| アブストラクト | OBJECTIVE: Spontaneous reports of adverse drug reactions (ADRs) are an essential data source for pharmacovigilance activities. However, spontaneous reporting is affected by under-reporting, which can lead to bias in statistical signal detection and failure to identify potential drug-associated risks. This study aimed to estimate the degree of under-reporting of suspected serious ADRs (sADRs) in spontaneous reports in Japan. METHODS: The new active ingredients approved in Japan between 2010 and 2016 for which all-case surveillance was conducted were selected for this study. Data of sADR reports were extracted from the Japanese Adverse Drug Event Report database (JADER). An interrupted time series (ITS) analysis was conducted to compare the number of sADR reports (sADR cases) obtained in the all-case surveillance period with that obtained in the spontaneous report period (after all-case surveillance had been completed). RESULTS: The ITS analysis of all sADR cases revealed that 24 (68.6%) of the 35 investigated drugs showed a statistically significant decrease in the intercept (level) in the spontaneous reporting period compared with that in the all-case surveillance period. The median of the reduction rate of the level was 60.1%. The number of drugs with a statistically significant decrease in the level of cases with sADRs in the Important Medical Event list and in that leading to death was 19/35(54.3%) and 6/35 (17.1%), respectively. CONCLUSION: This study demonstrated the existence of sADR under-reporting in spontaneous reports in Japan quantitatively. Meanwhile, it was suggested that information on sADRs was reported appropriately according to their level of severity. |
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| ジャーナル名 | Therapeutic innovation & regulatory science |
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| 投稿日 | 2022/2/7 |
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| 投稿者 | Ito, Satoru; Narukawa, Mamoru |
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| 組織名 | Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of;Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo,;108-8641, Japan. satoru.itou.fh@kyowakirin.com.;Kyowa Kirin Co., Ltd., Tokyo, Japan. satoru.itou.fh@kyowakirin.com.;108-8641, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35124790/ |
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