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Pharma: Under the gun on traceability

Chain of custody initiatives in health care supply chains face new FDA mandates, and compliance isn’t simple. Here’s a look at some of the considerations and systems involved.

Health care supply chains are at an inflection point, readying for new traceability regulations from the U.S. Food & Drug Administration (FDA). However, these latest challenges may best be seen as part of longer-standing movement toward improving “chain of custody” information from manufacturing to point of use.

You can’t get much more safety critical than “point of use” in health care, since it means a patient’s mouth for pills or inside the body for implantables like artificial joints. That’s why tracing the pedigree of these items is seen as necessary by the FDA, as well as beneficial to manufacturers who don’t want counterfeits slipping into the market.

For prescription drugs, the new traceability requirement comes from the FDA’s Drug Supply Chain Security Act (DSCSA), which was signed into law in November 2013. The act’s lot-level tracing requirements for manufacturers, wholesalers and “repackagers” began in January 2015. There are other DSCSA requirements to be phased in, culminating in item-level traceability using a “product identifier” format that can be supported with 2D data matrix bar codes. Manufacturers of regulated drugs must have product identifiers on items by late November 2017.

According to the FDA, the three key goals of the act are to:
• enable verification and legitimacy of drugs down to the item/package level,
• enhance detection of illegitimate products in supply chains, 
• and support efficient recalls.

Attaining these goals involves supply chain execution (SCE) software such as warehouse management system (WMS) solutions, and will rely on use of appropriate automatic identification and data capture (AIDC) technology. Other systems may be involved, such as inventory control and patient record systems at hospitals, and solutions from vendors that specialize in cloud-based management of traceability data. What’s more, traceability ultimately involves the whole supply chain, not just the manufacturer or distributor.

“The idea is to have effective, detailed traceability so you know that you got an item from a trusted partner upstream in the supply chain, who got it from somebody trusted in the supply chain,” says Robert Colosino, vice president of marketing and business development with TECSYS. “There needs to be complete confidence in that pill being dispensed.”

WMS capabilities
While the act starts with lot-level traceability, and most WMS solutions are capable of tracking lots, says Colosino, the rule progresses to item-level tracking, so distribution centers need to be ready to accomplish this as accurately and efficiently as possible. To facilitate item-level tracking, FDA collaborated with industry organizations including GS1 to establish the needed data elements, such as serial number, expiry date and unit of measure. Manufacturers can use a 2D bar code to comply with DSCSA, making use of GS1’s Global Trade Item Number (GTIN) format and appropriate GTIN guidelines for the DSCSA.

Actually attaining supply chain wide traceability, however, is more complex than slapping a 2D bar code on every pill box. One challenge, notes Colosino, is being able to accurately identify each item in a shipment being received without having to hand-scan items. To avoid that, says Colosino, WMS solutions should be able to “infer” serialized item data by accepting a single scan on inbound goods and cross-referencing the scan with advanced ship notice (ASN) messages and serialized item data from the manufacturer.

The WMS should also be able to manage and store items according to expiration date and other criteria, such as whether it needs to be refrigerated, adds Colosino. For distributors, the WMS also needs to account for, verify and communicate what is sent to downstream customers, down to the item level. “It’s a matter of being a trusted partner so that when the next entity in the chain receives a shipment, they can receive it efficiently,” says Colosino.

WMS solutions for pharmaceuticals distributors need to support serialized track and trace that spans every movement of goods, from receiving, through the warehouse, and even for reverse logistics, says Michael Armanious, vice president of sales and marketing for Datex. Reverse logistics comes into play with expired prescription drugs that return to a DC for destruction.

For certain drugs, such as prescription narcotics, pharmacies will send back sealed bags of expired products, with a signed statement saying how many pills are being returned, says Armanious. At some DCs, this reverse count for painkillers is done under camera surveillance, and if there is a discrepancy between the actual count and what is on the bag, the WMS needs to alert managers and reroute the bag for investigation.

Tweaking WMS or other database-driven systems used in the pharmaceuticals industry is a rigorous process because they might be FDA-validated systems. With FDA-validated systems, says Armanious, changes related to product attributes, such as changing the dimension of an item, should have audit control over changes, including a database record of who made the change and when. Some WMS vendors may not have this type of change control built into the database structure, he adds.

Making changes to FDA-validated systems, which might be needed to support item-level traceability, is a genuine concern because of the effort involved in being able to document changes and test them, says Sheila Dooley, a business analyst with Bastian Solutions. “It’s not a rapid process when making changes to validated systems,” she says.

With some older WMS solutions that don’t support processes such as matching scanned information from inbound shipments to ASNs and records of valid serial numbers, the system may need to be modified so that it has the proper routing steps to either accept goods or put them on hold, says Dooley. Some materials handling systems and scanning equipment may also need modification or upgrades, she adds, such as making sure that bar code readers can read 2D codes.

With DSCSA’s item-level tracking requirement on the horizon, it’s also possible that some picking systems such as pick-to-light may need to be modified to let pickers know that a scan needs to be performed on an item to capture the serialized item data, rather than the pick-to-light simply indicating the number of an item to pick. An extra color code might be all that’s needed, but that change would need to be tested, says Dooley.

“The best advice is to start sooner rather than later,” Dooley says. “It’s best to sit down now and figure out the changes that need to be made, then get those pieces in and fully tested, so that you can rule them out as problem issues when the deadline sets in.”

Verifying each shipment
Distributors, of course, aren’t just shipping out full pallets of one stock-keeping unit (SKU). One shipment in a tote might contain 100 different items. This makes it necessary for distributors to not only be able to pick items accurately and send a data file or an ASN to customers on what to expect, but to verify exactly what is in each shipment before it goes out the door.

For outbound order processing, hand scanning each GTIN code on each item as it is picked is time consuming, says Ross Halket, executive director of automation sales with Schaefer Systems International. For higher-volume scenarios, an efficient approach is to “decouple” the picking from the serialized bar code verification step, says Halket, by sending picked items to an order verification lane with a fixed-position scan tunnel.

The “order verifier” solution that Schaefer offers consists of narrow V-belts that move at different speeds to shift items or “singulate” them into a single line so they can be scanned with complete accuracy. The belts can singulate on their own with boxed items, but with vials or round items, it is recommended that a person manually singulate items. “We believe that by decoupling the outbound verification process, you can still have efficient, high-speed picking combined with an efficient, high-speed scanning and confirmation step,” says Halket.

Health care organizations and suppliers of medical devices also face a chain of custody challenge under the FDA’s Unique Device Identifier (UDI) rule. The rule, finalized in 2013 and being phased in over several years dependent upon the class of device, establishes an identification format and reporting system that goes down to the item level so that devices can be tracked through distribution and use. As part of the UDI, medical device manufacturers and others who label the devices are required to submit information to an FDA-administered data repository called the Global Unique Device Identification Database (GUDID).

The FDA has worked with organizations including GS1 and the Health Industry Business Communications Council (HIBCC) to establish standard data elements for UDI labeling, bar codes or radio frequency identification (RFID) tags. The FDA doesn’t specify what type of AIDC to use, but sets forth the data elements to be represented, including a mandatory “device identifier” portion, and a “production identifier” portion that holds information such as lot number, serial number, date of manufacture and expiration date, if applicable.

The UDI rule has health care organizations and medical device suppliers looking at the most accurate ways of generating UDI-compliant labels, scanning them and getting the data into the necessary supply chain and electronic health record (EHR) systems, as well as the GUDID, according to David Coons, vice president of advanced markets and technology for Zebra Technologies. The data collection isn’t as simple as acquiring some bar code printers and readers, Coons contends, because there are AIDC devices to manage, and a reliable network infrastructure is needed to support data gathering. Some organizations may even want to employ RFID and real-time locating system (RTLS) solutions as part of tracking some critical items under UDI.

Zebra offers a bundled approach for UDI compliance, Coons explains, which spans bar code printers, readers, label design software, printer device management and RFID/RLTS solutions. Zebra’s “Zatar” Internet of Things platform might also be used for organizations wanting to manage infrastructure centrally in the cloud, while some hospitals may want to upgrade their wireless LAN infrastructure. “We are bundling all of these components as needed by the client to provide an industry solution, rather than having the health care organization go out and acquire components from different vendors and piece together a reliable solution,” he says.

In health care, UDI traceability at the patient level means that data collected at the point of use should integrate with EHR systems to create an audit trail of which devices were used on specific patients. As are result, it’s important that AIDC vendors work closely with EHR vendors so that bar code labeling and scanned data works flawlessly with EHR systems. “The aspect of working closely with these independent software vendors is critical,” says Coons.

Supply chain thinking
The biggest factor working in favor of better traceability in health care supply chains might just be the attitude of health care organizations. Not too many years ago, most health care organizations treated supply chain management as overhead or at best a sideline to their real mission of providing health care. But steadily over the last decade, more health care companies have come to realize that supply chain excellence is crucial to their profitability and effectiveness as providers of care, says Colosino.

Hospitals have undertaken supply chain initiatives such as pooling their buying power by starting group purchasing organizations. More recently, hospitals have streamlined distribution by establishing consolidated service centers (CSCs) rather than having individual hospitals work with distributors to procure supplies. They’ve even brought in distribution professionals to run these CSCs and are using WMS and other SCE solutions to better manage operations. “They’ve really transformed the way they are operating by becoming supply chain companies,” says Colosino.

Hospitals also have begun using better inventory control solutions and data capture technology to manage the point of use without interfering with the work of clinicians, says Colosino. While bar code scanning is the backbone of inventory tracking at most hospitals, in some areas, RFID is used so that clinicians can just grab and use high-value items without having to stop and scan them.

For example, says Colosino, in some operating rooms, RFID-enabled case carts are used to track high-value items consumed during an operation. A supply chain staff person loads up each cart with RFID-tagged items. During the operation, after each item is used, it is placed in a receptacle outfitted with a reader, which records each item consumed. RFID can be a good solution for scenarios where the goods are high value, and you don’t want to distract highly paid clinicians with data collection tasks, Colosino says. “You need to build clinician friendly solutions for traceability,” he says.

The new attitude at hospitals toward supply chain management bodes well for improved traceability, says Colosino, even if many hospitals still have a long way to go. As Colosino sums up, “The majority of hospitals aren’t there yet in achieving supply chain excellence, but the majority recognize they need to get there and have active initiatives to try to get them there.”

Companies mentioned in this article
• Bastian Solutions
• Datex
• Schaefer Systems International
• Zebra Technologies

Article Topics

Automatic Data Capture
Bastian Solutions
Internet of Things
SATO America
SSI Schaefer
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About the Author

Roberto Michel's avatar
Roberto Michel
Roberto Michel, senior editor for Modern, has covered manufacturing and supply chain management trends since 1996, mainly as a former staff editor and former contributor at Manufacturing Business Technology. He has been a contributor to Modern since 2004. He has worked on numerous show dailies, including at ProMat, the North American Material Handling Logistics show, and National Manufacturing Week. You can reach him at: [email protected].
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