Serialization of pharmaceutical packages has been a hot topic in the last 10 years, as we seek to prevent counterfeiting and diversion of products in commercial supply chains. Proponents of the technology, both inside and outside the industry, highlight the additional business value of inventory control, recall management and supply-chain visibility that accrue to serialized, tracked products. But nowadays, the healthcare industry is looking at a broader picture—one focused on patient safety and improved health outcomes. Medication adherence plays a key role, and maybe serialization can help.
In the US, drugs that make it through the rigors of clinical trials and FDA approval are not taken properly more than 40% of the time. Poor medication adherence has an almost one-for-one dollar impact on the US. We spend $320 billion a year on pharmaceuticals, and another $290 billion correcting errors created from poor adherence. Show me another industry where this occurs. Show me another industry where this would be tolerated. The manufacturers and pharmacists are well aware of the poor adherence problem—they’ve known about it for a long time. Where is the action?
Actually, healthcare providers are taking action regarding medication adherence, and the insurance industry is certainly interested. This is in large part due to changes in payment models, which focus on improved health outcomes, not frequency of treatment. (Search Patient Centered Medical Homes, CMS Care Transitions and Medicare 5 Star Ratings.) Suddenly healthcare providers find themselves responsible for improved health outcomes and hospital readmissions. Improved medication adherence offers significant relief in both areas.
One critical problem is our prehistoric prescription filling process. Prescription packaging has gone largely unchanged in this country since 1955, when the amber vial was introduced. The world has moved on. Every other developing technology has progressed dramatically in the last 60 years. What happened to pharmaceutical packaging? In a day when my phone has more memory and capability than a computer of 20 years ago, why am I staring at this lifeless, mute package on the counter that may contain lifesaving medicines, and that was introduced to the market when Eisenhower was in office? Why haven’t technology and pharmaceutical packaging gotten together?
Now back to the beginning, and track and trace. Should medication adherence and serialization be linked? I think they should, and here are a few reasons why.
1) Driving the original manufacturer’s serialized container through the pharmacy to the patient will virtually eliminate dispensing errors that occur regularly in today’s “count, pour, lick and stick” environment
2) Putting a serialized container in the patient’s hand will allow them to authenticate the package
3) That same container, or more appropriately the serial number, will allow patients to link to a variety of compliance tools, allowing them to track their individual performance and link to a variety of reminder tools (many have been developed with limited uptake, but I think the serial link would enhance the effort)
4) That serial number creates the opportunity for direct-to-consumer notification of recalls; for example, not depending on the pharmacist to track the lot and then research which patients’ scrips were affected
5) That serial number could be used in reverse logistics to prevent the reissuance of a container previously delivered back into the marketplace (California, Heparin, 2008)—and reduce diversion.
All these benefits from the introduction of the most basic technology. Many more impressive packaging solutions have been developed and await implementation.
But we can’t gain these benefits without item level serialization—track and trace and smarter packaging. Without the tracking component, we lose visibility in the supply chain and will only learn of problems after they occur. The intent of track and trace is to prevent problems from occurring.
We’ve entered an age in our medical establishment where prevention is being embraced. Shouldn’t our pharmaceutical supply chain follow suit? After trailing in technology for almost 60 years, why not make a quantum leap, bring pharmaceutical packaging into the 21st century, take advantage of the smart tools and help make pharmaceuticals safer for all of us.
ABOUT THE AUTHOR
Walter Berghahn has spent 26 years in the packaging industry, the last 15 exclusively in pharmaceuticals. Currently, he is president of SmartRmeds for Life (www.smartrmeds4life.com), a consulting business dedicated to medication adherence solutions. He also serves as Executive Director of the Healthcare Compliance Packaging Council (HCPC), a nonprofit trade association focused on compliance-prompting packaging in support of improved medication adherence. Previous affiliations include AmerisourceBergen Packaging Group and Uhlmann Packaging Systems. He holds a BS in packaging engineering from Rutgers University.