Kit
Check, the leader in automated medication management solutions for
hospitals, today announced the acceptance of their pilot program that
includes partnerships with leading pharmaceutical organizations and
health systems to the Drug Supply Chain Security Act (DSCSA) from the
Food and Drug Administration (FDA). The focused pilot will enhance
requirements for package-level tracing and verification and explore RFID
as an alternative data carrier to the 2D barcode. The program, which
includes efforts from Hackensack
University Medical Center, Coral
Gables Hospital, Nephron
Pharmaceuticals and Sandoz,
a Novartis division.
The goal of this pilot is to demonstrate how an RFID data carrier for
electronic data exchanges can bring interoperability and tracking
improvements while lowering the costs associated with DSCSA compliance.
With RFID technologies in place, all parties involved will be able to
exchange product tracing information across the pharmaceutical
distribution supply chain, while identifying, managing, and preventing
the distribution of suspect and illegitimate products.
“Since the implementation of DSCSA in 2015, the FDA has made impressive
strides to improve the safety and security of the drug supply chain,”
said Lou Kennedy, chief executive officer, Nephron. “There are powerful
technologies operating today, such as RFID, that can significantly
improve our industry operations further. We are confident our pilot will
shine light on the impact RFID can have on the drug supply chain for
years to come and become a standard practice amongst all stakeholders.”
The pilot will leverage existing 2D barcode monitoring technology and
RFID so both methods can be evaluated and analyzed. This will allow
participants to show the areas for growth from the existing
technologies, while expanding the use cases and supporting data for
RFID. The labels and markers will be included on a range of injectable
drugs in vials and pre-filled syringes that meet the definitions laid
out by the FDA – following their journey from manufacturing through the
hospital.
“The DSCSA’s pilot program is intended to assist drug supply chain
stakeholders, including the FDA, to find innovative technologies that
can help track drugs that are distributed throughout the county. This is
of the utmost importance given the opioid epidemic and growing impact of
drug diversion in hospitals,” said Kevin MacDonald, CEO and co-founder
of Kit Check. “We are thrilled to partner with these forward-thinking
organizations that understand investing in next-generation technology
solutions will make an impact on the way drugs are distributed across
the U.S.”
The program is scheduled to last six months. Upon conclusion, the FDA
will make the final reports public alongside other DSCSA 2023
participants’ findings, with the hope that all supply chain stakeholders
can benefit from the data. To learn more about the DSCSA please visit
the FDA website at www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.
Additionally, a full list of FDA accepted pilot programs can be found
here: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/dscsa-pilot-project-program.
About Kit Check™
Kit Check is the leading provider of
automated medication management solutions for hospital pharmacies. Our
solutions blend powerful machine learning and advanced tracking
technology to streamline medication inventory, workflow, and auditing
processes and help hospital pharmacies cut costs, reduce risk, and get
more done. To date, our more than 500 U.S. and Canadian hospital
partners have tracked over 50 million medications using the Kit Check
and Bluesight™ for Controlled Substances software. More information
about Kit Check and our software solutions can be found at kitcheck.com.
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