Pharmacovigilance in pregnancy using population-based linked datasets
Pharmacovigilance in pregnancy using population-based linked datasets
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DOI：
10.1002/pds.1705
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发表时间：
2009-03-01
影响因子：
2.6
通讯作者：
Bower, Carol
中科院分区：
文献类型：
--
作者：
Colvin, Lyn;Slack-Smith, Linda;Bower, Carol
目的国家补贴处方药配药数据最近已被批准与西澳大利亚州以人口为基础的健康数据集相关联，为研究这些药物的使用方式及其对怀孕结果的影响创造了能力。方法2002年至2005年，在医院发病率数据系统中确定怀孕事件(N=164278入院；N=98265名妇女)，并与助产士通报系统、出生和死亡登记、西澳大利亚州出生缺陷登记和药品福利计划相联系。结果共分娩106074例，宫外孕1527例，终止妊娠25180例。配药与28.0%的怀孕事件有关。多胎妊娠在怀孕前三个月服用药物的可能性要高出50%。随着产次的增加，在怀孕期间分发药物的可能性也增加了。服用药物的女性在怀孕期间吸烟的可能性是女性的两倍，患有登记出生缺陷的可能性增加了14%。在怀孕的前三个月，D或X类药物在怀孕期间的使用风险被分配到所有怀孕事件的2.1%。世界卫生组织ATC的“精神分析药物”类别被分配到所有怀孕事件的3.8%。结论将分配数据与怀孕事件联系起来是可行的，这种用于上市后监测的方法将增加澳大利亚现有的资源，以调查怀孕期间安全使用处方药的怀孕结果。版权所有(C)2009 John Wiley&Sons，Ltd.
Purpose National dispensing data for subsidised prescription medicines have recently been approved for linkage to the population-based health datasets in Western Australia (WA), creating the capacity to study how these medicines are used and their impact on pregnancy outcomes.Methods Pregnancy events were identified in the Hospital Morbidity Data System from 2002 to 2005 (N = 164278 admissions; N= 98 265 women) and linked to the midwives' notification system (MNS), the registry of births and deaths, the Western Australian birth defects registry and the pharmaceutical benefit scheme. Dispensing records were extracted for each pregnancy event (N = 1276 084 dispenses).Results There were 106074 births, 1527 ectopic pregnancies and 25 180 terminations of pregnancy. Dispensed medicines were linked to 28.0% of the pregnancy events. Multiple birth pregnancies were 50% more likely to be dispensed a medicine in the first trimester. As parity increased, so did the likelihood of a medicine being dispensed in pregnancy. Women who were dispensed a medicine were twice as likely to smoke during pregnancy and were 14% more likely to have a registered birth defect. During the first trimester, medicines from category D or X of the risk of drug use in pregnancy were dispensed to 2.1% of all pregnancy events. The WHO ATC 'Psychoanaleptics' category was dispensed to 3.8% of all pregnancy events.Conclusion Linkage of dispensing data to pregnancy events is feasible and this approach to post-marketing surveillance will add to the resources available in Australia to investigate pregnancy outcomes in relation to the safe use of prescribed medicines in pregnancy. Copyright (C) 2009 John Wiley & Sons, Ltd.