Adverse drug reactions in hospitalized cardiac patients: Characteristics and risk factors

Mugosa, Snezana; Bukumirić, Zoran; Kovacevic, Aleksandra; Bošković, Aneta; Protić, Dragana; Todorović, Zoran

doi:10.2298/vsp140710104m

Cited by 17 publications

(17 citation statements)

References 46 publications

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“…It is known that most ADR evidence arises from hospitals, due to the high risks associated with treatments in the tertiary health care level[ 11 ]. Therefore, the causality assessment in high complexity institutions contributes to: i) the early recognition of adverse effects, which helps to prevent iatrogenic complications; ii) therapy optimization[ 2 ]; iii) establishing barriers to prevent recurrence; iv) reducing the time of hospitalization and unnecessary burden with hospitalizations that could be avoided[ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Imputation of adverse drug reactions: Causality assessment in hospitals

et al. 2017

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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.

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Section: Introductionmentioning

confidence: 99%

Imputation of adverse drug reactions: Causality assessment in hospitals

et al. 2017

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“…The majority of patients (97.3%) recover without consequences. The multivariate analysis shows independent significant associations between ADR and age, gender, co-morbidities, polypragmasia and duration of hospitalization 47 .…”

Section: Spontaneous Reporting and Intensive Monitoring Of Adrsmentioning

confidence: 85%

“…In order to analyze occurrence, characteristics and risk factors for developing ADRs using intensive monitoring system of ADRs, we conducted a prospective study in 2014, which included 200 patients, hospitalized at Cardiology Center of the Clinical Center of Montenegro 47 . ADRs were collected using a specially designed questionnaire, based on the list of symptoms and signs that could point out to the potential ADR.…”

Section: Spontaneous Reporting and Intensive Monitoring Of Adrsmentioning

confidence: 99%

Pharmacovigilance as an imperative of modern medicine - experience from Montenegro

et al. 2017

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“…After the admission to the Institute, each patient was provided with a copy of the questionnaire designed for the purpose of this study. 8 (The questionnaire can be made available to researchers on request.) The questionnaire was made according to the suggestions of Edwards 9 and Somers et al 10 The questionnaire introduction contained an explanation that data would be used solely for the assessment of drug safety.…”

Section: Methodsmentioning

confidence: 99%

Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

Protić¹,

Vujasinovic‐Stupar²,

Bukumirić³

et al. 2016

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BackgroundAdverse drug reactions (ADRs) have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system.MethodsSemi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261) completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history.ResultsGroup 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found between rheumatology patients with and without neurological comorbidities regarding their awareness of ADRs. The majority of patients reported ADRs of cytotoxic drugs. The most reported ADRs were moderate gastrointestinal discomforts.ConclusionWe may draw a profile of rheumatological patients willing to report ADRs: 1) The majority of them suffer from systemic inflammatory diseases and are slightly more prone to neurological comorbidities. 2) They are predominantly aware of their diagnosis but less able to identify the drugs that may cause their ADRs. 3) They tend to report mainly moderate gastrointestinal ADRs; that is, other cohorts of patients and other types of ADRs remain mainly undetected in such a reporting, which could represent a bias. Counseling and education of patients as well as developing a network for online communication might improve patients’ reporting of potential ADRs.

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Adverse drug reactions in hospitalized cardiac patients: Characteristics and risk factors

Cited by 17 publications

References 46 publications

Imputation of adverse drug reactions: Causality assessment in hospitals

Imputation of adverse drug reactions: Causality assessment in hospitals

Pharmacovigilance as an imperative of modern medicine - experience from Montenegro

Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

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