Assessment of geriatric information on the drug label for commonly prescribed drugs in older people.
Assessment of geriatric information on the drug label for commonly prescribed drugs in older people.
复制标题
评估老年人常用处方药药物标签上的老年信息。
DOI：
10.1111/j.1532-5415.2005.53273.x
复制
发表时间：
2005
影响因子：
6.3
通讯作者：
Pollock,BruceG
中科院分区：
文献类型：
--
作者：
Steinmetz,KarenL;Coley,KimC;Pollock,BruceG
老年人占美国所有处方药使用和支出的很大一部分。尽管如此，老年人往往被排除在检查药物安全性和有效性的临床试验之外。目前尚不清楚老年人常用药物在其产品标签上包含老年人处方信息的程度。本研究的目的是确定65岁及以上患者常用处方药的产品标签或药品说明书（PI）上关于老年人的药代动力学、安全性和剂量信息的可用性。匹兹堡大学医学中心处方的前50种口服药物是通过计算机搜索药房记录确定的。评价这些药物的PI，以获得老年患者的信息。在41名（82%）PI中发现了有关老年人药物使用的信息。1990年以后上市的药物更有可能包含老年人使用的信息，药代动力学信息是最常见的类型。大约50%的PI包含老年人的预防说明，但大多数没有提供在这一人群中可能遇到的任何具体问题。只有28名（56%）PI提供了剂量信息，其中只有8名为老年患者提供了具体的毫克建议。这项分析提供的证据表明，应该做更多的工作，以提高处方信息的可用性，特别是剂量和安全性，对老年人的药物标签。可能需要采取额外的监管措施，要求将该信息纳入制剂标签。
Older people contribute to a significant portion of all prescription drug use and expenditures in the United States. Despite this, older people are often excluded from clinical trials examining the safety and efficacy of drugs. It is unclear to what extent drugs commonly used in older people contain information about prescribing in older people on their product labeling. The objective of this study was to determine the availability of pharmacokinetic, safety, and dosing information with reference to older people on product labels or package inserts (PIs) for commonly prescribed drugs in patients aged 65 and older. The top 50 oral drugs prescribed at the University of Pittsburgh Medical Center were identified through a computerized search of pharmacy records. PIs for these drugs were evaluated for information on elderly patients. Information on drug use in older people was found in 41 (82%) of the PIs. Drugs marketed after 1990 were more likely to contain information on geriatric use, with pharmacokinetic information being the most common type. Approximately 50% of the PIs contained precautionary statements for older people, but most did not provide any specific problems that might be encountered in this population. Only 28 (56%) PIs had dosing information available, and of these, just eight provided specific milligram recommendations for elderly patients. This analysis provides evidence that more should be done to improve the availability of prescribing information, particularly dosing and safety, on drug labels for older people. Additional regulatory action requiring this information to be included on drug product labels may be warranted.