JOHNS HOPKINS MEDBIQUITOUS PROJECT SUPPORTS FDA REMS INITIATIVE ADDRESSING ER/LA OPIOID ABUSE
New MedBiquitous standards to enable the integration of continuing education data from across the health professions
Baltimore, Maryland, August 21, 2012. A new project by MedBiquitous will support data collection to measure the scope of continuing health care education on the risks of opioid medications, safe prescribing, and safe use practices. The project will meet the requirements of the FDA’s extended-release and long-acting (ER/LA) opioid analgesics Risk Evaluation and Mitigation Strategy (ER/LA REMS). The MedBiquitous project is funded by the REMS Program Companies, a consortium of ER/LA opioid analgesics companies.
The centerpiece of the opioid REMS is an education program for clinicians who prescribe such drugs. The organizations that accredit continuing education in the health professions are working together to facilitate the development of the prescriber education. The education will involve teaching prescribers how to assess patients for treatment with ER/LA opioid analgesic therapy, initiate and manage therapy, modify dosing, and discontinue use. Prescribers will learn about the drugs, including the risks, and about how to counsel patients and caregivers about safe use.
Each accreditor collects data about the CE activities in their respective professions. The MedBiquitous project will permit data about REMS-compliant CE programs from across the health professions to be successfully aggregated into a single data set describing the entire nation’s accredited CE efforts in support of the FDA’s REMS initiative.
The Medical Education Metrics Standard 1.0, ANSI/MEDBIQ ME.10.1-2009, helps organizations to bring data together for better research on the reach and impact of CE. Also known as MEMS, the MedBiquitous standard gives organizations the ability to digitally compile continuing education data across multiple systems. The MedBiquitous Metrics Working Group is developing MEMS 2.0, a revision of this American National Standard that addresses the unique requirements of the FDA’s ER/LA Opioid REMS.
MEMS 2.0 will offer a streamlined, efficient, and effective system for collecting data about REMS-compliant continuing education across the health professions. Accreditors can integrate MEMS 2.0 into their already existing data collection processes, enabling accredited CE providers to use their own accreditor’s data collection system to input information about REMS CE activities. This data could then be compiled in central systems to assist the FDA and other stakeholders in analyzing the reach and impact of the REMS programs.
“Continuing Education is an important tool in promoting safe prescribing practices for opioid analgesics,” says Peter Greene, M.D., executive director of MedBiquitous and chief medical information officer of Johns Hopkins Medicine. “MEMS 2.0 will provide an unprecedented opportunity to look across the CE profession with respect to REMS-related education. We look forward to working with the CE profession and its stakeholders on this important work.”
“MEMS 2.0 will give continuing health care education accreditors a common format for our REMS-related data, enabling the FDA, the continuing health care education community, and other stakeholders to assess the overall scope of REMS-related education for health professionals,” says Murray Kopelow, M.D., chief executive of the Accreditation Council for Continuing Medical Education. "We appreciate the efforts of MedBiquitous to support this important public health and safety initiative."
“The American Nurses Credentialing Center’s accreditation program supports the MEMS 2.0 initiative to integrate data for better research on the reach and impact of continuing education in support of professional registered nurses, and the patients they serve,” said Kathy Chappell, M.S.N., R.N. director of the ANCC’s accreditation program.
“Recognizing the importance of prescriber education for ER/LA REMS programs, the American Osteopathic Association is pleased to be a part of this collaborative metrics working group as one of the developers of the continuing education standards," said Ray E. Stowers, D.O, president of the American Osteopathic Association (AOA). "The opportunities presented by being a part of this effort will only bring forth better quality educational programs. Having the AOA at the forefront of this mission is a challenge we relish.”
“MEMS 2.0 will be an essential tool in our armamentarium for continuous improvement in the provision of CME designed to improve practice performance in the safe use of opioid analgesics,” said Mike Saxton, M.Ed., CCMEP, FACME, chief learning officer for the American Academy of Physician Assistants.
The MedBiquitous Metrics Working Group will begin work on revising the standard in August. Members of MedBiquitous are welcome to participate in this project. In addition, all materially affected parties are welcome to participate through the MedBiquitous Standards Committee. For more information on MEMS 1.0 and MedBiquitous, visit http://www.medbiq.org.
About the FDA Extended-Release and Long-Acting Opioid Analgesics REMS
On July 9, 2012, the FDA announced the REMS for extended-release and long-acting opioid analgesics. Under the REMS, opioid manufacturers are required to make educational training available for health care professionals about the risks of opioid medications as well as safe prescribing and safe use practices. The education will be funded by opioid manufacturers through educational grants to accredited CE providers, so that it is available free of charge or at nominal cost to prescribers. A consortium of manufacturers, called the REMS Program Companies (RPC), will administer the grants. Requests for grant applications will be announced in August. Manufacturers are prohibited from having any involvement in education design or curriculum. Prescriber education will be based on the FDA blueprint, and controlled, designed, and delivered by accredited continuing health care education providers in compliance with accreditation standards for independence.
For more information on the ER/LA opioid REMS, visit http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.
For more information on the RPC and updates related to RPC-supported REMS CE, visit
Founded by Johns Hopkins Medicine and leading professional medical societies, the MedBiquitous Consortium is creating a technology blueprint for health care education. Based on XML and Web services standards, this blueprint will seamlessly support the health care learner in ways that will improve patient care and simplify the administrative work associated with education and competence assessment. MedBiquitous also provides a neutral forum for educators and industry alike to exchange ideas about innovative uses of Web technologies for health care education and communities of practice. It is the mission of MedBiquitous to advance health care education through technology standards that promote professional competence, collaboration, and better patient care. For more information on MedBiquitous, please visit www.medbiq.org.
The Accreditation Council for Continuing Medical Education (ACCME®)is a nonprofit organization based in Chicago that is responsible for accrediting US institutions that offer continuing medical education through a voluntary, self-regulatory system. The ACCME also has a system for recognizing state medical societies as accreditors for local organizations offering CME.
The ACCME's mission is to identify, develop, and promote standards for quality continuing medical education that improves health care for patients and their communities. There are approximately 2,000 accredited CME providers in the United States, whose educational activities draw more than 20 million health care practitioner participants annually.
The ACCME's member organizations include the American Board of Medical Specialties, the American Hospital Association, the American Medical Association, the Association of American Medical Colleges, the Association for Hospital Medical Education, the Council of Medical Specialty Societies and the Federation of State Medical Boards of the US, Inc.
For more information, visit www.accme.org.
AAPA is the national professional society for PAs. The mission of AAPA is to ensure the professional growth, personal excellence and recognition of PAs, and to support their efforts to enable them to improve the quality, accessibility and cost-effectiveness of patient-centered health care.
The Academy has 81 constituent organizations:
- Fifty-six chartered chapters representing all 50 states, the District of Columbia and five federal services
- Twenty-five recognized specialty organizations made up of individuals working within a specific medical or surgical specialty
The Bureau of Labor Statistics predicts that PAs will be the second-fastest-growing profession in the next decade, increasing from 74,800 in 2008 to 103,900 in 2018. AAPA projects that in 2020, there will be between 137,000 and 173,000 certified PAs.
About the Accreditation Council for Pharmacy Education
The Accreditation Council for Pharmacy Education (ACPE) is the national agency for the accreditation of professional degree programs in pharmacy and providers of continuing pharmacy education. The mission of the organization is to assure and advance excellence in education for the profession of pharmacy. ACPE is an autonomous and independent agency whose Board of Directors is derived through the American Association of Colleges of Pharmacy (AACP), the American Pharmacists Association (APhA), the National Association of Boards of Pharmacy (NABP), and the American Council on Education (ACE).
About The American Nurses Credentialing Center
The mission of the American Nurses Credentialing Center (ANCC), a subsidiary of the American Nurses Association (ANA), is to promote excellence in nursing and health care globally through credentialing programs. ANCC’s internationally renowned credentialing programs certify and recognize individual nurses in specialty practice areas. It recognizes healthcare organizations that promote nursing excellence and quality patient outcomes, while providing safe, positive work environments. In addition, ANCC accredits healthcare organizations that provide and approve continuing nursing education. It also offers educational materials to support nurses and organizations as they work toward their credentials.
The ANCC Accreditation program recognizes the importance of high-quality continuing nursing education (CNE) and skills-based competency programs. Around the world, ANCC-accredited organizations provide nurses with the knowledge and skills to help improve care and patient outcomes. www.nursecredentialing.org
About the AOA
The American Osteopathic Association (AOA) proudly represents its professional family of more than 100,000 osteopathic physicians (DOs) and osteopathic medical students; promotes public health; encourages scientific research; serves as the primary certifying body for DOs; is the accrediting agency for osteopathic medical schools; and has federal authority to accredit hospitals and other health care facilities. More information on DOs/osteopathic medicine can be found at www.osteopathic.org.
The Association of Regulatory Boards of Optometry (ARBO) is a nonprofit organization based in Charlotte, NC. ARBO offers programs to assist its members, the state, provincial, territorial optometry licensing Boards in regulating the practice of optometry for the public welfare. ARBO’s Council on Optometric Practitioner Education (COPE®) program accredits optometric continuing education courses to assure the quality and independence of continuing education. COPE requires compliance with standards for commercial support to ensure that COPE accredited CE is of the highest integrity and free of commercial bias.
For more information, visit www.arbo.org
About Johns Hopkins Medicine
From the 1889 opening of The Johns Hopkins Hospital, and the Johns Hopkins University School of Medicine four years later, there emerged the concept of combining research, teaching and patient care. This model, the first of its kind, became the foundation of modern academic medicine as we know it, and fostered a national and international reputation for excellence and discovery that continues to the present day. Today, Johns Hopkins uses one overarching name—Johns Hopkins Medicine—to identify its entire medical enterprise. Johns Hopkins Medicine in is a $6.5 billion integrated global health enterprise and one of the leading health care systems in the United States. This enterprise unites the physicians and scientists of the Johns Hopkins University School of Medicine with the health professionals and facilities that make up the broad, integrated Johns Hopkins Health System.