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Preliminary Results of a Novel Algorithmic Method Aiming to Support Initial Causality Assessment of Routine Pharmacovigilance Case Reports for Medication-Induced Liver Injury: The PV-RUCAM

Scalfaro, Erik, Streefkerk, Henk Johan, Merz, Michael, Meier, Christoph, Lewis, David·2017·Drug Safety
DOI 10.1007/s40264-017-0541-2
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Abstract

Introduction Data incompleteness in pharmacovigilance (PV) health records limits the use of current causality assessment methods for drug-induced liver injury (DILI). In addition to the inherent complexity of this adverse event, identifying cases of high causal probability is difficult. Objective The aim was to evaluate the performance of an improved, algorithmic and standardised method called the Pharmacovigilance-Roussel Uclaf Causality Assessment Method (PV-RUCAM), to support assessment of suspected DILI. Performance was compared in different settings with regard to applicability and differentiation capacity. Methods A PV-RUCAM score was developed based on the seven sections contained in the original RUCAM. The score provides cut-off values for or against DILI causality, and was applied on two datasets of bona fide individual case safety reports (ICSRs) extracted randomly from clinical trial reports and a third dataset of electronic health records from a global PV database. The performance of PV-RUCAM adjudication was compared against two standards: a validated causality assessment method (original RUCAM) and global introspection. Results The findings showed moderate agreement against standards. The overall error margin of no false negatives was satisfactory, with 100% sensitivity, 91% specificity, a 25% positive predictive value and a 100% negative predictive value. The Spearman's rank correlation coefficient illustrated a statistically significant monotonic association b…

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Research works printed but not linked: 36

  1. Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience. Pharmacoepidemiol Drug Saf. 2006;15(4):213–20. doi: 10.1002/pds.1207 . · DOI
  2. Sarges P, Steinberg JM, Lewis JH. Drug-induced liver injury: highlights from a review of the 2015 literature. Drug Saf. 2016;38:801. doi: 10.1007/s40264-016-0427-8 . · DOI · Paper page
  3. Watkins PB, Merz M, Avigan MI, Kaplowitz N, Regev A, Senior JR. The Clinical Liver Safety Assessment Best Practices Workshop: rationale, goals, accomplishments and the future. Drug Saf. 2014;37(1):1–7. doi: 10.1007/s40264-014-0181-8 . · DOI
  4. Teschke R, Danan G. Diagnosis and management of drug-induced liver injury (DILI) in patients with pre-existing liver disease. Drug Saf. 2016;39(8):729–44. doi: 10.1007/s40264-016-0423-z . · DOI
  5. Teschke R, Wolff A, Frenzel C, Schwarzenboeck A, Schulze J, Eickhoff A. Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment. World J Hepatol. 2014;6(1):17–32. doi: 10.4254/wjh.v6.i1.17 . · DOI · Paper page
  6. Regev A, Seeff LB, Merz M, Ormarsdottir S, Aithal GP, Gallivan J, et al. Causality assessment for suspected DILI during clinical phases of drug development. Drug Saf. 2014;37(1):47–56. doi: 10.1007/s40264-014-0185-4 . · DOI
  7. Senior JR. Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges. Drug Saf. 2014;37(1):9–17. doi: 10.1007/s40264-014-0182-7 . · DOI
  8. Danan G, Teschke R. RUCAM in drug and herb induced liver injury: the update. Int J Mol Sci. 2015;17(1):1–33. doi: 10.3390/ijms17010014 . · DOI · Paper page
  9. Close P, Collins W, Pellet P, Warner BA. Hepatotoxicity clinical safety standard guideline. Novartis Drug Saf Epidemiol. 2013;1:22–37.
  10. Avigan MI, Bjornsson ES, Pasanen M, Cooper C, Andrade RJ, Watkins PB, et al. Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. Drug Saf. 2014;37(1):19–31. doi: 10.1007/s40264-014-0183-6 . · DOI
  11. Agarwal VK, McHutchison JG, Hoofnagle JH. Important elements for the diagnosis of drug-induced liver injury. Clin Gastroenterol Hepatol. 2010;8(5):463–70. doi: 10.1016/j.cgh.2010.02.008 . · DOI
  12. Miljkovic M, Dobric S, Dragojevic-Simic V. Accuracy and reproducibility of two scales in causality assessment of unexpected hepatotoxicity. J Clin Pharm Ther. 2012;37(2):196–203. doi: 10.1111/j.1365-2710.2011.01282.x . · DOI
  13. Garcia-Cortés M, Stephens C, Lucena MI, Fernandez-Castañer A, Andrade RJ. Causality assessment methods in drug induced liver injury: strengths and weaknesses. J Hepatol. 2011;55(3):683–91. doi: 10.1016/j.jhep.2011.02.007 . · DOI · Paper page
  14. Raschi E, de Ponti F. Drug- and herb-induced liver injury: progress, current challenges and emerging signals of post-marketing risk. World J Hepatol. 2015;7(13):1761–71. doi: 10.4254/wjh.v7.i13.1761 . · DOI
  15. Danan G, Benichou C. Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol. 1993;46(11):1323–30. doi: 10.1016/0895-4356(93)90101-6 . · DOI · Paper page
  16. Benichou C, Danan G, Flahault A. Causality assessment of adverse reactions to drugs-II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J Clin Epidemiol. 1993;46(II):1331–6. doi: 10.1016/0895-4356(93)90102-7 . · DOI · Paper page
  17. Björnsson E, Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology. 2005;42(2):481–9. doi: 10.1002/hep.20800 . · DOI · Paper page
  18. Marrero J, Ahn J, Rajender Reddy K. ACG clinical guideline: the diagnosis and management of focal liver lesions. Am J Gastroenterol. 2014;109:1–20. doi: 10.1038/ajg.2014.213 . · DOI
  19. Rockey DC, Seeff LB, Rochon J, Freston J, Chalasani N, Bonacini M, et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method. Hepatology. 2010;51(6):2117–26. doi: 10.1002/hep.23577 . · DOI · Paper page
  20. Hoofnagle JH. Drug-Induced Liver Injury Network (DILIN). Hepatology. 2004;40:773. · DOI
  21. Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, et al. Drug-induced liver injury network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55–68. doi: 10.2165/00002018-200932010-00005 . · DOI · Paper page
  22. Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005;85(3):257–68. · DOI · Paper page
  23. Ludbrook J. Statistical techniques for comparing measurers and methods of measurement: a critical review. Clin Exp Pharmacol Physiol. 2002;29(7):527–36. doi: 10.1046/j.1440-1681.2002.03686.x . · DOI
  24. Cohen J. A coefficient of agreement for nominal scales. In: Educational and Psychological Measurement. 1960. p. 37–46. doi: 10.1177/001316446002000104 . · DOI · Paper page
  25. Walsh JF, Reznikoff M. Bootstrapping: a tool for clinical research. J Clin Psychol. 1990;46:928– 930. · DOI
  26. Attia J. Moving beyond sensitivity and specificity: using likelihood ratios to help interpret diagnostic tests. Aust Prescr. 2003;26(5):111–3. doi: 10.18773/austprescr.2003.082 . · DOI
  27. 8. International Conference on Harmonisation. ICH harmonised tripartite guideline post-approval safety data management: definitions and standards for expedited reporting E2D. 2003
  28. Moore TJ, Furberg CD. Electronic health data for postmarket surveillance: a vision not realized. Drug Saf. 2015;38(7):601–10. doi: 10.1007/s40264-015-0305-9 . · DOI
  29. Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology. 1997;26(3):664–9. doi: 10.1002/hep.510260319 . · DOI · Paper page
  30. Théophile H, André M, Miremont-Salamé G, Arimone Y, Bégaud B. Comparison of three methods (an updated logistic probabilistic method, the Naranjo and Liverpool algorithms) for the evaluation of routine pharmacovigilance case reports using consensual expert judgement as reference. Drug Saf. 2013;36(10):1033–44. doi: 10.1007/s40264-013-0083-1 . · DOI
  31. Agbabiaka TB, Savović J, Ernst E. Methods for causality assessment of adverse drug reactions: a systematic review. Drug Saf. 2008;31(1):21–37. doi: 10.2165/00002018-200831010-00003 . · DOI · Paper page
  32. Arimone Y, Bégaud B, Miremont-Salamé G, Fourrier-Réglat A, Molimard M, Moore N, et al. A new method for assessing drug causation provided agreement with experts’ judgment. J Clin Epidemiol. 2006;59(3):308–14. doi: 10.1016/j.jclinepi.2005.08.012 . · DOI · Paper page
  33. Théophile H, André M, Arimone Y, Haramburu F, Miremont-Salamé G, Bégaud B. An updated method improved the assessment of adverse drug reaction in routine pharmacovigilance. J Clin Epidemiol. 2012;65(10):1069–77. doi: 10.1016/j.jclinepi.2012.04.015 . · DOI
  34. Garcia-Cortes M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R, Andrade RJ. Evaluation of Naranjo Adverse Drug Reactions Probability Scale in causality assessment of drug-induced liver injury. Aliment Pharmacol Ther. 2008;27(9):780–9. doi: 10.1111/j.1365-2036.2008.03655.x . · DOI · Paper page
  35. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts E a, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–45. doi: 10.1038/clpt.1981.154 . · DOI · Paper page
  36. Kaplowitz N. Causality assessment versus guilt-by-association in drug hepatotoxicity. Hepatology. 2001;33(1):308–10. doi: 10.1053/jhep.2001.21083 . · DOI

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Metadata

Authors
Scalfaro, E., Streefkerk, H. J., Merz, M., Meier, C., & Lewis, D.
ORCID
Scalfaro, Erik
Venue
Drug Safety
Publisher
Springer Science and Business Media LLC
Published
2017-05-15
Volume
40
Issue
8
Pages
715-727
ISSN
  • 0114-5916
  • 1179-1942
DOI
10.1007/s40264-017-0541-2
Cited by
16
References
1
Language
en
Licence
www.springer.com/tdm (tdm)

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