“Do your job”!
This mantra comes from Bill Belichick, coach of the New England Patriots. While I am a Giants fan, I love this mantra; and if you compound sterile or nonsterile medications, I ask you to do your job! Our job is to compound medications that are correct, accurate and safe to use. This responsibility means that you must understand, embrace and comply with the requirements of USP chapters on compounding.
Currently, there are two USP chapters: one for sterile compounding (General Chapter 797) and one for nonsterile compounding (General Chapter 795). A new chapter specifically for the safe handling of hazardous drugs (General Chapter 800) looms in the wings. If followed, these chapters will help protect patients from harm associated with compounding errors.
It is time to face our naïveté and arrogance about safe compounding practices. The results from the CriticalPoint Compliance Surveys - that many of you have participated in since 2011 - continue to show we have work to do. I continue to be perplexed by the attitudes of some of my colleagues who still believe that the principles of contamination control and robust quality systems don’t apply to them or are unnecessary. The U.S. Department of Justice indicted 14 employees of New England Compounding Center on charges ranging from racketeering to second-degree murder. I ask, what are you doing for your patients to protect them from harm?
Whether you agree or disagree with USP Chapter <797> and other USP chapters critical to compounding, the message couldn’t be clearer. Business as usual is no longer acceptable. We must embrace standards that incorporate evidence-based science and best practices that have been vetted through public comment and review cycles.
Pharmacy staff members must know not only what is expected of them as they prepare sterile dosage forms, but also why they are expected to do these things. We must move away from the pure apprenticeship model of training and instead deploy methods and procedures that establish a solid foundation for quality work practices that will prevent compounding errors.
Pharmacy practitioners are increasingly challenged to prepare compounded sterile dosage forms that are not commercially available; at times using nonsterile active pharmaceutical ingredients. Handling and transforming these components into appropriate sterile dosage forms may require greater experience and expertise than a particular pharmacy possesses. In such cases, we must take these limitations into account and recognize the risks they pose to our patients. We have the responsibility to ensure that any compounded preparation is what it is expected to be and, to the best degree possible, to ensure and measure its sterility. Conversely, if we don’t have the requisite expertise, we should not undertake these activities.
As Julius Caesar’s armies crossed the Rubicon in 49 BC, he said “alea iacta est”—“The die is cast.” Pharmacy has crossed its own Rubicon. In November 2013, the Drug Quality and Security Act (DQSA) was signed into law. The FDA’s inspections of U.S. compounding pharmacies have been aggressive. Several state boards of pharmacy are now inspecting for compliance with USP Chapter <797> in community and hospital pharmacies (regardless of whether current state regulations require such compliance). Many states are changing their sterile compounding laws and regulations and harmonizing with USP chapters on compounding, because dozens of others are mobilizing to address deficiencies in their laws.
When the American Society of Health-System Pharmacists (ASHP) published its guidelines in 1993, Kenneth E. Avis, considered by many as the father of good compounding practices in pharmacy, was quoted as saying, “This is not new science, but rather old news that few bothered to heed.”
How sad is it that twenty-two years has elapsed, and we are still “debating” how to do our job. We have to compound, so do your job!
Author: Eric S. Kastango, RPh, MBA, FASHP