Title:Event Monitoring and Evaluation by Community Pharmacists in Japan: A Pilot Study on Fenofibrate and
Pemafibrate
Volume: 17
Issue: 4
Author(s): Masao Takahashi, Nobuhiro Ooba*, Marina Nagamura, Makoto Ushida, Eiji Kawakami, Masaomi Kimura, Tsugumichi Sato, Yoshinori Takahashi, Junichi Tokuyoshi, Hajime Hashiba, Miwako Kamei, Choichiro Miyazaki and Mitsuaki Shimada
Affiliation:
- Department of Clinical Pharmacy, Nihon University School of
Pharmacy, Chiba, Japan
Keywords:
Retrospective cohort study, new-user design, event monitoring, concurrent control, primary data collection, community pharmacist.
Abstract:
Background: The Japan Pharmaceutical Association has conducted drug event monitoring
to detect drug events related to pemafibrate. As there are a few studies on the safety of pemafibrate
in clinical settings, a pilot study evaluating the association between drug use and detected
events was performed in Japan.
Aims: In this study, the association between detected events and the use of pemafibrate, utilizing
pharmacy records maintained by community pharmacists, was investigated. We identified the newuser
cohort using a test and active comparison drug and collected the baseline information. An active
comparison group comprising new users was used to assess the events.
Methods: A retrospective cohort study using questionnaires regarding 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 involving suspected adverse reactions and add-on
drugs were increased blood pressure and lipid-lowering effects with pemafibrate use, and nasopharyngitis,
pruritus, dizziness, and lipid-lowering effects with fenofibrate use. No significant differences
were found in commonly occurring events, except that an add-on anti-hypertensive drug
has been used by pemafibrate users compared to fenofibrate users.
Conclusion: This study conducted 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. However, further research is required.
