本文關(guān)鍵詞： 最佳兒童藥品法 兒科研究公平法 兒童用藥 立法　出處：《中國(guó)藥房》2017年13期 　論文類型：期刊論文

【摘要】：目的:為促進(jìn)我國(guó)兒童用藥相關(guān)立法工作的開展、保障兒童用藥提供借鑒。方法:介紹并分析美國(guó)兒童用藥立法歷程及現(xiàn)行《最佳兒童藥品法》《兒科研究公平法》實(shí)施以來對(duì)美國(guó)兒童用藥的影響,提出保障我國(guó)兒童用藥可及性和安全性的建議。結(jié)果與結(jié)論:《最佳兒童藥品法》中的"6個(gè)月的兒科獨(dú)占保護(hù)期"政策激勵(lì)了藥企開展兒科研究的積極性,但是同時(shí)影響了其仿制藥的上市�！秲嚎蒲芯抗椒ā吠ㄟ^強(qiáng)制措施強(qiáng)制藥企開展兒科評(píng)估,在保障兒童用藥安全方面取得了顯著的效果,但是對(duì)于尚未廣泛應(yīng)用于兒童患者的已上市藥品無(wú)足夠強(qiáng)制力。激勵(lì)與強(qiáng)制措施并行是促進(jìn)兒童用藥發(fā)展的有效途徑,建議我國(guó)采取修改《處方管理辦法》中關(guān)于"一品雙規(guī)"的條款、在保證藥品安全性前提下加速相關(guān)兒童用藥的審批、對(duì)相關(guān)兒童藥品生產(chǎn)企業(yè)實(shí)行稅收優(yōu)惠政策、推進(jìn)兒童用藥納入醫(yī)保報(bào)銷目錄、賦予國(guó)家食品藥品監(jiān)督管理總局強(qiáng)制藥企開展兒科研究的權(quán)力等措施,保障我國(guó)兒童用藥的可及性和安全性。
[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.
【作者單位】： 南京中醫(yī)藥大學(xué)衛(wèi)生經(jīng)濟(jì)管理學(xué)院;
【基金】：教育部哲學(xué)社會(huì)科學(xué)研究重大課題攻關(guān)項(xiàng)目(No.14JZD025)
【分類號(hào)】：D922.16;R95
【正文快照】： 長(zhǎng)期以來,我國(guó)在保障兒童用藥的可及性和安全性等方面存在不少挑戰(zhàn)。兒童用藥普遍以成人藥品代替,將成人劑量進(jìn)行調(diào)整,類似于“小兒慎用或酌減”“謹(jǐn)遵醫(yī)囑”等描述廣泛存在于藥品說明書中。兒童正處于生長(zhǎng)發(fā)育階段,具有獨(dú)特的生理特點(diǎn),藥物在兒童體內(nèi)呈現(xiàn)的藥動(dòng)學(xué)和藥效學(xué)特，

本文編號(hào)：1469948