Abstract
BACKGROUND: Currently, in Japan, shifting tasks from physician to hospital pharmacist is being developed to reduce physician workload and improve the quality of pharmacotherapy. This study aimed to investigate the effects of pharmacist involvement in the choice of inhaler as the task on the clinical outcomes of patients with chronic obstructive pulmonary disease (COPD). METHODS: This prospective, single-center, single-arm study included 36 outpatients with newly diagnosed COPD indicating inhaler therapy. Eligible patients were immediately interviewed by pharmacist. Then, pharmacist assessed patient's inhalation flow rate, physical function to handle an inhaler, comprehension, and value, and finally recommended a personalized inhaler based on originally developed inhaler choice protocol, and pulmonologist prescribed a pharmacist-selected inhaler. The primary endpoint was the improvement in trough forced expiratory volume in 1 s (FEV(1)) between baseline and week 26. The secondary endpoints were safety, and improvements at week 26 in scores for the COPD Assessment Test (CAT), modified British Medical Research Council Dyspnea Scale (mMRC), and Adherence Starts with Knowledge-20 (ASK-20). RESULTS: The pneumonologists completely agreed with the pharmacist-recommended inhaler. Mean FEV(1) significantly increased from baseline to week 26 (1.60, SD 0.54 L vs. 1.98, SD 0.56 L; p < 0.0001). Significant improvements in CAT, mMRC, and ASK-20 scores were also observed. The prevalence of CAT responders as a negative predictor of acute exacerbation, defined as those with a decrease in CAT score of ≥2 points from baseline, was 86%. None of the patients experienced exacerbation during the study period. CONCLUSIONS: Pharmacist involvement in the choice of inhaler for patients with newly diagnosed COPD was associated with improved lung function, health status, clinical symptoms, and adherence to inhaler therapy. Shifting task of choosing appropriate inhaler from physician to hospital pharmacist may be performed effectively and safely with an inhaler choice protocol. TRIAL REGISTRATION NUMBER: UMIN000039722 , retrospectively registered on March 10, 2020.