USP <797>: The Most Challenging revisions: Part 1

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USP <797>: The Most Challenging revisions: Part 1

This set of USP <797> revisions are often most shocking to hospital leaders and compliance teams.

The revisions to USP <797> are long-awaited in the world of hospital and home infusion pharmacy, and our clients are busy getting prepared.  Are you? 

Several weeks ago, I told you we'd be breaking down USP <797> insights and best practices into four categories. My team and I constantly interact with managed and consulting hospital pharmacy clients and are exposed to a wide range of questions and issues. These "buckets" are where we focus.

  1. What’s clearer?
  2. What’s easier?
  3. What’s more challenging?
  4. What’s new?

Today, let's get the hard stuff out of the way first: What's more challenging? 

What's causing the biggest concerns? In our experience, the most common challenges are related to competencies--particularly hands-on activities like gloved fingertip testing and media fill. We hear hospitals worry:

  1. How the increased frequency will affect finances and operations.
  2. How to perform the more complex activities and document the results.

We'll cover #1 today - the material implications. When we're talking to hospital sterile compounders and leaders, we start with the supplies that will be needed. It's a concept many folks are still absorbing, so I illustrate what's needed through the following graphics:

Usually, eyes get wide and calculators come out when I bring out this illustration. People realize the needs are much more than they expected.

For example, this illustration shows the average hospital will soon need ten plates or paddles per compounder every year for biannual testing--that's a big increase from the two that are needed. It will also require a significant budget increase for touch media expenses - a 5x increase in this situation, for example. Source for illustration: Eagle Analytical

Additionally, compliance teams need to be thinking about the logistical details they'll need to address with 5x more plates or paddles needing to be incubated as part of the competency process. For example,  looking at the number of compounders you have, will your incubators be able to fit all of the media (plates/paddles and bags)? Will you be able to adhere to the specific temperatures and timeframes spelled out in the new revision? I encourage you to see what incubation space you have and determine exactly how many plates or paddles will fit at one time. 

The takeaway? Consider preparing your administrators and finance leaders now. 

You should also start looking at your supply chain options and backups to make sure you have adequate materials as you transition. Everyone preparing for the changes will be challenged with this issue, so you’re not alone.

Interested in learning more about what we're hearing among compliance teams getting ready for November?


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