薬学教育において新生児医療の概要，小児薬物療法を学ぶ機会は限られている．そこで本学では薬学部5年生を対象に「医療プロフェッショナリズム」のなかで「新生児医療と薬剤師」（3コマ）の授業を実施している．授業では，新生児集中治療室の紹介や新生児蘇生のビデオを視聴し，命の誕生の尊さや新生児医療の緊急性など具体的にイメージをもち理解できるよう工夫した．学生へのアンケート結果から，新生児集中治療室における薬剤師の役割理解についてほぼ全員の学生が理解できたとし，98%の学生が6年間の薬学教育のなかで新生児医療を学ぶことは意義があると回答した．約半数の学生が薬剤師として新生児分野へ貢献したいとし，子どもの命を「救う」「助ける」「守る」ことに対し自身の役割を見出していた．本授業は学生自身が新生児医療への具体的な目標設定をする機会となり，医療プロフェッショナリズム教育としての有効性が示唆された．

　はじめに

　18トリソミー（症候群，T18）は18番染色体の，13トリソミー（症候群，T13）は13番染色体の全部あるいは一部が3コピーあることに基づく常染色体異数性異常症である．有病率はT18では1/3,500〜8,500人，T13では1/5,000〜12,000人とされている^1）．T18では先天性心疾患，食道閉鎖などの，T13では先天性心疾患，全前脳胞症などの多彩な合併症を有し，ともに胎児期からの成長障害（T18では重度）と出生後の重度精神運動発達遅滞を呈する．生命予後に関して，大規模なpopulation-based studyに基づく2000年頃までのエビデンスでは，1年生存率はT18，T13ともに5.6〜9.0％であり，生存期間の中央値はT18で10〜14.5日，T13で7〜10日とされた^2）．また，死亡原因はともに中枢性無呼吸であり，先天性心疾患に対する外科的治療は適応がないとされていた^3）4）．

薬剤師としての倫理観は日々の学びや経験のなかで醸成され，薬学6年間及び卒後の実践を通して培われていくものである．東京薬科大学薬学部2年生の履修科目「ゼミナール」において，独自に製作した倫理ビデオ教材「残薬調整を嫌がる患者」「若年性認知症の家族への対応」「問診表とお薬手帳を活用しきれていないケース」を用い，薬剤師が日常業務のなかで直面する倫理的問題を題材にし，気づきを促すための講義を行った．臨床の場面を可視化したビデオ教材の活用により，学生は患者一人ひとりの状況や背景をより具体的に捉え，患者の価値観を受容するとともに，患者の自己決定を促すよう解決策を考えることができた．また，グループワークからは他者の意見を聞くことにより自分とは異なる多様な考えや視点があることに気づきを得た．本講義の試行は実践的な臨床倫理教育におけるアクティブ・ラーニングの導入モデルとしての有効性が示唆された．

In Japan, the centralization of institutional review boards (IRBs) has been considered with the objectives to standardize the quality of the review process for multicenter studies and to facilitate efficient and speedy implementation of clinical trials and research. Therefore, we visited some core facilities in Taiwan to observe the IRB meetings for clinical studies, and to exchange ideas with staff of the IRB secretariats. Furthermore, we researched the pioneering review mechanisms for multicenter, sponsor-initiated clinical trials in Taiwan. In Taiwan, the Joint IRB (J-IRB: a type of centralized review system) was established in 1997. This review system contributed to improve the quality of ethical reviews in the country. However, because the J-IRB was not fully government-initiated, many co-operating sites gradually started to conduct their own reviews, and this tendency caused a decline in the efficacy of the J-IRB. Following this, the Taiwanese government enacted a law called the Human Subjects Research Act in 2011. Moreover, the government also started the Central IRB (C-IRB) system in 2013, which is a central-local hybrid type of ethical review system for multicenter clinical trials. The establishment of the C-IRB system increased the number of sponsor-initiated clinical trials. The new Human Subjects Research Act allowed each site to develop appropriate organizational structures, and thus maintained the high quality of clinical studies, regardless of whether they were sponsor-initiated or investigator-initiated studies. Considering the future Japanese goals to conduct ethical reviews and to organize the operational structures of medical facilities, we identified many constructive ideas based on the Taiwanese challenges in past decades.

背景：近年18トリソミーの先天性心疾患（CHD）に対する手術の報告が増加している．当院は在宅移行を目標として治療を行っているがCHD手術の経験はない．積極的な新生児治療下でのCHD手術非介入例の経過を検討する．

方法：2005年4月から2015年12月に出生した18トリソミー計17例を対象とし，出生状況，生存率，在宅移行率，死亡原因などについて診療録に基づき後方視的に検討した．さらに心不全が症候化しうると考えられた肺血流増加型疾患のCHD例をLarge Shunt（LS）群として症状の有無を追加検討した．

結果：全例にCHDを認めた．1年生存率64.7％，在宅移行率70.6％，退院日齢は16～285日（中央値129日）であった．死亡例の生存期間は0～1,054日（中央値104.5日）であった．LS群8例のうち5例（62.5％）が1年以上生存し，いずれも心不全は症候化しなかった．死亡3例のうち2例は心不全が原因と考えられた．

結論：本検討ではCHD手術以外の標準的な新生児治療により，高い生存率・生存退院率が得られた．肺血流増加型のCHDを合併した18トリソミーは手術介入なく安定して経過する場合がある．肺血管閉塞性病変により生後の肺高血圧が持続することで，心不全が進行しなかったことが原因と考えられた．遠隔期の予後改善を目的としたCHD手術が有効であるかは明らかではなく，治療の選択肢として提案するにあたり，情報の蓄積が望まれる．

 近年，神経・筋疾患，小児がん，造血器疾患に対する新しい遺伝学的解析法と治療薬が次々に開発され，これらは難治疾患を抱える子どもと家族に大きな希望を与えた．一方，小児科医が判断すべき治療法とその選択過程は複雑・多様化した．小児科医が子どもの代弁者として決断すべき選択肢は，法的・倫理的妥当性が許容される範囲内で，今後さらに多様化すると予測される．患児の利益をどのように擁護し，何を守るべきかに関して，主治医は決断までの過程を短縮・効率化することはできない．生と死の臨界点に際し，家族・医療者が双方に納得する合意を形成するには，合意を求めずに議論を尽くす覚悟もまた必要である．小児科におけるトランスレーショナル研究とは，実践臨床から生命倫理の本質を見出す努力に他ならず，答えのない難問について悩み続ける科学ではなかろうか．

Gifu Pharmaceutical Association conducted a survey on the actual situation of family pharmacists in collaboration with Gifu Pharmaceutical University in 2016. Data of 3,340 people were obtained from 342 pharmacies. A total of 2,666 patients received prescriptions in May 2017 and family pharmacists were assigned to 221 patients (8.3％). The patients group who selected family pharmacists had a greater tendency to bring all the prescriptions to the same pharmacy, to bring the medicine notebook with the prescriptions, and to buy over the counter drugs (OTC) from the family pharmacy than the group not covered by the family pharmacists. The patients ask family pharmacists for reliability, health consultation, and advice in selecting OTC. They are satisfied with family pharmacists on consultations being responded to at any time and feeling that they could ask questions that they could not ask the doctor.

In response to the “Pharmacy Vision for Patients in Japan,” the family pharmacist system began in 2016. Gifu Pharmaceutical University, in collaboration with the Gifu Prefectural Pharmaceutical Association, investigated the correspondence situation of pharmacies one year after the system commenced. Items surveyed in this study were dispensing fees, prescription checking fees, and so forth. We divided the pharmacies into family pharmacies (certified as a family pharmacist), and control (not certified as a family pharmacist) groups. The dispensing fees and prescription checking fees, such as preventing duplicate administration and drug interactions, were significantly higher in the family pharmacy group. We also investigated the awareness of the function and role of pharmacists. Most pharmacists in the family pharmacy group recognized the role of pharmacists as consultants for residents. Findings suggest that family pharmacies fulfill the function required by the pharmacy vision for patients, and have a high awareness of community health consultation.

【Objective】 Nowadays, the pharmacist’s work changed from product-centered to patient-centered care. In this research, we make it clear through patient’s talk what a patient expects of a family pharmacist and a pharmacy. We think it is utilized to construct a communication standard required for family pharmacists. 【Method】 Focus group interviews were conducted with 3 groups of 11 patients who utilize pharmacies, recruited through snowball sampling. Interview data were categorized using qualitative analysis method. 【Results】 As a result of analysis, 7 categories and 43 subcategories were generated. Based on these, a diagram was created representing the relationships between categories. 【Discussion】 The generated categories indicated “factors influencing patient’s relationship with pharmacists” and subcategories indicated “requests to or expectations from pharmacists by patients.” Many of them overlapped with the image of “family pharmacist/pharmacy” depicted in the “Pharmacy Vision for Patients” indicated by the Ministry of Health, Labour and Welfare in 2017. Meanwhile, patients wanted attitude, ethics, and sense of mission as basic qualifications originally required in a medical professional. Moreover, the research showed broader viewpoints and expectations for advanced communication skills such as support of patient’s self-determination of medication, relationship between the patient and the physician, and consideration of social and economic background of the patient.

Object: In this study, we conducted a fact-finding investigation to determine the reason for the gap between medical services provided by family pharmacists and the medical needs of patients, and examined factors that affect the rate of signing consent forms.

Methods: This study implemented an Internet questionnaire survey of patients who regularly use pharmacies owing to chronic diseases, and family pharmacists, surveying information on the services provided by family pharmacists.

Results: The survey extracted “inventory of leftover drugs”, “providing consultations outside pharmacy hours”, “introducing local medical/nursing facilities”, and “home visits”, as characteristic services that patients expected to be provided by family pharmacists. In addition, family pharmacists provided these four services at rates of 87.4, 75.9, 51.7 and 48.5%.

Conclusion: These results suggest a possible discrepancy between the functions of family pharmacies required by patients and the medical services provided by family pharmacists. Steps should be taken to match services provided by family pharmacists with the needs of the patients, to increase the rate of signing consent forms.