Prepare for the Last Mile

For marathon runners, the last mile is often the most critical. Turns out, the last mile is also critical for pharmaceuticals and medical devices.

Both industries define last mile a bit loosely. Some use the term to refer to the last link of the supply chain, such as from distributor to pharmacy. Others say that the definition covers product storage and handling, even by patients at home.

For instance, Claudia Okeke, PhD, calls the risks that products face as they move from pharmacy to patient “most critical.” Okeke, who serves as scientific fellow for the U.S. Pharmacopeia’s department of healthcare quality and information, spoke via phone in January to a group of attendees gathered at “Advanced Cold-Chain Management and Distribution for the Regulated Industry,” sponsored by SWE Enterprises in San Diego.

“Manufacturers have to make sure that their products are handled properly,” said Okeke. “Serious risks occur when patients store 90-day supplies in their bathrooms. Moisture-sensitive drugs like those prescribed to control blood pressure and cholesterol levels are exposed to humidity and moisture in those bathrooms.”

Okeke also pointed out that drug samples stored in the car trunks of drug company representatives as well as those stored in ambulances and other emergency vehicles are also at risk of degradation.

“Storage requirements specified in labeling must be observed throughout article distribution,” she warned, quoting General Chapter <1150>, “Pharmaceutical Stability. “How do we educate all these people?” Okeke asked, rhetorically. “It’s an issue to work on.”

Jan Gates agrees. Gates is principal packaging engineer for Abbott Vascular. “How do you control what distributors do during the last mile?” she asked. “Regulators say to work with them, but it is hard to do. And there is nothing official.”

Gates appreciates the risks that medical devices face during the last mile. Her advice is to understand last-mile risks and design packaging to protect against those risks. “Measure the environment yourself, especially the last mile,” she advised attendees during the day-long packaging conference at Medical Design & Manufacturing West 2007 in Anaheim, CA. “Test products in the lab and then follow those products on their route to the customer. Try to measure shock and vibration yourself. It isn’t always easy to do, though.”

Mark Escobedo, chief technologist for Westpak Inc., says, “Overtest so you don’t have to overpack.” During his presentation, which concluded the session, Escobedo recommended to “develop excursion data, especially if you market biologics.”

Okeke’s advice is education. “Look for ways to educate patients and distributors.”

In other words—study up on the last mile so you can better educate your customers.

Daphne Allen

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