1.Rationale for Contraindications for Pregnant and Breast-Feeding Women in the Package Inserts of Prescription Drugs and Changes in Information by the Revised Instructions
Shoji SERA ; Ayumu FURUYA ; Yoshiki KAMEDA ; Akira OKADA ; Naomi NAGAI
Japanese Journal of Social Pharmacy 2024;43(1):31-39
The package inserts revision regarding prescription drugs is an ongoing process. In this study, we examined the status of this revision and how the content of the information provided has been updated with the new instructions, including the rationale for contraindications for pregnant and breast-feeding women. A total of 407 prescription drugs for pregnant and breast-feeding women were contraindicated, accounting for approximately 15% of the 2,627 nonproprietary names. The number of contraindicated drugs for pregnant, breast-feeding, and both pregnant and breast-feeding women were 406, 44, and 43, respectively. The majority of the contraindications were based on nonclinical data, such as teratogenicity and fetotoxicity data in reproductive toxicity studies involving pregnant animals and pharmacokinetic information in breast-feeding animals. The overall revision rate for the new instructions was 16.2% after three years of revision work for each drug. The alert wording has been revised to provide more clarity and consistency, with three categories of statements: “should not be administered/avoid breastfeeding,” “advisable not to administer/breastfeed,” and “should be administered/breastfeed in consideration of the therapeutic benefit (benefit-risk consideration).” The statement indicating that the drug should not be administered to pregnant women remained in the revised instructions. Conversely, the revision of the description for breast-feeding women from “should be discontinued/avoided” to “benefit-risk consideration” may have improved the usefulness of the product, allowing healthcare professionals to make more informed decisions after considering the transfer of the drug into milk, its pharmacological effects, and other factors.
2.Association Between Lipid Profile and Exercise Capacity in Phase II Cardiac Rehabilitation for Patients with Acute Coronary Syndrome
Satoru MATSUOKA ; Akira SHOJI ; Gen ABE ; Yoshikazu TAMURA ; Takashi SAITO
Journal of the Japanese Association of Rural Medicine 2022;70(5):437-447
Exercise training is reported to have beneficial effects on both lipid profile and exercise capacity in patients with coronary artery disease. In this retrospective study, we investigated the association between the effect of phase II cardiac rehabilitation (CR) on lipid profile and that on exercise capacity in patients with acute coronary syndrome (ACS). We analyzed 104 consecutive patients with ACS on statin therapy (age 62 ± 8 years, men 86) who received phase II CR after successful percutaneous coronary intervention (PCI). We examined lipid measurements and cardiopulmonary exercise test results before and after phase II CR. After 4 months of phase II CR, percentage of predicted aerobic threshold (%AT) based on age and gender significantly increased from 67 ± 11% to 76 ± 12% (p<0.001), high-density lipoprotein cholesterol (HDL-C) significantly increased from 41.5 ± 11.8mg/dL to 51.4 ± 12.6mg/dL (p<0.001), and ratio of lowdensity lipoprotein cholesterol to HDL-C (LDLC/HDLC) significantly decreased from 2.3 ± 0.8 to 1.8 ± 0.6 (p<0.001). A positive correlation was found between change in HDLC and change in %AT (r = 0.463), as well as between percent change in HDLC and percent change in %AT (r = 0.485). A negative correlation was found between change in LDLC/HDLC ratio and change in %AT (r =-0.379), as well as between percent change in LDLC/HDLC ratio and percent change in %AT (r =-0.374). Multiple regression analysis showed that change in %AT was the only factor associated with both change in HDLC and change in LDLC/HDLC and that percent change of %AT was the only factor associated with both percent change in HDLC and percent change in LDLC/HDLC ratio. In conclusion, improvement of lipids profile was correlated with improvement of %AT in phase II CR for patients with ACS on statin therapy after successful PCI.
3.Characteristics of Emergency Patients in Northern Akita City and Clinical Features of Elderly Patients With Heart Failure
Takashi SAITO ; Masaru SAKUSABE ; Chiaki HATAZAWA ; Tomoyasu KOMAGATA ; Yukou SUGIMOTO ; Yoshiaki ITO ; Yoshikazu TAMURA ; Satoru MATSUOKA ; Gen ABE ; Akira SHOJI ; Tsukasa KATO ; Takayuki YAMANAKA ; Syusaku NIREI
Journal of the Japanese Association of Rural Medicine 2020;69(2):126-136
This study investigated the characteristics of emergency patients, including walk-in patients and those brought in by ambulance, who visited Akita Kousei Medical Center in the 6 months from April 2019, and the clinical features of elderly patients with heart failure. Elderly patients above 70 years of age accounted for 38.7% of emergency cases and up to 61.7% of ambulance cases. The most common diseases and disorders were orthopedic, digestive, otorhinolaryngeal, respiratory, neurological, dermatological, and cardiovascular disease, in that order. In total, 56 patients with heart failure were admitted during this period (age 83.5±8.3 years, male: female ratio, 1:1.67). Hospitalization from homes accounted for 66.1% of admissions, with the remainder from nursing homes. After treatment, 35.7% of patients moved to nursing homes and 19.6% died despite in-hospital care. Because heart failure is one of the most common conditions in elderly patients, it is pertinent to recognize the importance of quality of outpatient care to prevent hospitalization and also to preserve quality of life by focusing on alleviating overall pain and discomfort.
4.A survey of home care provided by hospitals and clinics in an urban area of Japan
Masakatsu Shimizu ; Takuya Shinjo ; Shigeyuki Kobayashi ; Shoji Hamano ; Toru Okano ; Hiroomi Nakamura ; Akihiro Ishikawa ; Masako Sekimoto ; Hiroyuki Makimura ; Akira Honjo ; Kobe Medical Association Home Care Group
Palliative Care Research 2015;10(1):301-305
Objective:The aim of this study was to investigate the current status of home care provided by hospitals and clinics in Kobe City. Methods:In July 2013 a survey was mailed to a cross-section of all clinics and hospitals in Kobe City. Results:Questionnaires were sent to 1,589 clinics and hospitals and 899(57%)responded. Regular and urgent home visits by doctors were provided by 50% and 65% of respondents, respectively. End-of-life care for dying patients at home and in nursing homes was provided by 31% and 18% of respondents, respectively. The average time spent on home visits was 2.3±1.7 days per week. Care for cancer patients, participation in national palliative care lectures, and holding a discussion at the admitting hospital before discharge for home care, were performed by 23%, 7.0%, and 6.9% of respondents, respectively. Conclusion:The majority of hospitals and clinics in Kobe City provided home care.
5.Factors contributing to the burden of home care for doctors
Takuya Shinjo ; Masakatsu Shimizu ; Shigeyuki Kobayashi ; Shoji Hamano ; Toru Okano ; Hiroomi Nakamura ; Akihiro Ishikawa ; Masako Sekimoto ; Hiroyuki Makimura ; Akira Honjo ; Kobe Medical Association Home Care Group
Palliative Care Research 2014;9(1):107-113
Objective: The aim of this study is to explore the factors associated with the burden of home care for doctors. Methods: In July 2013 a survey was mailed to a cross-section of clinics and hospitals in Kobe City. Results: Questionnaires were sent to 1,589 clinics and hospitals and 899 (57%) responded. Of these, data from 807 respondents were available for analysis. The burden of home care was felt to be considerable for 30% and slight for 31% of respondents. Determinants associated with the burden of home care were; 80 years and older doctors (P=0.05), particular medical measures (P=0.036), building links with other medical facility or care staff (P=0.002), and ensuring the sufficient time and staff (P<0.001). Conclusion: The majority of doctors reported a burden associated with home care.
6.Comparison of Medical Education in Japan with that in Thailand and Singapore
Hironari Matsuda ; Yu Orihara ; ShoSho Ra ; Chikashi Takano ; Akira Miyahara ; Akihiko Mohri ; Meiko Kimura ; Eri Shoji ; Kenji Suzuki ; Kazuhisa Takahashi ; Hiroshi Tsuda
Medical Education 2012;43(2):127-129
1)We had the opportunity to study medical education in Thailand and Singapore while we visited medical schools in those countries as a member of the Japan Tropical Medicine Association.
2)In Thailand, undergraduate medical education last for 6 years, which is the same length as in Japan. All lectures are in English. Medical students in Thailand are more deeply related to patients at bedside learning than are students in Japan. In Singapore, undergraduate education lasts for 5 years, and lectures are in English. In the third year, medical students start clinical medicine. Recently, a new program has been adopted in which medical students can easily choose their specialties right after graduation.
3)Japanese medical students study medicine in Japanese. In contrast, greater emphasis should be placed in Japan on medical education in English.
7.A Survey on the Current State of Postgraduate Medical Ethics Education in Japan
Noriko NAGAO ; Yoshiyuki TAKIMOTO ; Akira AKABAYASHI ; Masashi SHIRAHAMA ; Masayuki OBAYASHI ; Naoki MORISHITA ; Shin'ichi SHOJI
Medical Education 2006;37(4):215-220
To examine the present state of postgraduate ethics education for residents in Japan, we sent an anonymous self-administered questionnaire to the directors of all 640 hospitals in Japan with a registered postgraduate clinical residency program. A total of 258 hospitals returned the questionnaire (response rate: 40.3%). Of these hospitals, 69 (26.7%) had a program for ethics education and 189 (73.3%) did not. The presence of a program was strongly correlated with the number of hospital beds and a history of problems with ethics education. Respondents showed a high degree of awareness about such significant topics in ethics education as “informed consent, ” “patient privacy, ” “patient rights, ” and “physician duties.”
8.Human Resource Development in International Medical Cooperation in the United Kingdom
Susumu TANIMURA ; Shoji SAKANO ; Hideki YAMAMOTO ; Shunsaku MIZUSHIMA ; Akira ISHII ; Tsutomu MIZOTA
Journal of International Health 2005;20(2):2_38-2_43
Medical doctors in the United Kingdom who wish to work overseas have severe problems such as job security on return, childcare, and uncertain career due to lack of institutionalised career path in the field of international medical cooperation. The same applies in Japan. It is, however, different from Japan that media for job opportunities and career related information have been far developed.
Recently, Department of Health, the UK has started to encourage human resource development in the field, which hold out the hope to extricate from severe situation of human resources in the future.
9.Report of the First Workshop on Medical Ethics Education
Shinichi SHOJI ; Masayuki OBAYASHI ; Akira AKABAYASHI ; Naoki MORISHITA ; Masashi SHIRAHAMA
Medical Education 2003;34(3):187-192
The first workshop on medical ethics education was held for 28 members including mainly university tutors and hospital tutors in November 2002 at Gifu. Trail for training of several kinds of medical ethics education technique was evaluated to a certain extent. We submit report of the practice and participants' evaluation of the workshop.
10.The Medical Ethics Education Manual in the Undergraduate Medical Education.
Shinichi SHOJI ; Masayuki OBAYASHI ; Naoki MORISHITA ; Akira AKABAYASHI ; Masashi SHIRAHAMA
Medical Education 2002;33(2):113-119
We proposed the curriculum plan of medical ethics in the medical school in our country. That was the curriculum throughout a few years and the participating education. Now we present the manual for one case of the each six strategies. When the teacher holds classes according to this manual or with some modifications, the medical students will probably participate the education with high motivation to learn.


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