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URAC 4.0 and Package Performance Qualification Testing

This is the second 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. This article goes into the specifics and best practices of Package Performance Qualification (PPQ) testing in more depth.

URAC 4.0, announced at the end of 2019,  expands on previous requirements around qualification – or Package Performance Qualification (PPQ) – testing. There are two key differences that specialty pharmacies either seeking or looking to renew URAC accreditation need to understand. First, PPQ testing now needs to be conducted on frozen and controlled room temperature (CRT) medication – not just refrigerated products as in the past. Second, testing needs to take place at least twice a year compared to only once as previously required.

With these changes, Mike Becker, Director of Quality and Accreditation for Trellis Rx, says pharmacies should put some thought into and resources behind their PPQ testing process. “When it comes down to doing package testing, you have to be very, very precise with the materials you’re using, how you layer different things into the box, how much refrigerant you’re using, what type of refrigerant are you using and more. It’s a process, and it’s going to take time, but it’s incredibly important.”

Mike recommends scheduling testing during the hottest and coldest months, based on location. This, he says, will ensure your packout is up to the challenge of maintaining stability in the event of a delay – which happens very often. He also cautions that PPQ testing should include all types and sizes of packouts in use. “No one – especially pharmacies shipping to multiple geographies – uses one packout,” he says. Specialty pharmacies should also take into account different shipment methods used, temperature profiles (frozen, refrigerated and CRT) of the medication they send out and geographies they service in their testing. It’s also wise not to rely simply on chamber testing and manufacturer validation in place of true PPQ testing, Mike adds. “Chamber testing adds a lot of value, but there are some things chambers can’t replicate – making it vital to have your own internal tests that are specific to your service area.”

Specialty pharmacies have two options for PPQ testing. They can conduct testing on their own, following URAC protocols, or they can use a third party. Even those who opt to use a third-party vendor to do their PPQ testing may also implement other processes for improved patient safety and customer satisfaction by auditing cold chain packages on a regular basis – monthly or quarterly. For instance, a specialty pharmacy might select 20 out-of-state packages and 10 in-state to monitor, following up with patients to see if shipments arrived on time and measure patient satisfaction.

Mel Nelson, Regional Operations Manager for Fairview Specialty Pharmacy says that while they leverage a third-party vendor, they also conduct their own internal testing first. “We’ve been experimenting with a lot of different packouts,” she explains. “So we’ll do our own testing initially to determine what we think is best before handing it over to our vendor for more official phase two and phase three testing.”  They do this for a few of reasons, she says. To begin, Fairview found it helpful to work with a vendor because they did have suggestions for improving the performance of certain packouts. “Since they have experience with a wide range of organizations, they can provide us with a lot of insight.” This includes helping the specialty pharmacy better understand some of the industry standards around excursion allowances. A third-party vendor can also typically provide more comprehensive reporting that verifies packouts were properly tested and validated to satisfy URAC requirements.

So far, Mel says Fairview has only tested their refrigerated packouts. “Our URAC reaccreditation is coming up in 2022, however,” she says. “So CRT testing will happen soon.” Aside from complying with URAC 4.0, Mel is also interested in seeing the results of the testing. “We do use coolers for some CRT medication, which is an extra cost,” she explains. “But we don’t have a lot of data showing how much coolers help – so I’m wondering if we’ll find that we need to use coolers year-round, for example, or just in summer months.”

PPQ Testing – Best Practices for New Specialty Pharmacies

Where testing is concerned, Mel says the earlier you get started, the better. “It takes time, and you’ll want multiple seasons of data – even before you’re ready to start shipping orders.” The other thing she tells those new to specialty pharmacy is to look for space. “If you look at our warehouse, you’ll see it takes a significant amount of space to store packing materials including materials, ice packs and more.”

Others have looked outside the pharmaceutical industry to those who understand what the cold chain is all about.  Visiting as many different types of organizations, such as food services which has stricter controls where cold chain shipping is concerned, can provide a lot of valuable information about testing and goal setting when first getting started.

Mike agrees, saying that doing your homework is key. “Make sure you’re getting information from qualified individuals across the industry, implementing best practices and doing the testing to refine policies and procedures that will stand up to URAC 4.0 as well as improve patient satisfaction.

In the third article in our series of three, Mike, Mel and Doug will discuss their greatest cold chain challenges. You can also view the original webinar on-demand.