Abstract
AimThe aim of this scoping review was to determine the extent of off-patent prescription medicine use beyond registered indications in various Australian clinical settings.MethodThe 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.ResultsOverall, 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.ConclusionThe 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.
Highlights
Medicine repurposing includes a wide range of areas where new therapeutic uses are found for existing medicines
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
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
Summary
Medicine repurposing includes a wide range of areas where new therapeutic uses are found for existing medicines. These new therapeutic uses can be: for an additional condition/disease (repositioning), patient population (extension of indication), a different dosage form or route of administration (reformulation) or a combination of these [1, 2]. In Australia, medicines must be assessed for safety, quality and efficacy by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied [3]. In the case of registered prescription medicines that are no longer patent protected (and have lost market exclusivity due to the availability of generic versions), sponsors are unlikely to request registration updates [4]. The use of prescription medicines beyond the limits of their registration or “off-label” is legal [3] and is a form of medicine repurposing where formal regulatory authority approval has not been sought
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