Eric S. Kastango, MBA, RPh, FASHP

By the time you read this article, the 90day comment period for the proposed changes to USP Chapter <797> will have closed. Based on the reported
number of comments, estimated to exceed 500, a lot of you took the time to read the proposed revisions and weigh in with your comments. As a pharmacist, and a potential patient, I thank you. So, with that behind us, what have you done for your patients today?

Whether you agree or disagree with the proposed changes to the USP chapter, the message should be clear that business as usual is no longer acceptable. The mandate to improve patient safety is manifest in this document. And USP is not the only organization that is beating the patient safety drum. JCAHO, CDC, ISMP, and others can also be counted as cheerleaders. As Michael Cohen of ISMP said, “Unfortunately, there are too many in health care who feel that if it hasn’t happened to them, the adverse experiences of others do not apply.” Take the time to read the FDA’s warning letter to CAPS (www.fda.gov/foi/warning_letters/g5817d.pdf). Do you allow similar things to occur in your pharmacy, or have you witnessed similar events? If so, stop now. Proper supervision and effective leadership is required to maintain a good compounding operation.

As a reminder, over 100,000 patients die annually from hospital-acquired infections. Let us not fool ourselves into thinking that the compounded sterile preparations we make do not contribute – directly or indirectly – to that number. We are not perfect, and even a 1% contribution to those total infections results in 100 deaths a year. That is 100 too many, especially if you or someone you love is one of those patients.

Let us also not forget that USP Chapter <797> is part of the federal Food, Drug and Cosmetic Act and, as such, is enforceable by boards of pharmacy and in a court of law, and will be used to judge any transgressor of patient safety. Many state boards of pharmacy have adopted USP <797> or have beefed up their sterile compounding regulations. Dozens of others are mobilizing to address the deficiencies in their laws. The National Association of Boards of Pharmacy (NABP) has endorsed USP Chapter <797>, and has recommended to individual state boards of pharmacy that the chapter should be used as a gauge to evaluating sterile compounding. The Food and Drug Administration (FDA) has been very busy visiting pharmacies that compound sterile preparations, although I am not aware of any visits to hospital pharmacies as of yet.

The pharmacy literature is nearly void of the “required evidence” to support the requirements of the proposed changes. Other bodies of work, however, from the CDC MMWR (Morbidity and Mortality Weekly Report), infection control journals, and pharmaceutical manufacturing are peppered with reports of contamination and the science necessary to prevent these events from occurring. The science behind the requirements found in USP Chapter <797> is not new. We must remember Dr. Kenneth E. Avis, who many consider to be the father of good compounding practices in pharmacy. Ken started publishing the precursors to the ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products, USP Chapter <1206>, and USP Chapter <797> in the ’70’s.

As Henri Manasse, executive vice president and CEO of ASHP, wrote in a USA Today letter to the editor, “The merits of best practices and evidenced-based compounding are a well-established fact.” Do what you need to do to follow this USP chapter, because it is the right thing to do and – if for no other reason – one day your life or a loved one’s life may depend on it.

Eric S. Kastango, RPh, MBA, FASHP, provides expertise in aseptic processing, medical-device manufacturing, and the implementation of extemporaneous com-
pounding quality systems through his New Jersey-based consulting company, Clinical IQ, LLC.