2020 Volume 10 Issue 3 Pages 87-98
An internet-based questionnaire survey was conducted to evaluate effectiveness of an additional risk minimization activity in the Risk Management Plan (RMP), an information material of Xofluza (baloxavir marboxil) for patients, in terms of receipt and understanding of the material and implementation of countermeasures according to the material. The result showed that high percentage of parents who received and read the material took countermeasures to minimize the risk. At the same time, various and practical challenges from the viewpoints of the contents as well as the procedure of the survey came out. Risk minimization activities are planned and conducted to ultimately secure and enhance safety of patients, and there is no question about the necessity of checking whether the activities are actually accomplishing their original purpose. However, the process and methodology have not been established, and we need to deepen our consideration of them based on the accumulating information and experience along with the implementation of the RMP scheme.
