Development and commercialization of support tools to promote safety and adoption of pharmacist prescribed contraceptive services.

Ovaryit, Llc, Lancaster PA

Investigators

Abstract

SUMMARY Access to high efficacy contraceptive options and family planning services enable women to control the size and timing of their families which is paramount to reducing gender inequities and allowing women to reach their full social, economic, and educational potential. On Friday, June 24, 2022, the United States Supreme Court overturned the Dobbs decision, which removed the nearly 50 years of precedent of federal protection to the right to abortive services. In the US, more than 19 million women live in a county without reasonable access to the full range of contraceptive services, and 1.2 million of these women live in a county without a single health center offering the full range of services. Because 90% of the population lives within 5 miles of a pharmacy, pharmacist- prescribed contraceptive services (PPCSs) can dramatically increase access to care, decrease health inequities, and combat the high unintended pregnancy rate in the US. In July 2023, the Food and Drug Administration (FDA) cleared Opill, the first over-the-counter progestin-only contraceptive. Currently, only 4% of oral contraceptive users take a progestin-only option. More patients will now turn to the pharmacy for contraceptive services, but pharmacies are not well-equipped to assist. To increase the adoption of PPCSs, an Electronic Health Records (EHR) system must be utilized to increase safety, compliance, reimbursements, and scalability to meet the nation’s needs. The OvaryIt Pharmacy Platform (OPP) is a smart, contraceptive-specific EHR with embedded clinical decision support (CDS) tools to increase workflow efficiencies and assist providers in delivering safe, high-quality contraceptive care to patients. The OPP layers the CDC’s United States Medical Eligibility Criteria for Contraceptive Use (USMEC) guidelines with contraceptive prescribing best practices to create an end-to-end solution for prescribing contraceptives. The Phase I results demonstrate that the OPP has safety, efficiency, workload assessment, and usability benefits for pharmacists compared to the current standard paper charting workflow. The pharmacist participants in the Phase I study overwhelmingly preferred the OPP and indicated that it increases confidence and the feasibility of incorporating contraceptive services into their clinical workflows. The Specific Aims proposed in this application are designed to build upon the Phase I prototype lessons learned, to create a commercialized Software-as-a-Service (SaaS). Aim 1: Modify the OPP prototype to incorporate user interface (UI) changes to the system’s CDS features based on lessons learned from Phase I and repeat a study of 10 new pharmacist end-users performing a simulated encounter on the modified system to study the effect of the UI changes. Aim 2: Completion of the Software Development Life Cycle (SDLC) to create the OPP SaaS platform. Aim 3: Completion of a 120-day OPP Pilot Program utilizing the OPP SaaS platform in 5 pharmacies in the US to collect real-world data. The successful completion of this SBIR Phase II project is expected to result in the creation and commercialization of an end-user driven SaaS platform that incentivizes the adoption of pharmacist contraceptive services.