Cargando…
A systematic review of observational studies evaluating costs of adverse drug reactions
INTRODUCTION: The growing evidence of the increased frequency and severity of adverse drug events (ADEs), besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these s...
Autores principales: | , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5003513/ https://www.ncbi.nlm.nih.gov/pubmed/27601925 http://dx.doi.org/10.2147/CEOR.S115689 |
_version_ | 1782450662474252288 |
---|---|
author | Batel Marques, Francisco Penedones, Ana Mendes, Diogo Alves, Carlos |
author_facet | Batel Marques, Francisco Penedones, Ana Mendes, Diogo Alves, Carlos |
author_sort | Batel Marques, Francisco |
collection | PubMed |
description | INTRODUCTION: The growing evidence of the increased frequency and severity of adverse drug events (ADEs), besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these studies being more susceptible to bias than experimental designs, they are more competent in assessing ADEs and their associated costs. OBJECTIVE: To identify and characterize the best available evidence on ADE-associated costs. METHODS: MEDLINE, Cochrane Library, and Embase were searched from 1995 to 2015. Observational studies were included. The methodological quality of selected studies was assessed by Cochrane Collaboration tool for experimental and observational studies. Studies were classified according to the setting analyzed in “ambulatory”, “hospital”, or both. Costs were classified as “direct” and “indirect”. Data were analyzed using descriptive statistics. The total incremental cost per patient with ADE was estimated. RESULTS: Twenty-nine (94%) longitudinal observational studies and two (7%) cross-sectional studies were included. Twenty-three (74%) studies were assessed with the highest methodological quality score. The studies were mainly conducted in the US (61%). Twenty (65%) studies evaluated any therapeutic group. Twenty (65%) studies estimated costs of ADEs leading to or prolonging hospitalization. The “direct costs” were evaluated in all studies, whereas only two (7%) also estimated the “indirect costs”. The “direct costs” in ambulatory ranged from €702.21 to €40,273.08, and the in hospital from €943.40 to €7,192.36. DISCUSSION: Methodological heterogeneities were identified among the included studies, such as design, type of ADEs, suspected drugs, and type and structure of costs. Despite such discrepancies, the financial burden associated with ADE costs was found to be high. In the light of the present findings, validated methods to measure ADE-associated costs need future research efforts. |
format | Online Article Text |
id | pubmed-5003513 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-50035132016-09-06 A systematic review of observational studies evaluating costs of adverse drug reactions Batel Marques, Francisco Penedones, Ana Mendes, Diogo Alves, Carlos Clinicoecon Outcomes Res Review INTRODUCTION: The growing evidence of the increased frequency and severity of adverse drug events (ADEs), besides the negative impact on patient’s health status, indicates that costs due to ADEs may be steadily rising. Observational studies are an important tool in pharmacovigilance. Despite these studies being more susceptible to bias than experimental designs, they are more competent in assessing ADEs and their associated costs. OBJECTIVE: To identify and characterize the best available evidence on ADE-associated costs. METHODS: MEDLINE, Cochrane Library, and Embase were searched from 1995 to 2015. Observational studies were included. The methodological quality of selected studies was assessed by Cochrane Collaboration tool for experimental and observational studies. Studies were classified according to the setting analyzed in “ambulatory”, “hospital”, or both. Costs were classified as “direct” and “indirect”. Data were analyzed using descriptive statistics. The total incremental cost per patient with ADE was estimated. RESULTS: Twenty-nine (94%) longitudinal observational studies and two (7%) cross-sectional studies were included. Twenty-three (74%) studies were assessed with the highest methodological quality score. The studies were mainly conducted in the US (61%). Twenty (65%) studies evaluated any therapeutic group. Twenty (65%) studies estimated costs of ADEs leading to or prolonging hospitalization. The “direct costs” were evaluated in all studies, whereas only two (7%) also estimated the “indirect costs”. The “direct costs” in ambulatory ranged from €702.21 to €40,273.08, and the in hospital from €943.40 to €7,192.36. DISCUSSION: Methodological heterogeneities were identified among the included studies, such as design, type of ADEs, suspected drugs, and type and structure of costs. Despite such discrepancies, the financial burden associated with ADE costs was found to be high. In the light of the present findings, validated methods to measure ADE-associated costs need future research efforts. Dove Medical Press 2016-08-24 /pmc/articles/PMC5003513/ /pubmed/27601925 http://dx.doi.org/10.2147/CEOR.S115689 Text en © 2016 Batel Marques et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Review Batel Marques, Francisco Penedones, Ana Mendes, Diogo Alves, Carlos A systematic review of observational studies evaluating costs of adverse drug reactions |
title | A systematic review of observational studies evaluating costs of adverse drug reactions |
title_full | A systematic review of observational studies evaluating costs of adverse drug reactions |
title_fullStr | A systematic review of observational studies evaluating costs of adverse drug reactions |
title_full_unstemmed | A systematic review of observational studies evaluating costs of adverse drug reactions |
title_short | A systematic review of observational studies evaluating costs of adverse drug reactions |
title_sort | systematic review of observational studies evaluating costs of adverse drug reactions |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5003513/ https://www.ncbi.nlm.nih.gov/pubmed/27601925 http://dx.doi.org/10.2147/CEOR.S115689 |
work_keys_str_mv | AT batelmarquesfrancisco asystematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT penedonesana asystematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT mendesdiogo asystematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT alvescarlos asystematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT batelmarquesfrancisco systematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT penedonesana systematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT mendesdiogo systematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions AT alvescarlos systematicreviewofobservationalstudiesevaluatingcostsofadversedrugreactions |