BACKGROUND/AIM High morbidity and mortality rates, chronic course of disease and numerous clinical complications, make diabetes mellitus (DM) type 2 bear significant financial burden for healthcare system of Serbia. The aim of this study was to compare true disease-related expenses measured in the random sample of patients originating from the Central Serbia in 2007 and national estimate of total expenses based on available evidence on antidiabetic drugs and insulins acquisition costs in the same fiscal year. METHODS The study design was prevalence-based, bottom-up cost of illness analysis. It was implemented on a randomized sample of 99 adults with confirmed diagnosis of DM type 2. During 2007 all direct (drug acquisition, medical services, medical devices usage) and indirect costs associated with their primary disease (premature death, impaired working ability, early retirement, absentism), were taken into account. Other approach was to calculate average national rate of antidiabetic drugs and insulin utilization and sales at the domestic market during the mentioned period of time. Taking into consideration available estimate from the Institute of Public Health of Serbia of 475,000 people with this disease at the national level, we were able to compare these data. Assuming that our sample was enough representative and that the structure of costs was approximately similar at the local and national level, we were able to calculate an estimate of total cost of the disease. All costs were expressed in Serbian official currency, dinar (CSD). RESULTS Values of costs measured per patient in our sample in a given year were for drug acquisition 20,352.45 CSD, medical services 24,338.26 CSD, medical devices 3174.46 CSD and loss of productivity and absentism 5547.78 CSD. There were 2 cases of early retirement due to the disease and no cases of dialysis treatment or premature death. A total number of sickness absence days of employed patients, was 1025 and a total number of hospital treatment days was 360. A total amount of all costs was 53,412.96 CSD per patient per year. According to the National Medicines and Medical Devices Agency an overall value of oral antidiabetic drug sales for 2007 per patient was 1835.32 CSD and for insulins and analogs 2948.18 CSD. CONCLUSION Comparing true size of national financial burden of DM type 2 with experiences of other authors, we can see that it is comparable with European OECD average. But, if the structure of expenses is taken into account, Serbia is more similar tothose countries reported in the Third World economies. Ourlocal findings on a sample of diabetic population show that real patient expenses were even 2.28 times higher than those estimated at the national level.

BACKGROUND/AIM A cost-effectiveness analyses of immunomodulatory treatments for relapsing-remitting multiple sclerosis (RRMS) in developed countries have shown that any benefit from these drugs is achieved at very high cost. The aim of our study was to compare the cost-effectiveness of five treatment strategies in patients diagnosed with RRMS (symptom management alone and in combination with subcutaneous glatiramer acetate, intramuscular interferon beta-1a, subcutaneous interferon beta-1a, or intramuscular interferon [beta-1b) in a Balkan country in socio-economic transition. METHODS The Markov model was developed based on the literature about effectiveness and on local Serbian cost calculations. The duration of a cycle in the model was set to a month. The baseline time horizon was 480 months (40 years). The societal perspective was used for costs and outcomes, and they were discounted for 3% annually. Monte Carlo micro simulation with 1000 virtual patients was done. RESULTS Significant gain with immunomodulatory therapy was achieved only in relapse-free years, while the time spent in health states EDSS 0.0-5.5 was longer with symptomatic therapy only, and gains in life years and QALYs were only marginal. One QALY gained costs more than a billion of Serbian dinars (more than 20 million US dollars), making each of the four immunomodulatory therapies cost-ineffective. CONCLUSION Our study suggests that immunomodulatory therapy of RRMS in a Balkan country in socioeconomic transition is not cost-effective, regardless of the type of the therapy. Moderate gain in relapse-free years does not translate to gain in QALYs, probably due to adverse effects of immunomodulatory therapy.

Kvalitet i bezbednost upotrebe biljnih preparata ostaju i dalje prioritet koji treba zakonski urediti na svetskom nivou. Za registraciju biljnog preparata kao leka postoje isti zahtevi kao i za registraciju drugih lekova u pogledu dokumentacije koja treba da sadrži predklinicka i klinicka ispitivanja. Ovakva ispitivanja vrlo su zahtevna, a kako složenost molekulske građe, cak i jednokomponentnih biljnih preparata, ometa utvrđivanje jedinstvenih kriterijuma za jasno pracenje njihovih terapijskih efekata, ispunjavanje zahteva za registrovanje biljnih preparata kao lekova u praksi jos uvek je izazov i za naucnike i za proizvođace.

The purpose of this study was to perform population pharmacokinetic (PPK) analysis on carbamazepine and to determine the population model of clearance of this drug in terms of individual patient characteristics. A total of 107 steady-state serum concentrations from 97 adult and pediatric epileptic patients, collected during routine clinical care, were used for the analysis. To determine the influence of different covariates on the estimate of carbamazepine clearance we used the non-linear mixed effects modeling (NONMEM) software package with ADVAN1 subroutine. This is a one-compartment model with first-order elimination and without absorption. The typical mean value for carbamazepine clearance, estimated by the base model (without covariates), in our population was 3.43 l/h. The final results of our analysis show that carbamazepine clearance increased nonlinearly with total body weight and age, and linearly with concomitant administration of valproate. The magnitude of the effect of valproate was +0.874 l/h. The interindividual variability (coefficient of variation) for clearance and the residual variability (including intraindividual variability), described by an exponential error model, were 16.76% and 31.14%, respectively. The results of this PPK analysis were validated in a group of 16 epileptic patients and suggested good predictive performance of the final model. The derived model describes carbamazepine clearance in terms of characteristics of Serbian patients, using minimal data obtained from routine clinical care of epileptic patients. This is the basis for future pharmacokinetic studies on a specific epileptic population, which will lead to better overall management of epilepsy in Serbia.

OBJECTIVES In countries with high income, tocolytic therapy with beta-mimetic agents is a cost-effective strategy compared to placebo. In our study, the cost-effectiveness of two beta-mimetic agents, ritodrine and fenoterol, used in the management of preterm labor was compared in the setting of a low-middle-income transitional country, Serbia & Montenegro. METHODS This case study was conducted at the Gynecology-Obstetrics Clinic, Clinical Center "Kragujevac," in Kragujevac, Serbia & Montenegro, between October 2004 and January 2006. In total, 235 pregnant patients with threatened preterm labor were enrolled, but 35 were lost to follow-up. Of the remaining 200 patients, 85 were given ritodrine, and 115 fenoterol. The perspective of Republic Institute for Health Insurance in Serbia was taken into account. Only direct costs were calculated; primary outcomes of the study were length of pregnancy (in weeks), time passed from the onset of uterine contractions to delivery (in weeks), and score on modified Flanagan's quality-of-life scale for chronic diseases, measured after discharge from hospital. RESULTS Prolongation of pregnancy was significantly longer in the fenoterol group (12.7 +/- 8.4 weeks) than in the ritodrine group (11.6 +/- 7.1 weeks). The mean duration of hospitalization was shorter in the fenoterol group (11.9 +/- 8.8 days) than in the ritodrine group (14.9 +/- 11.3 days). The treatment with fenoterol was less costly and more cost-effective than the treatment with ritodrine, but the difference in cost-effectiveness was not statistically significant. The cost of treatment per gained week of pregnancy prolongation was 3345.51 +/- 7668.04 CSD in the fenoterol group, and 4181.96 +/- 12,069.83 CSD in the ritodrine group. CONCLUSIONS The observed differences in treatment costs and duration of hospitalization per patient did not translate into significant differences in cost-effectiveness ratios, because of low costs of hospitalization and human labor in Serbian health system. Nevertheless, fenoterol treatment still has a tendency to be more cost-effective, and its lower acquisition cost is an advantage to this treatment option.