Background and aims: Medicine Access Programs (MAPs) enable timely access to medicines that are yet to attract Pharmaceutical Benefits Scheme reimbursement, patients unable to gain medicine access via clinical trial enrolment or access to subsidised medicines that are currently marketed 1,2. MAPs involve a high level of complexity that may add a number of ethical, regulatory and clinical strains, which require careful consideration and exploration 3. In a recent study, pharmacists and prescribers expressed an increased workload in administrative tasks around the implementation of systems for procurement, storage and dispensing of medicines, where remuneration for the administrative load was necessitated and justified.4 Hence, this project aimed to investigate the operational workload and staff time associated with the management of MAPs.
Methods and findings: In a 125 bed metropolitan cancer speciality hospital, a time and motion study was conducted over a one month period. The average time to complete the following MAPs procedures; regulatory administration processes, inventory management, manufacturing, dispensing of medicines, coordinating with treating clinicians and sponsor representatives was investigated. These findings were then extrapolated to active MAPs in 2019. Over one year, 48 MAPs were active, within those programs there were 1075 dispensing episodes. Compared with intravenous medicines, the supply of oral medicines was associated with reductions in active healthcare professional time (21 minutes versus 67 minutes). In total, this equated to 982 staff hours per year, translating to 0.5 full time equivalents.
Conclusion: MAPs open avenues for patients to access potentially lifesaving medicines in a timely manner when other funding means are exhausted. However, without allocated funding to drive MAPs, the current delivery model is insufficient to ensure the sustainability of MAPs. Consequently, avenues to ensure continued equitable and sustainable access to medicines is imperative to ensure the best possible patient outcomes are achieved.