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Rbfhss.2021.121.0602 Nogueira WS, Silva LT, Provin MP, et al. Drug-Related Adverse Events: description of an active search process in a teaching hospital of the Sentinela Network. Rev Bras Farm Hosp Serv Saude. 2021;12(1):0602: 10.30968/rbfhss.2021.121.0602. RBRevista Brasileira deFHSS Farmácia Hospitalar e Serviços de Saúde Original Paper Open Access Drug-Related Adverse Events: description of an active search process in a teaching hospital of the Sentinela Network Wanessa da Silva NOGUEIRA1, Lunara Teles SILVA2, Mércia Pandolfo PROVIN3, Rita Goreti AMARAL3, Tatyana Matteucci FERREIRA4, Ana Carolina MODESTO4 1Residência Multiprofissional em Saúde Hospital das Clínicas-Universidade Federal de Goiás; 2Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina-UFG; 3Faculdade de Farmácia-Universidade Federal de Goiás; 4Hospital das Clínicas-Universidade Federal de Goiás Corresponding author: Modesto AC, [email protected] Submitted: 20-02-2021 Resubmitted: 14-03-2021 Accepted: 15-03-2021 Peer review: Suelem Tavares da Silva-Penteado, Daniela Archanjo and Jôseffer Wianey Trindade-Medeiros Abstract Objective: To describe the implementation of an active search service for adverse drug events (ADE) in a teaching hospital in the Midwest region of Brazil. Method: Observational sectional study conducted at the Pharmacovigilance Service in a University hospital in the Midwest Region of Brazil, from March to August/2019. All patients admitted to a medical clinic unit were included and those who did not find medical records were excluded. A work process structured in six stages was elaborated: 1) elaboration of a list of triggers through literature review; 2) elaboration of a list of patients whose previously selected triggers appeared; 3) visiting the wards and reviewing medical records; 4) validation of ADE; 5) notification of ADE to Agência Nacional de Vigilância Sanitária; 6) registration of information in databases. Results: The Positive Predictive Value (PPV) of each trigger was calculated individually and globally. The relative and absolute frequency of ADE was calculated as to the type, description and the drug involved. A total of 479 searches were made in the period and the frequency of ADE was 7.48%. The global triggers PPV was 0.04. The trigger with the best performance was promethazine (1.00), followed by the Activated Partial Thromboplastin Time (0.67). Regarding the identified ADE, it was observed that most of the time, 24.14% were related to infusion reactions. It was observed that 53.85% of the drugs involved in ADE were high alert medications. Conclusion: It was observed that the implementation of an active search service for ADE in hospitals that do not have the support of an electronic medical record system is feasible to be performed. It was also observed a high frequency of ADE and that the active search guided by triggers allows to identify events that otherwise could not be identified. Keywords: pharmacovigilance; drug-related side effects and adverse reactions; medication errors; patient safety; pharmacy service, hospital; risk management. Eventos Adversos a Medicamentos: descrição de um processo de busca ativa em um hospital de ensino da Rede Sentinela Resumo Objetivo: descrever a implantação de um serviço de busca ativa de eventos adversos (EAM) em um hospital de ensino da região Centro- Oeste do Brasil. Método: estudo observacional seccional realizado no Serviço de Farmacovigilância em um hospital Universitário da Região Centro-Oeste do Brasil, no período de março a agosto/2019. Foram incluídos todos os pacientes internados em uma unidade de clínica médica e excluídos aqueles que não foram encontrados os prontuários. Foi elaborado um processo de trabalho estruturado em seis etapas: 1) elaboração de uma lista de rastreadores por meio de revisão de literatura; 2) elaboração de uma lista de pacientes cujos rastreadores previamente selecionados apareceram; 3) visita às enfermarias e revisão de prontuário; 4) validação do EAM; 5) notificação dos EAM para a Agência Nacional de Vigilância Sanitária; 6) registro das informações em bancos de dados. Foi calculado o Valor Preditivo Positivo (VPP) de cada rastreador individual e globalmente. Foi calculada a frequência relativa e absoluta dos EAM quanto ao tipo, descrição e o medicamento envolvido. Resultados: foram feitas 479 buscas no período e a frequência de EAM foi de 7.23%. O VPP global dos rastreadores foi de 0.04. O rastreador que apresentou a melhor performance foi a prometazina (1.00), seguido do Tempo de Tromboplastina Parcial Ativada (0.67). Em relação aos EAM identificados, observou-se que a maioria das vezes, 24.14% estiveram relacionados a reações infusionais. Verificou-se que 53.85% dos medicamentos envolvidos nos EAM eram de alta vigilância. Conclusão: Evidencio-se que a implantação de um serviço de busca ativa de EAM em hospitais que não contam com o apoio de sistema de prontuário eletrônico é factível de ser executada. Observou-se ainda uma alta frequência de EAM e que a busca ativa orientada por rastreadores permite identificar eventos que de outra maneira não poderiam ser identificados. Palavras-chave: farmacovigilância; efeitos colaterais e reações adversas relacionados a medicamentos; erros de medicação; segurança do paciente; serviço de farmácia hospitalar; gestão de riscos. eISSN: 2316-7750 rbfhss.org.br/ © Authors 1 pISSN: 2179-5924 Nogueira WS, Silva LT, Provin MP, et al. Drug-Related Adverse Events: description of an active search process in a teaching hospital of the Sentinela Network. Rev Bras Farm Hosp Serv Saude. 2021;12(1):0602: 10.30968/rbfhss.2021.121.0602. RBRevista Brasileira deFHSS Farmácia Hospitalar e Serviços de Saúde Introduction team of researchers and does not demand large investments, in addition to being able to identify DRAEs that could not be Approximately 6% of the hospitalized patients are subjected to identified by other methods. some type of Drug-Related Adverse Event (DRAE); more than Considering the importance of safety in the use of medications 700,000 emergency room visits and 120,000 hospitalizations in the global health agenda, this study aims to describe the are caused by DRAEs in the United States alone.1 It is estimated implementation of an AS process for DRAEs through triggers in that nearly 1% of the world health budget is spent on treating order to contribute to the generation of evidence that promotes the harms associated with medication use.2 In this context, patient safety. DRAEs have emerged in recent years as a public health problem and have been on the global health agenda as a priority since 2017 with the publication of the “Third WHO Global Patient Safety Challenge: Medication without Harms”, whose objective Methods is to reduce by 50% the severe and avoidable harms related to medication use worldwide, until 2022.2 This is a cross-sectional and observational study. It was This global challenge can be even more challenging for Brazil, carried out in the Pharmacovigilance Service (PVS) of the Risk since the assessment of DRAEs in the country is still incipient, Management Unit (RMU) of the Quality Management and as identified in a systematic review of DRAEs in hospitals, where Health Surveillance Sector, hierarchically linked to the Health it was shown that only 6.9% (n=2) of the studies retrieved were Care Management of the Clinical Hospital of the Federal conducted in Brazil.3 To attain the goal proposed by the World University of Goiás/Brazilian Company of Hospital Services Health Organization (WHO), it is first necessary to know the (Hospital das Clínicas da Universidade Federal de Goiás-Empresa frequency of DRAEs to assess the increase or reduction in harms Brasileira de Serviços Hospitalares, HC-UFG/EBSERH). The PVS over time. was incorporated into the RMU organization chart in February 2017 and has a staff composed of two pharmacists with an Nearly 95% of the DRAEs are not informed through Spontaneous exclusive dedication of 30 hours a week each and students of Notification (SN) by the health professionals, either for fear of the Multidisciplinary Residency in Health Course, according to suffering penalties or even due to shame.4 A study carried out availability of rotation. in a Brazilian public institution showed that, among 356 DRAEs, only one was notified by health professionals.5 Underreporting The data were obtained through documentary research in the of DRAEs is a problem faced by several countries in the world physical files (standard operating procedures, forms, flows) and electronic spreadsheets of the PVS and refer to the period and can compromise the implementation of measures to st st promote safety in the use of medications.6 from March 1 , 2019 to August 31 , 2019. The study population consisted of all patients hospitalized in the inpatient unit of Another method for the identification of DRAEs could be the medical clinic who had at least one trigger identified, and used by the health institutions.5 The conventional active those whose medical records were not found during the search search (AS) for DRAEs consists of reviewing medical records were excluded. The stages for the implementation of the active both retrospectively and prospectively to identify potential search service are described in Figure 1. incidents.7 Although it presents better results when compared to the SN, this method still has the major disadvantage of being In the referred period, the AS occurred in an inpatient unit time-consuming and expensive, in addition to presenting great of a 60-bed Medical Clinic, which provides care to patients in variability of results between different evaluators.7 numerous specialties: hematology, pneumology, cardiology, gastroenterology and neurology. This inpatient unit was The need to use more efficient methods for detecting DRAEs has selected to start the implantation of the AS guided by triggers emerged since the 1970s, but it was only in 2003 that this gap because it is a 60-bed ward with patients from different medical was filled when a group of researchers proposed a method of specialties.
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