دورية أكاديمية
Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study.
| العنوان: | Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study. |
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| المؤلفون: | Glamočlija U; Una Glamočlija, School of Medicine, University of Mostar, Bijeli brijeg bb, 88 000 Mostar, Bosnia and Herzegovina, una.glamoclija@gmail.com., Tubić B, Kondža M, Zolak A, Grubiša N |
| المصدر: | Croatian medical journal [Croat Med J] 2018 Jun 30; Vol. 59 (3), pp. 124-131. |
| نوع المنشور: | Comparative Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Medicinska Naklada Country of Publication: Croatia NLM ID: 9424324 Publication Model: Print Cited Medium: Internet ISSN: 1332-8166 (Electronic) Linking ISSN: 03539504 NLM ISO Abbreviation: Croat Med J Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2001- : Zagreb : Medicinska Naklada Original Publication: Zagreb : University of Zagreb Medical School, [1992- |
| مواضيع طبية MeSH: | Pharmacovigilance*, Adverse Drug Reaction Reporting Systems/*organization & administration , Adverse Drug Reaction Reporting Systems/*statistics & numerical data, Bosnia and Herzegovina/epidemiology ; Croatia/epidemiology ; Female ; Humans ; Male ; Montenegro/epidemiology ; Pharmacoepidemiology ; Retrospective Studies ; Serbia/epidemiology |
| مستخلص: | Aim: To compare individual case safety reports (ICSR) rates and characteristics between Croatia, Serbia, Montenegro, and Bosnia and Herzegovina (B&H). Methods: This retrospective pharmacoepidemiological study used the data from ICSR received by the Agency for Medicines and Medical Devices in B&H in 2011-2016. The number, characteristics, and sources of reports, suspected drugs, and patient characteristics were analyzed. The results were compared with the publicly available data from Croatia, Serbia, and Montenegro. Results: The number of reported adverse drug reactions per one million of inhabitants was lowest in B&H and highest in Croatia. There were significant differences in reporter characteristics, sources of reports, and the percentage of missing data in ICSR, while the Anatomical Therapeutic Chemical product classes, patient's sex, and adverse drug reaction System Organ Classes were similar. Conclusion: Despite the historical and geographical vicinity of B&H and its neighboring countries, there were significant differences in indicators of pharmacovigilance development. |
| References: | Pharmacoepidemiol Drug Saf. 2016 Sep;25(9):1061-9. (PMID: 27174034) Drug Saf. 2016 Apr;39(4):335-45. (PMID: 26754924) PLoS One. 2016 Jun 01;11(6):e0155385. (PMID: 27249414) Expert Opin Drug Saf. 2017 May;16(5):515-522. (PMID: 28395523) J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S7-S19. (PMID: 24347987) Expert Rev Clin Pharmacol. 2015;8(4):449-60. (PMID: 26041035) Ther Adv Drug Saf. 2013 Oct;4(5):211-9. (PMID: 25114782) Drug Saf. 2013 Jan;36(1):25-30. (PMID: 23315293) Int J Clin Pharm. 2017 Dec 16;:null. (PMID: 29248988) |
| تواريخ الأحداث: | Date Created: 20180705 Date Completed: 20180820 Latest Revision: 20190609 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC6045893 |
| DOI: | 10.3325/cmj.2018.59.124 |
| PMID: | 29972735 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1332-8166 |
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| DOI: | 10.3325/cmj.2018.59.124 |