Hawcutt Daniel B, Russell Nicki-Jayne, Maqsood Hannah, Kouranloo Koushan, Gomberg Simon, Waitt Catriona, Sharp Andrew, Riordan Andrew, Turner Mark A
Department of Women's and Children's Health, University of Liverpool.
NIHR Alder Hey Clinical Research Facility.
Br J Clin Pharmacol. 2016 Dec;82(6):1601-1612. doi: 10.1111/bcp.13067. Epub 2016 Sep 12.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years.
Data on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA.
For infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0.96 YC per day. There was a male preponderance (male 49.1%, female 44.4%, unknown 6.5%), and only 34 (1.0%) of YC reports stated a gestational age. The medications most frequently reported were: transplacental and transmammary (fluoxetine, n = 21 and n = 4 respectively), neonate (swine flu vaccine, n = 8) infant (oseltamivir, n = 37) and vaccines (meningococcal vaccine, n = 693). Paternal, transmammary, neonatal and infant YC did not reflect clinical concerns raised by the UK regulator. Transplacental and vaccination reports did correlate with some of the changes in practice and clinical alerts received.
The frequency of YC reports for those <2 years is low, neonates are poorly represented, and recording of gestational age is poor. With the exception of vaccinations, spontaneous reports alone are not currently generating the data required, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies are required to improve the quantity and quality of suspected ADR data in young children.
英国药品和医疗产品监管局（MHRA）运行一个全国性自发报告系统（黄卡计划）来收集“疑似”药品不良反应（ADR）数据。我们旨在描述2岁以下患者收到的黄卡报告的内容和效用。
MHRA提供了2001年至2010年期间使用黄卡报告的所有2岁以下婴儿ADR的数据。
对于2岁以下婴儿，使用黄卡报告了3496例疑似ADR（受孕前父亲用药n = 3，经胎盘n = 246，经母乳n = 30，新生儿n = 97，婴儿n = 477，疫苗接种n = 2673），平均每天0.96份黄卡。男性占比更高（男性49.1%，女性44.4%，未知6.5%），只有34份（1.0%）黄卡报告注明了胎龄。报告最频繁的药物是：经胎盘和经母乳（氟西汀，分别为n = 21和n = 4），新生儿（猪流感疫苗，n = 8），婴儿（奥司他韦，n = 37）和疫苗（脑膜炎球菌疫苗，n = 693）。父亲、经母乳、新生儿和婴儿的黄卡未反映出英国监管机构提出的临床问题。经胎盘和疫苗接种报告确实与实践中的一些变化以及收到的临床警报相关。
2岁以下人群的黄卡报告频率较低，新生儿代表性不足，胎龄记录不佳。除疫苗接种外，目前仅靠自发报告无法生成所需数据，监管机构的重要安全信息与报告模式不匹配。需要额外的报告策略来提高幼儿疑似ADR数据的数量和质量。
