Department of Health Services Research and Policy, Research School of Population Health, College of Health and Medicine, The Australian National University, Canberra, Australia.
Clinical and Health Sciences Unit, University of South Australia, Adelaide, Australia.
PLoS One. 2021 Dec 3;16(12):e0261022. doi: 10.1371/journal.pone.0261022. eCollection 2021.
The aim of this scoping review was to determine the extent of off-patent prescription medicine use beyond registered indications in various Australian clinical settings.
The review followed the Joanna Briggs Institute approach and reported using PRISMA Extension for Scoping Reviews. Online databases were used to identify published literature about off-patent registered prescription medicines used for off-label indications in Australian public hospital, community and primary healthcare settings. In addition, empirical data from the Queensland and the South Australian state-wide medicine formularies were screened for the same medication/off-label indication dyads identified in the literature, and other locally approved uses.
Overall, fourteen studies were included, conducted in public hospitals (n = 11), palliative care units (n = 2) and the community setting (n = 1). There were 213 reports extracted from the literature describing off-patent registered prescription medicines used for off-label indications, representing 128 unique medication/off-label indication dyads and 32 different medicines. Of these, just five medication/off-label indication dyads were approved for use on both the Queensland and South Australian state-wide medicine formularies, with 12 others only approved for use in Queensland and 16 others only approved for use in South Australia. Further examination of these state-wide formularies demonstrated that the use of off-patent registered prescription medicines beyond registered indications is more extensive than has been reported to date in the literature. There were 28 additional medication/off-label indication dyads approved on the Queensland state-wide medicine formulary and 14 such examples approved for use in South Australia. Of these, just two medication/off-label indication dyads were approved for use on both formularies.
The extent to which off-patent registered prescription medicines have been repurposed in clinical settings for off-label indications in Australia is greater than previously reported in the literature. Usage and funded availability of certain medication/off-label indication dyads, varies across Australia. These results further expose the two tiered system of medicines regulation in Australia, and its impact on equity of access to medicines. Further research is required to support policy change to encourage submission of registration updates for off-patent prescription medicines.
本范围综述的目的是确定在澳大利亚各种临床环境中超出注册适应证的专利过期处方药的使用程度。
该综述遵循乔安娜·布里格斯研究所（Joanna Briggs Institute）的方法，并使用 PRISMA 扩展范围综述报告。在线数据库用于确定有关在澳大利亚公立医院、社区和初级保健环境中使用专利过期注册处方药的已发表文献。此外，昆士兰州和南澳大利亚州药品处方集的经验数据也被筛选，以寻找文献中确定的相同药物/适应证对和其他当地批准的用途。
共有 14 项研究被纳入，其中 11 项在公立医院进行，2 项在姑息治疗病房进行，1 项在社区环境中进行。从文献中提取了 213 份描述专利过期注册处方药用于适应证的报告，代表 128 种独特的药物/适应证对和 32 种不同的药物。其中，只有 5 种药物/适应证对被批准在昆士兰州和南澳大利亚州的药品处方集上使用，12 种药物仅在昆士兰州批准使用，16 种药物仅在南澳大利亚州批准使用。进一步检查这些州级处方集表明，专利过期注册处方药超出适应证的使用范围比文献中迄今报道的更为广泛。在昆士兰州药品处方集上又批准了 28 种药物/适应证对，在南澳大利亚州又批准了 14 种。其中只有 2 种药物/适应证对被批准在两个处方集上使用。
在澳大利亚，专利过期注册处方药在临床环境中被重新用于适应证的程度比文献中以前报道的要大。某些药物/适应证对在澳大利亚的使用和资金可用性因地区而异。这些结果进一步暴露了澳大利亚药品监管的两级制度及其对药品可及性公平性的影响。需要进一步研究以支持政策改革，鼓励为专利过期处方药提交注册更新。
