URAC’s New Specialty and Mail Service Pharmacy Accreditation Standards, v. 5.0: Part 5
(Pharmacy Operations)
In October 2022, URAC unveiled the new Specialty Pharmacy and Mail Service Pharmacy Accreditation Programs, v. 5.0. In this video, the fifth of a series of eight videos, we explore what’s new as it relates to the Pharmacy Operations (“P-OPS”) 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:
Pharmacy Operations
Pharmacist Oversight
E-prescribing and NCPDP Compliance
Drug Utilization Review Coverage/ Benefits
Out of Stock/ Backorder Products
Labeling and Packaging of Products
Packaging to Maintain Integrity
Medication Verification
Verification of Educational Materials
Machines and Equipment
Compounding
Counterfeit Medications
Inventory Management
Inventory Temperatures and Excursions
Fridge, Freezer, Room Temperature and Humidity
Medication Returns
Controlled Substance Handling
Inventory Management and Security
Hazardous Medications and Materials
USP 800
Unacceptable Medications
Access Levels / Facility Security
Dispensing Accuracy
Dispensing Errors
Transcription
[00:00:22.100] - Thomas Goddard
How about the more general operations standard? What have you found in that cluster of focus areas?
[00:00:29.000] - Jill Paslier
Yeah. So for general operations, let's see. Some of the standards have been combined into one new standard, and this is about reviewing drug utilization review, coverage benefits, and out-of-stock process. And specifically, URAC wants you to have a process for a timely communication for resolving these issues. So it's grouped those three topics together into one, and it's more about the communication process. So making sure you have that. And just remember, anytime that URAC says timely, we want to make sure to define what that timely means. How long until you actually can complete that.
[00:01:12.810] - Thomas Goddard
Right, URAC can say timely, but you can't. You've got to be specific about what you mean by timely. That's one of the great issues that our clients have often tripped over. Another word like that is prompt.
[00:01:28.480] - Jill Paslier
Sure.
[00:01:29.050] - Thomas Goddard
URAC can say prompt, but you can't say prompt.
[00:01:32.020] - Jill Paslier
You need to define it. Exactly. So one of the other reasonably large changes I thought was regarding the process for handling hazardous medications and materials. You probably already had a process to handle, store, and dispose of them. Specifically, URAC is now saying you should handle, store, and dispose them in accordance with USP 800. Many of you may have already been doing that, which is fine. The requirement for the hazardous risk assessment now only needs to be completed if the organization decides to implement alternative containment strategies apart from or different from the USP 800 requirements. If you're doing USP 800, that's fine. You can just document that. But if you want to do something different, maybe for drug specific or specific products, then you'll want to do the risk assessment to show that it's appropriate to deviate from those otherwise required guidance. Then two other small changes. The dispensing accuracy section now requires sharing the safety and error prevention recommendations and updates with your staff. Specifically on all those dispensing accuracy, so you're looking at dispensing errors, proactive risk assessments, published safety literature. Those are the topics within that standard, so making sure that you're sharing any of those recommendations with your staff.
[00:03:04.490] - Jill Paslier
Then related to the dispensing and the distribution accuracy, which is in a later standard, URAC has actually better defined exactly what this means. So you'll want to look at the interpretive information and make sure that you're defining dispensing accuracy and distribution accuracy the same way that URAC does. And this is going to be similar to the reportable measures that you may already be doing. So it should look familiar.
[00:03:33.630] - Thomas Goddard
That's helpful. So that's the new or revised concepts. This seemed like one of those sections of the P-OPS, P-PROD, and P-MD where URAC did a lot of streamlining by removing a lot of concepts that are in that pharmacy 101 category. Is that a fair characterization of the change?
[00:03:53.570] - Jill Paslier
Yes, exactly. So a lot of the changes, like the concepts that have been removed, and I'll give a quick summary in just a moment here, I think you're probably already doing it, and it's a normal process. It's just not necessarily spelled out any longer in the year at guide. To go through these quickly, the concept has been removed for the pharmacist oversight for supporting E-prescribing and compliance with NCPDP, you no longer need to spell out your methods for receiving prescriptions, labeling and packaging of products as far as maintaining integrity and how you label and things like that. You no longer need to spell that out. The process for medication verification and verification of educational material is no longer included. The section about purchasing medications from certain types of entities, monitoring for unacceptable medications and counterfeit inventory management, which could be expiration dating checks and things like that. Those concepts have been removed. There is some slight change to the verbiage in that section, which is talking about medication excursions. This can be allowed, determined by the manufacturer or other published literature. Looking into those. Then one other change is regarding the freezer temperatures. In the previous standards, the freezer temperatures should always be continuously monitored, whereas this one specifically says they only need to be continuously monitored if they're storing medications.
[00:05:29.590] - Jill Paslier
If they're storing ice packs or something else, you don't necessarily need to continuously monitor your freezers. Then as far as the excursions in general, and I'll talk about this more in the distribution section as well, but you'll want to define your medication excursions, both for excursions within the pharmacy, those are in the P-OP standard, and then also for excursions during shipping and delivery. That'll be in the PMD, which is medication distribution section. A couple other removed topics no longer need to discuss medication returns, controlled substance handling, inventory management and security, handling and removal of unacceptable medications, access levels and facility security, and compounding requirements. Again, a lot of these are your pharmacy, your retail 101 topics. You're already doing a lot of these. You just no longer need to spell it out as a part of the URAC requirements.