As fall 2016 kicks in, pharmaceutical manufacturers and those involved in the supply chain are grappling with the roll out of The Drug Supply Chain Security Act (DSCSA). For many, activities have been in full swing for a few years and others are still planning how they will approach it. I pity the latter group. They’ve likely misjudged the complexity of the task and the market resources available to accomplish it.
Our election looms in the background. These two events could be seen as separate, but are they? Well unfortunately, no. This current challenge in pharmaceutical packaging is driven by DSCSA passed in 2013. It affects the entire pharmaceutical supply chain and will continue to do so through full implementation in 2023 but typical of Washington, D.C., the legislation missed the mark and will fall short of its goal, a secure supply chain.
So what about the next U.S. presidency? Will the shortcomings of DSCSA be recognized before 2020 when the next election rolls around? I hope so. I hope that legislators recognize that DSCSA with continued repackaging in pharmacy falls woefully short of a secure supply chain. A little research shows that much of the counterfeit and gray market drugs entering our supply chain gain access through pharmacy. This fact means that a secure supply chain needs manufacturers’ original packaging passing through the pharmacy to patients – meaning more packaging done by manufacturers and contract packagers.
It means more packaging lines and a lot more packages in the supply chain. The engineers will love it. The brand packaging engineers have always been frustrated that their work is lost in pharmacy. They understand that the generic amber vial used across the U.S. was not designed for “their” drug; it was not tested with “their” drug. Their efforts at creating a proper FDA- and USP-rated package and label are finished in pharmacy. Their product is in someone else’s hands and someone else’s package.
If supply chain safety was the only problem we might find some workarounds, but there is more. Pharmacy repack is not only an unsafe process but provides an unsafe package – unsafe for the drug itself and unsuitable for improving adherence.
The same vial that wrecks supply chain security efforts opens the door to product degradation as well.
One HCPC study looked at several common drugs in three different packages and across several environmental conditions. The study found that any container other than a high-barrier blister exposed the product to environmental conditions that accelerated degradation in a relatively short period of time, less than 30 days.
As well, current pharmacy packaging does nothing to advance medication adherence, which is known to be a critical problem in U.S. healthcare.
So, not only does DSCSA fail to fix supply chain security, but it also ignores more glaring problems with pharmaceutical distribution that have broad impact. Fixing these problems will come down to a Congress and a president willing to put the public welfare in front of pharma manufacturers’ bottom line.
The Healthcare Compliance Packaging Council is a not-for-profit trade association whose mission is to promote the greater use of compliance-prompting packaging to improve patient adherence and patient outcomes which will lead to reduced healthcare costs. The positive effects of this style of packaging have been proven by numerous studies over the past twenty years, yet U.S. pharmaceutical distribution still clings to an antiquated amber vial for a majority of prescriptions. While advances have been made in every facet of our daily lives, life-saving medication packaging remains in a vial introduced in the 1950s. The HCPC is working to change this.
For more information on HCPC, please visit www.hcpconline.org.