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Pharmacy Board Under Pressure to Push Out Deadline for Electronic Drug Tracking

Drug companies, wholesalers, distributors and pharmacies won’t have to electronically track California’s drug supply until 2009, but Temecula-based FFF Enterprises is leading the nation in keeping its drug supply safe.

The privately held company, which supplies 80 percent of the nation’s hospitals with biopharmaceuticals such as flu vaccines and plasma products, has used a self-designed electronic system that traces the supply chain from manufacturer to patient since 2004.

The state Board of Pharmacy is feeling pressure from pharmaceutical companies to delay a second time the deadline by which companies must implement an ill-defined electronic drug tracking system known as an “e-pedigree,” said the board’s executive director, Virginia Herold.

This time, Herold said, the board could consider delaying the requirement , which the California Legislature passed in 2004 , to 2011.

But some fear added delays will increase the dangers to consumers.

The death of 21-year-old Andrea Benitez serves as a reminder of the prevalence of counterfeit drugs and smuggling in this border region.

Benitez died in March 2006 of an allergic reaction to what police believe was penicillin smuggled from Mexico, which she bought from a small San Diego grocery store.


Guilty Pleas

Last month, the owners of Golden Hill’s Acapulco’s Produce Market, Luis Eduardo Herrera, 59, and Olga Gonzalez de Herrera, 54, pleaded guilty to felony conspiracy to furnish a dangerous drug without a prescription. The market was not a licensed pharmacy.

Hector Chaidez, acting supervisor of the commercial fraud group at the U.S. Immigration and Customs Enforcement’s San Diego office, said trafficking pharmaceuticals continues to be a “constant problem” here.

“If we are talking about a few tablets in someone’s pocket walking across the border, (the person is less likely to face questioning), but if we’re talking about several large boxes, we call the trademark holder and they test it,” Chaidez said.

A widely implemented e-pedigree system may not have prevented Benitez’s death, but it might deter criminals from trying to counterfeit or smuggle and make it easier and quicker for officials to detect fakes, experts say.

FFF’s vice president of communications, KB Gressitt, said there needs to be more education to pharmacists and patients about counterfeit drugs and more affordable medicines to prevent people seeking back room cures.

“Our industry has been avoiding fixing this problem, and patients die,” Gressitt said. “If the industry doesn’t fix this problem, the Legislature will. The longer we wait, the more patients die.”


Reducing Risk

FFF cuts risk of counterfeiting, unethical pricing and diversion of drugs by buying only from manufacturers and selling only to health care providers, she said.

In 2004, the Food and Drug Administration said e-pedigree implementation was feasible by 2007, citing the fact that stakeholders such as pharmaceutical companies told the agency it was a “realistic goal.”

The companies would be responsible for paying the cost of implementing the system, a figure unknown at this time.

Since 1987, federal law has required a pedigree, but the FDA said in 2006 that it does not yet have enough information to set standards for an e-pedigree.

Part of the confusion extends from the industry’s indecision on whether to use bar coding or RFID, which stands for radio frequency identification, to track drugs.

FFF recently decided to enhance its electronic pedigree system with help from Woburn, Mass.-based SupplyScape Corp., one of at least two companies with tracking technologies that are eager for regulators to adopt earlier mandates for e-pedigrees. SupplyScape and Mountain View’s VeriSign Inc. said last year that their systems are interoperable.

California companies must meet a Jan. 1, 2009, deadline , moved back by the pharmacy board last summer from Jan. 1, 2007.

Florida’s and Indiana’s deadlines went into effect last summer, and Texas and Nevada are also leading the way with new e-pedigree laws.


Quality Concerns

San Diego’s Amylin Pharmaceuticals Inc. declined to comment for the story and wouldn’t say what type of tracking system it uses to ensure the integrity of its two FDA-approved diabetes drugs, Symlin and Byetta.

Gressitt said there is concern that RFID could affect the quality of biologic products, made of living matter, such as Amylin’s drugs.

Pfizer Inc., with 1,000 workers in its La Jolla facility, has extended the RFID tracking program it has been using to trace Viagra to include arthritis drug Celebrex.

“It’s one of those we find that’s been counterfeited, and it’s made at more than one site, so it gives us extra protection,” said Pfizer spokesman Bryant Haskins.

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