Hepatocyte proliferation activity in untreated rats, measured by immunohistochemical detection of Ki-67: The effect of age on the repeated-dose liver micronucleus assay.

The repeated-dose liver micronucleus (RDLMN) assay is a widely accepted method for detecting genotoxic substances. We investigated the effect of animal age on this assay. Proliferation activity in the liver tissue of untreated rats at age = 3.5, 6, 8, 10, or 12 weeks was measured via immunohistochemical expression of Ki-67 protein. The percentage of Ki-67-positive hepatocytes decreased markedly with age, reaching very low levels after 10 weeks, indicating decline with age of proliferative capacities in the liver. We calculated the area under the curve (AUC) of the approximate curve generated from the percentage of Ki-67-positive cells, to estimate the hepatocyte proliferation activity over the dosing period in the two regimens of the 4-week RDLMN assay: dosing initiated at age = 6 or 8 weeks. Hepatocyte proliferation activity of the former regimen was approximately double that of the latter. We also calculated the AUC for the juvenile-rat method, in which rats are treated for two days at age = 3.5 weeks. The AUC calculated for that method was approximately half of that for the 4-week repeated-dosing regimen initiated at 6 weeks of age. These findings suggest that the 4-week RDLMN assay with dosing initiated at age = 6 weeks could be approximately twice as sensitive as the other two methods.

[Physiological Function and Congenital Deficiency of α-TTP, a Determinant of Vitamin E Transport in the Body -One Portion of the Research for Which the Pharmaceutical Society of Japan Award Was Given].

This review summarizes one portion of the research for which the author received the Pharmaceutical Society of Japan Award. The complete title of the awarded research is "Pharmacological Studies on Metabolism and Functions of Biomembrane Lipids". Because the awarded research is a very broad study, this review describes the discovery, physiological functions, and congenital defects of α-tocopherol transfer protein (α-TTP), a critical factor in determining the transport of vitamin E in the body, which has been the focus of the author's work throughout his research career.

Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology Industries.

The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on December 9, 2020, to provide a forum to discuss N-nitrosamine control strategies in the pharmaceutical and biotechnology industries. The panel included staff from the US Food and Drug Administration (FDA) and industry subject matter experts. Meeting topics included acceptable intake levels for nitrosamine impurities, definitions of "acceptable level of risk," water as a contributor in nitrosamine risk assessments, nitrosamine impurity control strategies based upon fate/purge data, early vs. late development assessment expectations, application to oncology programs developed under ICH S9, and Drug Master File (DMF) regulatory expectations. During the meeting, divergence in global health authority expectations was additionally discussed. One of the most important outputs from this AAPS panel discussion was the criticality of continued dialog between industry and health authorities to help understand actual versus perceived risks and provide pragmatic, scientifically justified solutions to ensure patients are provided with an uninterrupted supply of safe medicines based on globally harmonized requirements.

International Society of Oncology Pharmacy Practitioners (ISOPP) position statement: Role of the oncology pharmacy team in cancer care.

The Oncology Pharmacy Team (OPT), consisting of specialty-trained pharmacists and/or pharmacy technicians, is an integral component of the multidisciplinary healthcare team (MHT) involved with all aspects of cancer patient care. The OPT fosters quality patient care, safety, and local regulatory compliance. The International Society of Oncology Pharmacy Practitioners (ISOPP) developed this position statement to provide guidance on five key areas: 1) oncology pharmacy practice as a pharmacy specialty; 2) contributions to patient care; 3) oncology pharmacy practice management; 4) education and training; and 5) contributions to oncology research and quality initiatives to involve the OPT. This position statement advocates that: 1) the OPT be fully incorporated into the MHT to optimize patient care; 2) educational and healthcare institutions develop programs to continually educate OPT members; and 3) regulatory authorities develop certification programs to recognize the unique contributions of the OPT in cancer patient care.

Ensuring Healthcare Worker Safety When Handling Hazardous Drugs.

Hazardous drugs (HDs) are chemicals that demonstrate one or more of the following characteristics: carcinogenicity, genotoxicity, teratogenicity, reproductive toxicity, or organ toxicity. In addition, newer drugs with a structural or toxicity profile that mimics an agent known to be hazardous by one of the aforementioned criteria also should be treated as such. Any HD-handling activity can result in exposure for healthcare workers, as documented in a multitude of case reports and studies throughout the medical literature. Exposure to HDs has been associated with acute symptoms (e.g., nasal sores, hair loss, skin rash), adverse reproductive outcomes (e.g., infertility, miscarriage), genetic changes (e.g., chromosomal aberrations, sister-chromatid exchanges), and an increased occurrence of cancer.

[Promotion of Pharmaceutical Care and Sciences: Focus of the Japanese Society of Pharmaceutical Health Care and Sciences].

The 6-year education system for pharmacists was introduced in Japanese schools of pharmacy in 2006, after which a 4-year doctoral course system was established for advancing clinical pharmaceutical research. The roles of hospital pharmacists and community pharmacists have been expanded from drug dispensing to patient care. Clinical pharmacists practice patient care daily using evidence-based medicine and shared decision making. Clinical pharmacists also carry out research proactively for resolving clinical questions encountered in practice. The Japanese Society of Pharmaceutical Health Care and Sciences (JSPHCS) was established in June 1990, and its membership has expanded significantly. The society has over 12000 members including clinical pharmacists and those in pharmacies who participate in practice, research, and education. The JSPHCS functions as the main platform for pharmacy professionals. It holds annual meetings, publishes an academic journal, supports overseas study, and confers awards on exceptional individuals. It also authorizes JSPHCS-Certified Clinical Pharmacists, Board-Certified Oncology Pharmacists, and Board-Certified Pharmacotherapy Specialists. Recently, clinical pharmacy educational seminars and conferences for newly qualified pharmacists have been held to improve the quality of clinical research performed. Several subcommittees under the JSPHCS were newly established for promoting clinical pharmacy research. The mission of the JSPHCS is to promote clinical pharmacy research and systematize the evidence and information, thereby contributing to the healthcare of all.

Ethylene glycol and methanol ingestion cared for by tele-emergency pharmacy and tele-emergency medicine.

We believe this is the first documented case of a critically ill patient managed by telepharmacy in a remote, rural critical access hospital. We outline the case and the benefits of telepharmacy in under-resourced, rural critical access emergency departments.

[Supporting an Academic Society with the Active Learning Tool Clica].

　Within school classrooms, Active Learning has been receiving unprecedented attention. Indeed, Active Learning's popularity does not stop in the classroom. As more and more people argue that the Japanese government needs to renew guidelines for education, Active Learning has surfaced as a method capable of providing the necessary knowledge and training for people in all areas of society, helping them reach their full potential. It has become accepted that Active Learning is more effective over the passive listening of lectures, where there is little to no interaction. Active Learning emphasizes that learners explain their thoughts, ask questions, and express their opinions, resulting in a better retention rate of the subject at hand. In this review, I introduce an Active Learning support tool developed at Digital Knowledge, "Clica". This tool is currently being used at many educational institutions. I will also introduce an online questionnaire that Digital Knowledge provided at the 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences.

[Designing the Annual Meeting and Active Learning System].

　At the 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences our theme centered on active learning systems where adult learners engage on their own initiative. Many of the participants were pharmacists active in clinical practices. Regardless of their specialized skill-sets, pharmacists are constantly faced with difficult challenges in their daily work. Passive, one-way lectures are one resource for them, but unfortunately such lectures provide limited insights for resolving concrete problems. The present meeting aimed to show participants how to obtain information they need to solve specific real-world problems. This paper summarizes how we planned this year's meeting, including details about the debate symposium, social lunch, and online questionnaires. All these elements had the end goal of enabling learners proactivity to become their own best resource for learning. It is sincerely hoped that the design and execution of this meeting will prove resourceful for future annual meetings.

[Participants-centered Design of Annual Meeting: From the Perspectives of Instructional Systems].

　This paper examines the reform experience of the 10th Annual Meeting of the Japanese Society for Pharmaceutical Palliative Care and Sciences from Instructional Systems perspectives, to check whether it was effective, efficient, and appealing for participants. "Instructional Systems" has been a research area in educational technology for the past 50 years, and has also been applied to training and human resource development in healthcare domains. If an annual meeting is to be designed for participants' learning, then perspectives of Instructional Systems can be applied to interpret the effort of the reform. First, fill in the gaps of participants' knowledge, using before-and-after comparison. Design a conference to meet the needs of its participants by checking why they attend (expectations) and what they bring in (starting status). Second, design the conference as a process of innovation. The bigger the expected changes, the more carefully participants should be prepared to accommodate them. Third, follow plan-do-check-action cycles with data for confirming and revising the new ways of running the meeting. Plan to check "exportability" of the new ways, to assess whether it can be generalized to future meetings.

Aligning the AACP Strategic Engagement Agenda with Key Federal Priorities in Health: Report of the 2016-17 Argus Commission.

The Argus Commission identified three major federal priorities related to health care, including the precision medicine initiative, the Cancer Moonshot and the opioid abuse epidemic. Current activities at the federal level were summarized and an analysis of activities within the profession, and academic pharmacy specifically, was prepared. The implications for pharmacy education, research and practice are compelling in all three areas. Recommendations, suggestions and two policy statements aim to optimize the attention to these priorities by the academy. Further, aligning the AACP Strategic Engagement agenda with the opportunities and threats acknowledged in the analysis is essential.

Proposal for the Creation of a National Strategy for Precision Medicine in Cancer: a position statement of SEOM, SEAP and SEFH.

Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. Precision medicine is transforming clinical and biomedical research, as well as health care itself from a conceptual, as well as a methodological viewpoint, providing extraordinary opportunities to improve public health and lower the costs of the healthcare system. However, the implementation of precision medicine poses ethical-legal, regulatory, organizational and knowledge-related challenges. Without a national strategy, precision medicine, which will be implemented one way or another, could take place without the appropriate planning that can guarantee technical quality, equal access of all citizens to the best practices, violating the rights of patients and professionals and jeopardizing the solvency of the healthcare system. With this paper from the Spanish Societies of Medical Oncology (SEOM), Pathology (SEAP), and Hospital Pharmacy (SEFH) we highlight the need to institute a consensual national strategy for the development of precision medicine in our country, review the national and international context, comment on the opportunities and challenges for implementing precision medicine, and outline the objectives of a national strategy on precision medicine in cancer.

La medicina de precisión es un enfoque emergente para el tratamiento y prevención de las enfermedades que tiene en cuenta la variabilidad individual en los genes, el medio ambiente y el estilo de vida de cada persona. La medicina de precisión está transformando la investigación clínica y biomédica así como la asistencia sanitaria, tanto desde un punto de vista conceptual como metodológico, ofertando oportunidades extraordinarias para mejorar la salud pública y reducir los costes del sistema sanitario. Sin embargo, la implementación de la medicina de precisión supone un reto a nivel ético-legal, regulatorio, organizativo y de conocimiento. Sin una estrategia nacional, la medicina de precisión, que se implantará en cualquier caso, lo podría hacer sin la adecuada planificación que permita garantizar la calidad técnica, la equidad de los ciudadanos en el acceso a las mejores prácticas, vulnerando los derechos de pacientes y profesionales y arriesgando la solvencia del sistema de salud. Con este artículo de las sociedades españolas de Oncología Médica (SEOM), Anatomía Patológica (SEAP) y Farmacia Hospitalaria (SEFH) señalamos la necesidad de establecer una estrategia nacional consensuada para el desarrollo de la medicina de precisión en nuestro país, revisamos el contexto nacional e internacional, comentamos las oportunidades y los retos para la implementación de la medicina de precisión, y delineamos los objetivos de una estrategia nacional sobre medicina de precisión en el cáncer.