儿科药品说明书之外用法的用药调查

Survey and Analysis of Drug Use beyond Dispensatory in Pediatrics

目的:了解我院儿科药品说明书之外用法的用药情况,以促进临床合理用药。方法:依据《药品说明书和标签管理规定》、《化学药品非处方药说明书规范细则》和《化学药品和生物制品说明书规范细则》及其他参考资料,对我院2010年6～12月儿科门诊4 200份处方进行调查分析。结果:存在药品说明书之外用法的处方259份(6.17%),其中西药处方171份(4.07%),多于中成药处方的88份(2.10%)。表现形式主要为:超适应证给药(47.10%)、超适应人群给药(27.41%)、超剂量给药(13.90%)、改变剂型给药(11.58%)。结论:药品说明书之外的用法在我院儿科较常见,可能引发药品安全性和有效性、医疗责任和伦理学等问题。应借鉴国外经验寻求立法,确保儿童用药的安全、有效。

Objective： To probe into the situation of drug use beyond dispensatory in pediatrics of our hospital and to promote clinical rational drug use. Method： A total of 4200 prescriptions between June and December 2010 collected from the pediatric out-patient ~tepartment of our hospital were analyzed in accordance with Provisions for Drug Insert Sheets and Labels, Regulatory Guidelines for the Chemicals Non-prescription Drug, Regulatory Guidelines for Chemicals and Living Creature Product and other references. Result：Of the total 4200 prescriptions, 259 （6.17%） involved drug use beyond dispensatory, and proportion of chemicals drug prescription （4.07%） was more than the proportion of Chinese patent medicine prescription（2.10% ）. The problems such as super indications for medicine（47.10% ）, super adapt to the crowd to medicine（27.41% ）, super dosage of medicine （ 13.90% ） and change drug dosage form（ 11.58% ） were main type. Conclusion：It is widespread for drug use beyond dispensatory in pediatrics. Some problems such as safety, effectivity , responsibility, ethics will be produced. The experience of other countries should be studied to introduce legislation, in order to ensure the safety and effectiveness about drug use in pediatrics.