來源: 發布時間:2021-08-24 編(bian)輯(ji):
關于規范藥品零售企業配備使用 執業藥師的通知 (征求意見稿) 執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)是開展(zhan)藥(yao)(yao)品質(zhi)量(liang)管(guan)理(li)和藥(yao)(yao)學(xue)服務的(de)(de)專業(ye)(ye)力量(liang),是合理(li)用藥(yao)(yao)的(de)(de)重要(yao)保障。近年來,國家藥(yao)(yao)監局不(bu)(bu)斷加(jia)強執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)制(zhi)度建(jian)設和隊伍建(jian)設,持續推(tui)動執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)配(pei)備(bei)(bei)使用,積極發揮執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)在保障公眾(zhong)用藥(yao)(yao)安(an)全有效方面的(de)(de)重要(yao)作用。但是,目(mu)前執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)隊伍發展(zhan)不(bu)(bu)平衡(heng)、不(bu)(bu)充分,部(bu)分地(di)區(qu)藥(yao)(yao)品零售(shou)企業(ye)(ye)執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)配(pei)備(bei)(bei)不(bu)(bu)到位的(de)(de)問(wen)題還(huan)比較突出。根據新修訂的(de)(de)《中華(hua)人民共和國藥(yao)(yao)品管(guan)理(li)法》(以下(xia)簡稱《藥(yao)(yao)品管(guan)理(li)法》)有關規(gui)定,為規(gui)范執(zhi)(zhi)業(ye)(ye)藥(yao)(yao)師(shi)(shi)(shi)配(pei)備(bei)(bei)使用,現將有關要(yao)求通知如下(xia): 一 堅持執業藥師配備政策,穩步提高配備水平 《藥(yao)(yao)(yao)(yao)品(pin)管(guan)理法》規定(ding)(ding)(ding),從事藥(yao)(yao)(yao)(yao)品(pin)經(jing)(jing)營活(huo)動(dong)應當有依法經(jing)(jing)過資(zi)格(ge)認定(ding)(ding)(ding)的(de)(de)藥(yao)(yao)(yao)(yao)師(shi)或(huo)者其他藥(yao)(yao)(yao)(yao)學(xue)技(ji)術人員。藥(yao)(yao)(yao)(yao)品(pin)經(jing)(jing)營領域依法經(jing)(jing)過資(zi)格(ge)認定(ding)(ding)(ding)的(de)(de)藥(yao)(yao)(yao)(yao)師(shi)是指執(zhi)(zhi)業(ye)(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi),依法經(jing)(jing)過資(zi)格(ge)認定(ding)(ding)(ding)的(de)(de)其他藥(yao)(yao)(yao)(yao)學(xue)技(ji)術人員包括衛生(sheng)(藥(yao)(yao)(yao)(yao))系列(lie)職稱(含藥(yao)(yao)(yao)(yao)士、藥(yao)(yao)(yao)(yao)師(shi)、主(zhu)管(guan)藥(yao)(yao)(yao)(yao)師(shi)、副主(zhu)任藥(yao)(yao)(yao)(yao)師(shi)、主(zhu)任藥(yao)(yao)(yao)(yao)師(shi))、從業(ye)(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)等。藥(yao)(yao)(yao)(yao)品(pin)零(ling)(ling)售企(qi)(qi)業(ye)(ye)(ye)(ye)按規定(ding)(ding)(ding)配(pei)(pei)備(bei)執(zhi)(zhi)業(ye)(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)是維護(hu)公眾用藥(yao)(yao)(yao)(yao)安全的(de)(de)基本要求(qiu),也是實(shi)現(xian)“健(jian)康中國”戰略、促進行業(ye)(ye)(ye)(ye)高(gao)質(zhi)量(liang)發(fa)展的(de)(de)現(xian)實(shi)需要。要堅持和完善執(zhi)(zhi)業(ye)(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)職業(ye)(ye)(ye)(ye)資(zi)格(ge)準入制度(du),堅持藥(yao)(yao)(yao)(yao)品(pin)經(jing)(jing)營企(qi)(qi)業(ye)(ye)(ye)(ye)執(zhi)(zhi)業(ye)(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)依法配(pei)(pei)備(bei)使用要求(qiu)。原則上,經(jing)(jing)營處(chu)(chu)方藥(yao)(yao)(yao)(yao)、甲類非處(chu)(chu)方藥(yao)(yao)(yao)(yao)的(de)(de)藥(yao)(yao)(yao)(yao)品(pin)零(ling)(ling)售企(qi)(qi)業(ye)(ye)(ye)(ye),應當配(pei)(pei)備(bei)執(zhi)(zhi)業(ye)(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi);只經(jing)(jing)營乙類非處(chu)(chu)方藥(yao)(yao)(yao)(yao)的(de)(de)藥(yao)(yao)(yao)(yao)品(pin)零(ling)(ling)售企(qi)(qi)業(ye)(ye)(ye)(ye),應當配(pei)(pei)備(bei)經(jing)(jing)過藥(yao)(yao)(yao)(yao)品(pin)監督管(guan)理部門(men)組織(zhi)考(kao)核合格(ge)的(de)(de)業(ye)(ye)(ye)(ye)務人員。 針對當(dang)前部(bu)分(fen)地區執(zhi)業藥(yao)(yao)師(shi)不夠用(yong)、配(pei)備(bei)難的實(shi)際情況(kuang),各(ge)省藥(yao)(yao)品監督管(guan)理部(bu)門在不降低現有執(zhi)業藥(yao)(yao)師(shi)整體配(pei)備(bei)比(bi)例前提下,可制定實(shi)施差(cha)異化(hua)配(pei)備(bei)使用(yong)執(zhi)業藥(yao)(yao)師(shi)的政策,并設(she)置過渡(du)期(qi)。過渡(du)期(qi)內,對于執(zhi)業藥(yao)(yao)師(shi)存(cun)在明顯缺口的地區,允許藥(yao)(yao)品零售企業配(pei)備(bei)使用(yong)其他藥(yao)(yao)學技術人員承(cheng)擔執(zhi)業藥(yao)(yao)師(shi)職責,過渡(du)期(qi)不超(chao)過2025年(nian)。 二 細化落實執業藥師配備要求,強化監督檢查責任 各省(sheng)藥品(pin)監(jian)督管理部門(men)要根據(ju)轄區(qu)內(nei)執業(ye)藥師和(he)藥學(xue)技術(shu)人員隊(dui)伍(wu)實(shi)際情況,結合經(jing)營(ying)品(pin)種(zhong)、經(jing)營(ying)規模、地域差(cha)異以及(ji)藥品(pin)安全風險(xian)等因(yin)素(su),制(zhi)定(ding)具體實(shi)施方案,分(fen)階段、分(fen)區(qu)域推進執業(ye)藥師配備(bei)使用,穩步提升藥品(pin)零售企業(ye)執業(ye)藥師配備(bei)使用比(bi)例。各省(sheng)藥品(pin)監(jian)督管理部門(men)制(zhi)定(ding)的差(cha)異化配備(bei)使用執業(ye)藥師過渡政策和(he)實(shi)施方案應及(ji)時向社會公開,并做好宣傳引(yin)導工作。 過渡期內,各市縣負責藥(yao)(yao)(yao)品(pin)(pin)監管的(de)(de)(de)部門(men)要加(jia)強對轄(xia)區內藥(yao)(yao)(yao)學(xue)(xue)技(ji)術(shu)(shu)人(ren)員(yuan)的(de)(de)(de)管理,對藥(yao)(yao)(yao)品(pin)(pin)零售企業(ye)按規(gui)定(ding)配(pei)(pei)備(bei)藥(yao)(yao)(yao)學(xue)(xue)技(ji)術(shu)(shu)人(ren)員(yuan)的(de)(de)(de)情況進行登記,建立相關(guan)信息(xi)檔案。要落實“四(si)個最(zui)嚴”監管要求,對新(xin)開辦藥(yao)(yao)(yao)品(pin)(pin)零售企業(ye)嚴格(ge)審核把關(guan);加(jia)強對執(zhi)(zhi)(zhi)業(ye)藥(yao)(yao)(yao)師(或藥(yao)(yao)(yao)學(xue)(xue)技(ji)術(shu)(shu)人(ren)員(yuan))配(pei)(pei)備(bei)和在崗執(zhi)(zhi)(zhi)業(ye)情況的(de)(de)(de)監督(du)檢查,督(du)促其(qi)盡職履(lv)責。對于不按規(gui)定(ding)配(pei)(pei)備(bei)且整改(gai)不到位的(de)(de)(de)藥(yao)(yao)(yao)品(pin)(pin)零售企業(ye),應當依法查處(chu),并按規(gui)定(ding)核減(jian)其(qi)處(chu)方藥(yao)(yao)(yao)和甲類非處(chu)方藥(yao)(yao)(yao)的(de)(de)(de)經營范圍(wei)。對查實的(de)(de)(de)“掛證”執(zhi)(zhi)(zhi)業(ye)藥(yao)(yao)(yao)師要錄入(ru)全國執(zhi)(zhi)(zhi)業(ye)藥(yao)(yao)(yao)師注冊管理信息(xi)系(xi)統、撤銷其(qi)注冊證書并堅決予以曝光;還要將(jiang)“掛證”執(zhi)(zhi)(zhi)業(ye)藥(yao)(yao)(yao)師納(na)入(ru)信用管理“黑名單(dan)”,實施多部門(men)聯(lian)合懲戒。 三 切實發揮執業藥師作用,持續加強隊伍建設 藥(yao)(yao)(yao)品(pin)(pin)(pin)零售(shou)企(qi)業(ye)(ye)執業(ye)(ye)藥(yao)(yao)(yao)師(shi)(shi)應當負(fu)責(ze)本企(qi)業(ye)(ye)藥(yao)(yao)(yao)品(pin)(pin)(pin)質量管(guan)(guan)理(li)(li)(li),督促執行(xing)藥(yao)(yao)(yao)品(pin)(pin)(pin)管(guan)(guan)理(li)(li)(li)相關(guan)的(de)法(fa)(fa)律(lv)法(fa)(fa)規及規范(fan);負(fu)責(ze)處方審核和監督調配(pei),向公眾(zhong)提供合理(li)(li)(li)用(yong)藥(yao)(yao)(yao)指導和咨詢服務;負(fu)責(ze)收集反饋藥(yao)(yao)(yao)品(pin)(pin)(pin)不(bu)良反應信息等藥(yao)(yao)(yao)學工作(zuo)。藥(yao)(yao)(yao)品(pin)(pin)(pin)零售(shou)企(qi)業(ye)(ye)要(yao)嚴格執行(xing)《藥(yao)(yao)(yao)品(pin)(pin)(pin)管(guan)(guan)理(li)(li)(li)法(fa)(fa)》有關(guan)規定,在堅持執業(ye)(ye)藥(yao)(yao)(yao)師(shi)(shi)配(pei)備原則的(de)同(tong)時,更(geng)要(yao)發揮執業(ye)(ye)藥(yao)(yao)(yao)師(shi)(shi)的(de)作(zuo)用(yong)。 各地(di)(di)要高(gao)度重視執業(ye)藥師(shi)隊(dui)伍建設,制(zhi)定相關政策引導(dao)藥學技(ji)術(shu)人才積極參加執業(ye)藥師(shi)資格考試,逐(zhu)年提升轄區內執業(ye)藥師(shi)的配備(bei)使(shi)用(yong)比例;要規范執業(ye)藥師(shi)繼續教育(yu),促進執業(ye)藥師(shi)持續更(geng)新(xin)專業(ye)知識,更(geng)好地(di)(di)發揮作用(yong);要探(tan)索建立多部門政策聯動(dong)機制(zhi),促進執業(ye)藥師(shi)配備(bei)使(shi)用(yong)和(he)執業(ye)藥師(shi)隊(dui)伍健康發展。 本通(tong)知自2020年(nian) 月(yue) 日起實施。各地(di)關(guan)于藥品零售企業執業藥師配備使用要(yao)求(qiu)與本通(tong)知要(yao)求(qiu)不一致的,按本通(tong)知執行。
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