Category: Social and Community Context

26 - Assessing Medication Safety: Analysis of Drug Labeling for Information Specific to Geriatric Populations

Geriatric use sections of drug labels lacking key information could potentially contribute to adverse drug events (ADEs) in older adults. Considering $35.7 million is spent annually on hospitalization of elderly from ADEs (Nair, et al., 2016), this analysis aims to identify knowledge gaps in recently approved drug product labels and assess Food and Drug Administration Safety and Innovation Act (FDASIA) adherence for greater participation of geriatrics age 75+ in clinical trials (CT). From, the content and specificity of 2015- 2017 Novel Drug Approval geriatric drug labels were examined in 4 areas: reference to a CT including geriatrics, percentage of CT subjects age 65 and/or 75+, dosage recommendations for geriatrics, determination of product safety and efficacy for geriatrics.

Of the total 99 drug labels examined, 23% did not reference a CT involving geriatrics. 33% indicated insufficient evidence to determine the product’s safety and efficacy for geriatrics and 71% did not provide dosage recommendations for geriatric populations. 42% of labels did not include information on the number of CT participants age 75+. Of those lacking dosage recommendations, 37% state there was insufficient geriatric CT participants. Even in labels referencing CT participation by geriatrics ages 65+, 20% did not specify the number of participants ages 75+.

We expected to see increases in new drug labels referencing CT information in geriatric populations following 2014 implementation of FDASIA Section 907, which calls for improved CT participant diversity and demographic reporting. However, we observed an increase over time in only one of four areas examined-- the number of labels reporting CT participation by geriatrics.

These findings demonstrate knowledge gaps in how new drug products affect older adults. The inadequate language currently found in geriatric drug labels can create challenges for clinicians when prescribing these medications for geriatric patients, potentially contributing to ADEs. With US life expectancy averaging 78 years old and anticipated doubling of the elderly population in coming decades (NIH, 2016), there is urgent need for greater inclusion and reporting of CT participants age 75+ to inform healthcare providers and patients on safe and effective use of new drugs in this growing segment of the world’s population.



Jacqueline Chen

Undergraduate Student
University of Southern California Department of Regulatory and Quality Sciences
Wellington, Florida

Jacqueline is a rising undergraduate senior at the University of Southern California, majoring in Health and Human Sciences and simultaneously pursuing a progressive Master of Science degree in Gerontology. Jacqueline volunteers as a research associate at the Department of Regulatory and Quality Sciences within the USC School of Pharmacy. There, she conducts regulatory science research that focuses on the inclusion of geriatric populations in clinical trials and the barriers to their participation. Jacqueline aspires to a career in medicine and public health, in which she can help improve the health and wellbeing of older adults.