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1、按一下以編輯母片標題樣式,按一下以編輯母片,第二層,第三層,第四層,第五層,,,*,數位資訊法律專題報告,網路購藥之處方箋認證問題,,,95741105 Jason Chen,陳懷玄,,95741122 Jason Lee,李再松,,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，

2、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,酒類,依據成藥及固有成方製劑管理辦法第十六條規定

3、：,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

4、或限由醫師使用,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,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,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

5、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,」,,,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

6、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,,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，假如就醫的,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,,15,第一節 處方箋釋出,第一款 一般處方箋,,保

7、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,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,,1

8、7,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

9、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

10、、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

11、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、未經核准擅自輸入之藥品。但旅客或隨交通工具服,務人員攜帶自

12、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,NABP 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. territories, nine Canadia

13、n provinces, and two Australian states make up the association membership.,,National Association of Boards of Pharmacy,®,(NABP,®,),,,25,,,,,National 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.,,,26,,,,,National Association of Boards of Pharmacy,®,(NABP,®,),National Association of Boards of Pharmacy®,1600 Feehanville Dri

15、ve • Mount Prospect, IL 60056,Tel: 847/391-4406         Fax: 847/391-4502  Carmen A. Catizone, MS, RPh, DPh, Executive Director/Secretary,,27,,,,,Verified Internet Pharmacy Practice Sites,™,(VIPPS,®,),,,28,In response to public concern of the safety of pharmacy practices on the Internet, the,Associ

16、ation developed the Verified Internet Pharmacy 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

17、 follow.,(VIPPS,®,),,29,To be VIPPS accredited, 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

18、,patient rights to,,privacy,,,authentication and security of prescription orders,, adherence to a recognized,quality assurance policy,, and provision of,meaningful consultation,between patients and pharmacists.,(VIPPS,®,),,30,VIPPS pharmacy sites are identified by the VIPPS hyperlink seal displayed

19、on their Web sites. By clicking on the seal, a visitor is 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,®,

20、),,32,NABP has reviewed numerous Web sites selling prescription medicine and has created three categories to help patients make informed choices:,,(VIPPS,®,),,33,Recommended Internet Pharmacies:,NABP recommends that patients use sites accredited through the,Verified Internet Pharmacy Practice Sites™

21、,(VIPPS®) program. These sites have undergone and successfully completed the rigorous 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 f

22、acilities used by the site to receive, review, and dispense medicine.,,(VIPPS,®,),,34,Reviewed 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 pharma

23、cy practice standards. NABP advises patients to use these sites with caution, as information 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 wit

24、h state and federal laws or NABP criteria, for example, dispensing medicine without a valid 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,®,),,35,Not Recommended Sites,:,These Int

25、ernet drug outlets appear to be out of compliance with state and federal laws or NABP patient safety and pharmacy practice standards.,(VIPPS,®,),,36,A federal judge in Chicago, IL, has shut down a worldwide spam operation soliciting Web sites selling prescription medications illegally, ABC News repo

26、rted on October 14, 2021. The newscast, available on the ABC Web site under the headline “Authorities 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 estab

27、lished patient safety and pharmacy practice standards. A similar newscast also appeared October 14 on 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 Newscasts Feature NABP,,37,Recommended Internet Pharmacies,,38,Wha

28、t are the dangers of obtaining a prescription for medicine over the Internet?,,,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 prescri

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

30、 the patient in-person.,Completing 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 medic

31、al condition to be overlooked or misdiagnosed.,,Buying Medicine Online,,39,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 medi

32、cines.,For this reason, it is important to discuss taking prescription medicine with a doctor who is familiar with your medical history and has performed an in-person examination.,Buying Medicine Online,,40,Questionable professional practices:,Many Internet drug outlets operate,without a license,or

33、in,conflict with the laws and regulations,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

34、 ordered,, or that the site operators,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 Online,,41,Risk to personal, medical, or financia

35、l information:,Many illegitimate Internet 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 ill

36、egitimate prescribing outlets frequently sell 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 schem

37、es.,,Buying Medicine Online,,42,Counterfeit drugs:,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

38、 of legitimate drug sales, estimated at 13% 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 cr

39、ude mixtures of glue, chalk, and sugar to nearly 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

40、 not receive the benefits of the medicine you need, but you also could place your health at risk from unsafe ingredients.,Buying Medicine Online,,43,No prescription required,,Prescription based solely upon online questionnaire,,No phone number or street address,,No pharmacist consultation,,Waivers,,

41、Limited medicines,,International Web sites,,Spam solicitations,,What are the signs of a questionably operating Internet drug outlet?,,44,Avoid Counterfeit Drug Scams,,,45,Avoid Counterfeit Drug Scams Counterfeit Drug Facts,An estimated 1-2% of drugs in North America are fraudulent,Worldwide drug cou

42、nterfeiting is a $32 billion business,Worldwide 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 increas

43、ing at nearly twice the pace of legitimate 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 a

44、nd sugar to nearly exact chemical replicas 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 dru

45、gs purchased at reputable pharmacies to be counterfeit,Avoid Counterfeit Drug Scams,,46,Licensure and Residency,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 pharm

46、acy in all applicable jurisdictions.,The pharmacy, in accordance with applicable state and federal laws and regulations, must not be or not have been subject to significant disciplinary action.,The pharmacy, in accordance with applicable state and federal laws and regulations, must be registered wit

47、h the US,Drug Enforcement Administration (DEA),if dispensing,controlled substances,.,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,,,47,Prescriptions,The ph

48、armacy, in accordance with applicable state and 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 h

49、ave been established: a) The patient has a legitimate,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 approv

50、ed by the appropriate Practitioner Board; and c) Some logical connection exists between the medical complaint, the medical history, and the physical examination and the drug prescribed.,The pharmacy, in accordance with applicable state and federal laws and regulations, must adhere to the Federal Con

51、trolled Substances Act and DEA rules regarding prescriptions for,controlled substances,, including but not limited to the following: a) Prescriptions for Schedule II controlled substances must be provided in writing by the prescriber; b) Prescriptions for Schedule III - V controlled substances must

52、be provided in writing by the patient or prescriber, or verbally or by facsimile by the prescriber; c) Schedule II controlled substance prescriptions may not be refilled; a new prescription must be issued for each quantity of the substance.,,Program Criteria: Patient Safety and Pharmacy Practice Sta

53、ndards,,48,Prescriptions,The pharmacy, in accordance with applicable state and federal laws and regulations, must,not,dispense or offer prescriptions originating from,telephonic, electronic, or online medical consultations without a pre-existing patient-prescriber relationship,that has included a fa

54、ce to face physical examination.,The pharmacy, in accordance with applicable state and federal laws and regulations, must,not,offer to dispense or dispense medications that have not been approved by the US Food and Drug Administration (FDA).,Program Criteria: Patient Safety and Pharmacy Practice Sta

55、ndards,,49,Patient Privacy,The pharmacy, in accordance with applicable state and federal laws and regulations, must maintain a,secure Web site and ensure patient identifiable information,and prescription transactions are encrypted per industry standards.,The pharmacy, in accordance with applicable s

56、tate and federal laws and regulations, must have and provide patients with a Notice of Privacy Practices for Protected Health Information, as required by the HIPAA Privacy Rule (45 CFR 164.520).,Program Criteria: Patient Safety and Pharmacy Practice Standards,,50,Patient Services,The pharmacy must p

57、rovide, on the Web site,,a 24-hour toll free number,for patients who experience or believe they have experienced an,adverse event involving their medication.,The pharmacy must provide, on the Web site, the US,street address of the pharmacy,that dispenses prescription medications on behalf of (or thr

58、ough) the Web site.,The pharmacy must provide, on the Web site, the US street address of the site’s corporate,headquarters or primary place of business.,The pharmacy must provide, on the Web site, instructions to patients describing how to submit complaints or concerns.,The pharmacy must offer,pharm

59、acist medication consultation,via secure means through the Web site, via telephone, or in person for walk-in patients.,Program Criteria: Patient Safety and Pharmacy Practice Standards,,51,Professional Practices,The pharmacy must attest and provide documentation to NABP that it obtains medications,fr

60、om US licensed wholesale drug distributors and/or US licensed or FDA registered pharmaceutical,,manufacturers.,The pharmacy must maintain a currently registered domain name.,Program Criteria: Patient Safety and Pharmacy Practice Standards,,52,Upon receipt of the application form and supporting docum

61、entation, NABP staff will:,Verify all necessary state pharmacy licenses are in good standing;,Verify the pharmacist-in-charge licenses are in good standing;,Evaluate the submitted supporting documents; and,Notify the applicant if discrepancies arise or clarification is needed.,,Accreditation Process

62、,,,53,After review of the documentation, staff schedules an on-site survey of the pharmacy to evaluate the applicant's operations, policies and staff for compliance with the VIPPS criteria.surveys may be required:,Upon notice of a complaint against a VIPPS-accredited pharmacy.,At the request of a p

63、articipant in the course of VIPPS accreditation suspension action.,Re-surveys of VIPPS-accredited pharmacies are required,once every three years,.,,Accreditation Process,,,54,Following review of the application materials, verification of submitted information and licensure, and survey, a written rep

64、ort will be sent to the pharmacy. If the review is satisfactory, a recommendation to award accreditation is submitted to,NABP’s accreditation committee,. Upon accreditation approval,,a VIPPS Letter of Agreement,to be signed by an authorized representative or agent of the entity will be sent to the p

65、harmacy.,,Accreditation Process,,,55,Upon receipt of the executed Letter of Agreement and fee, NABP releases a code to the applicant which allows access to a secure area of the VIPPS Web site where the applicant may retrieve and download their,VIPPS hyperlink Seal,and carry out other administrative

66、functions. Guidelines for the use of the Seal are included in the Letter of Agreement.,The VIPPS,accreditation is renewable annually,following an update of the registration information and re-verification of licensure status.,,Accreditation Process,,,56,只要善用網路特性及便利性，網路藥局不但可提供慢性病人另一個取藥、服務窗口，也可加速醫藥分業落實,,台灣網路購買處方藥之未來建議,,57,為了開放民眾上網買藥，美國目前採VIPPS 制度〔網路藥局認證規範〕，即網路藥局必須先向主管機關申請，獲得認證後，才能在網路上提供民眾購藥服務；英國、德國計畫跟進，以認證制管理網路藥局。,台灣網路購買處方藥之未來建議,,58,以臺灣的網路藥局為例，按照現有醫療相關法規，只再配合電子簽章法，提供專業人員電子憑證，網路藥局即可如一般藥局，由專業人員執業，提供