Pharmacoepidemiology Research Network, Dunedin, New Zealand.
Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Eur J Clin Pharmacol. 2020 Jun;76(6):887-896. doi: 10.1007/s00228-020-02868-2. Epub 2020 Apr 4.
This study describes dispensing of potentially teratogenic prescription medicines before and during pregnancy in New Zealand over the period 2005-2015.
Records in a national dispensing database were linked with the members of the New Zealand Pregnancy Cohort to determine the proportion of pregnancies with at least one dispensing of a Category D or X medicine, using the Australian pregnancy risk categorisation system. Exposure was examined from 270 days prior to conception through to the end of pregnancy. Pregnancy outcomes of D/X-exposed pregnancies were reviewed.
In the study, 874,884 pregnancies were included. Overall, Category D and X medicines were dispensed during 4.3% and 0.058% of pregnancies, respectively. After excluding misoprostol, X exposure decreased to 0.035%. Generally, dispensing declined through the 270-day pre-pregnancy period and continued to decline throughout pregnancy. Dispensing of X medicines increased over the study timeframe, whereas dispensing of D medicines increased from 2005 to 2011 then declined slightly. Smokers were more likely than non-smokers to have been dispensed a D/X medicine, and compared with European women, Māori and Pacific women were less likely to have been dispensed a D/X medicine. Excluding misoprostol, pregnancies exposed to an X medicine were more likely than D/X-unexposed pregnancies to have ended in termination.
Dispensing of potentially harmful medicines in pregnancy in New Zealand was low, particularly for Category X medicines. However, exposure did increase over the study timeframe. The inclusion of pregnancies that did not progress past early pregnancy better reflects population-level pregnancy exposure to potentially teratogenic medicines.
本研究描述了 2005 年至 2015 年期间新西兰在怀孕前后配药潜在致畸性处方药的情况。
通过国家配药数据库中的记录与新西兰妊娠队列的成员进行了关联,以确定使用澳大利亚妊娠风险分类系统,至少有一种 D 类或 X 类药物配药的妊娠比例。从受孕前 270 天到妊娠结束时对暴露情况进行了检查。审查了 D/X 暴露妊娠的妊娠结局。
在研究中,共纳入了 874884 例妊娠。总体而言,D 类和 X 类药物分别在 4.3%和 0.058%的妊娠中配药。排除米索前列醇后,X 类药物的暴露率降至 0.035%。一般来说,在受孕前 270 天的时间里,配药量逐渐减少,并且在整个怀孕期间继续下降。X 类药物的配药量在研究期间有所增加,而 D 类药物的配药量从 2005 年增加到 2011 年,然后略有下降。与非吸烟者相比,吸烟者更有可能被配药 D/X 药物,与欧洲女性相比,毛利人和太平洋岛民女性被配药 D/X 药物的可能性较小。不包括米索前列醇,暴露于 X 类药物的妊娠比 D/X 未暴露的妊娠更有可能终止。
新西兰怀孕期间配药潜在有害药物的情况较低,特别是 X 类药物。然而,在研究期间,暴露量确实有所增加。纳入没有发展到早期妊娠的妊娠可以更好地反映人群中潜在致畸药物的妊娠暴露情况。