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Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China

BACKGROUND: The present study investigates changes in spontaneous reporting (SR) compliance and ADR patterns following adoption of a new hospital SR system, and multiple interventions designed for its improvement use under modified drug administration guidelines. METHODS: In total, 1389 ADR cases we...

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Autores principales: Fang, Huan, Lin, Xiaowen, Zhang, Jun, Hong, Zhen, Sugiyama, Kenji, Nozaki, Takao, Sameshima, Tetsuro, Kobayashi, Susumu, Namba, Hiroki, Asakawa, Tetsuya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5485713/
https://www.ncbi.nlm.nih.gov/pubmed/28651624
http://dx.doi.org/10.1186/s40360-017-0159-0
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author Fang, Huan
Lin, Xiaowen
Zhang, Jun
Hong, Zhen
Sugiyama, Kenji
Nozaki, Takao
Sameshima, Tetsuro
Kobayashi, Susumu
Namba, Hiroki
Asakawa, Tetsuya
author_facet Fang, Huan
Lin, Xiaowen
Zhang, Jun
Hong, Zhen
Sugiyama, Kenji
Nozaki, Takao
Sameshima, Tetsuro
Kobayashi, Susumu
Namba, Hiroki
Asakawa, Tetsuya
author_sort Fang, Huan
collection PubMed
description BACKGROUND: The present study investigates changes in spontaneous reporting (SR) compliance and ADR patterns following adoption of a new hospital SR system, and multiple interventions designed for its improvement use under modified drug administration guidelines. METHODS: In total, 1389 ADR cases were reviewed. Cases were divided into two groups, cases from period 1 (n = 557, from January 2006 to June 2011) under the old SR system and cases in period 2 (n = 832, from July 2011 to December 2016) under the new SR system with multiple interventions to improve physician SR compliance. General information, drug information, and clinical manifestations were investigated and compared between periods. RESULTS: Interventions for improved clinician training, education on knowledge, attitudes, and practices (KAP), and economic incentives substantially improved SR adherence. We also found that changing drug usage patterns (based on the new drug administration guidelines) greatly influenced ADR occurrence and type. CONCLUSIONS: We found the SR compliance can be improved by multifaceted interventions. Drug usage patterns also influence ADR occurrence, so programs tailored for rational use are essential. These results could lead to further improvements in the SR system for ADRs in China, and provide guidance for establishing better methods of pharmacovigilance.
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spelling pubmed-54857132017-06-30 Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China Fang, Huan Lin, Xiaowen Zhang, Jun Hong, Zhen Sugiyama, Kenji Nozaki, Takao Sameshima, Tetsuro Kobayashi, Susumu Namba, Hiroki Asakawa, Tetsuya BMC Pharmacol Toxicol Research Article BACKGROUND: The present study investigates changes in spontaneous reporting (SR) compliance and ADR patterns following adoption of a new hospital SR system, and multiple interventions designed for its improvement use under modified drug administration guidelines. METHODS: In total, 1389 ADR cases were reviewed. Cases were divided into two groups, cases from period 1 (n = 557, from January 2006 to June 2011) under the old SR system and cases in period 2 (n = 832, from July 2011 to December 2016) under the new SR system with multiple interventions to improve physician SR compliance. General information, drug information, and clinical manifestations were investigated and compared between periods. RESULTS: Interventions for improved clinician training, education on knowledge, attitudes, and practices (KAP), and economic incentives substantially improved SR adherence. We also found that changing drug usage patterns (based on the new drug administration guidelines) greatly influenced ADR occurrence and type. CONCLUSIONS: We found the SR compliance can be improved by multifaceted interventions. Drug usage patterns also influence ADR occurrence, so programs tailored for rational use are essential. These results could lead to further improvements in the SR system for ADRs in China, and provide guidance for establishing better methods of pharmacovigilance. BioMed Central 2017-06-26 /pmc/articles/PMC5485713/ /pubmed/28651624 http://dx.doi.org/10.1186/s40360-017-0159-0 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted 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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Fang, Huan
Lin, Xiaowen
Zhang, Jun
Hong, Zhen
Sugiyama, Kenji
Nozaki, Takao
Sameshima, Tetsuro
Kobayashi, Susumu
Namba, Hiroki
Asakawa, Tetsuya
Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China
title Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China
title_full Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China
title_fullStr Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China
title_full_unstemmed Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China
title_short Multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in China
title_sort multifaceted interventions for improving spontaneous reporting of adverse drug reactions in a general hospital in china
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5485713/
https://www.ncbi.nlm.nih.gov/pubmed/28651624
http://dx.doi.org/10.1186/s40360-017-0159-0
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