Rastreadores para a busca ativa de eventos adversos a medicamentos em recém-nascidos

Fabretti, Sandra de Carvalho; Brassica, Sandra Cristina; Cianciarullo, Marco Antonio; Romano-Lieber, Nicolina Silvana

doi:10.1590/0102-311x00069817

Cited by 8 publications

(8 citation statements)

References 14 publications

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“…Rozenfeld et al . observed that hyperkalemia is a high-performance trigger to detect ADE in neonates 51. Serum potassium could also be used as a predictor of adverse clinical outcomes in patients with chronic ADE, and identify those likely to benefit from strategies that treat hyperkalemia, and prevent iRAAS discontinuation 52…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Varallo¹,

Trombotto

Lucchetta

et al. 2019

Pharm Pract (Granada)

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Background: Although the management of hyperkalemia follows expert guidelines, treatment approaches are based on traditionally accepted practice standards. New drugs have been assessed such as sodium zirconium cyclosilicate and patiromer; however, their safety and efficacy or effectiveness have not yet been compared to traditional pharmacotherapy. Objective: The present systematic review had the purpose to evaluate the efficacy, effectiveness, and safety of hyperkalemia pharmacotherapies. Methods: PubMed, LILACS, Cochrane Library, and ClinicalTrials were searched through November 2018. Clinical trial, cohort and case-control were searched. The risk of bias (RoB v2.0 and ROBINS-I) and quality of evidence (GRADE) at the level of outcomes were assessed. Results: Sixteen clinical trials and one retrospective cohort were identified regarding efficacy and safety of 24 different alternatives. The management of hyperkalemia remains empirical and off-label, since sodium zirconium cyclosilicate and patiromer are not available in several countries and further studies are required to assess efficacy, effectiveness and safety. Sodium or calcium polystyrene sulfonate (moderate confidence), sodium zirconium cyclosilicate (moderate confidence), and insulin plus dextrose (moderate confidence) showed superior efficacy to, respectively, placebo, no treatment, placebo, and dextrose. Other therapies (low confidence) showed similar efficacy compared to active or inactive alternatives. Most of the adverse events reported were nonspecific, so it was not possible to assign the cause and to classify as defined or probable. Conclusions: Comparative cohort and case-control studies are need to evaluate the safety and effectiveness of new and traditional pharmacotherapies to support the development of guidelines about acute and chronic hyperkalemia, with high-quality evidence.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Varallo¹,

Trombotto

Lucchetta

et al. 2019

Pharm Pract (Granada)

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“…This information corroborates the data found in the selected articles, where studies using the IHI triggers identified 120 (Roque et al, 2018) and 44 (Giordani,et al, 2014) ADEs, and 79 (Roque et al, 2016) ADRs. While other trackers proposed by the authors identified 115 (Fabretti et al, 2018), 62 (Figueiredo et al, 2017) ADEs.…”

Section: Discussionmentioning

confidence: 86%

Adverse drug events in hospitalized patients in Brazil: Integrative literature review

Sousa

Prete

Gomes

et al. 2021

RSD

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Objective: Analyzing studies related to Adverse Drug Events (ADE) in hospitalized patients in Brazil. Method: integrative review, for which the National Library of Medicine (PubMed), Biblioteca Virtual de Saúde (BVS), Repository of the Fundação Oswaldo Cruz (FIOCRUZ) and Capes Journals databases were selected for searching the studies primary, with the descriptors: Patient Safety, Drug-related side effects and adverse reactions, Patient harm, Hospitalization, Inpatients. Results: Twenty articles were identified, 50% (10) were from the southeast region of Brazil. Regarding the methodology adopted to identify the ADEs, 70% (14) used the retrospective data review. The trackers were used in 5 (25%) articles, 3 of which used the triggers proposed by the Institute for Healthcare Improvement, and the other 2 the trackers used were proposed by the researchers themselves. The number of adverse drug reactions ranged from 12 to 96, while the occurrence of AE ranged from 4 to 122. In one study 50% (41) of participants had at least one adverse drug event. Conclusion: There is great variability in scientific production in Brazil, and in the occurrence of Adverse Drug Events as well. There is a need for strategies to identify these events and create strategies to promote patient safety.

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“…The triggers "abrupt medication stop" has shown similar performance in studies with adults and newborns. 10,21,22 Comparing the ability to detect ADE of each trigger, three groups were observed. The ones that showed the best performance were "excessive seda- tion/lethargy/fall/hypotension", "diphenhydramine use", and "phytomenadione use".…”

Section: Discussionmentioning

confidence: 99%

“…The calculated performance was categorized into three groups -high (100%), intermediate (between 30 and 70%), and low (< 30%). 9,10 This present study was approved by the Research Ethics Committees at Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira and at Hospital Universitário Antônio Pedro, registry numbers (CAAE) 68461417.7.0000.5243 and 68461417.7.3001.5269.…”

Section: Methodsmentioning

confidence: 99%

Identifying adverse drug events in patients at a pediatric ward in a Brazilian hospital: application and performance of the triggers

Caetano

Silva

Guaraldo

et al. 2021

Rev. Bras. Saude Mater. Infant.

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Objectives: to evaluate the performance of a trigger tool in identifying adverse drug events (ADE) in hospitalized children. Methods: a retrospective cohort study review on 133 medical records at a federal maternal and child reference hospital in Rio de Janeiro in 2016. A list of 14 triggers was developed to detect ADE in the pediatric population. Three steps were performed: (1) search for triggers; (2) selection of suspected cases of ADE and (3) final determination of ADE by experts’ consensus. Results: 360 triggers were identified in 100 hospitalizations (75.2%), with an average of 2.7 triggers/ hospitalization. The most frequent triggers were “abrupt medication stop” (79.7%); “antiemetics use” (8.9%) and “laxatives use” (7.2%); while the “diphenhydramine use”, “phytomenadione use” and “excessive sedation/lethargy/fall/hypotension” obtained the highest performance indicating ADE every time they occurred. Thirty-one ADE were identified in 12.8% of the hospitalizations; 11 (35.5%) ADE were detected without the aid of the triggers thus, pruritus and diarrhea were the most frequent. Conclusion: the trigger tool proved to be useful in identifying ADE in hospitalized children, especially if high performance and high frequency triggers are used in identifying the events. The inclusion of the triggers “diarrhea” and “pruritus”, may favor the identification of ADE in patients at pediatric wards.

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Rastreadores para a busca ativa de eventos adversos a medicamentos em recém-nascidos

Cited by 8 publications

References 14 publications

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Adverse drug events in hospitalized patients in Brazil: Integrative literature review

Identifying adverse drug events in patients at a pediatric ward in a Brazilian hospital: application and performance of the triggers

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