3．Revision of Procedures for Appropriate Management of Revlimid® and Pomalyst® （RevMate®）and Issues for the Future / 薬剤疫学

ABSTRACT

RevMate®is one of risk minimization activities in Japanese RMPs of Revlimd®and Pomalyst®, of which indications are hematological malignancy including multiple myeloma. This is a proper management procedure approved by Japanese health authorities in order to prevent exposure to pregnant women because these agents are derivatives of thalidomide. RevMate® was revised in 2015 after the discussion in MHLW's Taskforce and its operation started from April 2016. Due to this revision of version 5.0, the manufacture no longer receives the patient name, and this and other information must be managed by the hospital. In addition, with regard to the same objective in the format used in the management procedure（TERMS®）of thalidomide drug products, unification was attempted concerning the name of the format andthe notation of confirmation items. Physician becomes to make judgment to omit explanation of some RevMate® requirements based on the patient's level of their understandings to RevMate®. Periodical survey sheet regarding compliance with RevMate® requirement filled by a patient is to be submitted directly to a physician on his/her visit instead of sending it to the manufacturer by mail under previous procedures. A representative person of the manufacture is required to visit the hospital periodically and confirm filing condition of the survey sheets and compliance check lists of RevMate® for every prescription as well appropriately at the hospital. Furthermore, RevMate® was revised to add clear role description of relevant pharmacists and nurses for in-patients and its strict drug-handling procedures at bedside as version 5.1, as we received four reports from hospitals of medication error of our drug to the another patient in the hospital within 2016. After getting approval of additional indications for Revlimid® from March 2017, RevMate® of version 5.2 started. In the view of implement RevMate® as strict “risk minimization activities” to prevent pregnant women from exposure, we will continue to solve each problem recognized from the actual operation, constantly keep basics in mind by providing necessary training to our employees about thalidomide drug problem etc. In addition, we appreciate the understanding and support from the patient, patient family, Healthcare Professional, etc. involved in this procedure without incompleteness as well as non-compliance with procedures caused by habituation. Including all these, we consider it is important to endeavor as a manufacture continuously in the future.