ALEXANDRIA, Va. — As Congress considers measures to protect the nation's prescription drug distribution system, the National Association of Chain Drug Stores on Wednesday voiced its strong opposition to a piece of legislation sponsored by U.S. Rep. Jim Matheson, D-Utah, which would require a mandatory track-and-trace system — a move that could cost the typical pharmacy chain millions of dollars to implement across all stores.
In a letter to Rep. Matheson, NACDS president and CEO Steve Anderson expressed the industry's opposition to his proposed Safeguarding America’s Pharmaceuticals Act of 2011 (H.R. 3026).
“While the National Association of Chain Drug Stores salutes your commitment to the safety and security of the prescription drug supply chain, I must express our objections to the portions of your legislation that call for a system of tracking and tracing prescription drugs,” Anderson stated in the letter to Matheson. “Requiring pharmacists to adopt immature technologies will distract them with complex compliance issues, taking time away from providing services to patients. There is also a great likelihood that track and trace would actually slow down the movement of prescription drugs — especially with labor intensive ‘line of sight’ technologies, such as ‘two-dimensional bar codes,’” Anderson wrote.
According to NACDS, the estimated cost to implement an electronic track and trace system could run as high as $110,000 per location.
Anderson did say, however, that NACDS did commend provisions that were designed to help ensure the safety and security of the prescription drug distribution system including: authorizing the destruction of drugs that have been offered for importation into the United States, or deemed to be counterfeit, adulterated or misbranded; and strengthening federal guidelines for licensure of wholesale distributors to “achieve national uniformity rather than a patchwork of state requirements.”
In related news, NACDS threw its support behind a competing bill in the Senate, The Drug Safety and Accountability Act of 2011 (S.1584), which was sponsored by Sen. Michael Bennet, R-Colo. Anderson said that NACDS supported Bennet's bill, as "the provisions that will establish drug manufacturer quality management plans for the drug, as well as the active ingredients and materials used to manufacture the drugs, and the requirements for audits, monitoring and testing as part of the plans," he said. The organization also expressed support for the bill’s provision that would stop distribution of a drug by manufacturers, importers, distributors and retailers where the risk of serious, adverse health consequences or death exists.
However, NACDS did express concerns about notification of pharmacies when such a situation occurs.
"The language does not mention community pharmacies in the provision for immediate notification," Anderson wrote. "We also have questions about how this would impact patients for whom the drug has been prescribed. We respectfully ask that consideration be given to the impact on patients’ drug treatment regimens and the patients’ likely need for alternate therapy. Pharmacies as the most accessible healthcare provider will be at the forefront of assisting patients and their prescriber with addressing alternate therapy."