Application of the Plan-Do-Check-Act Cycle for Managing Immune-Related Adverse Events

• Satoshi Hibi

  Department of Hospital Pharmacy, Nagoya Memorial Hospital, Japan and Chemotherapy team, Nagoya Memorial Hospital, Japan

• Yuko Shirokawa

  Department of Nursing, Nagoya Memorial Hospital, Japan and Chemotherapy team, Nagoya Memorial Hospital, Japan

• Kengo Nanya

  Department of Clinical Laboratory, Nagoya Memorial Hospital, Japan and Chemotherapy team, Nagoya Memorial Hospital, Japan

• Yuko Kato

  Medical Social Work Consultation Room, Nagoya Memorial Hospital, Japan and Chemotherapy team, Nagoya Memorial Hospital, Japan

• Nobuto Ito

  Department of Hospital Pharmacy, Nagoya Memorial Hospital, Japan

• Takae Kataoka

  Department of Clinical Oncology, Nagoya Memorial Hospital, Japan

• Takashi Yoshida

  Department of Clinical Oncology, Nagoya Memorial Hospital, Japan and Chemotherapy team, Nagoya Memorial Hospital, Japan

• Yoshiaki Marumo

  Department of Clinical Oncology, Nagoya Memorial Hospital, Japan

• Satoshi Kayukawa

  Department of Clinical Oncology, Nagoya Memorial Hospital, Japan and Chemotherapy team, Nagoya Memorial Hospital, Japan

• Shu Yuasa

  Department of Hospital Pharmacy, Nagoya Memorial Hospital, Japan

• Yoshiteru Tanaka

  Shinseikai Daiichi Hospital, Nagoya, Japan

• Kenji Ina

  Shinseikai Daiichi Hospital, Nagoya, Japan

Background: Immune checkpoint inhibitors (ICIs) sometimes cause immune-related adverse events (irAEs), the timing of occurrence of which is difficult to predict. We created a system to safely manage the patients treated with ICIs who visit hospital during an emergency.

Methods: We utilized the Plan-Do-Check-Act (PDCA) cycle method to improve the quality of countermeasures for irAEs in the emergency room. First, an icon showing the patients treated with ICIs was developed for inclusion in electronic medical records. Second, ICI-specified urgent sets of clinical laboratory tests were prepared to cover the spectrum of irAEs. Third, a direct call system to either the attending physician or the chemotherapy team was established. A flow chart for managing irAEs has been prepared since September 2018. We retrospectively analyzed the electronic medical records from September 2018 to December 2020 to determine the effectiveness of the developed system.

Results: In the first cycle of PDCA, 24 patients administered ICIs were retrospectively surveyed and seven visited the emergency room. Six cases were examined according to the flow chart, whereas the other patient complaining of grade 2 diarrhea were not examined because of incomplete knowledge regarding ICIs and irAEs. As part of the “Act” step, we reminded the doctors of the flow chart and gave a lecture to the residents on how to manage irAEs. During the second and seventh cycle, no cases were observed without consulting the flow chart.

Conclusions: Quality improvement activities for the management of irAEs were conducted using the PDCA cycle methodology. Patients on ICIs are now being continuously monitored to further improve management quality.

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