SPECIAL FOCUS
recognizes that emerg- ing requirements under the Drug Supply Chain Security Act motivates the pharmaceutical industry track-and-trace efforts using systems and stan- dards, including Elec-
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.
Carl Gomberg
tronic Product Code Information Services (EPCIS) and Global Location Number (GLN) to monitor end-to-end logistics, prevent theft and stop counterfeit prod- uct before it enters the supply chain. The leap to managing vaccine distribution and administration isn’t a difficult one, he added.
“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 vis- ibility down to the lot number,” Gomberg indicated. “With COVID-19, there is a criti- cal need to accurately identify and match people to their vaccine administration data since there are multiple vaccinations avail- able, some requiring multiple doses, and people may receive their first and second vaccine doses in different locations.” Further, Gomberg opines that this pro- cess could be applied to personal protec- tive 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 Yet, the key COVID-19 vaccine manu- facturing and distribution services have concentrated their efforts on bulk con- tainer-based supply chain tracking and tracing and temperature monitoring, according to Chris Caulfield, Vice Pres- ident, Temptime Opera- tions, Zebra Technologies. “The Biden Administra- tion’s desire to accelerate vaccination throughput via a network of mass
Chris Caulfield
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
Caulfield recommends that in the short term, 2-D bar code and scanning technol- ogy 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 ID tags on multi-pack boxes can help, too, as they can be scanned at any point in the sup- ply chain, according to Caulfield. “This enables automated visibility of product shipments at the lot/batch level and accountability for vaccine dose manage- ment until the last mile delivery. ID tags provide another layer of anticounterfeiting technology and allow an automated means of expediting vaccine dose receipt, distri- bution, and use,” he added. Further, using the GS1 standard to represent “item iden- tification 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.” Carl Henshaw, Director, Standards Implementation, Vizient, homed in on the product temperature requirements as a valid and reliable reason for tracking, tracing and data standards use.
“The Moderna and the Pfizer vaccines are both based on mNA tech- nology that requires much colder tem- peratures to remain stable. For example, the Pfizer COVID-19 vaccine must be stored between -112 and -76 Fahrenheit,” Henshaw said. “To effectively adminis- ter 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.”
Carl Henshaw 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 Data- base (GUDID). The UDI represents the
combination of a device identifier (GTIN UPNISBT12) 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 require- ment to comply pushed to September 2022. “Once UDI standards are fully imple- mented, tracking PPE will be easier,” he assured.
Four-leafed closer
Carrie Gorman, Account Executive, Healthcare, Tecsys Inc., encapsulates the premise and promise of global data stan- dards in four ways.
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 pro- vide manufacturers with actionable data to enable accurate volumes of vaccine produc- tion 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 pro- duce 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 manufac- turer to report actual regional demand for second doses.”
Carrie Gorman
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 procure- ment. 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 usu- ally 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 accu-
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