Immediate and long-term effects of COVID-19 on antibiotic dispensing: increasing use of Watch antibiotics.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic affected antibiotic usage worldwide. However, there is limited data from Serbia. Dispensing of oral antibiotics in Serbian pharmacies was analyzed to calculate monthly and yearly changes between 2018-2021, and to explore immediate and long-term effects of COVID-19 on antibiotic dispensing during this period. METHODOLOGY: The number of antibiotic packages dispensed from pharmacies during the study period was analyzed with a Chi-square test to assess the average change in annual dispensing, and an interrupted time-series analysis was used to evaluate the impact of the pandemic on antibiotic dispensing. The data from 2018-2021 were retrieved from the database of a large community pharmacy chain in Serbia. RESULTS: The average number of antibiotic packages dispensed per day and per pharmacy was higher in 2021 compared to 2018 by one package. However, the dispensing of macrolides increased significantly; 17.7% (2018) vs. 22.5% (2021) (p < 0.05). In general, an increase in antibiotic dispensing was detected during COVID-19 for total antibiotics (16.4%), Watch antibiotics (44.8%), third-generation cephalosporins (80.4%), macrolides (45.5%) and azithromycin (83.7%). However, the immediate effect of COVID-19 was a decrease in the dispensing of Watch antibiotics, penicillin, and third-generation cephalosporins (p < 0.05); and a notable long-term COVID-19 effect was an increase in the dispensing of azithromycin (p < 0.05). CONCLUSIONS: In spite of a relatively stable trend of total antibiotic dispensing before and during COVID-19 pandemic, the use of Watch antibiotics, third-generation cephalosporins, and macrolides (particularly azithromycin) showed an increasing trend in dispensing that should be optimized.

Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure.

Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological frameworks. Multivariate statistical analysis was used to investigate the associations of generic status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment, orphan drug status, years on the market, administration route, and inclusion on the Essential Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately 36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs; the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.

Exploring experiences of pharmacists and pharmacy students using mHealth apps: A qualitative study of user experience.

PURPOSE: Pharmacists can enhance mHealth delivery by promoting the awareness and use of health apps, while pharmacy students and early career pharmacists allow broader perspective for further development. This study aimed to explore the experiences and attitudes of pharmacy students and pharmacists, on the use, advantages and possible improvement of available mHealth platforms in Serbia. METHODS: One-on-one interviews were conducted online in two phases, during March and April 2020 (n = 40) and during March 2021 (n = 20), using a published, validated interview guide which was adapted for this study. Interviews were transcribed ad verbatim, coded and thematically analysed. RESULTS: Although participants recognized room for optimization, most apps had satisfactory user experience. Participants used health apps as a source of updated information and tools in education and work, but also for self-development. During working hours, participants mostly used medication-related apps, however, it was shown that they use different health apps in order to provide the best possible care to patients. CONCLUSIONS: Greater insight into usage, expectations, benefits and challenges of mHealth in pharmacy was obtained and can lead into better informed design of health apps to encourage students and pharmacists, both as professionals and individuals, on the path of their continuous improvement.

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.

Exploring Muslims' Health-Related Behaviours in Portugal: Any Impact on Quotidian Community Pharmacy Practice?

Muslims are a growing community in European countries. General health habits, including therapy-related behaviours, have been described, though implications to pharmacy practice might vary with the local dominant culture and setting. This exploratory study aimed to describe Muslims' prevalent health and medication-related practices and possible implications for culturally competent community pharmacy practice. A descriptive cross-sectional survey was administered to a convenient sample of 100 participants at Lisbon Central Mosque, Portugal. Demographics, dietary, Traditional Arabic and Islamic Medicine (TAIM) and religious practices were examined, including health conditions and conventional biomedical treatments. Participant reported ailments (26%) were aligned with prevalent conditions in the general population. Ill participants were significantly associated with TAIM and Islamic dictates (p < 0.05), particularly Zam-Zam water and milk thistle usage. Participants' orientation to dietary options and Qur'an restrictions were observed regarding forbidden substances in medication, raising issues on medication adherence for some oral dosage forms. TAIM and religious beliefs supplement illness recovery and health improvement instead of replacing conventional healthcare in a religious minority well integrated within the dominant culture. Portuguese community pharmacists should not neglect religious specificities if seamless care is delivered, enhancing professionals' collaboration skills with multicultural patients.

Comparative analysis of the access to health-care services and breast cancer therapy in 10 Eastern European countries.

AIM: The aim of this study is to compare the differences in breast cancer therapy, health-care service practices, and their availability in ten European countries-Albania, Bosnia and Herzegovina, Bulgaria, Kosovo, Montenegro, Republic of North Macedonia, Croatia, Romania, Slovenia, and Republic of Serbia. METHODS: An inquire survey was conducted among oncologists in the participating countries. The questionnaire was of qualitative character and focused on several key areas as screening practices, diagnosing, treatment, and health-care procedures utilization. The results were processed through comparative and percentage analysis. RESULTS: All of the observed countries have national registries for breast cancer, but only in five, a mechanism of controlled action of early detection is implemented. Ninety percent of the countries have implemented in the national guidelines the European Society of Medical Oncology recommendations, while National Comprehensive Cancer Network is considered in only 50%. In all countries, digital mammography is a universal diagnostic method. Pathohistological analysis, including HER2 receptor expression and determination of the level of progesterone and estrogen receptors, is routinely performed in all countries prior to therapy. Some differences are observed in terms of FISH/CISH methods, determination of Ki-67 volume, and prognostic molecular assays. Trastuzumab is used as neo-adjuvant therapy in HER2-positive disease in all countries, while in Bosnia and Herzegovina and Croatia, only pertuzumab is used. Psychological support is integrated into the professional guidelines for treatment and monitoring in Bosnia and Herzegovina, Bulgaria, and Serbia. CONCLUSIONS: The international guidelines should be followed strictly, and some improvements in the health policies should be made in order to decrease the differences and inequalities in the availability of the breast cancer (BC) health services in the Central and Eastern European countries.

Analysis of the economic situation of the South East European pharmaceutical industry.

Background: The pharmaceutical industry in the countries of Southeast Europe is still underdeveloped. Despite experience and tradition as well as significant research efforts and innovation potential, there are still big differences among the companies in the pharmaceutical sector of the SEE countries. It is for this reason that the subject of the study is the analysis of the comparative advantage in exports of the pharmaceutical sector of the SEE countries.Aim: The aim is to point out the potential of the sector and the directions of its development. The study also aims to define the position of the pharmaceutical sector in the SEE countries in today's global context. The study has comprised the pharmaceutical products belonging to group 30 in the HS6 classification and SITC 54 classification in the period 2005-2018.Conclusions: The results of the study indicate that the SEE countries have negative comparative advantage in exports, in the analysed period, except for Slovenia, which stands out with positive values of the RCA index. The products, dominating the foreign trade of the SEE pharmaceutical sector, belong to the group of Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses.

Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries.

Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures. Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined. Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are ~214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014-2016 is presented in Bulgaria and Slovakia. Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant.

Patients' willingness to pay for cognitive pharmacist services in community pharmacies.

AIM: To determine the general population willingness to pay for cognitive pharmacist service in community pharmacy, describe the behavior of participants regarding health care issues, and evaluate correlation between participants' sociodemographic characteristics or attitudes and their willingness to pay. METHODS: A questionnaire-based survey was conducted among general population visiting community pharmacies. The participants were asked about receiving cognitive pharmacist services to identify and resolve potential medication therapy problems after the initiation of a new medicine to optimize health outcomes of the patients. A univariate and multivariate analysis were used to analyze associations between different variables and willingness to pay for pharmacy service. RESULTS: Of 444 respondents, 167 (38%) reported that they were willing to pay for a medication management service provided in the community pharmacy. Univariate analysis showed significant association between the willingness to pay for pharmacist-provided service and respondents' socio-demographic factors, health-related characteristics, and behavior, dilemmas, or need for certain pharmacist-provided service. The logistic regression model was statistically significant (χ2=4.599, P<0.001). CONCLUSIONS: The respondents expressed their willingness to pay for cognitive pharmacist services, which has not been fully recognized within the health care system. In future, pharmacists should focus on practical implementation of the service and models of funding.

Biomarkers for Major Depressive Disorder: Economic Considerations.

Preclinical Research Major depressive disorder (MDD) is a major psychiatric illness and it is predicted to be the second leading cause of disability by 2020 with a lifetime prevalence of about 13%. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly used therapeutic class for MDD. However, response to SSRI treatment varies considerably between patients. Biomarkers of treatment response may enable clinicians to target the appropriate drug for each patient. Biomarkers need to have accuracy in real life, sensitivity, specificity, and relevance to depression. Introduction of MDD biomarkers into the health care system can increase the overall cost of clinical diagnosis of patients. Because of that, decisions to allocate health research funding must be based on drug effectiveness and cost-effectiveness. The assessment of MDD biomarkers should include reliable evidence of associated drug effectiveness, adverse events and consequences (reduced productivity and quality of life, disability) and effectiveness of alternative approaches, other drug classes or behavioral or alternative therapies. In addition, all the variables included in an economic model (probabilities, outcomes, and costs) should be based on reliable evidence gained from the literature-ideally meta-analyses-and the evidence should also be determined by informed and specific expert opinion. Early assessment can guide decisions about whether or not to continue test development, and ideally to optimize the process. Drug Dev Res 77 : 374-378, 2016. © 2016 Wiley Periodicals, Inc.

Cost-effectiveness analysis of acute kidney injury biomarkers in pediatric cardiac surgery.

INTRODUCTION: Acute kidney injury (AKI) is significant problem in children with congenital heart disease (CHD) who undergo cardiac surgery. The economic impact of a biomarker-based diagnostic strategy for AKI in pediatric populations undergoing CHD surgery is unknown. The aim of this study was to perform the cost effectiveness analysis of using serum cystatin C (sCysC), urine neutrophil gelatinase-associated lipocalin (uNGAL) and urine liver fatty acid-binding protein (uL-FABP) for the diagnosis of AKI in children after cardiac surgery compared with current diagnostic method (monitoring of serum creatinine (sCr) level). MATERIALS AND METHODS: We developed a decision analytical model to estimate incremental cost-effectiveness of different biomarker-based diagnostic strategies compared to current diagnostic strategy. The Markov model was created to compare the lifetime cost associated with using of sCysC, uNGAL, uL-FABP with monitoring of sCr level for the diagnosis of AKI. The utility measurement included in the analysis was quality-adjusted life years (QALY). The results of the analysis are presented as the incremental cost-effectiveness ratio (ICER). RESULTS: Analysed biomarker-based diagnostic strategies for AKI were cost-effective compared to current diagnostic method. However, uNGAL and sCys C strategies yielded higher costs and lower effectiveness compared to uL-FABP strategy. uL-FABP added 1.43 QALY compared to current diagnostic method at an additional cost of $8521.87 per patient. Therefore, ICER for uL-FABP compared to sCr was $5959.35/QALY. CONCLUSIONS: Our results suggest that the use of uL-FABP would represent cost effective strategy for early diagnosis of AKI in children after cardiac surgery.

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.

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.

Cost-effectiveness analysis of different types of labor for singleton pregnancy: real life data.

INTRODUCTION: Views on the conduct of labor have changed over time, and a significant difference exists in relation to obstetric centers. OBJECTIVE: To assess cost, clinical outcomes and cost-effectiveness of different types of labor in singleton pregnancies. METHODS: A decision model was used to compare vaginal labor, induced labor and planned cesarean section. All data were taken from the Book of Labor from the University Hospital for Gynecology and Obstetrics "Narodni Front", Belgrade, Serbia for labors conducted during one month period in 2011. Successful delivery (i.e. labor that began up to 42 gestation weeks, without maternal mortality and the newborn Apgar scores greater than or equal to seven in the fifth minute of life) was considered as the outcome of the cost effectiveness-analysis. To test the robustness of this definition probabilistic sensitivity analysis was performed. RESULTS: From a total of 667 births, vaginal labor was conducted in 98 cases, induced vaginal in 442, while planned cesarean section was performed 127 times. Emergency cesarean section as a complication was much higher in the vaginal labor cohort compared to the induced vaginal cohort (OR=17.374; 95% CI: 8.522 to 35.418; p<0.001). The least costly type of labor was induced vaginal labor: average cost 461 euro, with an effectiveness of 98.17%. Both, vaginal and planned cesarean labor were dominated by the induced labor. The results were robust. CONCLUSION: Elective induction of labor was associated with the lowest cost compared to other types of labor, with favorable maternal and neonatal outcomes.

Economic evaluation of different screening alternatives for patients with clinically suspected acute deep vein thrombosis.

INTRODUCTION: We examined the cost-effectiveness of the three different D-dimer measurements in the screening of DVT in models with and without calculation of pre-test probability (PTP) score. Moreover, we calculated the minimal cost in DVT detection. MATERIAL AND METHODS: In the group of 192 patients with clinically suspected acute DVT, we examined the three different D-dimer measurements (Innovance D-dimer, Hemosil D-dimer HS and Vidas D-dimer Exclusion II) in combination with and without PTP assessment. RESULTS: The diagnostic alternative employing Vidas D-dimer Exclusion II assay without and with PTP calculation gave lower incremental cost-effectiveness ratio (ICER) than the alternative employing Hemosil D-dimer HS assay (0.187 Euros vs. 0.998 Euros per one additional DVT positive patient selected for CUS in model without PTP assessment and 0.450 vs. 0.753 Euros per one DVT positive patient selected for CUS in model with PTP assessment). According to sensitivity analysis, the Hemosil D-dimer HS assay was the most cost effective alternative when one patient was admitted to the vascular ambulance per day. Vidas D-dimer Exclusion II assay was the most cost effective alternative when more than one patient were admitted to the vascular ambulance per day. Cost minimisation analysis indicated that selection of patients according to PTP score followed by D-dimer analysis decreases the cost of DVT diagnosis. CONCLUSIONS: ICER analysis enables laboratories to choose optimal laboratory tests according to number of patients admitted to laboratory. Results support the feasibility of using PTP scoring and D-dimer measurement before CUS examination in DVT screening.

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.

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.

A multimarker approach for the prediction of coronary artery disease: cost-effectiveness analysis.

OBJECTIVES: Coronary artery disease (CAD), as the leading cause of death, poses a huge economic burden on health-care systems. We used a multi-marker approach to explore discriminative abilities of several lipid, inflammatory, and oxidative stress/antioxidative defense markers as CAD predictors. We assessed their cost-effectiveness compared with the Framingham risk score (FRS). METHODS: Using a decision model, we evaluated the costs, accuracy, and cost-effectiveness of each model. The FRS was used as the baseline model. Other models were formed with the consecutive addition of selected markers: apolipoprotein A-I (apoA-I), apolipoprotein B (apoB), apolipoprotein (a) [apo(a)] isoform, lipoprotein (a), high-sensitivity C-reactive protein, malondialdehyde, superoxide dismutase (SOD), sulfhydryl, and superoxide anion (O(2) (-) ). A best-case model was formed from a combination of diagnostic markers to yield the best patient stratification algorithm. All models were assessed by their predictive probabilities using receiver operating characteristic curves. To accomplish our goals, we recruited 188 CAD patients (verified by coronary angiography) and 197 asymptomatic CAD-free subjects for comparison. The analysis was performed from a third-party payer perspective. RESULTS: Only two strategies had outstanding discriminative abilities: the best-case model (FRS, SOD, and O(2) (-) ) and FRS plus SOD with area under the curve (AUC) values of 0.924 and 0.906, respectively. The cost-effectiveness ratio varied between €593 per AUC for the baseline model to €2425 per AUC for FRS plus apo(a) isoform. Strategies involving oxidative stress/antioxidative defense markers were more cost-effective than strategies involving lipid or inflammatory markers. All results were robust. CONCLUSION: Our results support the feasibility of a multimarker approach for CAD screening. The introduction of oxidative stress/antioxidative defense markers in the clinical laboratory would be convenient and cost-effective.

Cost of outpatient hypertension pharmacotherapy: comparative study between Bulgaria and Serbia / Coste de la farmacoterapia antihipertensiva ambulatoria: estudio comparativo entre Bulgaria y Serbia

Objective: To compare the prescribing practice and pharmacotherapy outpatient cost of hypertension and its common complications between two neighboring countries, Bulgaria and Serbia. The study questions focus on consistency of the prescribing practice with the treatment guidelines; comparability of the treatment patterns among both countries, and burden of hypertension cost to the population and third party payer in the countries under consideration. Methods: Retrospective study, one year time horizon is for outpatient therapy. Results: Patients with arterial hypertension in Bulgaria are most often on monotherapy (61% vs 6% in Serbia), as well as those with complications (66% vs 0% Serbia). In both countries the first choice of therapy are the ACE inhibitors (37.01% in Serbia and 41% in Bulgaria) and then follows the calcium antagonists, beta-blockers, and diuretics. The weighed monthly cost of hypertension and complicated hypertension is almost doubled in Serbia (12.56 vs 8.23 EUR for hypertension, and 13.39 vs 8.23 EUR) and prevailing part is reimbursed (88% vs 44% in Bulgaria). Conclusion: Our study confirms that hypertension and its complications therapy consumes a huge amount of financial resources. In both countries under consideration the therapy is corresponding with the European treatment guidelines. The international cost comparisons are possible but they depend on many external factors as the regulatory measures, prescribing habits and reimbursement policy and should be analysed within this framework (AU)

Objetivo: Comparar las prácticas de prescripción y el coste del tratamiento ambulatorio de la hipertensión y sus complicaciones comunes en dos países vecinos, Bulgaria y Serbia. Las preguntas de investigación se centran en la consistencia de las prácticas de prescripción con las guías de tratamiento; la comparabilidad de los patrones de prescripción entre los dos países, y el peso del coste de la hipertensión para la población y las aseguradoras en los países en estudio. Métodos: Estudio retrospectivo con un horizonte temporal de un año para el tratamiento ambulatorio. Resultados: Los pacientes con hipertensión arterial en Bulgaria están más frecuentemente en monoterapia (61% vs 6% en Serbia). En ambos países la primera elección de tratamiento son los IECA (37,01% en Serbia y 41% en Bulgaria) seguidos de los calcio-antagonistas, betabloqueantes y diuréticos. El coste mensual ponderado de la hipertensión complicada es casi el doble en Serbia (12,56 vs 8,23 EUR para hipertensión y 13,39 vs 8,23 EUR) y la parte principal es reembolsada (88% vs 44% en Bulgaria). Conclusión: Nuestro estudio confirma que la hipertensión y sus complicaciones consumen una enorme cantidad de recursos financieros. En ambos países estudiados el tratamiento se corresponde con las guías europeas de tratamiento. Las comparaciones internacionales de costes son factibles pero dependen de muchos factores externos como las medidas regulatorias, los hábitos de prescripción y las políticas de reembolso, y deberían analizarse en estos marcos (AU)