Objective: In Japan, beta 2 agonist (BA) has an indication for acute bronchitis with airway obstruction. To investigate BA prescribing practices for children whose diagnosis were acute bronchitis without asthma in Japan, a database study and interviews with pediatricians were conducted.
Design: Database study
Methods: We conducted a database study. Using the Japan Medical Data Center database, medical receipts of about 100,000 children younger than 18 years old were obtained between 2005 and 2008. First we identified all the new incidences (362,287 cases) of upper respiratory tract infection, influenza, or acute bronchitis. Outcome measure was prescription of BA within 21 days of the incidence. We calculated the prescription proportions of BA for the asthma group (41,064 cases) and the non-asthma group (321,223 cases). We then interviewed 10 pediatricians to elucidate the reason why they prescribe BA for patients.
Results: The proportion of children prescribed BA at least once a year in 3-5 years old was 49.9 %. Among 3-5 year olds with acute bronchitis, the BA prescription proportions in the asthma group (58.6%) was nearly as high as that in the non-asthma group (56.6%). Although BA prescription proportions in the asthma group decreased annually with the exception of 0-2 years old, those in the non-asthma group remain unchanged. Based on the interview study, we found interpretations of airway obstruction for acute bronchitis without asthma were broadly-divided into 2 types: the effect of inducing bronchospasm and the effect of producing large amounts of secretions in the airways.
Conclusion: In this study, it was revealed that pediatric patients with acute bronchitis were commonly prescribed BA in Japan. To promote an appropriate use of BA, prescriptions of BA to non-asthma pediatric patients should be carefully watched. (Jpn J Pharmacoepidemiol 2012; 17(1): 1-12)

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Objective: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.
Method: Among all of the newly approved medicines in Japan in 2010, 12 marketed products in the U. S. are selected. First, to examine the U. S. system, post-marketing safety concerns over those drugs at the time of approval in the U. S. were collected as well as its postmarketing requirements (PMR) which are studies or clinical trials that sponsors are required to conduct under one or more statutes of regulations. Then, the same drugsʼ safety issues discussed as special cautions listed during the approval process in Japan and the corresponding postmarketing safety studies were reviewed.
Result: Both countries have many safety concerns in common, however, in Japan, ongoing studies are only conventional studies, such as post-marketing surveillance studies or all-cases studies, while the U. S. conducts studies to meet each individual requirement need. Ideal post-marketing safety study designs proposed by the task force, seemed beyond sponsors capabilities, particularly with regard to conduct studies with control group, and require involvement of academia external research organizations, or establishment of the national registry system for cancer and other major diseases.
Conclusion: In Japan, Risk Management Plan (RMP) will soon be implemented in 2013, and that is expected to secure patientsʼ safety by the scientific pharmacovigilance plan with the international standard. It is an urgent task to discuss what plan is feasible in Japan and how to make the corporation of industry-government-academia a reality. (Jpn J Pharmacoepidemiol 2012; 17 (1): 55-66)

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