22% of Hospitals Currently Meet USP 797 Regulations

From Pharmacy Purchasing & Products annual State of Pharmacy Compounding Survey for 2010 based on 322 pharmacy director responses:

  • 22%   Meet/exceed all requirements
  • 56%   Meet most requirements
  • 15%   Meet some requirements
  • 4%    Plan to address
  • 3%    No plan for compliance

With less than a quarter of pharmacies currently fully compliant, here is the projected timeline to compliance for those not there yet:

  • 31%   Within 6 months
  • 32%  6 months – 1 year
  • 23%  1-2 years
  • 5%    2-3 years
  • 9%   No plans for compliance
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What if your loved one was the recipient of the next CSP you make?

Would you do anything differently if you knew that the next CSP you are preparing was for your mother or your child? Eric Kastango recommends that the the “Loved-one Rule” be part of your training program:

Any compliance approach should integrate the ‘loved-one’ rule, where staff are asked to picture loved ones as the recipient of the final CSPs, making the patients they may never meet more real.

Cell Phones in the Cleanroom

You’ll notice that I post a lot of material from articles in Pharmacy Purchasing & Products magazine. They have put a focus on USP 797 compliance that I haven’t seen in other magazines, probably because there is a lot of extra “stuff” to buy in order to get an IV room in compliance with USP 797 and to keep it that way. As a free publication about products and purchasing, it obviously makes its money through advertising, but I have found the articles to be excellent as well, especially those on USP 797.

One article I read last week online intrigued me: “Ask the Expert: Cell Phones in the Cleanroom”. The expert is none other than Eric Kastango, and his answer is that having cell phones (or MP3 players) in the cleanroom does not keep with the intent of USP 797  for two reasons. First, Appendix I states that only required materials should be brought into the cleanroom, which cell phones are clearly not. Second, it is recommended that procedures be performed in a manner to reduce the risk of touch contamination. When I was at the Baxa STAR Center receiving training, the instructors showed us how many particles a person creates just by walking by a hood. Imagine how many are created when a person is digging under their gown to fish out their cell phone or skip to the next song on their iPod. And you’ve heard studies about how many germs are on a phone’s keypad…

See the short article at http://www.pppmag.com/documents/V6N11/p15.pdf.

USP 797 Tip: Spread out Employee Competencies for Early Warning System

I liked this suggestion given by Eric Kastango in Pharmacy Purchasing & Products magazine’s Cleanrooms & Compounding supplemental issue in 2009:

The activities associated with hand hygiene, media fill, surface sampling, and gloved fingertip sampling are often misunderstood. The purpose of these quality elements is to demonstrate proper aseptic technique for compounding personnel…

Once all compounding and supervisory personnel—including pharmacists and technicians—have completed their initial training (regardless of their previous experience), these elements can be integrated into each employee’s annual or semi-annual training. It may be best to validate the competency of a few employees each month, avoiding a mass staff competency verification performed once a year. By dividing staff and performing these activities on a monthly basis, this process will also provide a baseline of microbial bioburden data for the controlled work areas. These data can serve as an early warning system to prevent processes, personnel, and/or facility operations from migrating out of a state of control.

By spreading media fill, glovetip, and surface sample competencies through the year, not only do you avoid the stress of doing them all at once, but perhaps more importantly you will know as soon as results are starting to creep out of range rather than waiting until the 6-month certification.

53% Expect Compounding Volume to Rise: 2010 State of Pharmacy Compounding Survey

From Pharmacy Purchasing & Products annual State of Pharmacy Compounding Survey for 2010 based on 322 pharmacy director responses:

Current Daily Compounding Volume (by Number of CSP’s):

  • 1-50 CSPs: 36%
  • 51-100 CSPs: 21%
  • 101-200 CSPs: 13%
  • 201-500 CSPs: 12%

Future Compounding Volume:

  • Increase: 53%
  • Stay the Same: 35%
  • Decrease: 12%

I was hoping to compares these data to last year, but it was presented in a different format that would have a made it very difficult without having the underlying data. I actually prefer the way they presented it last year, broken down by bedsize.

61% of Hospitals Have Undergone Recent Cleanroom Renovations: 2010 State of Pharmacy Compounding Survey

From Pharmacy Purchasing & Products annual State of Pharmacy Compounding Survey for 2010 based on 322 pharmacy director responses:

Recent Cleanroom Renovations:

2008: 47%
2009: 53%
2010: 61%

Good to see that the numbers are growing, even in the tough economy. Elsewhere in the survey it shows that 78% feel that meet most or all USP 797 requirements, so it will be interesting to see the pace that the number of renovations continues to grow.

State of Pharmacy Compounding 2010 Survey

Pharmacy Purchasing & Products Magazine is a great resource for information on USP 797 compliance, including articles by experts and searching for vendors who offer products to assist you. I just received their 3rd annual State of Pharmacy Compounding 2010 Survey and was very interested to learn how the nation is doing in meeting the regulations. It offers a good high level overview based on survey responses from 322 pharmacy directors.

My intent over the next several posts and tweets is to focus on some of the more interesting results. The entire digital edition is here, but I highly recommend you subscribe to the hard copy if you don’t already – its much easier to read.