SPECIAL FOCUS COVID-19 vaccine shots setting,
bending bar on data standards COVID-19 dose administration illuminates need for tracking, tracing accuracy by Rick Dana Barlow
Photo credit: Lubo Ivanko |
stock.adobe.com was needed. T
But it did happen. Back in late April at a southwest sub- urban Chicago mass vaccination center (MVC), healthcare workers administered the wrong branded vaccine to eight per- sons receiving their second shots. They received one brand for their first shot and the other brand for their second shot. As healthcare experts tiptoed around
the possibility of some type of adverse reactions, none was recorded – or at least reported to the media. However, the incidents amplify a salient question: If the vaccine dosage bottles sported the proper bar codes or passive radio frequency identification (RFID) tags on the packaging, and the healthcare workers properly scanned the labels to match with a patient’s vaccination record kept by administrators in the county or state health department, how would this have happened? Further, how might the adoption and implementation of product data standards have affected the process and situation to follow?
Reporter Rebecca Robbins highlights
another issue as she wrote in The New York Times in late April that “millions of Americans are not getting the second doses of their COVID-19 vaccines, and their ranks are growing.” She cites data received from the Centers for Disease Control and Prevention (CDC) that “more than five million people, or nearly 8% of those who got a first shot of the Pfizer or Moderna vaccines, have missed their second doses.” One of the only ways for the CDC to know that is if the federal agency tracks
his wasn’t supposed to happen. At least it wasn’t designed to hap- pen this way. Or maybe more design
usage data provided by state and county health departments.
The same process used to track and trace the authenticity and production of drugs and devices for recalls and usage also can be used to track and trace patients as recipients, thereby closing the loop. “Because of the reliance on experi- enced manufacturers and on established distribution partners, there are systems in place to label and track shipments as well as record what products and lots are included,” acknowledged Keith Lohkamp, Senior Director, Industry Strategy, Workday. “This facilitates the exchange of information electronically so shipments and individual lots can be tracked to their destination.”
POU needs 4-1-1
Questions linger as to what happens once the individual lots are used at their desti- nation or the point of use. “Most pharmaceutical products, includ- ing vaccines, are labeled with bar codes containing standardized data that includes GS1 Global Trade Item Numbers (GTINs) with the U.S. FDA National Drug Code (NDC) for unique product identifica- tion, as well as expiration dates, serial numbers and lot numbers,” said Angela ernandez, Vice President Community Engagement, GS1 US. “Using global data standards, such as GS1, allows all stakeholders to communicate effectively about products’ move- ment through the supply chain from manufacturer all the way to the patient. “Standards
enable robust track and trace pro- 10 June 2021 • HEALTHCARE PURCHASING NEWS •
hpnonline.com Angela Fernandez
cesses, accurate inventory management and so much more – all critical factors for safe, effective and efficient distribution,” ernandez continued. “Sharing standard- ized data between suppliers, wholesale distributors and dispensers makes it pos- sible for all to understand what products are on order and where they are located – in shipping process or already onsite. This visibility helps ensure that clinicians can access them when needed. It also enables track and trace by assigning standardized product and location identifiers that can be captured and stored automatically at every point in the supply chain, maintain- ing those unique identifiers throughout a product’s journey for reliable information exchange and traceback capability. Fully implemented across the supply chain, standards keep products from ending up ‘lost’ in the chain, delaying or complicating inventory and availability for use.” But while inherently valuable, it’s not enough just to adopt and implement data standards, according to ernandez. “The key to making the most of stan-
dards is full implementation of a well- managed data quality program that is incorporated in day-to-day operations,” she insisted. “Pharmaceutical manufactur- ers have been building their technology and data management infrastructure for several years now, leveraging GS1 Stan- dards to meet regulatory requirements and improve supply chain visibility. As healthcare providers obtain scanners and train personnel on how to use them at point of care, all of the relevant product data can be captured, shared and accessed by stakeholders for full traceability.” Carl Gomberg, Lead Solution Analyst, ITS Cost Management, Premier Inc.,
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