Search

Aoi Noda,1– 3 Masami Tsuchiya,4,5 Takamasa Sakai,6 Taku Obara,1– 3 Nariyasu Mano3,4 1Division of Preventive Medicine and Epidemiology, Tohoku University, Tohoku Medical Megabank Organization, Sendai, Miyagi, Japan; 2Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan; 3Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, Miyagi, Japan; 4Laboratory of Clinical Pharmacy, Tohoku University Graduate School of Pharmaceutical Sciences, Sendai, Miyagi, Japan; 5Department of Pharmacy, Miyagi Cancer Center, Natori, Miyagi, Japan; 6Drug Informatics, Faculty of Pharmacy, Meijo University, Nagoya, Aichi, JapanCorrespondence: Taku ObaraDivision of Preventive Medicine and Epidemiology, Tohoku University, Tohoku Medical Megabank Organization, 2-1 Seiryou-Cho, Aoba-Ku, Sendai, 980-8573, JapanTel +81 22 717 8104Fax +81 22 717 8106Email obara-t@hosp.tohoku.ac.jpPurpose: The purpose of this study was to assess the differences between consumer (patient) and healthcare professional submissions of adverse drug reaction (ADR) reports associated with certain antiviral treatments in children.Material and Methods: We extracted ADR reports for children aged < 20 years who received oseltamivir or similar drugs (zanamivir and amantadine) between April 2004 and May 2020 from the Japanese Adverse Drug Event Report database. Abnormal behavior after oseltamivir administration was reported frequently in the news in November 2005, and a Dear Healthcare Professional letter about abnormal behavior after oseltamivir use was issued on March 20, 2007. We compared the number of ADR reports by three periods: (1) before the news, (2) between the news and the letter, and (3) after the letter. These reports were tabulated and analyzed after stratification according to the reporter (healthcare professionals only, patients and healthcare professionals, patients only), patient age (< 10 years, 10– 19 years), and ADR (abnormal behavior, other ADRs).Results: For the reports from healthcare professionals only, the number of reports per quarter associated with oseltamivir was largest during the period between the news about abnormal behavior after oseltamivir use and publication of the Dear Healthcare Professional letter. The reports from patients only about abnormal behavior after oseltamivir use were first reported after publication of the letter. The proportions of reports from patients only about abnormal behavior with oseltamivir were 81.0% and 92.2% for ages < 10 and 10– 19 years, respectively. A ripple effect of increasing reports was observed with zanamivir or amantadine.Conclusion: Reports from patients only might increase in response to the media more than reports from healthcare professionals only or patients and healthcare professionals do. The ADR reports from patients must be carefully assessed from the perspective of when they were reported.Keywords: children, oseltamivir, drug safety, spontaneous reporting system, pharmacovigilance

Taku Obara,1–3 Shinya Abe,4 Michihiro Satoh,1 Sergio Ramón Gutiérrez Ubeda,5 Shoko Yoshimachi,4 Teruaki Goto4 1Department of Pharmacy, Tohoku University Hospital, Sendai, 2Division of Molecular Epidemiology, Environment and Genome Research Center, Tohoku University Graduate School of Medicine, Sendai, 3Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization, Tohoku University, Sendai, 4Tsuruha Holdings, Sapporo, 5Department of Geriatric Behavioral Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan Abstract: Advances in pharmacogenetic analysis technology have accelerated the movement to incorporate pharmacogenetic analysis data into medicine. Therefore, pharmacists will soon have to provide guidance and raise pharmaceutical questions regarding prescriptions based on patient pharmacogenomic information. The objective of this study was to clarify Japanese pharmacists' awareness of pharmacogenetics. We conducted a postal questionnaire survey among 372 pharmacists belonging to Tsuruha Holdings. Available data were collected from 268 pharmacists (male [n=133],

Two-stage gas-gun ballistic experiments are performed to investigate the feasibility of stratified mixtures with variable global equivalence ratios Φ global for the formation of sphere-induced oblique detonation wave (ODW) and quantify their critical behaviors, which include local quenching and transitional structure to ODW, by testing conventional detonation criteria for uniform mixtures. 2 Φ global H2 + O2 + 3Ar mixtures are tested with different concentration gradients for each fuel-lean/fuel-rich global composition. Opposite responses are observed depending on the global equivalence ratio: the lean mixture of Φ global = 0.7, which forms ODW in the uniform mixture, fails partly in the strongest stratification, whereas the richest mixture of Φ global = 2.0 turns to ODW in the strongly stratified conditions. As elucidated in the authors' previous work, Chapman–Jouguet (C–J) theory, including the curvature effects, reproduces the wave angles of the stable ODWs, as well as provides a good prediction on the local quenching of ODW occurring in the area with less reactive composition. Comparison of different wave regimes observed in the explored conditions reveals that wave curvature governs the critical behaviors of ODW far away from the projectile, whereas the initiation structure around the projectile is also influenced by the non-dimensional diameter. Surface energy theory is proven to quantify well the initiation structure on the projectile using a local equivalence ratio. These results indicate a new possibility of controlling the methodology of ignition and stabilization of detonation in aerospace engines, in which perfect mixing is difficult and non-stoichiometric and non-uniform mixtures are expected. [ABSTRACT FROM AUTHOR]

BACKGROUND: To investigate the use of calcineurin inhibitors (CNIs) in pregnant Japanese women and to evaluate their safety in infants. METHODS: Data were extracted from the claims database of the Japan Medical Data Center. The prevalence of CNIs was evaluated 180 days before pregnancy onset, during pregnancy, and within180-days post partum. We investigated the characteristics of the infants, including the presence of major malformations and their diagnoses, for 1 year after birth. RESULTS: A total of 91,865 pregnancies in 80,049 women were included. Fifty-three women were prescribed CNIs between 180-day before pregnancy onset and 180-day postpartum; 35 of the 53 women were prescribed the drugs during pregnancy, and 10 of their infants were born preterm. Three were diagnosed with major congenital malformations, such as patent ductus arteriosus. Six preterm infants presented with infant respiratory distress syndrome. CONCLUSIONS: No congenital anomalies were clearly attributable to the use of CNIs during pregnancy. [ABSTRACT FROM AUTHOR]