A systematic analysis of package insert information referencing race and ethnicity for 100 medications commonly used...

To evaluate the use of terms denoting race/ethnicity in product labeling for 100 of the medications most commonly used in critically ill patients and to assess this information for overall frequency, frequency by drug class, and frequency within package insert sections to highlight the need for standardized and consistent use of Food and Drug Administration-approved terminology in drug packaging and other informational materials.

Data were collected by reviewing individual drug manufacturer package inserts. Each package insert was assessed for terminology that explicitly referenced race or ethnicity, and these terms were coded and quantified. After evaluating each of the 100 package inserts, a spreadsheet detailing the usage and presence of race and ethnicity terminology, including its location within the insert and frequency was created. This composite list was then analyzed to identify patterns in using such terminology.

A cumulative analysis of all race/ethnicity-based terminology found in the package inserts for the top 100 intensive care unit drugs demonstrated that race/ethnicity-related terminology occurred 94 times in 21 package inserts. Summarizing these categories by number of occurrences showed that the race/ethnicity-based term "Black" occurred most frequently (in 29.8% [28/94] of package inserts]). Concerning the frequency of race/ethnicity-related terminology by agent class, the most frequent use of these terms was (in descending order): diabetes medications, anticoagulation, antimicrobials, antihypertensives, and medications used for cholesterol/lipid lowering. Regarding the frequency of the terms in the main sections of a package insert, most of these terms (a third of the total occurrences) were in the "Adverse Reactions" section (in 31.9% [30/94] of package inserts]).

Some of the terminology found in the package inserts in our study was either not listed or specifically not recommended for use in federal government reporting. These findings elucidate the prevalence and contexts in which race/ethnicity-related terminology is employed, highlighting its potential impact on clinical decision-making and drug use evaluation.