Safety of mirogabalin and pregabalin in Japanese patients with neuropathic pain: a retrospective cohort study.

BACKGROUND: Few studies have compared the safety risks between the gabapentinoids, pregabalin, and mirogabalin in post-marketing clinical settings. We assessed reported events associated with gabapentinoid use in patients with neuropathic pain. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study between September 2020 and December 2020 using the community pharmacies records in Japan. The pharmacists identified new vs. prevalent users of mirogabalin and pregabalin in September 2020 and reported data regarding baseline and adverse events to the Japan Pharmaceutical Association using web-based questionnaires. The incidence of events and hazard ratio (HR) were consequently compared. RESULTS: New users of mirogabalin and pregabalin were identified (n = 1,650 and 2,244; mean age (SD): 69 (15) and 68 (16) years; women: 59% and 56%, respectively). Although serious events were not reported, a marked difference in HRs of common adverse events, including somnolence (1.6), dizziness (1.3), nausea (2.8), edema (3.1), and acetaminophen (2.0)/antidepressant (2.4) addition, was observed. CONCLUSION: No new serious safety concerns were found for mirogabalin and pregabalin use in patients with neuropathic pain, although the HR of some events indicated increased risk among mirogabalin users. However, further studies are needed as estimates for events occurring in small numbers with wide confidence intervals.

Pharmacists' Adherence Support System FollowNavi for Patients with Type 2 Diabetes.

In Japan, the Pharmaceutical and Medical Device Act was amended in December 2019 and now requires pharmacists to follow-up patients continuously during treatment to ensure proper use of medicines. According to some reports on patients with type 2 diabetes mellitus (T2DM), follow-up by doctors is effective for improving treatment. Enhanced face-to-face medication counseling by pharmacists leads to good glycemic control in patients with diabetes. However, the effects of information and communication technology (ICT)-based follow-up during the medication period are not well-understood. We determined the efficacy of pharmacists' follow-up using FollowNavi, a patient compliance instruction support system, and using our developed LINE tool for patients with T2DM. Through a before-after study, changes in glycemic control and medication adherence after 6 months of follow-up were investigated, and multiple regression analysis was performed to investigate the factors associated with changes in hemoglobin A1c (HbA1c) levels. Questionnaire surveys related to usability were completed by patients and pharmacists. In the 35 patients with T2DM, HbA1c levels decreased significantly after 6 months, although fasting blood glucose levels and medication adherence showed no significant differences. Changes in HbA1c levels were significantly associated with age (p = 0.044), baseline HbA1c levels (p < 0.001), and diabetes duration (p = 0.004). In the questionnaire, 81.8% of patients responded that they would prefer to continue using FollowNavi. These results suggest that follow-up using FollowNavi is useful for glycemic control in patients with T2DM.

Exploration of Trends in Antimicrobial Use and Their Determinants Based on Dispensing Information Collected from Pharmacies throughout Japan: A First Report.

The purpose of this study was to evaluate the defined daily doses (DDD)/1000 prescriptions/month (DPM) as a new indicator that can be used in pharmacies, and to describe antimicrobial use patterns in pharmacies nationwide in Japan. Dispensing volumes, number of prescriptions received, and facility information were obtained from 2638 pharmacies that participated in a survey. DPM was calculated based on the dispensing volume and number of prescriptions, which are routinely collected data that are simple to use. Use of third-generation cephalosporins, quinolones, and macrolides in pharmacies that received prescriptions primarily from hospitals or clinics decreased from January 2019 to January 2021. In particular, the antimicrobial use was higher in otorhinolaryngology departments than in other departments, despite a decrease in the antimicrobial use. In the linear multiple regression analysis, otorhinolaryngology department was independently associated with the third-generation cephalosporin, quinolone, and macrolide prescription in all periods. This study reveals for the first-time trends in antimicrobial use through a new indicator using the volume of drugs dispensed in pharmacies throughout Japan. Antimicrobial use differed by the medical department, suggesting the need to target interventions according to the department type.

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 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.