Evidence map›Paper›PMID 36002314›Full record

Observational studyBritish journal of clinical pharmacology2023

Incidence and preventability of hospital admissions for adverse drug reactions in France: A prospective observational study (IATROSTAT).

Marie-Laure Laroche, Sophie Gautier, Elisabeth Polard, Marie-Blanche Rabier, Laurent Chouchana, Bénédicte Lebrun-Vignes, Jean-Luc Faillie, Nadine Petitpain, Laurence Lagarce, Annie-Pierre Jonville-Bera and 1 more

Open access · bronzeAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in British journal of clinical pharmacology, 2023. 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
5.6field-weighted citation impact, top 3% of its field
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, 38 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Falls in older patients treated for cancer in French outpatient departments: screening and prevention-a prospective observational study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Observational
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Observational
  11. Article
  12. Article
  13. Article
  14. Article
  15. Observational
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

11 authors at 10 institutions in 1 country.

Marie-Laure LarocheRegional Pharmacovigilance Centre of Limoges, Department of Pharmacology-Toxicology and Pharmacovigilance, CHU Limoges, Limoges, France.ORCID 0000-0003-4344-0359
Sophie GautierRegional Pharmacovigilance Centre of Lille, Pharmacology Department, CHU Lille, Lille, France.
Elisabeth PolardRegional Pharmacovigilance Centre of Rennes, CHU Rennes, Rennes, Francie, France.
Marie-Blanche RabierRegional Pharmacovigilance Centre of Besançon, CHU Besançon, Besançon, France.ORCID 0000-0001-5737-5733
Laurent ChouchanaRegional Pharmacovigilance Centre of Cochin, Pharmacology Department, AP-HP. Centre - Université Paris Cité, Paris, France.ORCID 0000-0002-9626-3571
Bénédicte Lebrun-VignesRegional Pharmacovigilance Centre of Pitié and Saint Antoine Hospital, APHP Sorbonne Université, Paris, France.ORCID 0000-0001-6676-5063
Jean-Luc FaillieRegional Pharmacovigilance Centre of Montpellier, CHU Montpellier, Montpellier, France.ORCID 0000-0003-0100-4073
Nadine PetitpainRegional Pharmacovigilance Centre of Nancy, CHRU Nancy, Nancy, France.ORCID 0000-0003-0225-3178
Laurence LagarceDepartment of Pharmacology-Toxicology and Pharmacovigilance, CHU Angers, Regional Pharmacovigilance Centre of Angers, Angers, France.ORCID 0000-0002-7609-6972
Annie-Pierre Jonville-BeraRegional Pharmacovigilance Centre - Centre-Val de Loire, Pharmacosurveillance Unit, CHRU Tours, Tours, France.ORCID 0000-0002-2635-3360
IATROSTAT study group
Centre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Besançon · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire de Tours · FRHôpital Universitaire Dupuytren · FRInserm · FRSorbonne Université · FRUniversité Paris Cité · FR

Funding

ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé)
6 · The paper itself

Abstract

aimsIn the last French study in 2007, the incidence of hospital admissions (HAs) related to adverse drug reactions (ADRs) was 3.6%. The objective was to assess the current ADR-HA incidence in France and to describe both its characteristics and preventability.

methodsA prospective multicentre study was conducted among randomly selected French public hospital medical wards (April-July 2018). Patients admitted during a week period were included. ADR-HA cases were collected by the French Regional Pharmacovigilance Centres network. An independent committee validated potential cases and ADR preventability.

resultsADR-HA incidence was 8.5% (95% confidence interval [CI]: 7.6-9.4%), increasing with age (3.3% [95%CI: 1.8-5.5%] ≤16 y vs. 10.6% [95%CI: 9.3-12.0%] ≥65 y). The most common ADRs were haemorrhagic events (8.8%), haematological disorders (6.5%), acute renal failure (6.3%), fluid and electrolyte disorders (6.0%), and falls (5.2%). New drugs were involved: targeted therapies (22.8% of antineoplastics), direct oral anticoagulants (29.6% of antithrombotics) and incretin-based drugs (20.0% of antidiabetics). ADRs were preventable in 16.1% of cases because the drugs involved had not been used in accordance with monographies, package leaflets or other therapeutic guidelines. The main situations of noncompliance addressed either dose or duration of use (27.9%), warning (23.2%), use precaution (18.6%) and inappropriate self-medication or misuse by patients (11.6%).

conclusionIn France, ADR-HA incidence dramatically increased over the last decade. A significant proportion was related to new pharmacological classes and considered as preventable. These findings should lead to in-depth thought on preventive actions on at-risk drug classes.

Indexed as

Drug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsFranceHospitalizationHospitalsHumansIncidenceProspective Studiesadverse drug reactionsdrug safetyhospitalisationincidenceobservational studypharmacovigilancepreventability

Identifiers

PMID36002314
PMCPMC10087906
OpenAlexW4293009200

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.