MediMergent Announces Pilot Program for its National Medication Safety, Outcomes and Adherence Program (NMSOAP)

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NMSOAP collaboration with FDA to bring the “voice of patient” to the real-world evaluation of recently-approved medications

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Healthcare data integration and analytics company MediMergent today announced its pilot study of the National Medication Safety, Outcomes, and Adherence Program (NMSOAP), established under a Research Collaboration Agreement with the Center for Drug Evaluation Research (CDER) at the U.S. Food and Drug Administration (FDA). NMSOAP is a partnership among patients, providers, pharmacists, payers, and regulators designed to collect important near real-time data directly from patients who voluntarily provide the information via monthly surveys. These patient responses will be integrated with information from their electronic health records (EHR), prescription and claims data and other health care analytics. The goal of NMSOAP is to establish longitudinal profiles on disease management and treatment, medication adherence and persistence, patient safety, clinical outcomes, and drug effectiveness. The pilot program will collect information from patients treated with either a novel oral anticoagulant (NOAC) - Xarelto® (rivaroxaban), Pradaxa® (dabigatran) or Eliquis® (apixaban) - or standard-of-care Coumadin® (warfarin) for the prevention of atrial fibrillation-related stroke or venous thromboembolic (VTE) disease related pulmonary embolus.

Through pharmacies, physicians’ offices, and direct patient outreach, NMSOAP will recruit individuals taking one of the drugs of interest. Enrolled patients will report on experiences with their NOAC or warfarin therapy with emphasis on medication associated side effects, clinical outcomes, medication adherence/persistence, impact of concomitant branded and/or over-the-counter medications, and their sense of “well-being.” The American Pharmacists Association (APhA) will develop and implement a national training program for pharmacists and their staff to aid in collecting “voice of patient” information into the NMSOAP database. National retailer The Kroger Co. hopes to leverage its networks of 7,000 pharmacists in nearly 2,000 pharmacies nationwide to enroll patients into NMSOAP, which will serve as a Medication Therapy Management (MTM) program. Additional partners include nationwide health information network Surescripts, independent pharmacy chain The Medicine Shoppe, and StopAfib.org, a global atrial fibrillation patient advocacy organization.

“NOACs have been quite well-characterized with regard to their safety and efficacy profile for the prevention of atrial fibrillation-related stroke. This creates an opportunity to explore whether a more patient-centric, electronic medical records-based paradigm will provide similar and complementary information,” said Norman Stockbridge, M.D., Ph.D., director, Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “The FDA is hopeful that NMSOAP’s approach to patient-directed healthcare data will build upon the information the Agency already has from existing systems such as FAERS and SENTINEL. Opportunities exist to improve post-marketing tracking of safety, to evaluate evolving patterns of real-world medication adherence/persistence, to pilot EHR-based study enrollment and data collection, and to assess the effectiveness of risk mitigation strategies.” The FDA convened a meeting of NMSOAP stakeholders to preview and discuss the pilot study on October 24, 2014.

Kenneth M. Borow, M.D., President and Chief Medical Officer for MediMergent stated, “In the U.S., 20-30% of all medication prescriptions are never filled. Of those prescriptions that are filled for cardiovascular medications for chronic use, the non-adherence rate is 50% at six months. Overall, poor medication adherence results in nearly $300 billion per year of incremental healthcare costs in the U.S., and results in approximately 125,000 deaths. The ultimate intention of NMSOAP is to identify early ‘warning signs’ of issues that may impact medication adherence as well as signal an important adverse event that can potentially be averted by physician intervention. The pilot study is expected to begin patient enrollment in December 2014 and enroll in excess of 12,000 patients.”

About MediMergent, LLC
MediMergent, LLC is a data collection, integration and analytics company. It is building digital platforms that will integrate patient directed information from multiple modalities including smart phones, tablets, call centers, pharmacy-based kiosk devices, interactive voice recognition technologies as well as a number of mobile diagnostic applications. Under a Research Collaboration Agreement with the Center for Drug Evaluation Research (CDER) at the U.S. Food and Drug Administration (FDA), MediMergent established the National Medication Safety, Outcomes and Adherence Program (NMSOAP) to longitudinally assess safety, outcomes, and medication adherence using innovative, prospective approaches towards recently approved drugs under real-world conditions. The result will be the ability to collect health information directly in the “Voice of the Patient” without third party interpretation. This information will be integrated with other sources of patient information (e.g., electronic medical records and claims data) to create databases of real-world safety, clinical outcomes, medication adherence, REMS and comparative effectiveness data.

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Shelley Ducker

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