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印度药品不良反应报告:当前情况、障碍及可能的解决办法综述

Reporting of adverse drug reactions in India: A review of the current scenario, obstacles and possible solutions.

作者信息

Mulchandani Rubina, Kakkar Ashish Kumar

机构信息

Indian Institute of Public Health, Gurgaon, India.

Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Int J Risk Saf Med. 2019;30(1):33-44. doi: 10.3233/JRS-180025.

Abstract

Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug's life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians' perceptions towards reporting, problems with establishing reporting systems in hospitals and insufficient training to recognize ADRs. Measures to improve the situation include greater involvement of nurses, pharmacists as well as consumers in the reporting of ADRs, making the process simpler and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading awareness about the reporting system amongst caregivers and receivers alike. Providing a momentum to the pharmacovigilance system and ensuring a robust reporting process is a challenge but proper planning, feasible solutions and focussed efforts can help bring about the change ensuring patient safety - the ultimate goal of pharmacovigilance.

摘要

药物警戒是一种旨在监测现实生活条件下药物安全性并在药物生命周期的上市后阶段捕获药物不良事件的实践。但不良反应报告不足是一个主要的关注点,对药物警戒系统构成威胁。本文探讨了影响印度药物不良反应自发报告的主要障碍以及可能的解决方案。根据现有科学文献,药物不良反应报告的主要障碍包括卫生专业人员知识和意识不足、临床医生对报告的看法、医院建立报告系统的问题以及识别药物不良反应的培训不足。改善这种情况的措施包括让护士、药剂师以及消费者更多地参与药物不良反应报告,通过电子手段使报告过程更简单、更快,为医疗保健提供者引入教育干预和培训项目,并在护理人员和接受者中传播关于报告系统的意识。为药物警戒系统提供动力并确保强有力的报告过程是一项挑战,但适当的规划、可行的解决方案和有针对性的努力有助于带来变革,确保患者安全——药物警戒的最终目标。

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