英文阅读材料Word文件下载.docx
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英文阅读材料Word文件下载.docx
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Essentialmedicinesarethosethatsatisfythepriorityhealthcareneedsofthepopulation.Theyareselectedwithdueregardtopublichealthrelevance,evidenceonefficacyandsafetyandcomparativecosteffectiveness.Essentialmedicinesareintendedtobeavailablewithinthecontextoffunctioninghealthsystemsatalltimesinadequateamounts,intheappropriatedosageforms,withassuredqualityandadequateinformation,andatapricetheindividualandthecommunitycanafford.Theimplementationoftheconceptofessentialmedicinesisintendedtobeflexibleandadaptabletomanydifferentsituations;
exactlywhichmedicinesareregardedasessentialremainsanationalresponsibility.
Theconceptofessentialmedicinesisthatalimitednumberofcarefullyselectedmedicinesbasedonagreedclinicalguidelinesleadstoamorerationalprescribing,tobettersupplyofdrugsandlowercosts.
Thepracticalimplicationoftheessentialmedicinesconceptisthatnationalessentialmedicineslistsandnationaldrugformularies,togetherwithclinicalguidelines,shouldserveasabasisofformaleducationandin-servicetrainingofhealthprofessionals,andofpubliceducationaboutdruguse.Theyshouldalsoserveasthemainbasisforpublicsectordrugprocurementanddistribution,aswellasfordrugdonations.
Essentialmedicineslistsandteachingaboutthebenefitsofdrugselectioncouldalsobeusedtoinfluencepracticeintheprivatesector,forexamplethroughthebasictrainingofmedicalstudents,andprogramsofcontinuingmedicaleducationwithuniversitiesandprofessionalassociations.
Medicinesstrategy
TheWHOmedicinesstrategyprovidesaframeworkforcoordinatedactioninessentialdrugsandmedicinesbyWHOanditsstrategicpartners.WHOisintheprocessofdevelopingitsmedicinesstrategyfortheperiod2004-2007.Itisenvisagedthatthestrategyaddressesfourmajorobjectives:
Policy
Ensurecommitmentofallstakeholderstonationaldrugpolicies,tocoordinatedimplementation,andtomonitoringofpolicyimpact.
Access
Ensureequitableavailabilityandaffordabilityofessentialdrugs,withanemphasisondiseasesofpriority.
Qualityandsafety
Ensurethequality,safetyandefficacyofallmedicinesbystrengtheningandputtingintopracticeregulatoryandqualityassurancestandards.
Rationaluse
Ensuretherapeuticallysoundandcosteffectiveuseofdrugsbyhealthprofessionalsandconsumers.
Detailedplanningelementsofthestrategywillbepublishedwhenapproved.
本材料节选自WHO网站http:
//www.who.int/countries/eth/areas/medicines/en
阅读以上材料后,请回答下列问题:
1.
简述国家基本药物政策的宗旨。
2.
什么是基本药物?
3.
简述WHO制定药物策略的目的。
4.
谈谈你对建立和完善我国基本药物制度的认识。
阅读材料2:
GoodManufacturingPractice
Detailedplanningelementsofthestrategywillbepublishedwhenapproved.
GoodManufacturingPracticeorGMP(alsoreferredtoas'
cGMP'
or'
currentGoodManufacturingPractice'
)isatermthatisrecognizedworldwideforthecontrolandmanagementofmanufacturingandqualitycontroltestingoffoods,pharmaceuticalproducts,andmedicaldevices.
Sincesamplingproductwillstatisticallyonlyensurethatthesamplesthemselves(andperhapstheareasadjacenttowherethesamplesweretaken)aresuitableforuse,andend-pointtestingreliesonsampling,GMPtakestheholisticapproachofregulatingthemanufacturingandlaboratorytestingenvironmentitself.AnextremelyimportantpartofGMPisdocumentationofeveryaspectoftheprocess,activities,andoperationsinvolvedwithdrugandmedicaldevicemanufacture.Ifthedocumentationshowinghowtheproductwasmadeandtested(whichenablestraceabilityand,intheeventoffutureproblems,recallfromthemarket)isnotcorrectandinorder,thentheproductdoesnotmeettherequiredspecificationandisconsideredcontaminated(adulteratedintheUS).Additionally,GMPrequiresthatallmanufacturingandtestingequipmenthasbeenqualifiedassuitableforuse,andthatalloperationalmethodologiesandprocedures(suchasmanufacturing,cleaning,andanalyticaltesting)utilizedinthedrugmanufacturingprocesshavebeenvalidated(accordingtopredeterminedspecifications),todemonstratethattheycanperformtheirpurportedfunction(s).
CounterfeitDrugsQuestionsandAnswers
Questions(Q):
Whatisthedefinitionofacounterfeitmedication?
Answers(A):
U.S.lawdefinescounterfeitdrugsasthosesoldunderaproductnamewithoutproperauthorization.Counterfeitingcanapplytobothbrandnameandgenericproducts,wheretheidentityofthesourceisdeliberatelyandfraudulentlymislabeledinawaythatsuggeststhatitistheauthenticapprovedproduct.Counterfeitproductsmayincludeproductswithouttheactiveingredient,withaninsufficientquantityoftheactiveingredient,withthewrongactiveingredient,orwithfakepackaging.
Q:
Whatrisksareinvolvedwithtakingcounterfeitmedications?
A:
Anindividualwhoreceivesacounterfeitmedicationmaybeatriskforanumberofdangeroushealthconsequences.Patientsmayexperienceunexpectedsideeffects,allergicreactions,oraworseningoftheirmedicalcondition.Anumberofcounterfeitsdonotcontainanyactiveingredients,andinsteadcontaininertsubstances,whichdonotprovidethepatientanytreatmentbenefit.Counterfeitmedicationsmayalsocontainincorrectingredients,improperdosagesofthecorrectingredients,ortheymaycontainhazardousingredients.
WhatistheprevalenceofcounterfeitmedicationsintheU.S.?
CounterfeitingoccurslessfrequentlyintheU.S.thaninothercountriesduetothestrictguidelines,regulations,andenforcementtheFDAprovidesthroughouttheproductionanddistributionchain.However,recentlyFDAhasseentwohighlypublicizedexamplesofcounterfeitLipitorandProcritwithintheU.S.distributionsystem.TheFDAcontinuestobelievethattheoverallqualityofdrugproductsthatconsumerspurchasefromU.S.pharmaciesremainshigh.TheAmericanpubliccanbeconfidentthatthesemedicationsaresafeand
effective.
WhatisFDAannouncingtoday?
FDAisundertakingamajornewinitiativetomoreaggressivelyprotectconsumersfromdrugsthathavebeencounterfeited.Thenewinitiativeincludescreatinganinternaltaskforcetoexploretheuseofmoderntechnologiesandothermeasuresthatwillmakeitmoredifficultforcounterfeitdrugstogetmixedupwith–ordeliberatelysubstitutedfor–safeandeffectivedrugs.FDAhasalreadyincreaseditsenforcementefforts,morethanquadruplingthenumberofcounterfeitdrugcasessince2000.
WhyisFDAtakingthesesteps?
AlthoughFDAdoesnotbelievethatthenumberofcounterfeitsenteringtheU.S.drugsupplyhassignificantlyescalatedinrecentyears,theagencybelievesthatitneedstobeproactivetopreventthenumberofcounterfeitdrugsreachingconsumersfromincreasing.Growthincounterfeitingmaybespurredbytheeconomicincentivesprovidedbyanincreasingvolumeofhighcostdrugs,thedevelopmentoftechnologiesthatmakeiteasiertocounterfeitdrugs,andtheabilitytoselldrugsdirectlytoconsumerswithoutface-to-facecontactthroughpurchasesovertheInternet.
WillFDAberequestingnewlegislationtopreventcounterfeitingfromincreasing?
Thereareclearopportunitiestodoabetterjobprotectingdrugproductsfromcounterfeitersusingmoderntechnologies.NewapproachesthatwerenotpossiblewhenthePrescriptionDrugMarketingAct(PDMA)wasimplemented15yrsagoareavailableoronthehorizon.Thetaskforcewillbelookingforthebestsolutionstotheproblemsrecentlyuncoveredbyourinvestigatorsandwemayhavemoretosayonthisissuelater.FDAdoesintendtoworkwithCongresstostiffenpenaltiesforthosewhocounterfeitdrugproducts.
本材料节选自FDA网站http:
//www.fda.gov/oc/initiatives/counterfeit/qa.html
阅读以上材料后,请回答下列问题:
1.
美国法律是如何界定假药的?
2.
假药带来的健康风险有哪些?
3.
目前美国假药的状况如何?
4.
为了遏制假药,保护公众利益,美国FDA采取了哪些措施?
为什么要采取这些措施?
5.
在遏制假药蔓延方面FDA有哪些新举措?
阅读材料3:
PreparingtheFuturePharmacist——the“SevenStarPharmacist”
TheWorldHealthOrganization,inthereportofitsconsultativegroupon“PreparingtheFuturePharmacist”(Vancouver,CANADA,27-29AUGUST1997)identifiedsevenroles,(the“sevenstarpharmacist”),whichshouldbeconsideredessential,minimumcommonexpectationsofpharmacistsbyhealthcaresystemsworld-wide.
Theidentifiedrolesandresponsibilitieswere:
caregiver,decisionmaker,communicator,leader,manager,life-longlearner,andteacher.
Caregiver
Thepharmacygraduatecallsuponhis/herexpertiseasamedicationexperttoprovidehighqualitycaringservicesinprimarilytwoareas.First,pharmacygraduates,inpartnershipwithpatientsandotherhealthcareproviders,usetheirknowledgeandskillstodirectly(e.g.clinical,dispensing)orindirectly(e.g.analytical,technological,log
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