口服药药品说明书用药时间与方法标注情况调研

Investigation on Labeling of Medication Time and Method in Oral Drug Instructions

目的促进临床安全、合理、有效地使用口服药。方法收集医院在用的788种口服药药品说明书,依据世界卫生组织解剖学治疗学及化学分类(ATC)系统分类,并对其中服药时间和用药方法的标注情况进行分类统计,并分析其标注意义。结果788份口服药药品说明书中,标注服药时间的占41.75%(329/788),其中空腹、餐前、餐时、餐后、睡前、特殊时间(包括肠胃镜检查、手术或化疗前等)服药的分别占9.52%,6.09%,7.36%,10.53%,4.06%,4.19%;标注有服药方法(包括咀嚼服、顿服、含服等)的占17.39%(131/788)。上述药物服用时间和服用方法的确定依据包括安全性,如为了降低胃肠道刺激、减少直立性低血压等药品不良反应发生率等;有效性,如药物代谢动力学、药物效应学、时辰药理学等方面因素。口服药药品说明书的服药时间和服药方法的标注率偏低,且分散在“用法用量”“注意事项”“药物代谢动力学”等内容中;同一药品不同生产厂家的标注情况也存在差异;同时,对于所推荐的服药时间的描述不够清晰准确。结论该院口服药药品说明书服药时间和服药方法标注不足,会给患者用药的安全性和有效性带来一定的风险。建议相关部门进一步规范和完善药品说明书的信息标注,药师也应进一步提高药学服务水平,确保患者合理用药。

Objective To promote the safe,rational,and effective use of oral drugs.Methods The 788 kinds of drug instructions in the hospital were collected,the labeling of the medication time and method was classified according to the Anatomical Therapeutic Chemical(ATC)classification system of the World Health Organization(WHO),and the significance of labeling was analyzed.Results Among the 788 kinds of oral drug instructions,41.75%(329/788)of them labeled the medication time,of which 9.52%were taken on an empty stomach,6.09%were taken before meals,7.36%were taken with meals,10.53%were taken after meals,4.06%were taken before bedtime,and 4.19%were taken at a special time(including gastrointestinal endoscopy,before surgery or chemotherapy,etc.).Among the 788 kinds of oral drug instructions,17.39%(131/788)of them labeled the medication methods(including chewing,taking in a single dose,buccal-administration and so on).The basis for determining the medication time and method of the above drugs included safety(reducing the incidence of adverse reactions such as gastrointestinal irritation and orthostatic hypotension),effectiveness(such as pharmacokinetics,pharmacodynamics,chronopharmacology and other factors).The labeling rate of medication time and method in the oral drug instructions was low,which was scattered in″usage and dosage″″precautions″″pharmacokinetics″and other contents.The labeling of the same ingredient varied among different manufacturers.Meanwhile,the description of the recommended medication time was not clear and accurate.Conclusion The labeling of the medication time and method in oral drug instructions in the hospital is not enough,which will bring uncertain risks to the safety and effectiveness of medication in patients.It is suggested that relevant departments should further standardize and improve the information labeling of drug instructions,and pharmacists should also further improve the level of pharmaceutical care to ensure the rational drug use for patients.