数位资讯法律专题报告.ppt

數位資訊法律專題報告網路購藥之處方箋認證問題95741105JasonChen陳懷玄95741122JasonLee SoochowUniversitySchoolofLaw 第一章藥品分級 依照藥品使用方法及安全性分為 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 第一節成藥 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 第一節成藥 甲乙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 第二節指示用藥 安全性高 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 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 第三節處方藥 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 第三節處方藥 限制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 第四節合法藥品辨識方法 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 第四節合法藥品辨識方法 指示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 第四節合法藥品辨識方法 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 第四節合法藥品辨識方法 第二章處方藥取得途徑分析 第一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 第二章處方藥取得途徑分析 第二節藥局合法購得配合全民健康保險及醫藥分業的實施全民健康保險特約藥局 接受醫師處方箋據以調劑藥品 第二章處方藥取得途徑分析 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判定不好意思對醫師啟口國家的醫療保險制度並不給付 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品 並提供藥物諮詢民眾在醫療院所就診後 持醫師開立的處方箋 可以選擇在該聘有合格藥事人員的醫療院所調劑 如果就醫的醫療院所未聘有合格的藥事人員 則可以選擇到住家附近的健保特約藥局調劑 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 需依規定繳交藥品部分負擔金額 第三章醫藥分業 藥費部分負擔100元以下0元101 200元20元201 300元40元301 400元60元401 500元80元501 600元100元601 700元120元701 800元140元801 900元160元901 1000元180元1001元以上200元 第三章醫藥分業 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 合於中央健康保險局所公告之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 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 可免繳藥品部分負擔費用 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 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 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 因此禁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 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 第五章網路購買處方藥之安全性 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 將他人產品抽換或摻雜者 四 塗改或更換有效期間之標示者 第五章網路購買處方藥之安全性 第二節劣藥藥事法第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 第五章網路購買處方藥之安全性 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禁止製造 調劑 輸入 輸出 販賣或陳列之毒害藥品 二 未經核准擅自輸入之藥品 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 NABPwasestablishedin1904toassiststatelicensingboardsindeveloping implementing andenforcinguniformstandardstoprotectthepublichealth Pharmacyboardsfromfiftystates theDistrictofColumbia threeU S territories nineCanadianprovinces andtwoAustralianstatesmakeuptheassociationmembership NationalAssociationofBoardsofPharmacy NABP NationalAssociationofBoardsofPharmacy NABP NationalAssociationofBoardsofPharmacy NABP VerifiedInternetPharmacyPracticeSites VIPPS InresponsetopublicconcernofthesafetyofpharmacypracticesontheInternet theAssociationdevelopedtheVerifiedInternetPharmacyPracticeSites VIPPS programinthespringof1999 Acoalitionofstateandfederalregulatoryassociations professionalassociations andconsumeradvocacygroupsprovidedtheirexpertiseindevelopingthecriteriathatVIPPS accreditedpharmaciesfollow VIPPS TobeVIPPSaccredited apharmacymustcomplywiththelicensingandsurveyrequirementsoftheirstateandeachstatetowhichtheydispensepharmaceuticals Inaddition pharmaciesdisplayingtheVIPPSsealhavedemonstratedtoNABPcompliancewithVIPPScriteriaincludingpatientrightstoprivacy authenticationandsecurityofprescriptionorders adherencetoarecognizedqualityassurancepolicy andprovisionofmeaningfulconsultationbetweenpatientsandpharmacists VIPPS VIPPSpharmacysitesareidentifiedbytheVIPPShyperlinksealdisplayedontheirWebsites Byclickingontheseal avisitorislinkedtotheNABPVIPPSsitewhereverifiedinformationaboutthepharmacyismaintainedbyNABP ThepublicisalsowelcometoaccesstheVIPPSsitetosearchforaVIPPSInternetpharmacythatmatchestheirneeds VIPPS VIPPS NABPhasreviewednumerousWebsitessellingprescriptionmedicineandhascreatedthreecategoriestohelppatientsmakeinformedchoices VIPPS RecommendedInternetPharmacies NABPrecommendsthatpatientsusesitesaccreditedthroughtheVerifiedInternetPharmacyPracticeSites VIPPS program ThesesiteshaveundergoneandsuccessfullycompletedtherigorousNABPaccreditationprocess whichincludesathoroughreviewofallpoliciesandproceduresregardingthepracticeofpharmacyanddispensingofmedicineovertheInternet aswellasanon siteinspectionofallfacilitiesusedbythesitetoreceive review anddispensemedicine VIPPS ReviewedInternetPharmacyPracticeSites NABPhasreviewedthepublicinformationavailableforthesesitesanddeterminedthattheyappeartocomplywithstateandfederallawsandNABPpatientsafetyandpharmacypracticestandards NABPadvisespatientstousethesesiteswithcaution asinformationneededtoconclusivelydeterminethelegitimacyandlegalityofthesesitesmaynothavebeenavailable WeaskpatientstoimmediatelyreporttoNABPanyactivityindicatingthatthesitesdonotcomplywithstateandfederallawsorNABPcriteria forexample dispensingmedicinewithoutavalidprescription ordispensingnon FDA approvedmedicine NABPwillcontinuetomonitortheactivityofthesesitestodeterminecontinuedinclusiononthislist VIPPS NotRecommendedSites TheseInternetdrugoutletsappeartobeoutofcompliancewithstateandfederallawsorNABPpatientsafetyandpharmacypracticestandards VIPPS AfederaljudgeinChicago IL hasshutdownaworldwidespamoperationsolicitingWebsitessellingprescriptionmedicationsillegally ABCNewsreportedonOctober14 2008 Thenewscast availableontheABCWebsiteundertheheadline Authoritiesshutdownglobalspamoperation alsocitesNABPanditsfindingthat97 oftheInternetdrugoutletsithasreviewedappeartobeoperatingoutofcompliancewithstateandfederallawsandestablishedpatientsafetyandpharmacypracticestandards AsimilarnewscastalsoappearedOctober14onFOXNewsChicagoandispostedontheFOXWebsiteundertheheadline FTCCracksDownonEmailSpam DrugSpamNetworkBusted TVNewscastsFeatureNABP RecommendedInternetPharmacies WhatarethedangersofobtainingaprescriptionformedicineovertheInternet Harmfuleffects Somemedicinescanbedangerousifnottakenwithongoingmedicalsupervision Forthisreason mostlawenforcementauthoritiesandprofessionalhealthcareorganizationsadvisedoctorsagainstprescribingmedicineonlineandcautionpatientsagainstobtainingprescriptionsonline exceptfromsitessuchasNABP sVIPPS accreditedpharmacies Thispracticeisillegalinsomestates unlesstheprescriptioniswrittenbyadoctorwhoknowsthepatient smedicalhistoryandpreviouslyhasexaminedthepatientin person Completingonlyanonlinequestionnairedoesnotestablishavaliddoctor patientrelationship Moreimportantly withoutaphysicalexaminationyoucouldreceivemedicinethatisnotrightforyourcondition worsenyourmedicalcondition orcauseaseriousunderlyingmedicalconditiontobeoverlookedormisdiagnosed BuyingMedicineOnline Druginteractions Somemedicines incombinationwithotherdrugsyoumightbetaking cancompoundorinhibittheeffectsofeitherorbothdrugs leadingtoatoxiccombinationorcancellingouttheeffectsofneededmedicines Forthisreason itisimportanttodiscusstakingprescriptionmedicinewithadoctorwhoisfamiliarwithyourmedicalhistoryandhasperformedanin personexamination BuyingMedicineOnline Questionableprofessionalpractices ManyInternetdrugoutletsoperatewithoutalicenseorinconflictwiththelawsandregulationscreatedtoensurepatientsafety Furthermore someofthemedicinesbeingsoldontheseWebsitesmaybetoostrong tooweak fake expired stolen diluted orimpure Frequently deceivedpatientsnotifyusthattheyhavenotreceivedthemedicinestheyordered orthatthesiteoperatorsrefusetoremovecreditcardcharges Manyalsocomplainthattheyareunabletocontactanyoneattheorganization phonelinesaredisconnected nooneanswers ornophonenumberisprovided BuyingMedicineOnline Risktopersonal medical orfinancialinformation ManyillegitimateInternetdrugoutletsdonotprotectcustomers personalinformationwithSSL SecureSocketLayer encryption leavingyourmedicalandfinancialinformationvulnerabletoanyonewhomightwanttouseitfortheirowngain Furthermore evidenceindicatesthatillegitimateprescribingoutletsfrequentlyselltheircustomerliststootherillegitimateonlinedrugoutletsandoperatorsofInternetscamandpornographysites BybuyingdrugsfromanillegitimateInternetoutlet youmaybeidentifyingyourselfassomeonewhoisagoodtargetforrip offschemes BuyingMedicineOnline Counterfeitdrugs TheWorldHealthOrganizationestimatesthatmedicinespurchasedovertheInternetfromoutletsthatconcealtheiractualphysicaladdressarecounterfeitinover50 ofcases Worldwidecounterfeitdrugsalesareincreasingatnearlytwicethepaceoflegitimatedrugsales estimatedat13 annuallybytheCenterforMedicineinthePublicInterest andwillexpandtoa 75billionindustryby2010 ManycounterfeitdrugsaremanufacturedinAsian LatinAmerican andEasternEuropeancountries Thecontentofcounterfeitdrugsrangesfromcrudemixturesofglue chalk andsugartonearlyexactchemicalreplicasofcomplexmedicines Becausethesedrugsareneitherproperlyproducednorregulated itisnearlyimpossibleforpatientstoknowexactlywhattheyaregetting Ifyouunknowinglyreceivecounterfeitmedicine notonlydoyounotreceivethebenefitsofthemedicineyouneed butyoualsocouldplaceyourhealthatriskfromunsafeingredients BuyingMedicineOnline NoprescriptionrequiredPrescriptionbasedsolelyupononlinequestionnaireNophonenumberorstreetaddressNopharmacistconsultationWaiversLimitedmedicinesInternationalWebsitesSpamsolicitations WhatarethesignsofaquestionablyoperatingInternetdrugoutlet AvoidCounterfeitDrugScams AvoidCounterfeitDrugScamsCounterfeitDrugFactsAnestimated1 2 ofdrugsinNorthAmericaarefraudulentWorldwidedrugcounterfeitingisa 32billionbusinessWorldwidedrugcounterfeitingwillbea 75billionindustryby2010AccordingtotheUSFoodandDrugAdministration thenumberoffraudulentprescriptiondrugsinterceptedbycustomsofficialsnearlydoubledbetween2004and2005Counterfeitsalesareincreasingatnearlytwicethepaceoflegitimatepharmaceuticalsales estimatedat13 annuallybytheCenterforMedicineinthePublicInterestCounterfeitdrugsarecommonlymanufacturedincountrieslikeChinaandIndiaThecompositionoffraudulentdrugsrangesfromcrudemixturesofglue chalkandsugartonearlyexactchemicalreplicasofcomplexpharmaceuticalsChangesinpackaging labeling color taste pillshape andunanticipatedsideeffectsaretelltalesignsofcounterfeitingManycounterfeitdrugsareboughtvialegitimate lookingWebsitesAlthoughpossible itisrarefordrugspurchasedatreputablepharmaciestobecounterfeit AvoidCounterfeitDrugScams LicensureandResidencyThepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustbelicensedorregisteredingoodstandingtooperateapharmacyorengageinthepracticeofpharmacyinallapplicablejurisdictions Thepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustnotbeornothavebeensubjecttosignificantdisciplinaryaction Thepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustberegisteredwiththeUSDrugEnforcementAdministration DEA ifdispensingcontrolledsubstances Thepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustbedomiciledintheUnitedStates ProgramCriteria PatientSafetyandPharmacyPracticeStandards PrescriptionsThepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustassurethelegitimacyandauthenticityofallprescriptiondrugorders Alegitimateandauthenticprescriptiondrugordermustbebaseduponavalidpatient prescriberrelationship whichrequiresthefollowingtohavebeenestablished a Thepatienthasalegitimatemedicalcomplaint b Aface to facephysicalexaminationadequatetoestablishthelegitimacyofthemedicalcomplainthasbeenperformedbytheprescribingpractitionerorintheinstancesoftelemedicinethroughatelemedicinepracticeapprovedbytheappropriatePractitionerBoard andc Somelogicalconnectionexistsbetweenthemedicalcomplaint themedicalhistory andthephysicalexaminationandthedrugprescribed Thepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustadheretotheFederalControlledSubstancesActandDEArulesregardingprescriptionsforcontrolledsubstances includingbutnotlimitedtothefollowing a PrescriptionsforScheduleIIcontrolledsubstancesmustbeprovidedinwritingbytheprescriber b PrescriptionsforScheduleIII Vcontrolledsubstancesmustbeprovidedinwritingbythepatientorprescriber orverballyorbyfacsimilebytheprescriber c ScheduleIIcontrolledsubstanceprescriptionsmaynotberefilled anewprescriptionmustbeissuedforeachquantityofthesubstance ProgramCriteria PatientSafetyandPharmacyPracticeStandards PrescriptionsThepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustnotdispenseorofferprescriptionsoriginatingfromtelephonic electronic oronlinemedicalconsultationswithoutapre existingpatient prescriberrelationshipthathasincludedafacetofacephysicalexamination Thepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustnotoffertodispenseordispensemedicationsthathavenotbeenapprovedbytheUSFoodandDrugAdministration FDA ProgramCriteria PatientSafetyandPharmacyPracticeStandards PatientPrivacyThepharmacy inaccordancewithapplicablestateandfederallawsandregulations mustmaintainasecureWebsiteandensurepatientidentifiableinformationandprescriptiontransactionsareencryptedperindustrystandards Thepharmacy inaccordancewithapplicablestateandfederallawsandregulations musthaveandprovidepatientswithaNoticeofPrivacyPracticesforProtectedHealthInformation asrequiredbytheHIPAAPrivacyRule 45CFR164 520 ProgramCriteria PatientSafetyandPharmacyPracticeStandards PatientServicesThepharmacymustprovide ontheWebsite a24 hourtollfreenumberforpatientswhoexperienceorbelievetheyhaveexperiencedanadverseeventinvolvingtheirmedication Thepharmacymustprovide ontheWebsite theUSstreetaddressofthepharmacythatdispensesprescriptionmedicationsonbehalfof orthrough theWebsite Thepharmacymustprovide ontheWebsite theUSstreetaddressofthesite scorporateheadquartersorprimaryplaceofbusiness Thepharmacymustprovide ontheWebsite instructionstopatientsdescribinghowtosubmitcomplaintsorconcerns ThepharmacymustofferpharmacistmedicationconsultationviasecuremeansthroughtheWebsite viatelephone orinpersonforwalk inpatients ProgramCriteria PatientSafetyandPharmacyPracticeStandards ProfessionalPracticesThepharmacymustattestandprovidedocumentationtoNABPthatitobtainsmedicationsfromUSlicensedwholesaledrugdistributorsand orUSlicensedorFDAregisteredpharmaceuticalmanufacturers Thepharmacymustmaintainacurrentlyregistereddomainname ProgramCriteria PatientSafetyandPharmacyPracticeStandards Uponreceiptoftheapplicationformandsupportingdocumentation NABPstaffwill Verifyallnecessarystatepharmacylicensesareingoodstanding Verifythepharmacist in chargelicensesareingoodstanding Evaluatethesubmittedsupportingdocuments andNotifytheapplicantifdiscrepanciesariseorclarificationisneeded AccreditationProcess Afterreviewofthedocumentation staffschedulesanon sitesurveyofthepharmacytoevaluatetheapplicant soperations policiesandstaffforcompliancewiththeVIPPScriteria surveysmayberequired UponnoticeofacomplaintagainstaVIPPS accreditedpharmacy AttherequestofaparticipantinthecourseofVIPPSaccreditationsuspensionaction Re surveysofVIPPS acc