Doing Our Part to Protect Patients
Elizabeth A. Gallenagh, Esq., VP, Gov't
Affairs & General Counsel for HDMA
The following guest blog is provided by Elizabeth A. Gallenagh, Esq., Vice President, Government Affairs and General Counsel of the Healthcare Distribution Management Association (HDMA), a PSM member.
The opinions expressed are not necessarily PSM's policy.
The U.S. healthcare supply chain remains one of the strongest in the world, but it is not immune to bad actors and incidents that compromise patient safety and security. For example, in the past year alone we have seen major headlines of counterfeit Avastin reaching patients and “gray market” profiteers.
The lesson for our industry is this: it is incumbent on the entire supply chain to be vigilant and work collaboratively to protect patients. This means knowing your customer, knowing your trading partners and getting the education to spot red flags as they arise.
To improve the safety and security of the supply chain, the industry has come together through a healthcare stakeholder coalition, the Pharmaceutical Distribution Security Alliance (PDSA), to advocate for a single, uniform traceability framework. Such a framework would ensure that only properly licensed entities are buying and selling prescription drugs, and would clearly indicate where medicines are coming from and where they are going in the supply chain. While talks with Congress and other groups are ongoing, we remain hopeful that agreement and a legislative vehicle are found in the near future to achieve this goal.
At HDMA, we also are offering education opportunities that will enhance the value of the healthcare supply chain and promote patient safety. To that end, we are hosting our annual “Track-and-Trace Technology Seminar” on November 12-14 in Arlington, Virginia. There are a lot of issues that securing the supply chain touches that will be covered in this seminar, including hospital level serialization, planning for aggregation, cargo security and global track-and-trace efforts.
With the potential for progress on supply chain security legislation still strong, this year’s seminar will provide an opportunity for distributors, manufacturers, retailers and beyond to hear updates on how Congress, FDA and the industry are addressing evolving pedigree and technology requirements in the U.S. Seminar and registration information can be found through HDMA’s website.
About the Author
Elizabeth A. Gallenagh, Esq., is Vice President,
Government Affairs and General Counsel for HDMA. She is responsible for
overseeing federal and state advocacy on behalf of HDMA member companies and is
the organization’s chief in-house attorney. Additionally, she serves as HDMA’s
primary expert on prescription drug pedigree, licensure and tax issues. Prior
to joining HDMA, Gallenagh specialized in Medicare Part B reimbursement and
coverage policy. Gallenagh holds a JD from the George Mason University School
of Law, and a BA from The George Washington University.
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