This wasn’t supposed to happen.
At least it wasn’t designed to happen this way. Or maybe more design was needed.
But it did happen.
Back in late April at a southwest suburban Chicago mass vaccination center (MVC), healthcare workers administered the wrong branded vaccine to eight persons 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 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 experienced 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 destination or the point of use.
“Standards enable robust track and trace processes, accurate inventory management and so much more – all critical factors for safe, effective and efficient distribution,” Fernandez continued. “Sharing standardized data between suppliers, wholesale distributors and dispensers makes it possible 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, maintaining 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 Fernandez.
“The key to making the most of standards is full implementation of a well-managed data quality program that is incorporated in day-to-day operations,” she insisted. “Pharmaceutical manufacturers have been building their technology and data management infrastructure for several years now, leveraging GS1 Standards 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.”
“Couple this with Health Information Exchange (HIE) under Meaningful Use – which facilitates electronic transport of patient data from medical records – and we could record and share if a patient has received a vaccine, garnering supply visibility down to the lot number,” Gomberg indicated. “With COVID-19, there is a critical need to accurately identify and match people to their vaccine administration data since there are multiple vaccinations available, some requiring multiple doses, and people may receive their first and second vaccine doses in different locations.”
Further, Gomberg opines that this process could be applied to personal protective equipment (PPE), expanding the use of Unique Device Identification (UDI) beyond recording implantable devices in patient medical records also to include PPE in clinical environments to better track usage and need.
To each his/her own
“The Biden Administration’s desire to accelerate vaccination throughput via a network of mass vaccination sites and retail pharmacies will require the addition of a strong vial-based focus to vaccine supply chain tracking and tracing and temperature monitoring,” Caulfield urged. “This is due to the workflows at local vaccination sites, including onsite vaccine vial management, patient injection recordation, second dose administration tracking, and wastage rate data collection. All of these workflows require vial-level information that lends itself to 2-D bar coding and scanning – as an alternative to manual data entry.
“Moreover, the data needed to identify counterfeit product or support product recalls will require vial-level detail,” he added.
Caulfield recommends that in the short term, 2-D bar code and scanning technology can help fulfill the track-and-trace goal, consistent with the policy noted in the Drug Supply Chain Security Act of 2013.
Vaccine manufacturer-affixed RFID tags on multi-pack boxes can help, too, as they can be scanned at any point in the supply chain, according to Caulfield. “This enables automated visibility of product shipments at the lot/batch level and accountability for vaccine dose management until the last mile delivery. RFID tags provide another layer of anticounterfeiting technology and allow an automated means of expediting vaccine dose receipt, distribution, and use,” he added. Further, using the GS1 standard to represent “item identification and other extended data fields will enable all supply chain operations to encode and read this data without the need for proprietary or custom arrangements.”
“The Moderna and the Pfizer vaccines are both based on mRNA technology that requires much colder temperatures to remain stable. For example, the Pfizer COVID-19 vaccine must be stored between -112 and -76 Fahrenheit,” Henshaw said. “To effectively administer these types of vaccines, the ability to demonstrate that the Cold Chain remains unbroken is critical. Standards from the Drug Supply Chain Security Act (DSCSA) require that to remove the threat of counterfeit and stolen products from the market, the chain of custody must begin with the manufacturer, continue on to the distributor and then the pharmacy. Those data standards include labeling the various levels of vaccine packaging and ensuring material handlers at vaccine sites have machine-readable codes for appropriate tracking.”
The U.S. Food and Drug Administration (FDA) requires items, like PPE, bear a unique device identifier (UDI) for that data to be submitted to the federal agency’s Global Unique Device Identification Database (GUDID). The UDI represents the combination of a device identifier (GTIN/UPN/ISBT128) and a production identifier (lot/batch/serial number/expiration date, manufactured date).
“While many manufacturers apply barcodes that meet these requirements already ahead of schedule, not everyone does because it is not yet mandated,” Henshaw said. The FDA began phasing in standards by device class in 2014. The final phase, involving Class I and unclassified devices, of which PPE is categorized, has been postponed twice with the requirement to comply pushed to September 2022.
“Once UDI standards are fully implemented, tracking PPE will be easier,” he assured.
The first involves demand planning and forecasting, which emerged as a hot button at the start of the pandemic in early 2020.
“Global data standards – worldwide, not just at a federal level – can provide manufacturers with actionable data to enable accurate volumes of vaccine production and be much better prepared when the next pandemic or emergency comes along,” Gorman said. “This is the No. 1 lesson that COVID-19 has taught us with regard to PPE: There wasn’t a shortage of PPE as much as there was a shortage of data that manufacturers needed to produce the right quantity of PPE. Applied to a two-dose vaccination effort, consistent data standards ensure accurate data is shared with the state and the manufacturer to report actual regional demand for second doses.”
The second spans interoperability.
“Consistent data standards around the world would mean that all systems can digest, store, track and share the same data across systems,” she continued. “This is a challenge today in healthcare procurement. One distributor may abbreviate the [Unit-of-Measure] (UOM) Case as CA and another distributor uses CS. When data like UOM is inconsistent, the systems usually need to be manually updated to ensure accuracy. Aligning on a standard would eliminate the risk of ordering the wrong item or the wrong quantity of items.”
The third covers traceability.
“As basic as it sounds, consistently applied data standards allows for accurate reconciliation of the location of vaccines during transport and administration processes — enabling a true and complete chain of custody,” Gorman indicated. “Unfortunately, today, this level of data is not consistent across state lines or countries, which fragments the data being used to report on distribution and administration. That degree of visibility means if there is an error that occurs during the distribution process – truck is in an accident, vaccines are spoiled in route or late to the site – having accurate data standards can help easily identify which vaccines were impacted.”
The fourth ensures labor optimization.
“From an efficiency standpoint, juggling data standards is a major drain on labor,” she noted. “One large health system’s Cath Lab administrative director estimates the annual cost for participating in and supporting cardiac data registries is over $1 million and employs 15 highly skilled registered nurses.”
As a snapshot of supply chain organization and momentum, COVID-19 vaccine production, distribution and administration has unearthed several questions and concerns that are inherently solvable, according to Ashok Muttin, Founder & CEO, SupplyCopia.
“Tracking vaccines from the point of manufacture through distribution to the point of care – wherever that may be – has illuminated more of the gaps we have in supply data standards,” Muttin noted. “While COVID-19 vaccine lot data is consistently identified and tracked, challenges occur in the last mile of distribution, and disparate systems make it difficult to bridge gaps. At the end of this process, do we know where all of the data will be and how to access it? How much is now on paper? What processes are in place to gather data from different locations? We have to close these gaps. Yet, it’s easy to see how challenges are exacerbated in the example we’re living through today, with vaccines requiring multiple doses, and potentially booster shots that also must be tracked.”
Better supply chain tracking mechanisms would help identify “wastage” and whether damaged vaccines are destroyed, helping to prevent black market resale of damaged doses, Muttin observes.
Muttin believes that improving visibility to PPE, which experienced seemingly insatiable demand during the last 14 months, can be achieved today. “With more consistent capture of product identification data, it becomes easier to track and understand PPE throughout a healthcare system, even across the industry and globe,” he insisted. “Accurate demand planning – and supplier risk analysis – become reality with consistent application of product identification data.”
But Muttin cautions about persistent challenges to demand planning efforts that include a “vast array of suppliers based outside our traditional boundaries, with their own PPE requirements, and political situations that influence exporting abilities.” This can include a container ship, for example, that runs ashore and blocks a canal used in global shipping routes.
“Consistent, global product identification builds greater visibility to these suppliers, while allowing providers to understand opportunity and risk,” he noted. “For accurate demand planning at the local level, an organization has to connect in real time to the number of COVID-19 cases, in a particular geography, down to the ZIP code level.”