Consideration of post-marketing drug safety assessment in hospitals

[Speaker] Takahiro Kawakami:1,2
[Co-author] Katsuhiko Nagase:1, Yuko Yokoi:1,2, Akiko Kuwajima:1, Shingo Itai:2, Yusuke Hara:2, Tsutomu Shimada:2, Yoshimichi Sai:2, Toshinori Murayama:1,3
1:Innovative Clinical Research Center, Kanazawa University, Japan, 2:Department of Hospital Pharmacy, University Hospital, Kanazawa University, Japan, 3:Department of Clinical Development, Kanazawa University Hospital, Japan

Background: Recently, pharmacovigilance and drug safety assessment in post-marketing phase have become more important as various regulations for early access to medicines have developed. Approval review is conducted based on clinical trial data, in which severity assessment of adverse events (AEs) is strictly performed. If similar severity assessment has been done also in post-marketing, safety information in the real world will be available by extracting data from the assessment. However, it is unknown how rigorously the side effect monitoring is performed in clinical practice. We therefore considered what post-marketing drug safety assessment would be in the future through examining how clinical pharmacists assess the severity of AEs.
Methods: We carried out questionnaire survey for 26 pharmacists in Kanazawa university hospital who are responsible for drug management guidance about following contents; the state of severity assessment, the index of assessment, the type of drugs to be assessed, and the criteria of spontaneous reports.
Results: All of 26 pharmacists assessed the severity of AEs based on some index. Twenty-six pharmacists used Common Terminology Criteria for Adverse Events (CTCAE) and 6 pharmacists used the severity classification (mild / moderate / severe) regarding interference with daily living. The assessed drugs were anti-tumor agents (81%, n = 21), agents with dose reduction / withdrawal criteria in the label (46%, n = 12), all agents (19%, n = 5), and immunosuppressant (15%, n = 4). The criteria of reporting adverse reactions were seriousness (100%, n = 26), expectability (50%, n = 13), and severity (12%, n = 3).
Conclusions: All pharmacists assessed the severity of AEs by CTCAE in clinical practice, especially for anti-tumor agents. By using the real world data extracted from those assessments, it is possible to complement safety information which could not be obtained sufficiently by clinical trials. Severity assessment of various medicines also may be significant in pharmacovigilance. If the awareness of post-marketing drug safety assessments permeates, the severity index can be useful criteria in spontaneous reports.
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