The $40-billion global counterfeit drug trafficking trade continues to be fought by federal and state regulators, pharmaceutical companies, wholesalers/distributors, and pharmacies. Whereas the vast majority of medications being dispensed to patients are safe, the growing movement toward using electronic pedigrees (e-pedigrees) to track drugs in the pharmaceutical supply chain may eliminate this serious, potentially deadly problem or at least prevent it from growing any bigger.
Experts in the field of e-pedigree solutions have identified several reasons why it is necessary:
SupplyScape Corp is a company that has been a pedigree technology leader in creating an application that uses a serial number or electronic product code to create an e-pedigree for pharmaceutical drugs. The company received certification from the standards organization EPCglobal for its E-Pedigree data management solution. The designation means that the software complies with EPCglobal?s drug pedigree specification. The drug pedigree standard provides the pharmaceutical industry with a universal system supply chain that partners can use to collect pedigree information.
Greg Cathcart, senior vice president of sales, marketing, and services, said drug safety and patient safety are crucial. ?E-pedigrees and other technologies have been introduced through laws and good business practices? to ensure the drug supply chain is not tainted. The use of an e-pedigree solution was first adopted by the manufacturers followed by the wholesalers/distributors. He said, ?We are seeing a big push for retailers in 2008.?
The Woburn, Massachusetts?based company has >70 customers using its electronic pedigree and EPC authentication solutions. He said implementation of the solution is relatively quick because the company sells the software as a service. ?We want to have a solution implemented quickly and not have the software sitting in your facility.?
Pfizer Inc is using the company?s EPedigree data management software to track its erectile dysfunction drug Viagra (sildenafil citrate), its most counterfeited product. The solution provides a secure chain of custody for a prescription drug by creating an electronic record or pedigree to trace each distribution of the drug, from the first sale by the manufacturer until the pharmacy dispenses the medication.
Pfizer?s implementation of the e-pedigree solution expands its security initiatives, which also includes SupplyScape?s RxAuthentication. The authentication solution enables pharmacies and wholesalers to verify the authenticity and status of the serial number on packages of Viagra at any time prior to final dispensing to the patient.
Cathcart said the technology allows a manufacturer to protect its brand, image, and, most importantly, patient safety. ?We all want to make sure at the end of the day our families are taking the right medications,? he said, speaking from personal experience. His son was taking a medication from a manufacturer that was cutting corners on patient safety. The family made the decision to switch to an Eli Lilly medication because they spend millions of dollars on anticounterfeiting solutions.
E-pedigrees are also valuable in the event of a product recall. US Oncology?s implementation of SupplyScape?s EPedigree enabled a quick and precise product recall. The oncology services network was alerted by the manufacturer of a recall of 2 lots of the cancer treatment drug methotrexate. The epedigree data tracked the product to 6 specific practices within minutes, and the practices were contacted with product details to isolate and return the product. The turnaround time was much faster because US Oncology was able to track a specific drug product through every step in the supply chain.
ANI Pharmaceuticals Inc, a specialty pharmaceutical company focused on generics and OTC products, recently implemented SupplyScape?s E-Pedigree data management solution. ?Supply- Scape gives a single application that covers all state and federal regulations,? said Jane Williams, senior vice president of sales and marketing, in a statement.
?EPCglobal electronic pedigrees are the cornerstone of any comprehensive product security program,? said Cathcart. ?ANI will benefit from E-Pedigree?s ability to provide drug transaction security that will significantly reduce diversion and counterfeiting.?
SupplyScape continues to evolve its offerings by taking into account its customer?s needs. On a quarterly basis, the company meets with manufacturers, wholesalers/ distributors, and retailers to ?help us develop what we want to do in the future. Our goal is stop it [counterfeiting],? said Cathcart.
On the state level, pedigree bills were introduced in 19 states in 2007; to date, 13 states have no legislation or regulations. Montana is the only to state to have vetoed legislation, and bills are anticipated in Massachusetts, Kentucky, Louisiana, New York, and Michigan in 2008.
Florida was one of the leaders in imposing pedigree laws that require a tracking system starting with the wholesaler, not the manufacturer. The Sunshine State began requiring pedigrees for all products effective July 1, 2006. Considered the most ambitious e-pedigree requirement is the 2004 California law that would require that drugs be tracked electronically from the manufacturer through the wholesaler to the pharmacy. The requirement, which was to take effect January 1, 2009, has been pushed back until January 1, 2011.
In March, the California State Board of Pharmacy voted to delay the requirement for 2 years. The board received letters from drugmakers, wholesalers, hospitals, and pharmacies that said they support the law?s intent but asked for a delay. Pharmaceutical manufacturers told the California board that including a unique serial number on every container would necessitate changing their package lines, which would be costly and take a long time.
Earlier in the year, the National Association of Chain Drug Stores (NACDS), with the California Pharmacists Association and the California Retailers Association, sent a letter to the California board explaining the critical need for a delay to ensure successful implementation for pharmacies and the patients they serve. NACDS and both associations testified before the California board to address concerns about a rapid implementation of the pedigree requirements.
In his January 23, 2008, testimony, Steve Perlowski, vice president of industry relations for NACDS, stated, ?This extension would allow pharmacies and pharmacy distribution centers to adopt and implement the necessary technologies and for the technology and business process changes to be resolved among manufacturers and wholesalers to avoid confusion at pharmacy distribution centers and pharmacies.? He continued, ?This extension would allow pharmacies to start receiving pedigrees and pedigree- related information, ensuring that processes in place are working properly, without having to balance compliance with new pedigree requirements against providing necessary patient care.?
Pharmacies and wholesalers said they would be unable to implement the software and equipment needed to read the serial numbers until drug manufacturers determined what system they would use.
Drug companies also called for a uniform national system, not a different one for each state. ?The clock is ticking at the federal level for the Department of Health & Human Services to come up with national standards,? said Cathcart. The FDA has said it would create a standardized identification numbering system for drugs by March 2010.