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【行業新聞】規范藥品零售企業配備使用執業藥師征求意見

來源: 發布時間(jian):2021-08-24 編輯:

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)業(ye)(ye)藥(yao)(yao)(yao)(yao)師是開展藥(yao)(yao)(yao)(yao)品質量(liang)管理(li)和藥(yao)(yao)(yao)(yao)學服務的(de)專業(ye)(ye)力量(liang),是合(he)理(li)用藥(yao)(yao)(yao)(yao)的(de)重要(yao)保障。近年來,國家藥(yao)(yao)(yao)(yao)監局不(bu)斷加強執(zhi)業(ye)(ye)藥(yao)(yao)(yao)(yao)師制(zhi)度(du)建設和隊(dui)伍建設,持續推動執(zhi)業(ye)(ye)藥(yao)(yao)(yao)(yao)師配(pei)備(bei)使用,積極發(fa)揮(hui)執(zhi)業(ye)(ye)藥(yao)(yao)(yao)(yao)師在保障公(gong)眾(zhong)用藥(yao)(yao)(yao)(yao)安全有(you)(you)效(xiao)方面的(de)重要(yao)作用。但是,目前執(zhi)業(ye)(ye)藥(yao)(yao)(yao)(yao)師隊(dui)伍發(fa)展不(bu)平(ping)衡、不(bu)充分,部分地區藥(yao)(yao)(yao)(yao)品零(ling)售(shou)企業(ye)(ye)執(zhi)業(ye)(ye)藥(yao)(yao)(yao)(yao)師配(pei)備(bei)不(bu)到位的(de)問題還比較(jiao)突出。根據(ju)新修訂的(de)《中華人(ren)民(min)共和國藥(yao)(yao)(yao)(yao)品管理(li)法(fa)》(以下簡稱《藥(yao)(yao)(yao)(yao)品管理(li)法(fa)》)有(you)(you)關規定,為規范執(zhi)業(ye)(ye)藥(yao)(yao)(yao)(yao)師配(pei)備(bei)使用,現(xian)將有(you)(you)關要(yao)求通知如下: 

堅持執業藥師配備政策,穩步提高配備水平

 

 

《藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)管理法》規(gui)定(ding),從事藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)經(jing)(jing)(jing)營(ying)活動應當(dang)有依法經(jing)(jing)(jing)過資格(ge)(ge)認(ren)定(ding)的(de)(de)(de)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)或者其他(ta)藥(yao)(yao)(yao)(yao)(yao)(yao)學(xue)(xue)技(ji)術人員。藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)經(jing)(jing)(jing)營(ying)領域依法經(jing)(jing)(jing)過資格(ge)(ge)認(ren)定(ding)的(de)(de)(de)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)是(shi)指執(zhi)(zhi)業(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi),依法經(jing)(jing)(jing)過資格(ge)(ge)認(ren)定(ding)的(de)(de)(de)其他(ta)藥(yao)(yao)(yao)(yao)(yao)(yao)學(xue)(xue)技(ji)術人員包括(kuo)衛生(藥(yao)(yao)(yao)(yao)(yao)(yao))系列(lie)職(zhi)稱(cheng)(含藥(yao)(yao)(yao)(yao)(yao)(yao)士、藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)、主管藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)、副(fu)主任(ren)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)、主任(ren)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi))、從業(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)等。藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)零售(shou)企(qi)(qi)業(ye)(ye)(ye)按規(gui)定(ding)配(pei)備(bei)執(zhi)(zhi)業(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)是(shi)維護公眾用藥(yao)(yao)(yao)(yao)(yao)(yao)安全的(de)(de)(de)基本要(yao)求,也是(shi)實現“健康中(zhong)國”戰略、促進行業(ye)(ye)(ye)高質量發展的(de)(de)(de)現實需要(yao)。要(yao)堅持和(he)完善(shan)執(zhi)(zhi)業(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)職(zhi)業(ye)(ye)(ye)資格(ge)(ge)準入(ru)制度,堅持藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)經(jing)(jing)(jing)營(ying)企(qi)(qi)業(ye)(ye)(ye)執(zhi)(zhi)業(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi)依法配(pei)備(bei)使(shi)用要(yao)求。原則上,經(jing)(jing)(jing)營(ying)處(chu)方(fang)(fang)藥(yao)(yao)(yao)(yao)(yao)(yao)、甲類非(fei)處(chu)方(fang)(fang)藥(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)零售(shou)企(qi)(qi)業(ye)(ye)(ye),應當(dang)配(pei)備(bei)執(zhi)(zhi)業(ye)(ye)(ye)藥(yao)(yao)(yao)(yao)(yao)(yao)師(shi)(shi);只經(jing)(jing)(jing)營(ying)乙類非(fei)處(chu)方(fang)(fang)藥(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)零售(shou)企(qi)(qi)業(ye)(ye)(ye),應當(dang)配(pei)備(bei)經(jing)(jing)(jing)過藥(yao)(yao)(yao)(yao)(yao)(yao)品(pin)監督管理部門(men)組(zu)織考(kao)核合(he)格(ge)(ge)的(de)(de)(de)業(ye)(ye)(ye)務人員。

 

針對當前部分地區(qu)執(zhi)(zhi)業(ye)(ye)藥(yao)師(shi)(shi)不(bu)夠(gou)用(yong)、配備(bei)難的實際情況,各省藥(yao)品監(jian)督管理部門(men)在不(bu)降低現有執(zhi)(zhi)業(ye)(ye)藥(yao)師(shi)(shi)整體配備(bei)比例前提下,可(ke)制(zhi)定實施差異化配備(bei)使用(yong)執(zhi)(zhi)業(ye)(ye)藥(yao)師(shi)(shi)的政(zheng)策,并設置過(guo)(guo)渡(du)(du)期。過(guo)(guo)渡(du)(du)期內,對于執(zhi)(zhi)業(ye)(ye)藥(yao)師(shi)(shi)存在明顯缺口(kou)的地區(qu),允(yun)許藥(yao)品零售企業(ye)(ye)配備(bei)使用(yong)其(qi)他藥(yao)學技(ji)術人員承擔(dan)執(zhi)(zhi)業(ye)(ye)藥(yao)師(shi)(shi)職責,過(guo)(guo)渡(du)(du)期不(bu)超過(guo)(guo)2025年(nian)。

細化落實執業藥師配備要求,強化監督檢查責任 

 

 

各(ge)省藥(yao)(yao)(yao)(yao)品(pin)監督管(guan)理(li)部(bu)(bu)門要根據轄區內(nei)執業(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)和(he)藥(yao)(yao)(yao)(yao)學技(ji)術人員(yuan)隊伍(wu)實際情況,結合經營品(pin)種、經營規模、地域(yu)(yu)差異以及(ji)藥(yao)(yao)(yao)(yao)品(pin)安全風險(xian)等因素,制定(ding)具體實施方(fang)案,分階(jie)段、分區域(yu)(yu)推進(jin)執業(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)配備使(shi)用,穩步提升藥(yao)(yao)(yao)(yao)品(pin)零(ling)售企業(ye)(ye)執業(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)配備使(shi)用比(bi)例(li)。各(ge)省藥(yao)(yao)(yao)(yao)品(pin)監督管(guan)理(li)部(bu)(bu)門制定(ding)的差異化配備使(shi)用執業(ye)(ye)藥(yao)(yao)(yao)(yao)師(shi)過渡政策和(he)實施方(fang)案應(ying)及(ji)時(shi)向社會公開,并做好宣傳引導工作。

 

過(guo)渡期內,各市縣負責藥(yao)品監管(guan)(guan)的(de)部門要加強對(dui)(dui)轄區內藥(yao)學(xue)技(ji)術(shu)人員(yuan)(yuan)(yuan)的(de)管(guan)(guan)理,對(dui)(dui)藥(yao)品零售(shou)企(qi)(qi)業按(an)規(gui)定(ding)配備藥(yao)學(xue)技(ji)術(shu)人員(yuan)(yuan)(yuan)的(de)情(qing)況進行登記,建立相關信(xin)息檔案(an)。要落實“四個最嚴”監管(guan)(guan)要求(qiu),對(dui)(dui)新開辦藥(yao)品零售(shou)企(qi)(qi)業嚴格(ge)審核把關;加強對(dui)(dui)執業藥(yao)師(shi)(或藥(yao)學(xue)技(ji)術(shu)人員(yuan)(yuan)(yuan))配備和在崗執業情(qing)況的(de)監督(du)(du)檢查(cha),督(du)(du)促其盡職履(lv)責。對(dui)(dui)于不(bu)按(an)規(gui)定(ding)配備且(qie)整改不(bu)到位(wei)的(de)藥(yao)品零售(shou)企(qi)(qi)業,應(ying)當依法查(cha)處,并(bing)按(an)規(gui)定(ding)核減(jian)其處方(fang)藥(yao)和甲(jia)類非(fei)處方(fang)藥(yao)的(de)經營范圍。對(dui)(dui)查(cha)實的(de)“掛證(zheng)”執業藥(yao)師(shi)要錄(lu)入(ru)全國執業藥(yao)師(shi)注冊管(guan)(guan)理信(xin)息系統、撤銷其注冊證(zheng)書并(bing)堅決予以曝光;還要將“掛證(zheng)”執業藥(yao)師(shi)納(na)入(ru)信(xin)用管(guan)(guan)理“黑名單”,實施多部門聯合懲戒。

 

切實發揮執業藥師作用,持續加強隊伍建設

 

 

藥品(pin)零(ling)售企(qi)(qi)業執業藥師應當負責本企(qi)(qi)業藥品(pin)質(zhi)量管理,督促執行藥品(pin)管理相關的(de)法律法規及規范;負責處方(fang)審核和監督調配,向公眾(zhong)提供(gong)合理用藥指導和咨詢服務(wu);負責收(shou)集(ji)反饋(kui)藥品(pin)不良反應信息等(deng)藥學工作。藥品(pin)零(ling)售企(qi)(qi)業要嚴格(ge)執行《藥品(pin)管理法》有關規定,在(zai)堅持(chi)執業藥師配備(bei)原則的(de)同時,更要發揮執業藥師的(de)作用。

 

各地要高度(du)重(zhong)視執(zhi)(zhi)業(ye)藥師(shi)隊伍建設,制定相關政策引導(dao)藥學技術人才積極參加執(zhi)(zhi)業(ye)藥師(shi)資格(ge)考試,逐年提升轄(xia)區內執(zhi)(zhi)業(ye)藥師(shi)的配備(bei)使用(yong)比例;要規范(fan)執(zhi)(zhi)業(ye)藥師(shi)繼續教(jiao)育,促(cu)進(jin)執(zhi)(zhi)業(ye)藥師(shi)持續更新專(zhuan)業(ye)知(zhi)識,更好地發揮作用(yong);要探(tan)索建立多部門政策聯動機制,促(cu)進(jin)執(zhi)(zhi)業(ye)藥師(shi)配備(bei)使用(yong)和執(zhi)(zhi)業(ye)藥師(shi)隊伍健康發展。

 

本通(tong)知(zhi)自2020年  月  日起實施。各地關于藥(yao)品(pin)零售企業執業藥(yao)師(shi)配備使用要求(qiu)與本通(tong)知(zhi)要求(qiu)不一(yi)致的,按本通(tong)知(zhi)執行。