Special Issue on “Evaluation of Risk Minimization Plan”
2．Points for Evaluation of the Revised Risk Minimization Plans on Thalidomide and its Derivatives
2017 Volume 22 Issue 1 Pages 9-18
Details
2017 Volume 22 Issue 1 Pages 9-18
Thalidomide and the derivatives, lenalidomide and pomalidomide, are the most potent teratogenic medicines. Thalidomide Education and Risk Management System （TERMS®）and RevMate® for lenalidomide and pomalidomide have been operated with a goal of no exposed embryo to the drugs. The TERMS®and the RevMate®, a centralized management system, were revised in 2016 according to a request by a patient group. After the revision, the patient self-check sheet on adherence to conception prevention is primarily confirmed by his/her doctor, and the content of the completed sheet is sent to the management center in the pharmaceutical company after dispensing of the drug. The points for evaluation of the revised system will be as follows. (1) Has an appropriate procedure in accordance with the revised system been established in respective hospitals? (2) The rate of non-compliance with the procedure by the doctors or pharmacists, (3) Effect on awareness and behavior of the patients. Questionnaire studies of the patients, doctors, and pharmacists have been performed by the third-party committees.
