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

Silva, Lunara Teles; Modesto, Ana Carolina Figueiredo; Martins, Renato Rocha; Bessa, Gabriela Guimarães; Lopes, Flávio Marques

doi:10.1016/j.jped.2017.10.009

Cited by 11 publications

(7 citation statements)

References 28 publications

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“…The research instrument used in this study was previously adapted and validated to Brazilian hospital settings. 16 The instrument includes a list of pediatric-specific triggers ( Fig. 1 ), with their detailed definitions and associated ADE, case examples of harm, and standard data collection forms.…”

Section: Methodsmentioning

confidence: 99%

“…Reviewers completed an intensive training on the method before starting data collection. A pharmacist from the Patient Safety Department conducted the training sessions using a study manual, 15 , 17 previous works, 10 , 16 and case examples of ADE detection based on triggers. A systematic process of chart review was performed as a pretest with ten charts, for which the trainer had previously known the presence of trigger and ADE.…”

Section: Methodsmentioning

confidence: 99%

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

Silva

Modesto

Martins

et al. 2020

Jornal de Pediatria

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

Silva

Modesto

Martins

et al. 2020

Jornal de Pediatria

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“…Study of the use of specific trigger tools for neonatal and pediatric patients is scarce in the literature. 24 However, our data indicate that it may be a necessary strategy, due to the low number of Use of trigger tools not related to DRARs. 6 Spontaneous (or voluntary) notification or other methods not involving trigger tools.…”

Section: Rbfhssmentioning

confidence: 76%

Análise de busca ativa de farmacovigilância em um hospital privado do Distrito Federal (DF) durante o primeiro semestre de 2021

Jovito¹,

Oliveira²,

Mourão³

et al. 2021

Rev Bras Farm Hosp Serv Saude

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Objetivo: Documentar a busca ativa de Farmacovigilância no primeiro semestre de 2021 em um hospital privado do DF por meio de medicamentos-gatilho e estabelecer o perfil da busca ativa e das reações adversas medicamentosas (RAM) identificadas por setor. Método: A busca ativa de farmacovigilância e as notificações de possíveis RAM foram identificadas e analisadas por meio de evoluções farmacêuticas e formulários de análise de RAM preenchidos durante o período, as quais foram estratificadas de acordo com o algoritmo de Naranjo\Karch e Lasagna. Foi realizada estatística descritiva com estimativas de frequências absolutas, frequências relativas e valor preditivo positivo (VPP). Resultados: No primeiro semestre de 2021, foram feitas 83 buscas ativas de farmacovigilância, com maior número de registros nos dois primeiros meses. As notificações de RAM mantiveram-se em 2 a 4 (2,5 ± 1,5) notificações por mês e representaram 18,07% do total de buscas realizadas. A quantidade, o perfil dos medicamentos-gatilho e as RAM identificadas foram diferentes entre os setores de internação. Os medicamentos-gatilho com maior número de registros de busca ativa foram: Vitamina K, com 38 registros (45,78%); Protamina, com 25 registros (33,73%); e naloxona, com 9 registros (10,84%). Os medicamentos-gatilho que identificaram possíveis RAM foram: protamina (n=7; 46,67%), vitamina K (n = 5; 33,33%) e naloxona (n = 3; 20%). O valor preditivo positivo (VPP) global foi 0,18. O rastreador naloxona foi o que apresentou melhor desempenho (VPP = 0,33), seguido de protamina (VPP = 0,25) e vitamina K (VPP = 0,13). Conclusão: Foi possível observar que os resultados sofreram variações de acordo com o setor analisado. Por meio desses dados, pretende-se coletar mais informações para aprimorar o serviço de Farmacovigilância de acordo com o setor e área de internação, visando otimizar a segurança dos pacientes internados na instituição.

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“…Although there are many tools already described in the literature that help these processes, 21 – 24 some are imprecise, 25 , 26 unavailable, or have no cross-cultural translation that meets the need and reality of Brazil and which seems to be indispensable. 27 According to the results obtained in the present study, these tools may be developed as systems or applications for mobiles, tablets or laptops; however, they should be able to operate in offline versions.…”

Section: Discussionmentioning

confidence: 91%

Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist

Andrade

Almeida

Santos³

et al. 2020

Therapeutic Advances in Drug Safety

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Aims: The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices. Methods: This study has a cross-sectional design and was carried out with hospital pharmacists in Brazil. The sample was obtained by voluntary recruitment. Pharmacists who worked at Brazilian hospitals and were registered in their respective regulatory councils were invited to participate in the present study. A personalized questionnaire was developed by the authors and was electronically filled out by the respondents on the platform ‘Google forms’. The questionnaire was nationally available on the digital platform of the Pharmacy Federal Council, the Brazilian Society of Hospital Pharmacy and Health Services, four Pharmacy regional councils and the social network farmacêuticoclínico®. Quantitative variables were analyzed by mean and standard deviation. The qualitative variables were analyzed by means of absolute and relative frequency. Difficulties related to pharmacovigilance activities are presented in an Ishikawa diagram in the Supplemental Material online. Results: Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% ( n = 23) of them. Among the pharmacovigilance practices developed by Brazilian pharmacists, the adverse drug reaction investigation (55.4%) and notification activities (47.0%) were worthy of note. Numerous difficulties were reported by the pharmacists, highlighting the difficulty in monitoring the medication and imputation of causality (27.7%). After categorizing the difficulties reported, it was observed that the category ‘people involved’ (45.1%) stood out from the others. Conclusion: This study pointed out numerous challenges to pharmacovigilance practices involving pharmacists in Brazil. It is believed that the correction of certain difficulties may impact on the better consolidation of pharmacovigilance activities in the country. However, regulatory agencies at all hierarchical levels of pharmacovigilance must work together to make it possible. Plain language Summary Challenges to the consolidation of pharmacovigilance This is a study that seeks to present the needs of Brazilian hospital pharmacists in relation to pharmacovigilance activities. Through online interviews, pharmacists answered a questionnaire, presented the pharmacovigilance activities they develop and expressed their anxieties and difficulties for the development of these activities. With this study, it was concluded that numerous activities of active search, investigation and notification of adverse drug reaction are developed by Brazilian pharmacists. However, each pharmacist performs a different method of pharmacovigilance. In addition, it was observed that among the interviewees there was a perception of insufficient professional training and a shortage of professionals to assist in pharmacovigilance activities. These were the main difficulties reported. Therefore, the search for models or agile solutions to solve problems involving adverse drug reactions seems necessary for a better consolidation of pharmacovigilance services in Brazil.

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

Cited by 11 publications

References 28 publications

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

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

Análise de busca ativa de farmacovigilância em um hospital privado do Distrito Federal (DF) durante o primeiro semestre de 2021

Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist

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