Delays thwart drug tracking system
News of as many as 19 deaths in the United States linked to contaminated blood thinner heparin from China has generated new concerns about how to keep bad drugs from finding their way into the marketplace.
But if California’s 5-year-old effort to fight counterfeit drugs is a guide, the task may be tougher than it looks.
The pharmaceutical industry has repeatedly balked at implementation of the state’s first-in-the-nation law approved in 2004 that would require manufacturers and retail pharmacies to create an electronic system to record a drug’s journey from factory to patient.
The system was to be in place by Jan. 1, 2007, but the California Legislature in 2006 extended the deadline until next January. Today, the state Board of Pharmacy will consider another extension -- this time until 2011.
Big pharmaceutical companies, drug wholesalers and retail pharmacy chains say they can’t meet California’s Jan. 1 deadline and are asking for more time. Various industry associations have begun a quiet, coordinated campaign to promote the extension, hiring lobbyists and both Republican and Democratic-oriented firms that specialize in political strategy and media.
But state regulators say they’re worried that further delays could endanger public health. “In 2011, they’ll want 2013. In 2013, they’ll want 2015,” said state board member Stan Goldenberg, a Los Angeles pharmacist. “They’ll keep the ball in the air until something bad happens.” He said, “They’re playing Russian roulette with the consumers of California.”
The board, Goldenberg said, wants to be proactive.
“We are desperately seeking cooperation from the pharmaceutical industry,” he said. “But we are not getting their cooperation” except for certain smaller manufacturers.
Stronger regulation is overdue, said Virginia Herold, executive officer of the pharmacy board. “We’ve learned that we cannot trust the supply train, and there are bad players.”
The U.S. Food and Drug Administration has also had no luck implementing a national system to fight counterfeit drugs.
FDA spokesman Christopher Kelly acknowledged that the agency has run into a number of legal and administrative delays in instituting its own rules over the last 20 years. The FDA, he said, “supports California’s efforts to further secure the drug supply chain.”
The World Health Organization estimates that counterfeit drugs account for less than 1% of the nation’s drug supply, but even that small number could mean that Californians are picking up 3 million prescriptions a year filled with phony pills and liquids, state regulators warn.
At the heart of the 2004 California law is the “electronic pedigree” system that would trace drugs back to production. When the Legislature postponed the start of the program in 2006, it also toughened it by mandating that the industry install electronic readers to track serial numbers on each salable unit of a drug at key points along the distribution system.
The Legislature first acted after an estimated 200,000 bottles of fake Lipitor, one of the nation’s most widely used medications for controlling cholesterol, were recalled in 2003, causing a national outcry.
Drug companies say that they’ve been working diligently to meet California’s tracking deadline but contend that they need more time to overcome technical and financial challenges.
“If the law were implemented next year, McKesson would not be able to deliver vital medications throughout the state,” said a letter to the board from McKesson Corp., the San Francisco drug company that is one of three main national drug wholesalers and distributors.
“The health and safety of Californians would be best served if the e-pedigree implementation date is delayed until 2011,” the company said in a letter to the board.
The industry wants the pharmacy board to approve the two-year delay today. As a backup, pharmaceutical companies are sponsoring a bill that, if passed, would indefinitely put off the date for starting to electronically track medicines.
Some drug makers say they aren’t sure they can meet a deadline, even if it’s extended to 2011.
“It’s going to be hard to know right now. We need time to do research and development,” said Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Assn. “The industry may need additional time.”
Even if they approve the two-year delay, state regulators say they hope to persuade all participants in the drug supply system, including manufacturers, distributors and retailers, to begin voluntarily complying with as much of the electronic tracking law as feasible: by putting bar codes or radio frequency identity chips on products and installing scanners throughout the manufacturing, distribution and sales system.
Under current law, the pharmacy board would be empowered to make such actions mandatory after Jan. 1, 2011.
Acting quickly is essential, said Rick Roberts, who discovered in 2000 that he’d been taking a counterfeit human growth hormone to counteract AIDS-related atrophy.
“It was a nightmare. Not knowing whether I did damage to myself really consumed me,” said the University of San Francisco professor, who has since recovered. Drug counterfeiting, he said, is a “heinous crime.”
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Safety suggestions
The state offers eight tips on how to avoid counterfeit, misbranded or adulterated prescription drugs.
* Know your supplier. Just because a supplier is licensed does not mean it is trustworthy.
* Watch out for “good deals,” especially with new suppliers.
* Be wary of offers that come via fax and e-mails.
* Look out for signs of removed labels such as tacky adhesive residue; discolored labels; slight differences in bottle or container sizes.
* Heed warnings from other patients.
* Notice sudden changes in blood and lab work results.
* Were the drugs purchased from foreign sources?
* If you suspect a problem: Contact the drug manufacturer; the U.S. Food and Drug Administration at www.fda.gov/medwatch or (800) 332-1088; or the California Board of Pharmacy at www.pharmacy.ca.gov, (916) 574-7900
Source: California Board of Pharmacy
