Mehta U, Heekes A, Kalk E, Boulle A
Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.
S Afr Med J. 2018 Apr 25;108(5):439-443. doi: 10.7196/SAMJ.2018.v108i5.12879.
In African settings, where there is a high disease burden, there is a need to improve the science of documenting and analysing accurate information regarding medicine exposures in women immediately before and during pregnancy to assess the extent of use and safety in pregnant women and their unborn children.
To compare evidence of medicine use during pregnancy, as documented in paper-based clinical records (maternity case records (MCRs)) against electronic health information resources (Provincial Health Data Centre (PHDC)) and assess the level of concordance between the two as part of baseline investigations before piloting a provincial pregnancy exposure registry and birth defect surveillance system. The PHDC consolidates electronic clinical and pharmacy data.
A folder review of completed pregnancies between November 2013 and January 2016 was conducted on randomly selected MCRs from midwife-run obstetric units and a secondary maternity hospital in Cape Town, South Africa. Medication exposures in the MCR were captured and compared with a customised PHDC data extract. The type and timing of drug exposures were compared. Total exposures were compiled from all data sources.
Two hundred and six MCRs from three facilities were sampled: 83 women had documented antiretroviral therapy (ART) exposure; all but 1 (1%) had been recorded in the PHDC extract. There was no evidence of ART use in the MCRs of 4 (5%) cases, despite evidence in the PHDC. There were imprecise drug names in the MCRs of 14 (17%) ART patients, discordant dates of onset between the MCRs and PHDC extracts in 10/83 (12%) and inaccurate medicine names and incorrect dates in 1 (1%) case each. Nine of 10 (90%) women who were administered antituberculosis medication were recorded in the PHDC extract. Ten of 21 (48%) isoniazid preventive therapy treatments appeared in the MCRs and PHDC; 9 (42%) in the PHDC only and 2 (10%) in the MCRs only. Half (n=18/36) of all antibiotic use was reflected only in the MCRs, while 13/36 (36%) appeared only in the PHDC extract. In the former cases, antibiotics used for treatment of sexually transmitted infections and urinary tract infections were dispensed from ward stock and not captured electronically. Antibiotics reflected only in the PHDC were either dispensed at a referral facility or before the first recorded antenatal clinic visit. Folic acid and iron were mostly documented in the MCR only (n=79/99 (80%) and n=107/128 (84%), respectively). However, analgesics and antihistamines more often appeared in the PHDC extract only (n=11/16 (73%) and n=5/5 (100%), respectively).
The PHDC extract provided a better and more complete reflection of chronic drug exposures compared with the MCRs, especially when women sought care at facilities other than the antenatal care unit where they first attended, or when exposures occurred before the initial antenatal visit. The exception was antibiotics dispensed from ward stock to treat sexually transmitted and urinary tract infections.
在疾病负担较高的非洲地区,有必要改进记录和分析妊娠前及妊娠期妇女用药准确信息的科学方法,以评估孕妇及其未出生子女的用药程度和安全性。
将纸质临床记录(产妇病例记录(MCR))中记录的孕期用药证据与电子健康信息资源(省级卫生数据中心(PHDC))进行比较,并评估两者之间的一致性水平,作为在试点省级妊娠暴露登记处和出生缺陷监测系统之前进行基线调查的一部分。PHDC整合了电子临床和药房数据。
对2013年11月至2016年1月期间在南非开普敦由助产士管理的产科单位和一家二级妇产医院随机抽取的已完成妊娠的MCR进行档案审查。记录MCR中的用药暴露情况,并与定制的PHDC数据提取物进行比较。比较药物暴露的类型和时间。从所有数据源汇总总暴露情况。
从三个机构抽取了206份MCR:83名妇女有抗逆转录病毒疗法(ART)暴露记录;除1例(1%)外,所有病例均记录在PHDC提取物中。4例(5%)病例的MCR中没有ART使用证据,尽管PHDC中有证据。14例(17%)接受ART治疗的患者的MCR中药物名称不准确,10/83(12%)的MCR与PHDC提取物之间的发病日期不一致,各有1例(1%)病例的药物名称不准确且日期错误。接受抗结核药物治疗的10名妇女中有9名(90%)记录在PHDC提取物中。21例异烟肼预防性治疗中有10例(48%)出现在MCR和PHDC中;仅在PHDC中有9例(42%),仅在MCR中有2例(10%)。所有抗生素使用的一半(n = 18/36)仅反映在MCR中,而13/36(36%)仅出现在PHDC提取物中。在前一种情况下,用于治疗性传播感染和尿路感染的抗生素是从病房库存中分发的,未进行电子记录。仅在PHDC中反映的抗生素是在转诊机构分发的或在首次记录的产前诊所就诊之前分发的。叶酸和铁大多仅记录在MCR中(分别为n = 79/99(80%)和n = 107/128(84%))。然而,镇痛药和抗组胺药更常仅出现在PHDC提取物中(分别为n = 11/16(73%)和n = 5/5(100%))。
与MCR相比,PHDC提取物能更好、更完整地反映慢性药物暴露情况,尤其是当妇女在首次就诊的产前护理单位以外的机构寻求护理时,或暴露发生在首次产前就诊之前时。例外情况是从病房库存中分发用于治疗性传播感染和尿路感染的抗生素。