Naloxone rescheduling in Australia: Processes, implementation and challenges with supply of naloxone as a 'pharmacist only' over-the-counter medicine

Numerous studies and systematic reviews have concluded that naloxone for take-home use is an effective intervention to reduce overdose morbidity and mortality, with few side effects and no abuse potential. One barrier to supply is that naloxone has traditionally been a prescription medication. In May 2015, the Therapeutic Goods Administration of Australia announced the intention to down-schedule naloxone when used for the treatment of opioid overdose, enabling sale in pharmacies without a prescription. The aim of this article is to describe process of rescheduling of naloxone and some of the challenges observed.We describe the process of rescheduling from initial proposal development to gaining support and submissions from a range of individuals and professional bodies to support this change. The implications of the change, particularly for pharmacy supply of naloxone, are discussed, including next steps to facilitate implementation of this change in the Australian context.A submission to reschedule naloxone was successfully instigated by a member of the public. The change may help remove access barriers to naloxone by allowing pharmacist supply. Cost, pharmacist training, existing naloxone formulation, presentation and packaging remain challenges to address.Naloxone down-scheduling has opened up an additional way to supply naloxone through community pharmacy. Further expansion of naloxone availability may be achieved through addressing cost as a barrier, and making naloxone more widely accessible through needle syringe programs, and other services that do not have medical staff.