Imputation of adverse drug reactions: Causality assessment in hospitals

Abstract

Background & objectivesDifferent algorithms have been developed to standardize the causality assessment of adverse drug reactions (ADR). Although most share common characteristics, the results of the causality assessment are variable depending on the algorithm used. Therefore, using 10 different algorithms, the study aimed to compare inter-rater and multi-rater agreement for ADR causality assessment and identify the most consistent to hospitals.MethodsUsing ten causality algorithms, four judges independently assessed the first 44 cases of ADRs reported during the first year of implementation of a risk management service in a medium complexity hospital in the state of Sao Paulo (Brazil). Owing to variations in the terminology used for causality, the equivalent imputation terms were grouped into four categories: definite, probable, possible and unlikely. Inter-rater and multi-rater agreement analysis was performed by calculating the Cohen´s and Light´s kappa coefficients, respectively.ResultsNone of the algorithms showed 100% reproducibility in the causal imputation. Fair inter-rater and multi-rater agreement was found. Emanuele (1984) and WHO-UMC (2010) algorithms showed a fair rate of agreement between the judges (k = 0.36).Interpretation & conclusionsAlthough the ADR causality assessment algorithms were poorly reproducible, our data suggest that WHO-UMC algorithm is the most consistent for imputation in hospitals, since it allows evaluating the quality of the report. However, to improve the ability of assessing the causality using algorithms, it is necessary to include criteria for the evaluation of drug-related problems, which may be related to confounding variables that underestimate the causal association.

Drug-induced hypersensitivity: A 5-year retrospective study in a hospital electronic health records database

“…17 There is also the possibility that clinicians do not acknowledge a causal relationship between the exposure to drugs and the development of hypersensitivity reactions. 18 Therefore, the real prevalence of these cases is probably higher than the estimations found here. A retrospective study using EHR data in Boston (USA) found that 0.3% of outpatients have hypersensitivity reactions to nonsteroidal antiinflammatory drugs (NSAIDs) within 1 year of prescription.…”

“…Furthermore, under‐reporting of ADRs is a known limitation of spontaneous reporting schemes . There is also the possibility that clinicians do not acknowledge a causal relationship between the exposure to drugs and the development of hypersensitivity reactions . Therefore, the real prevalence of these cases is probably higher than the estimations found here.…”

Specialist perioperative allergy clinic services in the UK 2018: Results from the Royal College of Anaesthetists Sixth National Audit Project (NAP6) investigation of perioperative anaphylaxis

“…Normal clinical diagnosis is a Bayesian process, the NAP6 panel diagnosis mimics and strengthens this approach by utilizing a methodology that ensures a consensus of multiple experts via independent structured reviews of the evidence. The NAP6 panel diagnosis and the clinic diagnosis agreed more frequently than published for the best Bayesian methods in general drug allergy . The ability to recognize the culprit may be assisted by the rapid presentation of perioperative reactions.…”

“…The NAP6 panel diagnosis and the clinic diagnosis agreed more frequently than published for the best Bayesian methods in general drug allergy. 20,32 The ability to recognize the culprit may be assisted by the rapid presentation of perioperative reactions.…”

Toxidermias em Idade Pediátrica

“…Na maioria das toxidermias o diagnóstico é clínico, feito através de uma história detalhada das manifestações clínicas, dos vários fármacos administrados e sua relação temporal com o início da toxidermia, as doses usadas e possível suscetibilidade individual. Muitos algoritmos de avaliação de causalidade das RAMs foram propostos ao longo dos anos para determinar a força da relação causal, parecendo que o algoritmo WHO-UMC é o melhor para avaliar os casos intra-hospitalares em comparação com o algoritmo proposto por Naranjo et al 44 Contudo, o estabelecimento de uma relação de causalidade de um fármaco nem sempre é aparente e a dificuldade de diagnóstico é ainda maior na idade pediátrica pela elevada incidência de exantemas víricos que mimetizam muitas das reações adversas a fármacos. Algumas característi-cas que podem ajudar a distinguir os exantemas víricos das toxidermias encontram-se resumidas na Tabela 3.…”