Assessment of geriatric information on the drug label for commonly prescribed drugs in older people

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.