1.Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association
Ryo KOTO ; Shinichi ASABE ; Akira ITO ; Kasumi DAIDOJI ; Manabu ISHII ; Kanae TOGO ; Hiroshi MATSUZAWA
Japanese Journal of Pharmacoepidemiology 2024;29(1):15-28
Objective:To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design:Web based-questionnaire surveyMethods:This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results:[Background] Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5%) have “experienced in utilization of RWD”, and 12 (11.8%) have “experienced in considering utilization of RWD”. [Utilization by RWD Type] By data source, hospital-based claim data was the most frequently used (65 cases, 63.7%), followed by insurance-based claim data (61 cases, 59.8%), surveys (38 cases, 37.3%), and EMR (36 cases, 35.3%) in experienced RWD utilization. Conclusion:This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.
2.Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association
Ryo KOTO ; Shinichi ASABE ; Akira ITO ; Kasumi DAIDOJI ; Manabu ISHII ; Kanae TOGO ; Hiroshi MATSUZAWA
Japanese Journal of Pharmacoepidemiology 2024;():29.e2-
Objective:To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design:Web based-questionnaire surveyMethods:This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results:[Background] Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5%) have “experienced in utilization of RWD”, and 12 (11.8%) have “experienced in considering utilization of RWD”. [Utilization by RWD Type] By data source, hospital-based claim data was the most frequently used (65 cases, 63.7%), followed by insurance-based claim data (61 cases, 59.8%), surveys (38 cases, 37.3%), and EMR (36 cases, 35.3%) in experienced RWD utilization. Conclusion:This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.
3.The Details of Inpatient Cancer Rehabilitation Provided by Designated Cancer Hospitals in Japan
Takuya FUKUSHIMA ; Tetsuya TSUJI ; Jiro NAKANO ; Shun ISHII ; Shinsuke SUGIHARA ; Hiroshi SATO ; Juichi KAWAKAMI ; Hitoshi KAGAYA ; Akira TANUMA ; Ryuichi SEKINE ; Keita MORI ; Sadamoto ZENDA ; Akira KAWAI
Palliative Care Research 2023;18(2):143-152
Objective: This study aimed to clarify the details of inpatient cancer rehabilitation interventions provided by designated cancer hospitals in Japan. Methods: This questionnaire-based survey asked specialists regarding the outline of their facilities’ inpatient cancer rehabilitation, Dietz classification, disease, and intervention details. Results: Restorative interventions were the most common, and the most common cancer was lung cancer followed by colorectal cancer; hematologic malignancy; gastric cancer; and liver, gallbladder, and pancreatic cancer. Intervention proportions for colorectal and gastric cancer were significantly higher in general hospitals than in university hospitals and cancer centers; in contrast, those for hematological malignancy were significantly higher in university hospitals than in general hospitals. For bone and soft tissue sarcomas, intervention proportions in cancer centers were significantly higher than those in university and general hospitals; and for oral, pharyngeal, and laryngeal cancers, they were significantly higher in university hospitals and cancer centers than in general hospitals. The most common intervention was walking training, followed by resistance training, basic motor training, activities of daily living training, and respiratory rehabilitation. Respiratory rehabilitation was performed significantly more frequently in university and general hospitals than in cancer centers.Conclusion: The diseases had differed according to the characteristics of the facilities, and the interventions were considered accordingly. In future, it will be necessary to verify the effectiveness of inpatient cancer rehabilitation according to facility characteristics and to disseminate information on inpatient cancer rehabilitation.
4.Effectiveness of 5-day Post-exposure Prophylactic Oseltamivir and Its Effect on Hospital Management
Takayuki MOKUBO ; Mayuko HAMADA ; Yasutomo ISHII ; Aya MIYAMOTO ; Koichiro MUKAI ; Yuki TOKUTAKE ; Koji UEDA ; Hiroshi MATSUOKA
Journal of the Japanese Association of Rural Medicine 2021;69(5):489-493
Prophylaxis is sometimes offered to inpatients who share a room with, or individuals who have been in close contact with, patients who have contracted influenza. In our hospital, 5-day prophylactic oseltamivir has been used as a standard procedure. Here, we investigated the effectiveness of this post-exposure prophylaxis for inpatients and healthcare professionals, as well as its effect on hospital management. The study period was 5 years from fiscal year 2013 to fiscal year 2017, and the effectiveness outcome was the secondary infection rate. Medication costs for this prophylaxis were compared with those for oseltamivir used according to the package insert. The secondary infection rates were 3.0% and 0.5% in 133 inpatients and 434 healthcare professionals who had received post-exposure oseltamivir, respectively. The medication costs were reduced by 50% compared with the estimated costs for 10-day oseltamivir administration. The effectiveness of 5-day prophylactic oseltamivir was similar to or higher than that reported previously, indicating that this prophylaxis was effective. Moreover, 5-day post-exposure prophylactic oseltamivir is expected to reduce the prolongation of hospital stay and influenza outbreaks and thus contribute to hospital management.
5.The impact of a school-based tooth-brushing program on dental caries: a cross-sectional study.
Yuri TASHIRO ; Keiko NAKAMURA ; Kaoruko SEINO ; Shiro OCHI ; Hiroshi ISHII ; Masaru HASEGAWA ; Yoshimichi KAWAUCHI ; Mitsuyuki CHIBA
Environmental Health and Preventive Medicine 2019;24(1):83-83
BACKGROUND:
Promotion of oral health in children is recognized as one of the components of health-promoting schools (HPSs). However, few studies have addressed supportive school environments for children's oral health. This study aimed to evaluate the status of dental caries in school children at HPSs, with the objective of examining the impact of a supportive school environment for oral health, considering the lifestyles of individual children and the socioeconomic characteristics of their communities.
METHODS:
Data of 2043 5th-grade students in 21 elementary schools in Ichikawa city between 2008 and 2013 were analyzed. Children's oral health status was evaluated using the decayed, missing, and filled permanent teeth (DMFT) index. A self-reported lifestyle questionnaire, a survey of the school environment promoting tooth-brushing, and community socioeconomic characteristics derived from the National Census data were included in the analyses. Bivariate analyses were conducted to evaluate the children's DMFT status, and zero-inflated negative binominal (ZINB) regression was used to assess the relationships between DMFT and other variables.
RESULTS:
Prevalence of dental caries in the permanent teeth of 5th-grade children (aged 10-11 years) was 33.3%, with a mean DMFT score (± SD) of 0.83 ± 1.50. According to multilevel ZINB regression analysis, children from schools with after-lunch tooth-brushing time showed a higher odds ratio (OR) for excess zero DMFT (OR = 1.47, 95% CI = 1.00-2.15, P = 0.049) as compared to those from schools without it. Neither bivariate analysis nor ZINB model analysis revealed any significant influence of children's gender or use of a toothpaste with fluoride.
CONCLUSIONS
The school-based environment supportive of oral health was significantly associated with a zero DMFT status in children. School-based efforts considering the socioeconomic characteristics of the area warrant attention even with declining prevalence of dental caries.
6.A Case of Abdominal Abscess Possibly Due to Digestive Tract Perforation by an Ingested Fish Bone
Masatsugu ISHII ; Junichi SANO ; Yuki HIRANO ; Hironobu KASHIWAGI ; Michihito NISHIOKA ; Hiroshi IIO ; Yasuo KABESHIMA
Journal of the Japanese Association of Rural Medicine 2018;67(1):87-91
A 74-year-old woman visited our hospital complaining of pain in the left lower quadrant of the abdomen. Physical examination revealed tenderness to palpation without peritoneal signs. Blood test results showed elevated inflammatory response. Both ultrasonography and computed tomography revealed an intra-abdominal abscess containing a foreign body (fish bone) immediately below the left inferior abdominal wall. Lower gastrointestinal endoscopy conducted under fluoroscopic guidance revealed no intraluminal lesion in the colon adjacent to the abscess, and contrast examination also revealed no communication between the colon and the abscess. Fasting and administration of antibiotics did not improve the symptoms. We planned surgical procedure. Partial resection of the sigmoid colon was performed because of the presence of strong adhesions between the colonic wall and abscess. The postoperative course was uneventful, and the patient was discharged on hospital day 12. Histological examination of the resected specimen showed chronic abscess formation, but no communication between the intestinal tract and abscess. Onset was thought to be chronic in this case, because of uncertainty about the history of ingestion of fish bone and failure to verify any communication with the intestinal tract.
7.Retrospective Study of Surgical Gastrojejunostomy versus Gastroduodenal Stenting for Malignant Gastroduodenal Obstruction
Toshihiko Matsumoto ; Kaori Hino ; Hiroyuki Terasawa ; Akio Nakasya ; Kazuhiro Uesugi ; Norifumi Nishide ; Takeshi Kajiwara ; Akinori Asagi ; Tomohiro Nishina ; Junichirou Nasu ; Shinichiro Hori ; Seijin Nadano ; Hiroshi Ishii
Palliative Care Research 2016;11(2):166-173
Background: We retrospectively compared endscopic gastroduodenal stenting with gastrojejunostomy as a means of palliating malignant gastric and duodenal obstruction. Methods: This retrospective study investigated patients treated for malignant gastric and duodenal obstruction from April 2011 to April 2015 at Shikoku Cancer Center. Results: Of the 40 patients in this study, 25 underwent gastroduodenal stenting and 15 had operative gastrojejunostomy. Comparing the stenting and operative patients, technical success rate was 100% in both group, clinical success rate was 84% in stenting patients and 93% in operative patients. The median time to fluid intake was significantly shorter in stenting patients than operative patients(0 day vs 2 days, p=0.0003), and the median time to intake of solids was also significantly shorter in stenting patients(1day vs 3 days, p<0.0001).The median hospital stay was significantly shorter in stenting patients(9 days vs 23 days, p=0.0116). Median cost of hospitalization is more expensive in operative patients than stenting patients(¥1,106,170 vs ¥752,290, p=0.0052). Conclusion: Our study suggested that gastoroduodenal stent was less length of time to fluid/solid intake, and less costly than gastrojejunostomy.
8.Primary Multiple Cardiac Myxomas in a Patient without the Carney Complex.
Shohei KATAOKA ; Masato OTSUKA ; Masayuki GOTO ; Mitsuru KAHATA ; Asako KUMAGAI ; Koji INOUE ; Hiroshi KOGANEI ; Kenji ENTA ; Yasuhiro ISHII
Journal of Cardiovascular Ultrasound 2016;24(1):71-74
Cardiac tumors are rare, and multiple myxomas are even rarer. The latter phenomenon is mostly associated with the Carney complex, a dominantly inherited disease characterized by multiple primary cardiac myxomas, endocrinopathy, and spotty pigmentation of the skin. We report the rare case of a patient who did not have the Carney complex but had multiple primary cardiac tumors. A 78-year-old woman with a past history of breast cancer was referred to our hospital for further examination of multiple cardiac tumors. Echocardiography showed 4 tumors in the left atrium and left ventricle. We could not diagnose them preoperatively and decided to resect them surgically because they were mobile and could have caused embolism and obstruction. The postoperative pathological findings of all 4 tumors were myxomas, although the patient did not meet the diagnostic criteria of the Carney complex. Therefore, a rare case of multiple primary cardiac myxomas was diagnosed.
Aged
;
Breast Neoplasms
;
Carney Complex*
;
Echocardiography
;
Embolism
;
Female
;
Heart Atria
;
Heart Neoplasms
;
Heart Ventricles
;
Humans
;
Myxoma*
;
Pigmentation
;
Skin
9.Effects of Using Generic Antimicrobial Drugs on Infection Control Costs and Susceptibility of Pseudomonas Aeruginosa
Takayuki MOKUBO ; Yuki TOKUTAKE ; Yasutomo ISHII ; Koji UEDA ; Hiroshi MATSUOKA ; Kazue ISHIHARA
Journal of the Japanese Association of Rural Medicine 2014;63(4):588-595
With the introduction of the diagnosis procedure combination (DPC) system, the reduction of the health expenditure is expected. The use of generic drugs is promoted. It is imperative for introduction of generic drugs to assure the appropriate use of drugs to decrease medical costs without reducing medical services. Additionally, we should make a concerted effort to prevent the injudicious use of antimicrobial agents resulting in the emergence of drug resistance. In this study, we assessed the effects of switching to generic antimicrobial drugs on drug purchases cost, AUD (antimicrobial use density), hospital days, and antimicrobial susceptibility of Pseudomonas aeruginosa. This study was carried out at Yashima General Hospital for the period from April 2008 to September 2011. The Health, Labor and Welfare Ministry designated Yashima General Hospital as a DPC hospital from July 2009. Since the DPC introduction, the drug purchase cost has been decreased about 40% without reduction of AUD, hospital days, and antimicrobial susceptibility of Pseudomonas aeruginosa. Hospitals are making efforts to assess and improve management efficiency while maintaining the quality of medical care. Our results suggested that the introduction of generic drugs with assessment of efficacy may be one of the useful methods for pharmacy management.
10.Study on the efficacy of and adverse reactions to high-dose dexamethasone therapy for neurological symptoms of spinal cord compression due to malignant tumors
Masayuki Sato ; Tadashi Miyamori ; Junko Koyanagi ; Jutarou Murase ; Shohei Saka ; Noburou Ishii ; Tomohiro Nishi ; Tadashi Yamagishi ; Hiroshi Ishiguro
Palliative Care Research 2013;8(1):515-522
Objective: Spinal cord compression symptoms are complications that greatly reduce the quality of life of cancer patients. We report a retrospective study on the efficacy of and adverse reactions to high-dose dexamethasone therapy for patients with concomitant spinal cord compression symptoms. Subjects: This study included 8 patients with concomitant spinal cord compression symptoms who received high-dose dexamethasone therapy at our hospital between May 2009 and September 2011. Results: Only high-dose dexamethasone therapy was performed in 8 patients who could not undergo radiotherapy or surgery in combination. Among them, the results of manual muscle testing were improved in 4 patients (50.0%), and grades according to the modified Frankel Classification showed improvement in 5 patients (62.5%). Out of 7 non-ambulatory patients, one (14.3%) regained independent ambulation with highdose dexamethasone therapy alone and was discharged home. No serious adverse reactions were observed in any of the 8 patients. Discussion: This study suggested high-dose dexamethasone therapy to possibly be a useful option for relieving neurological symptoms in patients with spinal cord compression who cannot undergo radiotherapy or surgery in combination.


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