Evidence map›Paper›PMID 30401998›Full record

ArticleThe Canadian journal of hospital pharmacy

Characterization of Serious Adverse Drug Reactions in Hospital to Determine Potential Implications of Mandatory Reporting.

Stephanie Gautron, Jason Wentzell, Salmaan Kanji, Tiffany Nguyen, Daniel M Kobewka, Erika MacDonald

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In one paragraph

Article in The Canadian journal of hospital pharmacy. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  6. The Neuropsychiatric Safety Profile of Lasmiditan: A Comparative Disproportionality Analysis with Triptans.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Article
  7. Adverse drug reactions of Rituximab in patients suffering from autoimmune neurological diseases.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2022
    Observational
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  14. IntravenousSAGE open medical case reports · 2020
    Article
  15. Article
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

6 authors.

Stephanie Gautron,BScPharm, ACPR, was, at the time of this study, a pharmacy resident at The Ottawa Hospital, Ottawa, Ontario. She is now a Pharmacist with the Centre de santé Saint-Boniface, My Health Team, St Boniface/St Vital, Winnipeg, Manitoba.
Jason Wentzell,BScPharm, ACPR, BCOP, is a Pharmacist with The Ottawa Hospital and a Clinician Investigator with The Ottawa Hospital Research Institute, Ottawa, Ontario.
Salmaan Kanji,BScPharm, ACPR, PharmD, is a Clinical Pharmacy Specialist with The Ottawa Hospital and an Associate Scientist with The Ottawa Hospital Research Institute, Ottawa, Ontario.
Tiffany Nguyen,BScPharm, ACPR, BCOP, is a Pharmacist with The Ottawa Hospital and a Clinician Investigator with The Ottawa Hospital Research Institute, Ottawa, Ontario.
Daniel M Kobewka,MD, FRCPC, MSc, is a Staff Physician with the Department of Medicine, The Ottawa Hospital; a Clinician Investigator with The Ottawa Hospital Research Institute; and an Assistant Professor with the University of Ottawa, Ottawa, Ontario.
Erika MacDonald,BScPharm, ACPR, MSc, is the Professional Practice Coordinator and a Pharmacist with The Ottawa Hospital and a Clinician Investigator with The Ottawa Hospital Research Institute, Ottawa, Ontario.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe

objectivesTo quantify and characterize suspected serious ADRs in patients admitted to a general medicine service, to assess the likelihood of causality, and to determine inter-rater agreement for identification of ADRs and assessment of their likelihood.

methodsThis prospective observational study involved 60 consecutive patients admitted to a general medicine service at a tertiary care teaching centre starting on March 28, 2016. The primary outcome was the number of serious ADRs, defined by Health Canada as ADRs that result in hospital admission, congenital malformation, persistent or significant disability or incapacity, or death; that are life-threatening; or that require significant intervention to prevent one of these outcomes. Medical records were reviewed independently by pairs of pharmacists for serious ADRs, and the likelihood of causality was assessed using the World Health Organization-Uppsala Monitoring Centre system. Inter-rater agreement was calculated using the kappa score, and disagreements were resolved by discussion and consensus.

resultsTwenty-three serious ADRs occurred in the sample of 60 patients. The proportion of patients experiencing a serious ADR that contributed to the original hospital admission was 19/60 (32%, 95% confidence interval [CI] 20%-43%), and 4 patients (7%, 95% CI 0%-13%) experienced a serious ADR during their hospital stay. Inter-rater agreement for occurrence of serious ADRs was moderate (kappa 0.58, 95% CI 0.35-0.76).

conclusionReportable serious ADRs were common among patients admitted to a general medicine service. Canadian hospitals would face difficulties reporting all serious ADRs because of the frequency of their occurrence and the subjectivity of their identification.

Indexed as

adverse drug reaction reportingadverse drug reactionshospital pharmacypostmarket surveillance

Identifiers

PMID30401998
PMCPMC6209500

What OpenQuestion holds

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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.