Survey of the Description of the Risk Minimization Activities in Pharmaceutical Risk Management Plans
10.11256/jjdi.19.32
- VernacularTitle:医薬品リスク管理計画におけるリスク最小化活動の 記載内容に関する調査
- Author:
Hiroyasu Sato
;
Shintaro Hirasawa
;
Sayumi Kadono
;
Tomohiro Haruyama
;
Kohei Fujita
;
Yusuke Kanetaka
;
Hiroshi Tamura
;
Hitoshi Komori
- Keywords:
risk management plan;
drug information;
risk minimization activities
- From:Japanese Journal of Drug Informatics
2017;19(1):32-36
- CountryJapan
- Language:English
-
Abstract:
Objective: Currently, the creation of a pharmaceutical risk management plan (RMP) for new drug information is obliged to pharmaceutical companies. The created RMP is published on the Pharmaceuticals and Medical Devices Agency (PMDA) website. RMP is a useful information source to ensure drug safety by healthcare professionals, including pharmacists. “Risk minimization activities” of the RMP are especially important elements for healthcare professionals because they describe measures to minimize risk to patients. We conducted a cross-sectional survey of the description of the contents of “risk minimization activities” in the RMP.
Methods: The RMP of 177 drugs that had been published in February 22, 2016 were investigated.
Results: Total risks enumerated for the study drugs were 1,678. “Routine risk minimization activities” constituted 92.0% of total risks. The most listed item on “routine risk minimization activities” was “attention on the product labeling of the drug package insert” (91.3%). Differences in the expression level on “attention on the product labeling” were observed. On the other hand, the most listed item of “additional risk minimization activities” was “the creation of documents for healthcare professionals” (38.3%) and “implementation of Early Post-marketing Phase Vigilance” (27.1%).
Conclusion: A clear understanding of RMP by healthcare professionals is important. In the RMP, “risk minimization activities” (especially “additional risk minimization activities”) are the most important contents for healthcare professionals, because they include information of documents created by the pharmaceutical company for patient safety. The level of description of the contents of RMP varies between drugs. It is essential that these descriptions be uniform the expression level to be easily and accurately utilized by healthcare professionals.
