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EMPOWERX INC SBIR Phase I Award, September 2022

A SBIR Phase I contract was awarded to EmpoweRx Inc. in September, 2022 for $243,500.0 USD from the U.S. Department of Health & Human Services and Centers for Disease Control and Prevention.

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sbir.gov/node/2344679
Is a
SBIR/STTR Awards
SBIR/STTR Awards

SBIR/STTR Award attributes

SBIR/STTR Award Recipient
EmpoweRx Inc.
EmpoweRx Inc.
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Government Agency
0
Government Branch
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
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Award Type
SBIR0
Contract Number (US Government)
1R43DP006691-010
Award Phase
Phase I0
Award Amount (USD)
243,5000
Date Awarded
September 30, 2022
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End Date
September 29, 2023
0
Abstract

Project Summary/Abstract: With 95% of unintended pregnancies in the United States attributed to incorrect, inconsistent, or non-use of contraception, improving access to reliable contraception is an important public health issue. Pharmacists are considered the most accessible health care provider and are well-positioned to improve contraception access by providing pharmacist- prescribed contraception services. The focus of this proposed work is on pharmacists who can provide greatest access – those in community pharmacies. There are more than 67,750 community pharmacies in the United States and only 3,500 are currently offering pharmacist prescribing of contraception. Research consistently identifies barriers to implementation of pharmacist contraception prescribing. In order to maximize access to contraception, barriers to pharmacist implementation must be addressed. This project will develop a Hormonal contraceptive Access via Pharmacist-Prescribing Implementation (HAPPI) package that will support effective and sustainable provision of pharmacist-prescribed contraception services. We will use a convergent, parallel design including both quantitative and qualitative data, grounded in implementation science using the Consolidated Framework for Implementation Research (CFIR) and Evidence-Based Quality Improvement (EBQI). The mixed methods approach will better inform development and refinement of the HAPPI package. A summary of the existing technology, tools, and resources that may be used, needed, and/or considered to overcome frequently cited barriers to the implementation of pharmacist-prescribed contraception services will be created. Model adopter case studies will be created to illustrate “best practices”. Pharmacy decision makers (owners and executives) and end-users (pharmacy manager pharmacists and staff pharmacists) will participate in focus groups for concept mapping and a multi-stakeholder advisory panel. The focus groups will identify and prioritize tools and resources to be included in the HAPPI package while the multi-stakeholder advisory panel will provide input on perceived acceptability, appropriateness, and feasibility of implementing pharmacist-prescribed contraception services with and without the HAPPI package. Pharmacist contraceptive prescribing has the potential to expand access to contraception. If successful, this project will create a prototype implementation package that will form the basis for our future SBIR Phase II grant to conduct usability testing and ultimately commercialize and measure the impact of the HAPPI package. PUBLIC HEALTH RELEVANCE: With 95% of unintended pregnancies in the United States attributed to incorrect, inconsistent, or non-use of contraception, improving access to reliable contraception is an important public health issue and pharmacists are well-positioned to improve access with pharmacist-prescribed contraception services. This application targets multiple stakeholders (e.g.; pharmacy owners and executives, pharmacy manager pharmacists and staff pharmacists) across various community pharmacy settings (e.g.; chain and independent, urban and rural, contraception prescribing service adopters and non-adopters). Using a rigorous mixed methods approach, we develop and refine the Hormonal contraceptive Access via Pharmacist Prescribing Implementation (HAPPI) package to overcome frequently cited barriers that limit the current implementation of pharmacist contraception prescribing services. Specific Aims Unintended pregnancies comprised 45% of all pregnancies in the United States in 2011,1 and 95% were due to incorrect, inconsistent, or non-use of contraception.2 Improving access to reliable contraception is an important public health issue, and pharmacists, as the most accessible healthcare providers,3 can provide contraception services. Fourteen states and the District of Columbia have passed specific legislation to allow pharmacists to prescribe hormonal contraceptives.4,5 The rationale of such policy is that pharmacist-prescribed contraception services improve patients’ access by allowing direct, convenient access to an array of prescription-only contraception methods. This eliminates the need to schedule appointments, reduces waiting time, and minimizes travel since pharmacies are generally closer in proximity than provider offices or clinics. Improved access to contraception will reduce the number of unintended pregnancies. Pharmacist contraception prescribing in Oregon is attributed to preventing unintended pregnancies and saving Medicaid $1.6 million on pregnancy, birth, and newborn care between 2016 and 2017.6 Despite strong interest from both patients7-9 and pharmacists,10-12 and policies which make it possible,4,5 adoption and overall implementation of pharmacist-prescribed contraception services is impeded by various barriers, including inadequate insurance coverage and billing mechanisms, training, workflow integration, and patient awareness of the service.9,11,13-14 An implementation package designed to overcome common barriers to pharmacist-prescribed contraception services will address the current gap in practice. Without an implementation package to improve and increase implementation of pharmacist-prescribed contraception services, patients, particularly those facing the most barriers to obtaining contraception, will be unlikely to benefit from these policies. The long-term goal is to improve patients’ access to contraceptives and reduce unintended pregnancies. The overall objective for this Phase I project is to develop an implementation package (Hormonal contraceptive Access via Pharmacist-Prescribing Implementation [HAPPI] package) for future commercialization that will address pharmacist (end-users) and pharmacy executive (decision- makers) needs and increase access to pharmacist-prescribed contraception services. The rationale for this project is that it will provide interested end-users and decision-makers with an acceptable and useful implementation package for pharmacist-prescribed contraception services. The approach will use a convergent, parallel design that is informed by the Consolidated Framework for Implementation Research (CFIR)15 and Evidence-Based Quality Improvement (EBQI),16 which support the incorporation of evidence-based practice into regular use by end-users.17 As well, the Centers for Dise

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