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.

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.

Safety of elobixibat and lubiprostone in Japanese patients with chronic constipation: a retrospective cohort study.

BACKGROUND: We aimed to discuss and compare reported adverse reactions and drug add-ons associated with elobixibat and lubiprostone use in chronic constipation treatment, as the safety of these drugs has not been well examined in post-marketing clinical settings. RESEARCH DESIGN AND METHODS: In this retrospective cohort study, using records of community pharmacies in Japan, we identified new users of elobixibat and lubiprostone. The Japan Pharmaceutical Association sent questionnaires regarding baseline and event data to community pharmacists. The incidence of events and hazard ratio (HR) associated with the study drugs were evaluated. RESULTS: New users of elobixibat (n = 979) and lubiprostone (n = 829) were identified (mean age: 74 and 77 years; females: 59% and 53%, respectively). Although the crude risk ratio of adverse events for elobixibat was 0.79 (95% confidence interval: 0.63-0.99), there was no significant difference in the HR for any of the common events, including drug add-ons (n ≥ 5), compared with those for lubiprostone. CONCLUSION: No new safety concerns have been raised in relation to elobixibat and lubiprostone use for treating chronic constipation, although the HR of different events varied. Further larger-scale study is needed as the estimates for events of small numbers were unstable.

The present status and future issues regarding the use of nonprescription drugs, obtained from the results of face-to-face surveys with the inhabitants of remote islands.

This study was conducted among 252 inhabitants aged 16 years or older of small remote islands in Gotoh. The survey was conducted in a direct interview format based on a questionnaire. In the interview, the respondents were asked about the statuses of their Internet usage, purchase/use/storage of nonprescription drugs, acquisition of information regarding nonprescription drugs, as well as regulations pertaining to the sale of nonprescription drugs, including the use of postal services. Among the respondents, 7.5% were Internet users, whereas people who had past experiences in purchasing nonprescription drugs through Internet accounted for as few as 0.8% of the total number of respondents; 63.9% of the inhabitants of small remote islands did not use nonprescription drugs, additionally, most inhabitants of small remote islands did not express any need for nonprescription drugs sold through Internet. Further, the findings suggested that a large number of people felt the need for the presence of pharmacists and experts to provide them with explanations and information regarding nonprescription drugs. However, because a large number of these people were unaware of the existence of pharmacists, it is important that in the future, pharmacists should conduct "consultation meetings and briefings regarding medications." These meeting may be held in a continuous manner in these small remote islands, such that the inhabitants recognize the difference in a pharmacists' profession. It is essential that "family pharmacies/pharmacists" play a central role in promoting the supply, management, and proper use of pharmaceutical products.

[Opinion survey about purchasing nonprescription drugs over the internet in remote islands--survey among internet-literate inhabitants].

The revised Pharmaceutical Affairs Act that came into force in June 2009 prohibits the sales of nonprescription drugs by mail. However, as a provisional measure, regular users and inhabitants of remote islands that do not have pharmacies or drug stores would be able to purchase nonprescription drugs by mail for two years. However, this regulation is now being discussed from the perspectives of safety and convenience. The purpose of this study was to conduct a survey on the purchasing of nonprescription drugs over the Internet by inhabitants of remote islands belonging to Goto City in Nagasaki prefecture. The results showed that approximately 78.0% of the Internet-literate respondents living on large islands (with pharmacies, drug stores, and pharmacists, e.g., Fukue-shima), 65.4% of the Internet-literate respondents living on small islands scattered around large islands (where pharmacies, drug stores, and pharmacists are not located, e.g., Mae-shima) had purchased necessities except nonprescription drugs, but the rate of purchasing nonprescription drugs over the Internet was approximately less than 10%. The results of this survey suggest that it is not necessary to purchase nonprescription drugs over the Internet. However, owing to a small but significant minority of inhabitants who need to purchase nonprescription drugs over the Internet, there is an urgent need for establishing an optimum system for supplying medicinal products to remote islands.