Drugs In Serbia Research Articles

The impact of the COVID-19 pandemic on the consumption of anxiolytic drugs in Serbia: an analysis for the period 2019 – 2021

The impact of the COVID-19 pandemic on the consumption of anxiolytic drugs in Serbia: an analysis for the period 2019 – 2021

Utilization of Gonadotropin-Releasing Hormone Agonists in the Treatment of Metastatic and Locally Advanced Prostate Cancer - Comparisons of Practices from Three European Countries

Abstract Introduction: Prostate cancer is one of the most common health threats for men in the developed world. With the advent of prostate cancer screening using serum prostate-specific antigen (PSA) tests, prostate cancer mortality has declined at the expense of substantial disease overtreatment. Modern prostate cancer therapy is performed according to certain guidelines. Antiandrogens are compounds that inhibit the action of androgens in prostate cancer cells by blocking receptors and preventing the binding of hormones to them. Aim: The aim of this research is to analyze the use of registered forms of LHRH agonists used in the treatment of locally advanced and metastatic prostate cancer in the last five years to examine trends in prescribing this group of drugs in Serbia whose patients gravitate towards the Urology Clinic at the UCC Kragujevac. Material and method: Using the ATC/DDD methodology, the use of LHRH agonists at the Urology Clinic of the UCC Kragujevac. A retrospective study of the use of this group of drugs according to the ATC classification was performed on the basis of data obtained from the hospital pharmacy for the period from year 2016 to year 2021, and the results are expressed by the number of DDD per 1000 inhabitants per day (1000/inhabitants/day). In the observed period, 1361 patients with a diagnosis of C61 (malignant prostate tumor) were treated at the Clinic of Urology. Results: In the observed period, a preparation containing triptorelin in a dose sufficient for one month of therapy was most often used. The total consumption of gonadorelin was lower compared to the rest of Serbia and EU countries, which was expected due to the protocol and the number of patients who gravitated towards the UCC Kragujevac. Conclusion: Despite certain limitations, this evaluation represents the first attempt to summarize the available evidence on the prescribing of LHRH agonists in Serbia. It was found that the consumption in UCCKG is lower compared to the consumption of these drugs in Serbia, Croatia and Italy at the same time intervals, for the same observed diagnosis.

Uporedna analiza upotrebe lekova u terapiji hiperlipoproteinemija u Republici Srbiji i Nordijskim zemljama u periodu 2015-2017. godine

Introduction: Cardiovascular diseases are the leading cause of death both in Serbia and in the rest of the world. It has been shown that as many as 80% of them are preventable. Control of serum lipid levels is one of the most important tasks of cardiovascular diseases prevention. Aim: The aim of the study was to analyze the use of serum lipid-modifying drugs in Serbia, Norway and Finland in the period 2015-2017. Methods: Data on drugs use during 2015, 2016 and 2017 were taken from the official websites of national drug regulatory authorities: the Serbian Medicines and Medical Devices Agency, the Norwegian Institute of Public Health and the Finnish Medicines Agency. Use was expressed as DDD/1000 inhabitants/day according to the Anatomical Therapeutic Chemical classification. Results: The share of drugs used for treatment of cardiovascular diseases in total drugs use was the largest in all three countries during the observed period. The use of lipidmodifying agents was 3-4 times lower in Serbia than in Norway or Finland. Of all lipidmodifying drugs, statins are most commonly prescribed in all three countries. Atorvastatin and rosuvastatin are the most widely used in Serbia, and simvastatin and atorvastatin in Norway and Finland. Conclusions: Use of lipid-modifying drugs in Serbia is lower than in Norway and Finland, but it is constantly increasing. This use in Serbia still represents the smallest share of all drugs for the treatment of cardiovascular diseases.

Heroino kontrabanda Serbijoje

[full article, abstract in English; abstract in Lithuanian]
 Drug trafficking is a very lucrative criminal activity, with a growing number of organized criminal groups from the Balkans. According to Europol’s report, about 5000 organized criminal groups are active in the European Union.2 According to the results of the National survey on the lifestyles of the citizens in the Republic of Serbia in 2014, the use of psychoactive substances and games of chance and illegal drug use at least once during a lifetime was recorded at 8.0% of the total population aged 18 to 64 (10.8% of males and 5.2% of females), with greater prevalence (12.8%) in the younger adult population aged 18 to 34. The number of heroin users who inject drugs in Serbia is between 10 000 and 25 000. The main estimated number is 20 000 heroin users who inject drugs, i.e., 0.4% of the population aged 15 to 64. Based on the analysis of data on drug-related deaths, it can be noted that there has been a decline in the number of deaths in the past five years, and most of these cases are related to opiates.
 In the territory of the Republic of Serbia, the production of heroin has not been recorded, and that gives trafficking a greater primacy, which is supported by the fact that high quality heroin is further trafficked in the form of a base that is mixed with other substances (paracetamol, caffeine, sugar etc.). In this way, such a high degree of purity of heroin allows the members of criminal groups to increase the quantity of narcotics by mixing substances suitable for this and, in that way, achieve greater profits.
 The most commonly used illegal drug among the adult population is cannabis (marijuana and hashish), and the use of the mentioned drugs has been recorded at least once during a lifetime in 7.7% of subjects aged 18 to 64 (10.4% of men and 4.9% of women). The use of other illegal drugs is very rare; 1.6% of questioned individuals (2.5% of the population aged 18 to 34) have used other illegal drugs.

Expenditure trends of orphan drugs in Serbia: 8-Year analysis of orphan drug market in Serbia

Background/Objective: Orphan drugs are medicinal products which treat life-threatening or chronically debilitating diseases which affect small patient populations. So far there is a substantial knowledge gap on actual expenditure on orphan drugs in Serbia. Therefore, the aim of this study was to provide insight into the expenditure trends of orphan drugs in Serbia. Material and methods: Annual reports on turnover and the consumption of pharmaceuticals in Serbia published by Medicines and Medical Devices Agency of Serbia (ALIMS) for the period 2006-2013 were used to extract data on expenditure on orphan drugs. Drugs were eligible for inclusion in the analysis if they had active European orphan designation and European marketing authorization during the period covered by the study (2006-2013). Data were analysed across time series. Simple descriptive analysis and observation of chronological trends were applied. Results: Data for annual expenditure on 12 different orphan drugs were available in the analysed reports. Orphan drug expenditure and share of orphan drug expenditure in total drug expenditure increased constantly from 2006 to 2010. Both began to slightly decrease over the next two years (2011-2012), and then suddenly declined nearly threefold in 2013. Share of orphan drug expenditure didn't exceed 1% of total drug expenditure over a period of eight years. The highest share of expenditure on orphan drugs was attributed to imatinib (87.36%-97.13%), so abrupt decline in 2013 could be explained by its withdrawal from European Community Register of Orphan Medicinal Products in 2012. Conclusions: Expenditure on orphan drugs in Serbia from 2006 to 2013 was considerably low compared to total expenditure on drugs. In the last available year we noted substantial decline of orphan drug expenditure, mainly because of imatinib losing its orphan designation. A broader time horizon would be needed to investigate long term trends.

The regulation of clinical trials in the Republic of Serbia

Introduction: Modern trends in drug production and traffic of drugs as a primary marketing resource of high quality efficient and safe drugs have an important task to provide safe, effective and quality medicines through clinical trials. Topic: Overview of current regulations established in the field of clinical trials of drugs and the importance of carrying out clinical trials is pointed herein. Methods: Pursuant to the applicable regulations in the Republic of Serbia and those established at the level of the European Agency (EMA) is provided an overview of the key elements essential for the objective procedures carried out in clinical trials of drugs in Serbia. Conclusion: Modern drug therapy today is exposed to serious challenges given the numerous studies in the field of medicine and pharmacy carried out in the world today. Clinical trials are particularly vulnerable segment in this area and require the participants in these processes to be highly educated and to have the serious ethical approach to all stages of the process.

Use of ACE-inhibitors in Serbia in 2009 and 2010

Introduction Cardiovascular diseases (CVD) are the most frequent cause of morbidity and mortality in many countries as well as in our country. That explains why medications for the treatment of CVD are the most used group of drugs. The aim of this study was to analyze the consumption of ACE-inhibitors in Serbia and Norway during 2009 and 2010. Material and methods The data about the use of ACE-inhibitors in Serbia and Norway in 2009 and 2010 were taken from the Agency for Drugs and Medical Devices of the Republic of Serbia and from the site of Norwegian Institute of Public Health. Results Use of drugs of first choice in the treatment of hypertension in Serbia was very uneven, where the consumption of ACE-inhibitors was dominant. Opposed to this condition, the consumption of the first choice antihypertensive drugs was very balanced in Norway. During both analyzed years large part of consumption of ACE-inhibitors was taken by more expensive drugs in Serbia, as fosinopril, cilazapril and quinapril. In Norway in the observed period, dominated the consumption of cheaper drugs such as enalapril and ramipril. The situation is similar when it comes to fixed combination of diuretics and ACE-inhibitors. In Norway dominated the fixed combination of diuretics and cheaper ACE-inhibitors like enalapril and lisinopril. However, in Serbia, we have large consumption fixed combinations of diuretics with expensive ACE-inhibitors, such as cilazapril and fosinopril. Conclusions In both countries, ACE-inhibitors and their fixed combination with diuretics are most frequently used drugs within the group of drugs which is used for treatment of CVD in Serbia in 2009 and 2010. The amount and structure of the utilized ACE-inhibitors in Serbia is different from the amount and structure of the utilized ACE inhibitors in Norway. From pharmacoeconomic point of view, high consumption of expensive ACE-inhibitors (plain and fixed combination with diuretics) in 2009 and 2010 in Serbia resulted in the higher spending of funds.

PCV10 - Analysis of Consumption of Antihypertensive Drugs in Serbia from 2007 to 2011

PCV10 - Analysis of Consumption of Antihypertensive Drugs in Serbia from 2007 to 2011

PCV31 - Analysis of consumption of antihypertensive drugs in Serbia in the period from 2006 to 2010 year

PCV31 - Analysis of consumption of antihypertensive drugs in Serbia in the period from 2006 to 2010 year

Consumption of serum lipid-reducing drugs in Serbia compared with Scandinavian countries: a population-based study, 2004–2010

Background Serbia is one of the leading countries in the world with respect to mortality from cardiovascular diseases. Drugs that reduce serum lipids belong to the group of drugs that can significantly lower complications of cardiovascular diseases and their utilization in Serbia deserves special attention. The aim of this study was to measure the consumption of serum lipid reducing drugs in Serbia from 2004 to 2010, to compare these data with those from Scandinavian countries, and to compare the consumption of lipid-lowering drugs and the rate of mortality from cardiovascular diseases in these countries.

An Insight on Differences in Availability and Reimbursement of Orphan Medicines Among Serbia, Bulgaria and Sweden

ABSTRACTIn the European Union (EU), rare diseases are defined as life-threatening or chronically debilitating diseases with prevalence lower than five in 10,000 inhabitants. Although individually rare, together, rare diseases affect a significant part of the population (27–36 million people in the EU). Therefore, patient access to orphan medicines is receiving increasing political attention in the EU.In order to assess the differences in availability of reimbursed orphan medicines among Serbia, Bulgaria and Sweden, National Reimbursement Lists were reviewed and identified orphan medicines were crossed with the List of orphan drugs in Europe, published in July 2011, available from Orphanet. The analysis of regulatory traits was based mainly on a review of the official documents setting out legislation regarding rare diseases and orphan medicines in the studied countries.Only 6.5% (4 out of 61) of the authorised orphan medicines in Europe with prior orphan designation and 25.0% (17 out of 68) without prior orphan designation were available and reimbursed in Serbia. In the Bulgarian Positive Drug List 44.3% (27 out of 61) of the drugs with prior orphan designation and 50.0% (34 out of 68) without prior orphan designation were identified. The share of reimbursed orphan medicines was the highest in Sweden among the observed countries—52.5% (32 out of 61) of the medicines with orphan designation and 60.3% (41 out of 61) without prior orphan designation. According to the first level of the ATC Classification System, most of the reimbursed orphan medicines in the three studied countries belonged to the group L: “Antineoplastic and immunomodulating agents”, while the most common indications for authorised and reimbursed orphan medicines were “Neoplasms” (C00-D48), with 19 available orphan drugs in Serbia, 26 in Sweden and 31 in Bulgaria.Inequities in the access to orphan medicines among Serbia, Bulgaria and Sweden may be explained by the differences in the approaches for registration, pricing and reimbursement of orphan medicines. The low share of reimbursed orphan drugs in Serbia may be due to incomplete compliance with EU legislation and existence of domestic procedure for authorisation as well. The EU legislation and policy on treatment of rare diseases obviously facilitate the penetration of orphan drugs on the EU market, but apparently there is also considerable budget impact on the availability of reimbursed orphan medicines.

PDB15 Use of Hypoglicemic Drugs in Serbia: Pharmacotherapeutic Versus Pharmacoeconomic Aspects

To analyse the use of hypoglycemic drugs in Serbia from pharmacotherapeutic and pharmacoeconomic point. To see the influence of pharmacotherapeutic guidelines and cost on use of hipoglicemic drugs when compared with the countries with developed pharmacotherapy. Use of hypoglicemic drugs in Serbia was obtained from National Agency for drugs in Serbia (ALIMS). The costs of hypoglycemic drugs was obtained from Serbian reimbursment company. The use of drugs was expressed in DDD/1000 inh/day, and compared to the price of drugs in the cathegory. The total use of hypoglycemic drugs in Serbia (56 DDD/1000inh/day) was similar to the use of drugs in this cathegory in another countries. Use of insulins was lower in Serbia, probably because slightly different pharmacotherapeutic approach to DM Typ II in Serbia. The structure of oral hypoglycemics was similar in Serbia and in comparator countries (Norway, Finland). While metformin was the most often used hypoglicemic drug in countries with developed pharmacotherapy, in Serbia the most often used drugs were sulfonylurea drugs, with glibenclamide and gliclaside being in the first place. Gliclaside, being on the second place in Serbia, is the most expensive hypoglicemic drug (price per DDD 12.15 Serbian dinars). If gliclaside would be changed with another, less expensive drug, the national reimbursment company would spare significant amount of money. Glimepiride, the most often used and the cheaper sulfonylurea derivative in countries with developed phrmacotherapy, was on the third place in Serbia. The total use of hypoglycemics in Serbia is comparable to countries with developed pharmacotherapy, indicating the satisfiing level of the treatment of diabetes mellitus. However, the structure og hypoglycemics used is suboptimal from pharmacotherapeutic and from pharmacoeconomic point of wiev. Significant improvement are needed, which would improve pharmacotherapy and pharmacoeconomic aspect of use of this drugs.

Erratum to: Consumption of non-steroidal anti-inflammatory drugs in Serbia: a comparison with Croatia and Denmark during 2005–2008

Erratum to: Consumption of non-steroidal anti-inflammatory drugs in Serbia: a comparison with Croatia and Denmark during 2005–2008

P02-450 - Pharmacoepidemiologic studies on psychiatric drugs use in Serbia

High rate of prescribing of psychiatric drugs causes medical, social and economic consequences.This research was performed by collecting and analysing all the papers published on this matter in Serbia.In former Yugoslavia (of which Serbia was a constitutive republic), during the eighties, a study of benzodiazepines use showed a trend of the increase of their use (17,9 defined daily doses - DDDs in 1983 - 22,3 DDDs in 1988) (Macolic V et al. Benzodiazepines utilization in Yugoslavia 1983–1988. Pharmaca 1990;217–97). Similar trends continued in the nineties. In 1994 diazepam was at the first position on the list of most prescribed drugs (Miljković M. et al. Analysis of Drug Utilization in Serbia During the Years 1996 and 1997. Pharmacoepidemiol Drug Saf 2000;9:59–64.). The analysis of the trend of prescribing of psychiatric drugs in Serbia (2000–2004) shows the increase, with the emphasis on the use of benzodiazepines and antidepressants (Divac N. et al. Trends in consumption of psychiatric drugs in Serbia and Montenegro 2000–2004. Pharmacoepidemiol Drug Saf. 2006;15:835–8.). There are also positive, qualitative changes in the prescribing practice: the increase of the use of SSRI antidepressants and atypical antipsychotics. Specific prescribing habits were noticed: the common practice of polypharmacy in the treatment of psychoses (Divac N. et al. Antipsychotic polypharmacy at the University Psychiatric Hospital in Serbia. Pharmacoepidemiol Drug Saf. 2007;16:1250–1.).Pharmacoepidemiologic methods have found its place in Serbian science. The methodology used in these studies is mostly up-to-date. Main limitation of these studies is the lack of databases.

Consumption of non-steroidal anti-inflammatory drugs in Serbia: a comparison with Croatia and Denmark during 2005–2008

To analyze the amount and pattern of use of non-steroidal anti-inflammatory drugs (NSAIDs) in Serbia and to compare these parameters with those in Croatia and Denmark. The prescribing pattern of NSAIDs in Serbia as a direct indicator of physicians' knowledge of these agents was also assessed. The use of NSAIDs in Serbia, Croatia, and Denmark was analyzed during a 4-year period (2005-2008). Data were retrieved from the annual reports of the Agency for Drugs and Medical Devices of Serbia, Croatia, and Denmark. Data on prescribing behavior were obtained from the Health Insurance Fund of Serbia and represent NSAIDs issued by prescription between 2005 and 2008. Results were expressed as the number of defined daily doses/1000 inhabitants/day. The drug utilization 90% method was also used. The total consumption of NSAIDs in Serbia was higher than that in Croatia and Denmark. Diclofenac accounted for approximately 50% of NSAID consumption during the observation period, followed (in much smaller quantities) by ibuprofen. The most commonly prescribed medicine was diclofenac, followed, in much smaller amounts, by ibuprofen. There was no trend of a reduced consumption of diclofenac or of an increased use of ibuprofen during the study period These data suggest that factors other than evidence-based medicine have a dominant effect on the use of NSAIDs in Serbia. Targeted education from independent sources in the prescribing, dispensing, and use of drugs is important to improve the quality of the prescribing behavior and the use of NSAIDs.

Consumption of serum lipid‐reducing drugs in Serbia compared with Scandinavian countries: a population‐based study, 2004–2008

The aim of this study was to measure the consumption of serum lipid reducing drugs in Serbia from 2004 to 2008, to compare this data with that from Scandinavian countries, and to compare the consumption of lipid lowering drugs and the rate of mortality from cardiovascular diseases in these countries. A population-based study was undertaken to analyse lipid lowering drug consumption using the Anatomical Therapeutic Chemical/Defined Daily Dose methodology. Cause-specific mortality rates were obtained from the WHOSIS annual report for the year 2009. In 2008, a total of 1207.44 DDD/1000 inh/day of all drugs, was used in Serbia, of which 38.89% belonged to drugs for cardiovascular diseases. While in Scandinavian countries 17.03-24.80% of drugs for cardiovascular diseases belonged to lipid-lowering drugs, in Serbia it was substantially lower (3%). In 2004 in Serbia, 1.50 DDD/1000 inh/day of statins were used. In 2008, this value was 14.24 DDD/1000 inh/day. In every investigated country, simvastatin made up more than 50% of the consumption of statins. After simvastatin, the next most frequently used statin was atorvastatin, with 5.52, 11.00, 11.17 and 24.82 DDD/1000 inh/day, in Serbia, Denmark, Finland and Norway, respectively. In 2004 Serbia has the highest mortality rate for cardiovascular diseases among investigated countries with 762/100.000 inhabitants and Norway has the lowest rate with 158/100.000 inhabitants. The use of lipid lowering drugs is 6-8 times lower in Serbia than in Scandinavian countries but there is an evident rise in lipid lowering drugs consumption in Serbia during years.

Utilization of psychiatric drugs in Serbia

Drug utilization has been defined by the World Health Organization (WHO) as the „marketing, distribution, prescription and the use of drugs in a society, with a special emphasis on the resulting medical, social, and economic consequences“ . Drug utilization studies are usually aimed at drug use-related problem detection and quantification. These studies may be quantitative (with the objective to quantify drug usage at various levels of health-care system), or qualitative (L) (which assess the appropriateness of drug utilization) 2, . Utilization of psychiatric drugs is often a subject of drug utilization studies. Increasing researchers’ interest in prescribing and utilization of psychiatric drugs is noted worldwide . It is understandable, bearing in mind that these drugs are, maybe more than other pharmacotherapeutic groups, related to different epidemiologic, social and economic variables. It is usually a high rate of prescribing of certain psychiatric drugs, as well as selfmedication (e.g. with benzodiazepines) that causes concern, as well as the consequences of such practice: development of tolerance and addiction, drug abuse, and increased treatment costs. Over the last decade in Serbia several drug utilization studies on the usage of psychiatric drugs have been conducted. These studies have addressed certain major issues: drug use patterns, prescribing behavior, gaps between guidelines and actual utilization and factors responsible for polypharmacy. Both, quantitative and qualitative aspects of psychiatric drugs use have been analysed using up-to-date methodology. Such a modern methodological approach enables comparison of the data from Serbian studies with the data from other countries, thus pointing out certain prescribers’ habits and/or patients’ preferences that are characteristic for our milieu.

Trends in consumption of psychiatric drugs in Serbia and Montenegro 2000–2004

To investigate the trends in psychiatric drugs utilization in Serbia and Montenegro over the 5-years period (2000-2004). The wholesale data issued by the manufacturers or distributors were used. Also, the lists of drugs used from the Institute of Mental Health (institution which provides primary, secondary and tertiary psychiatric care) were used to corroborate the wholesale data. The utilization of drugs in general population was calculated using ATC/DDD methodology, and was expressed in Defined Daily Doses (DDD) per 1000 inhabitants per day. The utilization of drugs in the Institute of Mental Health was calculated from the hospital pharmacy records and was expressed as the number of DDDs per 100 bed-days. The statistics was performed using standard statistical methods. The general consumption of psychiatric drugs in Serbia and Montenegro significantly increased during the 2000-2004 period (from 45.1 DDD/1000 inhabitants/day in 2000 to 69.1 DDD/1000 inhour/day in 2004). The general utilization of anxiolytic/hypnotic drugs surged significantly, but the inhospital use remained rather stable. The most prominent changes were noted in the utilization of antidepressants, which doubled in that period, both in general and inhospital settings. Among antipsychotics in general population, there is a significant increase in the utilization of clozapine. In inhospital setting, there is a significant increase of total utilization of antipsychotic drugs, but this is also mainly on the account of atypicals. The total consumption of psychiatric drugs significantly increased. The utilization of anxiolytic/hypnotic drugs in 2004 reached 60 DDDs/1000 inhabitants/day, which is in collision with the trend in developed countries. It is necessary to form national guidelines for prescribing anxiolytic/hypnotic drugs, in order to rationalize their use. More favourable is the antidepressant (SSRIs in particular) and atypical antipsychotic drugs utilization increase.