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Ana-Maria Atănăsoie, R. Ancuceanu, Dušanka M. Krajnović, Magdalena Waszyk-Nowaczyk, M. Skotnicki, Dorota Tondowska, G. Petrova, A. Niculae et al.

Diabetes mellitus is a complex, multifactorial, progressive condition with a variety of approved therapeutic options. The purpose of this study was to offer an overview of the authorized antidiabetic medicines (excluding insulin) compared with marketed products in seven European countries. Data were obtained from primary sources, including the websites of national authorities and directly from specialists in the countries of interest. The range of marketed medicines compared with the authorized group was assessed in terms of active pharmaceutical ingredients (>60% in Bulgaria, France, Serbia), brand names (>70% in Bulgaria, the Czech Republic, Romania, Serbia, Spain), pharmaceutical forms (>60% in all countries), strengths (>60% in Bulgaria, the Czech Republic, Romania, Serbia, Spain), marketing authorization holder (≥50% in all countries) and the status of medicine. Spain was found to have the highest number of products based on most of these attributes. Over 90% of authorized medicines had a pharmacy price in Serbia. Regarding the newer class of GLP-1 receptor agonists, a retail price for all approved substances was available in Bulgaria, Romania, Serbia, and Spain. Only one brand name with one concentration was found available for some agents, being susceptible to drug shortages: glibenclamide (Romania, Serbia, Spain), glipizide (the Czech Republic, Poland, Romania, Spain), glisentide (Spain), acarbose (the Czech Republic), sitagliptin (Bulgaria, Poland), vildagliptin (the Czech Republic, Poland) and saxagliptin (the Czech Republic, France, Romania, Serbia). An overview of the national and international therapeutic options may allow competent authorities and health professionals to take rapid measures in case of supply problems or health crises.

Branko Vujkovic, V. Brković, Ana Pajičić, V. Pavlovic, D. Stanisavljević, Dušanka M. Krajnović, Aleksandra Jovic Vranes

Background As digital health services are increasingly developing and becoming more interactive in Serbia, a comprehensive instrument for measuring eHealth literacy (EHL) is needed. Objective This study aimed to translate, culturally adapt, and investigate the psychometric properties of the Serbian version of the eHealth Literacy Questionnaire (eHLQ); to evaluate EHL in the population of primary health care (PHC) users in Serbia; and to explore factors associated with their EHL. Methods The validation study was conducted in 8 PHC centers in the territory of the Mačva district in Western Serbia. A stratified sampling method was used to obtain a representative sample. The Translation Integrity Procedure was followed to adapt the questionnaire to the Serbian language. The psychometric properties of the Serbian version of the eHLQ were analyzed through the examination of factorial structure, internal consistency, and test-retest reliability. Descriptive statistics were calculated to determine participant characteristics. Differences between groups were tested by the 2-tailed Students t test and ANOVA. Univariable and multivariable linear regression analyses were used to determine factors related to EHL. Results A total of 475 PHC users were enrolled. The mean age was 51.0 (SD 17.3; range 19-94) years, and most participants were female (328/475, 69.1%). Confirmatory factor analysis validated the 7-factor structure of the questionnaire. Values for incremental fit index (0.96) and comparative fit index (0.95) were above the cutoff of ≥0.95. The root mean square error of approximation value of 0.05 was below the suggested value of ≤0.06. Cronbach α of the entire scale was 0.95, indicating excellent scale reliability, with Cronbach α ranging from 0.81 to 0.90 for domains. The intraclass correlation coefficient ranged from 0.63 to 0.82, indicating moderate to good test-retest reliability. The highest EHL mean scores were obtained for the understanding of health concepts and language (mean 2.86, SD 0.32) and feel safe and in control (mean 2.89, SD 0.33) domains. Statistically significant differences (all P<.05) for all 7 eHLQ scores were observed for age, education, perceived material status, perceived health status, searching for health information on the internet, and occupation (except domain 4). In multivariable regression models, searching for health information on the internet and being aged younger than 65 years were associated with higher values of all domain scores except the domain feel safe and in control for variable age. Conclusions This study demonstrates that the Serbian version of the eHLQ can be a useful tool in the measurement of EHL and in the planning of digital health interventions at the population and individual level due to its strong psychometric properties in the Serbian context.

Ivana Stević, Maja Vajagić, Bojana Knežević, Branislava Raičević, Slobodan M. Janković, Dušanka M. Krajnović, Andrijana Milošević-Georgiev, D. Lakić et al.

Obesity is a chronic, complex, relapsing disease impacting healthcare systems and the economy worldwide. We aim to analyze the utilization trends of antiobesity drugs, and their reimbursement status on drug lists of health insurance funds (HIF) in selected European countries. The DDD/1000 inhabitants/day methodology is used for utilization trend analysis, where data from official national utilization reports were used. For the reimbursement status analysis of 5 antiobesity drugs (orlistat, semaglutide, liraglutide, naltrexone/bupropion, setmelanotide), the websites of national health insurance funds (HIF) of 22 European countries were screened. Trend analysis revealed fluctuation for almost all antiobesity drugs (the highest decrease seen for orlistat in Serbia, and the highest increase for liraglutide in Croatia). Novel antiobesity drugs show an increasing utilization trend in almost all the countries. In two out of three European countries, 437 antiobesity drugs are not covered by the HIF. Slovenia and Denmark reimburse most of the antiobesity drugs. The Netherlands is the only country where the cost of setmelanotide is paid by the HIF. Our results emphasize the importance of prioritizing the introduction and implementation of new strategies and reimbursement scheme models in global and national antiobesity policies.

The paper analyzes the effects of medicines policy on the functional separation of pharmacy and drugstore businesses from the early 19th century to the Second World War. Attempts to maintain personal and professional interests in the delivery of medicines prompted the long-standing dispute between pharmacists and druggists over the control and trade of drugs and poisons. The issue of state control generated complex processes that emphasized the professional role of pharmacists as providers of pharmaceutical services and druggists as wholesalers of medicines.

Dušan Vukmirović, Dušanka M. Krajnović, M. Odalović

Purpose: To determine the level of awareness, beliefs and experience of healthcare professionals (HCPs) regarding mobile applications for self-management of type 2 diabetes mellitus. Methods: This review was done by searching the literature using three databases viz: PubMed, Web of Science and Scopus. Assessment of quality of studies was carried out using the scale of the Agency for Healthcare Research and Quality. The results were presented in accordance with the PRISMA 2020 guidelines. Results: The search strategy identified 725 unique research papers, 4 of which were included. A survey among pharmacists showed that 56 % of participants were aware of the existence of mobile health applications, and that 60 % of those who were aware recommended their use. In the multi-HCPs setting, depending on the study, apps recommendation rate varied from 45.5 to 62 %. Most of the participants (88 %) agreed that a mobile app would help strengthen their treatment recommendations to the patients (88 %), and 84 % also agreed that it would help patients manage diabetes better. Conclusion: Not much research has been done on this topic. Available data suggest that the awareness of HCPs regarding mobile applications is unsatisfactory, and that those familiar with these apps find them useful and are ready to recommend them to patients. There is need for further research and measures to increase awareness and knowledge of HCPs about available mobile applications, in order to ensure adequate support to patients with diabetes.

Marija Levic, N. Bogavac-Stanojević, D. Lakić, Dušanka M. Krajnović

Introduction: Obtaining, understanding, interpreting, and acting on health information enables people with diabetes to engage and make health decisions in various contexts. Hence, inadequate health literacy (HL) could pose a problem in making self-care decisions and in self-management for diabetes. By applying multidimensional instruments to assess HL, it is possible to differentiate domains of functional, communicative, and critical HL. Objectives: Primarily, this study aimed to measure the prevalence of inadequate HL among type 2 diabetes mellitus patients and to analyze the predictors influencing health literacy levels. Secondly, we analyzed if different self-reported measures, unidimensional instruments (Brief Health Literacy instruments (BRIEF-4 and abbreviated version BRIEF-3), and multidimensional instruments (Functional, Communicative and Critical health literacy instrument (FCCHL)) have the same findings. Methods: The cross-sectional study was conducted within one primary care institution in Serbia between March and September 2021. Data were collected through Serbian versions of BRIEF-4, BRIEF-3, and FCCHL-SR12. A chi-square test, Fisher’s exact test, and simple logistic regression were used to measure the association between the associated factors and health literacy level. Multivariate analyses were performed with significant predictors from univariate analyses. Results: Overall, 350 patients participated in the study. They were primarily males (55.4%) and had a mean age of 61.5 years (SD = 10.5), ranging from 31 to 82 years. The prevalence of inadequate HL was estimated to be 42.2% (FCCHL-SR12), 36.9% (BRIEF-3) and 33.8% (BRIEF-4). There are variations in the assessment of marginal and adequate HL by different instruments. The highest association was shown between BRIEF-3 and total FCCHL-SR12 score (0.204, p < 0.01). The total FCCHL-SR12 score correlates better with the abbreviated BRIEF instrument (BRIEF-3) than with BRIEF-4 (0.190, p < 0.01). All instruments indicated the highest levels for the communicative HL domain and the lowest for the functional HL domain with significant difference in functional HL between the functional HL of FCCHL-SR12 and both BRIEF-3 and BRIEF-4 (p = 0.006 and 0.008, respectively). Depending on applied instruments, we identified several variables (sociodemographic, access to health-related information, empowerment-related indicators, type of therapy, and frequency of drug administration) that could significantly predict inadequate HL. Probability of inadequate HL increased with older age, fewer children, lower education level, and higher consumption of alcohol. Only high education was associated with a lower probability of inadequate HL for all three instruments. Conclusions: The results we obtained indicate that patients in our study may have been more functionally illiterate, but differences between functional level could be observed if assessed by unidimensional and multidimensional instruments. The proportion of patients with inadequate HL is approximately similar as assessed by all three instruments. According to the association between HL and educational level in DMT2 patients we should investigate methods of further improvement.

Andrijana Milošević-Georgiev, Dragiša Obradović, Dušanka M. Krajnović

Smoking is a global public health problem, and control measures should be implemented in the community so as to reduce the number of smoking-related diseases and healthcare costs. Community pharmacies are ideal places for providing tobacco cessation counselling as a type of public health service, because they are the most accessible health facilities with direct contact with patients. We aimed to examine attitudes towards the implementation of such services, conducting surveys on a sample of pharmacy students (N=300), community pharmacists (N=383) and the general public (N=987) in the Republic of Serbia. The introduction of smoking cessation services at pharmacies was supported by pharmacy students (59.7%), pharmacists (49.2%), and the general public (36.7%). No difference was found between pharmacistsàttitudes in terms of their gender, age, level of education and years of experience. We found evidence that pharmacists as public health practitioners were recognized mostly by students (94.3%). The majority of them (86.3%) recognized the need for additional education in order to implement new services, and every third pharmacist recognized a gap in their education. The data indicate the need for directed research in order to explore the educational needs and competences for practicing pharmacists and enable them to perform services such as smoking cessation in the future.

Marija Levic, N. Bogavac-Stanojević, Dušanka M. Krajnović

Thoroughly validated instruments can provide a more accurate and reliable picture of how the instrument works and of the level of health literacy in people with type 2 diabetes mellitus (T2DM). The present work aimed at cross-cultural adaptation and validation of the Functional, Communicative and Critical Health Literacy Instrument (FCCHL) in patients with T2DM in Serbia. After translation and back-translation, views from an expert group, one cognitive interview study (n = 10) and one survey study (n = 130) were conducted among samples of diabetic patients. Item analysis, internal consistency, content validity, confirmatory factor analysis (CFA) and reliability testing were performed. When all 14 items were analyzed, loading factors were above 0.55, but without adequate model fit. After removing two items with the lowest loadings FHL1 and IHL2 the fit indexes indicated a reasonable normed χ2 (SB scaled χ2/df = 1.90). CFI was 0.916 with SRMR = 0.0676 and RMSEA = 0.0831. To determine internal consistency, Cronbach’s alpha coefficient was 0.796 for the whole FCCHL-SR12. With only minor modifications compared to the English version, the 12-item FCCHL instrument is valid and reliable and can be used to measure health literacy among Serbian diabetic patients. However, future research on a larger population in Serbia is necessary for measuring the levels of HL and their relationship with other determinants in this country.

Dušan Vukmirović, I. Stević, M. Odalović, Dušanka M. Krajnović

The number of software - mobile applications intended for use in the field of people's health and well-being is constantly increasing. The aim of this review is to compare regulations on software - mobile applications as medical devices in the United States of America (USA), European Union (EU) and Serbia, with reference on the efforts for international harmonization of the regulations. The goal is to increase awareness of the broader healthcare professionals' (HCPs) audience about this topic. Publicly available information from official regulatory bodies websites was analyzed and synthesized for two regions and one country of interest. The results show differences in regulatory approaches in this area between two biggest medical device markets - the USA and the EU, while regulations in Serbia are being harmonized with the EU. Regulations clearly define criteria that software - mobile application needs to meet to be assessed as a medical device; on the other hand, they leave a number of applications that provide health-related services out of the regulated scope. Based on the increased awareness of regulations, recommendations for future research can be directed towards greater involvement of HCPs in patient counseling and decision making regarding the selection of mobile applications, to prevent the use of inadequate mobile applications and ensure that their patients are correctly using the right applications with positive effects on health and well-being.

Nataša Zdravković, Jelena Ristić, Andrijana Milošević-Georgiev, Diana Raketić, Dušanka M. Krajnović

Hospital pharmacy is a specialized field within pharmacy and an integral part of healthcare provided to hospitalized patients in a healthcare institution, striving to maintain and continuously improve medication management and pharmaceutical care for patients in line with the highest standards in a hospital environment. Purpose of the study was to monitor pharmaceutical healthcare quality indicators for in-hospital pharmacies, to explain the concept of quality and provide recommendations for the provision of pharmaceutical healthcare in secondary and tertiary healthcare institutions through pharmaceutical healthcare quality indicators. We used the case study method as an in-depth, intense and precisely focused method of descriptive research to present our three-case series. To analyse case studies, we selected hospital pharmacies in three healthcare institutions, the Clinical-Hospital Center (CHC) Zvezdara, University Clinical Center (UCC) Kragujevac and Special Hospital for Addiction Diseases (SHAD). Reference framework was established according to pharmaceutical healthcare quality indicators taken from a pilot project on quality indicators in hospital pharmacies entitled "Indicators of quality and patient safety in pharmaceutical healthcare - hospital pharmacy" from 2012. Data was collected from questionnaires that were filled in directly by pharmacists from pharmacy databases and records from regular everyday work activities. For the purposes of achieving second and third objectives of this study, we performed a literature search for the quality of pharmaceutical healthcare and quality indicators. Comparison of the calculated indicators from the 3 health care institutions presented in our case series provided insight into indicators that are monitored in all three healthcare institutions (6 indicators) as well as in the distribution of indicators by institutions encompassed by our research. Comparative analysis of the calculated indicators by healthcare institutions indicates that I1 is monitoring 12 indicators, I2 9 indicators and I3 8 indicators. Only 1 indicator from the pilot project is being monitored in line with the new "Rule-book on healthcare quality indicators and on the evaluation of the quality of professional work" in the observed institutions (adverse reactions to the medicines/medical devices). The same Rule-book imposes monitoring of another 4 indicators, pointing to improvement of the healthcare system and modernization of pharmaceutical healthcare. It can hence be concluded that the implementation of new indicators requires recommendations and that further research is necessary to determine how to assess pharmaceutical healthcare efficiency and quality that are to be improved through indicators introduced in the pharmaceutical healthcare practice.

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