USP soliciting comments for proposed changes to Chapter <797> Pharmaceutical Compounding—Sterile Preparations

By | October 1, 2015

The USP Compounding Expert Committee has published a Notice of Intent to Revise for General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.

I knew this was coming. I’ve talked to several people this year that indicated that revisions to Chapter <797> were imminent, especially with the introduction of USP <800> Hazardous Drugs—Handling in Healthcare Settings.

According the USP notice:

The General Chapter has been under review since 2010 and has been significantly revised to clarify requirements, and reflect stakeholder feedback and learnings since the last revision became official in 2008.

Major revisions of the General Chapter include:

  1. Reorganization of existing sections and placement of procedural information in boxes
  2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
  3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
  4. Introduction of the terminology “in-use time” to refer to the time before which a conventionally manufactured product used to make a CSP must be used after it has been opened or punctured, or a CSP must be used after it has been opened or punctured.

Items #2 and #3 are significant.

Most hospitals do not currently make CSPs that fall into the microbial high-risk category. Altering these categories could have significant impact on acute care pharmacies.

The introduction of USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings will make any mention of hazardous drugs in the current Chapter <797> obsolete. I suspect that the Compounding Expert Committee will likely remove management of hazardous drugs from Chapter <797> and simply defer to USP <800>, which has yet to be published in anything other than draft form.

I will be spending the next week or so going through the proposed changes to better understand what the USP Committee is thinking. Remember, these revisions aren’t final.

Revisions to General Chapter <797> will be published for public comment in Pharmacopeial Forum (PF) 41(6) [Nov.–Dec. 2015] on November 2, 2015. You can view the proposed revisions with line numbers in advance of publication here [PDF].

2 thoughts on “USP soliciting comments for proposed changes to Chapter <797> Pharmaceutical Compounding—Sterile Preparations

  1. Ray Vrabel, PharmD

    CSPs: Clean, but Deadly…

    Why does it strike me as odd that, after a pharmacy implements all of the gloving, garbing, cleanroom, monitoring, and other environmental controls associated with USP, there are NO CONTROLS imposed on the process of preparing a CSP to ensure that the correct ingredients are being used to prepare the CSP…?

    The outcome of this approach may help explain what happened in Bend, Oregon last December when a patient-specific fosphenytoin drip was prepared in the hospital pharmacy IV room. When this patient-specific IV was administered to the patient, the patient quickly went into cardiac arrest, suffered brain anoxia, went into a coma, was declared brain dead, and was later taken off life support and died.

    Did this happen because the IV was contaminated? No, it happened because the wrong ingredients were used to prepare the CSP (i.e., the neuromuscular-blocking drug, rocuronium, was used instead of fosphenytoin). A technician prepared this CSP and a pharmacist checked it before it was sent to the nursing unit.

    Why did it happen? Probably because we have humans involved in the CSP process and humans make errors. I doubt if this was a “mistake-type” of human error (i.e., when people don’t know what to do because they haven’t learned or been taught to do something properly). Instead, it is an example of a “slip-type” of human error (i.e., when people do know what to do, in fact that may have successfully done this thing before many times, but they still make an error). No matter how intelligent, experienced, or trained we are, we are all capable of make human “slip errors”.

    This case also demonstrated that it is possible for a human slip error to occur even when there are two people involved in the inspection process associated with preparing and checking a given CSP (i.e., the pharmacy technician who prepared it and the pharmacist who checked).

    So, if human inspection is not adequate, what can be done to ensure that a human slip error does not occur during the CSP preparation process? The answer is very simple: Barcode Scanning.

    Grocery stores figured this out in the 1970’s when a package of Wrigley’s gum was scanned in an Ohio grocery store. I’m sure the gift hospital in every hospital was using barcode scanning at the point-of-sale back in the 1990’s. By the early 2000’s many hospital pharmacies were using barcode scanning solutions for managing inventories in the central pharmacy and in their Automated Dispensing Cabinets (ADCs). In the past few years, we have achieved greater than 90% implementation of barcode scanning by nurses at the point-of-care when medications are administered to patients. In fact, in the hospital where this “rocuronium-containing” fosphenytoin drip was administered, the nurse was using such a system, but since the IV label was correct, the scanning system confirmed that this IV was the correct IV bag for the patient (i.e., the IV label was correct, but the contents were wrong).

    Unfortunately, even though the pharmacy IV room is where the highest risk activities are performed, mostly by pharmacy technicians, this is the last area to see any type of simple technology (i.e., barcode scanning) implemented. Even thought there are multiple types of IV Workflow Management (IVWM) systems available from EHR vendors and vendors with standalone systems, adoption and implementation has been very slow. At best, it may be occurring in 10-15% of US hospitals, and even there it may only be performed for high-risk drug, CSP preparation. If limited to high-risk CSPs, it would probably not have been used for a patient-specific fosphenytoin CSP.

    To make matters worse, recent surveys have reported that approximately 60% of pharmacy directors have NO PLANS to implement IVWM systems in the next FOUR years! I guess the humans that work in those pharmacy IV rooms are immune to making slip errors. Doesn’t this sound a little bit like the “Emperor’s New Clothes” fable? Only in this case, no one dares to say to the Pharmacy Director that the staff in the IV room are capable of making a human error.

    The fact is that UPS may be part of the problem. Why, because prior to implementation of USP, pharmacist spent more time actually working “in” the IV cleanroom. Now, it is deemed too inefficient to have a dedicated pharmacist in the IV cleanroom and/or have the pharmacist move in and out of the IV cleanroom because of the garbing requirements. So, now we have a system with LESS direct inspection of technician activities and the pharmacist performing the “final check” by looking at a proxy of what has been prepared (i.e., empty vials and syringes pulled-back to “show” the ingredient amount added to the CSP) outside of the IV cleanroom.

    The sad point in all of this is that the cost of implementing a simple IVWM system (e.g., barcode scanning with or without imaging/gravimetrics) is a small fraction of the initial and ongoing cost to support an IV cleanroom that will meet USP requirements. Hospitals have spent a lot of money to make sure that their CSP are not contaminated, but little to ensure that these “clean CSPs” are prepared using the correct ingredients (i.e., type and amount).

    Since it appears that only USP can make improvements happen in the nation’s hospital pharmacies, I would like to suggest that they add some workflow engineering controls (i.e., IV Workflow Management Systems) to their requirements, so that CSPs are not only “Clean”, but also “Safe”.

    As for our current situation, I have to conclude that today, in the absence of IVWM systems being used in the Pharmacy IV rooms, CSPs are “Clean, but Deadly”!

    Having seen the impact that a simple human slip error can have, it makes me wonder what to think if I were a hospitalized patient and the nurse came to my room with a pharmacy-prepared IV? Maybe patients and their family members should be asking hospital staff during the admission process whether or not the Pharmacy is using systems to prevent human errors during the preparation of patient-specific IV admixtures (CSPs). From my perspective, that is far more important than some of the other medication safety technologies that have been introduced in hospitals (e.g., barcode scanning inventory and ADC systems). How many more patient deaths is it going to take before hospital pharmacy administrators realize that minimizing the risk of human error during the process of preparing CSPs should be their TOP PRIORITY…???

  2. Jerry Fahrni Post author

    I agree with you, Ray. Nearly everything you said in your comment can be found on this site in the form of a post sometime during the last couple of years.

    I’ve said it before, and I’ll say it again, regulatory requirements are the cause of more problems than the fix. Most DOPs and operations managers are fixated on regulation and rarely, if ever, take the time to look around the pharmacy and do something innovative.

    I’ve recently thought of returning to pharmacy as a DOP to try and put my mark on the profession. The only problem – other than the fact that I likely couldn’t get hired – is that I would have to find a hospital willing to build a great pharmacy in spite of regulation. There are many things that should be done that aren’t. Your mention of barcode scanning in the IV room is a perfect example, but only one of several.

    Thanks for stopping by and taking the time to comment.

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