Systematic Evaluation of Australian Risk Management Plans for Biologic Medicines.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-05-31 DOI:10.1007/s40264-025-01557-2

Jun Ni Ho, Jodie Belinda Hillen, Benjamin Daniels, Renly Lim, Nicole Pratt

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引用次数: 0

Abstract

Background: Risk management plans (RMPs) are a critical element of pharmacovigilance. However, few studies have examined the quality and type of information included in RMPs, and none has examined the RMPs in the Australian medicines regulatory context.

Objectives: This study aims to characterise safety concerns, particularly missing information listed in the current Australian RMPs for commonly used biologic medicines, and identify additional pharmacovigilance and risk minimisation activities proposed to address identified gaps.

Methods: A descriptive review of RMPs included in the Australian Public Assessment Reports (2009-2024) was performed for 15 biologic medicines approved for use and universally funded in Australia for inflammatory arthropathies, inflammatory bowel diseases and inflammatory skin conditions. We extracted and quantified safety concerns (important identified risks, important potential risks and missing information) from the latest Australian Public Assessment Reports, and further categorised missing information by specific populations and conditions. We then qualitatively described the additional activities proposed.

Results: There were 246 safety concerns listed for the 15 medicines of interest: 85 important identified risks (34.6%), 81 important potential risks (32.9%) and 80 instances of missing information (32.5%). More than half (n = 9, 60%) of the reviewed medicines listed children and adolescents as the most common populations with missing information. Pregnant women (n = 8, 53%) and those with hepatic and renal impairment (n = 7, 47%) were also commonly listed as having missing information. Additional pharmacovigilance activities were proposed for two thirds of the medicines (n = 10, 77%) where missing information was listed. Only one third of the reviewed medicines (n = 5, 33%) had specific proposals or protocols listed in the current Australian Public Assessment Reports to address missing information.

Conclusions: Our study identified important gaps in RMPs for commonly used biologic medicines at the post-market phase. Despite some medicines having an extensive market history, these safety concerns remain unaddressed. Regular monitoring and critical review of RMPs are recommended to prioritise post-market studies and address outstanding safety concerns.

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澳大利亚生物药品风险管理计划的系统评价。

背景：风险管理计划（RMPs）是药物警戒的关键要素。然而，很少有研究检查了RMPs中包含的信息的质量和类型，并且没有研究在澳大利亚药品监管背景下检查了RMPs。目的：本研究旨在描述安全问题，特别是当前澳大利亚常用生物药物RMPs中列出的缺失信息，并确定提出的额外药物警戒和风险最小化活动，以解决已确定的差距。方法：对澳大利亚公共评估报告（2009-2024）中包含的15种生物药物的RMPs进行描述性回顾，这些生物药物已被批准在澳大利亚用于炎症性关节病、炎症性肠病和炎症性皮肤病。我们从最新的澳大利亚公共评估报告中提取并量化了安全问题（重要的已识别风险，重要的潜在风险和缺失信息），并根据特定人群和条件进一步分类缺失信息。然后，我们定性地描述了所提议的额外活动。结果：15种感兴趣的药物共列出246个安全问题：85个重要的已识别风险（34.6%），81个重要的潜在风险（32.9%），80个信息缺失（32.5%）。超过一半（n = 9,60 %）的审评药物将儿童和青少年列为最常见的信息缺失人群。孕妇（n = 8, 53%）和肝肾损害患者（n = 7, 47%）也常被列为信息缺失。建议对列出信息缺失的三分之二的药物（n = 10, 77%）开展额外的药物警戒活动。只有三分之一的审评药物（n = 5,33 %）在当前的澳大利亚公共评估报告中列出了具体的建议或方案，以解决缺失的信息。结论：我们的研究确定了常用生物药物上市后阶段RMPs的重要差距。尽管一些药物具有广泛的市场历史，但这些安全问题仍未得到解决。建议定期监测和严格审查rmp，以优先进行上市后研究并解决突出的安全问题。

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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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.