Evidence map›Paper›PMID 27601925›Full record

ReviewClinicoEconomics and outcomes research : CEOR2016

A systematic review of observational studies evaluating costs of adverse drug reactions.

Francisco Batel Marques, Ana Penedones, Diogo Mendes, Carlos Alves

Abstract readReview
In one paragraph

Review in ClinicoEconomics and outcomes research : CEOR, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Ex vivo Drug Metabolism Using Primary Human Hepatocytes for the Detection of Metabolite-Dependent Antibodies to Red Blood Cells.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2025
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  9. Adverse drug reactions and associated patient characteristics in older community-dwelling adults: a 6-year prospective cohort study.The British journal of general practice : the journal of the Royal College of General Practitioners · 2023
    Article
  10. Observational
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  15. The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.International journal of environmental research and public health · 2021
    Review
  16. Association between neonatal intensive care unit medication safety practices, adverse events, and death.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Francisco Batel MarquesCHAD - Centre for Health Technology Assessment and Drug Research, AIBILI - Association for Innovation and Biomedical Research on Light and Image; School of Pharmacy, University of Coimbra, Coimbra, Portugal.
Ana PenedonesCHAD - Centre for Health Technology Assessment and Drug Research, AIBILI - Association for Innovation and Biomedical Research on Light and Image; School of Pharmacy, University of Coimbra, Coimbra, Portugal.
Diogo MendesCHAD - Centre for Health Technology Assessment and Drug Research, AIBILI - Association for Innovation and Biomedical Research on Light and Image; School of Pharmacy, University of Coimbra, Coimbra, Portugal.
Carlos AlvesCHAD - Centre for Health Technology Assessment and Drug Research, AIBILI - Association for Innovation and Biomedical Research on Light and Image; School of Pharmacy, University of Coimbra, Coimbra, Portugal.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

objectiveTo identify and characterize the best available evidence on ADE-associated costs.

methodsMEDLINE, 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.

resultsTwenty-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.

Indexed as

drug costsdrug-related side effects and adverse reactionshealth care costsreview

Identifiers

PMID27601925
PMCPMC5003513

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.