[關(guān)鍵詞]
[摘要]
親愛(ài)的衛(wèi)生保健提供者(DHCP)信函由藥品生產(chǎn)商或美國(guó)食品藥品管理局(FDA)迅速直接發(fā)給醫(yī)生和其他需要者,傳遞藥品說(shuō)明書(shū)變化,分為重要藥物警告信、重要處方資料信和重要藥品信息更正信3種形式。2017年2月FDA發(fā)布了“DHCP信函:改善重要安全信息溝通的指導(dǎo)原則”,詳細(xì)說(shuō)明了3種信函撰寫(xiě)的內(nèi)容和格式并列舉了范本。介紹該指導(dǎo)原則的主要內(nèi)容,呼吁我國(guó)藥品生產(chǎn)企業(yè)和藥政管理部門借鑒FDA經(jīng)驗(yàn),建立符合我國(guó)國(guó)情的相應(yīng)機(jī)制,使醫(yī)生和其他需要者能及時(shí)獲得藥品說(shuō)明書(shū)重要的新信息,確保臨床用藥安全有效。
[Key word]
[Abstract]
Dear Health Care Provider (DHCP) letterspromptly are directed to doctors and other demanders by manufacturer or FDA to communicate change of description drug labeling, which are divided into three types-Important Drug Warning Letters, Important Prescribing Information Letters, and Important Correction of Drug Information Letters. FDA issued Guidance for Industry and FDA Staff Dear Health Care Provider Letters: Improving Communication of Important Safety Information in February 2017, described in detail the contents and format of the three letters; and listed the models. This paper introduces the main contents of the guidance. Call on China’s pharmaceutical production enterprises and regulatory agency from the FDA experience establish the corresponding mechanism in line with China's national conditions, so that doctors and other demanders can be timely access to important new information of labeling to ensure clinical safe and effective medication.
[中圖分類號(hào)]
[基金項(xiàng)目]
國(guó)家自然科學(xué)基金青年項(xiàng)目(81503342);中國(guó)博士后基金面上項(xiàng)目(2016M591967)