Ho Jun Ni, Hillen Jodie Belinda, Daniels Benjamin, Lim Renly, Pratt Nicole
Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Adelaide, SA, 5000, Australia.
School of Pharmacy and Pharmaceutical Sciences, Faculty of Health, Medicine and Behavioural Sciences, The University of Queensland, Brisbane, QLD, Australia.
Drug Saf. 2025 May 31. doi: 10.1007/s40264-025-01557-2.
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.
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.
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.
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.
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.
风险管理计划（RMPs）是药物警戒的关键要素。然而，很少有研究考察过风险管理计划中所包含信息的质量和类型，且尚无研究在澳大利亚药品监管背景下对风险管理计划进行考察。
本研究旨在描述安全性问题，尤其是当前澳大利亚常用生物药品风险管理计划中列出的缺失信息，并确定为弥补已发现的差距而提议开展的其他药物警戒和风险最小化活动。
对澳大利亚公共评估报告（2009 - 2024年）中包含的15种已批准在澳大利亚用于炎症性关节炎、炎症性肠病和炎症性皮肤病且由公共资金资助使用的生物药品的风险管理计划进行描述性综述。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性问题（已识别的重要风险、潜在重要风险和缺失信息），并按特定人群和情况对缺失信息进行了进一步分类。然后，我们对提议开展 的其他活动进行了定性描述。
在所关注的15种药品中列出了246个安全性问题：85个已识别的重要风险（34.6%）、81个潜在重要风险（32.9%）和80例缺失信息（32.5%）。超过半数（n = 9，60%）被审查药品将儿童和青少年列为缺失信息最常见的人群。孕妇（n = 8，53%）以及肝肾功能损害者（n = 7，47%）也常被列为存在缺失信息的人群。对于三分之二（n = 10，77%）列出缺失信息的药品，提议开展额外的药物警戒活动。在当前澳大利亚公共评估报告中，只有三分之一（n = 5，33%）的被审查药品有针对缺失信息的具体提议或方案。
我们的研究发现了常用生物药品上市后阶段风险管理计划中的重要差距。尽管一些药品有较长的市场历史，但这些安全性问题仍未得到解决。建议对风险管理计划进行定期监测和严格审查，以便将上市后研究列为优先事项并解决悬而未决的安全性问题。
