Characterization of adverse drug events identified by trigger in Brazilian pediatric inpatients.

OBJECTIVE: To describe the frequency and characteristics of adverse drug events in pediatric inpatients in a Brazilian tertiary teaching hospital. METHODS: A cross-sectional study was conducted by retrospective and manual chart review of 240 pediatric admissions to identify adverse drug events using 17 triggers. When triggers were detected in the chart, reviewers investigated the chart in depth to decide whether an event occurred. Consensus about the occurrence of the event was obtained in meeting with a healthcare team. Events were classified by harm category and drugs were classified according to the Anatomical Therapeutic Chemical Classification. Patients who had suffered were compared to those who had not experienced events using the chi-squared test and the Mann-Whitney U test. RESULTS: A total of 62 adverse events were found, and 18.8% of the patients had at least one event. Adverse events rates were 25.83 per 100 admissions, 20.27 per 1000 patient-days, 25.94 per 1000 drugs, and 2.12 per 1000 drug doses. All events found were classified as temporary harm, and cardiovascular drugs were most frequently related to events. Groups of patients with and without event were segregated (p<0.05) by the length of stay, number of drugs, and drug doses. CONCLUSION: The use of triggers demonstrated its utility in a pediatric setting by identifying harm. Adverse events rates were found to be higher than those of previous studies, but the harm rate was lower than other studies. This study enables the measurement of adverse events in order to define strategies to mitigate or reduce harm.

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients / A versão em Português-BR do Pediatric Trigger Toolkit é aplicável para mensurar eventos adversos a medicamentos em pacientes pediátricos internados em hospitais brasileiros

Abstract Objective: To describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. Methods: The validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back-translation from Brazilian Portuguese to English. Results: The translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value. Conclusion: The research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.

Resumo Objetivo: Descrever o processo de tradução, adaptação e validação para o português do Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. Métodos: O processo de validação do instrumento de pesquisa foi realizado em 5 etapas: (I) tradução do inglês para o português por dois tradutores independentes; (II) síntese das versões traduzidas; (III) adaptação dos rastreadores para realidade brasileira por meio do método Delphi modificado, em duas rodadas; (IV) aplicação do instrumento de pesquisa na revisão de 240 internações de 2014; e (V) retrotradução do português para o inglês. Resultados: A etapa de tradução resultou em duas versões traduzidas, que foram sintetizadas de forma a obter equivalência ao contexto cultural brasileiro. O processo de adaptação do instrumento de pesquisa possibilitou a inclusão e adaptação dos rastreadores, bem como a exclusão de rastreadores segundo consenso obtido entre os especialistas na etapa Delphi. O valor preditivo positivo do instrumento de pesquisa foi de 13,51% e o rastreador anti-histamínico foi o que apresentou maior valor preditivo positivo. Conclusão: O instrumento de pesquisa pode ser utilizado para rastrear a ocorrência de eventos adversos a medicamentos em pacientes pediátricos nos hospitais brasileiros. Apesar das adaptações realizadas, rastreadores que não foram identificados ou com baixo valor preditivo positivo podem indicar, ainda, a necessidade de modificações. Entretanto, mais estudos são necessários antes de modificar ou excluir algum rastreador.

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients.

OBJECTIVE: To describe the process of translation, adaptation, and validation of the Brazilian Portuguese version of the Pediatric Trigger Toolkit: Measuring Adverse Drug Events in the Children's Hospital. METHODS: The validation process for the research instrument was carried out in five steps: (I) translation from English into Brazilian Portuguese by two independent translators; (II) synthesis of the translated versions; (III) adaptation of the triggers to the Brazilian context using a modified Delphi method carried out in two rounds; (IV) application of the research instrument in the review of 240 hospitalizations during 2014; and (V) back-translation from Brazilian Portuguese to English. RESULTS: The translation step resulted in two versions, which were then synthesized to obtain equivalence within the Brazilian cultural context. The process of adapting the research instrument allowed the inclusion and adaptation of some triggers, as well as the exclusion of others, based on the consensus reached among experts during the Delphi step. The positive predictive value of the research instrument was 13.51%, and the antihistamine trigger presented the highest positive predictive value. CONCLUSION: The research instrument can be used to track the occurrence of adverse drug events in pediatric patients in Brazilian hospitals. Despite the adjustments made, triggers that were not identified or that had low positive predictive value can suggest the need for additional changes. However, more studies are needed before modifying or removing a trigger.

Impact of medication therapy management on pharmacotherapy safety in an intensive care unit.

Background Drug-related problems are mostly preventable or predictable circumstances that may impact on health outcomes. Clinical pharmacy activities such as medication therapy management can identify and solve these problems, with potential to improve medication safety and effectiveness. Objective To evaluate ability of medication therapy management service to detect drug-related problems and prevent adverse drug events. This study also aimed to assess the risk factors for drugrelated problem occurrence. Setting Medical intensive care unit of a public tertiary hospital in Brazil. Methods Patients were evaluated by a clinical pharmacist, who provided medication therapy management service. Detected drug-related problems were categorized according to the Pharmaceutical Care Network Europe methodology and analyzed in multinomial regression to identify risk factors. Main outcome measure Potential risk factors for drug-related problem occurrence. Results The proposed medication therapy management service allowed detection of 170 drug-related problems that had potential to reach patients causing harm and other 50 unavoidable adverse events. Drug-related problems identified were more often associated with antibacterial use, caused by improper combinations or inadequate drug dosage. These problems required interventions that were accepted by the multidisciplinary team, resulting in more than 85% adherence and total problem solving. Main risk factors identified were previous diagnosis of kidney injury (OR = 8.38), use of midazolam (OR = 7.96), furosemide (OR = 5.87) and vancomycin (OR = 4.82). Conclusion Medication therapy management proved to be an effective method not only for drug-related problem detection, but also for adverse drug event prevention, contributing to improve patient safety.

Pharmacotherapy of adolescents in the use of psychoactive substances

The use of Psychoactive Substances brings problems in several areas of the subject's life such as: health, psychological and social. It´s necessary evaluate the factors involved in drug use and potential drug interactions (PDI) in adolescents using psychoactive substances. It was a Cross-sectional, analytical and quantitative study. The research was carried out at the Center for Psychosocial Care and other drugs for children and adolescents 24h, with adolescents under 18 years of age, using medication. The data were obtained by reviewing the charts and the potential interactions were evaluated through the database Micromedex® and Medscape®. Of the 159 records used, there were 815 PDI. By gravity were 59.4% moderate, 23.8% secondary, 15.7% severe and 1.1% contraindicated. The drugs that presented the most PDI were Chlorpromazine (32.3%) and Diazepam (19.6%). The factors involved in polypharmacy were total PDI and those involved in the occurrence of total PDI were studying and the quantity diagnostic hypotheses. Due to the high PDI index, the relationship with polypharmacy and a high number of diagnostic hypotheses, it is necessary to increase the attention of health professionals regarding the topic and the development of protocols to support decision making.(AU)