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Development of a ‘ready-to-use’ tool that includes preventability, for the assessment of adverse drug events in oncology

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Abstract

Background Adverse drug events (ADEs) occur frequently in oncology and justify continuous assessment and monitoring. There are several methods for detecting them, but the trigger tool method seems the most appropriate. Although a generic tool exists, its use for ADEs in oncology has not been convincing. The development of a focused version is therefore necessary. Objective To provide an oncology-focused trigger tool that evaluates the prevalence, harm, and preventability in a standardised method for pragmatic use in ADE surveillance. Setting Hospitals with cancer care in France. Method The tool has been constructed in two steps: (1) constitution of an oncology-centred list of ADEs; 30 pharmacists/practitioners in cancer care from nine hospitals selected a list of ADEs using a method of agreement adapted from the RAND/UCLA Appropriateness Method; and (2) construction of three standardised dimensions for the characterisation of each ADE (including causality, severity, and preventability). Main outcome measure The main outcome measure was validation of the tool, including preventability criteria. Results The tool is composed of a final list of 15 ADEs. For each ADE, a ‘reviewer form’ has been designed and validated by the panel. It comprises (1) the trigger(s), (2) flowcharts to guide the reviewer, (3) criteria for grading harm, and (4) a standardised assessment of preventability with 6–14 closed sentences for each ADE in terms of therapeutic management and/or prevention of side-effects. Conclusion A complete ‘ready-to-use’ tool for ADE monitoring in oncology has been developed that allows the assessment of three standardised dimensions.

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Funding

The study was funded by the Directorate of Health Care Supply of the French Ministry of Health.

Conflicts of interest

The authors declare no conflicts of interest with the content of the article.

IATRIGGER Working Group

Dr Elias Assaf, Dr Christophe Bardin, Dr Florence Basuyau, Prof. Pierrick Bedouch, Dr Dominique Charlety, Dr Nathalie Contentin, Dr Mikael Daouphars, Prof. Frédéric Di Fiore, Dr Ludovic Doucet, Dr Cécile Guillemet, Dr Anne-Chrisitine Joly, Dr Charlotte Joly, Dr Fabien Le Bras, Dr Marianne Leheurteur, Dr Marion Lottin, Dr Mélodie Lucas, Dr Isabelle Madelaine, Prof. Véronique Merle, Dr Nathalie Pons-Kerjean, Dr Jordi Remon-Masip, Dr Benoit Rousseau, Dr Jean Rouvet, Dr Caroline Saldana, Dr Florian Slimano, Dr Anne-Claire Toffart, Prof. Christophe Tournigand, Prof. Remi Varin, Dr Anne Vekhoff and Dr Muriel Verlinde-Carvalho.

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Authors and Affiliations

  1. Département de Pharmacie Clinique, Gustave Roussy, 114 Rue Edouard Vaillant, 94805, Villejuif, France

    Guillaume Hébert, Florence Netzer, Sylvain Landry Kouakou & François Lemare

  2. Mission ‘Innovative Pathways’, Gustave Roussy, 114 Rue Edouard Vaillant, 94805, Villejuif, France

    Etienne Minvielle

  3. Research Team ‘Management des Organisations de Santé’ (EA 7348), École de Hautes Études en Santé Publique, 15 Avenue du Professeur Léon-Bernard, 35043, Rennes Cedex, France

    Guillaume Hébert, François Lemare & Etienne Minvielle

  4. Pharmacie Clinique, PRES Sorbonne Paris-Cité, Faculté de Pharmacie, 4 Avenue de l’Observatoire, 75006, Paris, France

    François Lemare

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  1. Guillaume Hébert
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the IATRIGGER Working Group

  • Elias Assaf
  • , Christophe Bardin
  • , Florence Basuyau
  • , Pierrick Bedouch
  • , Dominique Charlety
  • , Nathalie Contentin
  • , Mikael Daouphars
  • , Frédéric Di Fiore
  • , Ludovic Doucet
  • , Cécile Guillemet
  • , Anne-Chrisitine Joly
  • , Charlotte Joly
  • , Fabien Le Bras
  • , Marianne Leheurteur
  • , Marion Lottin
  • , Mélodie Lucas
  • , Isabelle Madelaine
  • , Véronique Merle
  • , Nathalie Pons-Kerjean
  • , Jordi Remon-Masip
  • , Benoit Rousseau
  • , Jean Rouvet
  • , Caroline Saldana
  • , Florian Slimano
  • , Anne-Claire Toffart
  • , Christophe Tournigand
  • , Remi Varin
  • , Anne Vekhoff
  •  & Muriel Verlinde-Carvalho

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Correspondence to Guillaume Hébert.

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François Lemare and Etienne Minvielle should be considered joint last authors.

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Hébert, G., Netzer, F., Kouakou, S.L. et al. Development of a ‘ready-to-use’ tool that includes preventability, for the assessment of adverse drug events in oncology. Int J Clin Pharm 40, 376–385 (2018). https://doi.org/10.1007/s11096-017-0542-3

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  • DOI: https://doi.org/10.1007/s11096-017-0542-3

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