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.

New California Compounding Regulations effective July 6, 2010

For those of you who live in California, there are new Compounding regulations going into effect soon. Many pharmacy directors, IV supervisors, and IV pharmacists and technicians that I have been talking to are not aware of thew new requirements. The complete Regulations for Pharmacies that Compound Medications (16 CCR 1745), which replaces 16 CCR 1716.1 and 1716.2, as well as amendments to 16 CCR 1751 (Sterile Injectable Compounding) can be found at http://www.pharmacy.ca.gov/laws_regs/new_laws.pdf (starts on page 24) and a summary of changes is at http://www.pharmacy.ca.gov/laws_regs/1716_statement_rev.pdf.

From those who are aware of the regulations, it seems that the section of greatest concern is 1735.3, Records of Compounded Drug Products (or it may be that I hear about this the most since the product I sell deals with this). This section adds a lot of record keeping for all sterile and non-sterile compounded products (the only exception is for immediate use products):

1735.3. Records of Compounded Drug Products (Effective 07/06/10)

(a) For each compounded drug product, the pharmacy records shall include:

(1) The master formula record.

(2) The date the drug product was compounded.

(3) The identity of the pharmacy personnel who compounded the drug product.

(4) The identity of the pharmacist reviewing the final drug product.

(5) The quantity of each component used in compounding the drug product.

(6) The manufacturer and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. Exempt from the requirements in this paragraph are sterile products compounded on a one-time basis for administration within twenty-four hours to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code.

(7) The equipment used in compounding the drug product.

(8) A pharmacy assigned reference or lot number for the compounded drug product.

(9) The expiration date of the final compounded drug product.

(10) The quantity or amount of drug product compounded.

What is your perspective on the new regulations? Are you ready??