优良药品采购的操作规范.docx

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1、WHO/EDM/PAIVWSOrigina1.:Eng1.ishDistribution:Genera1.Work!Hea1.thOrganizationOrganisationmondia1.edeIaSantc世界卫生组织Operationa1.princip1.esforgoodpharmaceutica1.procurement优良药M选购操作规冠Essentia1.DrugsandMedicinesPo1.icyInteragencyPharmaceutica1.CoordinationGroupGeneva,1999基本药物政策机构向药物协调小组F1.内瓦，1999作者和编辑Aut

2、horsandeditorsThecontentsofthisdocumentwereadaptedfrom:Chapter13:Managingprocurement.ManagementSciencesforHea1.th(MSH)inco1.1.aborationWiththeWor1.dHea1.thOrganization,ActionPrOgrammeonEssentudDrugs/ManaginggSu叩Msecondedition.Editeu1.byJ.D.Quick,J.RankinxR.IingzR.O,ConnorzI1.V.IIogerzei1.M.N.G.Dukes

3、andA.Garnett.Hartford,C:KumarianPress;1997.IhefirstdrafttextwaspreparedbyJ.Rankininco1.1.aborationwithJ.1.Quick-andS.MUZiki/AftCrinterna1.andexterna1.reviewthefina1.textwaseditedbyK.Wo1.deyesus,-D.A.Fres1.e,-G.Grayston-andH.V.Hogerzei1.-此文件改编自：选购管理(第13章)，医疗保健管理科学(MSH)与世界卫生组织(WHO)就基本药物的行动纲题K药品供应管理8其次

4、版，由JDQuickJRankin.R1.iing.R.O,Conncr.H.V.Hogcrzci1.M.N.GDukcsandA.Garnct1.Hartio111.C:库J1J瑞安(KUmarian)出版社：1997年.初稿由J.Rankin和JDQuick及S.Muziki合作完成,经内部及外部多方征求看法后，由K-Wo1.deyesus.D.A.Fres1.e.GGraysin及HAUIogerzeiI编辑定稿CAcknow1.edgements声明HiefbUowiiigpersonshavecontributedtothedae1.opnettandrcviecofthisdocu

5、mentandtheiradviceandsupportaregratefu1.1.yachte1.edged:H.denBcsten(IDA,Amsterdam),.Chidarikire(Zimbabwe),Z.Csizcr(UNIDO,Vienna),J.Immanue1.(WHO/BCI,),M.Everard(UK),Gorc(Wor1.dBank),R-Govindaraj(Wor1.dBank),J.vanHaperen(UgandaEssentia1.DrugsSupportProgramme),B.vonIIofsten(Ango1.aIissentia1.DrugsProg

6、ramme),K.1.mbeck(Wor1.dBank),SJarreM(UN1.eH)K.deJoncheere(WIIOEUKO),KinShein(VHOSERO),E.Kko1.os(Cyprus),.Kochi(WHO/CDS),S.Kopp-Kube1.(WHOEDM),R1.aing(Boston)RMedeS(PhamwchemieBV),TMerrick(Wor1.dBank),1.Mi1.Stien(W1.!OVAB)zK.Nair(WHOW1RO),P.OII(ICRCGeneva),KPease(Wor1.dBank),I1.Pedersen(UNICEF),J.1.,

7、ind(MSI;,France),C-Rambert(UNICEF),V.Remcdias(Copenhagen),I.E1Sabai(Egypt),H.Sandb1.adh(ICRC),C-Saunders(UNFPA),MseSay(CQ1.TUnOnWeaIthPharmaceutica1.Association),QShiSana(WHQ/C1.IS),the1.ate!,.Sodogandji(W1.IO/DAP),V.CoignezSter1.ing(Wor1.dBank),GSza1.av(WHO/SUP),Y.Tay1.er(Wor1.d1.knk),M.Tec1.eab(PH

8、ARMECOR,Eritrea),V.Vijayavcr1.(Wor1.dBank).以下人士参与了本文件的起草及评阅，现就他们的建议及支持致以谢意.(略)Acronymsandabbreviations首字母和缩略语BCTB1.OOdSafetyandC1.inica1.Iechno1.ogy血液平安和临床技术CDSCommunicab1.eDiseases传染性疾病QISIIca1.thSystemsandCommunityIIea1.th医疗保健体系和社区医疗保健DAPActionI,rogrammeonEssenUa1.Drugs基本药物行动纲要ECHOEquipmentforChar

9、ityHOSPitaISQvezeas侨民慈善医院设施ED1.EDMESSentia1.drugs1.ist基本药品书|：|IVpartmentof1.sentia1.Drugsan1.MediCineSPo1.icy星本药物政策部EURORegiona1.OfficeforEurope欧洲地区办事处FIP*FZGrationInternationa1.eI1Iiarmaceutique国际药物联介会ICRCInternationa1.CommitteeoftheRedCross国际红十字委员会IDAInternationa1.DiSpCnSaryAssociation国际药房联合会INNIn

10、ternationa1.NonproprietarvName国际非g用2称国际非专利商品名)IPCIntcragcncyPharmaceutica1.CrdinationGroup机构间药勃协调小组MISManagementInformationSystem管理信息系统MSFMddBnsSansFrontiers没有国界的医生（法语MSHManagementSciencesforIIea1.th医疗保健管理科学SEARoRegiOna1.OfficeforSouth-EastAsia东南亚地区办(J逸SUPSupp1.yServices供应服务UNFPAUnitedNationsPopu1.a

11、tionFund联合国人口基金会UNICEFUnitedNationsChi1.drensFund联合国儿羽基金会UNIDOUnitedNationsIndustria1.Deve1.opment(.Organization联合国工业发展组织USA1.DUnitedStatesAgencyforInternationa1.Deve1.opment美国国际发展机构VABVaccinesandBio1.ogicaE长笛和生物制品WUOWor1.d1IcaIth(.Organization世界卫生组银WPRORegiOnaIOffiCefortheWesternPaCifiC西太平洋地区办事处COn

12、tentS书目Introduction序言1. Prob1.emstatement3I.问题的提出2. Strategicobjectivesforgoodpharmaceutica1.procrement72.优良药物选购的战略目标1. PrOCUrethemostCoStYffeCtiVedrugsintherightquantities72. Se1.ectre1.iab1.esupp1.iersofhigh-ua1.ityproducts73. Ensuretime1.yde1.ivery.74. Achievethe1.owestpossib1.etota1.cost81 .适旗获得

13、以符合价格效果比的药品2 .选择军兜的供应商购买优旗药品3 .保证刚好送药4 .达到有可能实现的最低总开支5 .Operationa1.princip1.esforgoodpharmaceutica1.procurement一一-9EfficientandTransparentManagement9DrugSe1.ectionand(Quantification11FinancingandCompetition13Supp1.ierSe1.ectionandQua1.ityAsSUranCe173.优良药品选前的操作规范高效利透亮的管理药品逸选和浆化（确定购买数;资金筹集和竞争供应商选择和质瞅

14、保证4.Practica1.imp1.ementationissues一.一一一204.实际操作问题Bib1.iographyandfurtherreading25文献书目及进一步糊读（参阅书目IntroductionIntroduction序言Thisdocumentintroducesfourstrategicobjectivesandtwe1.veoperationa1.princip1.esforgoodpharmaceutica1.procurement.Iheseobjectivesandprincip1.eshavebeendeve1.opedandendorsedbytheIn

15、teragencyIJhannaeCUtiCaICoordinationGrOUP(IPC),invo1.vingthePiIarmaCeUtiCaIadvisersoftheUnitei1.NationsChi1.drensFUnd(UN1.CEF),theUnitedNationsPopu1.ationFund(UNPA),theWor1.dHea1.thOrganization(WHO)andtheWor1.dBank.木文件介绍了规范药品选购的4个战珞目标和12项操作原VA,这些R标和原则经过机恂间药物协调小加(IPC)的完善和认可，包括联合国儿政基金会，联合国人口基金会以及世界卫生组

16、织和世界银行的药物专家也供应/诸多建1.1.Theaimofthisdocumentistoimprovepharmaceutica1.PrOeUrementpracticesincountriesSerVedbytheIIXJmembers.hescoperationa1.princip1.esforgoodpharmaceutica1.procurementarenotmeanttoregu1.ateactivitiesofinternationa1.agencies,sovereigngovernmentsorprivatecompanies.Theyarepresentedstrict

17、1.yasasetofprincip1.eswhichcanbereviewedandadaptedbyindividua1.governmentsandpub1.icorprivateorganizationsintheprocessofdeve1.opingtheirovninterna1.procurementprocedures.,1.fT后在求善机构间药物协调小组(IPO成员国家的药品选购业务。这些操作原则对国际机构、主权政府或私人公M不具有约束力.作为严密阐述的一套原则,该文件对他国政府、公私组织在制定自己的内部选购程序时可司借卷并可加以调整改编，Theseobjectivesan

18、dprincip1.esarepub1.ishedbyW1.KySVpartmentOfESSentia1.DrugsandMedidnesPo1.icy(EDM)onbehaifoftheIPC,afteranextensivereviewbyexpertsfrominternationa1.agencies,governments,thepharmaceutica1.industry,essentia1.drugssupp1.yagenciesanduniversities.在向国际机构、政府、制药行业以及基本药物供应机构和高校广泛征求看法以后,本文件由世界1?生组织的基本药物政策部代表机

19、构间药物协调小组(IpC)出版发行.Pharmaceutica1.procurementOCCUrSinmanycontexts.A1.thoughtheoperationa1.princip1.espresentedhereareinmanyrespectsapp1.icab1.etoa1.1.procurementsettingsandformostIypCSofprocurementsituations,theirprimarytargetispharmaceutica1.procurementforpub1.icsectorhea1.thsystems.Itisrecognizedth

20、atpuNicsectorprocurementmaybemanagedinavarietyofways,rangingfromtota1.in-housesystems,throughvariousautonomousorSemi-autonomousprocurementagencies,totota1.privatization.Theseprincip1.esareapp1.icab1.etoeachofthosevariations.在许多章节中涉及了药品选购.尽管在大多数状况下，该操作凝则在许多方面适用于全部选购组织，其基本目的是公立医疗卫生系统的药物选曲.众所周知，公立医疗P.生

21、系统的药品选购可以通过多种渠道进行，不论是通过完全的内部系统、通过各种自治或半自治的选明机构，还是完全的易利性私立机构都可以进行。这些原则适用于全部的情形。ThedumentisComPOSedoffourchapters.Chapter1consistsofabriefprob1.emstatementwhichi1.1.ustratestheneedforimprovementsinprocurementpractices.Chapter2presentsthefourstrategicobjectivesofPhaE1.aCeUtiCa1.procurementWhiChapp1.yto

22、anyhea1.thsystem,whetheritispub1.icorprivate.Chapter3presentstwe1.veoperationa1.princip1.esforgoodpharmaceutica1.procurementgroupedintofourcategories(management;se1.ectionandquantification;financingandcompetition;supp1.ierse1.ectionandqua1.ityassurance).Chapter4givesmoreinformationonthepractica1.imp

23、1.ementationofthetwe1.veprincip1.esandsomeusefu1.informationonmechanismstofurtherimprovetheperformanceoftheprocurementsystem.Asectionofreferencesandfurtherreadingisa1.soinc1.uded.该文件分为4章.第I章提出向阳，简要阐明白改善药品选购实践活动的必要性.第2举提出了药品选购的4个战略目标，其适用于包括公立及私营的全部医疗保健体系.第3章陈述了规范药品透前的12个操作原则.它们分为4个方面(管埋：药从遏选和M化：财政拨款和

24、竞争；供应商遴选和质量保证)。第4电就12个操作阻则的具体实施作了说明,并对进一步改善药品选前体系的运行机制供应了有用的信息,最终列出了参考文献和参阅书目。COOrdinatiOnandco1.1.aborationamongtechnica1.deve1.opmentagenciescontinuestobeamajorissue.ItisthehopeoftheIIXJthattheseoperationa1.princip1.esWiufostercooperationandStdndardapproachesamongnationa1.governmentsanddonorsactiv

25、e1.yattemptingtoimprovepub1.ichea1.thanddrugmanagementaroundthewor1.d.Commentsonthisdocumentareactive1.yso1.icitedandcanbesubmittedto:heDirector,!*partmcntOfI1.ssentia1.DrugsandMedicinesPo1.icy,Wor1.dHea1.thOrganization,C1H211Geneva27,Switzer1.and;fax:+41227914167;e-mai1.:.技术开发机构之间的协调和合作依旧是个主要问鹿，机构间

26、的物协调小组(IPC)衿里这些操作原则将促使各国政附达成合作，建立标准统一的程序：捐助者也应主动主动地去尝试改善全球公共医疗保健体系和药品管理.恳请诸位对本文件的内容提出看法和建议，并寄往：JCH-I2II日内瓦27,世界12生组织(WHO).一本药品部主任fc)传真至；+41227914167：电子邮件:1.Prob1.emstatement问SS的提出(陈述)Pharmaceutica1.ProeUremtntisaCOmPIeXprocesswhichinvo1.vesmanysteps,agencies,ministriesandmanufacturers.Existinggovern

27、mentpo1.icies,ru1.esandregu1.ationsforprocurementaswe1.1.asinstitutiona1.structuresarefrequent1.yinadequateandsometimeshinderovera1.1.efficiencyinrespondingtothemodempharmaceutica1.market.药品选的是一个困难的过程，它牵涉到许多步臊、机构、部门和制药商.现行的有关药品选购的政策、规则、政府规章及体制结构常常地不充分、不成熟的.有时甚至阻码了现代弱品市场的整体效率。Marketconstraintsdifferf

28、romcountrytocountry.PUb1.iCsectordrugprocurementmusttakep1.aceinthecontextofboththe1.oca1.pharmaceutica1.marketandtheinternationa1.market.Inironycountriespub1.ichea1.thOffiCiaIShave1.imitedexperienceindesigninganoptima1.procurementsystemtofittheirmarketcontext.Anincreasingnumberofcountrieshavemoved,

29、oraremoving,awayfromapharmaceutica1.procurementanddistributionsystemwhichistota1.1.yoperatedbythepub1.icsector,andareinvestigatingvariousoptionsforinvo1.vingtheprivatesectorinordertoenhancepub1.iched1.th.ArecentMSI1./WiK)pub1.icationexp1.oresvariousmode1.swhichexist.Ichofthemode1.sdiscussedhthatbkha

30、sadvantagesanddisadvantages,andeachpresentsadifferentcha1.1.engetoeffectiveprocurementmanagement.不同国家的市场限制各有不同.公共部分的药M选购必定在地区和国际市场同时进行。许多国家的公共医疗保健部门在i殳计个G优的选购体系时，回历不足，不能满意市场需求,越来越多国家的药品选购流通体系己经或正从完全的公立体制，起先就引入部分私营的各种可选方案进行调研,目的旨在加强公共医疗保他体系,最近的一篇世界卫生81织的文章分析了业己存在的各种模式,各种模式各有优势和劣势，而每种模式都对高效的选购管理提出了不同的

31、挑战，Then?arcmanystepsintheprocurementprocess.Nomatterwhatmode1.isusedtonanagethePrOCUrementanddistributionsystem,efficientProCedUreSshou1.dbeinp1.ace:tose1.ectthemostcost-effectiveessentia1.drugstotreatcommon1.yencountereddiseases;toquantifytheneeds;topre-se1.ectpotentia1.supp1.iers;tomanageprocureme

32、ntandde1.ivery;toensuregoodproductqua1.ity；andtomonitortheperformanceofsupp1.iersandtheprocurementsystem.Fai1.ureinanyoftheseareasIeadSto1.ackofaccesstoappropriatedrugsandtowaste.Inmanypub1.icsupp1.ysystems,breakdownsregu1.ar1.yoccuratmu1.tip1.epointsinthisp11xess.选购过程涉及许多步舞.不论运用哪种模式来管理选购和流通体系，每个步骤都

33、须要是高效率的：选择最符合价格-效果比的基本药M来治疗常见病：计能药品需求依；时潜在的供应商进行初步筛选；管理选购和足送；保证药品侦审：监控供应商供货过程和选购体系的运行。这些方面的任何一个环节出了问题都会导致药品供货的失败,从而引起奢侈.在公立配送系统中,药品选购配送过程中的多个环节,定期都会发生故障.Ifthereisanappearanceofspecia1.inf1.uenceonthese1.ectionofproductsandsupp1.iersoriftheprocurementprocessisnotmanagedinanefficientandtransparentmann

34、er,interestamongsupp1.iersinCOmPetingforProeUrementcontractsdecreases,1.eadingtofewerchoicesandhigherpricesfordrugs.假如在药品和供应商的选择上6宣加了特殊影响，或者选购过程不是以高效、透亮的方式加以管理，供应商在竞争选购合同中的获利就会削减，导致选择削M而药价上升.IftheprocurementsystemCannOtguaranteeaccesstofundsatthetimetheyareneeded,drugshortagesandprocurementincffidcn

35、desarcinevitab1.e.GovernmentfundsforProCUrementare,insomecountries,re1.easedirregu1.ar1.yduringthefinancia1.year.Insomecountriesgovernmentregu1.ationsspecifythatfundsmustbespentintheyearforwhichtheyarca1.1.ocatedorbereturnedtothetreasury;thiscompoundstheprob1.em.Wherethiscombinationexistsitcompromis

36、esprocurementp1.anningandexecution.1.imitedorirregu1.arfundingwhich1.eadstode1.aysinPayrnentSworsensprocurementprob1.emsassupp1.iersdenycreditorinsistonadvancepayments.Adegreeoffinancia1.autonomyforthehea1.thSyStenVwhi1.eprovidingf1.exibi1.ity,requiresproperaccountabi1.ityandefficientmanagement.假如选购

37、系统不能保证时资金的需求刚好到位，药品短缺和选购活动的低效率就难以减开.在一些国家.一个财政年度内,政府用于药品选购的资金不是定期拨付的.而另一些国家政府规常规定：政府拨款必需在安排开支的当年用完，否则就被收回国库；这就使何题困旗化了。这两种状况同时存在时，选购安排和具体实施就只能达成妥防。黄如供货商不守信用或室持要提前付款，因资金不足或拨款不定期造成的廷期付款使选购难遨变得史相.一口供应敏徒性,医疗保健体系符享有肯定程度的财政自治，就要求相应的义务和彳T效的管理与之对应.Externa1.financingofdrugprocurementforthepub1.icsectorbyinter

38、nationa1.agencies,bi1.atera1.donorsordeve1.opmentbankscana1.sobeasourceofprob1.emsinsirnecountries.Insuchcasesthedonorsorbanksmayhaveconf1.ictingpo1.iciesandregu1.ationsregardingdrugPrOeUrement,whichinturnmayconf1.ictWithexisting1.oca1.1.awsandregu1.ations.Inthesesituationsitisextreme1.ydifficu1.tto

39、Carryoutprocurementinatime1.yandefficientmanner.Deve1.opmentassistanceshou1.dbemoreconsistentwiththepo1.iciesofthecountry.Anditisessentia1.thatthisassistanceshou1.dreinforcegoodpharmaceutica1.procurementpracticesandaimatsustainabi1.ity,ratherthanunderminingorde1.ayingthedeve1.opmentofsuchprocurement

40、practices.Thusinternationa1.,mu1.ti1.atera1.andbi1.atera1.agenciesmayneedtoreviewtheirownprocedures,requirementsandtechnica1.adviceinthe1.ightoftheoperationa1.PrinciPIeSpresentedhere.在某国家，由国际机构、双边捐助人或开发垠行供应的公立药品选购的外部资金也成了问题之故.在这种状况下,威助者或银行关于药品选曲的政策和规章就可旎足相互冲突的，问时与当地的法律法规也可能冲突.鉴此，阳好高效地完成选购地板端困难的。开发救济

41、资金政策与该国政策应当更加一样。救济应巩固规范的药品选购活动并旨在长期於彻卜去，而非战弱或搐延规范的药品选购活动的发展“因此，国际的、多边的及双边的机构可旎有必要依据下面隰述的操作规范,对自己的程芹.要求和技术需求作出回顾，加以检2i.Therecenttrendtowardsdecentra1.izingresponsibi1.ityforprocurementCanbepositive,inthatIoCa1.authoritiesshou1.dhavethestrongestinterestinmaintainingaconsistent1.yeffectivedrugsupp1.ysy

42、stem.IIowever,withoutprocedurestomaintaineconomica1.1.yviatteprocurementquantities,drugpricesnuyincreasedramatica1.1.y.Moreover,withoutmechanismstomonitor1.oca1.performanceandtoensureadherencetogoodprocurementpractice,pub1.ichea1.thobjectivesmaynotbemetandscarcefundsmaybewastedoninappropriatepurchas

43、es.ContractingoutpartsoftheProCUrement/distributionfunctionmayimproveefficiencyandreducecosts.Butthiswi1.1.on1.ybetrueifpub1.ichea1.thsystemscanproper1.ymonitorandmanagesuchcontracts.Inmanycountriesthenecessaryexperienceandinformationsystemsforthisano1.acking.Insomecountriesinitia1.decentra1.ization

44、ofdrugPrOCUrementwasfo1.1.owedbyPoo1.edprocurementbyhospita1.sorcooperatives.近期出现的分散选购贡任的趋势可能是主动的，因为地方政府时保持程定一样的有效的药品供应体系具有剧烈的啜好。然而，不实行措施去维持足够的选购数吊:，药品价格就会急剧上升.此外,没有监控地方选购活动及保证优良选购活动的机制.公共医疗保健的目标就难以实现，很有限的资金就会奢侈在不适当的购买上.分散部分选购/流通职能可能提高效率并降低费用，但是，只有公共医疗保健系统能彻底监控和管理分散出的.颂通活动，这一目标才能实现.在许多国家，仍IH缺乏监控所需的必

45、要问历和信息系统.在一些国家.采纳药品选购分散政策导致了医院或合作组织的联合囤积选购.UnbiasedmarketinformationonProdUCtavai1.abi1.ity*comparativepricing,productqua1.ityandsupp1.ierperformanceisdifficu1.ttoobtaininmanycountries.Pooraccesstoinformationismostmmonincountrieswhereitismostneededinthe1.ightofinadequateregu1.ationofthe1.oca1.market

46、Thisinformationdeficiencycanresu1.tingapsinessentia1.drugavai1.abi1.ityani1.inPrOCUrementofpoor-qua1.ityproductsatunnecessari1.yhighprices.Itmaya1.sofaci1.itateundueinf1.uenceontheprocurementprocessbyspecia1.interestgroups.在许多国家.很碓获得有关药品的来源、价格的比较、药品质址和供药商业务的公正的市场信息.就地方市场管理不充分而言，越是须要这些公正的市场估息的国家.信息不

47、公正的状况越普遍，信息不足会导致夔本药品的货源不足，也导致无谓地以高价选购劣质药品。而且可能引发特殊利益集团对选购过程施加不当影响。Evenifappropriatepo1.iciesandproceduresareinp1.ace,1.ackofproper1.ytrainedstaffinkeyPoSitiOnScand(ximanyp11urementsystemtofai1.ure.Whi1.eeffectivetrainingprogrammescanremedythisprob1.em,inmanysupp1.ysystemsthereis1.imitedaccesstotrain

48、ingingcx1.ProCUremRntpractices.A1.sounattractivepub1.icsectorsa1.ariesand1.ackOfcareerdeve1.opmenttendtorestrictcapacitytoattractandretainqua1.ifiedstaff.即使合理的政策和程序到位，任何一个选购系统，在美德历位上缺乏经过严格培训的工作人员也注定会失败.尽管有效的培训傥解决这个何即,但是，在许多供应系统,对优良选购具体实践的培训是很难进行的而且公共医疗保健系统薪水低,事业发展机会少，都往往限制了吸引和留住合格人才的空间.ProMemstatementSummaryofmainprob1.ems inadequateru1.es,regu1.ationsandstructures