IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines. On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. 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 Workshop
Taiwan
6 February 2015

2. Sheuan Lee RN, Ph.D (李選博士)
• ICN Board of Director (2013-2017)
• Minister without portfolio in Examination
Yuan, ROC (2008-2020)(考試院考試委員)
• Professor at the School of Nursing of
Chung Shan Medical University, Taiwan,
ROC (since 2001 till present)(中山醫學大學教授)
• Board Director of the Taiwan Nurses
Association (since 1989 till present)
(台灣護理學會理事)
• Standing Board Director of the Taiwan
Nursing Management Association (since
2011till present)
(台灣護理管理學會常務理事)

3. Brief Introduction to ICN
• ICN is a federation of 135
national nurses associations
(NNAs), representing the
more than 16 million nurses
worldwide.
• ICN was founded in 1899.
• ICN is the world’s 1st and
widest reaching
international organization
for health professionals.
• It operated by nurses and
leading nurses
internationally.
• 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

4. • ICN works to ensure
quality nursing care for
all, sound health
policies globally, the
advancement of
nursing knowledge, and
the presence worldwide
of a respected nursing
profession and a
competent and satisfied
nursing 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

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

6. • 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

7. 2014 ICN President met President Ma
(2014年ICN理事長晉見馬總統)

8. Introduction to the topic (主題簡介)
• In a 2004 Gallup survey on
the honesty and ethical
standards of various
professions, nurses topped the
list for the fifth year out of six.
• But public confidence in
health care professionals and
health systems is being
eroded by counterfeit
medicines.
• Patient health is being put at
risk and ICN strongly believe
that 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

9. • Counterfeit medicines are
unsafe and ineffective.
• They result in wasted
resources spent on
purchasing, inventory,
transport and dispensing
with little or no effect or
even with disastrous
patient outcomes such as
poisoning, disability and
death.
•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

10. ICN
Position
• ICN takes falsified medicines VERY
seriously. (ICN對偽藥議題極重視)
• ICN have been campaigning and
lobbying for increased vigilance and
control 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 for
Patient Safety: Targeting Counterfeit
and Substandard Medicines is the
launch and centrepiece of an ICN led
multi-sector campaign including other
health 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 IND
theme of Nurses
(2005年國際護士節
活動主題)

11. • Nurses are on the frontlines of
health, administering and often
prescribing medicines, particularly
in primary health care settings.
• Nurses are well positioned to
monitor drug effects and side
effects and must be vigilant for
signs of counterfeiting such as
improper packaging and labelling.
• Nurses also have a key role in
educating the public about the
dangers of buying medicines
through the Internet or on the
streets from unauthorized sources.
• Patients have trust and confidence
in nurses; it is nurses’ duty to
uphold 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

12. • By targeting counterfeit
medicines, nurses can help
ensure the safety of patients
and restore the public’s trust
in health care systems.
• ICN is working closely with
other health professional
organisations, with patient
organisations, pharmaceutical
companies and other
stakeholders to address this
threat to patient safety.
• This is an agenda that we all
share and an issue that
requires 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

13. • My esteemed colleagues here from
Retina Hong Kong and Pfizer will
shortly be giving you the
perspective of patients and the
pharmaceutical industry.
• I would like to concentrate on the
critical frontline role that nurses
and other healthcare professionals
play in increased vigilance,
reporting and raising awareness.
• And I would like to highlight the
need for collaboration between all
health professionals, the public,
governments, pharmaceutical
manufacturers and drug
regulatory 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

14. • As health professionals, we
are all concerned with the
growing problem of
counterfeit medicines and
the negative consequences
on the prevention and
treatment of disease,
which can include poor
treatment outcomes or
failure of treatment, loss of
confidence in healthcare,
resistance to antibiotics
and poisoning due to
harmful 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，

15. • Counterfeit medicines are
unsafe and ineffective, fail to
treat or prevent the intended
disease and can even cause harm
to the patient.
• In fact, fake tuberculosis and
malaria drugs alone are
estimated to KILL 700
THOUSAND PEOPLE A YEAR!
• In addition, fake medicines are
among the main cause of
antimicrobial resistance in
infectious diseases such as
tuberculosis.
•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

16. • Resistance to antibiotics flourishes
wherever they are abused, misused
or dispensed at levels lower than
recommended treatment guidelines.
• The consequences of antimicrobial
resistance are serious.
• Infections caused by resistant
microbes fail to respond to
treatment, resulting in prolonged
illness and greater risk of death.
• Treatment failures also lead to
longer periods of infectivity, which
increase the number of infected
people in the community and thus
expose the general population to the
risk of contracting a resistant strain
of 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

17. • When infections become
resistant to first-line
antimicrobials because of
counterfeit products or other
factors, treatment has to be
switched to second- or third-line
drugs, which are almost always
much more expensive and
sometimes more toxic as well.
• In many countries, the cost of
such replacement drugs is very
high and further encourages
fraudulent manufacturing of
counterfeit medicines, which are
sold 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

18. HCPs at the frontlines
• Healthcare professionals are
crucial to combating
counterfeit medical products.
• Now more than ever, health
professionals need to consider
counterfeit medicines as a
reason for non-response or
unexpected response to
treatment.
(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

19. • As health professionals,
we have a responsibility
to ensure that our
patients receive safe and
appropriate medications.
• We must let patients and
the public know the
importance of only
buying their medicines
from known and reliable
sources.
•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

20. • By visual inspections, nurses,
pharmacists, physicians and
dentists who are constantly
in contact with medicines
and medical devices may be
able to detect anomalies in
the physical appearances of
medical products and
trigger investigation.
• We need to be alert for any
signs of visual signs of drug
counterfeiting such as
integrity of packaging,
labelling and description of
dosage.
•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

21. • Of course, HCPs also need to
be constantly alert to
changes in the overall
condition of patients, their
response to treatment and
any signs of toxicity or
overdose, and then take
appropriate and timely
action.
• For example, we need to be
on 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

22. • the medicine prescribed has no effect;
• the medicine prescribed has an effect
that is different to the expected
outcome;
• the medicine package was not intact,
e.g. not properly sealed, blurred
expiry date etc.;
• the medicine has a different
consistency or appearance than
usual;
• the patient reports to the nurse that
the medicine has a different taste,
consistency or appearance than
usual.
•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

23. • It is nurses responsibility to
use only authorised sources
of drug supply, and to
document and report all
incidents or suspicions about
the drugs to the appropriate
regulatory authorities, police
and/or customs services in
our countries.
• This is part of our wider
public health responsibilities
as well as a real example of
fulfilling our duty of care to
the 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

24. • This is a tall order for busy
professionals who don’t
necessarily want to get
involved in bureaucracy.
• So we need to make it a
simple process and one that is
valued.
• This means of course that
health systems must invest in
continuous training so that
all health professionals are
mobilised 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

25. Creating Public
Awareness
• Patients and consumers are
the primary victims of
counterfeit medicines.
• In order to protect them
from the harmful effects of
counterfeit medicines,
nurses and other health
professionals can provide
them with appropriate
information and education
on signs and consequences
of 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

26. • They also have a key role
in educating the public on
the dangers of buying
medicines from
unauthorized sources,
such as the internet and
marketplace.
• Nurses and other health
workers can help by
lobbying for accessible
costs for medicines and
health 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

27. • Patients and consumers
expect to get advice from
national authorities, health
professionals and others on
where they should buy or
obtain their medicines; and
what measures they should
take in case they come across
counterfeit medicines or are
affected by the use of such
medicines.
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

28. Working with Industry
• It is vital that HCPs work together
with governments, pharmaceutical
manufacturers and drug regulatory
authorities. More specifically, we need
to support actions that aim to:
• Strengthen quality assurance and
regulatory authorities;
• Detect and expose sources of
counterfeit medicines;
• Improve supply of medicines to health
facilities;
• Educate health professionals in
detection and prevention of counterfeit
medicines; and
• Educate and create awareness of
counterfeit medicines amongst the
public.
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

29. Addressing the Challenges
How do we address the counterfeit
challenge?
• The first step is by working
together – now and in the long term.
We need a system-wide effort
involving all players, and a long-
term view to solutions.
• This global and deadly phenomenon
of counterfeit medical products will
only be eradicated through an
agreed framework of effective
coordination, cooperation and action
at the global level.
Patient
Government HCP
& NGO
Manufacturers
挑戰
建立全球協商
與合作體系

30. • ICN is committed to
ensuring access to safe
medicines.
• In 2005 along with our
partners at the World
Health Professions Alliance,
we launched a global anti-
counterfeiting campaign,
called Be Aware Take
Action.
•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

31. The campaign aims to
1. Increase awareness of the
existence and consequences of
counterfeit medicines.
2. Provide tools to identify
counterfeit drugs and to
report any suspicious
medicines.
3. Sensitise the public, and
4. Encourage nurses and other
health professionals to lobby
governments and regulatory
authorities for attention to the
existence and dangers of
counterfeit and substandard
medicines.
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)

32. • That same year ICN also produced
a toolkit for nurses, called
Counterfeits Kill, to help them
identify and report on fake drugs,
and we participated in an Interpol
Conference to discuss policy and
action.
• We also launched a new initiative
against counterfeit medicines in
partnership with the International
Federation of Pharmaceutical
Manufacturers and Associations,
the Pharmaceutical Security
Institute and the International
Alliance 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

33. • In 2009, in partnership
with the World
Medical Association
and the African
Pharmaceutical Forum,
we produced a
speaking book on the
safe use of medicines
which provides critical
health care education
to low literacy
communities.
•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

34. • Safe Medicines regional
workshops were held in
Costa Rica and Nigeria
in 2010, and in the Czech
Republic and Taiwan in
2011.
• The World Health
Professions Alliance has
also briefed UN Missions
on this topic and made
interventions at the
World 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

35. • In 2013, ICN joined the
Fight the Fakes multi-
stakeholder campaign that
aims to raise awareness
about the dangers of fake
medicines by giving a voice
to those who have been
personally impacted and
shares the stories of those
working to put a stop to this
threat 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

36. • Our aim is to put the issue
of safe medicines on
everyone’s agenda.
• But there is no doubt that
front line vigilance is
essential for patient and
population health and it is
up to all health care
professionals to remain
vigilant and to lobby for
safe 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.