Pharmacists' clinical knowledge and practice in the safe use of contraceptives: real knowledge vs. self-perception and the implications.

BACKGROUND: Pharmacists are often the first healthcare professionals that patients contact with their illnesses and requests for medical information, which is enhanced following the recent COVID-19 pandemic. Community pharmacists are expected and required to possess a broad spectrum of knowledge and skills. Self-assessment of these competencies is needed for their self-improvement. PURPOSE OF THE STUDY: To assess pharmacists' clinical knowledge and practice in the safe use of contraceptives, and to compare the scores obtained by external observation with pharmacists' self-assessment of their knowledge as well as investigate the significance of preceptorship experiences. Contraceptives was chosen as the subject area in view of high rates of abortions as a means of contraception in Bosnia and Herzegovina. METHODS: A questionnaire approach was used. The questionnaire included the following: the first domain contained two case scenarios (safe use of contraceptives), which evaluated clinical knowledge, a second domain in which pharmacists self-assessed their knowledge to resolve cases from the first domain and a third domain that measured the demographics of pharmacists (including experience in preceptorship). Dispensing practice was evaluated in the second domain. The questionnaires were distributed to a convenient sample of 100 pharmacists at the Annual Meeting of Bosnia and Herzegovina Pharmacists. The results were presented as counts (%). The groups (preceptors and non-preceptors) were compared using Mann-Whitney U test, paired assessments were analyzed by Wilcoxon signed-rank test and Spearman's correlation was used to assess the correlation between variables. RESULTS: Of the 100 pharmacists invited to participate, 84 completed the questionnaire (84 % response rate). There was no agreement between pharmacists' real knowledge (average score - case 1: 2.71, case 2: 3.3) and their self-assessment (average score - case 1: 3.77, case 2: 3.91). There was no statistically significant difference in the actual knowledge of pharmacists (experienced/non-experienced in precepting), while the difference in the self-assessment was significant between these two groups. CONCLUSION: Pharmacists appear to overrate themselves, which leads to self-enhancement bias, in which the experience in precepting has some influence. Pharmacists' capability in performing an objective self-assessment of their clinical knowledge needs to be carefully studied in the future to fully benefit patients.

Predictors and Motivation of Preceptors' Interest in Precepting of Pharmacy Interns-Do We Have a Useful Questionnaire?

PURPOSE: To determine the potential value of an adapted questionnaire to discover the predictors of preceptors' higher interest in precepting pharmacy interns and to evaluate preceptors' motivational factors and incentives for teaching as well as their professional satisfaction. METHOD: A link to the survey study of adapted questionnaire (JSAMPPP) was e-mailed to all pharmacists registered with the Pharmaceutical Chamber of the Republic of Srpska. Pharmacists' demographic and work experience characteristics, their attitudes related to motivation for precepting, value of incentives for precepting, job satisfaction, and influence of interns on pharmacists' professional practice were obtained. RESULTS: Half of the preceptors who reported feeling satisfied with their professional life also showed interest in teaching. In addition, teaching pharmacy students positively contributed to the overall job satisfaction of the preceptors. Pharmacy preceptors were found to be most motivated by intrinsic factors. The most valued incentives reported were those related to continuing education. CONCLUSIONS: The adapted questionnaire has potential value and it revealed the following predictors of preceptors' higher interest in precepting: enjoyment of teaching, satisfaction with professional life, satisfaction as a pharmacy preceptor, and interns' influence on preceptors. These identified predictors can be emphasized to improve pharmacy students' internship experiences, thereby reinforcing the pharmacy profession.

Reinforcement of the Framework for Experiential Education in Healthcare in Serbia: Post-Implementation Project Review within Pharmacy Education.

Background: The Erasmus+ project "Reinforcement of the Framework for Experiential Education in Healthcare in Serbia" (ReFEEHS) has been undertaken with the aim to: (i) reinforce and modernize experiential education (ExEd) in the health sciences curricula, (ii) introduce interprofessional education (IPE), and (iii) promote teaching competency development of academic staff and teacher practitioners/clinician educators. The aim of this paper is a post-implementation review of the project activities and outcomes with the emphasis on the impact and sustainability in pharmacy education. Methods: Project Logical framework matrix has been employed as planning, monitoring and evaluation tool which summarizes the main project objectives, project outcomes, relevant activities, indicators of progress, sources of verification, assumptions and risks. Results: The key project outcomes are: (i) update of competency-based curricula and development of quality assurance framework for students professional practice placements; (ii) development and introduction of interprofessional teaching and learning activities through joint curriculum delivery; and (iii) development and implementation of Teaching Certificate in Health Professions Education (TCinHPE) study program. The short-term impact of project activities and outcomes has been assessed based on the feedback received from relevant stakeholders, as well as self-evaluation of participants enrolled in new/updated curricula. Sustainability of project results is necessary in order to achieve long-term impact envisioned as increased level of professional competency of health science students; increased level of teaching competency of academic staff and teacher practitioners; improved patient healthcare and harmonisation with the EU practice and policies. Conclusions: The project outcomes contributed to building capacity at the Serbian universities involved in terms of collaboration between the healthcare professions and, in curriculum and academic staff development. It is expected that improved curricula will positively impact professional competency development of pharmacy students, graduates employability and increased workforce mobility. Meeting the quality standards of the European Higher Education Area will contribute to visibility of Serbian universities and their internationalisation, which is one of the strategic aims of improvement.

Applicability of EU(7)-PIM criteria in cross-national studies in European countries.

BACKGROUND: The European Union (EU)(7)-PIM (potentially inappropriate medication) list presents the most comprehensive and up-to-date tool for evaluation of PIM prescribing in Europe; however, several country-specific studies have documented lower specificity of this list on pharmaceutical markets of some countries. The aim of our study was to describe approval rates and marketing of PIMs stated by EU(7)-PIM criteria in six EU countries [in comparison with the American Geriatric Society (AGS) Beers 2015 criteria]. METHODS: Research teams of six EU countries (Czech Republic, Spain, Portugal, Serbia, Hungary and Turkey) participated in this study conducted by WG1b EU COST Action IS1402 group in the period October 2015-November 2018. Data on approval rates of PIMs and their availability on pharmaceutical markets have been obtained from databases of national drug-regulatory institutes and up-to-date drug compendia. The EU(7)-PIM list and AGS Beers 2015 Criteria (Section 1) were applied. RESULTS: PIMs from EU(7)-PIM list were approved for clinical use more often than those from the AGS Beers 2015 criteria (Section 1). Approval rates for EU(7)-PIMs ranged from 42.8% in Serbia to 71.4% in Spain (for AGS criteria only from 36.4% to 65.1%, respectively). Higher percentages of approved PIMs were documented in Spain (71.4%), Portugal (67.1%) and Turkey (67.5%), lower in Hungary (55.5%), Czech Republic (50.2%) and Serbia (42.8%). The majority of approved PIMs were also currently marketed in all countries except in Turkey (19.8-21.7% not marketed PIMs) and less than 20% of PIMs were available as over-the-counter medications (except in Turkey, 46.4-48.1%). CONCLUSIONS: The EU(7)-PIM list was created for utilization in European studies; however, applicability of this list is still limited in some countries, particularly in Eastern and Central Europe. The EU project EUROAGEISM H2020 (2017-2021) that focuses on PIM prescribing and regulatory measures in Central and Eastern European countries must consider these limits.

Medication use in older patients and age-blind approach: narrative literature review (insufficient evidence on the efficacy and safety of drugs in older age, frequent use of PIMs and polypharmacy, and underuse of highly beneficial nonpharmacological strategies).

INTRODUCTION: The importance of rational drug therapy is increasing with the aging of the population. Since one of the main reasons for inappropriate drug prescribing is also the "age-blind" approach, which results in ageist practices, this narrative literature review focuses on the description of the main barriers related to insufficient individualization of drug regimens associated with such age-blind approaches. METHODOLOGY: A narrative literature review using the PubMed, WoS, Embase, and Scopus databases was conducted by the EU COST Action IS1402. Experts in different scientific fields from six countries (the Czech Republic, Spain, Portugal, Hungary, Serbia, and Turkey) worked in four specific areas: (1) underrepresentation of older adults in clinical trials and clinical and ethical consequences; (2) insufficient consideration of age-related changes and geriatric frailty in the evaluation of the therapeutic value of drugs; (3) frequent prescribing of potentially inappropriate medications (PIMs); and (4) frequent underuse of highly beneficial nonpharmacological strategies (e.g., exercise). RESULTS: Older patients are underrepresented in clinical trials. Therefore, rigorous observational geriatric research is needed in order to obtain evidence on the real efficacy and safety of frequently used drugs, and e.g. developed geriatric scales and frailty indexes for claims databases should help to stimulate such research. The use of PIMs, unfortunately, is still highly prevalent in Europe: 22.6% in community-dwelling older patients and 49.0% in institutionalized older adults. Specific tests to detect the majority of age-related pharmacological changes are usually not available in everyday clinical practice, which limits the estimation of drug risks and possibilities to individualize drug therapy in geriatric patients before drug prescription. Moreover, the role of some nonpharmacological  strategies is highly underestimated in older adults in contrast to frequent use of polypharmacy. Among nonpharmacological strategies, particularly physical exercise was highly effective in reducing functional decline, frailty, and the risk of falls in the majority of clinical studies. CONCLUSION: Several regulatory and clinical barriers contribute to insufficient knowledge on the therapeutic value of drugs in older patients, age-blind approach, and inappropriate prescribing. New clinical and observational research is needed, including data on comprehensive geriatric assessment and frailty, to document the real efficacy and safety of frequently used medications.

Provision of pharmaceutical care by community pharmacists across Europe: Is it developing and spreading?

RATIONALE, AIMS, AND OBJECTIVES: Pharmaceutical care involves patient-centred pharmacist activity to improve medicines management by patients. The implementation of this service in a comprehensive manner, however, requires considerable organisation and effort, and indeed, it is often not fully implemented in care settings. The main objective was to assess how pharmaceutical care provision within community pharmacy has evolved over time in Europe. METHOD: A cross-sectional questionnaire-based survey of community pharmacies, using a modified version of the Behavioural Pharmaceutical Care Scale (BPCS) was conducted in late 2012/early 2013 within 16 European countries and compared with an earlier assessment conducted in 2006. RESULTS: The provision of comprehensive pharmaceutical care has slightly improved in all European countries that participated in both editions of this survey (n = 8) with progress being made particularly in Denmark and Switzerland. Moreover, there was a wider country uptake, indicating spread of the concept. However, due to a number of limitations, the results should be interpreted with caution. Using combined data from participating countries, the provision of pharmaceutical care was positively correlated with the participation of the community pharmacists in patient-centred activities, routine use of pharmacy software with access to clinical data, participation in multidisciplinary team meetings, and having specialized education. CONCLUSIONS: The present study demonstrated a slight evolution in self-reported provision of pharmaceutical care by community pharmacists across Europe, as measured by the BPCS. The slow progress suggests a range of barriers, which are preventing pharmacists moving beyond traditional roles. Support from professional bodies and more patient-centred community pharmacy contracts, including remuneration for pharmaceutical care services, are likely to be required if quicker progress is to be made in the future.

Pharmacists counselling of pregnant women: Web-based, comparative study between Serbia and Norway.

OBJECTIVES: To describe, compare and evaluate whether pharmacists in two European countries, Serbia and Norway, give appropriate counselling for common ailments in pregnancy. DESIGN: A cross sectional, web-based study. PARTICIPANTS AND SETTINGS: A study was conducted among Serbian and Norwegian pharmacists during two four-month study periods in 2012 respectively 2014. Participants were recruited through postal and electronic invitation facilitated by several pharmacy chains. Participation in the study was anonymous and voluntary. MEASUREMENT INSTRUMENT: Pharmacists were presented with the questionnaire that included five scenarios (back pain, heavy legs, nausea, cold and constipation in pregnancy) and were asked to give their advice about use of medicines, supplements (e.g. herbal products, vitamins, minerals), non-pharmacological treatment and referral to physician in each condition. FINDINGS: In total, 276 pharmacists, 119 in Serbia and 157 in Norway, accepted to participate in the study. Recommendation about medicines use ranged from 32% (heavy legs) to 71% (back pain) in Serbia and from 3% (heavy legs) to 92% (constipation) in Norway. Several pharmacists' recommendations on medicines and supplements use were inappropriate. Recommendation about non-pharmacological treatments ranged from 11% (nausea) to 50% (heavy legs) in Serbia and from 12% (constipation) to 63% (cold) in Norway. Approximately 12% of the Norwegian and Serbian pharmacists offered referral to a physician as only advice for nausea in pregnancy, indicating a lack of confidence in or knowledge about this common ailment in pregnancy. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Large differences in counselling of pregnant women by pharmacists in Serbia and Norway were observed. Enhancement of pharmacists' knowledge about treatment of common ailments in pregnancy is needed and will enhance pharmacists' role in improving maternal health.

Towards medicines regulatory authorities' quality performance improvement: value for public health.

The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions.

Translation and factor analysis of structural models of Edinburgh Postnatal Depression Scale in Serbian pregnant and postpartum women - Web-based study.

BACKGROUND: The Edinburgh Postnatal Depression Scale (EPDS) is well accepted for detecting symptoms of postnatal depression. The aim of this study was to examine psychometric properties and to evaluate structural models of the Serbian translation of EPDS in pregnant and postpartum women. METHODS: The original English version of the EPDS was translated into Serbian, and checked by means of back-translation. Data were collected via an anonymous online questionnaire posted on a Serbian website devoted to pregnancy topics. The study sample included 201 women (76 pregnant, 125 postpartum). The internal consistency of the scale was measured by Cronbach's α coefficient. Principal component analysis was used to determine scale dimensions while confirmatory factor analysis was used to evaluate model fit. FINDINGS: Cronbach α coefficient was 0.84 and 0.83 in pregnant and postpartum women, respectively, which indicated good internal consistency of the Serbian EPDS. Three dimensions of the scale were revealed in both groups of women. Goodness of fit indices described good and excellent model in pregnant and postpartum women, respectively. High level of depression symptoms (score ≥13) was recorded in 27.6% and 24.8% (p>0.05) of pregnant and postpartum women, respectively. Moderate level of depression symptoms (score 10-12) was recorded in 21.1% and 16.8% (p>0.05) of pregnant and postpartum women, respectively. CONCLUSION: The Serbian translation of the EPDS showed good consistency and good model characteristics in pregnant and postpartum women. However, cut-off values, sensitivity and specificity of the scale should be determined in the further studies with more representative samples of women.

Analysis of antibiotic consumption for treating respiratory tract infections in children and compliance with the national clinical guidelines.

INTRODUCTION: Respiratory infections are the most common infections in children. The aims of the study were to analyze the use of antibiotics for respiratory infections in the period 2008-2010 in children's population in region of Nis and to estimate the rational use of antibiotics in relation to the recommendations of the National Guidelines for physicians in primary care. MATERIAL AND METHODS: Data source was a Pharmacy Nis database. Antibiotics prescriptions were selected for the following diagnoses: H65-H75 (acute otitis media, mastoiditis), J01 (acute sinusitis), J02-J03 (tonsillopharyngitis), J12-J18 (community acquired pneumonia), J20 (acute bronchitis), J32 (chronic sinusitis), J42 (chronic bronchitis). Antibiotic consumption was expressed in defined daily dose/1000 ihhabitants/day. RESULTS: The most widely prescribed antibiotic for the treatment of upper respiratory tract infections in children during the three years was amoxicillin (34.63; 32.50 and 31.00 defined daily dose/1000 inhabitants/day in 2008, 2009 and 2010, respectively). In the treatment of infections of the middle ear and mastoid, the combination of amoxicillin and clavulanic acid, was the most prescribed antibiotics (60% of total consumption of antibiotics for this indication). Azithromycin was the most widely prescribed antibiotic for the treatment of lower respiratory tract infections in children during the observed period (6.92; 8.20 and 7.18 defined daily dose/1000 inhabitans/day in 2008, 2009 and 2010, respectively). CONCLUSION: Recommendations of national guidelines are not complied with the treatment of upper and lower respiratory infections in the children population in region of Nis. This could be a sign of potentially irrational use of antibiotics that need to be further examined. Education of physicians can influence irrational use of antibiotics.

The impact of education on adolescents' sun behavior: experiences from Serbia.

INTRODUCTION: In Serbia, there have been no broad campaigns or educational programs focused on adolescents' sun protection. OBJECTIVE: The aim of the study was to assess whether an educational program would have impact on changes of attitudes and sun-protective behaviors of high school students. More specific aim was to examine whether sex and age differences in sun behavior exists. METHODS: Educational program was designed to provoke changes in attitudes towards sun protection and sun behavior. The investigation was carried out in Belgrade, Serbia in two educational cycles, during spring 2007 and 2008. Sixteen- and 17-year old high schools students were targeted and assessed before and after the educational intervention by means of self-report questionnaire designed for this study (about skin types and sun behavior). The students' attitudes towards sun protection and sun behavior before and after the educational intervention were compared and analyzed by the Pearson's chi-square test and logistic regression analyses. In the second educational cycle (2008) age and gender differences in sun behavior were analyzed. RESULTS: Overall 3205 students in 2007, and 2155 students in 2008 year from 11 high schools participated. A statistically significant behavior change was observed for the use of sunglasses in 2007--the number of students using them increased from 41.6% to 45.6% (p < 0.05). There were no significant changes in other ways of protection i.e. sunscreen use, protective clothes or staying in shade. CONCLUSION: Educational program had an impact, but broader activities involving schools, local communities and media are needed for significant changes in sun behavior and attitude.

Economic burden of cardiovascular diseases in Serbia.

BACKGROUND/AIM: Cardiovascular disease imposes a burden to society in terms of mortality, morbidity and economic losses. The aim of this study was to estimate the economic burden of cardiovascular disease in Serbia in 2009 from the perspective of the society. METHODS: For the purpose of the study cardiovascular disease was defined by the International Classification of Diseases, 10th revision, as the following diagnosis: hypertension, coronary heart disease, cardiomyopathy, heart failure and cerebrovascular disease. The prevalence, top-down method was used to quantify the annual cardiovascular costs. Productivity losses were estimated using the human capital approach and the friction cost method. A discount rate of 5% was used to convert all future lifetime earnings into the present value. RESULTS: The total direct costs of cardiovascular disease in 2009 were Euro 400 million. The results showed that more than half a million working days were lost due to incapacity resulting from cardiovascular diseases, yielding the Euro 113.9 millon. The majority of total costs (Euro 514.3 million) were for: medication (29.94%), hospital days (28.97%) and hospital inpatient care--surgical and diagnostic interventions (17.84%). The results were robust to a change in 20% of volume or the unit price of all direct and indirect cost and to discount rate 2% and 10%. CONCLUSIONS; The total cardiovascular disease costs in 2009 represented approximately 1.8% of the Serbian gross domestic product. The results of the study would be valuable to health policy makers to bridge the gap between invested resources and needs, in order to improve cardiovascular disease outcomes.

Predictors of the use of medications before and during pregnancy.

BACKGROUND: Drug use in pregnancy is often reason of concern for mothers and their physicians. However, only few studies investigated predictors of drug use in pregnancy. OBJECTIVES: To examine maternal characteristics as predictors of medication use in the 6 months before pregnancy and during the first 6 months of pregnancy. To examine whether prescription and over-the-counter (OTC) medication use in the 6 months before pregnancy had an impact on medication use in pregnancy. SETTING: Six maternity care units and five community pharmacies. METHOD: Data were collected using a specially designed self-reported questionnaire during the period March 2009-March 2010. Logistic regression was used to identify factors associated with medication use. MAIN OUTCOME MEASURE: Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were used as association measures. RESULTS: A total of 236 women were included in the analysis. After controlling for maternal characteristics, parity of more than one was associated with lower prescription medication use in pregnancy (aOR 0.46; 95% CI 0.22-0.93), higher household income with higher OTC medication use before pregnancy (aOR 3.13; 95% CI 1.22-8.00), and miscarriage with higher C and D Food and Drug Administration (FDA) risk category medication use in pregnancy (aOR 3.65; 95% CI 1.30-10.25). Prescription medication use before pregnancy was associated with higher prescription medication use in pregnancy (aOR 2.49; 95% CI 1.12-5.52), OTC medication use before pregnancy with higher OTC medication use in pregnancy (aOR 35.95; 95% CI 7.95-162.49), and C and D FDA risk category medication use before pregnancy with the same category medication use in pregnancy (aOR 3.54; 95% CI 1.23-10.17). CONCLUSION: Different maternal characteristics were shown as predictors of medication use before and during pregnancy. However, medication use before pregnancy was shown as the most important predicting factor for the medication use in pregnancy.

How much do we pay for caesarean section--a pilot study in Serbia.

BACKGROUND: Different types of labour need different resources. Subsequently, different costs should be expected. AIM: The aim of the study was to determine costs of planned Caesarean section (C-section) in relation to costs of spontaneous (SVD) and induced vaginal (IVD) delivery. METHODS: Retrospective study was conducted for the period January 1st-December 31st, 2010. Database of Health Insurance Fund of Republic of Serbia was used as a data source. Direct medical costs of labor were estimated for mother/newborn pair. RESULTS: The sample was consisted of 99 women where 46.5% had SVD, 28.3% IVD and 25.2% C-section. The average costs of labor, regardless of method, were 417.02+284.14 EUR. Costs of C-section were higher compare to SVD (640.18 +/- 240.04 vs. 243.27 +/- 131.70 EUR, p < 0.05) and IVD (640.18 +/- 240.04 vs. 497.10 +/- 327.91 EUR, p < 0.05). CONCLUSION: Considering high costs of C-section, it is necessary to review such clinical practice for the purpose of optimizing the use of resources.

Drug use before and during pregnancy in Serbia.

BACKGROUND: Observation of drug use patterns during pregnancy is necessary for the recognition of potential bad practices and improvement of safe drug use in pregnancy. OBJECTIVE: To investigate prescription and over the counter drug use among Serbian women in the 6 months before pregnancy and in the first 6 months of pregnancy, and to evaluate the drugs used according to the risk to a fetus. Setting Six maternity care units and five community pharmacies. METHOD: A multi-center study was performed in Serbia during the period from March 2009-March 2010. A self-reporting questionnaire was used as a data source. Food and Drug Administration (FDA) risk classification system was used to determine the risk of used drugs for the fetus. Differences between subgroups were assessed using McNemar's test on paired proportions. Main outcome measure Proportion of women exposed to drugs or class of drugs. RESULTS: The overall drug exposure was higher in pregnancy (34.7 %) than before pregnancy (29.9 %), p > 0.05, in the cohort of 311 pregnant women. A significantly greater prescription drug use, 19.0 versus 27.3 % of women, p < 0.05, and less selfmedication with over the counter drugs in pregnancy, 15.1 versus 8.7 %, p < 0.05, were observed. Commonly used drugs were musculoskeletal drugs, analgesics/antipyretics and respiratory system drugs before pregnancy (13.8, 12.5, and 6.4 % of women, respectively), and progestogens, analgesics/antipyretics, and antibiotics for the systemic use in pregnancy (9.0, 7.7, and 7.4 %, respectively). A greater exposure to drugs belonging to the FDA risk category A (3.9 vs. 60.8 %, p < 0.05), B (18.0 vs. 19.6 %, p > 0.05), C (10.0 vs. 10.3 %, p > 0.05) and D (2.9 vs. 10.9 %, p < 0.05), as well as less exposure to drugs belonging to category X (0.3 vs. 0 %, p > 0.05) were observed in pregnancy. Folic acid was used by 60.8 % of women in pregnancy, and by only 3.9 % before pregnancy. CONCLUSION: Besides higher overall drug use in pregnancy than before pregnancy, particularly the use of progestogens, and, subsequently, D category drugs, less selfmedication with over the counter drugs was observed in pregnancy. Insufficient use of folic acid before pregnancy requires public health service activities.

Validation of the osteoporosis quality of life questionnaire QUALEFFO-41 for the Serbian population.

BACKGROUND: Vertebral fractures could lead to reduced physical, social and mental functioning, and loss of personal independence. Therefore, during the treatment of osteoporosis, it has become necessary to examine the changes in everyday functioning, well-being and health related quality of life (HRQOL). To that effect, this study aims to translate, culturally adapt, and validate the Serbian version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) for patients with vertebral fractures. METHODS: Nine female patients with osteoporosis participated in the pre-validation study. A validation, case-control study included two groups of female patients: one that consisted of 50 female patients with osteoporosis, and with at least one vertebral fracture, and another one that consisted of 50 control patients with osteoporosis but without fractures. They completed the QUALEFFO-41 and the EuroQol group questionnaire with five dimensions (EQ-5D) twice within a month. The validation study examined internal consistency, concurrent validity, test-retest reliability, sensitivity and specificity. RESULTS: During the pre-validation study, three of the items in the QUALEFFO-41 were slightly changed. Afterwards, during the validation study, the statistically significant differences (adjusted for: age, duration of menopause, current employment and marital status) in the mean values of all domains and total scores between the groups were noted. For the case group, the internal consistency of the QUALEFFO-41 domains and of total questionnaire was above 0.70. The test-retest reliability was tested by the intraclass correlation coefficients (ICC) that were in range 0.87 - 0.96 for the case, and 0.15 - 0.83 for the control group. Correlations between the total scores of the QUALEFFO-41 and the EQ-5D health state value, for both groups were negative and statistically significant (r = -0.78, p<0.001 and r = -0.73, p<0.001, respectively). The QUALEFFO-41 had a better prediction of the value of HRQOL of cases compared to the generic questionnaire EQ-5D (the AUC difference was 0.099, p = 0.013). CONCLUSIONS: The Serbian QUALEFFO-41 version is reliable, valid, sensitive and predictive for examinations of HRQOL in patients with prevalent vertebral fractures and can be used in further studies.

Pharmacy network and access to medicines in selected eastern European countries: comparative analysis.

AIM: To analyze the pharmacy network (structure and resources) in Bulgaria, Croatia, Serbia, and Slovenia and its relation to public expenditures for medicines. METHODS: We performed a cross-sectional study using the officially published data for the period 2003-2008 in four selected countries. Data sources were relevant national institutions. RESULTS: In 2008, Serbia had 27.5, Bulgaria 66.8, Croatia 59.5, and Slovenia 71.2 pharmacists per 100000 inhabitants. There was a significant difference in the number of pharmacists per 100000 inhabitants between all countries except between Bulgaria and Slovenia. The number of inhabitants per one pharmacy was significantly different between all observed countries. The expenditures for medicines per capita in 2008 were between €30.34 in Bulgaria to €137.03 in Slovenia, with a significant difference between all countries except between Bulgaria and Serbia. The number of pharmacists per 100000 inhabitants and expenditures for medicines per capita were positively correlated in all observed countries, except in Bulgaria. CONCLUSION: There were significant difference in the structure and availability of the pharmacy service in all selected countries. Expenditures for medicines were positively correlated with the number of pharmacists in all countries, except in Bulgaria. Our findings could be valuable to national regulatory bodies for the creation of national drug policies.

Development of a shorter version of the osteoporosis knowledge assessment tool.

The aim of the authors of this study was to develop a short version of the Osteoporosis Knowledge Assessment Tool to be used for the target population of young adult Serbian females as an easily implemented add-on questionnaire. The 20-item Osteoporosis Knowledge Assessment Tool was translated and culturally adapted using the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures. The validation study was conducted on a sample of 250 female students studying at the Faculty of Pharmacy at the University of Belgrade, during a two-month period (November-December 2010). The difficulty index, item-total correlations, and internal consistency were calculated first. Afterward, confirmatory factor analysis was applied to test the structure of the Osteoporosis Knowledge Assessment Tool models and develop a short version. The mean total Osteoporosis Knowledge Assessment Tool score was 8.31 (possible range 0-20). The confirmatory factor analysis fit indices indicated poor fit of the data to the originally hypothesized structure. The confirmatory factor analysis fit indices, difficulty indices, and content validity allowed trimming of the original model and development of a short version with nine items. The average chi-square value for the Osteoporosis Knowledge Assessment Tool short version was 31.79 (p = 0.240, SE = 0.176) with Bollen-Stine bootstrap p = 0.249, Tucker-Lewis Index = 0.925, Comparative Fit Index = 0.944 and Root Mean Square Error of Approximation = 0.027. The Osteoporosis Knowledge Assessment Tool thus had acceptable characteristics and may be used for osteoporosis knowledge assessment.

Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: part II--a method of software documentary analysis.

A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level.

Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: part I--a method of manual documentary analysis.

Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis.