Abstract
Objective: Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website. The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.
Methods: The risks listed in RMPs on the PMDA website were assessed on February 10, 2014. We investigated the documentation of these risks on the PL.
Results: Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs. The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%). Ninety-four percent of risks listed in RMPs were documented on the PL. A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.
Conclusion: This study was clearly the relation between risks listed in RMPs and documents on the PL. Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information. It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.
