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International Journal of Clinical Pharmacy

, Volume 40, Issue 2, pp 376–385 | Cite as

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

  • Guillaume HébertEmail author
  • Florence Netzer
  • Sylvain Landry Kouakou
  • François Lemare
  • Etienne Minvielle
  • the IATRIGGER Working Group
Research Article
First Online:

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.

Keywords

Adverse drug event France Healthcare quality Oncology Patient cancer care Preventability Trigger tool 
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Notes

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.

Supplementary material

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Supplementary material 1 (DOCX 25 kb)
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Supplementary material 2 (DOCX 54 kb)
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Supplementary material 3 (PPTX 1264 kb)
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Supplementary material 4 (DOCX 21 kb)

References

  1. 1.
    World Health Organization. WHO draft guidelines for adverse event reporting and learning systems: from information to action [Internet]. Geneva. 2005. http://apps.who.int/iris/handle/10665/69797.
  2. 2.
    Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324:370–6.CrossRefPubMedGoogle Scholar
  3. 3.
    Bates DW, Leape LL, Carruthers SG. Melmon and Morrelli’s clinical pharmacology: basic principles in therapeutics. New York: McGraw-Hill; 2000.Google Scholar
  4. 4.
    Lipczak H, Neckelmann K, Steding-Jessen M, Jakobsen E, Knudsen JL. Uncertain added value of Global Trigger Tool for monitoring of patient safety in cancer care. Dan Med Bull. 2011;58:A4337.PubMedGoogle Scholar
  5. 5.
    Lipczak H, Knudsen JL, Nissen A. Safety hazards in cancer care: findings using three different methods. BMJ Qual Saf. 2011;20:1052–6.CrossRefPubMedGoogle Scholar
  6. 6.
    Nazer LH, Hawari F, Al-Najjar T. Adverse drug events in critically ill patients with cancer: incidence, characteristics, and outcomes. J Pharm Pract. 2014;27:208–13.CrossRefPubMedGoogle Scholar
  7. 7.
    Jha AK, Kuperman GJ, Teich JM, Leape LL, Shea B, Rittenberg E, et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc. 1998;5:305–14.CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Kilbridge PM, Campbell UC, Cozart HB, Mojarrad MG. Automated surveillance for adverse drug events at a community hospital and an academic medical center. J Am Med Inform Assoc. 2006;13:372–7.CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Wong BM, Dyal S, Etchells EE, Knowles S, Gerard L, Diamantouros A, et al. Application of a trigger tool in near real time to inform quality improvement activities: a prospective study in a general medicine ward. BMJ Qual Saf. 2015;24:272–81.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA. 1998;280:1000–5.CrossRefPubMedGoogle Scholar
  11. 11.
    Michel P, Quenon JL, de Sarasqueta AM, Scemama O. Comparison of three methods for estimating rates of adverse events and rates of preventable adverse events in acute care hospitals. BMJ. 2004;328:199.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Griffin FA, Resar RK. IHI Global Trigger Tool for measuring adverse events. 2nd ed. Cambridge: Institute for Healthcare Improvement; 2009.Google Scholar
  13. 13.
    Classen DC, Resar RK, Griffin FA, Federico F, Frankel T, Kimmel N, et al. ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011;30:581–9.CrossRefGoogle Scholar
  14. 14.
    Härkänen M, Kervinen M, Ahonen J, Voutilainen A, Turunen H, Vehviläinen-Julkunen K. Patient-specific risk factors of adverse drug events in adult inpatients – evidence detected using the Global Trigger Tool method. J Clin Nurs. 2015;24:582–91.CrossRefPubMedGoogle Scholar
  15. 15.
    Sharek PJ. The Emergence of the Trigger Tool as the Premier Measurement Strategy for Patient Safety. AHRQ WebM&M. 2012;2012:1–5.Google Scholar
  16. 16.
    Takata GS, Mason W, Taketomo C, Logsdon T, Sharek PJ. Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics. 2008;121:e927–35.CrossRefPubMedGoogle Scholar
  17. 17.
    Sharek PJ, Horbar JD, Mason W, Bisarya H, Thurm CW, Suresh G, et al. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics. 2006;118:1332–40.CrossRefPubMedGoogle Scholar
  18. 18.
    Mull HJ, Rosen AK, Shimada SL, Rivard PE, Nordberg B, Long B, et al. Assessing the potential adoption and usefulness of concurrent, action-oriented, electronic adverse drug event triggers designed for the outpatient setting. EGEMS (Washington, DC). 2015;3:1116.Google Scholar
  19. 19.
    Rosen AK, Mull HJ, Kaafarani HMA, Nebeker JR, Shimada S, Helwig A, et al. Applying trigger tools to detect adverse events associated with outpatient surgery. J Patient Saf. 2011;7:45–59.CrossRefPubMedGoogle Scholar
  20. 20.
    Klopotowska JE, Wierenga PC, Stuijt CCM, Arisz L, Dijkgraaf MGW, Kuks PFM, et al. Adverse drug events in older hospitalized patients: results and reliability of a comprehensive and structured identification strategy. PLoS ONE. 2013;8:e71045.CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    Carnevali L, Krug B, Amant F, Van Pee D, Gérard V, de Béthune X, et al. Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events: experience in a Belgian hospital. Ann Pharmacother. 2013;47:1414–9.CrossRefPubMedGoogle Scholar
  22. 22.
    Franklin BD, Birch S, Schachter M, Barber N. Testing a trigger tool as a method of detecting harm from medication errors in a UK hospital: a pilot study. Int J Pharm Pract. 2010;18:305–11.CrossRefPubMedGoogle Scholar
  23. 23.
    Kalenderian E, Walji MF, Tavares A, Ramoni RB. An adverse event trigger tool in dentistry: a new methodology for measuring harm in the dental office. J Am Dent Assoc. 2013;144:808–14.CrossRefPubMedGoogle Scholar
  24. 24.
    Hakkarainen KM, Andersson Sundell K, Petzold M, Hägg S. Methods for assessing the preventability of adverse drug events: a systematic review. Drug Saf. 2012;35:105–26.CrossRefPubMedGoogle Scholar
  25. 25.
    Mattsson TO, Knudsen JL, Lauritsen J, Brixen K, Herrstedt J. Assessment of the global trigger tool to measure, monitor and evaluate patient safety in cancer patients: reliability concerns are raised. BMJ Qual Saf. 2013;22:571–9.CrossRefPubMedGoogle Scholar
  26. 26.
    Hébert G, Netzer F, Ferrua M, Ducreux M, Lemare F, Minvielle E. Evaluating iatrogenic prescribing: development of an oncology-focused trigger tool. Eur J Cancer. 2015;51:427–35.CrossRefPubMedGoogle Scholar
  27. 27.
    Winterstein AG, Hatton RC, Gonzalez-Rothi R, Johns TE, Segal R. Identifying clinically significant preventable adverse drug events through a hospital’s database of adverse drug reaction reports. Am J Health Syst Pharm. 2002;59:1742–9.PubMedGoogle Scholar
  28. 28.
    Fitch K, Bernstein S, Aguilar M, Burnand B, LaCalle J, Lazaro P. The RAND/UCLA appropriateness method user’s manual. California: Santa Monica; 2001.Google Scholar
  29. 29.
    National Institutes of Health, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 [Internet]. 2010. http://www.evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf.
  30. 30.
    Bégaud B, Evreux JC, Jouglard J, Lagier G. Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France. Therapie. 1985;40:111–8.PubMedGoogle Scholar
  31. 31.
    Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapie. 1978;33:373–81.PubMedGoogle Scholar
  32. 32.
    Kaafarani HMA, Rosen AK, Nebeker JR, Shimada S, Mull HJ, Rivard PE, et al. Development of trigger tools for surveillance of adverse events in ambulatory surgery. Qual Saf Health Care. 2010;19:425–9.PubMedGoogle Scholar
  33. 33.
    Bourrée F, Michel P, Salmi LR. Méthodes de consensus: revue des méthodes originales et de leurs grandes variantes utilisées en santé publique. Rev Epidemiol Sante Publique. 2008;56:415–23.CrossRefPubMedPubMedCentralGoogle Scholar
  34. 34.
    Grenier-Sennelier C, Corriol C, Daucourt V, Michel P, Minvielle E. Développement d’indicateurs de qualité au sein des établissements de santé: le projet COMPAQH. Rev Epidemiol Sante Publique. 2005;53:22–30.CrossRefGoogle Scholar
  35. 35.
    Handler SM, Hanlon JT, Perera S, Roumani YF, Nace DA, Fridsma DB, et al. Consensus list of signals to detect potential adverse drug reactions in nursing homes. J Am Geriatr Soc. 2008;56:808–15.CrossRefPubMedPubMedCentralGoogle Scholar
  36. 36.
    Mull HJ, Nebeker JR, Shimada SL, Kaafarani HMA, Rivard PE, Rosen AK. Consensus building for development of outpatient adverse drug event triggers. J Patient Saf. 2011;7:66–71.CrossRefPubMedPubMedCentralGoogle Scholar
  37. 37.
    Unbeck M, Lindemalm S, Nydert P, Ygge B-M, Nylén U, Berglund C, et al. Validation of triggers and development of a pediatric trigger tool to identify adverse events. BMC Health Serv Res. 2014;14:655.CrossRefPubMedPubMedCentralGoogle Scholar
  38. 38.
    de Wet C, Bowie P. The preliminary development and testing of a global trigger tool to detect error and patient harm in primary-care records. Postgrad Med J. 2009;85:176–80.CrossRefPubMedGoogle Scholar
  39. 39.
    Miller L, Bainbridge D, Jordan C, Jolley H, Primary T. 1000 Lives Plus: How use Trigger Tool [Internet]. 2010. www.1000livesplus.wales.nhs.uk/opendoc/179568.
  40. 40.
    Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:377–84.CrossRefPubMedGoogle Scholar
  41. 41.
    Olivier P, Caron J, Haramburu F, Imbs J-L, Jonville-Béra A-P, Lagier G, et al. Validation d’une échelle de mesure: exemple de l’échelle française d’évitabilité des effets indésirables médicamenteux. Therapie. 2005;60:39–45.CrossRefPubMedGoogle Scholar
  42. 42.
    Ransohoff DF, Pignone M, Sox HC. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139–40.CrossRefPubMedGoogle Scholar
  43. 43.
    Aapro MS, Bohlius J, Cameron DA, Dal Lago L, Donnelly JP, Kearney N, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47:8–32.CrossRefPubMedGoogle Scholar
  44. 44.
    de Naurois J, Novitzky-Basso I, Gill MJ, Marti FM, Cullen MH, Roila F, et al. Management of febrile neutropenia: ESMO clinical practice guidelines. Ann Oncol. 2010;21(Suppl 5):v252–6.CrossRefPubMedGoogle Scholar
  45. 45.
    Flowers CR, Seidenfeld J, Bow EJ, Karten C, Gleason C, Hawley DK, et al. Antimicrobial prophylaxis and outpatient management of fever and neutropenia in adults treated for malignancy: American society of clinical oncology clinical practice guideline. J Clin Oncol. 2013;31:794–810.CrossRefPubMedGoogle Scholar
  46. 46.
    Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, et al. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010;6:91–6.CrossRefPubMedGoogle Scholar
  47. 47.
    Jha AK, Laguette J, Seger AC, Bates DW. Can surveillance systems identify and avert adverse drug events? A prospective evaluation of a commercial application. J Am Med Inform Assoc. 2008;15:647–53.CrossRefPubMedPubMedCentralGoogle Scholar
  48. 48.
    Classen DC, Burke JP, Pestotnik SL, Evans RS, Stevens LE. Surveillance for quality assessment: IV. Surveillance using a hospital information system. Infect Control Hosp Epidemiol. 1991;12:239–44.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG 2018

Authors and Affiliations

  1. 1.Département de Pharmacie CliniqueGustave RoussyVillejuifFrance
  2. 2.Mission ‘Innovative Pathways’Gustave RoussyVillejuifFrance
  3. 3.Research Team ‘Management des Organisations de Santé’ (EA 7348) École de Hautes Études en Santé PubliqueRennes CedexFrance
  4. 4.Pharmacie Clinique, PRES Sorbonne Paris-Cité, Faculté de PharmacieParisFrance

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