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It is NOT Just About Sterile Compounding!
—OR—
What About Nonsterile Compounding?
We must ALL think about ALL of the compounded preparations we make—how we prepare them, the equipment we use, and the environment in which we prepare them!
For obvious reasons, it is natural that institutional pharmacists think more about abiding by United States Pharmacopeia (USP) Chapter <797> when compounding sterile preparations than they do about abiding by USP Chapter <795> when compounding nonsterile preparations. However, as this newsletter points out, our patients deserve appropriate considerations for nonsterile compounds as well. Moreover, pharmacists should abide by the requirements in USP Chapter <1163> Quality Assurance of Compounded Preparations.1 Our human and animal patients expect the same of our compounded preparations whether it is:
| ·Capsules | ·Creams | ·Infusions |
| ·Injectables | ·Intrathecals | ·Lotions |
| ·Pastes | ·Powder packets | ·Solutions |
| ·Suppositories | ·Suspensions | ·Tablets |
Let's Ask Ourselves a Few Questions
| Q: | Are nonsterile compounded preparations at risk for contamination? |
| | Certainly! When you go to a restaurant do you expect the restaurant to take the necessary precautions to assure that your food will be free of human and/or animal hair…parts of paper towels…toothpicks…broken off pieces of cooking utensils…dirt…bacteria/mold? I do! |
| Q: | Is your nonsterile compounding… |
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- area segregated in a low traffic area?
- staff wearing masks, hair covers, and gloves when compounding nonsterile preparations?
- staff aware that USP <795> and <1163> were revised and became official May 1, 2011?1
- staff performing quality-assurance checks on each preparation?
- staff verifying your processes for preparing nonsterile compounded preparations?
- area properly ventilated? (Those raw chemicals and crushed tablets don't smell as good as momma's fried chicken and can be just as bad for you!)
- staff prepared to notify and or recall any preparation identified as contaminated or out of potency range?
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| Q: | To assure the quality of your compounded preparations are you… |
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- using clean equipment that decreases cross-contamination?2
Example: Items that can be put into a very hot dishwasher (e.g., all one-piece molded silicone spatulas that will withstand up to 350°C or greater [Throw those rubber ones out!], glass and stainless steel beakers for electric blender and mixers, dropper pH meter [no dunking please], homogenizer, chopper/grinders, sifters, electric mortar and pestle.)
- using barcodes or scanners for ingredients or an electronic balance?
- using disposable or dispensing equipment that decreases cross-contamination?
Examples: syringes, scrapers, plastic spoon straws, mortar and pestles, dispensing jars that can be used with an electronic mortar and pestle.
- using a checklist of steps to control handling from the time inventory arrives in your pharmacy until the patient receives their customized medication?
- using ingredients that have been protected from environmental contamination throughout the compounding process?
Examples: plastic wrap or Parafilm (yes, that stuff we used in chemistry lab) to place over beakers and mortar and pestles when they are sitting or stirring.
- using purified water?3
Water purifiers anyone?
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INVOLVE…INVOLVE…INVOLVE your staff!
EDUCATE…EDUCATE…EDUCATE yourself and your staff!
DOCUMENT…DOCUMENT…DOCUMENT the training and competency of you and your staff!
Doing so will let you know pretty quickly when something is not correct so that you can identify areas of improvement. Our patients deserve it!
Lisa D. Ashworth, BS Pharm, RPh
Vice-Chair, USP Compounding Expert Committee 2010-2015
Children's Medical Center
Dallas and Plano, Texas
References
- United States Pharmacopeial Convention, Inc. USP on Compounding. [USP Website.] Available at: www.usp.org/store/products-services/usp-compounding. Accessed October 25, 2012. (Note: USP on Compounding includes ALL compounding chapters currently official and the chapters referenced within.)
- Cabaliero J. Automatic dishwashers and detergents in the pharmacy: The basics. IJPC 2004; 8(3): 200.
- Mixon W, Fox S, Barnes D et al. Quality control: Undecided about buying an in-house water purification system? Pros, cons, and caveats that may provide the answers you need. IJPC 2011; 15(6): 480-487.
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