URAC’s New Specialty and Mail Service Pharmacy Accreditation Standards, v. 5.0: Part 6
(Medication Distribution)
In October 2022, URAC unveiled the new Specialty Pharmacy and Mail Service Pharmacy Accreditation Programs, v. 5.0. In this video, the sixth of a series of eight videos, we explore what’s new as it relates to the Medication Distribution (“P-MD”) module within those two accreditation programs.
In this educational video, IHS's CEO, Dr. Tom Goddard, sits down with the company's Chief Operating Officer and Senior Pharmacy Consultant, Dr. Jill Paslier, to discuss the changes in the URAC Specialty Pharmacy and Mail Service Pharmacy accreditation standards between version 4.0 and version 5.0.
Jill shares her insights and expertise on the updated standards, highlighting the key changes that impact specialty and mail service pharmacies seeking URAC accreditation. She also offers practical advice on how specialty pharmacies can ensure they meet the new requirements and maintain their accreditation status.
Whether you are a specialty or mail service pharmacy owner, operator, or clinician, this video is a must-watch. You'll gain valuable knowledge and a deeper understanding of the URAC Specialty Pharmacy and Mail Service Pharmacy accreditation standards and what it takes to achieve and maintain accreditation in today's healthcare landscape.
So, sit back, relax, and get ready to learn from the experts at IHS!
Topics covered include:
Medication Distribution
Shipping and Delivery
Shipping Temperatures and Excursions
Qualification Testing
Auditing Packing and Shipping Process
Ongoing Testing
Transcription
[00:00:22.320] - Jill Paslier
We'll be talking about the shipping and delivery section first, and this covers the P-OPS and the old P-PROD standards, and some of those have been combined into PMD, which is medication distribution. So it's a new focus area that just looks at the shipping and delivery. Those are all combined in what we'll be talking about next here. So the main changes, they've defined a little bit more what they're looking for with the shipping and delivery and qualification testing. So the first thing that you'll need to do is define your temperature excursions. It's for the medications that you're delivering. You define the ideal range that you'll keep it in between for the temperature, but then also how warm it can go and how cold and for how long. Those will be the excursions. You've already defined those for medications that are stored in the pharmacy. This is a little bit new that you're actually defining it separately and specifically for medications that are in distribution. As part of defining your shipping procedures as well, you'll need to determine the appropriate temperature ranges, the appropriate packing products that you're using, and shipping duration. You define, do you ship for 24 hours or 48 hours? Then based on those variables, you're going to be doing your qualification testing. Making sure that your boxes that you pack actually maintain the medications for that defined temperature range with the allowable excursions for the duration that you've established. That's the process that they're going for. As a part of that, you can also determine which room temperature medications are going to be shipped under controlled room temperature. That's a little bit of new verbiage under this module.
[00:02:11.450] - Tom Goddard
What is that about controlled room temperature?
[00:02:16.960] - Jill Paslier
Yeah. You're going to be defining the ranges for any room temperature medications, any refrigerated medications, and any frozen medications. Those are the three main temperature profiles. Room temperature medications are a little unique because some of them might have very specific temperature stability where they really should be only at room temperature. Some of them may have more flexibility where you could ship them in a different temperature profile and they're still going to be stable. You have just the freedom to define how exactly you're going to be shipping your room temperature medications, but this should be based on clinical guidelines and manufacturer guidelines and USP guidance and things like that.
[00:03:02.530] - Jill Paslier
A little bit more detail on the qualification testing. So URAC has updated the verbiage from testing based on the geographic distribution and regions that you're shipping to, to now testing based on the temperature profile where medications are shipped. This is related because if you're shipping to Alaska and to Florida, those are different geographic regions, and they're also different temperature profiles. But also thinking about summer and winter, those are also two different temperature profiles. You want to just consider where you're shipping and what are some of the different temperature profiles and make sure that you ship to all temperature profiles or a region or time of year that's going to be representative of the areas that you're shipping to. Got it.
[00:03:48.090] - Tom Goddard
That makes sense. I mean, just Alaska is not always Alaska. It's not always the tundra up there.
[00:03:55.610] - Jill Paslier
Right, exactly.
[00:03:56.630] - Tom Goddard
Got it.
[00:03:58.710] - Jill Paslier
Then one other change to this version that's interesting is the change for the ongoing periodic distribution testing. So in the previous standard, you had to do the qualification testing twice a year. Normally, that was to come for summer and winter. Now they've already established that in the different temperatures that you're testing. But now what you need to do is do some periodic testing. So you're going to be auditing each of your packing and shipping processes. You can do that once a year. And that can include either doing a periodic, ongoing qualification test for all your different pack outs and locations and temperature profiles, or you have some other options. So you can also do an audit of staff completed packouts, or you can do an audit on packout waits for consistency. Those are some examples that URAC is for how you're going to monitor your distribution process on an ongoing basis, which is a little bit new. And just remember that as you're doing that, you want to make sure to test every single packout that you have, every temperature profile and every area where you're shipping it.
[00:05:14.330] - Tom Goddard
The word periodic, URAC uses the word periodic because I'm mindful that historically, when URAC uses periodic, the applicants cannot use periodic. They need to specify a specific time. Does this look like that's the case for this standard as well. While you're looking, I'll just give the background on that. URAC will use words like periodic to require you to do certain things. And this has been true for a lot of years. But you, the applicant, have to come up with a time frame that will be your version of the periodic. Your policy has historically not been able to say periodic.
[00:06:00.090] - Jill Paslier
Right, that's correct. So looking at this specific standard, it does say at least annually. So they've defined somewhat periodic for you. It's got to be at least annual in this case.
[00:06:10.070] - Tom Goddard
Okay. And that's certainly our default advice. When URAC says periodic, it should be at least annual, as a general rule. There are exceptions to that, but at least annual as a general rule. There are exceptions to that, that at least annual as a general rule. Great. Thanks for that.
[00:06:24.140] - Jill Paslier
Yeah.