Rayburn W F, Turnbull G L
Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, USA.
J Reprod Med. 1995 Mar;40(3):186-8.
Off-label drug use occurs when physicians prescribe a drug recommended for indications other than those listed on the prescription labeling. The purpose of the present investigation was to describe patterns of off-label drug use during pregnancy, including the types of drugs and their timing of use. All study pregnancies had to receive prenatal care at our state university clinics before 14 weeks' gestation and deliver at our institution during a five-month period. Prenatal records were reviewed, and subjects were interviewed after delivery. A total of 165 (22.6%) of the 731 eligible subjects took > or = 1 (average 1.7, 95% confidence interval 1.3-3.8) drugs for off-label indications. Nearly all drugs were taken for a short term during the third trimester. The primary purposes were to avoid an obstetric complication (premature labor and delivery, preeclampsia/eclampsia) or improve the capacity for eventual postnatal adaptation. Despite discussions with patients, on no occasion was it recorded on the chart that the patient was informed that the drug was recommended for an off-label indication. Results from this study should help drug manufacturers, insurance companies and federal regulatory agencies understand the common use of recommending certain drugs for off-label indications during pregnancy.
当医生开出用于处方标签所列适应症以外的药物时，即发生了药物的非标签使用情况。本调查的目的是描述孕期药物非标签使用的模式，包括药物类型及其使用时间。所有参与研究的孕妇在妊娠14周前必须在我们州立大学诊所接受产前护理，并在五个月内于我们机构分娩。查阅了产前记录，并在产后对受试者进行了访谈。731名符合条件的受试者中，共有165名（22.6%）服用了≥1种（平均1.7种，95%置信区间1.3 - 3.8）用于非标签适应症的药物。几乎所有药物都是在孕晚期短期服用。主要目的是避免产科并发症（早产和分娩、先兆子痫/子痫）或提高最终产后适应能力。尽管与患者进行了讨论，但在病历上从未记录患者被告知该药物是用于非标签适应症的情况。本研究结果应有助于药品制造商、保险公司和联邦监管机构了解孕期推荐某些药物用于非标签适应症的常见情况。
