リスクコミュニケーション推進のためのPMDAの情報提供への取り組みと課題

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タイトル別名
  • The Pharmaceuticals and Medical Devices Agency's Approach to Facilitate Risk Communication and Its Challenges
  • Symposium Review リスクコミュニケーション推進のためのPMDAの情報提供への取り組みと課題
  • Symposium Review リスク コミュニケーション スイシン ノ タメ ノ PMDA ノ ジョウホウ テイキョウ エ ノ トリクミ ト カダイ

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抄録

　The issue of drug lag in Japan has been rapidly reduced in recent years, and newly approved drugs now become available on Japanese and international markets at the same time. In this context, the risk management plan (RMP) system was introduced in 2012. RMPs describe important safety concerns recognized by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and marketing authorization holders (MAHs), as well as safety measures that MAHs request healthcare professionals (HCPs) to follow. The publication of RMPs is expected to support the sharing of drug risk management among HCPs during the postmarketing phase. In addition, to encourage risk communication between HCPs and patients, the PMDA website provides drug guides for patients and other information to promote proper understanding of drugs by patients and their families and enable them to identify serious adverse drug reactions at an early stage. However, the results of surveys conducted by the PMDA in FY2014 and FY2015 revealed low levels of awareness of RMPs and drug guides for patients in hospitals and other healthcare institutions. The surveys also showed that information regarding the proper use of drugs from MAHs and the PMDA was not incorporated into practice at healthcare institutions, resulting in the repeated release of identical safety alerts. To facilitate the increased utilization of risk communication tools, the PMDA has been providing and disseminating these tools through its website. This study addresses those efforts and the associated challenges.<br>

収録刊行物

  • 薬学雑誌

    薬学雑誌 138 (3), 307-314, 2018-03-01

    公益社団法人 日本薬学会

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