论文部分内容阅读
美国食品药物管理局(FDA)针对老年人用药问题,于1990年11月对药品标签作出了进一步规定。65岁以上的老年人产生药物不良反应的机会相应增加,例如他们很可能肾功能不全,有2种或多种疾病,因而服用多种药物。目前老年人占美国总人口的12%,但却消费30%以上的药品。FDA的规定并没有改变药品报批的形式和报批材料的数量,也不要求增加另外的研究资料,仅仅要求针对老年患者总结出结构清楚的、综合性的、可接受的资料。新规定要求上市药品的厂家及公司收集并阐述所有的有关老年人使用该药品的信息,其中包括申报人对老年人使用该药品的评价,对照研究或其它的长期性研究,药品销售前后的研究,以及从文献研
In November 1990, the US Food and Drug Administration (FDA) made further provisions on the labeling of medicines for the use of medicines for the elderly. Older persons over the age of 65 have a corresponding increase in adverse drug reactions. For example, they are likely to have renal insufficiency with 2 or more diseases and therefore taking multiple medications. At present, the elderly account for 12% of the total population in the United States, but consume more than 30% of the drugs. FDA regulations do not change the form of drug approval and the amount of material submitted for approval, nor do they require additional research data, merely requiring that well-structured, comprehensive, and acceptable data be summarized for older patients. The new regulation requires listed pharmaceutical companies and companies to collect and elaborate on all information about the use of the drug by the elderly, including the applicant’s assessment of the use of the drug in the elderly, controlled studies or other long-term studies, pre- and post-marketing research , As well as from literature research