In a moment of pique...
Intending to commiserate with your frustration and encourage you to continue what I believe to be an important campaign to improve oversight of the CSP process, I wrote you a letter that failed to present both sides of this issue (CleanRooms, September 2006). In retrospect, the letter was a colorful, shoot-from-the-hip indictment of an entire, trusted professional community based upon very worst-case events, and bordered on personal invective. I offer no excuse for this lapse in professionalism, and apologize for my apparent denigration of American Pharmacy and Nursing Practice. This is the very last thing I intended to do.
For more than a generation, I have worked with numerous, dedicated practitioners who have attempted to provide the highest levels of patient care in the face of shrinking budgets and the erosion of quality endemic to ‘managed care’; practitioners who consistently lose sleep over concerns about the welfare of their patients. Without being given the benefit of quality science in their professional curriculum, or the financial resources needed to secure true CSP process control, these practitioners have worked tirelessly to learn and implement appropriate quality assurance concepts. Some have practically had to stand on their heads to secure what funds they could to assure the best possible facilities, training and equipment for their CSP efforts.
It is this lack of administrative, public and educational support for the practitioner that my ill-conceived letter actually decries; the corner he or she is backed into when dealing with an administration seemingly more concerned with the ‘bottom line’ than the Best CSP Practices that ultimately assure patient safety. Neither does the delayed and uncertain course of USP Standard <797> inspire confidence in the ‘system’; despite the labors of a dedicated <797> committee, mandatory implementation of this much-needed standard is stalled in thirty-four states (not fifty) while its opponents argue semantics, and the Joint Commission on Accreditation of Health-care Organizations (JCAHO) has suspended enforcement. No wonder that, in frustration, you and numerous others call for FDA regulation of compounding pharmacies.
In my humble opinion, the completion of USP <797> as a definitive and unambiguous roadmap to CSP process control is the appropriate initial step. While this task has been fraught with controversy, USP has traditionally employed good, uncompromising science in the promulgation of its mandatory standards (i.e., those numbered less than 1,000). Likewise, USP needs to unwaveringly incorporate long-recognized elements of quality assurance into its <797> requirements; elements like statistical process controls, training-oriented monitoring, technique training and verification requiring inclusion of all possible manipulative techniques encountered at a defined risk level, and end-product sterility, pyrogenicity, and identity auditing. USP also needs to recognize the learning curve necessary for some practitioners to holistically address the issue of process control, and incorporate the necessary glossary and specific guidance into the standard.
There will be planning and reasonable operational costs which are necessary to correctly implement USP <797>. But, despite this, FDA is not the answer, John; a cGMP approach to this issue would be nearly impossible to implement and is unimaginable. Pharmacy can do this thing under its own steam; voluntarily, as professionals. We can assure CSP process control without the need for crushing federal oversight.
One thing I will stand by in that letter: ‘It’s not that tough to fix.’ We just need the tools. And the support.
-Greg Peters, President,
Lab Safety Corporation, Cumberland, WI