Causality Assessment Of Adverse Reactions Research Articles

Perfil de uso de anticoagulantes en pacientes hospitalizados, interacciones farmacológicas y reacciones adversas identificadas

Son conocidos los efectos de los anticoagulantes como tratamiento o profilaxis de eventos trombóticos, esto permitió establecer una terapia individualizada según sus necesidades. Se realizó un estudio descriptivo, transversal, no aleatorizado, en 138 pacientes hospitalizados mayores de edad en una institución de cuarto nivel de atención con tratamiento anticoagulante terapéutico y profiláctico, se abordó el tipo de fármaco indicado, periodicidad, efectos adversos, controles de laboratorio, interacciones farmacológicas y causalidad de las reacciones adversas. Se encontró que el anticoagulante con mayor frecuencia de uso fue enoxaparina (68%), el control más utilizado fue el tiempo de protrombina (60,39%), interacciones farmacológicas se identificaron en 47,1%, las más frecuentes con ácido acetil salicílico (29,7% del total de interacciones), las reacciones adversas más frecuentes fueron de índole hematológico (58,3%); y la evaluación de causalidad de reacciones adversas fue 4,2% probable. El estudio mostró que el anticoagulante más utilizado fue enoxaparina. Las interacciones farmacológicas de los anticoagulantes fueron muy frecuentes, especialmente con warfarina. Las reacciones adversas de mayor ocurrencia fueron las de tipo hemorrágico; y la evaluación de causalidad fue de categoría posible para la mayoría de estas reacciones adversas.

Prescription Analysis of Antiepileptic Drugs in a Tertiary Care Hospital

The objective of the study was to analyze the prescription pattern and drug related problems of antiepileptic drugs. The prospective descriptive study was carried out for a period of 6 months in a tertiary care hospital. The prescriptions were analyzed to identify the polypharmacy, adverse drug reactions and medication error. The patients were included in the study was with all type of epilepsy of both male and female patients with any age group of in and out patients. The identified medication error was categorized with the help of NCC MERP category. Causality assessment of adverse reaction was performed by the Naranjo algorithm. Analyzed the obtained prescription and identified the Polypharmacy in geriatric patients. Total 50 patients with 406 drugs, of these 6 Polypharmacy (12%), 7 medication error (16%) and 6 serious ADR were identified. The current study observed that the prescription contains drug-related problems were assessed to a greater extent and are comparable with the existing literature. Continued relationship with clinical pharmacist should be encouraged for better treatment option thereby improving the patient's quality of life effectively.

An assessment of reported adverse drug reactions in a Tertiary Care Hospital in South India: A retrospective cross-sectional study.

Objective:The primary objective of this study was to assess the causality of ADRs using World Health Organization-Uppsala Monitoring Centre (WHO–UMC), Naranjo and Liverpool ADR Causality Assessment Tool (LCAT). Other primary objective was to assess the agreement between the WHO-UMC criterion, Naranjo algorithm and LCAT. The secondary objective was to assess the reported adverse drug reactions in a tertiary care hospital in South India.Materials and Methods:This was a cross-sectional retrospective study. All the ADRs which were reported by the Pharmacovigilance Unit between July 2016 and March 2017 were assessed. Causality assessment was performed by two well-trained independent pharmacologists by applying the three methods–WHO, Naranjo and LCAT. Concurrence between the two algorithms was compared using the Cohen's weighted kappa statistic.Results:Causality assessment of adverse reactions according to Naranjo criteria shows that 81% cases were of probable type, 9.5% cases were possible and 9.5% cases were unlikely. Causality assessment of adverse reactions according to WHO-UMC criteria shows that 85.7% cases were of probable type, 4.8% cases were possible, 4.8% cases were unlikely and 4.8% cases were definite. Causality assessment of adverse reactions according to Liverpool criteria shows that 61.9% cases were of probable type, 4.8% cases were possible and 33.3% cases were definite. Cohen's kappa test shows that negative and poor concurrence was seen between WHO and Naranjo causality comparison (κ = −0.161). Positive but poor concurrence based on kappa values was seen between Liverpool and Naranjo's causality comparison (κ = 0.133). Negative and poor concurrence based on kappa values was seen between WHO and Liverpool causality comparison (κ = −0.161).Conclusion:The most frequent causality category observed by the WHO-UMC criteria, Naranjo as well as the Liverpool algorithm was “Probable.” Full concurrence was not found between any of two scales of causality assessment.

Promiscuous T-cell responses to drugs and drug-haptens

Promiscuous T-cell responses to drugs and drug-haptens

Quality check of spontaneous adverse drug reaction reporting forms of different countries

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.

Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period

Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period

Causality assessment of adverse reactions to drugs—II. An original model for validation of drug causality assessment methods: Case reports with positive rechallenge

Standards are lacking for validation of drug causality assessment methods. An original model is proposed using a positive rechallenge as an external standard. This model was used to validate the novel causality assessment method (RUCAM) described in the previous article (Part 1; J Clin Epidemiol 1993; 46: 1323). Seventy seven reports of drug-induced acute liver injuries with positive rechallenge were collected from the medical literature and divided into 49 cases and 28 controls. The RUCAM was applied to information obtained prior to readministration. The score was significantly higher ( p < 10 −4) in cases than in controls with high levels of sensitivity, specificity and predictive values. It is concluded that (1) adverse drug reaction reports with a positive rechallenge can provide a standard for validation of causality assessment methods, (2) RUCAM applied to drug-induced liver injuries has been validated.

Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuries

Despite the great number of methods proposed, assessing the causal role of a drug in the occurrence of an adverse medical event remains one of the most controversial issues. Qualifying terms for criteria, such as “compatible”, “suggestive” of “inconclusive”, have never been strictly defined, leading to low reproducibility. Weights of the criteria are usually not adapted to the injured organ, decreasing the specificity of the method. In this paper, a new method for drug causality assessment is described. Contents and limits of the criteria have been defined by experts convened to organ-oriented international consensus meetings. Additional criteria have been introduced and weights attributed. The method was applied to reports of acute liver injuries. The reproducibility was tested by an independent team. The validity of this novel method is studied in the following paper, based on an original approach using reports with positive rechallenge as external standard.