Avaliação da implantação de busca ativa de reações adversas a medicamentos com auxílio de ferramentas informatizadas
The objective of this study was to assess the implementation of adverse drug reactions (ADR) active surveillance strategies using computerized tools in a pharmacovigilance program of a large private hospital. The study was developed in three phases: I. implementation of the pharmacovigilance service...
| Autores: | , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2017 |
| País: | Brasil |
| Institución: | Universidade Federal de Minas Gerais (UFMG) |
| Repositorio: | Repositório Institucional da UFMG |
| Idioma: | portugués |
| OAI Identifier: | oai:repositorio.ufmg.br:1843/53130 |
| Acceso en línea: | http://dx.doi.org/10.14450/2318-9312.v29.e3.a2017.pp235-240 http://hdl.handle.net/1843/53130 https://orcid.org/0000-0003-2183-4365 |
| Access Level: | acceso abierto |
| Palabra clave: | Farmacovigilância Efeitos colaterais e reações adversas relacionados a medicamentos Sistemas de notificação de reações adversas a medicamentos Prescrição eletrônica |
| Sumario: | The objective of this study was to assess the implementation of adverse drug reactions (ADR) active surveillance strategies using computerized tools in a pharmacovigilance program of a large private hospital. The study was developed in three phases: I. implementation of the pharmacovigilance service (passive surveillance – intensified voluntary notification); II. active surveillance based on managerial reports of consumption of tracer drugs; III. active surveillance based on the content of forms that were filled out in the electronic system whenever a tracer drug was prescribed. All the ADR detected by the pharmacovigilance service for three and a half years (n = 542) were analyzed. The difference between the ADR/100 patients-day was analyzed by the comparison of two proportions, with a 5% significance level and power of 80%. The rate of ADR/100 patient-day identified in phase II and III (0.26 and 0.15, respectively), that is, after the implementation of computerized tools, was higher than the rate detected in phase I (0.10). The difference between the proportions was statistically significant. The majority of ADR identified presented moderate severity (69%), and an increase in this proportion was observed after the implementation of computerized tools. Regarding the causality assessment, 83.6% of the identified ADR was classified as “possible causality”. The implementation of active surveillance using computerized tools provided a statistically significant increase in the identification of ADR identification, reinforcing the need to intensify such pharmacovigilance strategies. |
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