A review of the POYC medicines approval system

Abstract

The Pharmacy of Your Choice (POYC) is the government’s pharmaceutical service responsible for approving free medicine entitlements under the Schedule V legislation. According to the 2013 Annual Report, 50,251 applications were processed and 3,184 out of the 21,168 requests for protocol-regulated items were not approved due to failure to follow set protocols as per the Government Formulary List (GFL). With the increasing number of applications and non-approvals of medicine entitlements resulting in the delay of access to medicines, this research aimed to optimise the POYC medicines approval system through pharmacist interventions to ensure efficient service delivery to patients. A mixed-method three-phased development design was utilised. The reasons for non-approvals before and during the COVID-19 pandemic were characterised through retrospective database review and Pareto analysis. A panel composed of one community pharmacist, one prescribing doctor, and two POYC officers evaluated non-approval risks through Failure Mode and Effects Analysis (FMEA) via Delphi technique using expert-agreed risk matrix and fivepoint ordinal scales for severity, occurrence, and detectability to develop interventions to streamline access to entitlement approvals. From January 2012 to October 2020, characterisation of medicines not approved (n=26,785) showed that the top medicines contributing to non-approvals were clopidogrel (8%), levothyroxine (5%), and omeprazole (4%). Process-specific reasons which served as bottlenecks were: medicine not corresponding to the Schedule V condition (43%), application not according to government protocol (10%), and medicine not available on the GFL (7%). Research panelists agreed that the potential failure modes in order of criticality requiring interventions were: application was not according to government protocol, medicine did not correspond to Schedule V condition, application was awaiting for approval for exceptional cases, foreign patients failed to bring supporting documents to confirm eligibility to Schedule V scheme, and wrong prescriber criteria. Interventions identified in the study to mitigate risks in the medicines approval system included: orientation manual for applying prescribers and participating pharmacies, review of information technology systems to facilitate access to supporting documents, and monthly feedback system regarding data on non-approvals. Risk assessment and prioritisation of the most common causes of non-approvals through FMEA as a regular quality exercise is important to identify interventions or optimisation of processes which can reduce delays in access to entitlement approvals and enhance a patient-centric approach.