Designing Effective Protocol-Based Pharmacotherapy Management: Assessment of the Development Processes and Outcomes...

Prolonged working hours among physicians in Japan, alongside rising inflammatory bowel disease (IBD) cases, have heightened the need for additional support in IBD care. Protocol-based pharmacotherapy management (PBPM) has emerged as an effective approach that allows pharmacists to assist in prescription management under predefined protocols, potentially reducing physicians' workload. However, the detailed process of formulating PBPMs remains unclear. This study developed effective PBPM protocols by reviewing past provisional prescriptions. Provisional prescriptions made by pharmacists based on verbal instructions from physicians were reviewed to develop new PBPMs at Tsujinaka Hospital, Kashiwanoha. We retrospectively analyzed the PBPM application rate during three months before and after this initiative based on the proportion of prescriptions processed under standard procedure (SP), pharmacist provisional prescribing (PPP), and PBPM (PBPM-P). A total of 1259 prescriptions were retrospectively analyzed in this study. Before the initiative, there were 586 prescriptions (oral/topical, 128; injection, 458); after the initiative, there were 673 prescriptions (oral/topical, 242; injection, 431). The pre-initiative rates for SP, PPP, and PBPM-P were 68.3%, 30.7%, and 1.0%, respectively. Post-initiative, the rates were 48.3%, 26.6%, and 25.1%, respectively. A significant decrease was observed in the proportion of SP and PPP, while PBPM-P showed a significant increase after the initiative. Specifically, the proportion of PBPM-P increased by 24.1 percentage points, reflecting its broader adoption. In terms of safety, the proportion of pharmacists' prescription questions decreased significantly from 3.1% before to 0.3% after the initiative. Additionally, the proportion of prescription changes resulting from these questions decreased significantly, from 1.2% to 0%. The PBPM development process evaluated here could successfully form effective PBPMs, which have the potential to reduce physicians' workload, indicating that the process detailed in this study could be applied to future protocol development.