Label comprehension study for a proposed over-the-counter progestin-only pill

Abstract

Objective

As part of an over-the-counter switch application to the US Food and Drug Administration for a norgestrel 0.075 mg progestin-only pill (Opill), we aimed to determine if key messages from the proposed Drug Facts Label were adequately understood by potential users.

Study design

We conducted videoconference interviews with 703 individuals aged 11 to 50 years, who were female or born with a uterus, located throughout the United States. We drew our sample from two populations: (1) a general population and (2) a population that primarily included individuals with a history of breast cancer. Fourteen primary label message end points were selected based on messages from the Drug Facts Label with the greatest potential for clinical risk if misunderstood and were assessed against an a priori threshold of 90% correct or acceptable responses that was evaluated using the lower limit of the 95% confidence interval (CI). Nineteen secondary label message end points represented important messages but with lower potential for clinical risk if misunderstood, and had no preset thresholds.

Results

For nine of the 14 primary label messages, the end point met or exceeded the 90% threshold based on the lower limit of the 95% CI; the remaining five primary label messages were also well-understood, with point estimates ≥85% and lower limits of the 95% CI >82%. Sixteen of the 19 secondary label message end points were understood by ≥90% of the participants.

Conclusions

The Drug Facts Label for a norgestrel 0.075 mg progestin-only pill was well-understood by a diverse sample of potential users.

Implications

Study findings suggest that information in the label is sufficient to enable people to self-select for the norgestrel oral contraceptive and use it over time. These findings, along with other research, supported the US Food and Drug Administration’s approval of norgestrel 0.075 mg for nonprescription status.