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 2. ISSUES OF SAFETY INFORMATION LABELING IN CHINA 3. COMMENTS AND SUGGESTIONS ON SAFETY INFORMATION LABELING 1.DRUG SAFETY INFORMATION LABELING IS AN INPORTANT TOOL OF PHARMACOVIGILANCE Drug Information Associationwww.diahome.org3 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. 1. Drug Information Associationwww.diahome.org4 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. What is the function of drug product labeling ? Drug Information Associationwww.diahome.org5 Drug labeling is an important tool for PV Definition of pharmacovigilance (WHO): So, drug labeling is an important tool for pharmacovigilance. ISSUES OF DRUG SAFETY LABELING IN CHINA 2. Drug Information Associationwww.diahome.org7 2.2. 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more difficult to locate Did not facilitate finding answers to specific questions Omit important content, Keep the outdated on Concept error or Mistake in translation Poor Chinese grammar 1.Omit important; Keep the outdated on 1. Drug Information Associationwww.diahome.org9 Drug Information Associationwww.diahome.org10 Chinese edition of levofloxacin Outdated information !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. 2.Adverse events which the placebo rate equals or exceeds the rate for the drug are still included 2. Drug Information Associationwww.diahome.org11 12www.diahome.orgDrug Information Association Losartan potassium tablets (n=2085) Placebo (n=535) Abdominal 1.7 Asthenia/fatigue / Chest pain Oedema/swelling / Tachycardia Diarrhea 1.9 Dyspepsia Nausea muscular spasm Headache Pharyngitis Nasal sinuses disorder Losartan potassium tablets Last revised date: May 13,2010 3. Lengthy and tedious; Slips; Concept error or mistake in translation 3. Drug Information Associationwww.diahome.org13 Drug Information Associationwww.diahome.org14 Risperidone tablets Last revised date: Aug. 17, 2010 Risperidone 8mg/d (n=853) % Risperidone >8-16mg/d (n=198) % Risperidone (n=687) % ??? 1 1% (ADR) Poor Chinese 2 Frequency 2 times? Drug Information Associationwww.diahome.org15 AR Section occupies over 60% space of the label ! 5 Incidence can be derived from reporting rate? 3. 3. 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 Associationwww.diahome.org17 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 Associationwww.diahome.org18 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 Associationwww.diahome.org19 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. Safety information suggestions Drug Information Associationwww.diahome.org20 Drug Information Associationwww.diahome.org21