DSCSA making progress, but toward what?
As mid-2016 passes by, the pharmaceutical packaging world is surrounded by serialization and DSCSA (Drug Supply Chain Security Act) activity. As someone intimately involved in pharmaceutical packaging in practice and teaching, serialization is part of every single day.
At the Healthcare Compliance Packaging Council (HCPC), we try to imagine how DSCSA might support safer packaging for consumers. The opportunities are numerous but for the moment everyone is focused on getting the job done. HCPC does note however, that this effort is mute the second we enter pharmacy and begin the antiquated process of repackaging prescriptions into little amber vials which truly unravels the potentially safe supply chain being sought by DSCSA. As well, the process contributes to poor health outcomes, through lack of reminder packaging, and unsafe products, due to exposure to moisture and oxygen post-pharmacy. (The HCPC study on post-pharmacy exposure is available at hcpconline.org.)
At Pester Pac Automation, I see case packer after case packer being readied for serialization as pharma manufacturers and contract packagers scramble to meet looming deadlines. The serialization providers and case packing methods are varied but the end result is the same. A simple process made overly complicated by a procedure which does not integrate well with automated case packing, i.e., line of sight barcode read and capture for bottles and cartons as they are collated and transferred to cases. Thanks to creative engineering, the challenge has been met but the process is less than elegant.
Before we were tasked with barcode serialization, RFID was the likely carrier for serial ID from about 2003 until around 2011. Around that time it was decided that RFID was not mature or robust enough for the task (It was also expensive). Many did not concur with that opinion but the money won the argument. I sincerely believe that those who killed RFID hoped that the complexity and cumbersome nature of line of sight barcode capture would kill any national pedigree legislation. Serialization was undesirable in any fashion; they gambled and they lost. Here we are, saddled with inserting this task into what were formerly efficient packaging processes. This task would have been dramatically less complex with RFID.
The spring of 2016 saw the inaugural graduate pharmaceutical packaging course at Rutgers University. We heard how students new to this world of pharmaceutical packaging would respond to the serialization task. Some were already engaged in the process as entry level employees at pharmaceutical manufacturers. Without exception, they wondered why “we” chose barcode over RFID or some other method that did not hinder the packaging process.
“We” went into the explanation and these grad students began to learn that it is not technology that rules the day, but politics. Even in the world of packaging, special interest groups and the power of politics trump technology. That is why we continue to repack in pharmacy; that is why we still have paper printed outserts; and that is why we are struggling to capture barcode reads instead of RFID. It was a valuable if not humbling lesson for the students, but it will make them better prepared to combat the objections they will encounter.
Better packaging solutions are out there; we need leaders who will look past the bottom line to engage them.
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.