Medicines and Medical Devices Agency of Serbia

Belgrade, Serbia

Medicines and Medical Devices Agency of Serbia

Belgrade, Serbia
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Andjelkovic J.,Medicines and Medical Devices Agency of Serbia | Radonjic V.,University of Kragujevac
Serbian Journal of Experimental and Clinical Research | Year: 2017

Prudent use of antimicrobial medicine is an imperative in both human and veterinary medicine today. Antibiotic usage in humans and animals has increased over the years, consequently giving rise to antimicrobial resistance in pathogenic microorganisms. Mastitis is one of the most common conditions in bovine species, and intramammary antibacterial medicinal products are used in animal husbandry for mastitis treatment and prophylaxis. This paper presents the quantities of intramammary antibiotics sold in the Republic of Serbia from 2011 to 2014 based on data reported to the Medicines and Medical Devices Agency of Serbia by Marketing Authorization Holders. Furthermore, we assessed the number of treated cows and compared those results with the reported total number of cows in the same time period, providing information on animal exposure to particular antibiotics. In 2011 and 2012, beta-lactams were the most commonly used antimicrobials, while beta-lactams in combination with other substances were the most commonly used antibiotics in 2014, with a total of 80,927 treated animals. From 2011 to 2014, 15-25% of cows were treated with intramammary antimicrobials. Bearing in mind the growing importance of antibiotic resistance in humans and animals, these results reveal the scope of the potential human exposure to antibiotics via consumption of the milk of treated cows. © 2017, University of Kragujevac, Faculty of Science. All rights reserved.


Sipetic T.,Medicines and Medical Devices Agency of Serbia
Arhiv za Farmaciju | Year: 2011

The beginning of development of pharmacovigilance dates back to the 1960s and the so-called "thalidomide catastrophe", when the medicine thalidomide caused severe limb deformities - phocomelia - in 10 000 to 15 000 children, whose mothers had taken this medicine for treatment of nausea, or as a hypnotic during pregnancy. The National Center for Pharmacovigilance (NCF), as a part of the Medicines and Medical Devices Agency of Serbia organizes and monitors the collection and assessment of adverse drug reaction effects (ADR), as well as the processing and evaluation of data, in order to protect public health and provide health workers and, if necessary, the general public with proper information. Based on data on the number of spontaneously reported adverse effects from the period 2005-2010 that was presented on the website of the Medicines and Medical Devices Agency of Serbia (2005-2010: 102, 266, 337, 423, 572, 781), a steady increase in the number of reports is seen. When it comes to medicines used to treat diabetes, in 2008 NCF received 4 reports that they caused ADRs (1,33% of all reported drugs), in 2009 12 reports (2,60%), and in 2010 9 reports (1,65%). Side effects that can be expected in therapy with insulin are hypoglicemia, creation of antibodies to insulin, reaction on the place of application, temporary changes in vision, retention of water and sodium and lipodystrophy in the place of application. Oral antidiabetics can also cause hypoglicemia, but they cause gastrointestinal problems much more often, as well as changes on the skin. Sometimes they can cause temporary rise in liver enzymes, and cases of hepatitis are reporeted rarely. Pharmacovigilance in Serbia is under development, and the common goal of the Agency, the marketing authorization holders and health care workers is to provide safe medicines for the Serbian market through continuous improvement of its activities.


The beginning of development of pharmacovigilance dates back to the 1960s and the so-called thalidomide catastrophe, when the medicine thalidomide caused severe limb deformities - phocomelia - in 10.000 to 15.000 children, whose mothers had taken this medicine for treatment of nausea, or as a hypnotic during pregnancy. The National Center for Pharmacovigilance (NCF), as a part of the Medicines and Medical Devices Agency of Serbia organizes and monitors the collection and assessment of adverse drug reaction effects (ADR), as well as the processing and evaluation of data, in order to protect public health and provide health workers and, if necessary, the general public with proper information. Based on data on the number of spontaneously reported adverse effects from the period 2005-2010 that was presented on the website of the Medicines and Medical Devices Agency of Serbia (2005-2010: 102, 266, 337, 423, 572, 781), a steady increase in the number of reports is seen. When it comes to medicines used to treat obstructive pulmonary disease, in 2008 NCF received nine reports that they caused ADRs (3% of all reported drugs), in 2009 4 reports (0.87%), and in 2010 23 reports (4.21%). The most common side effects: 1. selective β2 - adrenoceptor agonists - tremor, headache, tachycardia, 2. inhaled glucocorticoids - mild irritation of the throat, candidiasis of the mouth and throat, cough and hoarseness, 3. Anticholinergics - local reactions such as dry mouth, irritation of the throat and allergic reactions, 4. xanthine medicines - nausea, vomiting, gastric irritation, anorexia, tachycardia, palpitations, arrhythmias and convulsions, 5. leukotriene receptor antagonists - abdominal pain, diarrhea, headache, upper respiratory tract infections. Pharmacovigilance in Serbia is under development, and the common goal of the Agency, the marketing authorization holders and health care workers is to provide safe medicines for the Serbian market through continuous improvement of its activities.


Zirojevic J.,Medicines and Medical Devices Agency of Serbia | Drljevic-uric K.,Medicines and Medical Devices Agency of Serbia | urdevic A.,Medicines and Medical Devices Agency of Serbia
Arhiv za Farmaciju | Year: 2014

A simple and rapid ultra - high performance liquid chromatographic (UHPLC) method for the separation and determination of oxcarbazepine and its related substances in tablets, was developed. Chromatographic separation of oxcarbazepine from its related substances (degradation and by-products) was achieved on a reversed phase C18 column (Pinnacle DB C18, RESTEK, 100 x 2.1 mm, 1.9 μm particle size) using gradient program with water (as mobile phase A) and acetonitrile (as mobile phase B), at a flow rate 0.5 mL min-1 and UV detection at 254 nm. The column temperature was 30°C.The method has good selectivity towards oxcarbazepine and its related substances. The accuracy of the method for oxcarbazepine assay, expressed as mean recovery was 101.8 %, and of the method for quantification of degradation products was 95.9 % – 103.3 %. Limit of quantification for oxcarbazepine and its degradation products ranged from 0.60 μg mL-1 to 1.30 μg mL-1. The linearity range for oxcarbazepine assay was from 2.4 to 3.60 mg mL-1 (R2=0.999). Mean value for oxcarbazepine assay from the tablets was 299.92 mg (label claim 300 mg). The method can be used for routine analysis and the quality control of oxcarbazepine drug substance and its formulated products. © 2014, Farmaceutsko Drustvo Srbije. All Rights Reserved.


Petronijevic M.,Medicines and Medical Devices Agency of Serbia | Ilic K.,University of Belgrade | Suzuki A.,Duke University
Pharmacoepidemiology and Drug Safety | Year: 2011

Purpose: The main aim of this study was to determine the most frequently reported drugs to the Serbian Pharmacovigilance Database (SPD) with suspected induced hepatotoxicity. Additionally, reasons for the low reporting rate of adverse drug reactions (ADRs) in Serbia were identified. Methods: Retrospective observational study of spontaneously reported ADRs recorded in the SPD from January 1995 to December 2008 was performed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hepatobiliary disorders (HD). Drugs were classified using the Anatomical Therapeutic Chemical (ATC) classification. Medline and WHO-UMC databases were used to address specific queries suggested by our results. The questionnaire was used to investigate the health care professionals' knowledge and practice related to spontaneous reporting. Results: Among the 1804 reports of ADRs recorded in the SPD between 1995 and 2008, 70 (3.9%) cases of HD were identified. Drugs most frequently associated with hepatotoxicity were anti-infectives for systemic use, drugs affecting the nervous system, herbal products, hypolipemics, and anticoagulant drugs (26.83, 24.39, 12.20, 9.76, and 8.54% cases, respectively). Four cases (5.71%) of liver injury resulted in death, which accounted for 10.26% of all ADR fatalities reported to the SPD. The main reasons for not reporting ADRs were lack of reporting knowledge (30.26%), well-known ADRs (29.89%), and insecurity about causality relationship (15.50%). Conclusions: Anti-infectives, nervous system drugs, and herbal products were the most common drug classes reported for hepatotoxicity in Serbia. There is a need for additional education about ADRs, and enhanced reporting by health care professionals. © 2011 John Wiley & Sons, Ltd.


Miljkovic M.M.,Medicines and Medical Devices Agency of Serbia | Dobric S.,Military Medical Academy | Dragojevic-Simic V.,Military Medical Academy
Pharmacoepidemiology and Drug Safety | Year: 2011

Purpose: Reliability and usefulness of scales for causality assessment in hepatotoxicity have not been fully explored. The goal of this study was to examine consistency between causality assessments obtained with two commonly used scales and their agreement with initial clinical assessments in hepatotoxicity reported in Serbia, and to review usefulness of these scales. Methods: We compared the two scales (CIOMS/RUCAM and NARANJO) in 80 cases reported during 1995-2009. The initial clinical assessments performed at the time of reporting served as a control for comparison with the subsequent causality assessments. The agreement between obtained causality assessments and the initial clinical assessments were analysed by Kappa weighted (Kw) statistical test. Results: In the 80 cases, the NARANJO scale showed better agreement with the initial clinical assessments (Kw: 0.62) than the CIOMS/RUCAM scale (Kw: 0.50) with moderate mutual agreement (Kw: 0.58). Results for 69 cases reported before the start of the study showed the same. In 11 cases reported in 2009 (after the start of the study) the CIOMS/RUCAM scale showed better agreement with the initial clinical assessments (Kw: 0.80) than the NARANJO scale (Kw: 0.70) with perfect mutual agreement (Kw: 1.0). Conclusion: The two scales showed good similarity and the same was true when their outcomes were compared with the clinical judgments provided by the reporting physicians. Both scales may be useful in pharmacovigilance and clinical practice, but the CIOMS/RUCAM scale provides more specific data. Our results also confirmed that the quality of data and documentation influence the reliability of the method. © 2011 John Wiley & Sons, Ltd.


Versporten A.,University of Antwerp | Abilova V.,Analytical Expertise Center for Medicines | Pyshnik G.,Ministry of Health | Spasojevic T.,Agency for Medicines and Medical Devices of Bosnia and Herzegovina | And 10 more authors.
The Lancet Infectious Diseases | Year: 2014

Background: There are no reliable data on antibiotic use in non-European Union (EU) southern and eastern European countries and newly independent states. We aimed to collect valid, representative, comparable data on systemic antimicrobial use in these non-EU countries of the WHO European region. Methods: Validated 2011 total national wholesale antibiotic-use data of six southern and eastern European countries and regions and seven newly independent states were analysed in accordance with the WHO anatomical therapeutic chemical (ATC)/defined daily doses (DDD) method and expressed in DDD/1000 inhabitants per day (DID). Findings: Total (outpatients and hospital care) antibiotic use ranged from 15·3 DID for Armenia to 42·3 DID for Turkey. Co-amoxiclav was mainly used in Georgia (42·9% of total antibiotic use) and Turkey (30·7%). Newly independent states used substantial quantities of ampicillin and amoxicillin (up to 55·9% of total antibiotic use in Azerbaijan). Montenegro and Serbia were the highest consumers of macrolides (15·8% and 19·5% of total antibiotic use, respectively), mainly azithromycin. Parenteral antibiotic treatment is common practice: 46·4% of total antibiotic use in Azerbaijan (mainly ampicillin; 5·3 DID) and 31·1% of total antibiotic use in Tajikistan (mainly ceftriaxone 4·7 DID). Interpretation: This study provides publicly available total antibiotic-use data for 13 non-EU countries and areas of the WHO European region. These data will raise awareness of inappropriate antibiotic use and stimulate policy makers to develop action plans. The established surveillance system provides a method to develop quality indicators of antibiotic use and to assess the effect of policy and regulatory actions. Funding: Netherlands Ministry of Health, Welfare, and Sport, and EU. © 2014 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved.


Mijac V.,University of Belgrade | Opavski N.,University of Belgrade | Markovic M.,University of Belgrade | Gajic I.,University of Belgrade | And 3 more authors.
Epidemiology and Infection | Year: 2015

We report the first study of macrolide resistance in respiratory tract pathogens in a Serbian paediatric population. It included 5293 Streptococcus pneumoniae, 4297 Streptococcus pyogenes, 2568 Moraxella catarrhalis and 1998 Haemophilus influenzae isolates derived from the respiratory tract and 110 invasive isolates from children aged up to 18 years during 2004-2009. Over the 6-year period, a significant increase (P <0 ·01) in macrolide resistance was found in both S. pneumoniae and S. pyogenes that reached 45% and 19%, respectively, in 2009. In the same period, consumption of macrolides increased continually from 2·46 to 5·8 defined daily dose/1000 inhabitants per day. The increase in macrolide resistance in S. pyogenes correlated with consumption of total macrolide and long-acting macrolides (r = 0·879, P = 0·05 and r = 0·922, P = 0·026, respectively). A similar trend was observed in pneumoccoci, although it did not reach statistical significance. The growing problem of macrolide resistance in pneumococci and S. pyogenes in Serbia requires further vigilant surveillance. © 2014 Cambridge University Press.


Malenovic A.,University of Belgrade | Dotsikas Y.,National and Kapodistrian University of Athens | Maskovic M.,Medicines and Medical Devices Agency of Serbia | Jancic-Stojanovic B.,University of Belgrade | And 2 more authors.
Microchemical Journal | Year: 2011

In the current paper the application of multiobjective optimization (MOOP) technique, via Derringer's desirability function, to a microemulsion liquid chromatographic (MELC) method is described. Chromatographic separation of perindopril tert-butylamine and its four impurities was selected as the case study. Central composite design (CCD) with fractional factorial design, ±. 0.5 α star design and four replications in central point was applied for a response surface study, in order to examine in depth the effects of the most important factors. As factors that influence the system mostly (i) content of ethyl acetate and (ii) butyl acetate in composite internal phase, (iii) content of sodium dodecyl sulfate (surfactant) and (iv) n-butanol (co-surfactant), as well as (v) pH of the mobile phase were selected. Retention factor of (a) perindoprilat and (b) impurity Y 31 and (c) resolution factor for impurities Y 32 and 33 were chosen for simultaneous optimization. By adjustment of the importance coefficients and weights, according to defined objectives, the optimal mobile phase composition was predicted to be: 0.24% w/v butyl acetate, 0.3% w/v ethyl acetate, 2% w/v SDS, 7.75% w/v n-butanol and pH of the mobile phase 3.7. The sensitivity analysis of desirability function for these optimal conditions was conducted for the first time in LC separations, by applying a sensitivity procedure. The performed sensitivity analysis confirmed that the higher overall desirability does not necessarily mean a better solution. The accuracy of prediction might be affected if the optimal levels of input variables, achieved from several design points, end up with equal settings and different corresponding overall desirability. In our study this was not the issue, which confirmed the adequacy of predicted optimum. © 2011 Elsevier B.V.


Petronijevic M.,Medicines and Medical Devices Agency of Serbia | Ilic K.,University of Belgrade
Journal of Clinical Pharmacology | Year: 2013

Patient gender and age are considered to be the risk factors for developing drug-induced liver injury (DILI). The aim of this study was to analyze gender and age differences in reporting of drug-induced hepatic failure (HF) to the VigiBase. VigiBasewas screened for the HF reports submitted from 2000 to 2009. The information retrieved referred to the suspected drug, age, gender, and a reporting country. Variables were examined by using descriptive statistics and the binomial test. During the 10-year period there were in total 6 370 HF reports from 38 countries. After the exclusion of cases with missing gender data (379 cases), females counted for 54.03%. The largest portion of HF cases referred to age <55 (42.57%) with female predominance (56.81%), whereas age 55 (32.57%) showed almost even gender distribution. Overall, there were 941 different drugs or their combinations reported. Females significantly predominated in HF cases associated with analgesics, antiepileptics, antiinflamatory and antirheumatic drugs, psychoanaleptics, antibacterials for systemic use, and antidiabetic drugs. Males were significantly overrepresented in HF cases associated with antivirals for systemic use. Differences between genders and/or age groups in the reporting of drug-induced HF depend on drug and/or drug class but may be influenced by multiple factors. © The Author(s) 2013.

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