Safety Evaluation and Information Provision for Appropriate Drug Usage in Elderly Patients in Japan

The elderly Japanese population is growing rapidly due to increasing longevity and declining birth rates. These findings have implications for drug development and safety in elderly patients; however, the Japanese stakeholders have been slow to adapt. This study aimed at examining methods for providing sufficient information on safe use of pharmaceuticals in elderly patients in Japan. For new drugs recently approved in Japan for diseases with a high prevalence among the elderly, we investigated the state of safety information provision for elderly patients through the package insert and also safety data evaluation in elderly patients in clinical studies. Of the 64 targeted drugs, only 14 provided geriatric use information based on clinical study data or indication, 38 had general cautionary descriptions, and 12 did not have geriatric use information. Most drugs met the recommendation of enrolling >100 elderly patients in the clinical development program. However, a discrepancy was observed in the proportion of elderly patients in clinical trials compared to that in real-world clinical setting. Twenty-nine drugs compared the incidence of key adverse events (AEs) in elderly and younger patients, whereas 25 only reported the overall incidence of AEs. To improve healthcare outcomes, healthcare professionals need access to sufficient safety information through package inserts containing data from clinical trials. Marketing authorization holders and regulatory authorities must work together to ensure that such safety information based on sufficient data is included in package inserts.