[Making Patient-focused Information Provision a Reality: One Company's Approach].

In recent years, as the market has seen the appearance of innovative medical products with novel mechanisms of action, adverse reactions that cannot be expected from the approved product label are being detected in the postmarketing phase. It is increasingly important to undertake timely product label updates and other drug safety measures through the monitoring, early detection, and reporting of adverse reactions. In 2013, the risk management plan (RMP) system was introduced in Japan. An RMP documents efforts to ensure the safety of a medical product, and sharing the RMP with stakeholders results in enhanced postmarketing safety measures. Healthcare providers have already started to utilize RMPs, but issues with perception and utilization remain. The industry, regulators, and academia are also working together to facilitate the use of RMPs. With the implementation of the RMP requirement, pharmaceutical companies are seeking to improve safety assurance by enhancing their drug safety functions, including the collection, assessment, and dissemination of drug safety information. Chugai Pharmaceutical is starting a completely new approach to patient-focused information provision, exemplified by the "PMS & SAFETY DB Tools," designed to give healthcare providers quick access to its extensive database of real-world drug safety information. This paper introduces Chugai Pharmaceutical's new efforts to manage adverse reactions and raises issues for future consideration.