Practices and Technologies for Prevention,Detection, Control and Monitoring

of fake medicines: Perspective of HCPs

(預防、偵測、控制與監督偽藥:醫事人員觀點)

Sheuan Lee, RN, Ph.D (李選博士)

ICN Board of Directors (ICN理事)

International Council of Nurses

IFPMA Counterfeit WorkshopTaiwan6 February 2015

Sheuan Lee RN, Ph.D (李選博士)

• ICN Board of Director (2013-2017)

• Minister without portfolio in ExaminationYuan, ROC (2008-2020)(考試院考試委員)

• Professor at the School of Nursing ofChung Shan Medical University, Taiwan,ROC (since 2001 till present)(中山醫學大學教授)

• Board Director of the Taiwan NursesAssociation (since 1989 till present)(台灣護理學會理事)

• Standing Board Director of the TaiwanNursing Management Association (since2011till present)(台灣護理管理學會常務理事)

Brief Introduction to ICN

• ICN is a federation of 135national nurses associations(NNAs), representing themore than 16 million nursesworldwide.

• ICN was founded in 1899.

• ICN is the world’s 1st andwidest reachinginternational organizationfor health professionals.

• It operated by nurses andleading nursesinternationally.

• ICN 為擁有135個護理學會的國際組織，代表全球1600萬位護士

• ICN 於1899年成立

• ICN 是全球第一個與最大的國際醫事人員組織

• ICN由護士主導，引領全球護理專業發展

• ICN works to ensurequality nursing care forall, sound healthpolicies globally, theadvancement ofnursing knowledge, andthe presence worldwideof a respected nursingprofession and acompetent and satisfiednursing workforce.

•ICN 的執掌在確保護理照護品質，為全球醫療政策發聲，提升護理專業知識，向全球展現護理專業受尊重與擁有效能與滿意的護理力量

Board of directors 2013-2017(2013-2017年理事會)

• Judith Shamian President (Canada)

Masako Kanai-Pak 1st Vice-President (Japan)

Bagooaduth Kallooa 2nd Vice-President (Mauritius)

Annette Kennedy 3rd Vice-President (Ireland)

• Members (12)Marlen Calvo Solano (Costa Rica)

Elsa B. Friðfinnsdóttir (Iceland)

Sheuan Lee (Taiwan)

Ioannis Leontiou (Cyprus)

Elba Olivera Choque (Bolivia)

Jürgen Osterbrink (Germany)

Paul Pace (Malta)

Peter Požun (Slovenia)

Eva Reyes Gómez (Mexico)

Marlene Smadu (Canada)

Pierre Théraulaz (Switzerland)

Jintana Yunibhand (Thailand) 2014 Board Meeting

2014 ICN President met President Ma(2014年ICN理事長晉見馬總統)

Introduction to the topic (主題簡介)

• In a 2004 Gallup survey onthe honesty and ethicalstandards of variousprofessions, nurses topped thelist for the fifth year out of six.

• But public confidence inhealth care professionals andhealth systems is beingeroded by counterfeitmedicines.

• Patient health is being put atrisk and ICN strongly believethat the time to act.

•2004年蓋洛普調查各專業的誠實與倫理標準排名中， 6年中有5年護士上榜

•但因偽藥議題使醫事人員與衛生體系的公共信賴度受損

•病患健康身陷危險，ICN堅信是提出行動的時刻

• Counterfeit medicines areunsafe and ineffective.

• They result in wastedresources spent onpurchasing, inventory,transport and dispensingwith little or no effect oreven with disastrouspatient outcomes such aspoisoning, disability anddeath.

•偽藥不安全且無療效

•偽藥導致資源浪費在毫無成效中的購買、存貨、運送與配置，甚至對病患造成災難，如中毒、失能與死亡

ICNPosition

• ICN takes falsified medicines VERYseriously. (ICN對偽藥議題極重視)

• ICN have been campaigning andlobbying for increased vigilance andcontrol of these substances since 2005.

• (ICN自2005年為控制偽藥與增加警覺而參與運動與遊說)

• In 2005, IND theme of Nurses forPatient Safety: Targeting Counterfeitand Substandard Medicines is thelaunch and centrepiece of an ICN ledmulti-sector campaign including otherhealth professions, patient groups,industry and regulators.

(ICN領導其他專業團體、病患、製造商與政策制定者參予活動)

2005 INDtheme of Nurses(2005年國際護士節

活動主題)

• Nurses are on the frontlines ofhealth, administering and oftenprescribing medicines, particularlyin primary health care settings.

• Nurses are well positioned tomonitor drug effects and sideeffects and must be vigilant forsigns of counterfeiting such asimproper packaging and labelling.

• Nurses also have a key role ineducating the public about thedangers of buying medicinesthrough the Internet or on thestreets from unauthorized sources.

• Patients have trust and confidencein nurses; it is nurses’ duty touphold that trust.

•護士在臨床第一線發藥

•護士能觀測藥物作用與副作用，及藥物包裝

•護士可以教育社會買偽藥的危險

•病患信賴護士，護士有責任承擔此職

• By targeting counterfeitmedicines, nurses can helpensure the safety of patientsand restore the public’s trustin health care systems.

• ICN is working closely withother health professionalorganisations, with patientorganisations, pharmaceuticalcompanies and otherstakeholders to address thisthreat to patient safety.

• This is an agenda that we allshare and an issue thatrequires joint action.

•護士能協助確保病患的安全與恢復社會對健康照護體系之信賴

•ICN 以病患安全為主軸，與各醫事團體、病患組織、藥商與權益保障者密切合作

•列舉ICN分享及參予有關活動

• My esteemed colleagues here fromRetina Hong Kong and Pfizer willshortly be giving you theperspective of patients and thepharmaceutical industry.

• I would like to concentrate on thecritical frontline role that nursesand other healthcare professionalsplay in increased vigilance,reporting and raising awareness.

• And I would like to highlight theneed for collaboration between allhealth professionals, the public,governments, pharmaceuticalmanufacturers and drugregulatory authorities.

•之後，我的同事會由病患與藥商的角度分享

•我將焦點置於護士與醫事人員於第一線所扮演的角色，以提高大家的警覺

•我也將強調需要醫事人員、社會、政府、藥商與政策制定者之通力合作

• As health professionals, weare all concerned with thegrowing problem ofcounterfeit medicines andthe negative consequenceson the prevention andtreatment of disease,which can include poortreatment outcomes orfailure of treatment, loss ofconfidence in healthcare,resistance to antibioticsand poisoning due toharmful ingredients.

•所有醫事人員關切偽藥問題之日益嚴重，及其在預防疾病、治療無效、產生抗藥性或中毒等層面產生的負向結果，

• Counterfeit medicines areunsafe and ineffective, fail totreat or prevent the intendeddisease and can even cause harmto the patient.

• In fact, fake tuberculosis andmalaria drugs alone areestimated to KILL 700THOUSAND PEOPLE A YEAR!

• In addition, fake medicines areamong the main cause ofantimicrobial resistance ininfectious diseases such astuberculosis.

•偽藥既不安全且無效、預防與治療失敗，甚至造成病患傷害

•僅是治療結核與瘧疾的偽藥預估一年殺死70萬人

•此外，偽藥會造成感染疾病如結核的抗藥性

• Resistance to antibiotics flourisheswherever they are abused, misusedor dispensed at levels lower thanrecommended treatment guidelines.

• The consequences of antimicrobialresistance are serious.

• Infections caused by resistantmicrobes fail to respond totreatment, resulting in prolongedillness and greater risk of death.

• Treatment failures also lead tolonger periods of infectivity, whichincrease the number of infectedpeople in the community and thusexpose the general population to therisk of contracting a resistant strainof infection.

•偽藥因濫用或過量使用會產生對抗生素的抗藥性

•抗感染與抗藥性的結果是很嚴重的，增加感染、治療無效、延長疾病與增加死亡風險

•以上問題也會增加社會受感染的機會

• When infections becomeresistant to first-lineantimicrobials because ofcounterfeit products or otherfactors, treatment has to beswitched to second- or third-linedrugs, which are almost alwaysmuch more expensive andsometimes more toxic as well.

• In many countries, the cost ofsuch replacement drugs is veryhigh and further encouragesfraudulent manufacturing ofcounterfeit medicines, which aresold at cheaper prices.

•當偽藥導致第一線抗生素產生抗藥性，需使用第二線或第三線藥物，藥物更貴與毒性更強，感染問題難以掌控

•許多國家代替藥物的價格很高，致使偽藥製造商販售價格便宜藥物

HCPs at the frontlines

• Healthcare professionals arecrucial to combatingcounterfeit medical products.

• Now more than ever, healthprofessionals need to considercounterfeit medicines as areason for non-response orunexpected response totreatment.

(醫事人員需要考量治療無效與偽藥有關)

醫事人員對抗偽藥扮演極重要之角色

• As health professionals,we have a responsibilityto ensure that ourpatients receive safe andappropriate medications.

• We must let patients andthe public know theimportance of onlybuying their medicinesfrom known and reliablesources.

•醫事人員有責任確保病患接受安全與適當的治療

•我們必須讓病人與社會了解購買可靠來源藥物之重要性

• By visual inspections, nurses,pharmacists, physicians anddentists who are constantlyin contact with medicinesand medical devices may beable to detect anomalies inthe physical appearances ofmedical products andtrigger investigation.

• We need to be alert for anysigns of visual signs of drugcounterfeiting such asintegrity of packaging,labelling and description ofdosage.

•護理師、藥師、醫師、牙醫師持續接觸藥物最能視覺檢測藥品外觀與包裝的異常，啟動調查

•我們應對偽藥的包裝、標籤、劑量等擁有高度的敏感性

• Of course, HCPs also need tobe constantly alert tochanges in the overallcondition of patients, theirresponse to treatment andany signs of toxicity oroverdose, and then takeappropriate and timelyaction.

• For example, we need to beon the look-out if:

•醫事人員應對病患之狀況、治療反應、毒性症候保持持續性了解，並採取適當的行動

•我們必須警覺

• the medicine prescribed has no effect;

• the medicine prescribed has an effectthat is different to the expectedoutcome;

• the medicine package was not intact,e.g. not properly sealed, blurredexpiry date etc.;

• the medicine has a differentconsistency or appearance thanusual;

• the patient reports to the nurse thatthe medicine has a different taste,consistency or appearance thanusual.

•處方藥物無效

•處方藥物的效果與期待結果不同

•藥物包裝有缺損或超出有效日期

•藥物包裝或外觀與過去不同

•病患告知藥物味道與外觀與過去不同

• It is nurses responsibility touse only authorised sourcesof drug supply, and todocument and report allincidents or suspicions aboutthe drugs to the appropriateregulatory authorities, policeand/or customs services inour countries.

• This is part of our widerpublic health responsibilitiesas well as a real example offulfilling our duty of care tothe individual.

•護理師有職責使用正規管道的藥物，若有任何可疑藥物或事件發生需要向各國法律規範的部門記錄與呈報

•這也是醫事人員的社會責任

• This is a tall order for busyprofessionals who don’tnecessarily want to getinvolved in bureaucracy.

• So we need to make it asimple process and one that isvalued.

• This means of course thathealth systems must invest incontinuous training so thatall health professionals aremobilised against counterfeits.

•對忙碌的醫事人員須簡化各種流程

•醫事人員亦須不斷接受對抗偽藥之訓練課程，動員起來對抗偽藥

Creating PublicAwareness

• Patients and consumers arethe primary victims ofcounterfeit medicines.

• In order to protect themfrom the harmful effects ofcounterfeit medicines,nurses and other healthprofessionals can providethem with appropriateinformation and educationon signs and consequencesof counterfeit medicines.

•病患與消費者是偽藥受害者

•為保護他們不售未要傷害，醫事人員應該提供給他們是當的資訊與教育他們未要產生的結果

增加社會警覺性

• They also have a key rolein educating the public onthe dangers of buyingmedicines fromunauthorized sources,such as the internet andmarketplace.

• Nurses and other healthworkers can help bylobbying for accessiblecosts for medicines andhealth care.

•教育民眾購買來源不明、網路或地攤藥物的危險性

•醫事人員可協助遊說最適當的藥物價格

• Patients and consumersexpect to get advice fromnational authorities, healthprofessionals and others onwhere they should buy orobtain their medicines; andwhat measures they shouldtake in case they come acrosscounterfeit medicines or areaffected by the use of suchmedicines.

病患與消費者期望由官方或專業者提供資訊，如何預防買到偽藥

Working with Industry

• It is vital that HCPs work togetherwith governments, pharmaceuticalmanufacturers and drug regulatoryauthorities. More specifically, we needto support actions that aim to:

• Strengthen quality assurance andregulatory authorities;

• Detect and expose sources ofcounterfeit medicines;

• Improve supply of medicines to healthfacilities;

• Educate health professionals indetection and prevention of counterfeitmedicines; and

• Educate and create awareness ofcounterfeit medicines amongst thepublic.

與製造商合作

•醫事人員應與政府、藥商與立法機構合作，共同支持以下的活動：

•強化品質保證與管理機制

•偵測與公佈偽藥來源

•改善醫療衛生機構藥品供應

•教育醫事人員偵測與預防使用偽藥

•教育社會增強對偽藥的警覺性

Addressing the Challenges

How do we address the counterfeitchallenge?

• The first step is by workingtogether – now and in the long term.We need a system-wide effortinvolving all players, and a long-term view to solutions.

• This global and deadly phenomenonof counterfeit medical products willonly be eradicated through anagreed framework of effectivecoordination, cooperation and actionat the global level.

Patient

Government HCP& NGO

Manufacturers

挑戰

建立全球協商與合作體系

• ICN is committed toensuring access to safemedicines.

• In 2005 along with ourpartners at the WorldHealth Professions Alliance,we launched a global anti-counterfeiting campaign,called Be Aware TakeAction.

•ICN 承諾確保安全藥物來源

•2005年與合作夥伴-全球醫事人員聯盟推動反偽藥活動

The campaign aims to1. Increase awareness of the

existence and consequences ofcounterfeit medicines.

2. Provide tools to identifycounterfeit drugs and toreport any suspiciousmedicines.

3. Sensitise the public, and

4. Encourage nurses and otherhealth professionals to lobbygovernments and regulatoryauthorities for attention to theexistence and dangers ofcounterfeit and substandardmedicines.

活動目標1. 增加對偽藥與影響

力之認識

2. 提供檢測偽藥工具與對可疑藥物報告

3. 增加社會敏感度

4. 鼓勵醫事人員向政府、法規制定者遊說此議題之危險)

• That same year ICN also produceda toolkit for nurses, calledCounterfeits Kill, to help themidentify and report on fake drugs,and we participated in an InterpolConference to discuss policy andaction.

• We also launched a new initiativeagainst counterfeit medicines inpartnership with the InternationalFederation of PharmaceuticalManufacturers and Associations,the Pharmaceutical SecurityInstitute and the InternationalAlliance of Patients’ Organisations.

•ICN同年製作護士工具組，稱為扼殺偽藥，協助護理師確認與呈報偽藥，ICN也參予政策制定研討會

•ICN發起與國際藥品製造商與相關學會、藥品安全機構與病患聯盟聯合抗偽藥活動

• In 2009, in partnershipwith the WorldMedical Associationand the AfricanPharmaceutical Forum,we produced aspeaking book on thesafe use of medicineswhich provides criticalhealth care educationto low literacycommunities.

•2009年ICN與世界醫學會、非洲藥學論壇聯合為教育低閱讀能力的社會出版：安全用藥口說書

• Safe Medicines regionalworkshops were held inCosta Rica and Nigeriain 2010, and in the CzechRepublic and Taiwan in2011.

• The World HealthProfessions Alliance hasalso briefed UN Missionson this topic and madeinterventions at theWorld Health Assembly.

• 2010年在哥斯大黎加與奈及利亞；2011年在捷克共和國、台灣舉辦區域性安全用藥工作坊

• 世界醫事人員聯盟也將聯合國使命與此議題的處置在世界衛生大會中提出

• In 2013, ICN joined theFight the Fakes multi-stakeholder campaign thataims to raise awarenessabout the dangers of fakemedicines by giving a voiceto those who have beenpersonally impacted andshares the stories of thoseworking to put a stop to thisthreat to public health.

• 2013 ICN 加入抗偽藥活動，目的是提升社會對偽藥產生危害的警覺性，及支持個人站出分享故事者發聲，以中止未要對社會健康產生之威脅

• Our aim is to put the issueof safe medicines oneveryone’s agenda.

• But there is no doubt thatfront line vigilance isessential for patient andpopulation health and it isup to all health careprofessionals to remainvigilant and to lobby forsafe medicines.

•ICN的目標是將安全用藥放在每人的議程中

•無疑的，病患、民眾與醫事人員的警覺性與遊說安全用藥是極為重要的

•感謝聆聽.