Objective: Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website.  The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.
Methods: The risks listed in RMPs on the PMDA website were assessed on February 10, 2014.  We investigated the documentation of these risks on the PL.
Results: Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs.  The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%).  Ninety-four percent of risks listed in RMPs were documented on the PL.  A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.
Conclusion: This study was clearly the relation between risks listed in RMPs and documents on the PL.  Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information.  It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.

A 63-year-old man had been receiving medical treatment for hypertrophic cardiomyopathy (HCM) for 20 years. Sustained ventricular tachycardia (VT) had often occurred over the previous 2 years in spite of the administration of antiarrhythmic drugs. He therefore received an implantable cardioverter defibrillator (ICD). However, his symptoms did not improve thus dilated-phase HCM was diagnosed. Because sustained VT often occurred subsequently, the ICD had to be frequently used. An electrophysiological study (EPS) using the CARTO electroanatomical mapping system revealed the earliest activation site to be in the posterolateral wall of the left ventricle (LV). VT did not stop despite 2 endocardial catheter ablation procedures. Therefore, the VT foci was thought to be a reentry circuit on the epicardial side of the posterolateral LV wall. A part of the posterolateral LV wall that involved the reentry circuit was therefore resected. Since undergoing this surgical procedure, the patient has experienced no recurrence of VT during a follow-up period of 14 months.

Background/Aims: Intestinal Behçet disease is typically associated with ileocecal punched-out ulcers and significant morbidity and mortality. Intestinal ultrasound is a noninvasive imaging technique for disease monitoring. However, no previous reports have compared intestinal ultrasound with endoscopic ulcer activity or histopathological findings for intestinal Behçet disease. We evaluated the usefulness of intestinal ultrasound for assessing the activity of ileocecal ulcers in intestinal Behçet disease. Methods: We retrospectively compared intestinal ultrasound findings with 73 corresponding endoscopic images and 6 resected specimens. The intestinal ultrasound findings were assessed for 7 parameters (bowel wall thickness, vascularity [evaluated using the modified Limberg score with color Doppler], bowel wall stratification, white-plaque sign [strong hyperechogenic lines or spots], mesenteric lymphadenopathy, extramural phlegmons, and fistulas), and endoscopic ulcer activity was classified into active, healing, and scar stages. Histopathological findings were evaluated by consensus among experienced pathologists. Results: Bowel wall thickness (P< 0.001), vascularity (P< 0.001), loss of bowel wall stratification (P= 0.015), and white-plague sign (P= 0.013) were significantly exacerbated in the endoscopic active ulcer stage. Receiver operating characteristic curve analysis revealed that a bowel wall thickness of > 5.5 mm (sensitivity 89.7%, specificity 85.3%) was potentially useful for detecting active lesions. When compared with histopathological findings, an increase in bowel wall thickness reflected the ulcer marginal ridge, and the white-plaque sign reflected the ulcer bottom. Conclusions Intestinal ultrasound is useful for monitoring intestinal ulcer activity in intestinal Behçet disease.

A questionnaire-based survey of board-certified rehabilitation physicians was conducted to identify issues in multidisciplinary interprofessional collaboration and to assess the abilities of board-certified rehabilitation physicians needed to develop assistive devices for individuals requiring long-term care. From the 366 responses, it was revealed that they consider “the ability to gain an insight into what patients need from assistive devices” and the “ability to communicate” as essential abilities needed to develop assistive devices. The respondents considered the ability to communicate and convey information important to overcome differences in thought-process between disciplines；the sharing of information, objectives, and knowledge as a requirement for teamwork；and collaboration, including with the patients, to be important. This approach to device development fits well with “design thinking” and “biodesign.” Unfortunately, more than 70％ of the respondents were unfamiliar with these concepts. Therefore, it is necessary to provide opportunities for rehabilitation physicians to learn innovative biodesign approaches.

A questionnaire-based survey of board-certified rehabilitation physicians was conducted to identify issues in multidisciplinary interprofessional collaboration and to assess the abilities of board-certified rehabilitation physicians needed to develop assistive devices for individuals requiring long-term care. From the 366 responses, it was revealed that they consider “the ability to gain an insight into what patients need from assistive devices” and the “ability to communicate” as essential abilities needed to develop assistive devices. The respondents considered the ability to communicate and convey information important to overcome differences in thought-process between disciplines；the sharing of information, objectives, and knowledge as a requirement for teamwork；and collaboration, including with the patients, to be important. This approach to device development fits well with “design thinking” and “biodesign.” Unfortunately, more than 70％ of the respondents were unfamiliar with these concepts. Therefore, it is necessary to provide opportunities for rehabilitation physicians to learn innovative biodesign approaches.