Drug tracing plan is delayed
A first-in-the-nation plan to keep counterfeit prescription drugs from reaching consumers was put on hold again Tuesday by the state Board of Pharmacy at a meeting in San Diego.
It was the second two-year delay for the start of a statewide electronic pedigree drug-tracking program first approved by the Legislature and governor in 2004. It would require factory-to-patient tracking of individual units of pills and other medications.
In its formal statement, the board said it reluctantly agreed to the postponement after most large pharmaceutical makers, distributors and retailers said they were not ready to implement the system in time to meet a previous legal deadline of Jan. 1, 2009. The vote approving the delay was 12 to 0, and no member of the board spoke in opposition.
“The board has concluded that in the absence of such a delay, the California drug supply and potentially the entire U.S. drug supply may very well be negatively impacted” by a shortage of life-saving medicines, the statement said.
“The board concludes that its primary duty to protect the public is better served by a delay permitting a less disruptive implementation than by a rush to secure industry compliance.”
The board said it had received “concrete assurances” from drug industry participants that “they can and will be ready for full implementation by Jan. 1, 2011.”
The extension will “allow critical time for the U.S. Food and Drug Administration and the industry to develop track-and-trace standards and for supply chain partners to conduct essential testing and expand current technology” pilot projects, said John M. Gray, president and chief executive officer of the Healthcare Distribution Management Assn., a trade group of wholesalers and national distributing firms.
The board’s decision was understandable but disappointing, said Mark O’Connell, president and chief executive officer of SupplyScape Inc., a Woburn, Mass., provider of e-pedigree systems. But at the same time, O’Connell said, he was heartened that the board “left a very clear message for industry that you need to get this job done.”
The proposed system, which is still being developed, would electronically track the name of a prescription medicine and information related to its dosage, manufacturer and its handling along the supply chain. Large shipments, pallet-loads of bulk pills and individual bottles would be identified by electronic scanners that read two-dimensional bar codes and high-tech computer chips, experts say.
It was the need for such stringent controls -- highlighted by the widespread counterfeiting of Lipitor, a popular drug for controlling cholesterol -- that partially inspired the board to seek passage of the 2004 law.
The board sponsored a second successful bill that tightened demands for tracking drug shipments but put off the original start date from Jan. 1, 2007, to Jan. 1, 2009.
In the meantime, problems connected with counterfeit drugs have worsened, the board warned.
“Recent incidents involving contamination or counterfeiting by overseas suppliers of the blood thinner Heparin underscores the importance of a safe and secure supply chain,” the board said. “Yet federal and state efforts to date have not brought an end to the efforts of counterfeiters or others to impact the U.S. supply chain.”
Worldwide sales of counterfeit drugs are expected to increase by 92% from 2005 to 2010, according to an estimate by the Center for Medicines in the Public Interest, a New York-based think tank and advocacy organization.
Although counterfeits account for less than 1% of drugs in the U.S. market, the estimated 3 million prescriptions sold each year in California represent a substantial threat to patients’ health, the Board of Pharmacy said.