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ABSTRACT OBJECTIVE To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.
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Humans , Databases, Factual , Pharmacoepidemiology , Drug-Related Side Effects and Adverse Reactions , HospitalizationABSTRACT
Resumo Objetivo Analisar o perfil farmacoterapêutico dos idosos atendidos em um Centro de Referência em Atenção à Saúde da Pessoa Idosa quanto ao uso de medicamentos potencialmente inapropriados (MPI) por meio de três critérios de rastreamento e determinar fatores associados à prescrição de MPI. Método Estudo transversal com dados obtidos por revisão retrospectiva dos prontuários de idosos, atendidos entre 2017 e 2018 por médico geriatra. Para identificar os MPI, utilizaram-se os Critérios de Beers, o Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) e o Consenso Brasileiro de Medicamentos Potencialmente Inapropriados para Idosos. Características relacionadas ao perfil sociodemográfico (idade e sexo), de hábitos de vida (tabagismo e consumo de álcool), clínico (doenças) e farmacoterapêutico (medicamentos e Índice de Complexidade da Farmacoterapia - ICFT) foram avaliadas. Resultados Foram analisados 406 prontuários e identificados 3.059 medicamentos prescritos, dos quais 32,1% são MPI segundo Critérios STOPP, 14,4% pelo Consenso Brasileiro e 11,7% pelos Critérios de Beers. No total, 81,1% dos idosos apresentaram ao menos um MPI. Regressão de Poisson demonstrou associação entre a prescrição de MPI com polifarmácia, maior número de sinais e sintomas e maior valor de ICFT em ao menos um dos critérios. A força de concordância entre os critérios de MPI foi moderada. Conclusões A maioria dos prontuários analisados possuíam ao menos um MPI prescrito, sendo que os Critérios STOPP identificaram uma maior quantidade de MPI. Estratégias devem ser implementadas para melhorar a farmacoterapia dos idosos com atenção para os que apresentam fatores associados a MPI em seu perfil.
Abstract Objective To analyze the pharmacotherapeutic profile of the old people assisted at a Reference Center in Health Care for Old People regarding the use of potentially inappropriate medications (PIM) using three screening criteria and to determine factors associated with the prescription of PIM. Method Cross-sectional study with data obtained by retrospective review of the medical records of the old people, attended between 2017 and 2018 by a geriatric doctor. To identify the PIM, the Beers Criteria, the Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and the Brazilian Consensus on Potentially Inappropriate Medications for Old People were used. Characteristics related to the sociodemographic profile (age and sex), lifestyle (smoking and alcohol consumption), clinical (diseases) and pharmacotherapeutic (medications and Medication Regimen Complexity Index - MRCI) were evaluated. Results 406 medical records were analyzed and 3,059 prescription medications were identified, of which 32.1% are PIM according to STOPP Criteria, 14.4% by the Brazilian Consensus and 11.7% by the Beers Criteria. In total, 81.1% of the old people had at least one PIM. Poisson regression demonstrated an association between the prescription of PIM with polypharmacy, a greater number of signs and symptoms and a higher MRCI value in at least one of the criteria. The strength of agreement between the PIM criteria was moderate. Conclusions Most of the analyzed medical records had at least one prescribed PIM, and the STOPP Criteria identified a greater amount of PIM. Strategies must be implemented to improve the pharmacotherapy of old people with attention to those who have factors associated with PIM in their profile.
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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.