Networking For Data Sharing

FDA’s approach for securing the drug supply chain was clarified last month when the agency issued final guidance on a serialized standard numerical identifier (SNI).

 

As with the agency’s draft guidance of January 2009, the agency said it should be viewed as recommendations and its current thinking on the topic. Though offered as recommendations—and without naming dates for implementation—the guidance defines a standard that will likely hasten companies’ investment in serialization solutions.

 

“In issuing final guidance and not a proposed regulation, FDA took an incremental approach, signaling its desire to continue to refine its concept and to receive industry feedback before publishing a proposed regulation,” says George Wright IV, vice president of Product Identification & Processing Systems (PIPS; New York City).

 

The guidance aligns the sNDC with GS1’s definition of a product serial number, expanding the number of digits described for the serial number appended to the NDC in the SNI from eight numbers to “no more than 20” alpha or numeric characters.

 

In saying that the SNI is compatible with international standards as required by the law, the guidance describes that: “Use of an sNDC is compatible with and may be presented within a GTIN, which can be serialized using an Application Identifier (A1) (21) to create a serialized GTIN (sGTIN) for use with RFID or for certain bar codes.”

 

The combination of the serial number of up to 20 characters with the NDC will be “sufficiently robust to support billions of units of marked products without duplication of an SNI,” the guidance notes.

 

 “The agency refined its draft guidance from January 16, 2009, incorporating recommendations from stakeholders so that the SNI is defined in conformance with the constructs of the most widely established national and international product coding and marking standards,” says Wright.

 

“Specifically, FDA now recognizes the product identification and serialization data structures of the global GS1 system as an appropriate vehicle for implementation of the SNI. The serial number portion of the SNI is made fully compatible with the GS1 Application Identifier 21 serial number structure,” Wright says.

 

“GS1 standards define the use of a GTIN for product identification at every level of packaging. The GTIN, with the NDC embedded, and its associated U.P.C. symbol, has been the de facto standard for OTC and drug package-level identification in the United States for more than 30 years,” Wright adds.

 

In establishing unique identification at the salable level of packaging with the guidance, FDA is favoring a user-driven process by not being overly prescriptive on the technology and symbology, an approach supported in many comments on the draft guidance.

 

The guidance states that the “SNI generally should be applied to each package in both human-readable and machine-readable form,” and maintains the data-carrier-neutral position of the draft version.

 

“At this time, FDA is not specifying the means of incorporating the SNI onto the package,” the agency says, noting that the SNI described is compatible with encoding into a variety of machine readable forms of data carriers, including 2-D bar codes and RFID.

 

The SNI guidance will be followed by agency standards for a track and trace system expected to be released later this year.

 

Industry is planning for the deadlines and high bar for electronic tracking of serialized packaging established by California. Those requirements would gain national scope should the federal Buyer-Matheson Act—whose deadlines for product coding and pedigree tracing mirror California’s—ever evolve into law.

 

Pedigree models and the Drug Pedigree Messaging Standard (DPMS) are being used to comply with pedigree legislation in place or pending in 30 states today. The nested-document format where each partner appends pedigree information with a digital signature as product moves unidirectionally through the chain provides investigators with documentation of products’ lineage.

 

Companies are exploring the benefits available when data on business events is shared on-demand, leveraging open standards. GS1’s EPCIS standard defines a framework for conveying business transaction events that promises advantages beyond product security.

 

“Both standards are very valuable, and I think the end-state will be a mix of the two,” said Bob Celeste, director, healthcare, GS1 US, at the Center for Business Intelligence (CBI) Summit
on anticounterfeiting last month in Philadelphia.

 

Celeste described EPCIS as “a general purpose tracking platform designed to describe, capture, and share product movements [through] discrete, lightweight information exchange. EPCIS was not designed for e-pedigree, but it can be used [for that purpose].”

 

Industry has identified 130 business processes where increased supply chain visibility—supported by serialized packaging—could yield business value. The benefit of serialized packaging would accrue, for example, in management of forward and reverse logistics and returns, shrink and loss prevention, and vendor-managed inventory as a mechanism to keep inventories down.

 

FORGING CONSENSUS

Johnson & Johnson (New Brunswick, NJ) is actively working toward GS1 standards in exploring the advantages of track and trace for its three business groups of medical devices, consumer products, and pharmaceuticals, said Michael Rose, vice president, supply chain visibility, Worldwide Supply Chain Group, Johnson & Johnson, at the CBI event.

 

“The critical issue is: How do we work together as an industry to solve this problem,” Rose said.

 

“We look at track and trace as a platform investment. Ultimately, it comes down to patient safety. [But in addition], on-demand sharing of information provides an opportunity to do a diagnosis of the supply chain [using more readily available and timely information]. Visibility into supply chain events provides a great opportunity to provide additional business value,” Rose said.

 

“The California mandate (and those of other countries) become an enabler that will force the supply chain to come together,” he added.

 

HDMA’s Center for Supply Chain Research has described the business advantages derived from data sharing when the status of serialized products can be tracked in the supply chain.

 

A network registry will be a key element for cross-supply chain visibility, as an agent for discovering and retrieving information over the Internet. “The complicating factor is how do we start managing these connections,” Rose said.

 

Rose said pharmaceutical companies are exploring leveraging GS1’s standards with the Global Healthcare Exchange (GHX) business hub for creating an interoperable track and trace system for the pharma supply chain.

GHX manages purchasing transactions in the medical and surgical device supply chain, synchronizing events among suppliers, group purchasing organizations (GPOs), wholesalers, and healthcare providers. In providing services that include content, inventory, and financial management, the exchange processed over $30 billion in medical/surgical supply transactions in 2009, says Margot Drees, director of corporate strategy, GHX.

 

DYNAMIC DATA CAPTURE

GHX is investigating how its service can be used to support pharmaceutical supply chain transactions, and has started educating the pharma sector about its services, Drees says.

 

“We have been invited to look at this by many members of the pharmaceutical industry. Manufacturers and wholesalers that handle both devices and drugs see that the infrastructure is in place for providing registry and track and trace services on the pharmaceutical side,” Drees says.

 

“GHX is an asset that has been used for ten years. We are an open and neutral business model. We have a strong data governance policy where only trading partners in a relationship have access to the data,” Drees says.

GHX’s attraction also lies in its status as a member-owned company, founded in 2000 by firms including J&J, GE, Medtronic, Abbott, and Baxter, Drees adds.

 

GHX today is owned by 20 companies representing all segments of the healthcare supply chain. Its membership includes 6000 manufacturers, 3500 hospitals, and the major wholesalers and GPOs.

 

In medical device transactions, GHX drives e-commerce by converting communications to the various formats that can be received by trading partners. The exchange hosts the AllSource repository that catalogs master data for three million medical/surgical items. Many manufacturers publish their master data to GHX’s Health ConneXion, a data pool that conforms to GS1’s Global Data Synchronization Network (GDSN) standard. As a global standard, GDSN offers a framework from which companies from any country can publish and subscribe to data through Health ConneXion.

 

For supporting pharma supply chain traceability, the data pools will need to correspond with a dynamic transaction registry. The registry hosts the trading partner relationships and the events that happen with the product, marrying cataloged master data with product flow information, Drees says.

 

“We are investigating how to build a registry, using EPCIS as the data information exchange standard for business events. Our hypothesis is we can do this to make a registry, but it will have to be supported by the development of additional standards,” she says.

 

Users will be able to query the registry on a product and generate the chain of custody of where the product has been in the supply chain, tracked to the point where it is received at the dispensing location.

Only a handful of medical device products are serialized today. A solution for pharma would need to anticipate serialization.

 

“We don’t see any particular barriers to entry. There will be an order of magnitude more data (with serialization). But we are well positioned to handle that based on the volumes we handle today,” Drees says.

 

GHX was certified as a GDSN data pool last year, as one of 30 GDSN data pools around the world, Celeste says.

“There are a number of different ways of using EPCIS. You can use a service, or a company can have its own data repository for sharing data with trading partners,” he adds.

 

DEMAND FOR VARIABLE PRINTING

Initiatives that favor bar coding in Europe are driving firms’ investment in in-line printing solutions. The European Commission is drafting regulation for anticounterfeiting laws in EU member states that would require identification of prescription meds at the package level for tracing their supply chain movement.

 

Biopharma companies, wholesalers, and pharmacies tracked linear and serialized 2-D bar coded packages in an EFPIA-sponsored pilot in Stockholm, Sweden, where pharmacists scanned the codes to authenticate packages prior to dispensing.

 

As companies gear up for serialization requirements, programmable printing offers advantages in printing efficiency and quality control, besides flexibility for package coding, says Tom Pugh, vice president of sales at Bell-Mark Corp. (Pine Brook, NJ).

 

“Our customers see the Unique Device Identifier coming for medical device packaging. They want to get prepared for it and are adding variable printing solutions to satisfy it,” Pugh says.

 

“In the short run, some companies might add a thermal ink-jet printer to supplement their contact printing technology. [But] companies buying a new packaging machine with a printing option certainly would not consider rotary flexography or platen printing. Why use a second printing system when you can buy something that prints the entire package?” Pugh observes.

 

Bell-Mark customers in Europe and the United States are adopting thermal-transfer printing for full web printing, says Pugh.

 

“With a programmable printing system, you are maximizing packaging line space, reducing or eliminating downtime associated with printing plates and ink changes, and eliminating preprinted web inventory. You are not plugging in rubber slugs to accommodate variable data,” Pugh says.

 

“The UDI regulation [in the United States] will change everybody’s thinking. I think you are going to see contact printing become obsolete,” he adds.

Bell-Mark’s EasyPrint MLP thermal-transfer printer supports in-line printing of package graphics, human readable data, and matrix-style and linear codes. The unit is typically mounted on horizontal form-fill-seal machines for direct printing on Tyvek, paper, poly films, and foils.

The EasyPrint MLP is now available with an 8.3-in. print head. “This is the largest print head in the market for this application. For many applications, customers will be able to print the full web with one print head,” Pugh says.

 

ENSURING BAR CODE
QUALITY

Hapa North America (Rockaway, NJ) couples flexographic and digital printing in one machine with the Hapa 230 Hybrid. The flexo portion of the machine features a reusable print mat that eliminates the need for using a different print mat for each batch due to the fact that the batch-specific information such as lot and expiry is printed digitally. The 230 Hybrid’s mat can be used for more than 2 million cycles, says Steve DiAngelis, director, Hapa NA.

 

For carton, label, and blister lid-stock applications, the printer provides “the best of both worlds” as it relates to both print quality and running costs. The printer prints in full flexo or digital modes, or with the two combined or as a two-color printer, DiAngelis says.

 

Flexographic printing provides a cost advantage for printing product specific information such as graphics and bar codes in medium-to-large-size batches. Printing the variable data digitally with the Hybrid requires only a small amount of consumables. The integrated WebJet piezo UV ink jet printer in the Hybrid 230 can be used for full digital printing cost-effectively for small batches, DiAngelis says.

 

Printing on difficult substrates like foil is supported by the use of UV inks offering enhanced adhesion and drying characteristics. “We have found strong acceptance across the board by big pharma, nutraceutical companies, and contract packagers since introducing the 230 Hybrid last year,” he adds.

 

For mid-sized batches, Hapa has introduced the Hapa 729 semi-digital screen press. The unit provides an interim solution between flexo printing and full digital printing for printing on non-serialized mid-sized batches. The 729 printer creates the print map internally. Computer-file-delivered art work is rendered at 600 dpi in a thin material with a plastic layer. Ink is then forced through the drum-mounted screen for printing on the passing substrate as a screen press.

 

Laetus North America (Rockaway, NJ) supports customers’ serialization needs with line-level, plant-level and corporate-level solutions. “At the line level, we are controlling the line configuration and unique serialized packaging operations. These include all devices for the inspection, marking, verification, and rejection necessary for product tracking,” says Jeff O’Neill, director Laetus NA.

 

The line level solution ensures every product’s integrity for accurate, complete aggregation throughout the packaging line. “At the plant level, we can generate the unique codes necessary for marking and aggregating and handle all batch and shipping orders and serialized warehousing,” O’Neill says.

 

Laetus now also offers a corporate-level solution that includes Corporate System Integration and Central Data Consolidation, with a large volume storage capacity.

 

O’Neill says the Laetus/Coesia approach to serialization is “unique, modular, and flexible” for easy incorporation for any level of customers’ serialization requirements.

For ensuring that printed bar codes meet or exceed standards for readability, Lateus includes the grading of the code in the verification process that follows ANSI standards.

 

“We recommend that the customer establishes the bar code ANSI grade on an off-line table-top calibrated grading system. Off-line table top systems require the lighting to be at specific angles, the product must be consistently the same distance away while grading, and [the system] must be calibrated often to ensure consistent grading,” he says.

 

With a simple routine, our on-line camera will match the off-line grade. We then ensure with our on-line camera—which uses ANSI requirements in the software—that the set grade does not drift below the required letter setting of the grade. We can display most of the ANSI grading values in real time while running production,” he says.