Safety Management System
Pharmaceuticals contribute to the health of people all over the world, and Daiichi Sankyo has established internal systems to ensure a high level of safety management. It conducts ongoing training to make sure that each employee is aware of and adheres to the Company's safety policies. Daiichi Sankyo exhaustively compiles safety management information (such as information on side effects) from around the world and provides accurate information on appropriate usage to medical professionals.
Provision of High-quality Information to Healthcare Professionals
Given that pharmaceuticals by nature have both benefits and risks that must be carefully balanced, it is important for pharmaceutical companies to generate high-quality information on their efficacy and safety, and to provide the information to the medical field in order to promote their proper use. In the early phase after the launch of a new drug, in particular, there is not a sufficient amount of information available to meet various needs in the medical practice, even though the efficacy and safety of the drug was confirmed in the development phase. Through cooperation among relevant units, the Daiichi Sankyo Group generates information through identifying necessary and missing information from professional viewpoints and conducting post-marketing surveillance*1 after obtaining cooperation from healthcare professionals. With the results provided on a timely basis to healthcare professionals through medical journals, conference presentations, and proper use materials, the proper use of drugs is promoted with the aim of contributing to medical technology.
High-quality information is information created under compliance with laws and regulations which possesses medical and scientific value. Therefore, we check compliance with relevant laws, regulations and guidelines, as well as ethical and scientific aspects, when conducting post-marketing surveillance. We also strive to create fair information by ensuring transparency through completing these procedures based on contracts with medical institutions and appropriately managing conflicts of interest.
Upon providing such information, the Safety Management Supervisor responsible for post-marketing safety control of pharmaceuticals, the Post-marketing Surveillance Management Supervisor responsible for post-marketing surveillance, the Quality Assurance Supervisor responsible for ensuring the quality of pharmaceuticals and shipping them to the market, and the marketing supervisor-general responsible for quality control of pharmaceuticals and post-marketing safety management collaborate as needed. All these supervisors are appointed and dismissed by the Company.
*1 A surveillance run by pharmaceutical companies for their products on day-to-day investigation through contracts with medical institutions based on the ministerial ordinance on GPSP (Good Post-Marketing Study Practice)
Collection of Information from Healthcare Professionals and its Feedback
Daiichi Sankyo collects about 44,000 pieces of safety information including side effects on commercially available products and study drugs annually from healthcare professionals in Japan. When including information from our partner companies abroad, about 95,000 pieces of information are collected in total (fiscal 2019 results). The Safety and Risk Management Department enters the information into the company’s global safety database management system to evaluate it and promptly send reports on findings to the regulatory authorities based on regulatory standards. Furthermore, once the safety information is analyzed globally, the latest findings are provided as feedback to healthcare professionals.
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Medical Affairs Division’s Activities
Since MA Unit launched a global MA structure in October 2017, a global medical plan for each product has been developed and activities related to creating and disseminating information based on the plan have been executed in 4 regions such as Japan, the US, Europe and ASCA with focus on the field of Oncology and the Specialty & Value Product.
Toward achieving the 2025 Vision, “MA unit strives to be a transformative strategic partner to deliver value-added medical solutions to enhance patient lives,” the Unit works every day with the aim of being a partner who delivers optimal medical solutions to stakeholders who provide and receive healthcare, including healthcare professionals, patients, patients groups, etc. around the world, by maximizing the contribution in pharmaceutical treatment through activities to generate and disseminate highly valuable evidence for pharmaceutics that the Daiichi Sankyo Group delivers to the world.
In fiscal 2019, data from clinical studies of edoxaban and prasugrel performed by the MA unit, as well as clinical study data on new products (mirogabalin, esaxerenone, quizartinib, and pexidartinib) and under-development oncology projects, were presented at academic conferences both in Japan and overseas and published in major journals to promote the dissemination of information to healthcare professionals. In fiscal 2020, we will further accelerate the dissemination of information. Based on the study results, we will exchange medical and scientific information with external medical experts to identify clinical questions (questions of patients and people practicing medicine regarding the use of pharmaceuticals) and obtain new evidence by planning and promoting company-initiated study programs for investigating such questions. We will thus promote activities to create and disseminate information needed by patients and people practicing medicine. The Unit also supports investigator-initiated study programs. Along with the activities to disseminate information, in fiscal 2020, we will work on a new product (trastuzumab deruxtecan) in the oncology field and will provide useful evidence to patients and healthcare professionals as early as possible.