藥品不良反應(yīng)報告和監(jiān)測工作中存在的問題與對策

1、holiday,pensi on a nd health,cult ural andcreativeexperience,sportshealth,farming,ruralbedandbreakfastsi n newformats.T hreeis t hebrand tocre atearticles.XX agriculturalcomparativeadvantageinto full play,e speciallytheexcl usive a dvantages ofclimate,mountainsa nd searesource s,tocreateagroup ofthe

2、city,the pr ovince's"calle d" XX seafood,s nackfoods a nd safeagricult uralproducts bra ndcharacteri stics.Meanwhil e, newi ndustrygui dance,supportmorefarmers toparticipatein entre prene urship, promoti ng large-scale pr oje cts such a s bed andbreakfasts,farm, seed breedi ng base con

3、struction.Four i sthe mechanism innovation ofthe article.Dee pe nagriculturalreform,focusingonsupportingfosterprofessionalmajor,familyfarms,cooperatives,enterprise s and other newsubjects of agricultural ma nagement,impr oveagriculturalpr oducti on andoperation of large-scale,professionallevel.Advan

4、cethe reform ofpropertyrightsystem in ruralareas,to payspecialattentionto landrights,improvet hefunction ofproperty rightstrading center to gui de la nd managementto professi onal users,familyfarms,cooperatives,leadinge nterprise s in circulation.Spare noefforttopr omotethe province's "Trin

5、ity"farmer cooperativeeconomyorgani zation systemreform of Countybuilding, andactively explore theTrinityofproduction,supply andmarketing, creditFarmercooperativeeconomyorgani zation system, realorganicaggregates uptoal lkindsof business e ntities, closelylinke dtothe alla spe cts of pr oducti

6、on and marketing. ( B)to makethe country sidem ore bea utiful. Promoting the construction ofnewt owns andnew countrysi de rea ctions together,stre ngthe ningthe construction ofruraleco-envir onment, create the beautifulcountry side construction upgra des, maki ng ruralareas morel ivable, suita blefo

7、rindustr y,and travel.Afocus on ruralenvironme ntimpr ovement.Asfaras therural,themostbasicistomakethee nvironme nt clea n and or derly. Pollution to extensivelymobilizet hemasses conti nue to carry water, clearrivers, downvi olations, treatmentofblea chi ng,suchas wa ste reduction,flow ering tree &

8、quot; big six",vigorouslycarry outwastereduction,re source re cover y, impr ove the clea ning me chanism,e nhance t helevel ofmeticul ous manageme nt ofthev lage.Second,we mustpayspecial attentiontothebe autiful re sidentialbuilding.A dher etothe "planninga hea d,be cause village system,co

9、mbi nation classificationimplementation, dem olition,alterationsimultane ously" policy,vig orously impleme nt the"five hundred"beautifulcountrysi deconstruction, a ctivelypr omote "bea utifulhouse"pil otexpa nsion.Ar ound 104 nati onalr oad, Ling Road, l ongji nda dao, sea r

10、oa d,Ju XI Liaoroadt ocat chthefive side softhe main roa ds in about 200village s,beautiful countrysi defeatures boutiquevillage created,g oodjobonplanning, environmental protecti on, culturalheritage ,industrial devel opment,craftingli nesto createthe bea utiful rural sce ner y,bouti quevillagebree

11、d characteristics.No matterwhich藥品不良反應(yīng)報告和監(jiān)測工作中存在的問題與對策近年來， 我國 ADR 監(jiān)測與報告工作取得了突破性的進(jìn)展，2011年 7 月 1 日，藥品不良反應(yīng)報告和監(jiān)測管理辦法正式頒布并實(shí)施，國家對此項工作的重視和投入也逐步加強(qiáng)。然而，從實(shí)際工作情況看， 我國 ADR 監(jiān)測工作基礎(chǔ)還比較薄弱，特別在基層，此項工作尚處于啟動階段，人員、設(shè)備、制度以及措施等還不夠完備，因此，基層監(jiān)測工作的開展還存在許多困難。筆者從事ADR 監(jiān)測工作幾年來，對此深有體會，現(xiàn)結(jié)合棗莊市市中區(qū)ADR 監(jiān)測工作的實(shí)際，就基層 ADR 報告和監(jiān)測工作情況談幾點(diǎn)粗淺的認(rèn)識。1.

12、 加強(qiáng)基層藥品不良反應(yīng)報告和監(jiān)測工作的必要性和重要性藥品是人們防病治病、調(diào)節(jié)生理功能、提高健康水平的重要武器，是關(guān)系到人的生命健康的特殊商品，不僅要求質(zhì)量合格、有效，還要使用安全，而安全性評價的最關(guān)鍵指標(biāo)就是其不良反應(yīng)發(fā)生的頻率和嚴(yán)重程度。要實(shí)現(xiàn)科學(xué)的評價、及時防范和減少 ADR,指導(dǎo)臨床合理用藥，必須對上市后的藥品進(jìn)行不良反應(yīng)監(jiān)測1 。而 ADR 監(jiān)測工作的源頭則在基層，因此基層藥品不良反應(yīng)報告和監(jiān)測工作開展的好壞，直接關(guān)系到整個ADR 監(jiān)測鏈條的成敗。2. 基層藥品不良反應(yīng)報告和監(jiān)測工作現(xiàn)狀本節(jié)從藥品監(jiān)管部門、ADR 監(jiān)測機(jī)構(gòu)、藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療衛(wèi)生機(jī)構(gòu)以及社會公眾的認(rèn)知等多

13、角度探討基層ADR報告和監(jiān)測工作現(xiàn)狀s long a s they caug ht up pea ch Lakea nd villageaftereight acre s to createa sta ndard,even ifthe Countyfinancialtobenervous,theCounty Governme ntwillfulfiltheir commitments,a nd 3 millionYua n/vi llage ofsubsi dies.Thir d,wem ustpayspe cialattention to devel opment ofbea utyindu

14、str y.Constructionand traditi onalvill agesa nd beautiful countrysi de protecti on of history a nd culture village ,ruraltourism, bed a nd breakfastin combi ning economi c,on ruralt ourism devel opment i npre ciseand accurate positi oni ng, preci sion marketing,supply, andvigorously promotet he beau

15、tifulr urallandscape ofruraltourism complex,line,fashion boutiquefarm villageconstruction andstrive to build agroup ofXX feature quality boutiqueaccommodationproject. (C)efforts to getfarmerstobecomeevenricher."Off notwell-off,the key to fellow",the "threeagri culture",finaldesti

16、nati on wasimpr oving f armers'welfare,improving farmers' livi ng standards.Focus onthreeaspect s: oneiholiday,pensi on a nd health,cult ural andcreativeexperience,sportshealth,farming,ruralbedandbreakfastsin newformats.T hreeis t hebrand tocre atearticles.XX agriculturalcomparativeadvantage

17、intofullplay,e speciallytheexcl usive a dvantages ofclimate,mountainsa nd searesource s,tocreateagroup ofthecity,the pr ovince's"calle d" XX seafood, snack foodsa nd safeagricult uralproducts bra ndcharacteri stics.Meanwhil e, newi ndustrygui dance,supportmorefarmers toparticipatein en

18、tre prene urship, promoti ng large-scale pr oje cts such a s bed andbreakfasts,farm, seed breedi ng base construction.Four i sthe mechanism innovation ofthe article.Deepenagriculturalreform,focusingon supporti ngfosterprofessionalmajor,family farms,cooperatives,enterprisesand other newsubjects of ag

19、ricultural ma nagement,impr oveagriculturalpr oducti on andoperation of large-scale,professionalleve l.Advancethe reform ofpropertyrightsystem in ruralareas,to payspecialattentionto landrights,improvet hefunction ofproperty rightstrading center to gui de la nd managementto professi onal users,family

20、farms,cooperatives,leading e nterprise s in circulation.Spare noefforttopr omotethe province's "Trinity"farmer cooperativeeconomyorgani zation systemreform of Countybuilding, andactively explore theTrinityofproduction,supply andmarketing, creditFarmercooperativeeconomyorgani zation sys

21、tem, realorganicaggregatesuptoal lkindsof business e ntities, closelylinke dtothe alla spe cts of pr oducti on and marketing. ( B)to makethe country sidem ore bea utiful. Promoting the construction ofnewt own s and new countrysi de rea ctions together,stre ngthe ningthe construction ofruraleco-envir

22、 onment, create the beautifulcountry side construction upgra des, maki ng ruralareas morel ivable, suita bleforindustr y,and travel.Afocus on ruralenvironme ntimpr ovement.Asfaras therural,themostbasicistomakethee nvironme nt clea n and or derly. Pollution to extensivelymobilizet hemasses conti nue

23、to carry water, clearrivers, downvi olations, treatmentofbleaching,suchaswa ste reduction,flow ering tree "big six",vigorouslycarry outwastereduction,re source re cover y, impr ove the clea ning me chanism,e nhance t helevel ofmeticul ousmanageme nt ofthev lage.Second,we mustpayspecial att

24、entiontothebe autiful re sidentialbuilding.A dher etothe "planninga hea d,be cause village system,combi nation classificationimplementation, dem olition,alterationsimultaneously" policy,vig orously impleme nt the"five hundred"beautifulcountrysi deconstruction, a ctivelypr omote &

25、quot;bea utifulhouse"pil otexpa nsion.Ar ound 10 4 nati onalr oad, Ling Road, l ongji nda dao, sea roa d,Ju XILiaoroadt ocat chthefive side softhe main roa ds in about 200village s,beautiful countrysi defeatures boutiquevillage created,g oodjobonplanning, environmental protecti on, culturalher

26、itage ,industrial devel opment,craftingli nesto createthe bea utiful rural sce ner y,bouti quevillagebreed characteristics.No matterwhich2.1 基層藥品監(jiān)管部門和基層ADR 監(jiān)測機(jī)構(gòu)2.1.1 監(jiān)測資金投入不足在 ADR 監(jiān)測實(shí)際執(zhí)行過種中，基層承擔(dān)著轄區(qū)藥品生產(chǎn)、經(jīng)營、使用單位的ADR 監(jiān)測具體工作，工作面廣、量大。 由于基層藥監(jiān)部門普遍存在人員少、經(jīng)費(fèi)不足等困難，在一定程度上影響了ADR 監(jiān)測工作的深入開展。ADR 監(jiān)測工作需要投入一定的人力、物力，但卻

27、不能給藥品生產(chǎn)、經(jīng)營、使用單位帶來直接的、明顯的效益，有時還會增加麻煩，導(dǎo)致許多單位和個人被動監(jiān)測。2.1.2 監(jiān)測人員力量薄弱目前，大部分基層藥監(jiān)部門編制偏少，許多工作人員身兼數(shù)職,真正專職的ADR 監(jiān)測人員基本沒有，加之藥械日常監(jiān)管任務(wù)日趨繁重 , 使得負(fù)責(zé)ADR 監(jiān)測與報告工作的人員無法做到統(tǒng)籌兼顧，沒有足夠的時間和經(jīng)歷去思考如何解決基層監(jiān)測工作中遇到的問題，造成工作的無序性和應(yīng)付性。這是制約基層ADR 監(jiān)測工作的一個重要因素。另外，現(xiàn)有的兼職人員中，藥學(xué)專業(yè)畢業(yè)的人員所占比例較少。專業(yè)和學(xué)歷的不平衡，使得監(jiān)測隊伍力量薄弱，不能行之有效地開展工作。2.1.3 報告方式缺乏有效監(jiān)督我國主要

28、依靠自愿報告方式來完成ADR 的收集，這種方法具有投資少、覆蓋面廣等優(yōu)勢，是國際上普遍采用的報告方式。但因缺乏有效監(jiān)督，往往存在著漏報率高，無法統(tǒng)計發(fā)生率的缺陷。2.1.4 監(jiān)測宣傳力度不夠Constructionand traditipositi oni ng, preci sion marketing,supply,andvigorously promotet he beautifulrurallandscape ofruraltourism complex,livillage constructionandstrive tobuild agroupofXX feature quality

29、 boutiqueaccommodationproject. (C)efforts to getfarmersto-off,the key to fellow",the "threeagriculture",finaldestinatin wasimpr oving farmers'welfare,improving farmers' living standards.Focushave to be base d on localconditions,use yourheathis year, theprovi nce' s"fi

30、vewatertreatmentd and breakfastineconomy, ensurea stableoperating incomegrowth.poweri n I .1 .out ofpoverty"of pov I J _ II _I _ -一一-_ - .L.II-JI 一 ng pr omine ntweakne一.- .I ,ihoodfacilities, suchast hrough theteaching,meI - 一一- I 1uralareas.ntralvillageto set up .II -1 一-一一 一 .L . , -一I >I

31、I .1一.holiday,pensi on a nd health,cult ural andcreativeexperience,sportshealth,farming,ruralbedandbreakfastsin newf ormats.T hreeis t hebrand tocre atearticles.XX agriculturalcomparativeadvantageinto full play,e speciallytheexcl usive a dvantages ofclimate,mountainsa nd searesource s,tocreateagroup

32、 ofthecity,the pr ovince's"calle d" XX seafood,snackfoodsa nd safeagricult uralproducts bra ndcharacteri stics.Meanwhil e, newi ndustrygui dance,supportmorefarmers toparticipatein entre prene urship, promoti ng large-scale pr oje cts such a s bed andbreakfasts,farm, seed breedi ng base

33、 construction.Four i sthe mechanism innovation ofthe article.Deepe nagriculturalreform,focusingon supporti ngfosterprofessionalmajor,family farms,cooperatives,enterprise s and other newsubjects of agricultural ma nagement,impr oveagriculturalpr oducti on andoperatio nof large-scale, professi onallev

34、e l.Advancethe reform ofpropertyrightsystem in ruralareas,to payspecialattentionto landrights,improvet hefunction ofproperty rightstrading center to gui de la nd managementto professi onal users,familyfarms,cooperatives,leading e nterprise s in circulation.Spare noefforttopr omotethe province's

35、"Trinity"farmer cooperativeeconomyorgani zation systemreform of Countybuilding, andactively explore theTrinityofproduction,supply andmarketing, creditFarm er cooperativee conomyorgani zation system, realorganicaggregates uptoal lkindsof business e ntities, closelylinke dtothe alla spe cts

36、of pr oducti on and marketing. ( B)to makethe country sidem ore bea utiful. Promoting the construction ofnewt owns andnew countrysi de rea ctions together,stre ngthe ningthe construction ofruraleco-envir onment, create the beautifulcountry side construction upgra des, maki ng ruralareas morel ivable

37、, suita bleforindustr y,and travel.Afocus on ruralenvironme ntimpr ovement.Asfaras therural,themostbasicistomakethee nvironme nt clea n and or derly. Pollution to extensivelymobilizet hemasses conti nue to carry water, clearrivers, downvi olations, treatmentofblea chi ng,suchas wa ste reduction,flow

38、 ering tree "big six",vigorouslycarry outwastereduction,re source re cover y, impr ove the clea ning me chanism,e nhance t helevel ofmeticul ousmanageme nt ofthev lage.Second,we mustpayspecial attentiontothebe autiful re sidentialbuilding.A dher etothe "planninga hea d,be cause villag

39、e system,combi nation classificationimplementation, dem olition,alterationsimultaneously" policy,vig orously impleme nt the"five hundred"beautifulcountrysi deconstruction, a ctivelypr omote "bea utifulhouse"pil otexpa nsion.Ar ound 104 nati onalr oad, Ling Road, l ongji nda

40、dao, sea roa d,Ju XILiaoroadt ocat chthefive side softhe main roa ds in about 200village s,beautiful countrysi defeatures boutiquevillage created,g oodjobonplanning, environmental protecti on, culturalheritage ,industrial devel opment,craftingli nesto createthe bea utiful rural sce ner y,bouti quevi

41、llagebreed characteristics.No matterwhich一些涉藥單位沒有接受過相關(guān)法律、法規(guī)和監(jiān)測報告知識的宣傳培訓(xùn)，一些涉藥人員及醫(yī)務(wù)人員不了解如何開展ADR 監(jiān)測報告工作，上報意識和能力都較差。特別是在一些基層藥店和診所，普遍存在從業(yè)人員不上報ADR 的現(xiàn)象。各級涉藥單位、藥品監(jiān)管部門對ADR 和監(jiān)測工作單位宣傳培訓(xùn)力度不夠的問題較為突出。2.2 藥品生產(chǎn)、經(jīng)營企業(yè)2.2.1 監(jiān)測上報意識缺乏在基層，藥品生產(chǎn)、經(jīng)營企業(yè)，普遍存在監(jiān)測上報意識不強(qiáng)的問題， 尤其是藥品經(jīng)營企業(yè)。包括對開展ADR 監(jiān)測義務(wù)和責(zé)任認(rèn)識不夠，對 ADR 概念不清，把ADR 等同于藥品質(zhì)量事故

42、，誤認(rèn)為不良反應(yīng)就是藥品質(zhì)量問題等。這些認(rèn)識誤區(qū)，都不同程度地制約著ADR 監(jiān)測工作的開展。同時，在藥品生產(chǎn)、經(jīng)營和使用中不重視已經(jīng)發(fā)生的ADR ,這種意識使得漏報現(xiàn)象嚴(yán)重2。2.2.2 不能正確認(rèn)識ADR長期以來,由于種種習(xí)慣意識和偏見導(dǎo)致人們對ADR 認(rèn)識不足甚至是錯誤的理解。如有的人把ADR 與藥品質(zhì)量問題等同起來，有人則認(rèn)為價格高的藥品不良反應(yīng)少；有的醫(yī)務(wù)人員認(rèn)為藥品不良反應(yīng)就是醫(yī)療事故，擔(dān)心承擔(dān)責(zé)任，陷入刑事或民事糾紛而不敢報告；還有人把藥品不良反應(yīng)歸因于個體差異，患者用藥后致死或致殘是自身的原因，與藥品和醫(yī)療行為無關(guān)，不需要報告。這些認(rèn)識上的誤區(qū),都不同程度的制約著ADR 監(jiān)測工作

43、的開展。2.2.3 從業(yè)人員業(yè)務(wù)水平有待提高s long a s they caug ht up pea ch Lakea nd villageaftereight acre s to createa sta ndard,even ifthe Countyfinancialtobenervous,theCounty Governme ntwillfulfiltheir commitments,a nd 3 millionYua n/vi llage ofsubsi dies.Thir d,wem ustpayspe cialattention to devel opment ofbea uty

44、industr y.Constructionand traditi onalvill agesa nd beautiful countrysi de protecti on of history a nd culture village ,ruraltourism, bed a nd breakfastin combi ning economi c,on ruralt ourism devel opment i npre ciseand accurate positi oni ng, preci sion marketing,supply, andvigorously promotet he

45、beautifulr urallandscape ofruraltourism complex,line,fashion boutiquefarm villageconstruction andstrive to buil d agroup ofX Xfeature qualityboutiqueaccommodationproject. (C)efforts to getfarmerstobecomeevenricher."Off notwell-off,the key to fellow",the "threeagri culture",finald

46、estinati on wasimpr oving farmers'welfare,improving farmers' livi ng standards.Focus onthreeaspect s: onei"increasi ng income-ge nerating"efforts.Activelydevelopingthe characteri stic agriculture ,processing,e -commerce,farmand bedand breakfastine conomy, ensurea stabl eoperating i

47、ncomegrowth.Deepenthe "threerights" rights empoweri ng the reform, promoti ng thepr operty i ncome growth.Strengthening of farmers'skills training,increaseempl oymentlevels,promotingsustaine d growt h inwagei ncome.Guide e nterpri ses to stre ngthe n socialresponsi bilit y,equalityand

48、mutualbe nefit, and signe d acontractof purchase a nd sale of agricultural product s for farmers,cooperativesandfarmersare encouraged "guaranteed ear nings + share" distributionsystem,sharingthevalue-added benefits ofindustrialdevelopment.Secondint hegrowi ng collective efforts.Cityha s de

49、vel ope dthe impl ementation ofvillage -levelcolle ctive economythree years cultivating meter, Requirest hreeyearsofhardw orkand largely kongke cun,themajority ofvillages haveoperatingincome.Against thistarget,wehave to be base d on localconditions,useyourhea d, anda ctively explor e andfind ways,an

50、d ensurecompleti on oftasks int he cit y.Thir d,w orkon strengthe ned safeguards.Adva nci ng pre cision of poverty, improvethe low -income house hol dtracking ,dynamicmanagement mechanism, e specially for"unemploye dca n hold, unable to get out ofpoverty"of pov erty,further strengtheningth

51、efallba ckofsubsi stence allowancesandsocialassi stance,and addresst heba sic needs of poor people. Deepe ningt hereform of publi c servi ces i n ruralareas, focus onresolving pr ominentweakne ss ofrural publi cservi cea nd people'slivel ihoodfacilities, suchast hrough theteaching,medicala nd ot

52、herwayst o improve e ducationallevel s, improvi nghealt h conditions in r uralareas.ByencouragingtheCentralvillagetosetupdaycare centrest opromoteol d-age home,ruralelderly pe nsi on probl ems.Thir d,firmly graspa ndconti nue dtoplay w ell "five watertreatmentof" winning thewar on February

53、29holiday,pensi on a nd health,cult ural andcreativeexperience,sportshealth,farming,ruralbedandbreakfastsin newformats.T hreeis t hebrand tocre atearticles.XX agriculturalcomparativeadvantageinto full play,e speciallytheexcl usive a dvantages ofclimate,mountainsa nd searesource s,tocreateagroup ofth

54、ecity,the pr ovince's"calle d" XX seafood, snack foodsa nd safeagricult uralproducts bra ndcharacteri stics.Meanwhil e, newi ndustrygui dance,supportmorefarmers toparticipatein entre prene urship, promoti ng large-scale pr oje cts such a s bed andbreakfasts,farm, seed breedi ng base co

55、nstruction.Four i sthe mechanism innovation ofthe article.Deepenagriculturalreform,focusingonsupportingfosterprofessionalmajor,familyfarms,cooperatives,enterprise s and other newsubjects of agricultural ma nagement,impr oveagriculturalpr oducti on andoperation of large-scale,professionalleve l.Advan

56、cethe reform ofpropertyrightsystem in ruralareas,to payspecialattentionto landrights,improvet hefunction ofproperty rightstrading center to gui de la nd managementto professi onal users,familyfarms,cooperatives,leading e nterprise s in circulation.Spare noefforttopr omotethe province's "Tri

57、nity"farmer cooperativeeconomyorgani zation systemreform of Countybuilding, andactively explore theTrinityofproduction,supply andmarketing, creditFarmercooperativeeconomyorgani zation system, realorganicaggregates uptoal lkindsof business e ntities, closelylinke dtothe alla spe cts of pr oducti

58、 on and marketing. ( B)to makethe country sidem ore bea utiful. Promoting the construction ofnewt own s and new countrysi de rea ctions together,stre ngthe ningthe construction ofruraleco-envir onment, create the beautifulcountry side construction upgra des, maki ng ruralareas morel ivable, suita bl

59、eforindustr y,and travel.Afocus on ruralenvironme ntimpr ovement.Asfaras therural,themostbasicistomakethee nvironme nt clea n and or derly. Pollution to extensivelymobilizet hemasses conti nue to carry water, clearrivers, downvi olations, treatmentofblea chi ng,suchas wa ste reduction,flow ering tree "big six",vigorouslycarry outwastereduction,re source re cover y, impr ove