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Industry's neglect of prescribing information for children.

机译:行业忽视了儿童的规定信息。

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摘要

Physicians caring for Canadian children are frequently denied easy access to important prescribing information. The reason? The pharmaceutical industry generally has not submitted evidence in its possession supporting safe pedi-atric doses and dosing intervals to Health Canada. As a result, the Compendium of Pharmaceuticals and Specialties (CPS), the most widely used source of prescribing information for primary care providers and pediatricians, is littered with the statement that safety and efficacy have not been established in the pediatric population. The statement is often untrue.Accurate pediatric prescribing information in all official documents including product inserts, labels on medications, the CPS, advertising and, frequently, national guidelines depends on manufacturers to bring forward evidence for a pediatric indication. Once approved, label wording is agreed upon between regulatory authorities such as Health Canada and manufacturers.
机译:照顾加拿大儿童的医生经常被拒绝进入重要的处方信息。 原因? 制药行业一般没有提交其拥有的证据,这些证据支持安全的Pedi-Atric剂量和加拿大卫生时间的给药间隔。 因此,制药和专业的纲要(CPS),是初级保健提供者和儿科医生的规定信息的最广泛使用的来源,并在儿科人群中尚未建立安全性和有效性。 该声明通常是不真实的。在包括产品插入的所有官方文件中,药物,药物,CPS,广告和,经常,国家准则的标签,国家指南中的所有官方文件都取决于制造商提出了儿科迹象的证据。 曾经批准后,在加拿大卫生和制造商等监管机构之间商定标签措辞。

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