Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, Western Cape, South Africa.
Health Impact Assessment, Department of Health, Provincial Government of the Western Cape, Cape Town, Western Cape, South Africa.
Drug Saf. 2021 Jan;44(1):41-51. doi: 10.1007/s40264-020-00987-4.
Growing evidence of the teratogenic potential of sodium valproate (VPA) has changed prescribing practices across the globe; however, the impact of this research and the consequent dissemination of a Dear Health Care Professional Letter (DHCPL) in December 2015, recommending avoidance of the teratogen VPA in women of childbearing age (WOCBA) and pregnant women in South Africa, is unknown. We explored trends and reasons for VPA use among pregnant women and WOCBA in the public sector in Western Cape Province from 1 January 2015 to 31 December 2017.
Using the provincial health information exchange that collates routine electronic health data via unique patient identifiers, we analysed clinical and pharmacy records from 2015 to 2017 to determine prescription patterns of VPA and other antiepileptic drug (AED) and mood-stabilising medicine (MSM) use in WOCBA and pregnant women. Senior clinicians and policy makers were consulted to understand the determinants of VPA use.
At least one VPA prescription was dispensed to between 8205 (0.79%) and 9425 (0.94%) WOBCA from a cohort of approximately 1 million WOCBA attending provincial health care facilities per year. Prescriptions were more likely in HIV-infected women compared with HIV-uninfected women (1.1-1.3% vs. 0.7-0.9%; p < 0.001). VPA use in WOCBA remained stable at 0.8-0.9% over the review period despite the 2016 DHCPL. VPA was the most prescribed AED/MSM, constituting 43.2-45.5% of all WOCBA taking at least one such agent, while lamotrigine, the other recommended first-line agent, was only prescribed in 7.8-8.9% of WOCBA. Over 3 years, approximately 663 pregnancies were exposed to VPA, with a steady rise in the number of exposures each year (n = 204, 214 and 245, respectively).
Despite warnings, VPA remained the most frequently prescribed AED or MSM in WOCBA. Contributing factors are described.
越来越多的证据表明丙戊酸钠(VPA)具有致畸性,这一发现改变了全球范围内的处方实践;然而,这项研究的影响以及随之而来的 2015 年 12 月发布的《致卫生保健专业人员的信》(DHCPL)的传播,建议南非育龄妇女(WOCBA)和孕妇避免使用这种致畸药物 VPA,其具体情况尚不清楚。我们研究了 2015 年 1 月 1 日至 2017 年 12 月 31 日期间,西开普省公立医院中孕妇和 WOCBA 中 VPA 以及其他抗癫痫药物(AED)和情绪稳定剂(MSM)的使用趋势和原因。我们咨询了资深临床医生和政策制定者,以了解 VPA 使用的决定因素。
我们使用省级卫生信息交换系统,通过唯一的患者标识符汇总常规电子健康数据,分析了 2015 年至 2017 年的临床和药房记录,以确定 WOCBA 和孕妇中 VPA 以及其他 AED 和 MSM 的处方模式。我们咨询了资深临床医生和政策制定者,以了解 VPA 使用的决定因素。
在每年约有 100 万 WOCBA 到省级卫生保健机构就诊的患者中,至少有 8205(0.79%)和 9425(0.94%)名 WOCBA 开具了至少一种 VPA 处方。与 HIV 未感染者相比,HIV 感染者中开具 VPA 处方的可能性更高(1.1-1.3%比 0.7-0.9%;p<0.001)。尽管 2016 年发布了 DHCPL,但在审查期间,WOCBA 中 VPA 的使用仍保持在 0.8-0.9%的稳定水平。VPA 是最常开的 AED/情绪稳定剂,占所有至少服用一种此类药物的 WOCBA 的 43.2-45.5%,而拉莫三嗪,另一种推荐的一线药物,仅占 WOCBA 的 7.8-8.9%。在 3 年期间,大约有 663 例妊娠暴露于 VPA,每年的暴露例数呈稳步上升趋势(n=204、214 和 245)。
尽管有警告,但 VPA 仍然是 WOCBA 中最常开的 AED 或 MSM。描述了促成因素。