Is There Still a Debate About USP <797>?

May 2011 - Vol.8 No. 5 - Page #1
Category: USP Training Programs

Whether you choose to scour the internet for stories related to compounding errors, or simply tune in to the nightly news, the topic cannot be avoided. Each story is different, and some are tragic beyond words, while others serve as cautionary tales. Despite the perceived variety among these events, there is always a basic concept that underlies all of these stories—compounding errors can harm and kill people. 

This is a broad assertion by design. For afflicted patients and their families, it certainly matters whether the error was caused by poor hand hygiene, contaminated products, or data entry mistakes. Grave injury or death may result from such mistakes, and clearly there is no point along the entire compounded sterile preparation (CSP) production process that is immune to error risk. A break in aseptic process or a data entry error, even one time, can have catastrophic ramifications. Perhaps the result is 19 stricken, 9 dead in Alabama or maybe it is the cardiac arrest and death of a premature neonate who received 982 mg of sodium chloride instead of the prescribed 14.7 mEq. 

What patients expect and deserve is relentless adherence to safe practices, and what physicians, pharmacists, and nurses must provide is a guarantee that they are doing the very maximum possible to avoid these errors. With this in mind, USP General Chapter <797> cannot be overlooked, undermined, or only partially complied with. There are many points along the continuum of care when mistakes can be made, but when it comes to CSPs, every point is critical, and the intent of <797> is to prevent such patient harm. Pharmacy Purchasing & Products wants the initiatives in <797> to be successful for you, and we will continue to do our part to cover this important topic. If you have any ways in which you promote techniques and requirements of USP <797>, let us know. There will always be mistakes to catch, and improvements to be made. Let’s accomplish this goal together.

All the best,

R. Mitchell Halvorsen

P.S. PP&P would like to congratulate the winner of our most recent market research survey of health system pharmacy directors, Willis Shu, PharmD, MBA! Willis, the pharmacy supervisor at Long Beach Memorial Medical Center, will receive a new 50” Panasonic 3D HDTV. We would like to thank Willis and every other pharmacy manager who has participated in our surveys. You have directly contributed valuable information to help shape health system pharmacy operations, as well as its development and coverage in PP&P. Keep an eye out for our next survey, and you could be our next grand prize winner!


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