Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization's Reporting? A Pharmacovigilance Study in Southern Italy.
Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization's Reporting? A Pharmacovigilance Study in Southern Italy.
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DOI：
10.3389/fphar.2018.01003
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发表时间：
2018
影响因子：
5.6
通讯作者：
Capuano A
中科院分区：
文献类型：
--
作者：
Scavone C;Rafaniello C;Brusco S;Bertini M;Menditto E;Orlando V;Trama U;Sportiello L;Rossi F;Capuano A
尽管疫苗的作用得到了广泛认可，但覆盖率远未达到最佳水平，特别是在儿童中，这在意大利也是一个日益令人关切的问题。为了扭转这一紧急情况，意大利卫生部于2017年7月批准了第119/2017号法律，规定0-16岁的患者必须免费接种10种疫苗。我们的目的是研究新法律119/2017对意大利药物警戒数据库（Rete Nazionale di Farmacovigilanza - RNF）中与强制性疫苗相关的免疫接种后不良事件报告的影响。因此，我们分析了2016年12月1日至2018年3月31日期间坎帕尼亚地区（意大利南部）记录的免疫接种后疑似不良事件的自发报告。在研究期间，向坎帕尼亚药物警戒区域中心发送了69份与强制性疫苗相关的报告，涵盖179起AEFI。在第119/2017号法律通过后，AEFI报告大幅增加。在69份报告中，62%报告的AEFI被认为不严重，78%的结局良好。在179例AEFI中，超过一半涉及以下SOC：“全身性疾病和给药部位状况”、“神经系统疾病”和“精神疾病”。最多的报告来自患者/公民。第119/2017号法律通过后，报告数量有所增加（法律通过前为18份，通过后为51份）。根据整个期间报告的AEFI，没有出现令人担忧的安全数据。我们认为，AEFI报告数量的增加应与疫苗接种覆盖率的增加以及新法实施后的激烈辩论有关。在此背景下，持续监测疫苗安全性和全面实施疫苗警戒计划对于提高免疫计划的信心和实现最佳疫苗接种覆盖率发挥着关键作用。
Despite the well-recognized role of vaccines, coverage is far from optimal especially in children, representing a growing concern also in Italy. In order to reverse this emergency, the Italian Ministry approved in July 2017 the Law 119/2017, which renders mandatory and free of charge 10 vaccinations for patients aged 0–16. We aim to investigate the effects of the new Law 119/2017 on the reporting of adverse events following immunization related to mandatory vaccines into the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza – RNF). Therefore, we analyzed the spontaneous reports of suspected adverse events following immunization recorded in Campania Region (South of Italy) from December 1, 2016, to March 31, 2018. During the study period, 69 reports, covering 179 AEFIs, related to mandatory vaccines were sent to Campania Pharmacovigilance Regional Center. A substantial increase in AEFIs reporting was observed after the adoption of Law 119/2017. Out of 69 reports, 62% reported AEFIs that were considered as not serious and 78% had a favorable outcome. Out of 179 AEFIs, more than half referred to the following SOC: “general disorders and administration site conditions,” “nervous system disorders,” and “psychiatric disorders.” The highest number of reports came from patient/citizen. After the adoption of the Law 119/2017, there was an increase in the number of reports (18 before the adoption of the Law vs. 51 after). According to reported AEFIs during the entire period, no worrying safety data have emerged. In our opinion, the increase in the number of AEFIs’ reports should be related to the increase in vaccination coverage as well as to the intense debate that has followed the new Law. In this context, the continuous monitoring of vaccine safety and the fully implementation of vaccine–vigilance programs play a key role in achieving higher confidence in immunization programs and optimal vaccination coverage rate.
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影响因子：
4.8
作者：
Levi, Miriam;Sinisgalli, Ersilia;Bonanni, Paolo
通讯作者：
Bonanni, Paolo
影响因子：
4.2
作者：
Ferrajolo, Carmen;Scavone, Cristina;Capuano, Annalisa
通讯作者：
Capuano, Annalisa
影响因子：
5.5
作者：
Harris, Tara;Nair, Jyotsna;Deeks, Shelley L.
通讯作者：
Deeks, Shelley L.
影响因子：
5.5
作者：
Cheng, Daryl R.;Perrett, Kirsten P.;Crawford, Nigel W.
通讯作者：
Crawford, Nigel W.
影响因子：
--
作者：
Hu, Yu;Li, Qian;Qi, Xiaohua
通讯作者：
Qi, Xiaohua