Status of Community Pharmacy Functions and Regional Medical Collaboration System Initiatives in Japan.

With the increase in life expectancy in Japan, the proportion of older adults requiring medical assistance continues to increase. Hence, the Japanese government proposed the establishment of a community-based integrated care system, aimed at ensuring housing, medical care, long-term care, prevention, and lifestyle support in a comprehensive manner by 2025. To achieve this paradigm shift, pharmacies must collaborate with their respective medical providers.

Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use.

Background: Methotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment and is highly effective with low-dose intermittent administration. MTX is occasionally used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (APAP)/paracetamol for pain or inflammation control. With MTX treatment, the side effects, such as hepatotoxicity, renal failure, and myelosuppression should be considered.

Methotrexate-related adverse events and impact of concomitant treatment with folic acid and tumor necrosis factor-alpha inhibitors: An assessment using the FDA adverse event reporting system.

Methotrexate (MTX) is an essential anti-rheumatic drug used to treat rheumatoid arthritis (RA). Prevention or management of adverse reactions, including interstitial lung disease (ILD), hepatotoxicity, myelosuppression, and infection, remains fundamental for safe MTX therapy. Using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) (JAPIC AERS), we performed disproportionality analyses of adverse events related to MTX use and the impact of concomitant medications.

The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.

Purpose: To determine if concerns toward adverse reactions (ARs) identified during the drug approval process are associated with their post-approval addition to package inserts.

Methods: Pre-approval concerns toward 24 target ARs were identified in the drug review reports and initial package inserts of 126 target drugs approved for use in Japan between April 2004 and March 2009. Each target drug was monitored for 5 years after approval for the addition of these ARs as clinically significant adverse reactions (CSARs) in the package inserts.

[Pharmaceuticals and Medical Devices Agency (PMDA)'s new action for Pharmaceutical Affairs Consultation on Research and Development (R&D) Strategy].

Universities, research institutions, and venture capitals that possess promising "seed" research or technologies in Japan, are not always familiar with development strategies that lead to commercialization of the products in spite of their excellent science and research. In order to create innovative pharmaceuticals and medical devices originating from Japan, Pharmaceuticals and Medical Devices Agency (PMDA) launched new scientific consultation service, named 'Pharmaceutical Affairs Consultation on R&D Strategy' for universities, research institutions, and venture capitals on July 1, 2011. Through these consultations, the guidance and advice on the tests needed in the early development stage and the necessary clinical trials would be provided toward commercialization.

[Social change and Pharmaceutical Affairs Law (PAL)].

Former Japanese pharmaceutical laws, originally based on the Pharmaceutical Marketing and Handling Regulations enacted in 1874 were in operation for many years before World War II. However, in order to address several drug issues, such as poor drug quality and insufficiences regarding the role of pharmacists during the War, the laws needed to be unified and revised. In this paper, we analyzed the record of discussions held by the Imperial Diet on the bill for the Pharmaceutical Affairs Law (PAL) in 1943.