Lessons learned from compounding tragedies.

Several months have passed since news broke of a horrific compounding tragedy at the New England Compounding Center (NECC) in Framingham, Massachusetts. An outbreak of fungal meningitis in fall 2012 was traced to contaminated methylprednisolone acetate prepared by the NECC. According to the US Centers for Disease Control and Prevention (CDC), as of May 11, 2013, 55 deaths and a total case count of 741 had been attributed to the contamination, and the numbers continue to rise. Patients who received medications from this pharmacy have also experienced paraspinal, spinal, and peripheral joint infections. The Institute for Safe Medication Practices (ISMP) has compiled a list of selected compounding misadventures since the 1990s. For legal reasons, many compounding misadventures never become public, but the US Food and Drug Administration (FDA) has been actively inspecting compounding pharmacies with a history or suspicion of large-scale compounding or quality concerns. Compounding problems are not isolated to the United States. Recently, more than 1200 cancer patients in Ontario and New Brunswick received chemotherapy solutions with concentrations below labelled specifications. It appears that jurisdictional issues regarding proper oversight of this operation and others were similar to the problems identified in relation to the NECC event. It is time to face our naïveté and our occasional arrogance about safe compounding practices. We must learn from these events and take measures to ensure that we are doing everything possible to protect patients and reduce the risk of improperly compounded sterile preparations. On a personal level, I have been profoundly affected by the NECC event, and I continue to be perplexed by the actions of some of my colleagues who somehow still believe that the principles of contamination control and robust quality systems don’t apply to them. As a pharmacist and a potential future patient, I ask, “What are you doing for your present-day and future patients in light of these recent issues?” Whether you agree or disagree with United States Pharmacopeia (USP) Chapter <797> and other USP chapters critical to compounding or the Pharmaceutical Inspection Cooperation Scheme’s compounding guide, the message couldn’t be clearer. Business as usual is no longer acceptable. We must embrace standards and guidelines that incorporate evidencebased science and best practices that have been vetted through public comment and review cycles. More specifically, it is time to perform risk assessments of the compounding methods used in our own pharmacies, so that inherent risks can be identified and mitigated through detailed policies and procedures, robust training programs and quality systems. 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. In particular, only robust and validated procedures should be used. We have the responsibility to ensure that any compounded preparation is what it is expected to be and, to the degree possible, to ensure and measure its sterility. Conversely, if we don’t have the requisite expertise, we should not undertake these activities. Historically, pharmacists compounded medications in a “just in time” manner. However, current distribution models require that more compounded sterile preparations be stored at room temperature, prompting the desire for longer beyond-use dating. The sterility tests described in USP Chapter <71>