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While the new regulations governing pharmacy compounding contained in the Drug Quality and Security Act, which received final congressional approval and was signed into law by President Obama last month, garnered most of the media attention, the bigger story is the provisions of the legislation giving the Food and Drug Administration the authority to create a system to enhance the security of the entire pharmaceutical supply chain.
The establishment of a national track-and-trace framework will give patients and health care professionals added confidence in the medications they rely on by reducing the chance of contamination, adulteration, diversion and counterfeiting, and make it far easier to identify the source of problems when they do occur.
When the system is fully operational after a decade or more of implementation, it will be possible to take any bottle of pills in any medicine cabinet across the country and recreate its path from manufacturer to distributor and retail pharmacy before it reached the consumer. Another benefit will be the greatly improved accuracy and efficiency with which product inventory, returns and recalls are handled.
The legislation — which received strong bipartisan support, a rare occurrence in the current Congress — helps ensure that the pharmaceutical supply chain will continue to operate smoothly. By immediately superseding the patchwork of state regulations that was taking shape in the absence of federal action, the Drug Quality and Security Act simplifies the already formidable task of tracking medications by all participants in the health care continuum.
(The compelling rationale for a single national standard governing the medication supply chain is equally applicable to community pharmacy practice. Congress should consider similar action in that sector.)
Almost a decade in the making, the law is a major victory for all health care stakeholders. But, as Liz Gallenagh, vice president of government affairs and general counsel at the Healthcare Distribution Management Association, points out, a lot of hard work remains to be done.
At the start of 2015, everyone involved in the supply chain will be required to document changes in ownership of pharmaceuticals. That mandate will gradually be extended to serialized product standards and electronic tracking.
“In terms of implementation, we’re going to work with FDA and our members, as well as the other stakeholders, to develop guidance on these initial transaction information and data exchanges,” says Gallenagh, whose organization was a key member of a broad-based coalition, which includes drug makers and pharmacy organizations, that lobbied for the Drug Quality and Security Act. “FDA will also have to work on licensure standards and direct the states as to how they’re going to adapt to the new federal benchmarks. Then, as we go forward through this first 10-year period, we’ll be working toward the ultimate unit-level traceability requirement.”
As with any undertaking of this scale, adjustments in the original plan are likely.
“There probably will be more changes behind the 10-year outlook envisioned in the legislation,” notes Gallenagh. “It assumes that the unit-level traceability system will be the future after that point. As with any new effort within the supply chain or with any new technology, lessons will continue to be learned. If we discover additional things that can improve the system, I’m sure that they’ll be considered.”
The Drug Quality and Safety Act envisions a high degree of cooperation between government and industry as the new track-and-trace system is developed. That will play into the strengths of the nation’s drug distributors.
“Our members are well positioned to deal with this challenge,” says Gallenagh. “This is not a simple implementation plan by any means; it’s not an easy task to do something of this magnitude across the entire country. But our members have been advocating for this for years, and in many cases have been at the heart of the technology exploration and testing that needs to occur. They’re committed to do everything that they can to make it work, because they see the benefit in it.”
