Expanding Pathways through OTC Contraceptive Provision
Open Access DepositedReshaping Reproductive Health Access
Guided by Aday and Andersen’s framework for the study of access, this dissertation aimed to
Integrated across phases, these findings reveal that regulatory liberalization alone is insufficient to ensure equitable and practical OTC contraceptive access. Realizing the full potential of this new access lane requires coordinated, system-wide policy strategies, including insurance coverage and retail infrastructure development, that extend beyond initial FDA approvals to close access gaps and sustain barrier-free contraceptive care.
1) examine how Rx-to-OTC contraceptive provision functions within a broader system of contraception access, 2) identify gaps in this system that detract from practical OTC procurement, and 3) recommend interventions necessary beyond the FDA’s initial regulatory liberalizations that expanded the nonprescription contraceptive landscape. Methods
Barrier-free access to contraceptive care is vital to public health as it fosters reproductive autonomy and combats adverse reproductive outcomes. As part of a broader effort to reduce systemic barriers to contraception, the Food and Drug Administration (FDA) used its regulatory authority to expand access through liberalizing prescription and point-of-sale requirements for certain hormonal contraceptives, starting with the emergency contraception (EC) pill and continuing with Opill®, a daily oral contraceptive. Each FDA decision to permit the over-the-counter (OTC) provision of a hormonal contraceptive represented a major milestone for the individual product involved, yet together these decisions represent an evolution in OTC provision, from provider-mediated contraceptive access of higher-efficacy methods toward a landscape where consumers may increasingly obtain a wider range of contraceptive options directly. With additional Rx-to-OTC contraceptive switches expected in the future, it is critical to examine how this evolving access lane is reshaping contraceptive access and whether existing delivery structures are prepared to support equitable and reliable use of OTC provision as a pathway. Objectives
Background
A three-phase, sequential mixed-methods design captured the past, present, and future dimensions of OTC contraceptive provision as an access pathway. In Phase 1, a cross-sectional secondary analysis of data from the National Survey of Family Growth (2006–2019) examined changes in EC use and procurement across survey periods prior to and following the FDA’s regulatory liberalizations of EC. Phase 2 tested whether the promise of expanded, barrier free access is realized in the current retail reality by directly observing Opill® availability in pharmacies in Washington, D.C. Phase 3 examined stakeholder perspectives on insurance coverage as the next policy frontier for expanding access to OTC contraceptives, using qualitative content analysis of comments submitted in response to a 2023 federal Request for Information on mandating insurance coverage for OTC preventive services. Results
Phase 1 findings indicate that the FDA’s regulatory liberalizations of EC were associated with measurable shifts in procurement and utilization patterns, including significant increases in EC ever-use and pharmacy-based procurement. However, demographic disparities persisted. Phase 2 revealed that Opill® availability was inconsistent
more than half of surveyed pharmacies lacked inventory, and stocked locations often required staff involvement. Barriers included restrictive security practices, staff knowledge gaps, limited protocols, and geographic variation. Phase 3 demonstrated broad stakeholder support for insurance coverage of OTC contraceptives while identifying implementation challenges that must be addressed within existing delivery structures to ensure equity and sustainability. Conclusion
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