After waiting for guidance from the Food and Drug Administration since 1988, states are coming up with their own requirements for electronic tracking systems that would discourage the distribution of counterfeit prescription medicines.
Donna Wall, president of the Indiana Board of Pharmacy, said her state has taken action because the FDA has delayed implementation of the Prescription Drug Marketing Act, which Congress enacted 18 years ago. The law requires prescription drugs handlers to keep records of the products' movement along the supply chain until they reach customers. The FDA has been slow to enforce those so-called pedigree provisions because of concerns about the federal government's role, the technology and its cost.
During the years of waiting, the Indiana University Medical Center, where Wall is a pharmacist, received counterfeit medicine and nearly distributed it to patients, Wall said. Although Indiana already has several measures for spotting counterfeit drugs, she said, the state plans to build an automated tracking system.
"I think that the FDA should take the leadership role," she told an FDA workshop audience in February. "It should set the standards so that we all know what we need to go to."
Florida and Indiana will start tracking some drugs using paper records July 1. The states then plan to adopt an electronic tracking system featuring radio frequency identification tags. California has a requirement for electronic tracking by Jan. 1, 2007, but the state will likely delay that requirement by at least a year.
Supply chain disruptions
Tracking systems would let officials observe the movement of prescription medicine from manufacturer to customer. Some proposals would create pedigrees for only a few dozen drugs that are expensive and in high demand. Others would require detailed tracking information only when a drug departs from the normal distribution line, which goes from manufacturer to wholesaler to retailer.
Many businesses have successfully resisted the federal law. But now those businesses worry that states could develop 50 different systems with 50 different sets of rules. Distributors and pharmacies might need to buy several scanners to read incompatible labels.
"We can't pound these issues out state by state," said Paul Fowler, vice president of emerging technology at McKesson, which processes 6 million prescription items daily. Fowler told the FDA workshop audience that state laws such as Florida's "will frustrate implementation of RFID because, for instance, many of the people in the room have literally stopped what they're doing in RFID to comply with the Florida law."
He also predicted disruptions in the supply chain because "we can't just pick up any item in California and ship it to Florida."¦ All of our distributors move product worldwide or countrywide every day, and when one state isolates itself in that supply chain, they will cause some problems in getting supplies there."
EPCglobal, an industry-sponsored organization, is developing the most likely candidate for a single national standard, but there are concerns about whether it is moving fast enough, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Cost is a legitimate concern when it comes to implementing RFID, Catizone said. Although an EPCglobal official said the price per RFID tag is likely to be less than 10 cents when used in volume, the first implementations will likely cost more. Everyone along the supply chain will need to invest in scanners and databases to keep records.
On the other hand, Catizone said, "the paper pedigrees are really " to be quite honest " a joke." Someone could easily forge or alter those records, he said, and "we're not going to put much stock in them."
California officials agreed with that assessment in 2004 when the state's legislature passed a law requiring electronic tracking. However, the law does not outline a specific technology to use for tracking systems.
Patty Harris, executive officer of the California Board of Pharmacy, said, "It's not the board's intent to specify the technology" or issue regulations on how to implement the law. "We're watching [the FDA] to see what they're going to do," she said.
FDA officials have vigorously endorsed electronic pedigrees. They would rather not issue rules requiring specific technology if the industry can voluntarily adopt common systems. The agency must decide on a course of action by December, when the latest official delay expires. An FDA task force was working on a report on the pedigree implementation issues this spring.
Considering that the policy issue has not reached a resolution in 18 years, the FDA is unlikely to find one until it chooses a permanent commissioner to lead the agency. President Bush nominated Andrew von Eschenbach, now the acting commissioner, in March, but the Senate shows no indication that it will act on the nomination soon.
Harris said she agreed that interoperability concerns are valid if each state plans to enact its own rules. She added that new problems could arise if only some states require pedigrees. In such a case, Harris said, counterfeiters would flock to the states that have weaker rules.
But states are protective of their role in regulating pharmacies. They don't want the FDA to commandeer a system that depends on state-level enforcement. For example, states license the wholesalers that distribute prescription medicines to retail pharmacies.
Hurdles to clear
Other issues remain unresolved. The FDA and Florida, for example, want wholesalers to generate pedigree records that follow each medication through the system, while California calls for manufacturers to generate the pedigree.
Privacy and data ownership are also contentious issues. The RFID technology must prevent anyone with a scanner from detecting what medicines people have in their pockets. Despite calls for an electronic pedigree system, little agreement exists on how to build one.
In the view of Catizone and many others, the FDA is the only organization in a position to move electronic pedigrees forward. The author of the Indiana state law, Sen. Marvin Riegsecker of Goshen, agrees. "They're the ones who should be doing it," he said, referring to the federal government.
Riegsecker, a pharmacist at a discount store, introduced the bill after one of his customers asked how he was sure that the prescription used real medicine and not counterfeit drugs. He checked the source of the drug, tracing it to a repackager. When asked for some reason to believe in the drug's authenticity, the repackager could only say, "Trust me."
"We cannot jeopardize the integrity of our system" for dispensing prescription medications, Riegsecker said.
"We're 18 years behind where we could have been" in implementing track-and-trace systems to thwart counterfeiting, Catizone said.