Approved and Commercialized Antidiabetic Medicines (Excluding Insulin) in Seven European Countries-A Cross-Sectional Comparison.

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.

Serbian Version of the eHealth Literacy Questionnaire (eHLQ): Translation, Cultural Adaptation, and Validation Study Among Primary Health Care Users.

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 Macva 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.

Association between culture and the preference for, and perceptions of, 11 routes of medicine administration: A survey in 21 countries and regions.

Medicines can be taken by various routes of administration. These can impact the effects and perceptions of medicines. The literature about individuals' preferences for and perceptions of the different routes of administration is sparse, but indicates a potential influence of culture. Our aim was to determine: (i) any association between one's culture and one's preferred route of medicine administration and (ii) individual perceptions of pain, efficacy, speed of action and acceptability when medicines are swallowed or placed in the mouth, under the tongue, in the nose, eye, ear, lungs, rectum, vagina, on the skin, or areinjected. A cross-sectional, questionnaire-based survey of adults was conducted in 21 countries and regions of the world, namely, Tunisia, Ghana, Nigeria, Turkey, Ethiopia, Lebanon, Malta, Brazil, Great Britain, United States, India, Serbia, Romania, Portugal, France, Netherlands, Japan, South Korea, Hong Kong, mainland China and Estonia, using the Inglehart-Welzel cultural map to ensure coverage across all cultures. Participants scored the pain/discomfort, efficacy, speed of onset and acceptability of the different routes of medicine administration and stated their preferred route. Demographic information was collected. A total of 4435 participants took part in the survey. Overall, the oral route was the most preferred route, followed by injection, while the rectal route was the least preferred. While the oral route was the most preferred in all cultures, the percentage of participants selecting this route varied, from 98% in Protestant Europe to 50% in the African-Islamic culture. A multinomial logistic regression model revealed a number of predictors for the preferred route. Injections were favoured in the Baltic, South Asia, Latin America and African-Islamic cultures while dermal administration was favoured in Catholic Europe, Baltic and Latin America cultures. A marked association was found between culture and the preference for, and perceptions of the different routes by which medicines are taken. This applied to even the least favoured routes (vaginal and rectal). Only women were asked about the vaginal route, and our data shows that the vaginal route was slightly more popular than the rectal one.

Pharmacotherapy literacy level and predictors of low literacy among diabetes mellitus type 2 patients in Serbia.

BACKGROUND: Pharmacotherapy literacy (PTHL) is a specific ability to safely access, appraise and understand the available information concerning medication and to calculate and act accordingly. The concept of PTHL is mostly unknown for the majority of diabetes mellitus type 2 (DMT2) patients in Serbia. With diabetes being one of the major public health problems in Serbia with a prevalence of 9.1%, this two-study research aims at constructing performance-based instrument and estimating the prevalence of PTHL levels and identification of predictors of low PTHL scores in patients with DMT2. METHODS: Multistage study was performed to adapt the existing performance-based instrument (PTHL-SR) into specific questionnaire for DMT2 population (PTHL-DM instrument). PTHL levels were assessed through cross-sectional study categorising patients into groups of low, medium, and high PTHL levels. We considered 19 predictors for low PTHL scores, from sociodemographic characteristics, health behaviours and health characteristics, access to health-related information and empowerment-related indicators. Univariate and multivariate logistic regression analyses were used to determine independent predictors of low PTHL. RESULTS: The final 15-item PTHL-DM instrument proved to have satisfactory reliability (KR20 = 0.475) and internal reliability [ICC for the whole instrument was 0.97 with 95% confidence intervals (0.95-0.99)]. Positive correlation (rho = 0.69) between PTHL-DM score (15 questions) and the total PTHL-SR score (14 questions) was also observed. It was demonstrated that the majority of 350 patients had low PTHL (62%), and only 5% high PTHL level. Mean score on PTHL-DM was 7.8 ± 2.3. Probability of low PTHL increased among smokers, patients with low interest in health and those who estimated their health as bad. Patients who used pharmacists as sourse of information were less likely to be pharmacotherapy illiterate. Combined therapy with insulin and Oral Hypoglycemic Agents was associated with higher PTHL. CONCLUSIONS: Our data indicate that specific PTHL-DM tool is objective, valid, and reliable. It was found that low level of PTHL prevailed among DMT2 patients. Medication literacy is influenced by age, residence, education, and family status. Patients with better health literacy also reported better health behaviours. Different patient empowerment programs and approaches aimed at raising PTHL would be essential to improve self-management and control of this widespread chronic disease in Serbia.

Predictors of Inadequate Health Literacy among Patients with Type 2 Diabetes Mellitus: Assessment with Different Self-Reported Instruments.

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.

Cross-Cultural Adaptation and Validation of the Functional, Communicative and Critical Health Literacy Instrument (FCCHL-SR) for Diabetic Patients in Serbia.

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.

A Questionnaire for Rating Health-related Quality of Life.

BACKGROUND: Translations of instruments for measuring quality of life developed in certain, mostly more developed, parts of the world usually do not cover regionally specific aspects of health-related quality of life, even after transcultural validation. The aim of this study was to develop and validate a reliable questionnaire in Serbian, Croatian, Bosnian, and Montenegrin languages suitable for measuring health-related quality of life in adults. METHODS: The study was of a cross-sectional type, assessing the reliability and validity of a newly developed questionnaire for measuring health-related quality of life (HRQoL) in adults residing in western Balkan states (WB-HRQoL). It was conducted on a sample of 489 adults from Serbia, Croatia, Bosnia & Herzegovina, and Montenegro, with a mean age of 52.2±14.4 years and a male/female ratio of 195/294 (39.9%/60.1%). RESULT: The definitive version of the WB-HRQoL scale with 19 items showed very good reliability, with Cronbach's alpha 0.905. The scale was temporally stable, and satisfactory results were obtained for divergent and convergent validity tests. Exploratory factorial analysis brought to the surface four domains of health-related quality of life, namely the physical, psychical, social, and environmental. CONCLUSION: The WB-HRQoL scale is a reliable and valid generic instrument for measuring HRQoL that takes into account the cultural specifics of the western Balkan region.

The Instruments Used to Assess Health Literacy and Pharmacotherapy Literacy of Diabetes Mellitus Type 2 Patients: A Scoping Review.

Background: Patients with chronic diseases, like diabetes need to continuously perform tasks associated with self-management especially with medications they use. It is shown that the patients with diabetes with limited HL and PTHL cannot read medication labels correctly, may misuse their medications, spend much more on therapy and generally have difficulties in understanding printed care instructions and perceiving health advice and warnings. There has been an increasing demand for valid and reliable instruments for HL and PTHL assessment in this population. This review aims to search and critically discuss instruments used to assess HL and PTHL in people with type 2 diabetes and propose their use in different settings. Methods: Authors conducted a comprehensive, electronic search of original studies using a structured approach of the Scopus and PubMed databases, during November and the first 2 weeks of December 2020 to find relevant papers. The review was conducted in accordance with the Cochrane guidelines and the reporting was based on the PRISMA-ScR. The comparison of instruments was made by utilizing a comparison model related to their structure, measurement scope, range, psychometric properties, validation, strengths, and limitations. Results: The final number of included studies was 24, extracting the following identified instruments: Korean Functional Test HL, NVS, FCCHL, HLS-EU-47, TOFLHA, S-TOFHLA, REALM-R, 3-brief SQ, REALM, HLQ and DNT-15. In all, FCCHL and 3-brief SQ are shown with the broadest measurement scopes. They are quick, easy, and inexpensive for administration. FCCHL can be considered the most useful and comprehensive instrument to screen for inadequate HL. The limitation is that the English version is not validated. Three-brief SQ has many advantages in comparison to other instruments, including that it is less likely to cause anxiety and shame. These instruments can be considered the best for measuring functional HL in patients with diabetes mellitus type 2 and other chronic diseases. PTHL instruments (REALM and DNT-15) did not find the best application in this population. Conclusions: The future research should be directed in validation of the FCCHL in English and establishing of the structural validity of this questionnaire. Developing a specific PTHL questionnaire for this population will be of great help in management of their disease.

A Cross-Sectional Survey of Salty Snack Consumption among Serbian Urban-Living Students and Their Contribution to Salt Intake.

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.

European Electronic Personal Health Records initiatives and vulnerable migrants: A need for greater ethical, legal and social safeguards.

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples' health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant-centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe.