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Current Drug Safety

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ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

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Research Article

Agreement Among Different Scales for Causality Assessment in Drug-Induced Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Author(s): Kiruthika Sivagourounadin*, Priyadharsini Rajendran , Sandhiya Selvarajan and Mahalakshmi Ganesapandian

Volume 17, Issue 1, 2022

Published on: 11 June, 2021

Page: [40 - 46] Pages: 7

DOI: 10.2174/1574886316666210611160123

Price: $65

Abstract

Background and Objective: Identification of the offending drug is crucial and challenging in cases of severe cutaneous adverse drug reactions (CADR) like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Poor reproducibility and varying levels of agreement have been observed among different causality assessment tools (CATs) in assessing severe CADRs. This study was conducted to examine the agreement among four different CATs in assessing cases of drug-induced SJS, TEN and SJS/TEN overlap.

Methods: All cases of drug-induced SJS, TEN and SJS/TEN overlap, which were reported between January 2012 and January 2020, were identified from the ADR register at an ADR monitoring centre. Causality assessment was done in these reported cases using the following CATs: The World Health Organization–Uppsala Monitoring Centre (WHO–UMC) scale, Naranjo algorithm, Liverpool algorithm and Algorithm of drug causality for epidermal necrolysis (ALDEN). Weighted kappa (κw) test was used to evaluate the agreement among four CATs.

Results: A total of 30 cases of drug-induced SJS, TEN and SJS/TEN overlap were included in our analyses. The most common offending groups of drugs were anticonvulsants (46.7%), antimicrobials (40%) and nonsteroidal anti-inflammatory drugs (13.3%). Of the anticonvulsants, phenytoin (13.3%), carbamazepine (10%), and valproate (10%) were the commonly reported offending drugs. Poor agreement was observed among the four different causality assessment scales.

Conclusion: Discrepancies were observed among four different CATs in assessing drug-induced SJS and TEN. A CAT, which is more specific to drug-induced SJS and TEN, simple, user-friendly with limited subjective interpretation, incorporating new immunological and pharmacogenetic markers, is necessary.

Keywords: Adverse drug reactions, causality assessment tool, drug-induced Stevens-Johnson syndrome, drug-induced toxic epidermal necrolysis, liverpool algorithm, naranjo scale.

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[1]
Wester K, Jönsson AK, Spigset O, Druid H, Hägg S. Incidence of fatal adverse drug reactions: A population based study. Br J Clin Pharmacol 2008; 65(4): 573-9.
[http://dx.doi.org/10.1111/j.1365-2125.2007.03064.x] [PMID: 18070216]
[2]
Hakkarainen KM, Hedna K, Petzold M, Hägg S. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions – a meta-analysis.PLoS ONE 2012; 7: p. (3)e33236.
[3]
Mockenhaupt M. Epidemiology of cutaneous adverse drug reactions. Allergol Select 2017; 1(1): 96-108.
[http://dx.doi.org/10.5414/ALX01508E] [PMID: 30402608]
[4]
Fakoya AOJ, Omenyi P, Anthony P, et al. Stevens - Johnson Syndrome and Toxic Epidermal Necrolysis; extensive review of reports of drug-induced etiologies, and possible therapeutic modalities. Open Access Maced J Med Sci 2018; 6(4): 730-8.
[http://dx.doi.org/10.3889/oamjms.2018.148] [PMID: 29731949]
[5]
Wang Y-H, Chen C-B, Tassaneeyakul W, et al. The medication risk of Stevens-Johnson syndrome and toxic epidermal necrolysis in Asians: The major drug causality and comparison with the US FDA label. Clin Pharmacol Ther 2019; 105(1): 112-20.
[http://dx.doi.org/10.1002/cpt.1071] [PMID: 29569740]
[6]
Mockenhaupt M, Viboud C, Dunant A, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: Assessment of medication risks with emphasis on recently marketed drugs. The EuroSCAR-study. J Invest Dermatol 2008; 128(1): 35-44.
[http://dx.doi.org/10.1038/sj.jid.5701033] [PMID: 17805350]
[7]
Bellón T. Mechanisms of severe cutaneous adverse reactions: recent advances. Drug Saf 2019; 42(8): 973-92.
[http://dx.doi.org/10.1007/s40264-019-00825-2] [PMID: 31020549]
[8]
Agbabiaka TB, Savović J, Ernst E. Methods for causality assessment of adverse drug reactions: A systematic review. Drug Saf 2008; 31(1): 21-37.
[http://dx.doi.org/10.2165/00002018-200831010-00003] [PMID: 18095744]
[9]
Pande S. Causality or Relatedness assessment in adverse drug reaction and its relevance in dermatology. Indian J Dermatol 2018; 63(1): 18-21.
[http://dx.doi.org/10.4103/ijd.IJD_579_17] [PMID: 29527021]
[10]
Das S, Behera SK, Xavier AS, Velupula S, Dkhar SA, Selvarajan S. Agreement among different scales for causality assessment in Drug-Induced Liver Injury. Clin Drug Investig 2018; 38(3): 211-8.
[http://dx.doi.org/10.1007/s40261-017-0601-5] [PMID: 29185238]
[11]
Sassolas B, Haddad C, Mockenhaupt M, et al. ALDEN, an algorithm for assessment of drug causality in Stevens-Johnson Syndrome and toxic epidermal necrolysis: Comparison with case-control analysis. Clin Pharmacol Ther 2010; 88(1): 60-8.
[http://dx.doi.org/10.1038/clpt.2009.252] [PMID: 20375998]
[12]
Khan LM, Al-Harthi SE, Osman A-MM, Sattar MAAA, Ali AS. Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions. Saudi Pharm J 2016; 24(4): 485-93.
[http://dx.doi.org/10.1016/j.jsps.2015.01.010] [PMID: 27330379]
[13]
Arimone Y, Miremont-Salamé G, Haramburu F, et al. Inter-expert agreement of seven criteria in causality assessment of adverse drug reactions. Br J Clin Pharmacol 2007; 64(4): 482-8.
[http://dx.doi.org/10.1111/j.1365-2125.2007.02937.x] [PMID: 17711539]
[14]
Théophile H, Arimone Y, Miremont-Salamé G, et al. Comparison of three methods (consensual expert judgement, algorithmic and probabilistic approaches) of causality assessment of adverse drug reactions: An assessment using reports made to a French pharmacovigilance centre. Drug Saf 2010; 33(11): 1045-54.
[http://dx.doi.org/10.2165/11537780-000000000-00000] [PMID: 20925441]
[15]
Kane-Gill SL, Forsberg EA, Verrico MM, Handler SM. Comparison of three pharmacovigilance algorithms in the ICU setting: A retrospective and prospective evaluation of ADRs. Drug Saf 2012; 35(8): 645-53.
[http://dx.doi.org/10.1007/BF03261961] [PMID: 22720659]
[16]
Behera SK, Das S, Xavier AS, Velupula S, Sandhiya S. Comparison of different methods for causality assessment of adverse drug reactions. Int J Clin Pharm 2018; 40(4): 903-10.
[http://dx.doi.org/10.1007/s11096-018-0694-9] [PMID: 30051231]
[17]
Adverse drug monitoring centre Available from: https://ipc.gov.in/images/LIST_OF_311_AMC_UNDER_PvPI.pdf [Cited: Sep 4 2020]
[18]
WHO causality assessment Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf?ua=1 [Cited: Sep 4 2020]
[19]
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-45.
[http://dx.doi.org/10.1038/clpt.1981.154] [PMID: 7249508]
[20]
Gallagher RM, Kirkham JJ, Mason JR, et al. Development and inter-rater reliability of the liverpool adverse drug reaction causality assessment tool. PLoS ONE 2011; 6: p. (12)e28096.
[http://dx.doi.org/10.1371/journal.pone.0028096]
[21]
Cohen J. Weighted kappa: Nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull 1968; 70(4): 213-20.
[http://dx.doi.org/10.1037/h0026256] [PMID: 19673146]
[22]
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33(1): 159-74.
[http://dx.doi.org/10.2307/2529310] [PMID: 843571]
[23]
McHugh ML. Interrater reliability: The kappa statistic. Biochem Med (Zagreb) 2012; 22(3): 276-82.
[http://dx.doi.org/10.11613/BM.2012.031] [PMID: 23092060]
[24]
Nguyen K-D, Tran T-N, Nguyen MT, et al. Drug-induced Stevens- Johnson syndrome and toxic epidermal necrolysis in vietnamese spontaneous adverse drug reaction database: A subgroup approach to disproportionality analysis. J Clin Pharm Ther 2019; 44(1): 69-77.
[http://dx.doi.org/10.1111/jcpt.12754] [PMID: 30129156]
[25]
Irungu K, Nyamu D, Opanga S. Characterization of stevens-johnson syndrome and toxic epidermal necrolysis among patients admitted to kenyatta national hospital: A retrospective cross- sectional study. Drugs Real World Outcomes 2017; 4(2): 79-85.
[http://dx.doi.org/10.1007/s40801-017-0105-x] [PMID: 28401493]
[26]
Lihite R J, Lahkar M, Borah A, Hazarika D, Singh S. A study on drug induced Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and SJS/TEN overlap in a tertiary care hospital of Northeast India. J Young Pharm 2016; 8(2): 149-53.
[http://dx.doi.org/10.5530/jyp.2016.2.18]
[27]
Yang M-S, Lee JY, Kim J, et al. Searching for the culprit drugs for stevens-johnson syndrome and toxic epidermal necrolysis from a nationwide claim database in korea. J Allergy Clin Immunol Pract 2020; 8(2): 690-695.e2.
[http://dx.doi.org/10.1016/j.jaip.2019.09.032] [PMID: 31614216]
[28]
Abe J, Umetsu R, Mataki K, et al. Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database. J Pharm Health Care Sci 2016; 2(1): 14.
[http://dx.doi.org/10.1186/s40780-016-0048-5] [PMID: 27330825]
[29]
Tan SK, Tay YK. Profile and pattern of Stevens-Johnson syndrome and toxic epidermal necrolysis in a general hospital in Singapore: Treatment outcomes. Acta Derm Venereol 2012; 92(1): 62-6.
[http://dx.doi.org/10.2340/00015555-1169] [PMID: 21710108]
[30]
Patel TK, Barvaliya MJ, Sharma D, Tripathi C. A systematic review of the drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Indian population. Indian J Dermatol Venereol Leprol 2013; 79(3): 389-98.
[http://dx.doi.org/10.4103/0378-6323.110749] [PMID: 23619444]
[31]
Beniwal R, Gupta LK, Khare AK, Mittal A, Mehta S, Balai M. Clinical profile and comparison of causality assessment tools in cutaneous adverse drug reactions. Indian Dermatol Online J 2019; 10(1): 27-33.
[PMID: 30775295]
[32]
Goldman JL, Chung W-H, Lee BR, et al. Adverse drug reaction causality assessment tools for drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: Room for improvement. Eur J Clin Pharmacol 2019; 75(8): 1135-41.
[http://dx.doi.org/10.1007/s00228-019-02670-9] [PMID: 30918988]
[33]
Belhekar MN, Taur SR, Munshi RP. A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions. Indian J Pharmacol 2014; 46(1): 117-20.
[http://dx.doi.org/10.4103/0253-7613.125192] [PMID: 24550597]
[34]
Macedo AF, Marques FB, Ribeiro CF, Teixeira F. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability. J Clin Pharm Ther 2003; 28(2): 137-43.
[http://dx.doi.org/10.1046/j.1365-2710.2003.00475.x] [PMID: 12713611]
[35]
Mittal N, Gupta MC. Comparison of agreement and rational uses of the WHO and Naranjo adverse event causality assessment tools. J Pharmacol Pharmacother 2015; 6(2): 91-3.
[http://dx.doi.org/10.4103/0976-500X.155486] [PMID: 25969656]
[36]
Rana DA, Bhadiyadara SN, Shah HJ, Malhotra SD, Patel VJ. Consistency between causality assessments obtained with various scales and their agreement for adverse drug events reported in pediatric population. J Young Pharm 2015; 7(2): 89-95.
[http://dx.doi.org/10.5530/jyp.2015.2.6]
[37]
Mouton JP, Mehta U, Rossiter DP, Maartens G, Cohen K. Interrater agreement of two adverse drug reaction causality assessment methods: A randomised comparison of the liverpool adverse drug reaction causality assessment tool and the world health organization-uppsala monitoring centre. PLOS ONE 2017; 12: p. (2)e0172830.
[http://dx.doi.org/10.1371/journal.pone.0172830]
[38]
Gupta SK, Kumar KD. An assessment of reported adverse drug reactions in a Tertiary Care Hospital in South India: A retrospective cross-sectional study. Int J Pharm Investig 2017; 7(4): 193-7.
[http://dx.doi.org/10.4103/jphi.JPHI_81_17] [PMID: 29692979]
[39]
Oshikoya KA, Ogunyinka IA, Ogar CK, Abiola A, Ibrahim A, Oreagba IA. Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: A database review from 2004 to 2017. Ther Adv Drug Saf 2020; 11: 2042098620905998.
[http://dx.doi.org/10.1177/2042098620905998] [PMID: 32110375]
[40]
Sukasem C, Katsila T, Tempark T, Patrinos GP, Chantratita W. Drug-induced stevens-johnson syndrome and toxic epidermal necrolysis call for optimum patient stratification and theranostics via pharmacogenomics. Annu Rev Genomics Hum Genet 2018; 19(1): 329-53.
[http://dx.doi.org/10.1146/annurev-genom-083115-022324] [PMID: 29652519]
[41]
Lonjou C, Thomas L, Borot N, et al. A marker for Stevens-Johnson syndrome: Ethnicity matters. Pharmacogenomics J 2006; 6(4): 265-8.
[http://dx.doi.org/10.1038/sj.tpj.6500356] [PMID: 16415921]
[42]
White KD, Abe R, Ardern-Jones M, et al. SJS/TEN 2017: Building multidisciplinary networks to drive Science and Translation. J Allergy Clin Immunol Pract 2018; 6(1): 38-69.
[http://dx.doi.org/10.1016/j.jaip.2017.11.023] [PMID: 29310768]
[43]
Lerch M, Mainetti C, Terziroli Beretta-Piccoli B, Harr T. Current perspectives on stevens-johnson syndrome and toxic epidermal necrolysis. Clin Rev Allergy Immunol 2018; 54(1): 147-76.
[http://dx.doi.org/10.1007/s12016-017-8654-z] [PMID: 29188475]

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