Abstruct
  Effective method for the management of information on adverse reactions is not uniformly in place, due to differences among medical facilities.  We have been developing a strategy for the effective management of adverse drug reactions on the transition of clinical records from paper to electronic media.
  We have taken a forward-thinking approach after 4 years identifying each year’s main target, predicted problems and how to address them in every year.  The targets for the four 1-year periods were: enabling the collection and analysis of information on adverse reactions from paper-based clinical records, standardized handling of adverse reactions in situations where paper records are still in use, transition of adverse reaction information to electronic records, and sharing of information on adverse reactions where electronic records are in use.  The Committee on Adverse Events conducted analysis of information on adverse reactions which were collected regardless of seriousness, disseminated useful information to all medical staff, and determined the degree to which each period target was achieved.
  The transition to electronic form of information on adverse reactions achieved 0% success within the target period.  Establishing effective management of adverse reactions will require 5 years, with as yet unresolved issues remaining.  During 5 years, 767 incidents of adverse reactions were reported, 73.1% by physicians, the proportion by nurses increasing from 6.7% to 22.3%.
  Strategic approach will help to establish a effective management of adverse reactions, which contribute to the adequate use of drugs and safety management of patients.

Surgical procedures for atlantoaxial (C1–C2) fusion in young children are relatively uncommon. The purpose of this study was to report on a surgical treatment for a case of atlantoaxial instability caused by os-odontoideum in association with quadriparesis and respiratory paralysis in a 5-year-old girl. We present the patient's history, physical examination, and radiographic findings, describe the surgical treatment and a five year follow-up, and provide a literature review. The instability was treated by halo immobilization, followed by C1–C2 transarticular screw fixation using a computed tomography-based navigation system. At the five year follow-up, the patient had made a complete recovery with solid union. The authors conclude that C1–2 transarticular screw fixation is technically possible as in a case of atlantoaxial instability in a five-year-old child.
Child* ; Child, Preschool* ; Female ; Follow-Up Studies ; Humans ; Immobilization ; Physical Examination ; Quadriplegia ; Respiratory Paralysis

Background/Aims: A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation. Methods: Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52. Results: Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo. Conclusions Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)