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WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems
Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest t...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing AG
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568200/ https://www.ncbi.nlm.nih.gov/pubmed/23329541 http://dx.doi.org/10.1007/s40264-012-0014-6 |
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author | Pal, Shanthi N. Duncombe, Chris Falzon, Dennis Olsson, Sten |
author_facet | Pal, Shanthi N. Duncombe, Chris Falzon, Dennis Olsson, Sten |
author_sort | Pal, Shanthi N. |
collection | PubMed |
description | Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed. |
format | Online Article Text |
id | pubmed-3568200 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Springer International Publishing AG |
record_format | MEDLINE/PubMed |
spelling | pubmed-35682002013-02-21 WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems Pal, Shanthi N. Duncombe, Chris Falzon, Dennis Olsson, Sten Drug Saf Leading Article Globally, national pharmacovigilance systems rely on spontaneous reporting in which suspected adverse drug reactions (ADRs) are reported to a national coordinating centre by health professionals, manufacturers or patients. Spontaneous reporting systems are the easiest to establish and the cheapest to run but suffer from poor-quality reports and underreporting. It is difficult to estimate rates and frequencies of ADRs through spontaneous reporting. Public health programmes need to quantify and characterize risks to individuals and communities from their medicines, to minimize harm and improve use, to sustain public confidence in the programmes, and to track problems due to medication errors and poor quality medicines. Additional methods are therefore needed to monitor the quantitative aspects of medicine safety, to better identify specific risk factors and high-risk groups, and to characterize ADRs associated with specific medicines and in specific populations. The present paper introduces two methods, cohort event monitoring and targeted spontaneous reporting, that are being implemented by the WHO, in its public health programmes, to complement spontaneous reporting. The advantages and disadvantages of these methods and how each can be applied in clinical practice are discussed. Springer International Publishing AG 2013-01-18 2013 /pmc/articles/PMC3568200/ /pubmed/23329541 http://dx.doi.org/10.1007/s40264-012-0014-6 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by-nc/2.5/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Leading Article Pal, Shanthi N. Duncombe, Chris Falzon, Dennis Olsson, Sten WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems |
title | WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems |
title_full | WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems |
title_fullStr | WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems |
title_full_unstemmed | WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems |
title_short | WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems |
title_sort | who strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems |
topic | Leading Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568200/ https://www.ncbi.nlm.nih.gov/pubmed/23329541 http://dx.doi.org/10.1007/s40264-012-0014-6 |
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