數(shù)位資訊法律專題報告課件

數(shù)位資訊法律專題報告網(wǎng)路購藥之處方箋認證問題95741105JasonChen陳懷玄95741122JasonLee李再松SoochowUniversitySchoolofLaw

1數(shù)位資訊法律專題報告SoochowUniversityS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(jīng)加工調(diào)製，製成一定劑型及劑量之藥品。 製劑分為醫(yī)師處方藥品、醫(yī)師藥師藥劑生指示藥品、成藥及固有成方製劑2第一章藥品分級依照藥品使用方法及安全性分為：2第一節(jié)成藥藥事法第9條 本法所稱成藥，係指原料藥經(jīng)加工調(diào)製，不用其原名稱，其摻入之藥品，不超過中央衛(wèi)生主管機關(guān)所規(guī)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(yī)師指示，即供治療疾病之用者。3第一節(jié)成藥藥事法第9條3第一節(jié)成藥甲乙類成藥的大分類如下：甲類成藥：傷風(fēng)藥水、足爽、金十字胃腸藥解熱鎮(zhèn)痛劑、鎮(zhèn)咳祛痰劑、胃腸藥劑、緩下劑（瀉藥）、驅(qū)蟲劑、營養(yǎng)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(yǎng)毛髮劑、含藥酒類依據(jù)成藥及固有成方製劑管理辦法第十六條規(guī)定：乙類成藥得由百貨店，雜貨店及餐飲服務(wù)商兼零售之。4第一節(jié)成藥甲乙類成藥的大分類如下：4第二節(jié)指示用藥安全性高，只用做癥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(yī)師、藥師、藥劑生指示藥品』的字樣衛(wèi)生署將指示藥品分為十類，包括有綜合感冒藥、解熱鎮(zhèn)痛藥、抗組織胺藥(過敏、流鼻水)、鎮(zhèn)咳痰藥、一般皮膚外用藥、暈車藥、眼用藥、瀉藥、胃腸用藥、驅(qū)蟲藥等。僅能於藥局或藥事人員執(zhí)業(yè)的處所內(nèi)，經(jīng)醫(yī)藥專業(yè)人士指導(dǎo)下，才可購得5第二節(jié)指示用藥安全性高，只用做癥狀的緩解而不是治療疾病的藥第三節(jié)處方藥藥事法施行細則第三條本法第八條第二項所稱醫(yī)師處方藥品指經(jīng)中央衛(wèi)生主管機關(guān)審定，在藥品許可證上，載明須由醫(yī)師處方或限由醫(yī)師使用者6第三節(jié)處方藥藥事法施行細則第三條6第三節(jié)處方藥限制由醫(yī)師開立處方箋後方可使用醫(yī)師針對每位病人的病情開立適當?shù)乃幤贰⒂梅ㄅc用量藥師依據(jù)處方箋調(diào)劑，再將藥品給予病人管制藥也屬於處方藥，同樣需由醫(yī)師開立處方，藥師調(diào)劑，在給予藥品時需核對證件，確認領(lǐng)藥人簽名後，發(fā)出藥品。

7第三節(jié)處方藥限制由醫(yī)師開立處方箋後方可使用7第四節(jié)合法藥品辨識方法處方藥藥品外盒包裝上印有衛(wèi)生署許可的證號：「衛(wèi)署藥製字第xxxxxx號」或「衛(wèi)署藥輸字第xxxxxx號」外盒包裝有「醫(yī)師處方藥」的標示8第四節(jié)合法藥品辨識方法處方藥8第四節(jié)合法藥品辨識方法指示用藥藥品外盒包裝上印有衛(wèi)生署許可的證號：「衛(wèi)署藥製字第xxxxxx號」或「衛(wèi)署藥輸字第xxxxxx號」外盒包裝有「醫(yī)師藥師藥劑生指示藥品」的標示9第四節(jié)合法藥品辨識方法指示用藥9第四節(jié)合法藥品辨識方法成藥藥品外盒包裝上印有「衛(wèi)署成製第xxxxxx號」「甲類成藥」或「乙類成藥」

10第四節(jié)合法藥品辨識方法成藥10第四節(jié)合法藥品辨識方法11第四節(jié)合法藥品辨識方法11第二章處方藥取得途徑分析第一節(jié)醫(yī)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(yī)師處方藥品，係指經(jīng)中央衛(wèi)生主管機關(guān)審定，在藥品許可證上，載明須由醫(yī)師處方或限由醫(yī)師使用者。12第二章處方藥取得途徑分析第一節(jié)醫(yī)院及診所之藥局12第二章處方藥取得途徑分析第二節(jié)藥局合法購得配合全民健康保險及醫(yī)藥分業(yè)的實施全民健康保險特約藥局，接受醫(yī)師處方箋據(jù)以調(diào)劑藥品

13第二章處方藥取得途徑分析第二節(jié)藥局合法購得13第二章處方藥取得途徑分析第三節(jié)

藥局非法購得用於改善生活品質(zhì)的產(chǎn)品減肥藥、生髮藥、性功能障礙、墮胎藥疾病或癥狀都很容易自我判定不好意思對醫(yī)師啟口國家的醫(yī)療保險制度並不給付

14第二章處方藥取得途徑分析第三節(jié)藥局非法購得14第三章醫(yī)藥分業(yè)醫(yī)藥分業(yè)是醫(yī)師與藥師的專業(yè)分工合作醫(yī)師負責診斷、處置及開立處方箋藥師則依醫(yī)師的處方調(diào)劑並交付藥品，並提供藥物諮詢民眾在醫(yī)療院所就診後，持醫(yī)師開立的處方箋，可以選擇在該聘有合格藥事人員的醫(yī)療院所調(diào)劑，如果就醫(yī)的醫(yī)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(diào)劑15第三章醫(yī)藥分業(yè)醫(yī)藥分業(yè)是醫(yī)師與藥師的專業(yè)分工合作15第一節(jié)處方箋釋出第一款一般處方箋保險對象有權(quán)向醫(yī)師索取處方箋至健保特約藥局調(diào)劑。其處方自就醫(yī)日起三日內(nèi)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(diào)劑，需依規(guī)定繳交藥品部分負擔金額

第三章醫(yī)藥分業(yè)16第一節(jié)處方箋釋出第三章醫(yī)藥分業(yè)16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(yī)藥分業(yè)17藥費部分負擔第三章醫(yī)藥分業(yè)17第一節(jié)處方箋釋出第二款慢性病連續(xù)處方箋係指醫(yī)師開立給慢性病患者的長期用藥處方箋。自醫(yī)師開立後，三個月內(nèi)有效，可以分兩至三次直接到藥局調(diào)劑。合於中央健康保險局所公告之98種慢性病，且經(jīng)醫(yī)師評估為病情穩(wěn)定，可以在三個月內(nèi)使用同樣處方藥品之患者，就可以使用慢性病連續(xù)處方箋第三章醫(yī)藥分業(yè)18第一節(jié)處方箋釋出第三章醫(yī)藥分業(yè)18第一節(jié)處方箋釋出第二款慢性病連續(xù)處方箋省時：減少就醫(yī)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(yī)醫(yī)院以慢性病連續(xù)處方箋領(lǐng)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(lǐng)藥。持慢性病連續(xù)處方箋再次調(diào)劑領(lǐng)藥，須與上次領(lǐng)藥至少相隔二十一天。如因即將出國而預(yù)估所領(lǐng)取藥品不夠使用時，可於領(lǐng)藥時出具足以證明出國之相關(guān)文件（如機票等），即可多領(lǐng)取一個月的藥品第三章醫(yī)藥分業(yè)19第一節(jié)處方箋釋出第三章醫(yī)藥分業(yè)19衛(wèi)生署認為利用網(wǎng)路販售藥物或醫(yī)療器材與實體通路有不同，而目前網(wǎng)路商店因?qū)偬摂M空間，無法滿足藥商營業(yè)場所之定義，因此禁止在網(wǎng)路上販售任何種類的藥品或醫(yī)療器材。衛(wèi)生署目前未核準任何網(wǎng)路藥局第四章網(wǎng)路販賣處方藥現(xiàn)況20第四章網(wǎng)路販賣處方藥現(xiàn)況20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(yī)療器材：血壓計、血糖機、隱形眼鏡、碎脂機、衛(wèi)生棉條、導(dǎo)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(yī)療用彈性襪(預(yù)防靜脈曲張彈性襪)。第四章網(wǎng)路販賣處方藥現(xiàn)況21藥品：善存、維骨力、威而剛、酸痛貼布、柔沛、正露第四章網(wǎng)路第五章網(wǎng)路購買處方藥之安全性第一節(jié)偽藥藥事法第20條本法所稱偽藥，係指藥品經(jīng)稽查或檢驗有左列各款情形之一者：一、未經(jīng)核準，擅自製造者。二、所含有效成分之名稱，與核準不符者。三、將他人產(chǎn)品抽換或摻雜者。四、塗改或更換有效期間之標示者。22第五章網(wǎng)路購買處方藥之安全性第一節(jié)偽藥22第五章網(wǎng)路購買處方藥之安全性第二節(jié)劣藥藥事法第21條本法所稱劣藥，係指核準之藥品經(jīng)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(zhì)、量或強度，與核準不符者。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、主治效能與核準不符者。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(zhì)者。八、裝入有害物質(zhì)所製成之容器或使用回收容器者。23第五章網(wǎng)路購買處方藥之安全性第二節(jié)劣藥23第五章網(wǎng)路購買處方藥之安全性第三節(jié)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(jīng)中央衛(wèi)生主管機關(guān)明令公告禁止製造、調(diào)劑、輸入、輸出、販賣或陳列之毒害藥品。二、未經(jīng)核準擅自輸入之藥品。但旅客或隨交通工具服務(wù)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(wèi)生主管機關(guān)會同財政部公告之。24第五章網(wǎng)路購買處方藥之安全性第三節(jié)禁藥24NABPwasestablishedin1904toassiststatelicensingboardsindeveloping,implementing,andenforcinguniformstandardstoprotectthepublichealth.Pharmacyboardsfromfiftystates,theDistrictofColumbia,threeU.S.territories,nineCanadianprovinces,andtwoAustralianstatesmakeuptheassociationmembership.

NationalAssociationofBoardsofPharmacy?(NABP?)

25NABPwasestablishedin1904tNationalAssociationofBoardsofPharmacy?(NABP?)TheNationalAssociationofBoardsofPharmacy?(NABP?)istheindependent,international,andimpartialassociationthatassistsitsmemberboardsandjurisdictionsindeveloping,implementing,andenforcinguniformstandardsforthepurposeofprotectingthepublichealth.

26NationalAssociationofBoardsNationalAssociationofBoardsofPharmacy?(NABP?)NationalAssociationofBoardsofPharmacy?

1600FeehanvilleDrive?MountProspect,IL60056Tel:847/391-4406

Fax:847/391-4502

CarmenA.Catizone,MS,RPh,DPh,ExecutiveDirector/Secretary27NationalAssociationofBoardsVerifiedInternetPharmacyPracticeSites?(VIPPS?)

28VerifiedInternetPharmacyPraInresponsetopublicconcernofthesafetyofpharmacypracticesontheInternet,theAssociationdevelopedtheVerifiedInternetPharmacyPracticeSites(VIPPS)programinthespringof1999.Acoalitionofstateandfederalregulatoryassociations,professionalassociations,andconsumeradvocacygroupsprovidedtheirexpertiseindevelopingthecriteriathatVIPPS-accreditedpharmaciesfollow.(VIPPS?)29InresponsetopublicconcernTobeVIPPSaccredited,apharmacymustcomplywiththelicensingandsurveyrequirementsoftheirstateandeachstatetowhichtheydispensepharmaceuticals.Inaddition,pharmaciesdisplayingtheVIPPSsealhavedemonstratedtoNABPcompliancewithVIPPScriteriaincludingpatientrightsto

privacy,authenticationandsecurityofprescriptionorders,adherencetoarecognizedqualityassurancepolicy,andprovisionofmeaningfulconsultationbetweenpatientsandpharmacists.(VIPPS?)30TobeVIPPSaccredited,apharVIPPSpharmacysitesareidentifiedbytheVIPPShyperlinksealdisplayedontheirWebsites.Byclickingontheseal,avisitorislinkedtotheNABPVIPPSsitewhereverifiedinformationaboutthepharmacyismaintainedbyNABP.ThepublicisalsowelcometoaccesstheVIPPSsitetosearchforaVIPPSInternetpharmacythatmatchestheirneeds.(VIPPS?)31VIPPSpharmacysitesareident(VIPPS?)32(VIPPS?)32NABPhasreviewednumerousWebsitessellingprescriptionmedicineandhascreatedthreecategoriestohelppatientsmakeinformedchoices:(VIPPS?)33NABPhasreviewednumerousWebRecommendedInternetPharmacies:NABPrecommendsthatpatientsusesitesaccreditedthroughtheVerifiedInternetPharmacyPracticeSites?(VIPPS?)program.ThesesiteshaveundergoneandsuccessfullycompletedtherigorousNABPaccreditationprocess,whichincludesathoroughreviewofallpoliciesandproceduresregardingthepracticeofpharmacyanddispensingofmedicineovertheInternet,aswellasanon-siteinspectionofallfacilitiesusedbythesitetoreceive,review,anddispensemedicine.(VIPPS?)34RecommendedInternetPharmacieReviewedInternetPharmacyPracticeSites:NABPhasreviewedthepublicinformationavailableforthesesitesanddeterminedthattheyappeartocomplywithstateandfederallawsandNABPpatientsafetyandpharmacypracticestandards.NABPadvisespatientstousethesesiteswithcaution,asinformationneededtoconclusivelydeterminethelegitimacyandlegalityofthesesitesmaynothavebeenavailable.WeaskpatientstoimmediatelyreporttoNABPanyactivityindicatingthatthesitesdonotcomplywithstateandfederallawsorNABPcriteria,forexample,dispensingmedicinewithoutavalidprescription,ordispensingnon-FDA-approvedmedicine.NABPwillcontinuetomonitortheactivityofthesesitestodeterminecontinuedinclusiononthislist.(VIPPS?)35ReviewedInternetPharmacyPraNotRecommendedSites:TheseInternetdrugoutletsappeartobeoutofcompliancewithstateandfederallawsorNABPpatientsafetyandpharmacypracticestandards.(VIPPS?)36NotRecommendedSites:TheseIAfederaljudgeinChicago,IL,hasshutdownaworldwidespamoperationsolicitingWebsitessellingprescriptionmedicationsillegally,ABCNewsreportedonOctober14,2008.Thenewscast,availableontheABCWebsiteundertheheadline“Authoritiesshutdownglobalspamoperation,”alsocitesNABPanditsfindingthat97%oftheInternetdrugoutletsithasreviewedappeartobeoperatingoutofcompliancewithstateandfederallawsandestablishedpatientsafetyandpharmacypracticestandards.AsimilarnewscastalsoappearedOctober14onFOXNewsChicagoandispostedontheFOXWebsiteundertheheadline“FTCCracksDownonEmailSpam.”DrugSpamNetworkBusted;TVNewscastsFeatureNABP37AfederaljudgeinChicago,ILRecommendedInternetPharmacies38RecommendedInternetPharmacieWhatarethedangersofobtainingaprescriptionformedicineovertheInternet?

Harmfuleffects:

Somemedicinescanbedangerousifnottakenwithongoingmedicalsupervision.Forthisreason,mostlawenforcementauthoritiesandprofessionalhealthcareorganizationsadvisedoctorsagainstprescribingmedicineonlineandcautionpatientsagainstobtainingprescriptionsonline,exceptfromsitessuchasNABP’sVIPPS-accreditedpharmacies.Thispracticeisillegalinsomestates,unlesstheprescriptioniswrittenbyadoctorwhoknowsthepatient’smedicalhistoryandpreviouslyhasexaminedthepatientin-person.

Completingonlyanonlinequestionnairedoesnotestablishavaliddoctor-patientrelationship.Moreimportantly,withoutaphysicalexaminationyoucouldreceivemedicinethatisnotrightforyourcondition,worsenyourmedicalcondition,orcauseaseriousunderlyingmedicalconditiontobeoverlookedormisdiagnosed.BuyingMedicineOnline39WhatarethedangersofobtainDruginteractions:

Somemedicines,incombinationwithotherdrugsyoumightbetaking,cancompoundorinhibittheeffectsofeitherorbothdrugs,leadingtoatoxiccombinationorcancellingouttheeffectsofneededmedicines.Forthisreason,itisimportanttodiscusstakingprescriptionmedicinewithadoctorwhoisfamiliarwithyourmedicalhistoryandhasperformedanin-personexamination.BuyingMedicineOnline40Druginteractions:BuyingMedicQuestionableprofessionalpractices:ManyInternetdrugoutletsoperatewithoutalicenseorinconflictwiththelawsandregulationscreatedtoensurepatientsafety.Furthermore,someofthemedicinesbeingsoldontheseWebsitesmaybetoostrong,tooweak,fake,expired,stolen,diluted,orimpure.Frequently,deceivedpatientsnotifyusthattheyhavenotreceivedthemedicinestheyordered,orthatthesiteoperatorsrefusetoremovecreditcardcharges.Manyalsocomplainthattheyareunabletocontactanyoneattheorganization;phonelinesaredisconnected,nooneanswers,ornophonenumberisprovided.BuyingMedicineOnline41QuestionableprofessionalpracRisktopersonal,medical,orfinancialinformation:ManyillegitimateInternetdrugoutletsdonotprotectcustomers’personalinformationwithSSL(SecureSocketLayer)encryption,leavingyourmedicalandfinancialinformationvulnerabletoanyonewhomightwanttouseitfortheirowngain.

Furthermore,evidenceindicatesthatillegitimateprescribingoutletsfrequentlyselltheircustomerliststootherillegitimateonlinedrugoutletsandoperatorsofInternetscamandpornographysites.

BybuyingdrugsfromanillegitimateInternetoutlet,youmaybeidentifyingyourselfassomeonewhoisagoodtargetforrip-offschemes.BuyingMedicineOnline42Risktopersonal,medical,orCounterfeitdrugs:

TheWorldHealthOrganizationestimatesthatmedicinespurchasedovertheInternetfromoutletsthatconcealtheiractualphysicaladdressarecounterfeitinover50%ofcases.Worldwidecounterfeitdrugsalesareincreasingatnearlytwicethe

paceoflegitimatedrugsales,estimatedat13%annuallybytheCenterforMedicineinthePublicInterest,andwillexpandtoa$75billionindustryby2010.

ManycounterfeitdrugsaremanufacturedinAsian,LatinAmerican,andEasternEuropeancountries.Thecontentofcounterfeitdrugsrangesfromcrudemixturesofglue,chalk,andsugartonearlyexactchemicalreplicasofcomplexmedicines.Becausethesedrugsareneitherproperlyproducednorregulated,itisnearlyimpossibleforpatientstoknowexactlywhattheyaregetting.

Ifyouunknowinglyreceivecounterfeitmedicine,notonlydoyounotreceivethebenefitsofthemedicineyouneed,butyoualsocouldplaceyourhealthatriskfromunsafeingredients.BuyingMedicineOnline43Counterfeitdrugs:BuyingMediNoprescriptionrequired

Prescriptionbasedsolelyupononlinequestionnaire

Nophonenumberorstreetaddress

Nopharmacistconsultation

Waivers

Limitedmedicines

InternationalWebsites

Spamsolicitations

WhatarethesignsofaquestionablyoperatingInternetdrugoutlet?44NoprescriptionrequiredWhatAvoidCounterfeitDrugScams

45AvoidCounterfeitDrugScams4AvoidCounterfeitDrugScams

CounterfeitDrugFactsAnestimated1-2%ofdrugsinNorthAmericaarefraudulentWorldwidedrugcounterfeitingisa$32billionbusinessWorldwidedrugcounterfeitingwillbea$75billionindustryby2010AccordingtotheUSFoodandDrugAdministration,thenumberoffraudulentprescriptiondrugsinterceptedbycustomsofficialsnearlydoubledbetween2004and2005Counterfeitsalesareincreasingatnearlytwicethe

paceoflegitimatepharmaceuticalsales--estimatedat13%annuallybytheCenterforMedicineinthePublicInterestCounterfeitdrugsarecommonlymanufacturedincountrieslikeChinaandIndiaThecompositionoffraudulentdrugsrangesfromcrudemixturesofglue,chalkandsugartonearlyexactchemicalreplicasofcomplexpharmaceuticalsChangesinpackaging,labeling,color,taste,pillshape,andunanticipatedsideeffectsaretelltalesignsofcounterfeitingManycounterfeitdrugsareboughtvialegitimate-lookingWebsitesAlthoughpossible,itisrarefordrugspurchasedatreputablepharmaciestobecounterfeitAvoidCounterfeitDrugScams46AvoidCounterfeitDrugScamsCLicensureandResidencyThepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustbelicensedorregisteredingoodstandingtooperateapharmacyorengageinthepracticeofpharmacyinallapplicablejurisdictions.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustnotbeornothavebeensubjecttosignificantdisciplinaryaction.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustberegisteredwiththeUSDrugEnforcementAdministration(DEA)ifdispensingcontrolledsubstances.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustbedomiciledintheUnitedStates.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards

47LicensureandResidencyProgramPrescriptionsThepharmacy,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:PatientSafetyandPharmacyPracticeStandards48PrescriptionsProgramCriteria:PrescriptionsThepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustnotdispenseorofferprescriptionsoriginatingfromtelephonic,electronic,oronlinemedicalconsultationswithoutapre-existingpatient-prescriberrelationshipthathasincludedafacetofacephysicalexamination.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustnotoffertodispenseordispensemedicationsthathavenotbeenapprovedbytheUSFoodandDrugAdministration(FDA).ProgramCriteria:PatientSafetyandPharmacyPracticeStandards49PrescriptionsProgramCriteria:PatientPrivacyThepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,mustmaintainasecureWebsiteandensurepatientidentifiableinformationandprescriptiontransactionsareencryptedperindustrystandards.Thepharmacy,inaccordancewithapplicablestateandfederallawsandregulations,musthaveandprovidepatientswithaNoticeofPrivacyPracticesforProtectedHealthInformation,asrequiredbytheHIPAAPrivacyRule(45CFR164.520).ProgramCriteria:PatientSafetyandPharmacyPracticeStandards50PatientPrivacyProgramCriteriPatientServicesThepharmacymustprovide,ontheWebsite,a24-hourtollfreenumberforpatientswhoexperienceorbelievetheyhaveexperiencedanadverseeventinvolvingtheirmedication.Thepharmacymustprovide,ontheWebsite,theUSstreetaddressofthepharmacythatdispensesprescriptionmedicationsonbehalfof(orthrough)theWebsite.Thepharmacymustprovide,ontheWebsite,theUSstreetaddressofthesite’scorporateheadquartersorprimaryplaceofbusiness.Thepharmacymustprovide,ontheWebsite,instructionstopatientsdescribinghowtosubmitcomplaintsorconcerns.ThepharmacymustofferpharmacistmedicationconsultationviasecuremeansthroughtheWebsite,viatelephone,orinpersonforwalk-inpatients.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards51PatientServicesProgramCriterProfessionalPracticesThepharmacymustattestandprovidedocumentationtoNABPthatitobtainsmedicationsfromUSlicensedwholesaledrugdistributorsand/orUSlicensedorFDAregisteredpharmaceutical

manufacturers.Thepharmacymustmaintainacurrentlyregistereddomainname.ProgramCriteria:PatientSafetyandPharmacyPracticeStandards52ProfessionalPracticesProgramUponreceiptoftheapplicationformandsupportingdocumentation,NABPstaffwill:Verifyallnecessarystatepharmacylicensesareingoodstanding;Verifythepharmacist-in-chargelicensesareingoodstanding;Evaluatethesubmittedsupportingdocuments;andNotifytheapplicantifdiscrepanciesariseorclarificationisneeded.

AccreditationProcess

53UponreceiptoftheapplicatioAfterreviewofthedocumentation,staffschedulesanon-sitesurveyofthepharmacytoevaluatetheapplicant'soperations,policiesandstaffforcompliancewiththeVIPPScriteria.

surveysmayberequired:UponnoticeofacomplaintagainstaVIPPS-accreditedpharmacy.AttherequestofaparticipantinthecourseofVIPPSaccreditationsuspensionaction.Re-surveysofVIPPS-accreditedpharmaciesarerequiredonceeverythreeyears.AccreditationProcess

54AfterreviewofthedocumentatFollowingreviewoftheapplicationmaterials,verificationofsubmittedinformationandlicensure,andsurvey,awrittenreportwillbesenttothepharmacy.Ifthereviewissatisfactory,arecommendationtoawardaccreditationissubmittedtoNABP’saccreditationcommittee.Uponaccreditationapproval,aVIPPSLetterofAgreementtobesignedbyanauthorizedrepresentativeoragentoftheentitywillbesenttothepharmacy.AccreditationProcess

55FollowingreviewoftheapplicUponreceiptoftheexecutedLetterofAgreementandfee,NABPreleasesacodetotheapplicantwhichallowsaccesstoasecureareaoftheVIPPSWebsitewheretheapplicantmayretrieveanddownloadtheirVIPPShyperlinkSealandcarryoutotheradministrativefunctions.GuidelinesfortheuseoftheSealareincludedintheLetterofAgreement.TheVIPPSaccreditationisrenewableannuallyfollowinganupdateoftheregistrationinformationandre-verificationoflicensurestatus.AccreditationProcess

56UponreceiptoftheexecutedL只要善用網(wǎng)路特性及便利性，網(wǎng)路藥局不但可提供慢性病人另一個取藥、服務(wù)窗口，也可加速醫(yī)藥分業(yè)落實

臺灣網(wǎng)路購買處方藥之未來建議57只要善用網(wǎng)路特性及便利性，網(wǎng)路藥局不但可提供慢性病人另一個取為了開放民眾上網(wǎng)買藥，美國目前採VIPPS制度（網(wǎng)路藥局認證規(guī)範），即網(wǎng)路藥局必須先向主管機關(guān)申請，獲得認證後，才能在網(wǎng)路上提供民眾購藥服務(wù)；英國、德國計畫跟進，以認證制管理網(wǎng)路藥局。

臺灣網(wǎng)路購買處方藥之未來建議58為了開放民眾上網(wǎng)買藥，美國目前採VIPPS制度（網(wǎng)路藥局認以臺灣的網(wǎng)路藥局為例，依照現(xiàn)有醫(yī)療相關(guān)法規(guī)，只再配合電子簽章法，提供專業(yè)人員電子憑證，網(wǎng)路藥局即可如一般藥局，由專業(yè)人員執(zhí)業(yè)，提供服務(wù)。利用網(wǎng)路二十四小時開放的便利性、即時性，衛(wèi)生署不妨考慮先開放在地區(qū)或區(qū)域級以上醫(yī)療院所就醫(yī)的慢性病患，經(jīng)醫(yī)師評估病況穩(wěn)定的情況下，讓患者透過認證的合法網(wǎng)路藥局領(lǐng)藥，不但可避免病患舟車往返及等候的不便，網(wǎng)路藥局的便利性及專業(yè)認證，也可讓醫(yī)師放心釋出處方箋，加速醫(yī)藥分業(yè)的進展。臺灣網(wǎng)路購買處方藥之未來建議59以臺灣的網(wǎng)路藥局為例，依照現(xiàn)有醫(yī)療相關(guān)法規(guī)，只再配合電子簽章網(wǎng)路藥局販售非法藥品及未經(jīng)處方的處方藥的弊端，其實在現(xiàn)實生活中，也一樣難以杜絕，必須從民眾衛(wèi)生教育著手。只是網(wǎng)路提供「匿名」服務(wù)，讓不願現(xiàn)身就醫(yī)的病患，例如性功能障礙、愛滋病患更喜歡利用網(wǎng)路買藥、尋求援助，因此，目前在網(wǎng)路非法流通的藥品仍以治療陽痿藥物「威而鋼」及減肥藥「讓你酷」為主，讓主管機關(guān)抓不勝抓。

臺灣網(wǎng)路購買處方藥之未來建議60網(wǎng)路藥局販售非法藥品及未經(jīng)處方的處方藥的弊端，其實在現(xiàn)實生活網(wǎng)路醫(yī)療服務(wù)如雨後春筍，反映了民眾對醫(yī)療相關(guān)資訊需求殷切，但如何善用網(wǎng)路的便利性、可近性，提供民眾更充分的保健資訊及安全、有效的醫(yī)療服務(wù)，整體提升民眾的醫(yī)療知識，減少諱疾忌醫(yī)的狀況，發(fā)揮網(wǎng)路時代的正面效益，除了主管機關(guān)的管理以外，教育是另一個更長遠的重要課題。

臺灣網(wǎng)路購買處方藥之未來建議

61網(wǎng)路醫(yī)療服務(wù)如雨後春筍，反映了民眾對醫(yī)療相關(guān)資訊需求殷切，但專業(yè)認證機構(gòu)的介入合法的網(wǎng)絡(luò)藥房可以

自願加入開展國際合作加強對跨國藥品交易的管理使用多種搜索工具，提升搜索能力，以增

強監(jiān)控和確認網(wǎng)站是否違法的能力需要積極借鏡美國等國外先進的監(jiān)管經(jīng)驗

結(jié)論

62專業(yè)認證機構(gòu)的介入合法的網(wǎng)絡(luò)藥房可以結(jié)論62Thanksforyourattention!6363數(shù)位資訊法律專題報告網(wǎng)路購藥之處方箋認證問題95741105JasonChen陳懷玄95741122JasonLee李再松SoochowUniversitySchoolofLaw

64數(shù)位資訊法律專題報告SoochowUniversityS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(jīng)加工調(diào)製，製成一定劑型及劑量之藥品。 製劑分為醫(yī)師處方藥品、醫(yī)師藥師藥劑生指示藥品、成藥及固有成方製劑65第一章藥品分級依照藥品使用方法及安全性分為：2第一節(jié)成藥藥事法第9條 本法所稱成藥，係指原料藥經(jīng)加工調(diào)製，不用其原名稱，其摻入之藥品，不超過中央衛(wèi)生主管機關(guān)所規(guī)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(yī)師指示，即供治療疾病之用者。66第一節(jié)成藥藥事法第9條3第一節(jié)成藥甲乙類成藥的大分類如下：甲類成藥：傷風(fēng)藥水、足爽、金十字胃腸藥解熱鎮(zhèn)痛劑、鎮(zhèn)咳祛痰劑、胃腸藥劑、緩下劑（瀉藥）、驅(qū)蟲劑、營養(yǎng)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(yǎng)毛髮劑、含藥酒類依據(jù)成藥及固有成方製劑管理辦法第十六條規(guī)定：乙類成藥得由百貨店，雜貨店及餐飲服務(wù)商兼零售之。67第一節(jié)成藥甲乙類成藥的大分類如下：4第二節(jié)指示用藥安全性高，只用做癥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(yī)師、藥師、藥劑生指示藥品』的字樣衛(wèi)生署將指示藥品分為十類，包括有綜合感冒藥、解熱鎮(zhèn)痛藥、抗組織胺藥(過敏、流鼻水)、鎮(zhèn)咳痰藥、一般皮膚外用藥、暈車藥、眼用藥、瀉藥、胃腸用藥、驅(qū)蟲藥等。僅能於藥局或藥事人員執(zhí)業(yè)的處所內(nèi)，經(jīng)醫(yī)藥專業(yè)人士指導(dǎo)下，才可購得68第二節(jié)指示用藥安全性高，只用做癥狀的緩解而不是治療疾病的藥第三節(jié)處方藥藥事法施行細則第三條本法第八條第二項所稱醫(yī)師處方藥品指經(jīng)中央衛(wèi)生主管機關(guān)審定，在藥品許可證上，載明須由醫(yī)師處方或限由醫(yī)師使用者69第三節(jié)處方藥藥事法施行細則第三條6第三節(jié)處方藥限制由醫(yī)師開立處方箋後方可使用醫(yī)師針對每位病人的病情開立適當?shù)乃幤?、用法與用量藥師依據(jù)處方箋調(diào)劑，再將藥品給予病人管制藥也屬於處方藥，同樣需由醫(yī)師開立處方，藥師調(diào)劑，在給予藥品時需核對證件，確認領(lǐng)藥人簽名後，發(fā)出藥品。

70第三節(jié)處方藥限制由醫(yī)師開立處方箋後方可使用7第四節(jié)合法藥品辨識方法處方藥藥品外盒包裝上印有衛(wèi)生署許可的證號：「衛(wèi)署藥製字第xxxxxx號」或「衛(wèi)署藥輸字第xxxxxx號」外盒包裝有「醫(yī)師處方藥」的標示71第四節(jié)合法藥品辨識方法處方藥8第四節(jié)合法藥品辨識方法指示用藥藥品外盒包裝上印有衛(wèi)生署許可的證號：「衛(wèi)署藥製字第xxxxxx號」或「衛(wèi)署藥輸字第xxxxxx號」外盒包裝有「醫(yī)師藥師藥劑生指示藥品」的標示72第四節(jié)合法藥品辨識方法指示用藥9第四節(jié)合法藥品辨識方法成藥藥品外盒包裝上印有「衛(wèi)署成製第xxxxxx號」「甲類成藥」或「乙類成藥」

73第四節(jié)合法藥品辨識方法成藥10第四節(jié)合法藥品辨識方法74第四節(jié)合法藥品辨識方法11第二章處方藥取得途徑分析第一節(jié)醫(yī)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(yī)師處方藥品，係指經(jīng)中央衛(wèi)生主管機關(guān)審定，在藥品許可證上，載明須由醫(yī)師處方或限由醫(yī)師使用者。75第二章處方藥取得途徑分析第一節(jié)醫(yī)院及診所之藥局12第二章處方藥取得途徑分析第二節(jié)藥局合法購得配合全民健康保險及醫(yī)藥分業(yè)的實施全民健康保險特約藥局，接受醫(yī)師處方箋據(jù)以調(diào)劑藥品

76第二章處方藥取得途徑分析第二節(jié)藥局合法購得13第二章處方藥取得途徑分析第三節(jié)

藥局非法購得用於改善生活品質(zhì)的產(chǎn)品減肥藥、生髮藥、性功能障礙、墮胎藥疾病或癥狀都很容易自我判定不好意思對醫(yī)師啟口國家的醫(yī)療保險制度並不給付

77第二章處方藥取得途徑分析第三節(jié)藥局非法購得14第三章醫(yī)藥分業(yè)醫(yī)藥分業(yè)是醫(yī)師與藥師的專業(yè)分工合作醫(yī)師負責診斷、處置及開立處方箋藥師則依醫(yī)師的處方調(diào)劑並交付藥品，並提供藥物諮詢民眾在醫(yī)療院所就診後，持醫(yī)師開立的處方箋，可以選擇在該聘有合格藥事人員的醫(yī)療院所調(diào)劑，如果就醫(yī)的醫(yī)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(diào)劑78第三章醫(yī)藥分業(yè)醫(yī)藥分業(yè)是醫(yī)師與藥師的專業(yè)分工合作15第一節(jié)處方箋釋出第一款一般處方箋保險對象有權(quán)向醫(yī)師索取處方箋至健保特約藥局調(diào)劑。其處方自就醫(yī)日起三日內(nèi)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(diào)劑，需依規(guī)定繳交藥品部分負擔金額

第三章醫(yī)藥分業(yè)79第一節(jié)處方箋釋出第三章醫(yī)藥分業(yè)16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(yī)藥分業(yè)80藥費部分負擔第三章醫(yī)藥分業(yè)17第一節(jié)處方箋釋出第二款慢性病連續(xù)處方箋係指醫(yī)師開立給慢性病患者的長期用藥處方箋。自醫(yī)師開立後，三個月內(nèi)有效，可以分兩至三次直接到藥局調(diào)劑。合於中央健康保險局所公告之98種慢性病，且經(jīng)醫(yī)師評估為病情穩(wěn)定，可以在三個月內(nèi)使用同樣處方藥品之患者，就可以使用慢性病連續(xù)處方箋第三章醫(yī)藥分業(yè)81第一節(jié)處方箋釋出第三章醫(yī)藥分業(yè)18第一節(jié)處方箋釋出第二款慢性病連續(xù)處方箋省時：減少就醫(yī)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(yī)醫(yī)院以慢性病連續(xù)處方箋領(lǐng)藥時，可免繳藥品部分負擔費用，且不必加蓋健?？ù琳隆７奖悖嚎梢赃x擇到住家附近之健保特約藥局領(lǐng)藥。持慢性病連續(xù)處方箋再次調(diào)劑領(lǐng)藥，須與上次領(lǐng)藥至少相隔二十一天。如因即將出國而預(yù)估所領(lǐng)取藥品不夠使用時，可於領(lǐng)藥時出具足以證明出國之相關(guān)文件（如機票等），即可多領(lǐng)取一個月的藥品第三章醫(yī)藥分業(yè)82第一節(jié)處方箋釋出第三章醫(yī)藥分業(yè)19衛(wèi)生署認為利用網(wǎng)路販售藥物或醫(yī)療器材與實體通路有不同，而目前網(wǎng)路商店因?qū)偬摂M空間，無法滿足藥商營業(yè)場所之定義，因此禁止在網(wǎng)路上販售任何種類的藥品或醫(yī)療器材。衛(wèi)生署目前未核準任何網(wǎng)路藥局第四章網(wǎng)路販賣處方藥現(xiàn)況83第四章網(wǎng)路販賣處方藥現(xiàn)況20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(yī)療器材：血壓計、血糖機、隱形眼鏡、碎脂機、衛(wèi)生棉條、導(dǎo)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(yī)療用彈性襪(預(yù)防靜脈曲張彈性襪)。第四章網(wǎng)路販賣處方藥現(xiàn)況84藥品：善存、維骨力、威而剛、酸痛貼布、柔沛、正露第四章網(wǎng)路第五章網(wǎng)路購買處方藥之安全性第一節(jié)偽藥藥事法第20條本法所稱偽藥，係指藥品經(jīng)稽查或檢驗有左列各款情形之一者：一、未經(jīng)核準，擅自製造者。二、所含有效成分之名稱，與核準不符者。三、將他人產(chǎn)品抽換或摻雜者。四、塗改或更換有效期間之標示者。85第五章網(wǎng)路購買處方藥之安全性第一節(jié)偽藥22第五章網(wǎng)路購買處方藥之安全性第二節(jié)劣藥藥事法第21條本法所稱劣藥，係指核準之藥品經(jīng)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(zhì)、量或強度，與核準不符者。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、主治效能與核準不符者。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(zhì)者。八、裝入有害物質(zhì)所製成之容器或使用回收容器者。86第五章網(wǎng)路購買處方藥之安全性第二節(jié)劣藥23第五章網(wǎng)路購買處方藥之安全性第三節(jié)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(jīng)中央衛(wèi)生主管機關(guān)明令公告禁止製造、調(diào)劑、輸入、輸出、販賣或陳列之毒害藥品。二、未經(jīng)核準擅自輸入之藥品。但旅客或隨交通工具服務(wù)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(wèi)生主管機關(guān)會同財政部公告之。87第五章網(wǎng)路購買處方藥之安全性第三節(jié)禁藥24NABPwasestablishedin1904toassiststatelicensingboardsindeveloping,implementing,andenforcinguniformstandardstoprotectthepublichealth.Pharmacyboardsfromfiftystates,theDistrictofColumbia,threeU.S.territories,nineCanadianprovinces,andtwoAustralianstatesmakeuptheassociationmembership.

NationalAssociationofBoardsofPharmacy?(NABP?)

88NABPwasestablishedin1904tNationalAssociationof