FDA approves pilot program using next-generation blockchain to track medicine transfers
MEMPHIS, Tenn., April 25, 2019 – The U.S. Food and Drug Administration has approved a multi-regional pilot project studying the use of blockchain-enabled data technology to track intra- and inter-health care system medicine transfers. The pilot advances emerging best practices for health care system data sharing and coordination, creating a connected health infrastructure that paves the way for the patient-centric future that health care innovators worldwide are working toward.
Encompassing health system medicine transfers in North Carolina, Indiana and Tennessee, the pilot studies the application of various technologies for monitoring high-value specialty medicine quality across supply chains. Improved supply monitoring will save lives by enhancing quality control of medicines making their way to patients and providing data for more targeted inventory and recall management.
The FDA selected the consortium, comprised of Good Shepherd Pharmacy, RemediChain, Rymedi, Temptime/Zebra Technologies, Indiana University Health, WakeMed Hospitals and Health, the Center for Supply Chain Studies and the Global Health Policy Institute, to test implementation of the Drug Supply Chain Security Act.
“It’s an honor to be part of this world-class team of health care innovators and to be recognized as thought leaders in this space,” said Phil Baker, CEO of Good Shepherd Pharmacy. “This FDA pilot program will help set the standards for the future of health care and provide life-saving opportunities for the most vulnerable patients across the globe.”
Good Shepherd and RemediChain will apply the solution to medicine transfers in their pioneering approach to connecting donors with patients unable to afford specialty and rare disease medications. The end-to-end traceability assures patients, providers and regulators of the donated medication’s origin and quality.
Rymedi has a next-generation blockchain platform, which eases both integration of upstream supply data going back to the manufacturer and linking of patient medicine use and outcomes data for high-value, regulatory-grade real world evidence along the entire patient care continuum.
“Applying emerging technologies alongside regulatory standards development will not only ensure safe, quality products in health care, but will also display how our industry is evolving and working toward connected care innovation,” said David Stefanich, CEO of Rymedi. “Our platform, which was developed for use within highly regulated industries, marries all these drivers into a nexus of value for patients and increasingly connected parties across the health care ecosystem.”
Temptime, now part of Zebra Technologies, will apply sensors that provide crucial temperature monitoring that is especially important for biologic specialty medicines.
The Center for Supply Chain Studies and the Global Health Policy Institute at the University of California San Diego will provide design and evaluation support to optimize the pilot’s impact on policy and industry standards development.
Indiana University Health, the largest hospital network in Indiana, along with WakeMed Hospitals and Health, a hospital network serving the Raleigh, North Carolina, region, will implement the consortium solution to track specialty medicines across provider locations in their networks, as well as transfers to other provider networks.
The pilot will commence in August 2019 and will run for six months.
About Rymedi
Rymedi exists to help the health care industry collaborate and create value across silos. With technology designed for the highest global regulations, Rymedi enables companies across the health care ecosystem to more effectively capture, track and share data for smarter, faster health impact and improved patient outcomes.
About Temptime/Zebra Technology
Temptime Corporation is deeply committed to improving global public health. For nearly 30 years, Temptime temperature monitoring devices have helped health care workers immunize millions of children around the world and extend care to regions previously thought to be unreachable.
Zebra empowers those on the front line in retail, health care, transportation and logistics, manufacturing and other industries to achieve a performance edge, which translates to delighted customers, good patient outcomes and superior business results. With decades of industry experience and more than 10,000 partners across 100 countries, Zebra designs with frontline users and workplaces in mind, providing the best action guidance needed to optimize in-motion operations and make critical business decisions.
About Indiana University Health
Indiana University Health is a nonprofit health system and the largest network of physicians in the state of Indiana providing primary and specialty care. A unique partnership with Indiana University School of Medicine, one of the nation’s leading medical schools, gives patients access to leading-edge medicine and treatment options that are available first, and often only, at IU Health.
About WakeMed Hospitals & Health
Serving the Raleigh, North Carolina, community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and wellbeing of our community, we are committed to providing outstanding and compassionate care.
About the Center for Supply Chain Studies
As a neutral nonprofit organization, the Center for Supply Chain Studies (C4SCS) aims to support the entire supply chain in its ongoing efforts to stay connected, advance education, improve efficiencies and streamline compliance. The C4SCS hosts an online forum for team exploration and collaboration, closely monitors the health care industry, and shares insights with its members on compliance issues, challenging topics, emerging technologies and trends.
About the Global Health Policy Institute at the University of California San Diego
Established in 2014 as an affiliate with the UC San Diego – MAS Program in Health Policy and Law, the Global Health Policy Institute (GHPi) is a safe space for multidisciplinary research, education and advocacy aimed at improving domestic and global health outcomes. Members of GHPi constitute a diverse group of individuals from academia, government, the private sector and civil society with real world experience in global health and health policy, law and governance.
About RemediChain
RemediChain is the first company of its kind to use blockchain technology to address the financial and environmental problems of prescription waste and connect individual medication donors with patients in need. Created by Jide Anyigbo, Phil Baker, Ayile’ Arnett and Jason Fisher, the company began collecting unopened oral chemotherapy drugs from individual donors in 2019 and has plans to expand its network of donation sites throughout the United States. It is a member of Tokenize Tennessee, a trade organization focused on realizing the full potential of emerging technologies to drive a new era in the state. For more information, visit https://www.remedichain.com.
About Good Shepherd Pharmacy
Good Shepherd is a nonprofit pharmacy designed to meet the needs of people who can’t afford their medications. The GoodShepRx membership program provides access to at-cost or donated medication to over 1,000 vulnerable patients with chronic conditions. In 2017, Good Shepherd Pharmacy gained national recognition for the creation of a prescription repository which accepts prescription donations from any individual in the United States. In 2018 the team launched RemediChain, a blockchain platform that connects people who wish to donate unopened chemotherapy drugs to those who would not otherwise be able to afford their life-saving medication.
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