The FDA report on counterfeit drugs has only been out for seven months and already at least one group has stepped forward to show that a “track and trace” method of tracking drugs is feasible.
On Sept. 28, a group managed by Accenture released its first report on utilizing EPC and RFID technologies across the pharmaceutical supply chain. The group was first formed back in February, days after the FDA report was released, and includes pharmaceutical manufacturers, distributors and retailers.
Findings based on shipping, tracking and tracing nearly 13,500 packages of pharmaceuticals over an eight week period, showed that EPC/RFID can help satisfy regulatory and retailer requirements, increase product security and consumer safety, enhance order accuracy and labor productivity, and increase the efficiency and speed of recalls and returns, according to Accenture. These tests, however, applied to the supply chain only and did not involve consumer-level testing.
Participants included Abbott Laboratories, Barr Pharmaceuticals, Inc., Cardinal Health, CVS Pharmacy, Johnson & Johnson, McKesson, Pfizer, Procter & Gamble and Rite Aid, just a few of the members of the group.
The first of several tests by the pharmaceutical industry comes on the heels of the FDA report released last February highlighting steps the agency plans to take to keep the U.S. drug supply secure against counterfeit drugs.
“We set out to prove the ability of an RFID-enabled supply chain to support three scenarios,” said Jamie Hintlian, a partner in Accenture’s Health & Life Sciences practice. “One, a safe and secure supply chain, two, efficient reverse logistics and three, an efficient supply chain operation, mainly the ability to automatically authenticate orders on receipt.
“The pioneering nature of this project and its participants has helped the industry make a huge leap toward realizing the benefits of this technology,” he added. “By making crucial connections both within organizations and across the industry, we’re creating innovative approaches to address key issues such as counterfeiting and supply chain visibility.”
The tests, said Mr. Hintlian, were modeled after Florida’s pedigree requirement which requires a paper trail (and wholesale distributor authentication), not an electronic trail, yet. But it is one of the more stringent in the country.
“We wanted to be able to create an electronic pedigree at the item level,” said Mr. Hintlian. “For each of those three areas we worked with industry participants to create a common set for ordering, tagging, monitoring across a specific infrastructure and distribution facility. Manufacturers selected two products each to be part of the program.”
He said the 13,500 items were tagged and were sent through the supply chain. “We created a real working RFID-enabled supply chain, right down to the pharmacy itself,” he said. “Essentially, we kept the product at the bulk level” so the product would be dispensed from a tagged bottle.
“We were able to demonstrate that you can create a pedigree and that you can do a better job to help reduce the amount of returned goods as a result of expired dates. You can receive and authenticate product and verify that all the items are there at the item level,” he said.
From a counterfeit prevention standpoint, “it’s not the magic bullet,” he added. “There will always be ways to cheat, but this provides a fairly significant barrier or hurdle for counterfeiting. If you can apply a tag at point of manufacture, then are able to authenticate that product at each pont, you provide a level of assurance that this product is not counterfeit.”
He said this “track and trace” technology is feasible by 2007, as recommended by the FDA, but tests so far don’t show to what degree and what scale. “We’re still getting this first wave of activity wrapped up,” he added. “From a commercial perspective, the technology is ready. There are certainly challenges that need to be addressed. Rather than more tests, the focus will be on building basic capabilities and scaling.”
According to Accenture, Michael Swenson, industry analyst at IDC’s Life Science Insights believes that “this proof-of-concept study by multiple participants throughout the supply chain is an important step in preparing for future use of RFID technology in the pharmaceutical industry. While confirming many of the expectations about increased visibility into the supply chain, the project also highlighted technical and organizational issues that will need to be solved by RFID vendors working closely with the pharmaceutical supply chain partners, regulatory agencies, and systems integrators who will design, install and support these complex systems.”
One challenge, said Mr. Hintlian, “is that the read rates of tags needs to be higher. You have items inside of a case and you have to be able to see and read all the tags at a higher level than what’s currently available. But the technology is rapidly getting there.”
From an organizational standpoint, he added, “one of things this project addresses is having the kinds of skills in-house to manage and operate a supply process that is RFID-enabled. It can mean modest changes, mostly around the technology.”
The second phase of the project will further explore the business value of RFID within the pharmaceutical supply chain. New companies such as Merck, Novartis, Sanofi-Synthelabo Inc., Walgreen’s and Wyeth have joined the group and will participate in the next phase, according to Accenture.
FDA’s “Combating Counterfeit Drugs” was issued by a task force, created in July 2003, to identify steps that the FDA, other government agencies and the private sector could take to minimize the risks to the public from phony medications entering the nation’s drug distribution system. These preventative measures addressed six areas:
- Securing the actual drug product and its packaging.
- Securing the movement of the product as it travels through the U.S. drug distribution chain.
- Enhancing regulatory oversight and enforcement.
- Increasing penalties for counterfeiters.
- Heightening vigilance and awareness of counterfeit drugs.
- Increasing international collaboration.
According to the report, implementing these steps would:
- Help prevent the introduction of counterfeit drugs into the U.S. drug distribution chain.
- Facilitate the identification of counterfeit drugs.
- Minimize the risk and exposure of consumers to counterfeit drugs.
- Avoid unnecessary additional costs in the prescription drug distribution system.