Comparing English- and Spanish-Reading Patients' Comprehension of the Drug Facts Label for a New Over-The-Counter Oral Contraceptive.

Background: Health literacy is known to impact health outcomes in a multitude of ways and is impacted by language barriers. Lower health literacy is also associated with higher rates of unintended pregnancies. A progestin-only oral hormonal contraception product, norgestrel (Opill-Perrigo), was approved for over-the-counter (OTC) use in the United States in July 2023.

Objective: (s): The objective was to utilize a knowledge assessment survey to determine participants' comprehension of norgestrel from its drug facts label and compare the comprehension between primarily English- and Spanish-reading participants.

Methods: A 7-item knowledge assessment was developed and distributed to English and Spanish readers at one site within a network of federally qualified health centers. English-reading participants completed the English survey alongside use of an English copy of norgestrel's drug facts label. Spanish-reading participants completed the Spanish survey and were randomized in a 1:1 fashion to either receive an English or Spanish copy of norgestrel's drug facts label.

Results: The English-reading/English label (E/E) group had a higher level of comprehension of norgestrel's drug facts label compared to the Spanish-reading/English label (S/E) or Spanish-reading/Spanish label (S/S) groups.

Conclusion: Differences exist in OTC label comprehension for norgestrel based on primary language able to be read. Advocacy for OTC labels to be readily available in languages other than English is imperative to mitigate unintended pregnancies associated with lower levels of health literacy.