R43HD110346

Implementation of support tools to promote safety in the prescribing of oral contraceptives - Summary

Nearly half of the pregnancies in the United States are unintended despite the discovery of the first combination hormonal contraceptive in the 1960s. Hormonal contraceptives are an efficacious and cost-effective strategy to decrease the rate of unintended pregnancy.

Lack of access to contraceptive services, especially for adolescents, minority women, and women of lower socioeconomic status creates significant health and financial inequities and leads to significant US government expenditures.

Pharmacist-prescribed contraceptive services have the potential to increase access to care, decreasing the number of unintended pregnancies in the US. Pharmacists have expressed interest in providing contraceptive services but have cited several barriers that currently serve to hinder their expansion.

For the widespread growth of pharmacist-prescribed contraceptive services, an implementation package is needed that addresses the barriers that currently exist. A contraceptive-specific electronic health record system that increases efficiency, incorporates point-of-care tools, and is affordable will be the foundation of a successful implementation package.

OVARYIT, a Florida-based small business, has developed a proprietary HIPAA-compliant contraceptive-specific platform for the provision of direct-to-consumer telehealth services. We propose to adapt this platform to serve as the foundation of a comprehensive implementation package to expand in-person pharmacist-prescribed contraceptive services.

Phase I will support studies to investigate the feasibility and establish a proof-of-concept of such a solution.

Aim 1: Conduct a needs assessment to determine operational requirements. This will result in project documentation and the roadmap needed to integrate contraceptive functionality within existing pharmacy management systems.

Aim 2: Completion of a study of 20 pharmacist end-users comparing the OVARYIT platform to the current standard paper charting process. Each pharmacist will complete two standardized contraceptive patient encounters, one utilizing each process. Outcomes will include time to completion of the encounter, compliance with the USMEC guidelines, appropriate prescription selection, and quantitative survey data.

Aim 3: Conduct a focus group with pharmacist end-users and administrative stakeholders to discuss the perceived strength and quality of the proposed project solutions for each of the identified barriers or pain points to implementation success.

At the end of Phase I, OVARYIT, LLC will have a roadmap for a comprehensive implementation package with vetted solutions for the many barriers that currently prevent the adoption of pharmacist-prescribed contraceptive services.

Phase II efforts will allow for the creation of a comprehensive implementation package ready for widespread commercialization to independent, large chain, and health system-based pharmacies.

A tremendous market opportunity exists for OVARYIT, LLC and participating pharmacies to create new revenue opportunities while significantly expanding access to contraceptives in the US.

Ovaryit

NOT APPLICABLE

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Lancaster, Pennsylvania 176014527 United States

Single Zip Code

Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial NOT Allowed) (PAR-22-073)

Amendment Since initial award the total obligations have increased 25% from $214,719 to $267,654.