Event Monitoring and Evaluation by Community Pharmacists in Japan: A Pilot Study on Fenofibrate and Pemafibrate

Background: The Japan Pharmaceutical Association has conducted drug event monitoring to detect drug-related events related to pemafibrate. A pilot study evaluating the association between drug use and detected events was performed in Japan, as there are few studies on the safety of pemafibrate in clinical settings. Aim: We investigated the association between detected events and pemafibrate, utilizing pharmacy records maintained by community pharmacists. We identified the new-user cohort comprising a test and active comparison drug and collected baseline information. An active comparison group comprising new users was used to assess the events. Method: A retrospective cohort study using questionnaires on baseline and event data was conducted by community pharmacists belonging to the Japan Pharmaceutical Association. The incidence of event and estimated hazard ratio were calculated using the Cox proportional hazards model that was adjusted for confounding factors, such as age and sex. Results: A total of 1294 patients using pemafibrate and 508 patients using fenofibrate were identified as new drug users. The most reported events for suspected adverse reactions and add-on drugs were increased blood pressure and lipid-lowering drugs with pemafibrate use, and nasopharyngitis, pruritus, dizziness, and lipid-lowering drug with fenofibrate use. No significant differences were found for common events, except for an add-on of an anti-hypertensive for pemafibrate compared with fenofibrate. Conclusion: Although further study is needed, this study by pharmacists can facilitate the safety assessment of newly marketed drugs, as few drug use investigations with a comparator are carried out by the Japanese authority for pharmaceutical companies.