Pending federal legislation aimed at fostering a safe and secure prescription drug distribution system has drawn different positions from the National Association of Chain Drug Stores.


National Association of Chain Drug Stores, NACDS, prescription drug distribution system, drug safety, Drug Safety and Accountability Act of 2011, S.1584, Michael Bennet, Safeguarding America's Pharmaceuticals Act of 2011, H.R. 3026, Jim Matheson, Steve Anderson, drug manufacturer quality management, community pharmacies, track and trace of prescription drugs, prescription drug supply chain, track-and-trace systems








































































































































































































































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Stance of NACDS differs on pair of drug safety bills

October 6th, 2011

ALEXANDRIA, Va. – Pending federal legislation aimed at fostering a safe and secure prescription drug distribution system has drawn different positions from the National Association of Chain Drug Stores.

NACDS said Wednesday that it supports the Drug Safety and Accountability Act of 2011 (S.1584), sponsored by Sen. Michael Bennet (R., Colo.), yet opposes the Safeguarding America's Pharmaceuticals Act of 2011 (H.R. 3026), a bill sponsored by Rep. Jim Matheson (D., Utah) that calls for mandatory track and trace within the prescription drug distribution system.

Steve Anderson, president and chief executive officer of NACDS, sent letters to both lawmakers, communicating NACDS' position on their bills.

In the letter to Bennet, NACDS endorsed the Drug Safety and Accountability Act of 2011, which seeks to bolster drug safety worldwide.

"We support 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," Anderson stated in the letter. "In addition, we endorse the requirement for the secretary [of the Department of Health and Human Services] to request documentation on persons involved with the manufacturing of the drug and its ingredients."

NACDS also commended the legislation's provision that would stop distribution of a drug by manufacturers, importers, distributors and retailers in which there's a risk of serious health consequences or death. The association, though, expressed concern about the notification of pharmacies in such a situation.

"The language does not mention community pharmacies in the provision for immediate notification," Anderson noted. "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 health care provider will be at the forefront of assisting patients and their prescriber with addressing alternate therapy."

In addition, NACDS requested that pharmacies be included in mandatory recall notifications and clarification on penalties related to those recalls.

In the letter to Matheson, NACDS outlined its stance on the Safeguarding America's Pharmaceuticals Act of 2011, expressing support for some of the bill's provisions but opposing the legislation overall because of a component that calls for mandated track and trace of prescription drugs.

"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 said in the letter.

NACDS cited the workability and trade-off costs to individual pharmacies and the overall health care system in order to implement such a mandate.

"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,' " according to Anderson.

"Chain drug stores have participated in pilot programs to test the feasibility of track and trace. These pilots identified many unresolved issues and have shown that these systems are not yet reliable or operationally effective," he pointed out in the letter. "These problems were recently recognized by the state of California, which decided to delay its track-and-trace mandate for two years, recognizing that the distribution chain was not ready to adopt the program."

What's more, track-and-trace systems can be costly, running as much as $110,000 per pharmacy location, the association added.

Still, NACDS expressed its support for provisions of the House bill that aim to promote the safety and security of the prescription drug distribution system, including authorizing drugs destroyed offered for importation into the United States if they are deemed counterfeit, adulterated or misbranded, and strengthening federal guidelines for licensing of wholesale distributors to "achieve national uniformity rather than a patchwork of state requirements," Anderson stated.

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