Pulling for Auto ID

As guidelines advance, the patient safety and business benefits of serialized drug packaging and uniquely marked devices are weighed.

By David Vaczek
Senior Editor

Supply-chain investment and collaboration for serialized package coding and tracking is gaining momentum. Packagers’ assessment and deployment of systems for variable printing and EPC coding to RFID tags has picked up steam, say vendors.

Bell-Mark offers its first continuous ink-jet printer with the InteliJet ci, which features a self-sealing nozzle for variable printing on flexible webs, labels, and vials.

The pace of interaction among trading partners has increased, as prevailing deadlines have provided room to maneuver, Ron Bone, senior vice president, distribution support, McKesson, reported at GS1 Healthcare’s Global GS1 Healthcare Conference last month in Washington, DC. Said Bone: “2009 and 2011 were unrealistic dates for serialization, so people gave up. We are seeing more interaction today with our brand and generic customers,” Bone said.

“As wholesalers, we have shortened the supply chain (shipping direct from manufacturers to the healthcare suppliers). Now we need to get this done electronically, with validated processes. We will have a big role to play in helping people get there,” he said.
The alignment of serialization and track and trace timelines in the Buyer-Matheson bill with those in California’s law provides industry with realistic deadlines, Bone said. He added that the bill will be reintroduced to Congress this year.

Buyer would create a national standard for product coding and pedigree tracing that would preempt the prevailing patchwork of state pedigree requirements. Discussion drafts of the bill call for the application of the SNI described in the FDAAA Act of 2007, while additionally establishing the deadlines for an electronic solution.

The bill defines an interim pedigree process as a migration path to electronic pedigree. Alternate requirements to FDA’s partially-implemented pedigree rule of 2006 revise the definition of an authorized distributor of record (ADR), among other things, says Kendra Martello, assistant general counsel, Pharmaceutical Research and Manufacturers of America (PhRMA).

See sidebar Novis Pharmaceuticals Provides E-Pedigree with Serialized Bar Codes

As a first step, abbreviated, or direct purchase, pedigrees would be required from ADRs, with standard pedigrees mandated from the secondary wholesalers.

“The interim steps set out in the bill attempt to circumvent some of the problems with (FDA’s PDMA pedigree rule). (But) eventually it does away with the ADR concept as set out in PDMA. Buyer moves to an end-state where pedigree requirements would apply equally on all partners in the supply chain,” Martello says.

Bone said the bill is expected to be reintroduced in Congress this year. 

FDA’s draft guidance on prescription drug package serialization addresses the requirement by the FDAAA Act for the agency to define a serialized numeric identifier by March 2010. The act also requires the agency to establish track and trace standards at some point, but doesn’t describe dates for industry implementation.

Bob Celeste, GS1 Healthcare US, says that “[FDA’s] desire is to have the track and trace guidance out by 2010. [They] have said on a number of occasions they will leave [the SNI guidance] as draft guidance for a while. They are not saying if they have to have a full-blown regulation.”

Companies are focused now on the California deadlines. “It’s anybody best guess if FDA is going to step in and preempt California by a couple of years (with tighter deadlines),” says Gregg Metcalf, industry market manager, Nosco, (Gurnee, IL).
“We are starting to see companies regrouping on serialization. They are looking to launch discussions on pilot projects in the later part of 2009 and early 2010 to begin to see what is required from investment and technology standpoints,” he said.

At the conference, Michael Rose, vice president, supply chain visibility, Johnson & Johnson, described “broad operational implications, as this is all very much emerging technology.”

Rose noted that the company’s complex portfolio of products includes wallets, prefilled syringes, and vials. Accurate and readable coding and data-capture solutions have to be evaluated for every line. A database for serial numbers needs to be established, and the firm will initiate the first leg of track and trace. The company is evaluating RFID for reliability in J&J and customer environments, Rose said.

“Industry-wide interoperability is an important consideration going forward. Our lines have to produce products for other markets, where there is a lot of regulatory diversity,” he added.

“We have to understand what is practical and cost-effective and try to prioritize based on risk,” said Steve Hess, executive director of packaging technology, Merck.

In submitted comments on the SNI, Merck and PhRMA and were among respondents urging a risk-based approach that would not require an SNI on all drugs, and also a phased-in implementation of the SNI.

“SNI should be required only for those products that present the highest levels of patient safety risk in order to balance the needs for improved supply-chain security with maintaining the continued availability of affordable healthcare,” Merck said, calling for a phased implementation over a 5–7 year timeframe.

Noting that the cost to benefit ratio of the technology still has to be proven in many cases, conference panelist Mike Wallace, director of global standards and serialization, Abbott Labs, observed that track and trace is largely “a trading partner issue. It’s important to know the supply chain. The Internet is the biggest source of counterfeit drugs in the United States.”

Referencing the GS1 system favored by many responding to FDA guidance, Wallace noted: “Six data elements allow us to meet the needs of everyone around the world: GTIN, serial number, lot, expiry, and GLN ship-to and GLN ship-from. With the right data and right format, we’ve licked 80% of the problem.”

The topic of the business value to be derived from serialization’s granular product and event data was broached by several participants. Says Celeste: “Since FDA came out with the draft regulations, the conversation has moved from regulatory compliance to patient safety and supply-chain efficiencies. Companies are asking, ‘How can I take advantage of this.’ ”

“It’s less about trying the technology out, and more about solving real business problems, assuming a serialized world,” Celeste adds.

GS1 Healthcare US’s Safe and Secure Supply Chain Task Force has identified 35 areas of impact on business processes and patient safety, including shrink and loss prevention, diversion, inventory management, and patient care areas. Members are using financial models to analyze the impact of leveraging the serialized data, Celeste says.

Among the issues raised in comments to FDA on the draft SNI guidance were concerns about redundant bar coding, given the agency’s bar code requirement of 2006, and also harmonizing the SNI with the upcoming guidance on unique device identification (UDI) for medical devices.

GS1 recommends in submitted comments that the guidance include exemptions for certain products to avoid duplicate coding with an sNDC and an NDC-based linear bar code, noting that “the industry’s predominate response to the FDA’s guidance on serialized identifiers is to use the GS1 DataMatrix or additionally EPC/RFID carriers.”

“We have asked FDA to consider allowing one carrier, without being specific as to which that would be. If you are carrying the GTIN with NDC and serial number in a 2D code or RF tag, that would make the linear code [duplicative],” says Celeste.

“As people are able to start reading the 2-D codes or RF tags, that is a good time to start transitioning from the linear code, or to one code.”

McKesson urged the agency to “review and reconcile” the developing SNI and UDI standards “to avoid conflicting requirements and costly implementation of these product safety initiatives. This is particularly important from a patient safety perspective. Medical devices sometimes include pharmaceutical drugs, and, once developed, both the UDI and SNI systems will need to be compatible.”

The product visibility afforded by a UDI system will promote safe healthcare delivery and business process efficiency. FDA intends to move expeditiously to define UDI system, but the standard setting is only half the battle.

This view emerged at the conference, where Jay Crowley, senior advisor for patient safety, FDA, said that downstream implementation will be the main challenge. “What keeps me awake at night is the realization of the progress hospitals have made with bar coding. One fifth of hospitals can take advantage of bar coded products. So the question is, how are we going to implement this?” Crowley said.

“Hospitals are not ready for [UDI],” echoed Jeff Secunda, vice president, technology & regulatory affairs, AdvaMed, the trade association for the medical device industry. “They will have to access IT capabilities, and [embrace] process change.”

Crowley said the agency is striving to draft regulations that will not be overly burdensome in order to promote adoption. Regulation will define a minimum data set for marking product in human readable and automatic identification format. The rule won’t stipulate data carrier technology. UDIs would be on higher levels of packaging for low-cost consumables, in a risk-based approach.

A UDI database will associate product attributes and information to the static ID and ensure that data is synchronous with all incidences of the device. “We want a database that is accessible in the United States and globally. The Global Data Synchronization Network (GDSN) would fill the requirement, but not every manufacturer participates in the GS1 system,” Crowley said.

Implementation by device makers, distributors, and hospitals would complete the UDI solution. “Right now, it’s a mess. It is very difficult to know where products are [throughout the supply chain],” Crowley said.

UDI promises benefits including visibility on which products are used with which patients, support for adverse event and product recall tracking, and security through supply-chain traceability. “Import safety is a huge issue for us. UDI can be a foundational element to assist with these issues,” he said.

Dr. Daniel Schultz, director, Center for Device and Radiological Health, FDA, said a UDI system is consistent with the agency’s postmarket transformation initiative. “Date-to-market is not the end of the story. In fact, it is the beginning. [Postmarket] is where we need to make the biggest effort (to ensure) that products are doing what they need to do to help patients.”

“We need a system to identify problems quickly and deal with them quickly,” said Schultz, noting that a standard ID system for devices will enable timely, fine-stroke, corrective actions.

Schultz said the agency wants to develop regulation that harmonizes with those of other counties, without unduly delaying the U.S. regulation. “It makes sense to have a single global system, if we can get there. That is our mission, that is our charge, and that is what we hope to see happen in the not too distant future.”

Drug manufactures have largely met the mandate for bar coding of drug packaging issued by FDA in 2006. One large teaching hospital supplied by Novation receives 89% of products with usable bar codes in place, says Rosanne Thurman, porfolio executive, pharmacy, Novation. “That still leaves more than 600,000 doses a year that must be outsourced for packaging or repackaged by the facility,” Thurman adds.

A 2007 survey on hospital information systems by ASHP found various approaches used in point-of-care technology. More than 50% use paper-based medication administration records (MAR) systems, with 24% using BCMA systems. Twenty percent of hospitals use a BCMA system with an electronic MAR (eMAR), and electronic nursing documentation. “The safest system for medication administration and documentation is one that includes all three components [eMAR, BCMA, and electronic nursing documentation],” the report says.

Will federal funding earmarked for a paperless healthcare system help hospitals develop automated identification infrastructure? The $787 billion American Recovery and Reinvestment Act (ARRA) sets aside $19.2 billion for healthcare IT. Specifically, doctors and hospitals will be eligible for funding if they demonstrate meaningful development of electronic medical records (EMR).

“UDI needs to be a part of the EMR process. We believe those working on the ARRA don’t understand the true importance of UDI, and supporting systems such as GS1,” says Joe Pleasant, chief information officer and senior vice president, Premier.
“We are not promoting safety and efficiency without the subsystems necessary for feeding medical device and drug information into the EMR,”  Pleasant says.

Premier is offering evidenced-based results to ARRA staff to highlight the importance of UDI. “We are receiving strong support from hospital materials managers that are spearheading EMR conversions,” he adds.

Subsystems might include camera-based scanners for reading the DataMatrix codes. The codes are favored for their robustness, forgiveness, capacity, and size.

“The future has to move toward the picture-based symbology. The systems hospitals are buying today will be camera based,” says Pleasant.

The pace of such deployment, however, may require incentives. “If there were dollars in the Obama stimulus program, institutions would be more inclined to move forward. Hospitals are more concerned with keeping their doors open than buying bar code scanners,” says Jim Umbdenstock, president, Griffin-Rutgers Co. (Ronkokoma, NY).

“Without stimulus dollars, a recognized reimbursement program, insurance premium reductions via actuarial tables, or federal and/or JACHO mandates, I don’t think there will be a mad rush to move ahead with this investment by hospitals,” Umbdenstock says.

GPOs including Premier and many hospitals have endorsed GS1 standards including the GTIN, the GLN and the GDSN. Many have implemented sunrise dates for the use of the GLN and GTIN.

“Anyone who contracts with us will be required to use the GLN by 2010, and the GTIN by 2012,” says Pleasant.  “There is a high level of institutional support for the GS1 standards. Most of the effort has been around [supplies other than pharmaceuticals], but it is assumed that drugs will also be involved.

We are trying the push the pharma side to use the GTIN without the NDC. The NDC works less well on the supply side as it’s not designed as a mechanism for identifying package sizes, Pleasant says.

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