Legislation on the Roles of the Pharmacist and Pharmacy in the Revision of the Pharmaceutical and Medical Device Act and the Pharmacists Act in Japan.

Japan's rapidly aging population has prompted a change in the country's pharmaceutical care framework from a drug-oriented to a patient-oriented approach. Pharmacies and pharmacists are expected to play central roles in this new patient-oriented approach by reconciling medication and managing polypharmacy, conducting home visits, and providing care to patients in collaboration with local clinics and hospitals. These additional roles are expected to lead to a reduction in the prevalence of adverse effects and improve the quality of life of patients in Japan's aging society. To promote patient-oriented care by pharmacists, these additional roles were legislated in a revision of the Japanese Pharmaceutical and Medical Device Act and other related Act in December 2019. Here, we overview how the revisions affect pharmacies, pharmacists, medical institutions, and outpatients.

Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan.

Recombinant viral vaccines expressing antigens of pathogenic microbes (e.g., HIV, Ebola virus, and malaria) have been designed to overcome the insufficient immune responses induced by the conventional vaccines. Our knowledge of and clinical experience with the new recombinant viral vaccines are insufficient, and a clear regulatory pathway is needed for the further development and evaluation of recombinant viral vaccines. In 2018, the research group supported by the Ministry of Health, Labour and Welfare, Japan (MHLW) published a concept paper to address the development of recombinant viral vaccines against infectious diseases. Herein we summarize the concept paper-which explains the Japanese regulatory concerns about recombinant viral vaccines-and provide a focus of discussion about the development of recombinant viral vaccines.

Pharmacokinetic-pharmacodynamic analysis of fluoroquinolones against Bacillus anthracis.

Based on the pharmacokinetic-pharmacodynamic (PK-PD) parameters of ciprofloxacin in rhesus monkeys, the efficacies of levofloxacin, sparfloxacin, norfloxacin, and tosufloxacin against anthrax in humans were examined. The optimal PK-PD parameter for the prophylaxis or treatment of infection with Bacillus anthracis is not clearly defined. To evaluate the efficacy of fluoroquinolones against anthrax, PK-PD parameters and the protein-binding effect of fluoroquinolones are used. B. anthracis is very susceptible to fluoroquinolones in vitro, and levofloxacin, sparfloxacin, and tosufloxacin may be as effective against anthrax as ciprofloxacin by PK-PD analysis. However, additional studies of the in vivo model are necessary to define more clearly efficacy against anthrax and the pharmacodynamic relationship of fluoroquinolones.