Lessons learned from the investigation of a sustained increase in paclitaxel hypersensitivity reactions (P-HSR) at a large community oncology practice: A mystery not fully solved.

233 Background: Trillium Health Partners (THP) is a large community oncology practice that has a culture of quality and safety. An investigation was triggered by a perceived increase in the rate of P-HSR during a weekly quality huddle in the chemotherapy suite. At the time THP had no formal hypersensitivity reaction tracking process. A retrospective review of P-HSR over the preceding 18 months identified an increase in reaction rates from a baseline of 1% to 4.5% that started 3 months prior to the raised concern. Methods: A systematic quality review was undertaken to identify triggers for the change and to identify steps to decrease P-HSR to baseline. There was no identified change in premedication, administration or compounding practice and no association with drug or lot number was identified. The increase in P-HSR was coincident with a change in the intravenous (IV) pumps and tubing system across the hospital. The change in IV pumps introduced several potential triggers including: a change in the options for priming the IV tubing which introduced a potential for variable concentrations of drug reaching the patient at the outset of the infusion, an interaction between drug and IV tubing, and a doubling of the IV tubing length which could result in incomplete delivery of the premedication. Results: Sequential practice changes were introduced to address each potential driver including i) a slow infusion protocol for first 2 cycles, ii) alternative tubing sets, iii) practice alert regarding potential for under-delivery of premedication. Over time P-HSR trended down towards the historic baseline, no single intervention had a sustained impact, although the practice alert regarding the administration of premedication seemed to induce the most change. A step wise withdrawal of interventions that were felt to be non impactful is underway. Conclusions: Although no clear cause for the increase in P-HSR was identified the systematic quality review resulted in improved standardization of nursing practice for chemotherapy delivery and the methodical approach also lead to the establishment of a more comprehensive hypersensitivity reporting system at THP.