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

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].

Pros and cons of IV workflow management systems

Pondering the need for an IV workflow management system (IVWMS)? You’re not alone if you are. According the most recent PP&P State of Pharmacy Automation Survey, 15% of facilities have already implemented something and another 29% plan to do so in the next few years. The only surprise is the relatively low percentage of facilities planning on implementation in the near future.
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What the NECC fiasco means for automation in pharmacy IV rooms

According to the CDC website, the fungal meningitis outbreak linked to a tainted batch of steroid injections made by the New England Compounding Center in Framingham, Massachusetts has resulted in more than 500 case reports and 36 deaths (as of November 28, 2012).

A lot of things happen when something like this occurs. People become fearful, regulatory agencies begin to scrutinize processes and practices, organizations like ASHP begin to formulate statements and create plans to deal with questions and backlash, healthcare systems begin to reconsider how they do things, and people begin to change the way they think. It’s a natural progression. I’ve seen it happen more than once during my career; never to this extent, but I’ve seen it before. It typically leads to practice changes and an entirely new market for consultants.

The NECC case has caused quite a stir in the pharmacy community. I’ve seen a wild swing in topics of discussion among pharmacists in the acute care setting, i.e. hospitals. Two things in particular have caught my attention: 1) all of a sudden everyone is worried about compounding safety in the IV room, and 2) everyone is talking about robotics. I’ve talked to a couple of friends that are still practicing pharmacy and they are “in the process of looking at IV robots”. Both cited NECC as the reason for their new interest in robotics.
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Yo, wouldn’t a high-tech laminar air flow hood be cool

We have so much technology around these days. I mean we have real-time patient monitoring, near field communication, telemedicine, smartphones, music and video in the cloud, and so on ad infinitum. So why is it that hospital pharmacies use the same old horizontal hoods that they’ve always used?

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Technology in the IV room – its time has come

The cleanroom environment, a.k.a. the IV room, is one of my favorite areas inside an acute care pharmacy. It is often alive with activity, and can often be the busiest area of the pharmacy. It is also a unique place since the use of intravenous (IV) medications is vital to the successful outcomes of patients, but at the same time can result in some of the most egregious errors in healthcare. While the IV compounding process is under tight control as demanded by USP guidelines, the method of preparation and distribution is decidedly more conventional, i.e. IV rooms often rely heavily on humans. It’s an interesting dichotomy found nowhere else in the pharmacy. It is for these reasons that I find it interesting that pharmacy IV rooms have lagged behind other areas of pharmacy operations in automation and technology. However, that’s beginning to change.

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Cleanrooms – the forgotten realm of acute care pharmacy

Cleanroom environments, a.k.a. IV rooms, inside acute care pharmacies compound some of the most complex and dangerous medications used inside a hospital. Unfortunately this area is often overlooked when implementing safety features such as bar-code verification, identification of high-alert medications, advanced training and competency and so on. I was reminded of the dangers of intravenous products by a recent story coming out of Alabama where the death of 9 patients was linked to TPN (total parenteral nutrition) contaminated with Serratia marcenscens.

While IV rooms remain a high risk area they tend to fall off the radar of many hospital administrators when it comes to implementing technology capable of reducing risk. USP <797> tends to get all the glory even though much of the guidelines proposed in this USP chapter have yet to be shown any more effective than diligent hand washing and impeccable technique.
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