Objective To investigate the off-label use status in obstetrics ward so as to provide references for carrying out obstetrics pharmaceutical care and promoting safe medication use in pregnant and parturient women. Methods The prescriptions for pregnant and parturient women from January to June, 2015 in obstetrics ward were investigated. According to drug instructions, the off-label drug use of prescriptions of all selected patients was analyzed in the following aspects:the category of off-label drug use, and drugs use information. In addition, a logistic regression was conducted that modeled the odds of receiving an off-label prescription as a function of the following possible risk factors:pregnant, parturient women and the rank of doctors. The clinical results including the unreasonable drug application, abortion rate and birth defect were compared between the off-label drug use and on-label drug use groups. Results Total of 384 patients were selected, and 5330 prescriptions involving 50 drugs were analyzed. The rate of off-label drug use was 68. 5%, 27. 7% and 24. 0% in patients, prescriptions and drug categories, respectively. The main categories of off-label drug use were super solvent use ( 76. 6%) and indication (14. 3%). The top 3 drugs of off-label use were those for urinary and reproductive (56. 2%), alimentary tract (46. 9%) and traditional Chinese medicine (43. 4%). In addition, there was no significant correlation between the risk of off-label drug use and maternal status and the level of doctors. And no significant difference between the two groups in the unreasonable drug application, abortion rate and birth defect was detected. Conclusion The off-label drug use in obstetrics ward is common in this hospital and most of them are supported by clinical evidence. Due to the lack of more authoritative evidence-based medication, the doctors are suggested to use the drug according to provisions of the drug instructions. When off-label drug use is really needed, it should be based on the surpport of evidence basde medicine,so as to ensure the drug safety for pregnant and parturient women and avoid professional risks.%目的 回顾性调查产科住院孕产妇超说明书用药现状,为开展产科药学服务、促进孕产妇安全用药提供参考.方法 随机抽取2015年1一6月某院产科住院孕产妇的用药医嘱和出院带药医嘱,依据药品说明书,判断其用药医嘱是否超说明书,分析各超说明书用药类型和各类药品超说明书用药情况、超说明书用药与孕产妇情况和医生级别的关系以及超说明书用药中不合理用药情况和临床结果.结果 共抽取产科住院患者384例,分析用药医嘱5330条,涉及药品50种.按患者、用药医嘱和药品品种计,超说明书用药发生率分别为68.5%,27.7%和24.0%.超说明书用药类型中超溶媒用药(76.6%)与超适应证用药(14.3%)发生率最高.超说明书用药排名前3位的药物种类为泌尿和生殖系统药物(56.2%)、消化系统药物(46.9%)及中成药(43.4%).超说明书用药发生的风险与孕产妇情况和医生级别无明显相关性.超说明书用药中不合理用药、不良反应发生情况、流产率、胎儿出生缺陷情况均与按说明书用药组差异无统计学意义.结论 该院产科住院孕产妇超说明书用药比较常见,建议医生临床用药时注意权衡利弊,尽量按药品说明书规范使用药物.确有需要超说明书用药时应以充分的循证医学证据支持为前提,以保障患者得到合理的药物治疗,规避执业风险.
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