As we all are aware, the practice of compounding is facing increased national scrutiny both in terms of regulatory review and in efforts to define exactly what constitutes the practice of medication therapy production. While some of these issues are outside the purview of hospital pharmacists, many are directly within that purview, and have been for some time. When USP General Chapter <797> was first introduced, it quickly became a polarizing topic, but its intentions were—and are—sound and progressive. At its most basic level, the chapter sets out practice standards to help ensure that compounded sterile preparations are of high quality and to prevent harm to patients suffered as a result of contaminated preparations. Regardless of whether your facility outsources its compounding, performs it in-house, or employs a hybrid model, these basic concepts should always be designated among pharmacy’s highest priorities.
It is the responsibility of the pharmacist overseeing the compounding process to ensure that appropriate standards are in place for producing safe CSPs based on risk level. For example, when outsourcing compounding, measures of the compounding facility’s compliance with USP <797> are necessary to assess the quality of the compounding process. If this information is not available, or until state boards of pharmacy improve their regulation and ensure compliance with USP <797>, an institution that relies on outsourcing may be warranted in hiring an independent surveyor. For a listing of consultants that specialize in USP <797> compliance, see page 22 of this issue.
Ultimately, when it comes time to request funding for pharmacy process improvements and acquisition of new technology, benchmarked data can be a powerful motivator for positive change. In order to support these efforts, PP&P makes much of its extensive survey data—such as the material found in this month’s supplement, The 2013 State of Pharmacy Compounding—available to hospital pharmacists (in slide format) to bolster internal proposals, educational presentations, and publication efforts. PP&P has built a significant stockpile of compounding data, and we are happy to share this with you to help improve pharmacy operations. Be sure to visit www.pppmag.com to see what data is available in slide format for your use.
We know how much emphasis our readers put on ensuring high quality CSPs are produced and delivered safely to their patients. We are happy to allow use of our data to further that cause.
All the best,
R. Mitchell Halvorsen
P.S. PP&P would like to congratulate the winner of our recent State of Pharmacy Compounding survey—Leonard Darling, RPh! Leonard is the pharmacy director at Three Rivers Health in Three Rivers, Michigan. As the randomly selected winner from all named participants in this survey, Leonard received a 16GB Apple iPod and a Nike Fuel Band!
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