The Food and Drug Administration has approved a pilot to study the use of healthcare blockchain to track and verify specialty prescription drugs.

April 29, 2019 – The Food and Drug Administration (FDA) has approved a pilot to study the use of healthcare blockchain to track and verify specialty prescription drugs.

The pilot consortium includes Indiana University Health, WakeMed Health and Hospitals, Good Shepherd Pharmacy and its RemediChain project, healthcare blockchain firm Rymedi, Zebra Technologies’ Temptime, the Center for Supply Chain Studies, and the Global Health Policy Institute.

The group said it will test implementation of the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines drug product tracking requirements for manufacturers, repackagers, distributors, dispensers, and third-party logistics providers. The requirements are being phased in through 2023.

This pilot will focus on health system medication transport and usage in North Carolina, Indiana, and Tennessee. It will examine the application of blockchain and Internet of Things (IoT) technology used to monitor specialty medication distribution across supply chains. Improved supply monitoring is expected to enhance quality control of medicine, provide data for more targeted inventory and recall management, and improve patient safety.

Beyond testing the implementation of blockchain and IoT technology, this pilot advances emerging best-practices for healthcare system data sharing and coordination. With movements toward value-based healthcare and precision medicine advancing in the United States and abroad, this connected health infrastructure paves the way for the patient-centric future that healthcare innovators are working towards.

“Applying emerging technologies alongside regulatory standards development will not only ensure safe, quality products in healthcare, but will also display how our industry is evolving and working towards connected care innovation,” said Rymedi CEO David Stefanich.

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 improve the pilot’s impact on policy and industry standards development.

Indiana University Health, the largest hospital network in Indiana, and WakeMed Health & Hospitals, a provider of health services in Raleigh, NC, will implement the blockchain solution to track specialty medicines across provider locations within their networks, as well as transfers to other provider networks to address 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 WakeMed Innovations Executive Director Diana Rhyne. “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.”

Good Shepherd Pharmacy and its associated RemediChain project will use the solution for medicine transfers in their approach to connecting patients unable to afford specialty and rare disease medications with donated medications, while assuring patients, regulators, and providers of the origin and quality of the donated medicines.

Temptime Managing Director Renaat Van den Hooff noted that global supply chains are “cold-chains that distribute highly temperature-sensitive, life-saving medicines. Improving patient safety, helping to preserve drug quality, and reducing fraud and waste in supply chains through the use of temperature sensors and smart labels is the reason we do what we do, and we believe this is essential to supporting FDA’s DSCSA implementation efforts.”

Drug supply chain management was identified as one of the use cases for healthcare blockchain in a HITInfrastructure.com feature article.

Blockchain can be employed to “track drugs, medications, from manufacturing to distribution, to use in dispensaries, to be able to root out counterfeit drugs, to be able to get better transparency and efficiencies on the usage sides, or the point of use at the dispensaries, like a pharmacy,” David Houlding, Principal Healthcare Lead at Microsoft Azure and chair of the HIMSS Blockchain in the Healthcare Task Force, told HITInfrastructure.com.

Aditya Kudumala, a principal at Deloitte Consulting, said that blockchain can increase traceability of drugs in the supply chain network.

“The blockchain is helping us create that whole chain of custody in a much better way than what we had before. We can have near real-time exchange of information happening from the manufacturer of the drug to the distributors, to the logistics providers, to the sites and, and ultimately to the patient,” he said.

Source: https://hitinfrastructure.com/news/fda-okays-healthcare-blockchain-pilot-to-track-specialty-drugs