Blockchain Pilot That Will Track Specialty Prescription Drugs Approved by FDA

May 3, 2019

The U.S. Food and Drug Administration (FDA) has approved a pilot in which an array of healthcare stakeholders will study the use of blockchain-enabled technology to track and verify specialty prescription drugs.

This pilot will focus on intra- and inter-health system medication transport and usage in North Carolina, Indiana and Tennessee, and will study the application of blockchain and Internet of Things (IoT) technology used to monitor specialty medication distribution across supply chains. “Improved supply monitoring will enhance quality control of medicine, provide data for more targeted inventory and recall management and save lives,” officials noted in an announcement.

The participating organizations include Indiana University Health, WakeMed Health & Hospitals, Good Shepherd Pharmacy, as well as healthcare blockchain company Rymedi and healthcare solutions company Temptime, which was recently acquired by Zebra Technologies. 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 help optimize the pilot's impact on policy and industry standards development, officials stated.

The group will test implementation of the Drug Supply Chain Security Act (DSCSA), starting in August 2019. Indiana University Health, the largest hospital network in Indiana, and WakeMed Health & Hospitals in Raleigh, N.C., will implement the blockchain solution to track specialty medicines across provider locations within their networks, as well as transfers to other provider networks—as is commonly done to address regional inventory shortages.

"Blockchain technology provides a platform to innovate healthcare delivery, and we are proud to be part of the collaborative effort to enhance interoperability for the benefit of patients," said Diana Rhyne, executive director for WakeMed Innovations. "Its applications have the potential to make a positive impact across the full spectrum of the healthcare continuum—from data integrity and pharmaceutical supply chain to improved patient safety and health outcomes."

Meanwhile, the Memphis-based Good Shepherd Pharmacy and its associated RemediChain project will look to apply the solution to medicine transfers in their pioneering approach to connecting patients unable to afford specialty and rare disease medications with donated medications.

On the technology side, Rymedi's data platform provides supply genealogy and multi-partner data access, alongside standard operating procedures within hospital networks after they take custody of medicines from wholesale distributors and third-party logistics providers, while the Temptime technology helps to monitor temperature- sensitive medical and biological products and devices.

Beyond testing the implementation of blockchain and IoT technology, officials contend that this pilot will aim to advance emerging best practices for healthcare system data sharing and coordination. “With movements toward value-based healthcare and precision medicine advancing in the U.S. and abroad, this connected health infrastructure paves the way for the patient-centric future that healthcare innovators worldwide are working towards,” they said.