A Dose of Reality—and Opportunity—at Pharma Labeling Event
by Laura Johnson, on March 9, 2017
While attending the recent Pharma Packaging and Labeling event in Philadelphia, a few startling statistics that we’ve heard before resurfaced:
- 50%: pharmaceutical recalls due to packaging and labeling errors
- 60%: pharmaceutical recalls caused by human error
- $8M: the average cost to companies for each product recall
Those figures alone should keep pharma companies on high alert as they look to implement best practices for their own packaging and labeling. Fortunately, there are industry conference like this that give pharma and biotech companies the opportunity to meet and discuss ongoing challenges—such as recalls— and explore possible solutions in an open, interactive forum.
We heard from a number of speakers representing leading manufacturers as well as solution providers, many of whom focused on the additional hurdle of meeting regulatory requirements, specifically the FDA’s impending Drug Supply Chain Security Act (DSCSA). As you know, starting this November the FDA's DSCSA will require all products to be clearly marked with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format.
It is expected that compliance with the DSCSA will significantly reduce the number of product recalls—and the costs associated with them. More importantly, it will also protect the health and safety of consumers exposed to mislabeled drugs. Attendees at the Pharma Packaging and Labeling event were provided several options to consider in helping them meet FDA compliance as well as shore up their supply chain operations.
While presenters and exhibitors offered their own unique perspectives and capabilities, there were some common practices shared throughout the conference that companies will want to adopt when evaluating or updating their pharmaceutical labeling:
- Take a programmatic, holistic approach – Break down organizational silos and get every department—from regulatory and package/label design to operations and supply chain—on the same page. And as one presenter pointed out, it’s helpful to understand your current or “as is” state prior to mapping out a new strategy. Collaboration is key with all stakeholders from the start, even if it adds time and effort. Use this approach for every key initiative from serialization to artwork and label workflow.
- Optimize processes with integrated, automated technology – When you can integrate systems with one another and share data, you greatly reduce duplication and the chance of errors. Automation brings much-needed velocity to operations to meet time to market goals and can be accomplished when you pull data and leverage information from “sources of truth.” Hand in hand with automating processes, like barcode labels in pharmaceutical, make sure you standardize on systems and solutions to reduce complexity and incompatibility.
- Think and act globally – While most of the attendees were based in the US, the message was clear from many presenters that you have to be prepared to do business on a global scale. This means not just complying with regional regulations, but ensuring proper translation of packaging and labels to avoid delays and disruptions across the supply chain. One presenter specifically focused on the content and writing of packaging to make sure that patients in any country can understand it—something that not all drug manufacturers consider, yet is critical to bridging the gap between US and international customers.
- Monitor, measure, report. Then repeat. – Obviously, with a process as large and complex as packaging and labeling, you’ll want the built-in steps to evaluate performance and make adjustments as needed. We heard about systems and tools that drive repeatable metrics. At the same time, look for solutions that have the flexibility to keep up with constant change—whether it’s coming from regulatory agencies or customers and providers. If you can apply business logic that helps automate formatting changes on pharma labels, for example, you can still meet requirements without costly downtime.
These were just a few of the takeaways from the event. In our conversations with customers, it seemed like many were in a similar situation: getting by with their labeling and packaging, but eager to find a better way to meet compliance (which also included the FDA's 21 CFR Part 11 for protecting electronic data within systems), improve operations and avoid being one of those scary statistics.
If you’d like to know how innovations in pharma labeling can help you sustain compliance while providing a competitive edge, we invite you to download our latest pharmaceutical white paper “7 Ways to Stay Compliant, Stay Competitive with Enterprise Labeling.”