Clinical indications treated with unregistered antimicrobials: regulatory challenges of antimicrobial resistance and access to effective treatment for patients
Date
2020
Authors
Hillock, N.T.
Paradiso, L.
Turnidge, J.
Karnon, J.
Merlin, T.L.
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Advisors
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Type:
Journal article
Citation
Australian Health Review, 2020; 44(2):263-269
Statement of Responsibility
Nadine T. Hillock, Lisa Paradiso, John Turnidge, Jonathan Karnon, Tracy L. Merlin
Conference Name
DOI
Abstract
Objective. Increasing antimicrobial resistance and a concurrent paucity of new antimicrobials marketed increases the risk that patients will develop infections resistant to currently available drugs. This study aimed to determine the range of clinical indications for which unregistered antimicrobials are prescribed at two tertiary hospitals in South Australia to identify any trends over a 2-year period. The effects of recent regulatory changes to the Special Access Scheme (SAS) were assessed. Methods. Data were extracted from application forms submitted to the Therapeutic Goods Administration to access unregistered antimicrobials via the SAS pathway at two Australian tertiary hospitals for the period July 2015–June 2017. Average weighted antimicrobial prices were retrieved from the hospital iPharmacy (DXC Technology, Macquarie Park, NSW,Australia) dispensing system. To estimate the effect of a new access pathway (Category C), the SASclassification for each application was retrospectively assessed over time with each regulatory change. Results. Between July 2015 and June 2017, 477 SAS applications for 29 different antimicrobials were submitted for 353 patients at the two hospitals. The most common indications were tuberculosis (43.6%) and refractory Helicobacter pylori (10%). Regulatory changes reduced the proportion of applications requiring preapproval for access. Conclusions. Although the introduction of a new pathway has decreased the administrative burden when accessing unregistered antimicrobials, this study highlights the range of clinical conditions for which there are no registered drugs available in Australia.
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published online 05/07/2020
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© AHHA 2020