Brought to you by the International Journal of Pharmaceutical Compounding
April 7, 2005 Volume 2, Issue 12
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Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Find Out What You Don't Know

"We don't always know what we don't know", OR, "Ignorance is bliss; but can be dangerous!"! How many times have you heard someone make statements that make it apparent that they don't really know what they are talking about. I'm not referring to those honest mistakes and "mis-statements" that we all make (and print) rather statements that are made and the individual strongly defends them as correct, but they may not be. Even in pharmacy, whether we are involved in patient counseling, working with physicians, teaching, or whatever, it happens.

A few months ago I was consulting with a hospital pharmacy director concerning the implementation of USP Chapter <797> for their intravenous admixture program. As we were meeting for the first time, he proceeded to inform me that he thought they had an excellent operation and they shouldn't really need much work to meet the requirements. This individual was basically wanting a "blessing" on their facility and operation.

It became readily apparent that the reason this Director thought everything was "A-OK" was because of a lack of training, education and awareness of current pharmacy practice. This individual's education had stopped about 20 years ago. If we are educated at a minimal level, our expectations and standards are at that level, and usually remain so. In today's practice of pharmacy compounding, this is no longer acceptable. Pharmacy practice is changing and pharmacists must change to keep up.

If we are educated more completely and continually strive to enhance our practices, we practice at a higher level, one that exceeds minimum standards and emphasizes patient safety and quality compounding.

The situation referred to earlier was actually quite dangerous as was observed later in the day in touring the facility and observing their practices. What was done to resolve the situation and get on with the work that needed to be done? The first step was to pose a series of questions to the Director about specific aseptic techniques and practices related to aseptic manipulations, quality control, and the assurance of knowing what was being compounded in the IV room. How did he really know that what was ordered was what was compounded and would stand up under quality control testing, etc. As the director was unable to answer even the more simpler questions, it became apparent to him that he was unsure of the quality of the IV admixtures being prepared in their IV room. At that point, this individual became very "teachable" and, in fact, began to realize the pharmacy department had some serious, serious problems in aseptic compounding. The rest of the visit was very fruitful and provided great teaching and learning opportunities. Today, the pharmacy is involved in implementing the necessary changes to satisfactorily comply with USP Chapters <795> and <797>.

How did this happen? It happened because this individual "didn't know what he didn't know" but found out that "he didn't know what he should have known". How can we minimize what we don't know? Or better still, how can we keep up to date?

  1. Select a core number of professional journals, newsletters and websites and read them consistently and faithfully.
  2. Read the USP chapters related to pharmacy compounding at least twice a year (USP Chapter <795> Pharmaceutical Compounding-Nonsterile Preparations, <797> Pharmaceutical Compounding, Sterile Preparations, <1075> Good Compounding Practices, <1160> Pharmaceutical Calculations in Prescription Compounding).
  3. Attend at least one seminar related to pharmacy compounding each year.
  4. Participate in the IJPC Listserv. It's free and contemporary questions are presented and addressed by other pharmacists and professionals from around the world.
  5. Thoroughly evaluate every compounded prescription for physicochemical characteristics, stability and investigate any potential question that is raised so you know everything about each prescription that is compounded.

We are all in this type of situation at some point(s) in our lives. It is very frustrating to realize every day how little we know out of the knowledge base with which we work. Learning is never-ending and one key to success is to realize that we don't know it all. "Ignorance may be bliss", but, "knowledge is power"�..the power to do what is right and needs to be done.

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

 

Quality Assurance Standard Operating Procedures (SOPs) Added to CT.com

These SOPs were added to CompoundingToday.com this week and are now available for you to download, customize and print according to your needs. New SOPs are added weekly to CT.com and more than 2,000 will be available by year's end.

  • SOP No. 9.001 - SOP: Quality Assurance Officer
  • SOP No. 9.005 - SOP: Evaluating and Selecting an Analytical Testing Laboratory
  • SOP No. 9.006 - SOP: Lab Proficiency Testing
  • SOP No. 9.008 - SOP: Complaint and Mishap Rectification
  • SOP No. 9.010 - SOP: Certificate of Analysis of Materials Used for Pharmaceutical Compounding
  • SOP No. 9.013 - SOP: Testing of Water Supply: Barnstead D4751 High Purity Water System
  • SOP No. 9.014 - SOP: Procedures in the Event of Nonconformance of Preparations or Chemicals
  • SOP No. 9.015 - SOP: Syringe-Determining the Volume Within
  • SOP No. 9.016 - SOP: Product Quarantine, Storage, and Release
  • SOP No. 9.018 - SOP: Sample Testing Frequency
  • SOP No. 9.021 - SOP: Sterility and Endotoxin Testing
  • SOP No. 9.022.1 - SOP: Soy Testing-Millipore Addi-chek

 
Psoriasis Abstracts Added to CT.com Database

This week on CompoundingToday.com, abstracts related to the treatment of psoriasis were added. Here is a sampling of some of the articles you will find in CT.com's literature search.

  • Carroll CL, Clarke J, Camacho F et al. Topical tacrolimus ointment combined with 6% salicylic acid gel for plaque psoriasis treatment. Arch Dermatol 2005; 141(1): 43-46.
  • Decroix J, Pres H, Tsankov N et al. Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis. Cutis 2004; 74(3): 201-206.
  • Hecker D, Worsley J, Yueh G et al. In vitro compatibility of tazarotene with other topical treatments of psoriasis. J Am Acad Dermatol 2000; 42(6): 1008-1011.
  • Katoh N, Kishimoto S. Combination of calcipotriol and clobetasol propionate as a premixed ointment for the treatment of psoriasis. Eur J Dermatol 2003; 13(4): 382-384.
  • Winterfield LS, Menter A, Gordon K et al. Psoriasis treatment: Current and emerging directed therapies. Ann Rheum Dis 2005; 64(Suppl 2): ii, 87-90.