藥(yao)(yao)(yao)品(pin)不(bu)良(liang)(liang)反(fan)應(ying)(ying)監測(ce)(ce)工(gong)(gong)作是生產企(qi)業獲得上市后(hou)藥(yao)(yao)(yao)品(pin)安全性資料的重要手段，是保(bao)護民族藥(yao)(yao)(yao)生命周期健康發(fa)展的科學措施之一，在食品(pin)藥(yao)(yao)(yao)品(pin)科學監管(guan)的大背(bei)景下，為(wei)進一步貫徹落實《藥(yao)(yao)(yao)品(pin)不(bu)良(liang)(liang)反(fan)應(ying)(ying)報告和監測(ce)(ce)管(guan)理辦法》，保(bao)障十二五期間我(wo)區生產企(qi)業藥(yao)(yao)(yao)品(pin)不(bu)良(liang)(liang)反(fan)應(ying)(ying)監測(ce)(ce)考核(he)評估(gu)重點工(gong)(gong)作順利開展2014年8月8日(ri)，由宇飛(fei)副局長帶(dai)隊(dui)的考核(he)評估(gu)小(xiao)組(zu)對山(shan)南地區雅礱(long)藏藥(yao)(yao)(yao)有限責任(ren)公司和雍布拉(la)康藏藥(yao)(yao)(yao)廠開展了不(bu)良(liang)(liang)反(fan)應(ying)(ying)監測(ce)(ce)工(gong)(gong)作考核(he)評估(gu)，標(biao)志著我(wo)區藥(yao)(yao)(yao)品(pin)生產企(qi)業不(bu)良(liang)(liang)反(fan)應(ying)(ying)監測(ce)(ce)考核(he)評估(gu)工(gong)(gong)作的啟動。
此次工(gong)(gong)(gong)作(zuo)以聽取生(sheng)(sheng)產(chan)企(qi)(qi)業工(gong)(gong)(gong)作(zuo)匯報(bao)、查看文字記錄、現場檢查及應(ying)急(ji)推(tui)演的(de)(de)方式開展考核評(ping)估(gu)，生(sheng)(sheng)產(chan)企(qi)(qi)業在開展和推(tui)動(dong)(dong)藥品不良反應(ying)監(jian)(jian)測工(gong)(gong)(gong)作(zuo)過程(cheng)中(zhong)取得了一(yi)定的(de)(de)成(cheng)績，但(dan)還存在以下問題：一(yi)是組織體系、制度(du)和工(gong)(gong)(gong)作(zuo)機制不健全，責任意識淡薄。二是工(gong)(gong)(gong)作(zuo)態(tai)度(du)和工(gong)(gong)(gong)作(zuo)成(cheng)效較差。三是未將不良反應(ying)監(jian)(jian)測工(gong)(gong)(gong)作(zuo)納入(ru)生(sheng)(sheng)產(chan)企(qi)(qi)業年度(du)績效考評(ping)，激勵機制未落實。四是主(zhu)動(dong)(dong)監(jian)(jian)測措(cuo)施有待完善，不良反應(ying)病(bing)例報(bao)告表的(de)(de)收(shou)集和上報(bao)工(gong)(gong)(gong)作(zuo)需要積極跟進(jin)。五(wu)是生(sheng)(sheng)產(chan)企(qi)(qi)業不良反應(ying)監(jian)(jian)測工(gong)(gong)(gong)作(zuo)開展比較孤立(li)，各(ge)部門間聯動(dong)(dong)工(gong)(gong)(gong)作(zuo)機制有待加強。
考核評(ping)(ping)估(gu)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)結束，宇飛副(fu)局長對藥(yao)(yao)品(pin)生(sheng)(sheng)產(chan)企(qi)(qi)業(ye)(ye)(ye)提出了具體(ti)的(de)(de)(de)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)要求。一是(shi)要在(zai)此次考核評(ping)(ping)估(gu)發現問題的(de)(de)(de)基礎上，采取具體(ti)有效的(de)(de)(de)措施(shi)，改進工(gong)(gong)(gong)作(zuo)(zuo)(zuo)態度，健(jian)全工(gong)(gong)(gong)作(zuo)(zuo)(zuo)體(ti)系、機(ji)制和制度，分工(gong)(gong)(gong)明(ming)確，責(ze)任落(luo)(luo)實(shi)(shi)，在(zai)提升品(pin)質、加(jia)(jia)(jia)強企(qi)(qi)業(ye)(ye)(ye)內(nei)控、完善(shan)制度的(de)(de)(de)同(tong)時(shi)，把(ba)不(bu)良(liang)(liang)(liang)反(fan)(fan)應(ying)(ying)(ying)監(jian)(jian)測(ce)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)納入生(sheng)(sheng)產(chan)企(qi)(qi)業(ye)(ye)(ye)的(de)(de)(de)重點工(gong)(gong)(gong)作(zuo)(zuo)(zuo)和績(ji)效考評(ping)(ping)中。二是(shi)強調(diao)在(zai)市場經濟和醫(yi)藥(yao)(yao)衛生(sheng)(sheng)體(ti)制改革的(de)(de)(de)大(da)環境下(xia)，必須認清形式(shi)，加(jia)(jia)(jia)強生(sheng)(sheng)產(chan)企(qi)(qi)業(ye)(ye)(ye)是(shi)不(bu)良(liang)(liang)(liang)反(fan)(fan)應(ying)(ying)(ying)監(jian)(jian)測(ce)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)的(de)(de)(de)第一責(ze)任人意(yi)識，用科學的(de)(de)(de)管(guan)理方(fang)式(shi)研究和發展(zhan)民族(zu)藥(yao)(yao)及民族(zu)藥(yao)(yao)企(qi)(qi)的(de)(de)(de)文化內(nei)涵。三(san)是(shi)監(jian)(jian)管(guan)是(shi)一種(zhong)督促(cu)手段(duan)，監(jian)(jian)管(guan)部(bu)門和生(sheng)(sheng)產(chan)企(qi)(qi)業(ye)(ye)(ye)必須相(xiang)互(hu)(hu)協(xie)作(zuo)(zuo)(zuo)、相(xiang)互(hu)(hu)支持，共同(tong)推進我區的(de)(de)(de)不(bu)良(liang)(liang)(liang)反(fan)(fan)應(ying)(ying)(ying)監(jian)(jian)測(ce)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)，保護民族(zu)藥(yao)(yao)生(sheng)(sheng)命周期的(de)(de)(de)健(jian)康持續(xu)發展(zhan)。四(si)是(shi)必須加(jia)(jia)(jia)強不(bu)良(liang)(liang)(liang)反(fan)(fan)應(ying)(ying)(ying)監(jian)(jian)測(ce)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)的(de)(de)(de)責(ze)任落(luo)(luo)實(shi)(shi)，在(zai)注(zhu)重生(sheng)(sheng)產(chan)效益及利潤的(de)(de)(de)情(qing)況下(xia)，加(jia)(jia)(jia)強藥(yao)(yao)品(pin)生(sheng)(sheng)產(chan)企(qi)(qi)業(ye)(ye)(ye)各(ge)部(bu)門間的(de)(de)(de)聯動(dong)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)機(ji)制，積極(ji)推動(dong)不(bu)良(liang)(liang)(liang)反(fan)(fan)應(ying)(ying)(ying)監(jian)(jian)測(ce)工(gong)(gong)(gong)作(zuo)(zuo)(zuo)的(de)(de)(de)開(kai)展(zhan)。
