Product Compounding: Who Should Monitor?

Author: James C. McAllister III, MS, FASHP; Pharmacy Times Editor, Health-Systems Pharmacy Section

You may have read an article in the August 7, 2006, issue of USA Today entitled "Deaths Spur Debate about Drugs Made in Pharmacies." The article describes events over 10 months from 2004 to 2005, which suggest that sterile cardioplegia solution compounded by a national compounding organization may have resulted in 11 patients contracting infections. The article was inflammatory and incomplete and in some ways failed to make important points on the topic. Nevertheless, it was probably read by millions of people and, in my opinion, tarnished our professional image.

One important point was made, in that responsibility for the oversight of the quality of compounded products was questioned. The compounding pharmacy that allegedly was involved fell under regular FDA oversight, but the author accurately revealed that oversight of smaller compounding operations and hospitals are governed primarily by state rules and regulations, which vary substantially across the country.A significant point that was not made was the breadth and depth of the compounding that is done, including compounding that is done outside hospitals.

Community and hospital pharmacists always have regarded it their right and responsibility to compound prescriptions to meet their patients' needs. Compounded products go far beyond sterile pharmaceuticals, to include capsules, topicals, ophthalmic products, and more. As pharmacy school curricula have changed, however, fewer new professionals have the interest and expertise to offer compounding services. As a result, many of us outsource this responsibility to compounding pharmacies. In the majority of cases, these pharmacies uphold standards of quality that we and our patients expect. We also assume that state regulatory agencies provide the necessary oversight to protect the public.

Most of us know, however, that there are far too many pharmacies that do not meet our standards for quality and accuracy. We know that state boards of pharmacy do not monitor for the quality our patients expect, and they have been reluctant to intervene proactively. In many cases, it is a matter of limited resources. Most board inspectors, moreover, have limited expertise and experience to ensure standard compliance and quality in all compounding pharmacies, but they do respond after alleged harm is done. Boards themselves struggle with developing guidelines and regulations that are intended to apply to compounding pharmacies. I suspect that politics are involved in coming to grips with this issue. Many independent pharmacists continue to offer basic (nonsterile) compounding services and do not encourage state board involvement.

Something needs to be done. I am not advocating more regulatory involvement at the federal level. I do believe that more of us need to partner with our state boards of pharmacy to pursue a solution to this problem. If we fail to resolve the issue of compounding pharmacies harming patients, we can anticipate a loss for secundum artem and a limit on patient and provider choices with federal intervention. I also can guarantee that our image will continue to deteriorate in the eyes of the public, and we will deserve the criticism.

Mr. McAllister is director of pharmacy at University of North Carolina (UNC) Hospitals and Clinics and associate dean for clinical affairs at UNC School of Pharmacy, Chapel Hill.