Cargando…

Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation

INTRODUCTION: In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECT...

Descripción completa

Detalles Bibliográficos
Autores principales: Ozcan, Gulnihal, Aykac, Emel, Kasap, Yelda, Nemutlu, Nergiz T., Sen, Ebru, Aydinkarahaliloglu, N. Demet
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4819489/
https://www.ncbi.nlm.nih.gov/pubmed/27747800
http://dx.doi.org/10.1007/s40801-015-0054-1
_version_ 1782425208493178880
author Ozcan, Gulnihal
Aykac, Emel
Kasap, Yelda
Nemutlu, Nergiz T.
Sen, Ebru
Aydinkarahaliloglu, N. Demet
author_facet Ozcan, Gulnihal
Aykac, Emel
Kasap, Yelda
Nemutlu, Nergiz T.
Sen, Ebru
Aydinkarahaliloglu, N. Demet
author_sort Ozcan, Gulnihal
collection PubMed
description INTRODUCTION: In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE: In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. METHODS: We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. RESULTS: The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. CONCLUSION: This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40801-015-0054-1) contains supplementary material, which is available to authorized users.
format Online
Article
Text
id pubmed-4819489
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-48194892016-04-10 Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation Ozcan, Gulnihal Aykac, Emel Kasap, Yelda Nemutlu, Nergiz T. Sen, Ebru Aydinkarahaliloglu, N. Demet Drugs Real World Outcomes Original Research Article INTRODUCTION: In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. OBJECTIVE: In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. METHODS: We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. RESULTS: The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. CONCLUSION: This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40801-015-0054-1) contains supplementary material, which is available to authorized users. Springer International Publishing 2016-01-08 /pmc/articles/PMC4819489/ /pubmed/27747800 http://dx.doi.org/10.1007/s40801-015-0054-1 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research Article
Ozcan, Gulnihal
Aykac, Emel
Kasap, Yelda
Nemutlu, Nergiz T.
Sen, Ebru
Aydinkarahaliloglu, N. Demet
Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation
title Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation
title_full Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation
title_fullStr Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation
title_full_unstemmed Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation
title_short Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation
title_sort adverse drug reaction reporting pattern in turkey: analysis of the national database in the context of the first pharmacovigilance legislation
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4819489/
https://www.ncbi.nlm.nih.gov/pubmed/27747800
http://dx.doi.org/10.1007/s40801-015-0054-1
work_keys_str_mv AT ozcangulnihal adversedrugreactionreportingpatterninturkeyanalysisofthenationaldatabaseinthecontextofthefirstpharmacovigilancelegislation
AT aykacemel adversedrugreactionreportingpatterninturkeyanalysisofthenationaldatabaseinthecontextofthefirstpharmacovigilancelegislation
AT kasapyelda adversedrugreactionreportingpatterninturkeyanalysisofthenationaldatabaseinthecontextofthefirstpharmacovigilancelegislation
AT nemutlunergizt adversedrugreactionreportingpatterninturkeyanalysisofthenationaldatabaseinthecontextofthefirstpharmacovigilancelegislation
AT senebru adversedrugreactionreportingpatterninturkeyanalysisofthenationaldatabaseinthecontextofthefirstpharmacovigilancelegislation
AT aydinkarahaliloglundemet adversedrugreactionreportingpatterninturkeyanalysisofthenationaldatabaseinthecontextofthefirstpharmacovigilancelegislation