High validity coefficients were determined between the true intake (I) and dietary assessment methods, F-FFQ (Q) and 24 h dietary recalls (R) (ρQIrbc = 0.871 and ρQIser = 0.814; ρRIrbc = 0.652 and ρRIser = 0.698), and moderate ones for biomarkers (B) (ρBIrbc = 0.428 and ρBIser = 0.421). The F-FFQ is valid instrument for the assessment of dietary folate intake in women living in Serbia, a country without mandatory folic acid food fortification.