Scales Used For Causality Assessment

Causality assessment in the context of adverse events or drug-related effects often involves the use of standardized scales or criteria to determine the likelihood of a causal relationship between a specific intervention (e.g., drug exposure) and an observed outcome. These scales aim to provide a systematic and structured approach to evaluate causality, considering various factors and criteria.

1. Welcome SCALES USED FOR CAUSALITY ASSESSMENT APOORVA MADARAPU BDS Student ID: CSRPL_INT_ONL_WKD_131/0722 https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcTiNa5Xtyhks492Sn_saDCziPYC5TqGnxPcoqMz2kvfdA&s 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#›

2. Index What is Causality Assessment??? Objectives Methods WHO-UMC system Naranjo scale BARDI REFERENCES 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#›

3. CAUSALITY ASSESSMENT: It is the assessment of relationship between a drug treatment and the occurrence of an adverse event Basically used for estimation and to investigate that the particular treatment is the cause of an observed adverse event or not It is the essential part of ADR reporting and important task,conducted by National Pharmacovigilance Program in each country 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#›

4. OBJECTIVES: Provide relationship between drug and event Provide a better evaluation of the benefit/harm profiles of drugs Plays an essential part of evaluating ADR reports in early warning systems and for regulatory purposes 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#›

5. METHODS: 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#› 1)Expert judgement/global introspection Wilholm, WHO &UMC, Miremont et al 2)Algorithms Naranjo et al. Karch and Lasagna Kramer et al. 3)Probabilistic methods(Bayesian Approaches ) Australian method for causality assessment BARDI MacBARDI

6. 1) Expert judgement/global introspection 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#› Clinician discussing observed adverse reaction and suspected medicine Causality assessment done by clinicians is purely based on previous knowledge and experience of the clinician in the relevant field.

7. World Health Organisation (WHO)- Uppsala Monitoring Centre(UMC) scale: It is basically combined assessment taking into account the clinical –pharmacological aspects of the case history and the quality of the documentation of the observation Includes the following four criteria Time relationship between the drug use and the adverse event Absence of other competing causes Response to drug withdrawal or dose reduction (de-challenge) Response to drug re-administration(rechallenge) 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#›

8. Causality association: Certain: When all criteria(a,b,c,d) are met Probable: When criteria a , b , c are met Possible: When only criteria a is met Unlikely: When criteria a and b are not met 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#› Besides the 4 categories ADR can be categorized into 5) Unclassified /Conditional : Applied when more data is needed and such data is being sought or is already under examination 6)Unassessable/Unclassifiable: Finally when the information in a report is incomplete or contradictory and cannot be verified ,then it is Unclassifiable

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10. Naranjo scale A ten-elemental questionnaire with yes ,no and unknown replies are developed Based on the replies , the score has been determined into categories 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#› 2)Algorithms An algorithm is a problem-specific flow chart with step-by-step instruction on how to arrive at an answer It contains some questionnaire whose answers provide the causality of particular ADR

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13. 3)Probabilistic methods(Bayesian Approaches) 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#› Bayesian methods for causality assessment make use of specific findings in a case to transform a prior into a posterior probability of drug causation Prior probability - from epidemiological information Posterior probability combines this background information with the evidence in the individual case.

14. Bayesian Adverse Reactions Diagnostic Instrument (BARDI): BARDI is used to calculate the odds in favor of a particular drug causing an adverse event compared with an alternative cause. These odds are referred to as the posterior odds. The posterior odds factor is calculated by considering six assessment subsets: one deals with background epidemiologic or clinical trials information (the prior odds) and the other five deal with case specific information (the likelihood ratios). 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#› PsO = PrO × LR(Hi) × LR(Ti) × LR(Ch) × LR(De) ×LR(Re)

15. REFERENCES: Pande S. Causality or Relatedness Assessment in Adverse Drug Reaction and Its Relevance in Dermatology. Indian J Dermatol. 2018 Jan-Feb;63(1):18-21. doi: 10.4103/ijd.IJD_579_17. PMID: 29527021; PMCID: PMC5838749. 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. PMID: 18095744. https://who-umc.org/media/164200/who-umc-causality-assessment_new-logo.pdf LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Adverse Drug Reaction Probability Scale (Naranjo) in Drug Induced Liver Injury. [Updated 2019 May 4]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548069/ https://saspublishers.com/media/articles/SJAMS15386-392_w8SI0KZ.pdf 10/20/2022 www.clinosol.com | follow us on social media @clinosolresearch ‹#›

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