Directly Speaking - USP 797: It’s been three years!

by Scott A. Meyers, Executive Vice President, RPh, MS, FASHP
August 15, 2011

Directly Speaking - USP 797: It’s been three years!

Yes, it’s hard to believe that it’s been three years since USP 797 was released, and the world of sterile product preparation was called on the carpet!  

In May, Mary Baker, member of the USP 797 Task Force back in 2007-2009 reported to the Illinois Board of Pharmacy at the request of Dr. Miriam Mobley-Smith, Board of Pharmacy member, to urge the Board and the Department to adopt this important standard as part of the Illinois Pharmacy Practice Act.  (This was reported in the May/June KeePosted Board of Pharmacy News article.)

Fortunately or unfortunately, depending on where you stand on 797, the Department attorneys reported that the State cannot adopt a non-governmental agency’s standards as part of its law.  So if the Board members desired incorporation of the 797 Standard into the Act, it would require adoption of the entire language without citing USP at all.  Then if USP made any changes, the State would have to consider those changes and, if desired, change the statute.  I personally believe that the Department could write the entire 797 Standard into the Pharmacy Practice Act Rules, but again, any changes would still require review and a relatively complicated process for adoption.

The Joint Commission initially declared that it would survey health systems that provided sterile compounding services using 797 as their standard but backed off after complaints of cost, time and space constraints.  Additionally, there has been limited research done on the impact of implementation of the 797 standard and the effect on infection rates within health systems and home care patients.

I know many if not most of our Pharmacy Director members have worked to implement 797 and meet its various standards.  Many have been able to build new state-of-the-art facilities that were long overdue for their institutions.  Others have hit various road blocks from their administrations.  Many of these road blocks are related to cost, space and time as mentioned above.  Some have been told that until it is required by law, they are not willing to provide the space, the time or the funds for building a facility that achieves the goal of 797.

So where are you at with your implementation of USP 797?  ICHP may be sending out a survey soon to our members to see where they are with implementation of USP 797.  If we do, we will want to know not only if you are trying to meet the standard but if you aren’t there yet, why not?  ICHP’s Mission is Advancing Excellence in the Practice of Pharmacy, and improving sterile compounding processes improves patient care which advances the practice.  But how far do we need to go in the case of 797?  The research on outcomes of implementation of USP 797 is still very limited, so the evidence-based requirement isn’t there yet.  Certainly there is a theoretical basis for implementation, but a concern that many of our members and I have is, “What happens to the product once it leaves the pharmacy?”

I personally have seen a nurse drop the IV tubing set end on a piggyback on a hospital room floor and then try to clean it with an alcohol pad!  I’ve been told of a nurse clearing a drip from the end of a tubing set by blowing it off!  I’m sure most of you have witnessed nightmare situations similar to this.

With the best sterile procedures and conditions implemented during the preparation of the product, there is still no guarantee that the final administered product will remain sterile and safe for its intended patient.  So is 797 enough?  Do we begin to require special training, procedures, and environments for the administration of these products, too?  We know nurses are trained in administering sterile products, but is there currently sufficient oversight on their end to equal the requirements of 797 on the pharmacy’s end?  

There are many questions that still exist with the implementation of USP 797, and while moving toward the ideal conditions is appropriate and encouraged, when can we determine if these efforts are working?  When can we determine if these efforts are enough?  What is the appropriate level of quality control and process refinement to be cost effective?  

The 797 survey is not a done deal, but if you receive it, I strongly urge you to complete it honestly and completely!  Your individual responses will be protected.  Even if you don’t receive a survey from ICHP, I urge you to reflect on your own institution’s progress toward compliance to determine if you’ve done all you can to provide the best care for your patients in a safe and cost-effective manner.  Finally, I think it might be time to seriously consider what other steps need to be taken in the sterile medication use process to insure patient safety and positive outcomes.  It’s hard to believe that it’s been three years already! â"    

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