Impact of expediting formulary oncology drug approvals at a tertiary care safety net hospital.

410 Background: Advances in drug development and novel clinical trials have resulted in accelerated FDA approvals for oncology agents. These approvals often outpace the speed at which these agents are made “formulary” by hospitals. Non-formulary agents at most organizations need to undergo rigorous regulatory processes before their use and even after the approval for use, ordering them in the EMR poses a significant burden to both providers and pharmacists. Providers need to manually create treatment plans consisting of labs, medications, diluents, and infusion rates for non-formulary agents, consuming valuable time and leaving room for errors requiring extensive pharmacy review. Oncology agents can be considered non-formulary for at least 1 year post-FDA approval before they are approved by the pharmacy and therapeutics (P & T) committee and only 1 agent is approved per meeting. To expedite the formulary approval of oncology drugs, the 1 drug approval per meeting and 1 year post-FDA approval time limit rules were lifted within our institution. Methods: In September 2023, 8 oncology drugs were approved for formulary use by the P & T committee and their pre-built drug templates were established in the EMR. We obtained baseline data to order such non-formulary drugs through EMR prior to formulary approval and when drug templates were not pre-built, requiring manual order entry by providers and review by pharmacists. Baseline data was compared with data obtained post formulary approval and implementation of the pre-builtdrug template. We also created a process map to identify workflow inefficiencies in the formulary drug approval process for further optimization. Results: After the implementation of the pre-built oncology drug templatesand 8 simultaneous formulary drug approvals, the average total time required by physicians and pharmacists was reduced from 97 minutes to 12 minutes per order. The average number of edits made by pharmacists during order review changed from 21 to 4 per treatment order (Table). The use of pre-built drug templates resulted in an 87% reduction in time spent ordering and reviewing agents and an 81% reduction in edits made per drug order. Conclusions: Integration of treatment protocol building quickly into EMR by expediting formulary drug approval significantly reduced physician and staff burden in oncology care at a safety net hospital. Health systems should adopt innovative processes to streamline the formulary approval process and use pre-built drug templates, minimizing staff fatigue and increasing patient safety. Breakdown for provider order entry and pharmacist review with and without drug template. Manual Entry During Non-Formulary Period Template Entry after Formulary Approval Average provider order entry time (mins) 75 6 Average pharmacist review time (mins) 22 6 Average total time taken per order (mins) 97 12 Average edits/order by pharmacist 21 4 mins=time in minutes.