Adverse drug reactions causality assessment

Hutchinson, T.A. (1992). Causality assessments of suspected adverse drug reactions. In Detection of New Adverse Drug Reactions (Stephens, M.B.D., Ed.). Macmillan, Press, London. 

CIOMS. Standardisation of definitions and criteria of causality assessment of adverse drug reactions -drug-induced cytopenia. Int J Clin Pharmacol Tker Toxicol 1991 29 75-81. 

Lane DA, Kramer MS, Hutchinson TA, et al. The causality assessment of adverse drug reactions using a Bayesian approach. Pharm Med 1987 2 265-83. 

World Health Organization Definitions—Causality Assessment of Suspected Adverse Drug Reactions... 

Miremont G, Haramburu F, Begaud B, Pere JC, Dangoumau. Adverse drug reactions Physicians opinions versus a causality assessment method. Eur J Clin Pharmacol 1994 46 285-9. 

Hutchinson TA, Lane DA. Assessing methods for causality assessment of suspected adverse drug reactions. J Clin Epidemiol 1989 42 5-16. 

Table 14.11 Method for causality assessment of adverse drug reactions...

Lane DA, Kramer MS, Hutchinson TA, Jones JK, Naranjo C. The causality assessment of adverse drug reactions using a bayesian approach. Pharm Med 1987 2 265-83. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981 30 239 5. 

Agbabiaka, T. B., Savovic,J., Ernst, E. (2008). Methods for causality assessment of adverse drug reactions A systemadc review. Drug Safety An InternationalJournal of Medical Toxicology and Drug Experience, Bl(l), 21-37. 

The primary evaluation (in our system at the end of the hospital stay) for such cases must be checked again by a secondary or even a further evaluation in connection with the specific characteristics of the problem studied. This final or secondary evaluation has to be independent from the causality level originally attributed (Inman 1982). Assessing the causality of adverse drug reactions, even with standardized approaches, should remain an activity under control of physicians (Venulet 1982). 

Reprinted from J Gin Epidemiol, Vol 46, Danan C, Benichou C. Causality assessment of adverse reactions to drugs-4. A novel method based on the conclusions of international consensus meetings- Application to drug-induced liver injuries pages 1323-1330, Copyright 1993, with permission from Elsevier. 

O Dormell, J., Adverse dmg reactions extent of the problem and causality assessment, in O Donnell, J.T., Ed., Drug Injury Liability, Analysis, and Prevention, L J Publishers, Tucson, AZ,... 

The most difficult part of ADE reporting is the accurate assessment of the causal relationship of a drug to an alleged reaction. The likelihood that a drug contributes to, or is responsible for, an adverse reaction with any degree of certainty can be established only if adequate information is available. 

Accurate assessment of a causal relationship of a drug to an adverse reaction is beset with many difficulties. Most prominent among these are (a) incomplete, time-related, drug-related information (b) multiplicity of drugs administered in most cases (c) lack of an objective means of demonstrating a direct relationship between a drug and an adverse reaction and (d) the limited number... 

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