Kroger, Medicine Shoppe to pilot National Medication Safety, Outcomes and Adherence Program
ROCKVILLE, Md. — Kroger and Medicine Shoppe are participating in MediMergent's pilot study of the National Medication Safety, Outcomes and Adherence Program (NMSOAP), which will evaluate novel oral anticoagulants compared with warfarin, MediMegent announced Monday.
"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," said Kenneth Borow, president and chief medical officer of MediMergent. "The pilot study is expected to begin patient enrollment in December 2014 and enroll in excess of 12,000 patients.”
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, prescription and claims data and other healthcare analytics.
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.”
“NOACs have been quite well-characterized with regard to their safety and efficacy profile for the prevention of atrial fibrillation-related stroke," said Norman Stockbridge, director, Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. "This creates an opportunity to explore whether a more patient-centric, electronic medical records-based paradigm will provide similar and complementary information,” he said. “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. ... 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 American Pharmacists Association 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.
MediMergent's NMSOAP was established under a Research Collaboration Agreement with the Center for Drug Evaluation Research at the U.S. Food and Drug Administration.