The US Food and Drug Administration (FDA) has issued a final report highlighting steps the agency is taking to keep the US drug supply secure in the face of increasingly sophisticated criminal efforts to introduce counterfeit drugs. And, with new technologies brought to the fore, RFID suppliers have been quick to announce their support and innovations in the field...
The FDA''s report (available here) addresses growing concerns about the threat to consumers posed by counterfeit drugs. Though counterfeiting is not widespread in the US drug market, the FDA is investigating more cases of such activity, often involving well-organised criminal operations working to introduce finished drug products that resemble legitimate drugs but may contain only inactive ingredients, incorrect ingredients, improper doses or be otherwise contaminated. 188.8.131.52 This article is copyright 2004 UsingRFID.com.
"The FDA will lead the way in taking the steps necessary to keep our nation''s drug supply safe and secure," said Commissioner Mark McClellan, M.D., Ph.D. "This report shows how to achieve modern, comprehensive security protections for our drug supply that can keep pace with the increasingly sophisticated threats we face."
Six types of protection
The report highlights ways to ensure that the drug distribution system remains free of counterfeits, including:
Securing the actual drug product and its packaging;
Securing product movement through the distribution chain;
Enhancing regulatory oversight and enforcement;
Increasing penalties for counterfeiters;
Heightening vigilance and awareness of counterfeit drugs;
Increasing international collaboration.
The report was issued by an FDA task force that was created in July 2003 to identify steps that the FDA, other government agencies, and the private sector could take to minimise the risks to the public from counterfeit medications. These steps include the implementation of new technologies to protect legitimate drugs against tampering or replacement with counterfeits - and that''s where RFID (radio frequency identification) enters the market, among other technologies. The adoption of reliable modern track and trace technology, which the FDA has concluded is feasible by 2007, is expected to accomplish the goals of the Prescription Drug Marketing Act.
The Healthcare Distribution Management Association (HDMA) strongly supports the FDA''s report on combating counterfeit drugs, particularly the agency''s recommendations for technology-based solutions for the electronic tracking, tracing, and authenticating of pharmaceuticals. It supports the adoption of secure best practices by all pharmaceutical supply chain stakeholders, and agrees that there is a need for stronger anti-counterfeiting laws and enforcement at the state level, along with a need for increased penalties for those that counterfeit drugs.
To that end, HDMA will support the FDA by urging the widespread adoption of RFID and EPC technology by pharmaceutical manufacturers, wholesale distributors, and pharmacy customers as the best solution for combating the public safety threat of counterfeit drugs. HDMA is solidly committed to this technology, and is in the process of developing business standards for RFID/EPC implementation.
Moreover, the nationwide pharmaceuticals distributor, McKesson Corporation, has also voiced its support for the FDA''s report, and is keen to see such protective measures introduced. McKesson purchases products from more than 450 pharmaceutical manufacturers and supplies more than 75,000 customers in North America.
Support from the RFID industry will no doubt make itself felt in many forms. One such initiative is the Electronic Pedigree from SupplyScape - a software solution that uses RFID to build a custodian history (effectively a pedigree) that traces each drug pack''s chain of ownership right from the pharmacy back to the original manufacturer.
The system complies with both the federal Prescription Drug Marketing Act and state drug pedigree laws, using the same RFID and EPC standards already adopted by the US Department of Defense, Wal-Mart, Procter & Gamble, and Gillette. The solution is expected to be available from the second quarter of 2004, and pilot project participation can be requested via the company''s web site.
Track and trace
MeadWestvaco Intelligent Systems (MWVIS) has also announced an RFID inventory system aligned with the FDA''s recommendations. In addition to meeting consumer safety needs, the MWVIS solution allows manufacturers to monitor drug delivery from production through to pharmacy distribution.
For example, a company that deploys the MWVIS system would tag every drug package during production, at which point it can be confirmed that the correct drug has been packaged. The manufacturer can then monitor the movement of each package by tracking its RFID tag. The manufacturer can then trace the packages'' movement throughout their facilities, through to delivery at the wholesaler''s premises, through to receipt at retail distribution centres and ultimately, to individual pharmacies.
RFID support project
Technology services and outsourcing company, Accenture, is also working with a group of pharmaceutical firms to evaluate the potential of RFID technology to enhance pharmaceutical product manufacturing, distribution, and retail operations within the United States.
Accenture is serving as programme manager for the group of pharmaceutical manufacturers, distributors and retailers, which includes Abbott Laboratories, Barr Pharmaceuticals Inc., Cardinal Health, CVS Pharmacy, Johnson & Johnson, McKesson, Pfizer, Procter & Gamble, Rite Aid, among others. The HDMA and National Association of Chain Drug Stores (NACDS) are also supporting the group by providing their members with additional information and education-related opportunities for the programme.
EPC - the right medicine
This project has been set up to explore the application of EPC and RFID and technologies to three areas: enhancing the safety and security of the pharmaceutical supply chain; improving the process of pharmaceutical returns management; and increasing the efficiency of distribution operations. The group plans to encourage the use of the electronic product code (EPC) digital identification standard throughout the entire pharmaceutical industry.
"The RFID initiative brings together leading companies across the pharmaceutical industry to not only design and evaluate ways to improve supply chain integrity and accuracy but also to help consumers receive authentic medicines," said Jamie Hintlian, a partner in Accenture''s health & life sciences practice.
In studying these issues, the group has been working with the FDA''s anti-counterfeiting task force to establish how RFID and EPC can mitigate the risk of counterfeit drugs reaching the marketplace. In addition, the group plans to test how RFID technology can improve expiration date management, lot and batch tracking, returns management processing, shipping and receiving accuracy, operational integrity, and product security and consumer safety.
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