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Cutting through cold chain confusion

Global harmonization efforts involve complexities such as meeting country-specific regulatory needs and optimizing shipping logistics and packaging—all while focusing on the patient.

Pw 45308 Cold Chain1

When a patient opens her mailbox and pulls out a small-parcel shipment that contains her prescription rheumatoid arthritis medicine for self-injection at home, she’s not likely to spend much time thinking of how the biologic-based treatment arrived safely at her address. Fortunately, there’s an entire supply chain dedicated to moving that temperature-sensitive Rx from the manufacturer to the patient’s mailbox—or to a hospital, physician’s office, etc.


This supply chain was the focus of the 10th Anniversary Cold Chain & Temperature Management Global Forum Sept. 24-28 in Chicago. And while the “cold chain” often refers to the 2° to 8° C temperature range required for many refrigerated pharmaceuticals, biologics, and combination products, manufacturers of these products must also consider broader ambient and frozen temperatures when evaluating packaging and logistics choices.


In “The Geography of Transport Systems,” authors Dr. Jean-Paul Rodrigue and Dr. Theo Notteboom note, “The cold chain refers to the transportation of temperature-sensitive products along a supply chain through thermal and refrigerated packaging methods and the logistical planning to protect the integrity of these shipments.”


Earlier this year, Healthcare Packaging magazine announced a partnership agreement with IQPC, an international events producer, whose Cold Chain IQ division is involved in cold chain education, conferences, and events. The agreement involved live editorial coverage from the Chicago event. This article reports on some of the forum’s events.


Supply chain track and trace—how close are we?


A lack of federal or global guidelines on track and trace and e-pedigree leaves more questions than answers. Where does all the data go? The tone of the session was that we can create the data, we’re just not sure what we are going to do with it.


With no central gateway, where will all this information be stored? Who will be able to access it? To what degree will others in the supply chain be able to access my production schedules?


John Roberts of GS-1 suggested that the GS-1 system of standards should be used to improve visibility and efficiency in the supply chain. GS-1 is based on the philosophy of identify, capture, and share. Any production information on the package should be included in the widely recommended 2D Matrix bar code, including lot, expiration date, serial number, production date, quantity, etc.


While the U.S. Food and Drug Administration has not officially commented on standards for pharmaceutical track and trace, recent movement with the UDI (Unique Device Identifier) for medical devices could be a blueprint for the future. Input from industry on the FDA UDI proposal was welcomed and the agency says it designed the program to build on “current standards and systems already in use by some companies” to “minimize industry costs and expedite implementation.”


This bodes well for GS-1, now in use in 110 countries. But don’t confuse a proposed U.S. ruling in the medical device market for global harmony in pharmaceutical serialization. One participant presented the scenario of 200 drugs manufactured in 40 countries for sale in 100 countries. That is a lot of data to generate, store, and pass. And a lot of “customization” is necessary to satisfy certain countries—even the state of Florida has separate rules and regulations.


A major distributor talked about not being able to send product from New York to Florida in case of a shortage, because the New York-based product had not been prepared properly.


And while GS-1 wholeheartedly supports 2D Matrix, other countries are still calling for stacked linear codes, with “legacy” readers flooding the landscape.


One speaker mentioned that the whole reason for serialization, patient safety, will be lost if pharmacies and hospitals don’t invest in new scanners and software.


Even the DEA, only concerned with controlled substances, is overwhelmed by the wide variety of technology it encounters with different manufacturers securing dangerous drugs.


Panelists felt this time California, “the fourth-largest economy in the world,” would stick with 2015 deadlines. But one participant tossed off the threat of California cracking down in 2015, commenting, “they don’t have the funds to do anything.”

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