Olesen C, Søndergaard C, Thrane N, Nielsen G L, de Jong-van den Berg L, Olsen J
Danish Epidemiology Science Centre, Department of Epidemiology and Social Medicine, University of Aarhus, Vennelyst Boulevard 6, DK-8000 Aarhus, Denmark.
Epidemiology. 2001 Sep;12(5):497-501. doi: 10.1097/00001648-200109000-00006.
Surveillance of drug safety in pregnancy often draws on administrative prescription registries. Noncompliance in the use of prescribed medication may be frequent among pregnant women owing to their fear of fetotoxic side effects. To estimate compliance in the use of prescription drugs dispensed during pregnancy, we compared prescription data from the North Jutland Prescription Database with information on drug use provided by pregnant women to the Danish National Birth Cohort (DNBC), which is a health interview survey. We used the North Jutland Prescription Database to identify all prescription drugs dispensed during pregnancy for the 2,041 women who were enrolled in the DNBC in the County of North Jutland, Denmark. Compliance was defined as the probability of reporting drug use in DNBC after purchasing a dispensed prescription drug. The overall compliance to drugs purchased within 120 days before the interview was 43% (95% confidence interval = 40-46). Drugs used for treating chronic diseases, for example, beta-blockers, insulin, thyroid hormones, and diuretic and antiepileptic drugs, were always reported to be used, but compliance was low for drugs used for local or short-term treatment such as antihistamines, antibiotics, antacids, nonsteroid anti-inflammatory drugs, and gynecologic drugs. Thus, for the latter drug groups the prescription database may provide an incomplete identification of exposure. Neither data source is unbiased regarding actual drug intake. Nevertheless, our results indicate that for some drug groups risk assessment studies based on prescription data may produce false negative results as a result of noncompliance.
孕期药物安全性监测通常借助行政处方登记系统。由于担心药物对胎儿产生毒性副作用,孕妇在使用处方药时不依从的情况可能很常见。为了评估孕期所配处方药的使用依从性,我们将北日德兰处方数据库中的处方数据与参与丹麦国家出生队列研究(DNBC,一项健康访谈调查)的孕妇所提供的用药信息进行了比较。我们利用北日德兰处方数据库,确定了丹麦北日德兰郡参与DNBC研究的2041名女性在孕期所配的所有处方药。依从性定义为购买所配处方药后在DNBC中报告用药情况的概率。访谈前120天内所购药物的总体依从率为43%(95%置信区间 = 40 - 46)。用于治疗慢性病的药物,如β受体阻滞剂、胰岛素、甲状腺激素、利尿剂和抗癫痫药物,总是被报告使用,但用于局部或短期治疗的药物,如抗组胺药、抗生素、抗酸药、非甾体抗炎药和妇科药物,依从率较低。因此,对于后一类药物组,处方数据库可能无法完全识别暴露情况。两个数据源在实际药物摄入方面都存在偏差。然而,我们的结果表明,对于某些药物组,基于处方数据的风险评估研究可能会因不依从而产生假阴性结果。