数位资讯法律专题报告.pptx

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1、數位資訊法律專題報告數位資訊法律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第一章 藥品分級按照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

2、有成方製劑 2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。3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

3、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第二節 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)、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

4、師使用者 6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。 7第四節 合法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第四節 合法藥品辨識方法指示用藥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 9第四節 合法藥品辨識方

5、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第四節 合法藥品辨識方法11第二章 處方藥获得途徑分析第一節 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。12第二章 處方藥获得途徑分析第二節 藥局合法購得配合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第二章 處方藥获得途徑分析第三節 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断定不好意思對醫師啟口國家的醫療保險制度並不給付

6、14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品，並提藥師則依醫師的處方調劑並交付藥品，並提供藥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，假如就醫的假如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第一節 處方箋釋出第一款

7、 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16藥費部分負擔藥費部分負擔 100100元以下元以下 0 0元元 101-200 101-200元元 20 20元元 201-300201-300元元 40 40元元 301-400 301-400元元 60 60元元 401-500401-500元元 80 80元元 501-600 501-600元元 100 100元元 601-700601-700元元 120 120元元 701-800 701-800元

8、元 140 140元元801-900801-900元元 160 160元元 901-1000 901-1000元元 180 180元元10011001元以上元以上200200元元第三章 醫藥分業17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

9、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19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

10、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21第五章 網路購買處方藥之平安性第一節 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第五章 網路購買處方藥之平安性第二節 劣

11、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第五章 網路購買處方藥之平安性第三節 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

12、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。24NABP was established in 1904 to assist state licensing boards in developing, implementing, and enforcing uniform standards to protect the public health. Pharmacy boards from fifty states, the District of Columbia, three U.S. terr

13、itories, nine Canadian provinces, and two Australian states make up the association membership. National Association of Boards of Pharmacy (NABP) 25National Association of Boards of Pharmacy (NABP) The National Association of Boards of Pharmacy (NABP) is the independent, international, and impartial

14、 association that assists its member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health. 26National Association of Boards of Pharmacy (NABP) National Association of Boards of Pharmacy 1600 Feehanville Drive Mount Pros

15、pect, IL 60056 Tel: 847/391-4406 Fax: 847/391-4502 Carmen A. Catizone, MS, RPh, DPh, Executive Director/Secretary27Verified Internet Pharmacy Practice Sites (VIPPS) 28In response to public concern of the safety of pharmacy practices on the Internet, the Association developed the Verified Internet Ph

16、armacy Practice Sites (VIPPS) program in the spring of 1999. A coalition of state and federal regulatory associations, professional associations, and consumer advocacy groups provided their expertise in developing the criteria that VIPPS-accredited pharmacies follow.(VIPPS)29To be VIPPS accredited,

17、a pharmacy must comply with the licensing and survey requirements of their state and each state to which they dispense pharmaceuticals. In addition, pharmacies displaying the VIPPS seal have demonstrated to NABP compliance with VIPPS criteria including patient rights to privacy, authentication and s

18、ecurity of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists. (VIPPS)30VIPPS pharmacy sites are identified by the VIPPS hyperlink seal displayed on their Web sites. By clicking on the seal, a visitor is

19、linked to the NABP VIPPS site where verified information about the pharmacy is maintained by NABP. The public is also welcome to access the VIPPS site to search for a VIPPS Internet pharmacy that matches their needs. (VIPPS)31(VIPPS)32NABP has reviewed numerous Web sites selling prescription medicin

20、e and has created three categories to help patients make informed choices:(VIPPS)33Recommended Internet Pharmacies: NABP recommends that patients use sites accredited through the Verified Internet Pharmacy Practice Sites (VIPPS) program. These sites have undergone and successfully completed the rigo

21、rous NABP accreditation process, which includes a thorough review of all policies and procedures regarding the practice of pharmacy and dispensing of medicine over the Internet, as well as an on-site inspection of all facilities used by the site to receive, review, and dispense medicine. (VIPPS)34Re

22、viewed Internet Pharmacy Practice Sites: NABP has reviewed the public information available for these sites and determined that they appear to comply with state and federal laws and NABP patient safety and pharmacy practice standards. NABP advises patients to use these sites with caution, as informa

23、tion needed to conclusively determine the legitimacy and legality of these sites may not have been available. We ask patients to immediately report to NABP any activity indicating that the sites do not comply with state and federal laws or NABP criteria, for example, dispensing medicine without a va

24、lid prescription, or dispensing non-FDA-approved medicine. NABP will continue to monitor the activity of these sites to determine continued inclusion on this list. (VIPPS)35Not Recommended Sites: These Internet drug outlets appear to be out of compliance with state and federal laws or NABP patient s

25、afety and pharmacy practice standards. (VIPPS)36A federal judge in Chicago, IL, has shut down a worldwide spam operation soliciting Web sites selling prescription medications illegally, ABC News reported on October 14, 2021. The newscast, available on the ABC Web site under the headline “Authorities

26、 shut down global spam operation, also cites NABP and its finding that 97% of the Internet drug outlets it has reviewed appear to be operating out of compliance with state and federal laws and established patient safety and pharmacy practice standards. A similar newscast also appeared October 14 on

27、FOX News Chicago and is posted on the FOX Web site under the headline “FTC Cracks Down on Email Spam. Drug Spam Network Busted; TV Drug Spam Network Busted; TV Newscasts Feature NABPNewscasts Feature NABP37Recommended Internet Pharmacies Recommended Internet Pharmacies 38What are the dangers of obta

28、ining a prescription for medicine over the Internet?1. Harmful effects: Some medicines can be dangerous if not taken with ongoing medical supervision. For this reason, most law enforcement authorities and professional health care organizations advise doctors against prescribing medicine online and c

29、aution patients against obtaining prescriptions online, except from sites such as NABPs VIPPS-accredited pharmacies. This practice is illegal in some states, unless the prescription is written by a doctor who knows the patients medical history and previously has examined the patient in-person. Compl

30、eting only an online questionnaire does not establish a valid doctor-patient relationship. More importantly, without a physical examination you could receive medicine that is not right for your condition, worsen your medical condition, or cause a serious underlying medical condition to be overlooked

31、 or misdiagnosed.Buying Medicine Online392.Drug interactions: Some medicines, in combination with other drugs you might be taking, can compound or inhibit the effects of either or both drugs, leading to a toxic combination or cancelling out the effects of needed medicines. For this reason, it is imp

32、ortant to discuss taking prescription medicine with a doctor who is familiar with your medical history and has performed an in-person examination. Buying Medicine Online403.Questionable professional practices: Many Internet drug outlets operate without a license or in conflict with the laws and regu

33、lations created to ensure patient safety. Furthermore, some of the medicines being sold on these Web sites may be too strong, too weak, fake, expired, stolen, diluted, or impure. Frequently, deceived patients notify us that they have not received the medicines they ordered, or that the site operator

34、s refuse to remove credit card charges. Many also complain that they are unable to contact anyone at the organization; phone lines are disconnected, no one answers, or no phone number is provided.Buying Medicine Online414.Risk to personal, medical, or financial information: Many illegitimate Interne

35、t drug outlets do not protect customers personal information with SSL (Secure Socket Layer) encryption, leaving your medical and financial information vulnerable to anyone who might want to use it for their own gain. Furthermore, evidence indicates that illegitimate prescribing outlets frequently se

36、ll their customer lists to other illegitimate online drug outlets and operators of Internet scam and pornography sites. By buying drugs from an illegitimate Internet outlet, you may be identifying yourself as someone who is a good target for rip-off schemes.Buying Medicine Online425. Counterfeit dru

37、gs: 6. The World Health Organization estimates that medicines purchased over the Internet from outlets that conceal their actual physical address are counterfeit in over 50% of cases. Worldwide counterfeit drug sales are increasing at nearly twice the pace of legitimate drug sales, estimated at 13%

38、annually by the Center for Medicine in the Public Interest, and will expand to a $75 billion industry by 2021.Many counterfeit drugs are manufactured in Asian, Latin American, and Eastern European countries. The content of counterfeit drugs ranges from crude mixtures of glue, chalk, and sugar to nea

39、rly exact chemical replicas of complex medicines. Because these drugs are neither properly produced nor regulated, it is nearly impossible for patients to know exactly what they are getting.If you unknowingly receive counterfeit medicine, not only do you not receive the benefits of the medicine you

40、need, but you also could place your health at risk from unsafe ingredients. Buying Medicine Online431. No prescription required 2. Prescription based solely upon online questionnaire 3. No phone number or street address 4. No pharmacist consultation 5. Waivers 6. Limited medicines 7. International W

41、eb sites 8. Spam solicitations What are the signs of a questionably operating Internet drug outlet?44Avoid Counterfeit Drug Scams 45Avoid Counterfeit Drug Scams Counterfeit Drug FactsAn estimated 1-2% of drugs in North America are fraudulent Worldwide drug counterfeiting is a $32 billion business Wo

42、rldwide drug counterfeiting will be a $75 billion industry by 2021 According to the US Food and Drug Administration, the number of fraudulent prescription drugs intercepted by customs officials nearly doubled between 2004 and 2005 Counterfeit sales are increasing at nearly twice thepace of legitimat

43、e pharmaceutical sales - estimated at 13% annually by the Center for Medicine in the Public Interest Counterfeit drugs are commonly manufactured in countries like China and India The composition of fraudulent drugs ranges from crude mixtures of glue, chalk and sugar to nearly exact chemical replicas

44、 of complex pharmaceuticals Changes in packaging, labeling, color, taste, pill shape, and unanticipated side effects are telltale signs of counterfeiting Many counterfeit drugs are bought via legitimate-looking Web sites Although possible, it is rare for drugs purchased at reputable pharmacies to be

45、 counterfeit Avoid Counterfeit Drug Scams46Licensure and Residency1.The pharmacy, in accordance with applicable state and federal laws and regulations, must be licensed or registered in good standing to operate a pharmacy or engage in the practice of pharmacy in all applicable jurisdictions.2.The ph

46、armacy, in accordance with applicable state and federal laws and regulations, must not be or not have been subject to significant disciplinary action.3.The pharmacy, in accordance with applicable state and federal laws and regulations, must be registered with the US Drug Enforcement Administration (

47、DEA) if dispensing controlled substances.4.The pharmacy, in accordance with applicable state and federal laws and regulations, must be domiciled in the United States. Program Criteria: Patient Safety and Pharmacy Practice Standards 47Prescriptions5.The pharmacy, in accordance with applicable state a

48、nd federal laws and regulations, must assure the legitimacy and authenticity of all prescription drug orders. A legitimate and authentic prescription drug order must be based upon a valid patient-prescriber relationship, which requires the following to have been established: a) The patient has a leg

49、itimate medical complaint; b) A face-to-face physical examination adequate to establish the legitimacy of the medical complaint has been performed by the prescribing practitioner or in the instances of telemedicine through a telemedicine practice approved by the appropriate Practitioner Board; and c

50、) Some logical connection exists between the medical complaint, the medical history, and the physical examination and the drug prescribed. 6.The pharmacy, in accordance with applicable state and federal laws and regulations, must adhere to the Federal Controlled Substances Act and DEA rules regardin