Survey of the Description of “Medication Guides for Patients” and “Early Post-Marketing Phase Vigilance” on Additional Risk Minimization Activities of Risk Management Plans
- VernacularTitle:医薬品リスク管理計画のリスク最小化活動における「患者向医薬品ガイド」および「市販直後調査」の 記載に関する実態調査
- Author:
Hiroyasu SATO
1
;
Kiyomi ISHIDA
1
;
Ayaka OGASAWARA
1
;
Sae KANAZAWA
1
;
Saki KOSHINO
1
;
Yusuke KANETAKA
1
;
Hiroshi TAMURA
1
;
Hiroaki WATANABE
1
Author Information
- Keywords: risk management plan (RMP); early post-marketing phase-vigilance; risk minimization activities; drug information
- From:Japanese Journal of Drug Informatics 2019;20(4):207-212
- CountryJapan
- Language:Japanese
- Abstract: Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.
