2.Current Progress of Acupuncture and Moxibustion Science-Review of Basic and Clinical ResearchReview of the Effects of Acupuncture and Moxibustion on Brain Function and Cerebral Disorders
Sae UCHIDA ; Ippei WATANABE ; Tadashi YANO ; Yuko SATO
Journal of the Japan Society of Acupuncture and Moxibustion 2004;54(1):27-51
Review of the effects of acupuncture and moxibustion on brain function and cerebral disorders in human and animals was presented. Firstly, in basic research on experimental animals, the change of cerebral blood flow induced by acupuncture and its mechanisms had been reviewed. Nextly, the effect of acupuncture and moxibustion on human brain function that measured from fMRI, PET, magnetoencephalography (MEG), EEG (including event related potential) have documented in the review of basic research on humans. Finally, effectiveness of acupuncture and moxibustion on stroke was reviewed, and its possibility of QOL-improvement of the patients was discussed.
6.Survey of the Description of “Medication Guides for Patients” and “Early Post-Marketing Phase Vigilance” on Additional Risk Minimization Activities of Risk Management Plans
Hiroyasu SATO ; Kiyomi ISHIDA ; Ayaka OGASAWARA ; Sae KANAZAWA ; Saki KOSHINO ; Yusuke KANETAKA ; Hiroshi TAMURA ; Hiroaki WATANABE
Japanese Journal of Drug Informatics 2019;20(4):207-212
Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.
7.Survey on Timing Related to Preparation and Publishing of Risk Management Plans
Hiroyasu SATO ; Kiyomi ISHIDA ; Yuki EBINA ; Sae KANAZAWA ; Yuki SANAI ; Tomoyuki SHIMAZU ; Hiroshi TAMURA ; Hiroaki WATANABE
Japanese Journal of Drug Informatics 2020;22(3):131-134
Objective: Risk Management Plan (RMP) is created and submitted by a pharmaceutical company while applying for new drug approval; it is published to be used by healthcare professionals. For example, healthcare professionals utilize RMP when considering whether to adopt a drug. However, there is no stipulation for the release date of RMPs; moreover, surveys regarding this are limited. We conducted a cross-sectional survey on the relationship between RMP-related timing and regulatory affairs-related timing.Methods: The surveyed drugs were those for which the first version of RMP was notified by PMDA Medinavi (mail delivery service) in FY2014 and FY2018. We examined regulatory affairs-related timing (i.e., “manufacturing and marketing approval date,” “drugprice standards listing date,” and “release date”) and RMP-related timing (i.e., “RMP creation date” and “Medinavi delivery date”).Results: For 7 of 43 items in FY2014 and 5 of 41 items in FY2018, the “RMP creation date” occurred later than the “drug-price standards listing date.” For one item in FY2014, the “RMP creation date” occurred later than the “release date.” For 12 items in FY2014 and 13 items in FY2018, the “Medinavi delivery date” occurred later than the “release date.”Conclusion: No considerable difference was confirmed between FY2014 and FY2018 regarding RMP-related timing and regulatory affairs timing. It was confirmed that there were several items for which the RMP creation occurred later than drug-price standard listing and items for which the publishing notice by Medinavi was delayed for drug marketing release. To promote the utilization of RMPs by healthcare professionals, RMPs must be created and published without delay.
8.Management of Male Infertility with Coexisting Sexual Dysfunction: A Consensus Statement and Clinical Recommendations from the Asia-Pacific Society of Sexual Medicine (APSSM) and the Asian Society of Men’s Health and Aging (ASMHA)
Eric CHUNG ; Jiang HUI ; Zhong Cheng XIN ; Sae Woong KIM ; Du Geon MOON ; Yiming YUAN ; Koichi NAGAO ; Lukman HAKIM ; Hong-Chiang CHANG ; Siu King MAK ; Gede Wirya Kusuma DUARSA ; Yutian DAI ; Bing YAO ; Hwancheol SON ; William HUANG ; Haocheng LIN ; Quang NGUYEN ; Dung Ba Tien MAI ; Kwangsung PARK ; Joe LEE ; Kavirach TANTIWONGSE ; Yoshikazu SATO ; Bang-Ping JIANN ; Christopher HO ; Hyun Jun PARK
The World Journal of Men's Health 2024;42(3):471-486
Male infertility (MI) and male sexual dysfunction (MSD) can often coexist together due to various interplay factors such as psychosexual, sociocultural and relationship dynamics. The presence of each form of MSD can adversely impact male reproduction and treatment strategies will need to be individualized based on patients’ factors, local expertise, and geographical socioeconomic status. The Asia Pacific Society of Sexual Medicine (APSSM) and the Asian Society of Men’s Health and Aging (ASMHA) aim to provide a consensus statement and practical set of clinical recommendations based on current evidence to guide clinicians in the management of MI and MSD within the Asia-Pacific (AP) region. A comprehensive, narrative review of the literature was performed to identify the various forms of MSD and their association with MI. MEDLINE and EMBASE databases were searched for the following English language articles under the following terms: “low libido”, “erectile dysfunction”, “ejaculatory dysfunction”, “premature ejaculation”, “retrograde ejaculation”, “delayed ejaculation”, “anejaculation”, and “orgasmic dysfunction” between January 2001 to June 2022 with emphasis on published guidelines endorsed by various organizations. This APSSM consensus committee panel evaluated and provided evidence-based recommendations on MI and clinically relevant MSD areas using a modified Delphi method by the panel and specific emphasis on locoregional socioeconomic-cultural issues relevant to the AP region. While variations exist in treatment strategies for managing MI and MSD due to geographical expertise, locoregional resources, and sociocultural factors, the panel agreed that comprehensive fertility evaluation with a multidisciplinary management approach to each MSD domain is recommended. It is important to address individual MI issues with an emphasis on improving spermatogenesis and facilitating reproductive avenues while at the same time, managing various MSD conditions with evidence-based treatments. All therapeutic options should be discussed and implemented based on the patient’s individual needs, beliefs and preferences while incorporating locoregional expertise and available resources.