(1126) Comprehension of a Drug Facts Label for a Newly Approved Over-the-counter Hormonal Contraception Pill in English- and Spanish-reading Populations

Objectives: The Food and Drug Administration (FDA) approved an oral hormonal contraception tablet, norgestrel (Opill®), in July 2023 to be marketed as an over-the-counter (OTC) product. As of October 2023, there is no formalized method to counsel patients who would like to purchase this product for use, or to determine the level of knowledge patients can understand from reading the norgestrel drug facts label. OTC drug facts labels available in the United States are primarily written in English. There are limited studies assessing user-testing and readability of OTC products and their drug facts labels with consideration of providing OTC drug facts labels in Spanish. The study’s objective is to utilize a knowledge assessment survey to determine respondents’ comprehension of norgestrel from its drug facts label and compare the comprehension between primarily English- and Spanish-reading patients.

Methods: A knowledge assessment will be developed and disseminated as a cross-sectional, anonymous, web-based survey (Qualtrics). English- and Spanish-reading patients aged 18 to 44 years old who identify as female or have pregnancy capable reproductive organs will be eligible to participate. Recruitment fliers will be distributed to eligible patients when picking up prescriptions at two pharmacies within federally qualified health centers (FQHC) in Northern Indiana. Survey items will include items assessing product administration techniques, use of secondary contraception methods, medication side effects, and participant demographics, such as current and prior contraceptive usage and primary language read. The norgestrel drug label will be embedded within the survey and provided as paper copies for participants to refer to when answering the survey. To establish face validity of survey items, it will be pilot-tested by five patients of each reading group, English and Spanish. Upon completion of the survey, participants will receive a $5 Walmart gift card if a valid email or mailing address is provided. Data analysis will be completed with a student’s t-test with p < 0.05. This protocol will be submitted to the Institutional Review Board for approval prior to data collection.

Results: Data collection and analysis is anticipated to occur from October 2023 through February 2024. Results will be presented at the APhA Annual Meeting.

Conclusions: With the lack of formalized counseling provided to patients on over-the-counter (OTC) products, it is important to understand that patients may take norgestrel incorrectly, especially in those with lower health literacy levels. In addition, lack of Spanish OTC labeling may create a disparity, given that there is a growing Spanish-reading population in the United States. Formal conclusions will be drawn upon data analysis.