Changes to protocol in the regulation of adverse drug reactions – historical and current European view

S. Mimica Matanović
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引用次数: 1

Abstract

Abstract Adverse drug reactions (ADRs) are an inevitable part of medication use. During clinical trials, limited information was gained on drug safety. After marketing authorization (MA), more safety data is available as more patients use the drug. Major changes in drug regulation came after drug disasters, like with sulphanilamide elixir or thalidomide use. In recent history, withdrawal of rofecoxib has demonstrated the importance of post-marketing safety monitoring. Subsequently, legislation on drug safety changed both in the United States (US) and in the European Union (EU), becoming simplified and more comprehensive. New EU legislation was implemented in 2012 and has broadened ADR definition to medication errors and overdoses. In the EU, the Pharmacovigilance Risk Assessment Committee (PRAC) has been formed within the European Medicines Agency (EMA), regulating all aspects of drug safety. Referral procedures enable a thorough scientific analysis on all issues of medication safety. In both the US and the EU, ADRs can be reported directly by patients. All reports of suspected ADRs are kept on electronic databases and are analyzed regularly using new technologies. New safety signals are subsequently discovered and evaluated. This author expects that the new regulations will effectively safeguard healthcare consumers from major drug risks.
药物不良反应监管协议的变化-历史和当前欧洲的观点
药物不良反应(adr)是药物使用过程中不可避免的一部分。在临床试验期间,获得的关于药物安全性的信息有限。在上市许可(MA)后,随着越来越多的患者使用该药,可以获得更多的安全性数据。药物监管的重大变化发生在药物灾难之后,比如磺胺酏剂或沙利度胺的使用。在最近的历史中,罗非昔布的停药已经证明了上市后安全监测的重要性。随后,美国(US)和欧盟(EU)的药品安全立法都发生了变化,变得更加简化和全面。新的欧盟立法于2012年实施,并将药品不良反应的定义扩大到用药错误和过量用药。在欧盟,在欧洲药品管理局(EMA)内成立了药物警戒风险评估委员会(PRAC),负责监管药物安全的所有方面。转诊程序能够对所有药物安全问题进行彻底的科学分析。在美国和欧盟,不良反应可以由患者直接报告。所有可疑adr的报告都保存在电子数据库中,并定期使用新技术进行分析。随后发现并评估新的安全信号。笔者期待新法规能有效保障保健消费者免受重大药品风险的侵害。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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