Accuracy and reproducibility of two scales in causality assessment of unexpected hepatotoxicity

Journal of Clinical Pharmacy and Therapeutics

Volumn 37, Issue 2, 2012, Pages 196-203

  Miljkovic, Milena ^a   Dobric, S ^b   Dragojevic Simic, V ^b  

^a ADOC Pharmaceuticals   (Serbia)

^b UNIVERSITY OF DEFENCE   (Serbia)

Author keywords

Accuracy; Causality assessment; Commonly used scales; Reproducibility; Signal detection; Unexpected hepatotoxicity

Indexed keywords

'PROSTATE'; AMLODIPINE; ANTIPROTOZOAL AGENT; CARBAMAZEPINE; CEFUROXIME; CILAZAPRIL; CONPROSTA; CYCLOPHOSPHAMIDE; DOLOREXA; DOXORUBICIN; ENALAPRIL; FOSINOPRIL; GADOLINIUM PENTETATE MEGLUMINE; HEPARIN; HERBACEOUS AGENT; HUMAN GROWTH HORMONE; NEBIVOLOL; NIFEDIPINE; RAMIPRIL; RITUXIMAB; SEVOFLURANE; SIMVASTATIN; TENONITROZOLE; UNCLASSIFIED DRUG; VALPROIC ACID;

ACCURACY; ADOLESCENT; ADULT; AGED; ARTICLE; CAUSAL ATTRIBUTION; CHILD; CLINICAL ARTICLE; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES OR ROUSEL UCLAF CAUSALITY ASSESSMENT METHOD; DRUG EFFECT; FEMALE; HUMAN; INTERMETHOD COMPARISON; LIVER TOXICITY; MALE; NARANJO ADVERSE DRUG REACTION PROBABILITY SCALE; RATING SCALE; REPRODUCIBILITY; SCHOOL CHILD;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; CHILD; DRUG-INDUCED LIVER INJURY; FEMALE; HUMANS; MALE; MIDDLE AGED; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE; REPRODUCIBILITY OF RESULTS; SERBIA;

EID: 84857997513     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2011.01282.x     Document Type: Article

References (33)

1. Bjornsson E Review article: drug-induced liver injury in clinical practice. Alimentary Pharmacology & Therapeutics, 2010;32:3-13.
2. Lucena MI, Garcia-Cortes M, Cueto R, Lopez-Duran JL, Andrade RJ Assessment of drug-induced liver injury in clinical practice. Fundamental and Clinical Pharmacology, 2008;22:141-158. (Pubitemid 351392952)
3. Andrade RJ, Robles M, Fernandez-Castaner A, Lopez-Ortega S, Lopez-Vega C, Lucena MI Assessment of drug-induced hepatotoxicity in clinical practice: a challenge for gastroenterologists. World Journal of Gastroenterology, 2007;13:329-340. (Pubitemid 46178965)
4. Lee WM, Senior JR Recognizing drug-induced liver injury: current problems, possible solutions. Toxicologic Pathology, 2005;33:155-164. (Pubitemid 40216814)
5. Lee WM Medical progress: drug-induced hepatotoxicity. New England Journal of Medicine, 2003;349:474-485.
6. Hussaini SH, Farrington EA Idiosyncratic drug-induced liver injury: an overview. Expert Opinion on Drug Safety, 2007;6:673-684. (Pubitemid 351308279)
7. Giannini EG, Testa R, Savarino V Liver enzyme alteration: a guide for clinicians. Canadian Medical Association Journal, 2005;172:367-379. (Pubitemid 40208726)
8. Navarro VJ, Senior JR Current concepts: drug-related hepatotoxicity. New England Journal of Medicine, 2006;354:731-739.
9. Holt MP, Ju C Mechanisms of drug-induced liver injury. American Association of Pharmaceutical Scientists Journal, 2006;8:E48-E55.
10. Reuben A, Koch DG, Lee WM, the Acute Liver Failure Study Group Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology, 2010;52:2065-2076.
11. Teschke R, Schwarzenboeck A, Hennermann KH Causality assessment in hepatotoxicity by drugs and dietary supplements. British Journal of Clinical Pharmacology, 2008;66:758-766.
12. Andrade RJ, Robles M, Ortiz N, Lucena MI Rechallenge in hepatotoxicity: proof of concept or therapeutic accident? Revista Espanola de Enfermedades Digestivas, 2008;100:255-258. (Pubitemid 351966961)
13. Meyboom RHB, Hekster YA, Egberts ACG, Gribnau FWJ, Edwards IR (Reprint 2005) Causal or casual? The role of causality assessment in pharmacovigilance. Drug Safety, 1997;17:374-389. (Pubitemid 28017927)
14. Agbabiaka TA, Savovic J, Ernst E Methods for causality assessment of adverse drug reactions. Drug Safety, 2008;31:21-37.
15. Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeutics, 1981;30:239-245. (Pubitemid 12149145)
16. 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. Journal of Clinical Epidemiology, 1993;46:1323-1330. (Pubitemid 23333873)
17. Benichou C, Danan G (1994) A new method for drug causality assessment: RUCAM. In: Benichou C, ed. Adverse drug reactions. A practical guide to diagnosis and management. Chichester: John Wiley &Sons Ltd, 277-287.
18. Maria VA, Victorino RM Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology, 1997;26:664-669. (Pubitemid 27392358)
19. Aithal GP, Rawlins MD, Day CP Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reaction. Journal of Hepatology, 2000;33:949-952.
20. Watanabe M, Shibuya A Validity of a new diagnostic scale for drug-induced liver injury in Japan - comparison with two initial scales. Hepatology Research, 2004;30:148-154. (Pubitemid 39654745)
21. Miljkovic MM, Dobric S, Dragojevic-Simic V Consistency between causality assessments obtained with two scales and their agreement with clinical judgments in hepatotoxicity. Pharmacoepidemiology and Drug Safety, 2011;20:272-285.
22. World Health Organization (WHO) Collaborating Center for Drugs Statistics Methodology (2009) Anatomical therapeutic chemical (ATC) classification index including defined daily doses (DDDs) for plain substances. Oslo: WHO Collaborating Cente for Drugs Statistics Methodology.
23. European Commission (EC) (2008) Volume 9A of the rules governing medicinal products in the European Union. Guidelines on pharmacovigilance for medicinal products for human use. Brisel: EC Reference Document.
24. Sim J, Wright CC The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Physical Therapy, 85:257-268.
25. Landis JR, Koch GG The measurement of observer agreement for categorical data. Biometrics, 1977;33:159-174. (Pubitemid 8054849)
26. Garcia-Cortes M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R Evaluation of Naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury. Alimentary Pharmacology & Therapeutics, 2008;27:780-789. (Pubitemid 351490076)
27. Tajiri K, Shimizu Y 2008;Practical guidelines for diagnosis and early management of drug-induced liver injury. World Journal of Gastroenterology, 14:6774-6785.
28. Lucena MI, Camargo R, Andrade RJ, Perez-Sanchez CJ, Sanchez de la Cuesta F (2001) Comparison of two clinical scales for causality assessment in hepatotoxicity. Hepatology, 33:123-130. (Pubitemid 32016894)
29. Lewis JH, Larrey D, Olsson R, Lee WM, Frison L, Keisu M Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: evaluation of the direct thrombin inhibitor ximelagatran. International Journal of Clinical Pharmacology and Therapeutics, 2008;46:327-329.
30. Rochon J, Protiva P, Seeff LB et al. Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Drug-Induced Liver Injury Network (DILIN). Hepatology, 2008;48:1175-1183.
31. Rockey DC, Seeff LB, Rochon J et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the oussel-Uclaf causality assessment method. Hepatology, 2010;51:2117-2126.
32. Fontana RJ, Seeff LB, Andrade RJ, Bjornsson E, Day CP, Serrano J, Hoofnagle JH Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepatology, 2010;52:730-742.
33. Teschke R, Fuchs J, Bahre R, Genthner A, Wolf A Kava hepatotoxicity: comparative study of two structured quantitative methods for causality assessment. Journal of Clinical Pharmacy and Therapeutics, 2010;35:545-563.