ALEXANDRIA, Va. New federal legislation to require that pharmacies and drug wholesalers establish electronic pedigrees for every drug they sell or distribute would throw both industries into turmoil and add “extraordinary” costs to their operations, the head of the National Association of Chain Drug Stores warned Thursday.
The Safeguarding America's Pharmaceuticals Act of 2008 was introduced Thursday by Reps. Steve Buyer, (R-Ind., and Jim Matheson, D-Utah. If passed and signed into law, the bill would mandate electronic pedigree requirements to assist in the tracking and tracing of prescription drugs in the domestic supply chain.
NACDS president and chief executive officer Steve Anderson responded quickly to the proposal. “While instances of drug counterfeiting may occur,” he said, a federal e-pedigree mandate is the wrong approach.
“Despite the perception that e-pedigree and track and trace mandates are quick solutions, their adoption and implementation would be extremely complex and costly for retail pharmacies and others in the supply chain, and without the desired benefit,” Anderson asserted. “These systems are many years away from full development, have not been fully tested and lack uniform standards and patient privacy safeguards.”
There are alternatives to assure a safer drug supply as the industry gears up for e-pedigrees, Anderson added. Among them: adopting tougher uniform federal licensing standards for drug distribution and using the Food and Drug Administration to certify that manufacturers, distributors and pharmacies follow secure supply-chain guidelines.
“These steps would go a long way in improving safety and further protecting the supply chain by building on effective systems currently in place,” Anderson said.