Prescription Drug Imbroglio
Prescription drug makers, pharmacists and major retailers will ask the state Board of Pharmacy on March 25 to postpone the effective date of a law aimed at preventing counterfeit drugs by electronically tracking every bottle.
The board says the new system is needed to stem a rising amount of counterfeit drugs, which the World Health Organization estimates represent less than 1 percent of the market in developed countries.
“We face an increasing threat to the security of the world, U.S. and California drug supply from counterfeit as well as misbranded, adulterated or diverted drugs,” the board says in introducing a 27-page Question & Answer document on the new system, known as ePedigree.
Those seeking the two-year delay, which also includes representatives of biotech, clinics and hospitals say the new system is the equivalent of trying to kill a fly with an anvil.
They say ePedigree fails to prevent counterfeiting and is needlessly complicated and expensive. Nor does technology exist to track prescriptions on a bottle-by-bottle basis, they say.
“The major flaw in the way the California law is written is that it is designed for enforcement purposes and not for public safety and prevention,” said John Cronin, a San Diego based pharmacist and pharmacist lawyer.
“This will create great trail for an investigator to look at after the fact but there isn’t a protection against counterfeit drugs getting in,” said Cronin, who formerly worked for the California Pharmacists Association.
State regulators counter that by making the drug distribution system more secure, the chance for phony drugs to be circulated is diminished.
The board, however, has not presented an incidence of counterfeit drugs in the California market since 2004 when drug makers elected to conduct nearly all their sales through formal distribution chains.
Created by 2004 legislation, ePedigree would require an electronic record of each transaction as a drug changes ownership along the supply chain of manufacturer to wholesaler to dispenser.
It would track these transactions for prescription human and animal drugs through an “interoperable” electronic system. Different manufacturers could use different technologies to track their product — RFID versus bar code, for example – but in theory the ePedigree system would be able to “speak” with both systems.
Seekers of the two-year extension say there is no system like that and the costs of installing multiple scanners to read competing tracking technologies would be prohibitive.
Rite Aid told the board that its first year costs of implementing ePedigree at its Woodland distribution center and 591 pharmacies statewide would be $53.2 million.
Originally set to take effect in January 2007, the board sponsored legislation in 2006 to push the ePedigree effective date to January 1, 2009. Based on the level of industry compliance, the board can push back the effective date until January 2011.
The way drugs are distributed now, roughly 90 percent of prescription drugs are sent by drug makers to three large wholesalers who, in turn, dispense them to pharmacies, nursing homes and hospitals.
Drug makers, both brand name and generic, say the safeguards in their primary distribution chain don’t require the added security of ePedigree.
Such added safeguards might be appropriate in the secondary drug market in which pharmacists or hospitals sell to each other or sell to other smaller wholesalers.
“That’s the real challenge and that’s why the board wants to put ePedigree in place. The poor quality and counterfeit drugs are coming in from the secondary market which has no requirement to track where all those drugs go to,” said Bryan Liang, executive director, Institute of Health law Studies at California Western School of Law and vice president of the Partnership for Safe Medicine.
The board notes that California law makes no distinction between primary or secondary distribution chains. Seekers of the extension have convinced Sen. Gil Cedillo, a Los Angeles Democrat, to carry a bill that could be used to change the law and create that distinction.
Liang, like Cronin, worries about the burden and cost ePedigree places on pharmacists.
“Federal law puts the responsibility for maintaining the pedigree on wholesalers. They have the records. They know where the drugs come from,” said Cronin.
“The way California law is written, the company that ends up dispensing this to a patient or a physician has to maintain all that. Right now, pharmacies don’t have any responsibility for maintaining pedigree but under California law they will be 100 percent responsible.”
It unclear what, if any, action the board will take at its meeting. The issue was also on the agenda of its January meeting but no decision was made.
Filed under: State Agencies
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