BIOEQUIVALENCE STUDIES

Development of pharmaceutical technology and occurence of different dosage forms and routes of administration of the same, well-known drugs leaded to greater role of bioequivalence testing. In this review, we would like to emphasize some aspects of bioequivalence testing between brand name and generic drug forms in both in vitro and in vivo conditions. We also consider important to present some examples of negative bioequivalence from marketed products in the past, together with the serious cosequences of their use

Assessment of diabetes mellitus type 2 treatment costs in the Republic of Serbia

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 3 174.46 CSD and loss of productivity and absentism 5 547.78 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 1 025 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 1 835.32 CSD and for insulins and analogs 2 948.18 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 to those countries reported in the Third World economies. Our local 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

The influence of sociodemographic factors on the use of antihypertensive drugs among adults in Serbia: Cross-sectional study

Background: Despite the knowledge that they have high blood pressure, which can be controlled with medicines, one portion of the patients still ignores doctor's advice. The aim of the research was to examine the impact of socio-demographic factors for treatment of hypertension among adults in Serbia. Subjects and methods: In the study, we used data from the National Health Survey of the Republic of Serbia in 2013. The sample consisted of respondents who had diagnosed hypertension, 5073 of them. The dependent variable in the study was binary (treatment, or no treatment of hypertension) and independent was socio-demographic characteristics of respondents. Logistic regression was used to determine sociodemographic predictors associated with blood pressure control. Results: From a total of 5073 diagnosed hypertensive patients, 91.3% of them cures high blood pressure. Women, older, medium rich patients, those who follow health topics on television and those who do not follow them on the Internet, who, in the past year, have been hospitalized or used the services of daily care significantly more often treat hypertension. The results of binary logistic regression in which the dependent variable is the treatment of high blood pressure, showed that a statistically significantly predictors are: age, gender, the wealth index and monitoring topics related to health through television and the Internet. In the treatment of hypertension, the strongest predictor was the index of well-being. Thus, people who are medium rich are almost three times more likely to treat high blood pressure compared to the richest (OR=2.94, 95%CI=1.54-5.59). A statistically significant difference in treatment is not recorded between the richest and the poorest (p> 0.05). Men are 1.5 times more likely to treat their tension as compared to women (OR=1.54, 95%CI=1.02-2.32). People following itopics related to the health via the internet are1.7 times more likely to treat hypertension in comparison to subjects who do not follow these topics via the Internet (OR=1.72, 95%CI=1.07-2.76). Conclusion: Analysis of the impact of sociodemographic characteristics on the awareness of patients about the importance of treatment of hypertension is an important step in defining the strategies for treatment of patients