Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.
Oseltamivir prescription and regulatory actions vis-à-vis abnormal behavior risk in Japan: drug utilization study using a nationwide pharmacy database.
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日本针对异常行为风险的奥司他韦处方和监管行动：使用全国药房数据库进行的药物利用研究。
DOI：
10.1371/journal.pone.0028483
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Kawakami K
中科院分区：
文献类型：
--
作者：
Urushihara H;Doi Y;Arai M;Matsunaga T;Fujii Y;Iino N;Kawamura T;Kawakami K
2007 年 3 月，出于对异常行为的安全考虑，日本发布了一项监管建议，限制 10-19 岁儿童使用奥司他韦。尽管监管风险最小化行动具有重大的公共卫生影响，但其有效性和有效性仍有待审查。评估监管行动对处方实践和安全报告的影响。在对全国药房数据库的回顾性审查中，我们分析了2006年11月至2009年3月期间的100,344份奥司他韦和扎那米韦的配药记录。这些抗病毒药物的配药时间趋势在监管行动之前和之后呈现，与媒体报道的强度和抗病毒药物自发不良反应报告的数量形成鲜明对比。 2007 年的监管行动，加上媒体的广泛报道，使 2008 财年目标患者的奥司他韦用药量减少至 2006 财年的 20.4%，尽管这些财年之间的流感活动相当。相比之下，所有年龄段的扎那米韦给药量增加了约九倍。从2006财年到2008财年，10-19岁儿童中与奥司他韦相关的异常行为报告数量有所下降（24例减少到9例）；这一下降被 10 岁以下儿童异常行为报告数量的增加（12 至 28 例）所抵消。与扎那米韦相关的报告数量随着该药物配药量的增加而增加（11 至 114 例）。 2007年的行动有效减少了奥司他韦的处方量和目标群体异常行为的报告数量。观察到的 10 岁以下奥司他韦患者和扎那米韦患者异常行为报告的增加表明这些患者群体也可能处于危险之中，这使人对当前按年龄和药物进行歧视的有效性提出质疑（摘要翻译有日语版：附录 S1）。
In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases); this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases). The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases). The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question the validity of the current discrimination by age and agent (Abstract translation is available in Japanese: Appendix S1).
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影响因子：
2
作者：
Satoh, Kanako;Nonaka, Ryouichi;Uehara, Shin-Ichi
通讯作者：
Uehara, Shin-Ichi
影响因子：
4.2
作者：
Pariente, Antoine;Gregoire, Fleur;Moore, Nicholas
通讯作者：
Moore, Nicholas
影响因子：
168.9
作者：
Jefferson, T;Demicheli, V;Rivetti, A
通讯作者：
Rivetti, A
影响因子：
11.8
作者：
Morishima, T;Togashi, T;Okabe, N
通讯作者：
Okabe, N
影响因子：
2.6
作者：
Moore, N;Hall, G;Begaud, B
通讯作者：
Begaud, B