A questionnaire survey of risk management systems for medical products was conducted with the cooperation of domestic and foreign pharmaceutical companies. As for the foreign companies, it was revealed that specialized safety management teams and data-management committees are established to formulate risk management plans in order to create systems that assure consistent risk management for each company. In addition, it was revealed that toxicologists are incorporated in the central decision making organization. As for domestic companies, it turned out that no less than half of the respondents pay attention to consistent risk management from the development stage through the post marketing stage. From now on, it will be essential to consolidate safety data, improve the accessibility of centralized safety data from the relevant departments, and establish systems to provide consistent risk management from the development stage to the post marketing stage.

We report the case of a 1-year-old female with invasive pneumococcal disease (IPD) after three administrations of the 13-valent pneumococcal conjugate vaccine (PCV13) according to the immunization schedule for children in Japan. Blood culture detected Streptococcus pneumoniae 24B, which is a non-vaccine serotype. In Japan, PCV7 introduced in 2010 reduced the number of IPD patients under 5 years of age. However, the number of children under 5 years of age with IPD due to non-vaccine serotypes gradually increased after 2014 even though PCV13 was introduced in 2013. Pneumococcal vaccination cannot completely prevent IPD. Therefore, medical practitioners should pay attention to IPD due to non-vaccine serotypes.

STUDY DESIGN: Retrospective study. PURPOSE: To assess treatment outcomes of snowboarding-related spinal and spinal cord injuries. OVERVIEW OF LITERATURE: Snowboarding-related spinal or spinal cord injury have a great impact on social and sporting activities. METHODS: A retrospective review of 19 cases of surgically treated snowboard-related injury was done. Analyzed parameters included site of injury, type of fracture, peri- and postoperative complications, pre- and postoperative neurological status, activities of daily living, and participation in sports activities at the final follow-up. RESULTS: The major site of injury was the thoracolumbar junction caused by fracture-dislocation (13/19 cases). The remaining 6 cases had cervical spine injuries. Over 60% of the patients had Frankel A and B paralysis. All patients were surgically treated by posterior fusion with instrumentation. Five underwent additional anterior fusion. Surgical outcome was restoration of ambulatory capacity in 12 patients (63.2%). Ultimately, 15 patients (78.9%) could return to work. Patients with complete paralysis upon admission showed reduced ambulatory capacity compared to those with incomplete paralysis. None of the patients again participated in any sports activities, including snowboarding. CONCLUSIONS: Snowboarding-related spinal or spinal cord injury has a great impact on social as well as sports activities. It is necessary to enhance promotion of injury prevention emphasizing the snowboarders' responsibility code.
Activities of Daily Living ; Follow-Up Studies ; Humans ; Paralysis ; Postoperative Complications ; Retrospective Studies ; Return to Work ; Skiing* ; Spinal Cord Injuries ; Spinal Injuries* ; Spine ; Sports

We report a case of a 57-year-old woman with radiation proctitis (RP) treated by shiunko (SK) enema with promising outcomes. The patient underwent interstitial brachytherapy for anterior vaginal vault recurrence of uterine cancer. Nine months after the treatment, she had anal pain and was diagnosed with RP by clinical course and colonoscopy. The rectal ulcer was so severe that a surgeon proposed permanent stoma formation as one option, given eventual risk of rectovaginal fistula. The patient rejected stoma formation and opted for Kampo medicine. Though she took keishibukuryogankayokuinin for blood stasis at first, her anal pain and rectal bleeding gradually worsened. Thereafter, she mainly used SK enema, kyukikyogaito and magnesium oxide. Anal pain and rectal bleeding decreased after applying SK to the rectal wall per rectum. Magnetic resonance imaging (MRI) and colonoscopy findings of the rectal ulcer also improved. SK effectively reduced anal pain and rectal bleeding as well as stimulated tissue repair in our patient, and therefore SK is worth considering in the treatment of RP.

[Introduction] In accordance with the 2018 revision of the Medical Care Act, prefectures have established career development programs for regional quota physicians aimed at both securing physicians committed to regional medical care and fostering their career development. We have surveyed and reviewed these programs across each prefecture.[Methods] The authors gathered information on the programs, which includes the acquisition of medical specialties, as well as the timing and duration of regional assignments, from the websites of each prefecture. The analysis of start timing and duration was limited to internal medicine.[Results] All prefectures have formulated programs. In more than 30% of the prefectures, regional quota physicians can choose any specialty from all available specialties. The regional assignment typically begins three years post-graduation, with a duration of four years in most cases.[Discussion] This nationwide trend provides a resource to evaluate the state of post-graduate education for regional quota physicians and to consider the future enhancement of these programs.