12月12日(ri)，國家(jia)衛(wei)健(jian)委發(fa)布《關(guan)于做好輔(fu)助用(yong)(yong)藥(yao)臨床應用(yong)(yong)管(guan)理(li)(li)有(you)關(guan)工作的通(tong)知》（下稱《通(tong)知》），對加強輔(fu)助用(yong)(yong)藥(yao)管(guan)理(li)(li)，提高合理(li)(li)用(yong)(yong)藥(yao)水平作出(chu)明確規定(ding)。


各(ge)省、自治區、直轄(xia)市(shi)及(ji)新(xin)疆生(sheng)產建(jian)設兵團衛生(sheng)健康委（衛生(sheng)計(ji)生(sheng)委）：

為加強醫療機構(gou)輔(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)(yao)臨(lin)床應(ying)用(yong)(yong)(yong)管理，規范輔(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)(yao)臨(lin)床應(ying)用(yong)(yong)(yong)行為，提高合理用(yong)(yong)(yong)藥(yao)(yao)水平(ping)，維護人民群眾健康權益，現就做好輔(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)(yao)臨(lin)床應(ying)用(yong)(yong)(yong)管理有關工(gong)作提出以下要求(qiu)：

一(yi)、提高認識，高度重(zhong)視輔助用藥臨床應用管(guan)理工作

    加強(qiang)輔助(zhu)用(yong)(yong)(yong)藥臨床(chuang)應(ying)用(yong)(yong)(yong)管(guan)理(li)，是落實深化(hua)醫(yi)藥衛(wei)生體制(zhi)(zhi)改革任(ren)務(wu)、控制(zhi)(zhi)公(gong)立醫(yi)院醫(yi)療費用(yong)(yong)(yong)不合(he)(he)理(li)增(zeng)長的明確要求，也是減輕患者(zhe)看病就醫(yi)負擔(dan)、維護(hu)人(ren)民健康權益的重要舉措。各級衛(wei)生健康行(xing)政部(bu)門和(he)(he)各級各類醫(yi)療機構必(bi)須高度(du)重視(shi)輔助(zhu)用(yong)(yong)(yong)藥臨床(chuang)應(ying)用(yong)(yong)(yong)管(guan)理(li)工作，本著對人(ren)民健康高度(du)負責和(he)(he)科學合(he)(he)理(li)的原則，加強(qiang)輔助(zhu)用(yong)(yong)(yong)藥臨床(chuang)應(ying)用(yong)(yong)(yong)管(guan)理(li)，努力實現安全有效(xiao)經(jing)濟的合(he)(he)理(li)用(yong)(yong)(yong)藥目標。

二、明確責(ze)任(ren)，建(jian)立輔助用(yong)藥臨床應用(yong)管(guan)理(li)制度(du) 

    醫療(liao)機(ji)構(gou)(gou)是輔(fu)助用(yong)藥(yao)(yao)臨(lin)床(chuang)應用(yong)管(guan)(guan)理的(de)(de)(de)責任主體，醫療(liao)機(ji)構(gou)(gou)主要(yao)負(fu)責人(ren)是輔(fu)助用(yong)藥(yao)(yao)臨(lin)床(chuang)應用(yong)管(guan)(guan)理第一責任人(ren)。要(yao)將輔(fu)助用(yong)藥(yao)(yao)管(guan)(guan)理作為醫療(liao)機(ji)構(gou)(gou)藥(yao)(yao)事管(guan)(guan)理的(de)(de)(de)重要(yao)內容，進行統籌(chou)管(guan)(guan)理。要(yao)建立健全(quan)(quan)管(guan)(guan)理制度和(he)工作機(ji)制，加強(qiang)輔(fu)助用(yong)藥(yao)(yao)遴選、采購、處方、調劑、臨(lin)床(chuang)應用(yong)、監測、評(ping)價(jia)等各環節(jie)的(de)(de)(de)全(quan)(quan)程管(guan)(guan)理。醫療(liao)機(ji)構(gou)(gou)在調整完善藥(yao)(yao)品處方集和(he)基(ji)本用(yong)藥(yao)(yao)供應目錄時，如需(xu)(xu)納(na)入輔(fu)助用(yong)藥(yao)(yao)，應當由(you)藥(yao)(yao)事管(guan)(guan)理與藥(yao)(yao)物治療(liao)學(xue)委員會，依(yi)據藥(yao)(yao)品說明(ming)書和(he)用(yong)藥(yao)(yao)指南等，充分(fen)評(ping)估(gu)論證輔(fu)助用(yong)藥(yao)(yao)的(de)(de)(de)臨(lin)床(chuang)價(jia)值(zhi),按照(zhao)既能滿足臨(lin)床(chuang)基(ji)本需(xu)(xu)求又適度從緊的(de)(de)(de)原(yuan)則，進行嚴(yan)格遴選。

三、制訂目錄(lu)，明(ming)確醫療機構輔助用(yong)藥范圍

（一）制(zhi)訂(ding)全國(guo)輔(fu)(fu)助(zhu)(zhu)(zhu)用(yong)藥(yao)(yao)目錄(lu)。各省級衛(wei)生健(jian)康(kang)(kang)行政部門(men)組織轄區內二級以上(shang)醫療(liao)(liao)機構(gou)，將(jiang)本機構(gou)輔(fu)(fu)助(zhu)(zhu)(zhu)用(yong)藥(yao)(yao)以通(tong)用(yong)名并(bing)(bing)按照年度使用(yong)金(jin)額（2017年12月(yue)(yue)1日至2018年11月(yue)(yue)30日）由(you)多到少排序(xu),形(xing)成輔(fu)(fu)助(zhu)(zhu)(zhu)用(yong)藥(yao)(yao)目錄(lu)，并(bing)(bing)上(shang)報省級衛(wei)生健(jian)康(kang)(kang)行政部門(men)。每個醫療(liao)(liao)機構(gou)輔(fu)(fu)助(zhu)(zhu)(zhu)用(yong)藥(yao)(yao)品種(zhong)原(yuan)則上(shang)不(bu)少于(yu)20個。各省級衛(wei)生健(jian)康(kang)(kang)行政部門(men)匯總轄區內醫療(liao)(liao)機構(gou)上(shang)報的(de)輔(fu)(fu)助(zhu)(zhu)(zhu)用(yong)藥(yao)(yao)目錄(lu)，以通(tong)用(yong)名并(bing)(bing)按照使用(yong)總金(jin)額由(you)多到少排序(xu)，將(jiang)前20個品種(zhong)信息上(shang)報國(guo)家(jia)衛(wei)生健(jian)康(kang)(kang)委（報送表(biao)格見附(fu)件）。國(guo)家(jia)衛(wei)生健(jian)康(kang)(kang)委制(zhi)訂(ding)全國(guo)輔(fu)(fu)助(zhu)(zhu)(zhu)用(yong)藥(yao)(yao)目錄(lu)并(bing)(bing)公布。

（二(er)）制訂(ding)省(sheng)(sheng)級和(he)各醫(yi)療(liao)機(ji)構(gou)輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)。各省(sheng)(sheng)級衛生健康行(xing)政部門在國(guo)家公(gong)布的(de)輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)基(ji)礎(chu)上(shang)，制訂(ding)本(ben)省(sheng)(sheng)份輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu),省(sheng)(sheng)級輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)不得少于國(guo)家輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)。二(er)級以上(shang)醫(yi)療(liao)機(ji)構(gou)在省(sheng)(sheng)級輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)基(ji)礎(chu)上(shang)，增加(jia)本(ben)機(ji)構(gou)上(shang)報的(de)輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)品種(zhong)，形成本(ben)機(ji)構(gou)輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)。其他醫(yi)療(liao)機(ji)構(gou)根(gen)據實際情(qing)況，在省(sheng)(sheng)級輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)的(de)基(ji)礎(chu)上(shang)，制訂(ding)本(ben)機(ji)構(gou)輔(fu)(fu)助(zhu)用(yong)(yong)藥(yao)(yao)(yao)(yao)目(mu)(mu)錄(lu)(lu)(lu)。

（三）制訂(ding)輔(fu)助用(yong)藥目錄(lu)(lu)的原(yuan)則和時限要求。各級衛生健(jian)康行政部(bu)門和各級各類醫(yi)療機(ji)構在(zai)(zai)(zai)制訂(ding)輔(fu)助用(yong)藥目錄(lu)(lu)的過程中，應當(dang)遵循“公(gong)(gong)開(kai)、公(gong)(gong)平、公(gong)(gong)正、透明”的原(yuan)則，將(jiang)輔(fu)助用(yong)藥目錄(lu)(lu)納入政務公(gong)(gong)開(kai)和院(yuan)務公(gong)(gong)開(kai)管理，在(zai)(zai)(zai)官方網(wang)站或以適當(dang)形(xing)式進(jin)行公(gong)(gong)布。各省級衛生健(jian)康行政部(bu)門應當(dang)于2018年12月31日(ri)前,將(jiang)匯總的輔(fu)助用(yong)藥目錄(lu)(lu)報(bao)送我委，并(bing)在(zai)(zai)(zai)我委公(gong)(gong)布全國(guo)輔(fu)助用(yong)藥目錄(lu)(lu)后10個工作(zuo)日(ri)內,公(gong)(gong)布省級輔(fu)助用(yong)藥目錄(lu)(lu)。我委將(jiang)定期對全國(guo)輔(fu)助用(yong)藥目錄(lu)(lu)進(jin)行調整(zheng)，調整(zheng)時間間隔原(yuan)則上不短于1年。

四、規范行(xing)為，持續提高臨床合理(li)用藥水平

    各(ge)級(ji)各(ge)類醫(yi)療(liao)(liao)機構要根據(ju)臨(lin)(lin)床(chuang)診療(liao)(liao)實際需求(qiu)，制訂本機構輔(fu)(fu)助用(yong)(yong)藥(yao)(yao)(yao)臨(lin)(lin)床(chuang)應用(yong)(yong)技術規(gui)范，明(ming)確(que)限定輔(fu)(fu)助用(yong)(yong)藥(yao)(yao)(yao)臨(lin)(lin)床(chuang)應用(yong)(yong)的(de)(de)(de)條件和(he)原則，要求(qiu)醫(yi)師嚴(yan)格(ge)掌握用(yong)(yong)藥(yao)(yao)(yao)指征，嚴(yan)格(ge)按照藥(yao)(yao)(yao)品說明(ming)書使(shi)用(yong)(yong)，不得隨意擴大(da)用(yong)(yong)藥(yao)(yao)(yao)適應證、改(gai)變用(yong)(yong)藥(yao)(yao)(yao)療(liao)(liao)程、劑量等。進一步加強(qiang)臨(lin)(lin)床(chuang)路徑(jing)管理，科學設計(ji)臨(lin)(lin)床(chuang)路徑(jing)，規(gui)范臨(lin)(lin)床(chuang)診療(liao)(liao)行為。對輔(fu)(fu)助用(yong)(yong)藥(yao)(yao)(yao)管理目錄(lu)中(zhong)的(de)(de)(de)全部(bu)藥(yao)(yao)(yao)品進行重點(dian)監控。嚴(yan)格(ge)落實處(chu)方(fang)審核和(he)處(chu)方(fang)點(dian)評(ping)制度(du)，將輔(fu)(fu)助用(yong)(yong)藥(yao)(yao)(yao)全部(bu)納入審核和(he)點(dian)評(ping)范疇(chou)，充分(fen)發(fa)揮藥(yao)(yao)(yao)師在輔(fu)(fu)助用(yong)(yong)藥(yao)(yao)(yao)管理和(he)臨(lin)(lin)床(chuang)用(yong)(yong)藥(yao)(yao)(yao)指導方(fang)面(mian)的(de)(de)(de)作用(yong)(yong)。

五(wu)、加強監測考核，推進(jin)輔助用(yong)藥科學管理

    各級(ji)(ji)衛生(sheng)健康行政部(bu)門和(he)各級(ji)(ji)各類醫(yi)療機(ji)構(gou)要建立完善輔(fu)(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)監(jian)測(ce)評價和(he)超(chao)常預(yu)警制度(du)，依托相關信(xin)息平臺，對(dui)輔(fu)(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)臨床(chuang)使(shi)(shi)用(yong)(yong)(yong)情(qing)況進(jin)行分(fen)析、評估，定期(qi)通(tong)報監(jian)測(ce)結(jie)果(guo)(guo)及相關預(yu)警信(xin)息。醫(yi)療機(ji)構(gou)要根據處方審核(he)和(he)處方點評結(jie)果(guo)(guo)、藥(yao)品(pin)使(shi)(shi)用(yong)(yong)(yong)量、使(shi)(shi)用(yong)(yong)(yong)金額等，科(ke)(ke)學設定輔(fu)(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)臨床(chuang)應(ying)用(yong)(yong)(yong)考(kao)(kao)核(he)指標(biao)，定期(qi)對(dui)本機(ji)構(gou)輔(fu)(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)合理應(ying)用(yong)(yong)(yong)情(qing)況進(jin)行考(kao)(kao)核(he)，考(kao)(kao)核(he)結(jie)果(guo)(guo)及時公示。各級(ji)(ji)衛生(sheng)健康行政部(bu)門要將(jiang)輔(fu)(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)臨床(chuang)應(ying)用(yong)(yong)(yong)情(qing)況作為(wei)醫(yi)療機(ji)構(gou)績效考(kao)(kao)核(he)工作的重要內容，充分(fen)運用(yong)(yong)(yong)考(kao)(kao)核(he)結(jie)果(guo)(guo)，促進(jin)提升輔(fu)(fu)(fu)助(zhu)用(yong)(yong)(yong)藥(yao)科(ke)(ke)學管理水平。