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Greatest Cold Chain Challenges for Specialty Pharmacies

This is the third and last in our special series of articles summarizing discussions between panelists in the Temptime-sponsored webinar – The Science Behind the Cold Chain for Medication – held in August 2020 (view on demand). The first article focused on URAC 4.0 and requirements for monitoring and testing controlled room temperature medication packouts, while the second looked more closely at the processes and best practices for Package Performance Qualification (PPQ) testing. Here our panelists share their greatest cold chain challenges and how best to overcome them.

For Fairview Specialty Pharmacy, Regional Operations Manager Mel Nelson says it’s the biggest issue they face is the fact that they ship to all 50 states. Being able to make sure our packaging is stable, regardless of where we’re shipping across the country, poses a challenge in and of itself,” she explains. If I’m shipping to my neighboring state, it’s probably fine – but if I’m sending it to Arizona, where it’s 90 degrees while it’s 30 here in Minnesota, that’s a different story.” The key, she says, is a delicate balance to ensure the packout is not freezing the medication while it’s in Minnesota, but still remains cold enough as it travels to and finally reaches Arizona. Mel also points out that summer months can be especially challenging. “About 10 years ago, we made the switch to a ‘green cooler’,” she explains. “The product we chose is cornstarch-based – so in the summer, if too much moisture gets into the package the insulation starts to break down, and we can see changes in the stability of the shipping environment.”

That’s why, Mike Becker, Director of Quality and Accreditation, says testing is critical.You want to validate everything on your end, to be certain you have consistency in your packaging materials and your packouts,” he says. This can be done with internal or third-party PPQ testing. Either way, Mike adds that teams need to be incredibly well-informed about how to use the packouts that have been tested. “They need to know the exact right mix of product, refrigerant, packout materials, etc., to make sure the medication shipment is going to remain stable.”

Fairview conducts their own internal tests as well as third-party PPQ testing. “We have done some testing and have found that using more bubble wrap to line the cooler does help,” says Mel. “We’ve noticed that over wrapping the product can actually be more detrimental to keeping the product cold.” As a result of this process, the pharmacy has found a particular layering process that works best for achieving their cold chain goals.

Some operations will take this a step further, testing a few different processes to validate a cooler itself with the goal of stretching timelines out as long as possible. This includes looking at a variety of factors such as the size of gel packs and corrugated versus paper barriers. The bottom line is that ongoing testing helps increase efficiency and preserve the cold chain to ensure medications maintain their efficacy throughout shipping, which saves both time and money.

Many thanks to Mike, Mel and Doug for their insights during our webinar – The Science Behind the Cold Chain for Medication – which served as the basis for our series of three articles, including The How and the Why of the Medication Cold Chain and URAC 4.0 and Package Performance Qualification Testing. You can view the original webinar on-demand.