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药品与人们的健康和生命息息相关,这一点,我们所有的医生和药师都了然于心。药品说明书担负着指导医生和患者安全用药的重要使命,这一点却常常被忽视。最近,SFDA下发的《药品说明书和标签管理规定》(征求意见稿)明确指出:药品说明书,是指药品生产企业印刷并提供的包含药理学、毒理学、药效学、医学等药品安全性、有效性、重要科学数据和结论的,用以指导临床正确使用药品的技术性资料。其对健康和生命的重要性不言而喻。由于医药界和广大民众对药品说明书重要性的忽视等多种原因,给了一些抱有投机心理和不负责任的药品生产企业以可乘之机。部分“只说不明”、“含糊其辞”、项目“缺斤少两”、“颠三倒四”的药品说明书大行其道,其内容让医生和患者一头雾水,给安全用药造成巨大隐患。那么,当前国内的药品说明书到底存在什么样的问题?根源何在?应当如何解决?本刊记者就此采访了相关政府部门、医生、药师、患者及法律界人士,以期拨开迷雾,思索出路。
Drugs and people’s health and life are closely related, this point, all of our doctors and pharmacists are aware of. It is often overlooked that pharmaceutical instructions play an important role in guiding physicians and patients in the safe administration of medicines. Recently, SFDA issued the “Pharmaceutical Manual and Labeling Regulations” (Exposure Draft) clearly states: Pharmaceutical specifications refer to the pharmaceutical products that are printed and provided by pharmaceutical manufacturers and contain pharmacological, toxicological, pharmacodynamic, medical and other drug safety , Effectiveness, important scientific data and conclusions, to guide the clinical use of drugs, the correct technical information. Its importance to health and life goes without saying. Due to many reasons, such as the neglect of the importance of pharmaceutical manuals by the pharmaceutical industry and the general public, it has given some opportunistic and irresponsible drug manufacturers an opportunity. Part of the “only say that unknown”, “vague”, the project “Quejinshaoliang”, “top to bottom” of the drug manual popular, its content so confused doctors and patients, to the huge potential safety problems. So, at present, what kind of problems exist in the current domestic pharmaceutical manuals? What are the root causes? What should we do? Our correspondents interviewed relevant government departments, doctors, pharmacists, patients and legal professionals for this purpose.