Transcript Slide 1

DRUG SAFETY LABELING
ISSUES IN CHINA
DA-YOU WANG, DIRECTER PHARMACIST
HUA SHAN HOSPITAL
FUDAN UNIVERSITY
MAY 2011 | BEIJING, CHINA
Outline
1.
DRUG SAFETY INFORMATION LABELING IS AN
INPORTANT TOOL OF PHARMACOVIGILANCE
药品说明书安全信息的编写是药物警戒的重要手段
2.
ISSUES OF SAFETY INFORMATION LABELING IN
CHINA
中国市场药品说明书的一些问题
3.
COMMENTS AND SUGGESTIONS ON SAFETY
INFORMATION LABELING
药品说明书安全信息的评论和建议
1. DRUG SAFETY INFORMATION
LABELING IS AN INPORTANT TOOL
OF PHARMACOVIGILANCE
药品说明书安全信息的编写是药物警
戒的重要手段
Drug Information Association
www.diahome.org
3
1.
Principle of communicating drug information:
• Drug information directed to the public
in whatever form should be balanced
with respect to risks and benefits.
• Drug safety information should be
ethically and effectively communicated
in both content and method.
Drug Information Association
www.diahome.org
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What is the function of drug product labeling ?
• Drug product labeling summarizes the
essential scientific information needed for
the safe and effective use of the drug.
• Compliance with product labeling is
expected to enhance the safe and effective
use and reduce the number of adverse
events resulting from medication errors due
to misunderstood or incorrectly applied drug
information.
Drug Information Association
www.diahome.org
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Drug labeling is an important tool for PV
• Definition of pharmacovigilance (WHO):
• So, drug labeling is an important tool for
pharmacovigilance.
2.
2. 中国市场药品说明书
安全信息的问题
ISSUES OF DRUG SAFETY
LABELING IN CHINA
Drug Information Association
www.diahome.org
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Drug Labeling Issues in China
•
•
•
•
Increased in length, detail, and complexity
Did not identify any recent change to the labeling
Made specific information more difficult to locate
Did not facilitate finding answers to specific
questions
• Omit important content, Keep the outdated on
• Concept error or Mistake in translation
• Poor Chinese grammar
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1.Omit important;
1. 遗漏重要的安
全性信息；
Keep the outdated
on
保留过时的信息
Drug Information Association
www.diahome.org
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Chinese edition of
levofloxacin
Outdated information !
Omit major safety
information:
•Anaphylactic reactions,
serious, occasionally
fatal, may occur.
•Prolongation of the QT
interval and torsade de
points have been
reported. Avoid use in
patient with known
prolongation, with
hypokalemia, and with
other drugs that
prolong the QT interval.
Drug Information Association
www.diahome.org
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2.Adverse events，
which the
placebo rate
equals or
exceeds the rate
for the drug are
still included
Drug Information Association
2. 等于或低于安
www.diahome.org
慰剂组发生率
的不良事件仍
列入
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Losartan potassium tablets
Last revised date: May 13,2010
Losartan potassium tablets
(n=2085)
Placebo (n=535)
Abdominal 腹痛
1.7
1.7
Asthenia/fatigue
3.8
3.9
Chest pain 胸痛
1.1
2.6
Oedema/swelling
1.7
1.9
Tachycardia 心动过速
1.0
1.7
Diarrhea 腹泻
1.9
1.9
Dyspepsia 消化不良
1.1
1.5
Nausea 恶心
1.8
2.8
muscular spasm
1.0
1.1
Headache 头痛
14.1
17.2
Pharyngitis 咽炎
1.5
2.6
Nasal sinuses disorder
1.0
1.3
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乏力/疲劳
水肿/肿胀
肌肉痉挛
Drug Information Association
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鼻窦疾病
3. Lengthy and
tedious;
Slips;
Concept error or
mistake in
translation
Drug Information Association
3. 冗长、繁复；
编写粗枝大叶；
概念错误或翻译
出错
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Last revised date:
Aug. 17, 2010
Risperidone tablets
？Poor
Chinese
表1在双盲、安慰剂对照试验中，不少于1%
的利培酮组成年患者报告的不良反应(ADR)
发生频率在2次及以上的不良反应
Frequency 2 times?
???
Risperidone
≤8mg/d
(n=853)
%
Risperidone
>8-16mg/d
(n=198)
%
Drug Information Association
Risperidone
(n=687)
%
www.diahome.org
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Incidence can
be derived from
reporting rate?
表5 依据自发报告频率，利培酮
上市后的不良反应按发生率分类
AR Section occupies
over 60% space of
the label !
Drug Information Association
www.diahome.org
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3.
3. 说明书安全信息的评议
COMMENTS AND SUGGESTIONS
ON SAFETY INFORMATION LABELING
• Confusing medical information and
flaws in drug safety communication at
all levels of society can lead to
mistrust, misinformation and
misguided actions resulting in harm,
and to create the climate where drug
safety data may be hidden, withheld, or
ignored.
Drug Information Association
www.diahome.org
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• ADVERSE REACTIONS, WARNING AND
PRECAUTION sections include only
information that would be useful to
health care practitioners making
treatment decisions and monitoring
and advising patients.
Drug Information Association
www.diahome.org
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• Listing events should be some basis to
believe there is a causal relationship
between the drug and the event.
• Lengthy lists of adverse events
unlikely to have been caused by the
drug are of little or no value to
prescribers, and therefore also will lead
mistrust.
Drug Information Association
www.diahome.org
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Safety information suggestions
• A detailed standard concerning
“Content and Format of Labeling for
Human Prescription Drug Products,"
should be developed in China, which
should also include A HIGHLIGHTS
SECTION, to help health care
practitioners easily find, read, and
convey information important for safe
use of the prescription.
Drug Information Association
www.diahome.org
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Drug Information Association
www.diahome.org
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