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药物警戒的有效性:与多学科医院工作人员的知识、技能和态度相关的多方面教育干预。

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff.

作者信息

Varallo Fabiana Rossi, Planeta Cleopatra S, Mastroianni Patricia de Carvalho

机构信息

Universidade Estadual Paulista - UNESP, Faculdade de Ciências Farmacêuticas, Departamento de Fármacos e Medicamentos, Araraquara/SP, Brazil.

Ministério da Educação do Brasil, Fundação CAPES, Brasília/DF, Brazil.

出版信息

Clinics (Sao Paulo). 2017 Jan 1;72(1):51-57. doi: 10.6061/clinics/2017(01)09.

Abstract

OBJECTIVES

: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals.

METHOD

: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1) an interactive lecture, 2) a practical class, 3) a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4) educational material. The intervention's impact on the professionals' knowledge and skills was assessed using the World Health Organization's definitions. The intervention's effect on the professionals' attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations) and the relevance (seriousness and expectancy) of the events.

RESULTS

: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals' form-completion skills (p<0.0001) and their knowledge of pharmacovigilance (p<0.0001). The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure.

CONCLUSIONS

: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in hospitals.

摘要

目的

大多数药物警戒方面的教育干预旨在鼓励医生报告药物不良反应。然而,多学科团队在报告药物相关问题方面可能发挥重要作用。本研究评估了药物警戒方面多层面教育干预对医院专业人员知识、技能和态度的影响。

方法

本前瞻性、开放标签、非随机研究在巴西圣保罗一家中等复杂程度的医院进行。干预包括四项活动:1)一次互动讲座,2)一次实践课程,3)对多学科团队中的专业人员进行前后问卷调查,4)教育材料。使用世界卫生组织的定义评估干预对专业人员知识和技能的影响。通过药物不良事件报告(药物不良反应、用药错误、治疗失败和药品质量偏差)的发生率以及事件的相关性(严重性和预期性)分析干预对专业人员态度的影响。

结果

共招募了173名专业人员。干预后12个月内观察到药物不良事件报告数量增加了70倍。干预提高了专业人员填写表格的技能(p<0.0001)以及他们对药物警戒的知识(p<0.0001)。干预还有助于发现严重的药物所致事件。护士报告了用药错误,药剂师和物理治疗师识别出严重的药物不良反应。医生传达了对治疗失败的怀疑。

结论

药物安全评估的多学科方法有助于识别新的、相关的药物相关问题并提高药物不良事件报告率。因此,这一策略可用于改善医院中的风险沟通。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62e8/5251201/d87e1ea24657/cln-72-01-051-g001.jpg

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