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Sökning: (L773:1573 2509 OR L773:0920 9964) > (2020-2024) > Revealing the repor...

Revealing the reporting disparity : VigiBase highlights underreporting of clozapine in other Western European countries compared to the UK

De las Cuevas, Carlos (författare)
Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine, University of La Laguna, Canary Islands, Spain; Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, San Cristóbal de La Laguna, Spain
Sanz, Emilio J. (författare)
Department of Physical Medicine and Pharmacology, School of Medicine, Universidad de La Laguna, Canary Islands, Spain; Hospital Universitario de Canarias, Tenerife, Spain
Gross, Jason A. (författare)
HLS Therapeutics, Toronto, Canada
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Correll, Christoph U. (författare)
Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany; The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, NY, Glen Oaks, United States; Department of Psychiatry, Zucker School of Medicine at Northwell/Hofstra, NY, Hempstead, United States
Verdoux, Hélène (författare)
Université Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, Bordeaux, France
Lally, John (författare)
Department of Psychiatry, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland; Department of Psychiatry, St Vincent's Hospital Fairview, Dublin, Ireland; Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, United Kingdom
de Filippis, Renato (författare)
Psychiatry Unit, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy
Schulte, Peter F.J. (författare)
Mental Health Services Noord-Holland-Noord, Alkmaar, Netherlands; Dutch Clozapine Collaboration Group, Castricum, Netherlands
Molden, Espen (författare)
Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway; Department of Pharmacy, University of Oslo, Oslo, Norway
Arrojo-Romero, Manuel (författare)
Department of Psychiatry, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain
Boström, Adrian, 1990- (författare)
Umeå universitet,Psykiatri,Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Schoretsanitis, Georgios (författare)
The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, NY, Glen Oaks, United States; Department of Psychiatry, Zucker School of Medicine at Northwell/Hofstra, NY, Hempstead, United States; Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Zürich, Switzerland
Fernandez-Egea, Emilio (författare)
Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom; Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn Hospital, Fulbourn, Cambridge, United Kingdom
de Leon, Jose (författare)
Mental Health Research Center at Eastern State Hospital, KY, Lexington, United States; Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol Hospital, University of the Basque Country, Vitoria, Spain
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 (creator_code:org_t)
Elsevier, 2023
2023
Engelska.
Ingår i: Schizophrenia Research. - : Elsevier. - 0920-9964 .- 1573-2509.
Relaterad länk:
https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Background: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs).Objective: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization's pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality.Methods: VigiBase reports from clozapine's introduction to December 31, 2022, were studied for ADRs and the top 10 causes of fatal outcomes. The UK was compared with 11 other top reporting Western countries (Germany, Denmark, France, Finland, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland). Nine countries (except Ireland and Switzerland) were compared after controlling for population and clozapine prescriptions.Results: The UK accounted for 29 % of worldwide clozapine-related fatal outcomes, Germany 2 % and <1 % in each of the other countries. The nonspecific label “death” was the top cause in the world (46 %) and in the UK (33 %). “Pneumonia” was second in the world (8 %), the UK (12 %), Ireland (8 %) and Finland (14 %). Assuming that our corrections for population and clozapine use are correct, other countries underreported only 1–10 % of the UK clozapine fatal outcome number.Conclusions: Different Western European countries consistently underreport to VigiBase compared to the UK, but have different reporting/publishing styles for clozapine-related ADRs/fatal outcomes. Three Scandinavian registries suggest lives are saved as clozapine use increases, but this cannot be studied in pharmacovigilance databases.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

Nyckelord

Clozapine/administration and dosage
Clozapine/adverse effects
Clozapine/therapeutic use
Drug labeling
Europe
Schizophrenia

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