A Health Mart pharmacy owner this week gave his take on pharmaceutical supply chain safety in a congressional hearing.

Health Mart, pharmacy owner, Tim Davis, Beaver Health Mart, National Community Pharmacists Association, NCPA, pharmaceutical supply chain safety, House Energy and Commerce Subcommittee on Health, Securing Our Nation's Prescription Drug Supply Chain, pharmaceutical supply chain, pharmacists, drug pedigree laws, track-and-trace, community pharmacies, Pharmaceutical Distribution Security Alliance

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Health Mart owner testifies on Rx supply chain security

April 26th, 2013

ALEXANDRIA, Va. – A Health Mart pharmacy owner this week gave his take on pharmaceutical supply chain safety in a congressional hearing.

On behalf of the National Community Pharmacists Association, Tim Davis, owner of Beaver Health Mart Pharmacy in Beaver, Pa., testified Thursday at a U.S. House Energy and Commerce Subcommittee on Health hearing titled "Securing Our Nation's Prescription Drug Supply Chain."

With legislation having recently been introduced in the House and the Senate, Davis' comments focused on the need for more uniform standards, concerns about potentially burdensome legislative requirements on community pharmacies, and ways that pharmacies are currently addressing the problem.

"It is my belief that the United States pharmaceutical supply chain is largely safe and secure," Davis told lawmakers. "Most practicing pharmacists today have a heightened awareness of the possibility of counterfeit or diverted drugs and therefore recognize the critical importance of purchasing medications only from trusted trading partners or wholesalers. In addition, pharmacists, as an integral part of their training and day-to-day practice, are taught to carefully examine and make note of both the drug packaging and the appearance of the drug itself to be sure there are no suspicious anomalies."

Touching on various points, Davis noted that with more than half of states passing drug pedigree laws, the patchwork nature of how the supply chain is regulated is creating uncertainty and possible vulnerabilities.

"Federal policy makers and supply chain participants alike have been discussing what a possible federal system to provide further assurances of supply chain security would look like for a number of years. But due to the widely varying business models, financial resources and technological capabilities of those involved in the pharmaceutical supply chain, the process has not yielded a coherent, comprehensive national proposal yet on the federal level," Davis explained.

"In the past, there have been numerous discussions about the practicality of a system that would track prescription drugs at the individual unit level. Pharmacists have had significant concerns about any system that would require each individual unit of medication to be electronically scanned upon arrival in a pharmacy due to the capital outlays that would be required and the time and labor costs associated with such a system," he said. "At the present time, the technologies that would be required to implement such a system are not fully developed and have not been designed or scaled to be feasible or affordable for use in individual community pharmacies."

Though "well-intentioned," California's law requiring manufacturers to track-and-trace drug products across the supply chain at the individual level would present a hefty burden to pharmacies, Davis pointed out.

"The cost of compliance with this law will be extremely high especially for small community pharmacies, when factoring in both initial implementation and ongoing expenses necessary to maintain and access the data," he told the subcommittee. "Imposing these challenges particularly on small-business supply chain participants like community pharmacies is not logical at a time when the nation is focused on trying to reduce the costs of health care."

Such factors underscore the need for a uniform, federal framework to provide further assurances of supply chain security and to assist the Food and Drug Administration and other federal regulators in instances of recalls and other investigations, Davis stated.

"We need a reasonable, commonsense federal approach that will strike the appropriate balance between enhanced patient safety and minimizing unreasonable burdens on supply chain stakeholders," he said.

Davis added that NCPA, as a member of the Pharmaceutical Distribution Security Alliance, agrees that setting national requirements for wholesaler licensing standards and attaching a unique identifier to prescription drugs at the unit and case levels would bolster Rx supply chain security.

"Community pharmacists take seriously our role in ensuring the safety of medications that we personally dispense to our patients and remain committed to working with our colleagues in the supply chain as well as with state and federal authorities to make any needed improvements," he said. "Moving forward, it is essential that all stakeholders make a concerted effort to keep the lines of communication open so that consumers can continue to trust the integrity of the medications that they depend on."

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