Overview of important methods used for Causality Assessment of adverse drug events in Pharmacovigilance
The method of assessing causality between adverse events and suspect drugs is the most challenging task in pharmacovigilance. It requires attentive consideration of both the adverse events and suspect drugs, patient-related factors, and co-suspect drugs and other medical conditions of the patient. Though different methods were developed to assess causality, no single method has been proved to produce an accurate or authentic ascertainable evaluation of the causal relationship. Hence, causality assessment has become an important step in evaluating drug safety. Due to a lack of uniformity, reliability, and rationality, no single method can be accepted as a standard one across the world. This review aimed to look for different methods available or reported for causality assessment and give a brief comparison between the methods. Many pieces of literature were reviewed to present a summary of commonly used important methods for causality assessment.
Begaud 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(2):111-8.
Benichou C, Danan G. Causality assessment in the European pharmaceutical industry: presentation of the preliminary results of a new method. Drug Information Journal, 1992; 26: 589-92.
Curtin F, Schulz P. Assessing the benefit: risk ratio of a drug randomized and naturalistic evidence. Dialogue of Clinical Neuroscience, 2011;13:183-190.
Danan G, Benichou C. Causality assessment of adverse reactions to drugs- a novel method based on the conclusions of international consensus meetings: application to drug induced liver injuries. Journal of Clinical Epidemiology, 1993; 46(1): 132-142.
Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapy, 1978; 33 (3): 373-81.
Ennis M, Ohmann C, Lorenz W, et al. Prediction of risk for pseudoallergic reactions and histamine release in patients undergoing anaesthesia and surgery: a computer-aided model using independence-Bayes. Agents Actions, 1988; 23: 366-9.
Gawai PP. Introduction and evaluation of Pharmacovigilance for beginners. International Journal of Scientific Reports, 2020; 6(10): 425- 32.
Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Annals of Pharmacotherapy, 2007; 41: 674-680.
Hoskins RE, Mannino S. Causality assessment of adverse drug reactions using decision support and informatics tools. Pharmacoepidemiology and Drug Safety, 1992; 1: 235-249.
Hutchinson T, Dawid A, Spiegelhalter D. Computerized aids for probabilistic assessment of drug safety: A spreadsheet program. Drug Information Journal, 1991; 25: 29-39.
Hutchinson TA. Computerized Bayesian ADE assessment. Drug Information Journal, 1991; 25: 235-41.
Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR; An algorithm for the operational assessment of adverse drug reactions: Background, description, and instructions for use. JAMA, 1979; 242: 623-632.
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. Pharmacoepidemiology and Drug Safety, 2005;14(12):885-890.
Miremont-Salame G, Theophile H, Haramburu F, Begaud B. Causality assessment in pharmacovigilance: The French method and its successive updates. Therapie, 2016; 71(2):179-86.
Naidu RP. Causality assessment: A brief insight into practices in pharmaceutical industry. Perspectives in Clinical Research, 2013; 4:233-6.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA et al. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeautics, 1981; 30:239-245.
Rehan HS, Chopra D, Kakkar A. Physician's guide to pharmacovigilance: Terminology and causality assessment. European Journal of Internal Medicine, 2009; 20: 3-8.
Wiholm BE. The Swedish drug-event assessment methods. Special workshop- regulatory. Drug Information Journal, 1984; 18: 267-9.
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