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DRUG SAFETY LABELING ISSUES IN CHINA

DRUG SAFETY LABELING ISSUES IN CHINA. DA-YOU WANG, DIRECTER PHARMACIST HUA SHAN HOSPITAL FUDAN UNIVERSITY MAY 2011 | BEIJING, CHINA. Outline. 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

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DRUG SAFETY LABELING ISSUES IN CHINA

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  1. DRUG SAFETY LABELING ISSUES IN CHINA DA-YOU WANG, DIRECTER PHARMACIST HUA SHAN HOSPITAL FUDAN UNIVERSITY MAY 2011 | BEIJING, CHINA

  2. Outline 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

  3. 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 www.diahome.org

  4. 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. www.diahome.org

  5. 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. www.diahome.org

  6. Drug labeling is an important tool for PV Definition of pharmacovigilance (WHO): So, drug labeling is an important tool for pharmacovigilance.

  7. ISSUES OF DRUG SAFETY LABELING IN CHINA 2. 中国市场药品说明书 安全信息的问题 2. Drug Information Association www.diahome.org 7

  8. 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more difficult to locate • Did not facilitate finding answers to specific questions • Omit important content, Keep the outdated on • Concept error or Mistake in translation • Poor Chinese grammar

  9. 1.Omitimportant; Keep the outdated on • 遗漏重要的安全性信息； 保留过时的信息 www.diahome.org

  10. Chinese edition of levofloxacin Outdated information !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. www.diahome.org

  11. 2.Adverse events， which the placebo rate equals or exceeds the rate for the drug are stillincluded 2.等于或低于安慰剂组发生率的不良事件仍列入 www.diahome.org

  12. Losartan potassium tablets Last revised date: May 13,2010 www.diahome.org

  13. 3.Lengthyandtedious;Slips;Concept error or mistake in translation 3.冗长、繁复； 　编写粗枝大叶； 　概念错误或翻译出错 www.diahome.org

  14. 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? www.diahome.org

  15. 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 ! www.diahome.org

  16. 3. 3. 说明书安全信息的评议 COMMENTS AND SUGGESTIONS ON SAFETY INFORMATION LABELING

  17. 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. www.diahome.org

  18. ADVERSE REACTIONS, WARNING AND PRECAUTION sectionsinclude only information that would be useful to health care practitioners making treatment decisions and monitoring and advising patients. www.diahome.org

  19. 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. www.diahome.org

  20. 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. www.diahome.org

  21. Thank you ! www.diahome.org

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