美国儿童用药立法保障评析及对我国的启示

发布时间：2018-01-28 05:50

  本文关键词： 最佳儿童药品法 儿科研究公平法 儿童用药 立法　出处：《中国药房》2017年13期 　论文类型：期刊论文

【摘要】：目的:为促进我国儿童用药相关立法工作的开展、保障儿童用药提供借鉴。方法:介绍并分析美国儿童用药立法历程及现行《最佳儿童药品法》《儿科研究公平法》实施以来对美国儿童用药的影响,提出保障我国儿童用药可及性和安全性的建议。结果与结论:《最佳儿童药品法》中的"6个月的儿科独占保护期"政策激励了药企开展儿科研究的积极性,但是同时影响了其仿制药的上市。《儿科研究公平法》通过强制措施强制药企开展儿科评估,在保障儿童用药安全方面取得了显著的效果,但是对于尚未广泛应用于儿童患者的已上市药品无足够强制力。激励与强制措施并行是促进儿童用药发展的有效途径,建议我国采取修改《处方管理办法》中关于"一品双规"的条款、在保证药品安全性前提下加速相关儿童用药的审批、对相关儿童药品生产企业实行税收优惠政策、推进儿童用药纳入医保报销目录、赋予国家食品药品监督管理总局强制药企开展儿科研究的权力等措施,保障我国儿童用药的可及性和安全性。
[Abstract]:Objective: to promote the development of legislation on drug use among children in China. Methods: to introduce and analyze the legislative course of American children's drug use and its influence on American children's drug use since the implementation of the Paediatric Research Fairness Act. Results and conclusion: the policy of "6 months' exclusive paediatric protection" in the Best Child Drug Law encourages pharmaceutical enterprises to carry out paediatric research. But at the same time affected its generic drug market. "Pediatric Research Equity Act" through coercive measures to conduct paediatric evaluation of pharmaceutical enterprises, in ensuring the safety of drug use in children has achieved significant results. However, there is not enough compulsive force for the listed drugs which have not been widely used in children. It is an effective way to promote the development of drug use in children. It is suggested that our country should amend the provisions of "one product and two regulations" in "prescription Management measures", and accelerate the examination and approval of relevant children's drug use under the premise of ensuring the safety of drugs. To implement the preferential tax policy for the relevant children's drug production enterprises, to promote the inclusion of children's drugs in the medical insurance reimbursement list, and to give the State Administration of Food and Drug Administration the power to carry out paediatric research in pharmaceutical enterprises. To ensure the availability and safety of drug use for children in China.
【作者单位】： 南京中医药大学卫生经济管理学院;
【基金】：教育部哲学社会科学研究重大课题攻关项目(No.14JZD025)
【分类号】：D922.16;R95
【正文快照】： 长期以来,我国在保障儿童用药的可及性和安全性等方面存在不少挑战。儿童用药普遍以成人药品代替,将成人剂量进行调整,类似于“小儿慎用或酌减”“谨遵医嘱”等描述广泛存在于药品说明书中。儿童正处于生长发育阶段,具有独特的生理特点,药物在儿童体内呈现的药动学和药效学特，

本文编号：1469948