数位资讯法律专题报告29175.pptx
數位資訊法律數位資訊法律(fl)專題報告專題報告網路購藥之處方箋認證問題網路購藥之處方箋認證問題95741105 Jason Chen 95741105 Jason Chen 陳懷玄陳懷玄95741122 Jason Lee 95741122 Jason Lee 李再松李再松Soochow University School of Law Soochow University School of Law 1第一页,共六十四页。第一章藥品分級按照(nzho)藥品使用方法及平安性分為:成藥、指示藥、處方藥藥事法第8條本法所稱製劑,係指以原料藥經加工調製,製成一定劑型及劑量之藥品。製劑分為醫師處方藥品、醫師藥師藥劑生指示藥品、成藥及固有成方製劑2第二页,共六十四页。第一(dy)節成藥藥事法第9條本法所稱成藥,係指原料藥經加工調製,不用其原名稱,其摻入之藥品,不超過中央衛生主管機關所規定之限量,作用緩和,無積蓄性,耐久(niji)儲存,使用簡便,並明示其效能、用量、用法,標明成藥許可證字號,其使用不待醫師指示,即供治療疾病之用者。3第三页,共六十四页。第一(dy)節成藥甲乙(jiy)類成藥的大分類如下:甲類成藥:傷風藥水、足爽、金十字胃腸藥解熱鎮痛劑、鎮咳祛痰劑、胃腸藥劑、緩下劑瀉藥、驅蟲劑、營養劑、眼藥液劑、漱口劑、浣腸劑、外用皮膚藥、外用殺菌劑、外用制汗劑、硬膏劑、脫毛劑、婦人科藥劑、小兒科藥劑乙類成藥:萬金油、綠油精、白花油、曼秀雷敦清涼劑、外用軟油膏類、外用撒布劑、養毛髮劑、含藥酒類依據成藥及固有成方製劑管理辦法第十六條規定:乙類成藥得由百貨店,雜貨店及餐飲服務商兼零售之。4第四页,共六十四页。第二(dr)節指示用藥平安性高,只用做症狀的緩解而不是治療疾病的藥品其含有主要作用的成分比成藥較多、藥效較強包裝上標示有醫師、藥師、藥劑生指示藥品的字樣衛生署將指示藥品分為十類,包括有綜合感冒藥、解熱鎮痛藥、抗組織胺藥(過敏、流鼻水(bshu)、鎮咳痰藥、一般皮膚外用藥、暈車藥、眼用藥、瀉藥、胃腸用藥、驅蟲藥等。僅能於藥局或藥事人員執業的處所內,經醫藥專業人士指導下,才可購得5第五页,共六十四页。第三(dsn)節處方藥藥事法施行細則第三條本法第八條第二項所稱醫師處方藥品指經中央(zhngyng)衛生主管機關審定,在藥品許可證上,載明須由醫師處方或限由醫師使用者6第六页,共六十四页。第三(dsn)節處方藥限制(xinzh)由醫師開立處方箋後方可使用醫師針對每位病人的病情開立適當的藥品、用法與用量藥師依據處方箋調劑,再將藥品給予病人管制藥也屬於處方藥,同樣需由醫師開立處方,藥師調劑,在給予藥品時需核對證件,確認領藥人簽名後,發出藥品。7第七页,共六十四页。第四節合法(hf)藥品辨識方法處方藥處方藥藥品外盒包裝上印有衛生署許可的證號:衛署藥製字第xxxxxx號或衛署藥輸字第xxxxxx號外盒包裝有醫師處方藥的標示8第八页,共六十四页。第四節合法(hf)藥品辨識方法指示指示(zhsh)用藥用藥藥品外盒包裝上印有衛生署許可的證號:衛署藥製字第xxxxxx號或衛署藥輸字第xxxxxx號外盒包裝有醫師藥師藥劑生指示藥品的標示9第九页,共六十四页。第四節合法(hf)藥品辨識方法成藥成藥藥品外盒包裝上印有衛署成製第xxxxxx號甲類成藥或乙類成藥10第十页,共六十四页。第四節合法(hf)藥品辨識方法11第十一页,共六十四页。第二章處方藥获得(hud)途徑分析第一(dy)節醫院及診所之藥局藥事法施行細則第3條本法第八條第二項所稱醫師處方藥品,係指經中央衛生主管機關審定,在藥品許可證上,載明須由醫師處方或限由醫師使用者。12第十二页,共六十四页。第二章處方藥获得(hud)途徑分析第二節藥局合法購得配合(pih)全民安康保險及醫藥分業的實施全民安康保險特約藥局,承受醫師處方箋據以調劑藥品13第十三页,共六十四页。第二章處方藥获得(hud)途徑分析第三節藥局非法購得用於改善生活品質的產品減肥藥、生髮藥、性功能障礙、墮胎藥疾病或症狀都很容易自我(zw)断定不好意思對醫師啟口國家的醫療保險制度並不給付14第十四页,共六十四页。第三章醫藥分業醫藥分業是醫師與藥師的專業分工合作醫藥分業是醫師與藥師的專業分工合作醫師負責診斷、處置及開立處方箋醫師負責診斷、處置及開立處方箋藥師則依醫師的處方調劑並交付藥師則依醫師的處方調劑並交付(jiof)藥品,藥品,並提供藥並提供藥物諮詢物諮詢民眾在醫療院所就診後,持醫師開立的處方民眾在醫療院所就診後,持醫師開立的處方箋,可以選箋,可以選擇在該聘有合格藥事人員的醫療院所調劑,擇在該聘有合格藥事人員的醫療院所調劑,假设就醫的假设就醫的醫療院所未聘有合格的藥事人員,則可以選醫療院所未聘有合格的藥事人員,則可以選擇到住家附擇到住家附近的健保特約藥局調劑近的健保特約藥局調劑15第十五页,共六十四页。第一節處方箋釋出第一款一般處方箋保險對象有權向醫師索取處方箋至健保特約藥局調劑。其處方自就醫日起三日內有效。自九十年七月(qyu)一日起,保險對象持處方箋至特約藥局調劑,需依規定繳交藥品局部負擔金額第三章醫藥分業16第十六页,共六十四页。藥費局部藥費局部(b fen)負擔負擔 100元以下元以下 0元元 101-200元元 20元元 201-300元元 40元元 301-400元元 60元元 401-500元元 80元元 501-600元元 100元元 601-700元元 120元元 701-800元元 140元元801-900元元 160元元 901-1000元元 180元元1001元以上元以上200元元第三章醫藥分業17第十七页,共六十四页。第一節處方箋釋出第二款慢性病連續處方箋係指醫師開立給慢性病患者的長期用藥處方箋。自醫師開立後,三個月內有效,可以分兩至三次直接到藥局調劑。合於中央(zhngyng)安康保險局所公告之98種慢性病,且經醫師評估為病情穩定,可以在三個月內使用同樣處方藥品之患者,就可以使用慢性病連續處方箋第三章醫藥分業18第十八页,共六十四页。第一節處方箋釋出第二款慢性病連續處方箋省時:減少就醫往返路程(lchng)與看病等候的時間。省錢:在健保特約藥局或原就醫醫院以慢性病連續處方箋領藥時,可免繳藥品局部負擔費用,且不必加蓋健保卡戳章。方便:可以選擇到住家附近之健保特約藥局領藥。持慢性病連續處方箋再次調劑領藥,須與上次領藥至少相隔二十一天。如因即將出國而預估所領取藥品不夠使用時,可於領藥時出具足以證明出國之相關文件如機票等,即可多領取一個月的藥品第三章醫藥分業19第十九页,共六十四页。衛生署認為利用網路販售藥物或醫療器材與實體通路有不同(btn),而目前網路商店因屬虛擬空間,無法滿足藥商營業場所之定義,因此制止在網路上販售任何種類的藥品或醫療器材。衛生署目前未核准任何網路藥局第四章網路販賣處方藥現況20第二十页,共六十四页。藥品:善存、維骨力、威而剛、酸痛貼布、柔沛、正露丸、銀杏、褪黑激素、犀利士、落建、諾美婷、眼藥水、洗眼(xyn)液、泰國Counterpain按摩膏。醫療器材:血壓計、血糖機、隱形眼鏡、碎脂機、衛生棉條、導入儀、體溫計、體脂計、保險套、3M美容膠、耳(額)溫槍、驗孕試紙、束(托)腹帶、OK繃、護具、輪椅、低周波治療器、醫療用彈性襪(預防靜脈曲張彈性襪)。第四章網路販賣處方藥現況21第二十一页,共六十四页。第五章網路購買處方藥之平安(pngn)性第一節偽藥藥事法第20條本法所稱偽藥,係指藥品經稽查(jch)或檢驗有左列各款情形之一者:一、未經核准,擅自製造者。二、所含有效成分之名稱,與核准不符者。三、將别人產品抽換或摻雜者。四、塗改或更換有效期間之標示者。22第二十二页,共六十四页。第五章網路購買處方藥之平安(pngn)性第二(dr)節劣藥藥事法第21條本法所稱劣藥,係指核准之藥品經稽查或檢驗有左列情形之一者:一、擅自添加非法定著色劑、防腐劑、香料、矯味劑及賦形劑者。二、所含有效成分之質、量或強度,與核准不符者。三、藥品中一部或全部含有污穢或異物者。四、有顯明變色、混濁、沈澱、潮解或已腐化分解者。五、主治效能與核准不符者。六、超過有效期間或保存期限者。七、因儲藏過久或儲藏方法不當而變質者。八、裝入有害物質所製成之容器或使用回收容器者。23第二十三页,共六十四页。第五章網路購買處方藥之平安(pngn)性第三節禁藥藥事法第22條本法所稱禁藥,係指藥品有左列各款情形之一一、經中央衛生主管機關明令公告制止製造、調劑、輸入、輸出、販賣或陳列之毒害藥品。二、未經核准(hzhn)擅自輸入之藥品。但旅客或隨交通工具服務人員攜帶自用藥品進口者,不在此限。前項第二款自用藥品之限量,由中央衛生主管機關會同財政部公告之。24第二十四页,共六十四页。NABPwasestablishedin1904toassiststatelicensingboardsindeveloping,implementing,andenforcinguniformstandardstoprotectthepublichealth.Pharmacyboardsfromfiftystates,theDistrictofColumbia,threeU.S.territories,nineCanadianprovinces,andtwoAustralianstatesmakeuptheassociationmembership.NationalAssociationofBoardsofPharmacy(NABP)25第二十五页,共六十四页。NationalAssociationofBoardsofPharmacy(NABP)TheNationalAssociationofBoardsofPharmacy(NABP)istheindependent,international,andimpartialassociationthatassistsitsmemberboardsandjurisdictionsindeveloping,implementing,andenforcinguniformstandardsforthepurposeofprotectingthepublichealth.26第二十六页,共六十四页。NationalAssociationofBoardsofPharmacy(NABP)NationalAssociationofBoardsofPharmacy1600FeehanvilleDriveMountProspect,IL60056Tel:847/391-4406Fax:847/391-4502CarmenA.Catizone,MS,RPh,DPh,ExecutiveDirector/Secretary27第二十七页,共六十四页。VerifiedInternetPharmacyPracticeSites(VIPPS)28第二十八页,共六十四页。InresponsetopublicconcernofthesafetyofpharmacypracticesontheInternet,theAssociationdevelopedtheVerifiedInternetPharmacyPracticeSites(VIPPS)programinthespringof1999.Acoalitionofstateandfederalregulatoryassociations,professionalassociations,andconsumeradvocacygroupsprovidedtheirexpertiseindevelopingthecriteriathatVIPPS-accreditedpharmaciesfollow.(VIPPS)29第二十九页,共六十四页。TobeVIPPSaccredited,apharmacymustcomplywiththelicensingandsurveyrequirementsoftheirstateandeachstatetowhichtheydispensepharmaceuticals.Inaddition,pharmaciesdisplayingtheVIPPSsealhavedemonstratedtoNABPcompliancewithVIPPScriteriaincludingpatientrightstoprivacy,authenticationandsecurityofprescriptionorders,adherencetoarecognizedqualityassurancepolicy,andprovisionofmeaningfulconsultationbetweenpatientsandpharmacists.(VIPPS)30第三十页,共六十四页。VIPPSpharmacysitesareidentifiedbytheVIPPShyperlinksealdisplayedontheirWebsites.Byclickingontheseal,avisitorislinkedtotheNABPVIPPSsitewhereverifiedinformationaboutthepharmacyismaintainedbyNABP.ThepublicisalsowelcometoaccesstheVIPPSsitetosearchforaVIPPSInternetpharmacythatmatchestheirneeds.(VIPPS)31第三十一页,共六十四页。(VIPPS)32第三十二页,共六十四页。NABPhasreviewednumerousWebsitessellingprescriptionmedicineandhascreatedthreecategoriestohelppatientsmakeinformedchoices:(VIPPS)33第三十三页,共六十四页。RecommendedInternetPharmacies:NABPrecommendsthatpatientsusesitesaccreditedthroughtheVerifiedInternetPharmacyPracticeSites(VIPPS)program.ThesesiteshaveundergoneandsuccessfullycompletedtherigorousNABPaccreditationprocess,whichincludesathoroughreviewofallpoliciesandproceduresregardingthepracticeofpharmacyanddispensingofmedicineovertheInternet,aswellasanon-siteinspectionofallfacilitiesusedbythesitetoreceive,review,anddispensemedicine.(VIPPS)34第三十四页,共六十四页。ReviewedInternetPharmacyPracticeSites:NABPhasreviewedthepublicinformationavailableforthesesitesanddeterminedthattheyappeartocomplywithstateandfederallawsandNABPpatientsafetyandpharmacypracticestandards.NABPadvisespatientstousethesesiteswithcaution,asinformationneededtoconclusivelydeterminethelegitimacyandlegalityofthesesitesmaynothavebeenavailable.WeaskpatientstoimmediatelyreporttoNABPanyactivityindicatingthatthesitesdonotcomplywithstateandfederallawsorNABPcriteria,forexample,dispensingmedicinewithoutavalidprescription,ordispensingnon-FDA-approvedmedicine.NABPwillcontinuetomonitortheactivityofthesesitestodeterminecontinuedinclusiononthislist.(VIPPS)35第三十五页,共六十四页。NotRecommendedSites:TheseInternetdrugoutletsappeartobeoutofcompliancewithstateandfederallawsorNABPpatientsafetyandpharmacypracticestandards.(VIPPS)36第三十六页,共六十四页。Recommended Internet Pharmacies Recommended Internet Pharmacies 38第三十八页,共六十四页。WhatarethedangersofobtainingaprescriptionformedicineovertheInternet?1.Harmfuleffects:Somemedicinescanbedangerousifnottakenwithongoingmedicalsupervision.Forthisreason,mostlawenforcementauthoritiesandprofessionalhealthcareorganizationsadvisedoctorsagainstprescribingmedicineonlineandcautionpatientsagainstobtainingprescriptionsonline,exceptfromsitessuchasNABPsVIPPS-accreditedpharmacies.Thispracticeisillegalinsomestates,unlesstheprescriptioniswrittenbyadoctorwhoknowsthepatientsmedicalhistoryandpreviouslyhasexaminedthepatientin-person.Completingonlyanonlinequestionnairedoesnotestablishavaliddoctor-patientrelationship.Moreimportantly,withoutaphysicalexaminationyoucouldreceivemedicinethatisnotrightforyourcondition,worsenyourmedicalcondition,orcauseaseriousunderlyingmedicalconditiontobeoverlookedormisdiagnosed.BuyingMedicineOnline39第三十九页,共六十四页。2.Druginteractions:Somemedicines,incombinationwithotherdrugsyoumightbetaking,cancompoundorinhibittheeffectsofeitherorbothdrugs,leadingtoatoxiccombinationorcancellingouttheeffectsofneededmedicines.Forthisreason,itisimportanttodiscusstakingprescriptionmedicinewithadoctorwhoisfamiliarwithyourmedicalhistoryandhasperformedanin-personexamination.BuyingMedicineOnline40第四十页,共六十四页。3.Questionableprofessionalpractices:ManyInternetdrugoutletsoperatewithoutalicenseorinconflictwiththelawsandregulationscreatedtoensurepatientsafety.Furthermore,someofthemedicinesbeingsoldontheseWebsitesmaybetoostrong,tooweak,fake,expired,stolen,diluted,orimpure.Frequently,deceivedpatientsnotifyusthattheyhavenotreceivedthemedicinestheyordered,orthatthesiteoperatorsrefusetoremovecreditcardcharges.Manyalsocomplainthattheyareunabletocontactanyoneattheorganization;phonelinesaredisconnected,nooneanswers,ornophonenumberisprovided.BuyingMedicineOnline41第四十一页,共六十四页。4.Risktopersonal,medical,orfinancialinformation:ManyillegitimateInternetdrugoutletsdonotprotectcustomerspersonalinformationwithSSL(SecureSocketLayer)encryption,leavingyourmedicalandfinancialinformationvulnerabletoanyonewhomightwanttouseitfortheirowngain.Furthermore,evidenceindicatesthatillegitimateprescribingoutletsfrequentlyselltheircustomerliststootherillegitimateonlinedrugoutletsandoperatorsofInternetscamandpornographysites.BybuyingdrugsfromanillegitimateInternetoutlet,youmaybeidentifyingyourselfassomeonewhoisagoodtargetforrip-offschemes.BuyingMedicineOnline42第四十二页,共六十四页。5.Counterfeitdrugs:6.TheWorldHealthOrganizationestimatesthatmedicinespurchasedovertheInternetfromoutletsthatconcealtheiractualphysicaladdressarecounterfeitinover50%ofcases.Worldwidecounterfeitdrugsalesareincreasingatnearlytwicethepaceoflegitimatedrugsales,estimatedat13%annuallybytheCenterforMedicineinthePublicInterest,andwillexpandtoa$75billionindustryby2021.ManycounterfeitdrugsaremanufacturedinAsian,LatinAmerican,andEasternEuropeancountries.Thecontentofcounterfeitdrugsrangesfromcrudemixturesofglue,chalk,andsugartonearlyexactchemicalreplicasofcomplexmedicines.Becausethesedrugsareneitherproperlyproducednorregulated,itisnearlyimpossibleforpatientstoknowexactlywhattheyaregetting.Ifyouunknowinglyreceivecounterfeitmedicine,notonlydoyounotreceivethebenefitsofthemedicineyouneed,butyoualsocouldplaceyourhealthatriskfromunsafeingredients.BuyingMedicineOnline43第四十三页,共六十四页。1.Noprescriptionrequired2.Prescriptionbasedsolelyupononlinequestionnaire3.Nophonenumberorstreetaddress4.Nopharmacistconsultation5.Waivers6.Limitedmedicines7.InternationalWebsites8.SpamsolicitationsWhatarethesignsofaquestionablyoperatingInternetdrugoutlet?44第四十四页,共六十四页。Avoid Counterfeit Drug Scams 45第四十五页,共六十四页。LicensureandResidency1.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustbelicensedorregisteredingoodstandingtooperateapharmacyorengageinthepracticeofpharmacyinallapplicablejurisdictions.2.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustnotbeornothavebeensubjecttosignificantdisciplinaryaction.3.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustberegisteredwiththeUSDrugEnforcementAdministration(DEA)ifdispensingcontrolledsubstances.4.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustbedomiciledintheUnitedStates.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards 47第四十七页,共六十四页。Prescriptions5.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustassurethelegitimacyandauthenticityofallprescriptiondrugorders.Alegitimateandauthenticprescriptiondrugordermustbebaseduponavalidpatient-prescriberrelationship,whichrequiresthefollowingtohavebeenestablished:a)Thepatienthasalegitimatemedicalcomplaint;b)Aface-to-facephysicalexaminationadequatetoestablishthelegitimacyofthemedicalcomplainthasbeenperformedbytheprescribingpractitionerorintheinstancesoftelemedicinethroughatelemedicinepracticeapprovedbytheappropriatePractitionerBoard;andc)Somelogicalconnectionexistsbetweenthemedicalcomplaint,themedicalhistory,andthephysicalexaminationandthedrugprescribed.6.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustadheretotheFederalControlledSubstancesActandDEArulesregardingprescriptionsforcontrolledsubstances,includingbutnotlimitedtothefollowing:a)PrescriptionsforScheduleIIcontrolledsubstancesmustbeprovidedinwritingbytheprescriber;b)PrescriptionsforScheduleIII-Vcontrolledsubstancesmustbeprovidedinwritingbythepatientorprescriber,orverballyorbyfacsimilebytheprescriber;c)ScheduleIIcontrolledsubstanceprescriptionsmaynotberefilled;anewprescriptionmustbeissuedforeachquantityofthesubstance.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards48第四十八页,共六十四页。Prescriptions7.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustnotdispenseorofferprescriptionsoriginatingfromtelephonic,electronic,oronlinemedicalconsultationswithoutapre-existingpatient-prescriberrelationshipthathasincludedafacetofacephysicalexamination.8.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustnotoffertodispenseordispensemedicationsthathavenotbeenapprovedbytheUSFoodandDrugAdministration(FDA).ProgramCriteria:PatientSafetyandPharmacyPracticeStandards49第四十九页,共六十四页。PatientPrivacy9.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustmaintainasecureWebsiteandensurepatientidentifiableinformationandprescriptiontransactionsareencryptedperindustrystandards.10.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,musthaveandprovidepatientswithaNoticeofPrivacyPracticesforProtectedHealthInformation,asrequiredbytheHIPAAPrivacyRule(45CFR164.520).ProgramCriteria:PatientSafetyandPharmacyPracticeStandards50第五十页,共六十四页。PatientServices11.Thepharmacymustprovide,ontheWebsite,a24-hourtollfreenumberforpatientswhoexperienceorbelievetheyhaveexperiencedanadverseeventinvolvingtheirmedication.12.Thepharmacymustprovide,ontheWebsite,theUSstreetaddressofthepharmacythatdispensesprescriptionmedicationsonbehalfof(orthrough)theWebsite.13.Thepharmacymustprovide,ontheWebsite,theUSstreetaddressofthesitescorporateheadquartersorprimaryplaceofbusiness.14.Thepharmacymustprovide,ontheWebsite,instructionstopatientsdescribinghowtosubmitcomplaintsorconcerns.15.ThepharmacymustofferpharmacistmedicationconsultationviasecuremeansthroughtheWebsite,viatelephone,orinpersonforwalk-inpatients.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards51第五十一页,共六十四页。ProfessionalPractices16.ThepharmacymustattestandprovidedocumentationtoNABPthatitobtainsmedicationsfromUSlicensedwholesaledrugdistributorsand/orUSlicensedorFDAregisteredpharmaceuticalmanufacturers.17.Thepharmacymustmaintainacurrentlyregistereddomainname.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards52第五十二页,共六十四页。Uponreceiptoftheapplicationformandsupportingdocumentation,NABPstaffwill:oVerifyallnecessarystatepharmacylicensesareingoodstanding;oVerifythepharmacist-in-chargelicensesareingoodstand