Safe Use of Recent New Drugs-Current Status and Challenges

Abstract

In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.