SPECIAL FEATURE
Serialization...
An Alternative Jumps to the Forefront
at the SecurePharma Conference
By Bruce Kneeland
Counterfeiting,
drug diversion and other challenges to the integrity of the pharmaceutical
supply chain were the focus of attention at the SecurePharma 2006 conference
held recently in Philadelphia.
The event, hosted by Worldwide Business Research, a commercial information and educational services company, attracted more than 100 manufacturer and distributor executives who came to learn the latest on the ethical, logistical and regulatory issues involving security and the pharmaceutical supply chain.
RFID was the central theme, with various speakers reporting on progress they have made implementing this new technology. However, most said they believe RFID is still too expensive and unproven to be successfully employed in the next few years.
One idea shared by a few of the presenters was a mechanical process called serialization. This method, championed by one of the meeting exhibitor companies — Aegate — provides for a unique serial number to be encrypted and printed on the paper label of each product. This unique number can be read by barcode equipment and authenticated by a central repository accessible to all players in the distribution channel.
Building the case for the adoption of serialization was Renard Jackson, executive vice president, business development, in Cardinal Health’s commercial packaging division. According to Jackson, the primary benefits of serialization are twofold. First, the technology is already in place for applying serial numbers within manufacturers’ production lines; and, second, the process is significantly less expensive than RFID.
Jackson said the cost of printing the serial numbers is about five cents per package compared to thirty-five cents for an RFID tag.
During a panel discussion, Patrick Schmidt, CEO and founder of FFF Enterprises, stunned the attendees by suggesting that RFID will not be implemented in the near future because far too many economic and policy issues still need to be resolved.
Instead, Schmidt said, the best way to insure the integrity of the supply chain is for manufacturers to step up to the plate and put in place — and enforce —distribution agreements that call for distributors to purchase product directly from manufacturers only, and sell only to health-care providers.
One deadline driving the RFID issue is California’s mandate for electronic pedigrees, which currently is scheduled to take effect January 1, 2007. During his remarks, Stanley Goldenberg, president of the California State Board of Pharmacy, said the California board is absolutely committed to the implementation of a pedigree program — the purpose of which it so make sure that no pharmacist ever has to worry about the legitimacy of the product that he/she is dispensing.
However, Goldenberg said there is a high likelihood that the state will reluctantly postpone the January 1 deadline because it now appears that the industry simply cannot meet it. That left the audience to wonder whether the FDA’s January 1 deadline for electronic track-and-trace technology may also be relaxed.
In response to that notion, speaker
Katherine Eban, author of the book Dangerous Doses, called on the FDA to
stand firm and not back down again from its published implementation date of
January 2007 for adoption of the Prescription Drug Marketing Act’s pedigree
requirements.
Dangerous Doses outlines the process by which nearly 100,000
doses of adulterated Procrit and Epogen entered the supply chain in Florida in
1999 and 2000.
Eban said the issue has now been debated and delayed for more than a dozen years, and she insisted that the time has come to implant the act and assure all consumers that the products they are purchasing at the drugstore are indeed safe and effective. (Editor’s note — The FDA announced on June 9 that it would proceed with the 2007 implementation date.)
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Bruce Kneeland is the president of PharmacyConnections and a special projects editor for Community Pharmacist and its sister publication, HealthCare Distributor.