Objective: The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.
Design: Document analysis.
Methods: We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.
Results: Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.
Conclusion: About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.

BACKGROUND: Although the utility of flaps for the treatment of sternal wound infections following median sternotomy has been reported for 30 years, there have been few reports on the risk factors for complications after reconstruction. The objective of this investigation was to identify factors related to complications after the reconstruction of sternal wound infections. METHODS: A retrospective analysis of 74 patients with reconstructive surgery after sternal wound infection over a 5-year period was performed. Clinical data including age, sex, body mass index (BMI), comorbidities, bacterial culture, previous cardiac surgery, wound depth, mortality rate, type of reconstructive procedure, and complication rate were collected. RESULTS: The patients' BMI ranged from 15.2 to 33.6 kg/m2 (mean, 23.1+/-3.74 kg/m2). Wound closure complications after reconstructive surgery were observed in 36.5% of the cases. The mortality rate was 2.7%. Diabetes mellitus significantly affected the rate of wound closure complications (P=0.041). A significant difference in the number of complications was seen between Staphylococcus aureus (S. aureus) and coagulase-negative Staphylococci (P=0.011). There was a correlation between harvesting of the internal thoracic artery and postoperative complications (P=0.048). The complication rates of the pectoralis major flap, rectus abdominis flap, omentum flap, a combination of pectoralis major flap and rectus abdominis flap, and direct closure were 23.3%, 33.3%, 100%, 37.5%, and 35.7%, respectively. CONCLUSIONS: Diabetes mellitus, S. aureus, harvesting of the internal thoracic artery, and omentum flap were significant factors for complications after reconstruction. The omentum flap volume may be related to the complications associated with the omentum flap transfer in the present study.
Body Mass Index ; Comorbidity ; Diabetes Mellitus ; Humans ; Mammary Arteries ; Mediastinitis ; Mortality ; Omentum ; Postoperative Complications ; Rectus Abdominis ; Retrospective Studies ; Risk Factors* ; Staphylococcus aureus ; Sternotomy ; Surgical Flaps ; Thoracic Surgery ; Wound Infection* ; Wounds and Injuries

OBJECTIVE: Autistic spectrum traits are postulated to lie on a continuum that extends between individuals with autism and individuals with typical development. The present study was carried out to investigate functional and network abnormalities associated with autistic spectrum trait in healthy male subjects. METHODS: Subjects were 41 healthy male subjects who underwent the social responsiveness scale-adult (SRS-A) and magnetic resonance imaging. RESULTS: There was significant positive correlation between the total score of SRS-A and the regional cerebral blood flow (CBF) in posterior cingulate cortex (PCC). Also, there were changes in functional network such as in cingulate corti, insula and fusiform cortex. Further, we also found the significant difference of functional networks between the healthy male subjects with high or low autistic spectrum trait, and these points were congruent with the previous perceptions derived from autistic-spectrum disorders. CONCLUSION: These findings suggest a biological basis for the autistic spectrum trait and may be useful for the imaging marker of autism symptomatology.
Autism Spectrum Disorder ; Autistic Disorder ; Cerebrovascular Circulation* ; Gyrus Cinguli ; Humans ; Magnetic Resonance Imaging ; Male* ; SRS-A

Objective: Owing to the potential benefits of minimally invasive hysterectomy for endometrial cancer, the practice pattern has recently shifted in Japan. This study examined the trends in minimally invasive surgery (MIS) in patients with endometrial cancer in Japan. Methods: This retrospective observational study examined the Japan Society of Obstetrics and Gynecology Tumor Registry database between 2015–2019. This study examined the time-specific proportion change and predictors of MIS use in initial endometrial cancer treatment in Japan, and compared it with the use of abdominal surgery. Additionally, the association between hospital surgical treatment volume and MIS use was examined. Results: A total of 14,059 patients (26.5%) underwent minimally invasive hysterectomy, and 39,070 patients (73.5%) underwent abdominal hysterectomy in the study period. Patients who underwent MIS were more likely to be treated at high-volume centers, younger, central, or western Japan residents, registered in recent years, and had a tumor with stage I disease, type 1 histology, and less myometrial invasion (all adjusted p<0.05). The proportion of MIS treatments increased from 19.1% in 2015 to 34.3% in 2019 (p<0.001). On multivariable analysis, treatment at high-volume centers was a contributing factor for MIS (adjusted odds ratio=3.85; 95% confidence interval=3.44–4.30). MIS at high-volume centers increased significantly from 24.8% to 41.0% (p<0.001) during the study period, whereas MIS at low-volume centers remained at median 8.8%. Conclusion MIS has increased significantly in recent years, accounting for nearly 34% of surgical management of endometrial cancer in Japan. High-volume treatment centers take the lead in performing MIS.

Objective: In the instructions for package inserts (PI) of prescription drugs revised in June 2017, the section “persons with reproductive potential” was established under “precautions concerning patients with specific backgrounds.” The description rules associated with contraceptive duration were modified in these. In this study, we investigated descriptions of contraceptive duration in PI that were prepared based on the revised instructions, interview forms (IF), and other proper use materials (PM).Methods: We collected PI, IF, and PM of prescription drugs containing a new active ingredient approved from April 2017 to March 2022 for which the PI were prepared based on the revised instructions and investigated descriptions of PI, contraceptive duration, and its evidence in each information material.Results: Of the 181 drugs studied, 43.1 and 12.7% required females and males to use contraception during the period of drug consumption, respectively. Among these, the ratio of drugs that had descriptions of contraceptive duration were 15.4 and 0% for females and males at PI, respectively; 51.3 and 39.1% for female sand males at IF, respectively. Anticancer drugstended to describe contraceptive duration in the PM rather than PI or IF. For some drugs, there was no description of contraceptive duration in any of the materials. Contraceptive durations ranged from the period of administration of that drug to over a year for females and approximately one week to six months for males. The reasons for these contraceptive durations were diverse.Conclusion: Contraceptive information in the PI based on revised instructions were not sufficient for use by healthcare workers, even when the IF and PM were confirmed. These results suggest that there is a need for standardizing the descriptions, types of materials to be described, and choice of evidence for contraceptive duration.