Quantity of product and the training of the pharmacy professional are factors to consider in this question.
In light of the recent tragic consequences to many individuals because of improperly compounded injectable steroid preparations, it seems to be a reasonable question to ask if pharmacists should be able to compound. First, let’s accept that what happened in New England was not pharmacy compounding in that the product was not being prepared in response to an individual prescription order. Even if this specific incident is more manufacturing than compounding, much of the public attention seems to be focused on pharmacy compounding, so some will be asking if pharmacists should continue to be able to compound. My answer is “yes.”
When done according to “best practices” and following the current rules, this practice meets patient needs that cannot be met in any other way, and therefore it is necessary.
Some have suggested that pharmacist compounding should become a specialty. On first pass that might seem to make sense. Currently, pharmacy education may limit the amount of compounding training in the curriculum. I have run into many student pharmacists interesting in compounding who have attended a PCCA compounding training program because their school didn’t provide that level of training. Maybe we should work to develop “pharmacist compounding” as the newest pharmacy specialty. When a pharmacist makes an intravenous admixture in a hospital, is that compounding and would that individual need to be certified in compounding? How about a nuclear pharmacist who compounds pharmaceuticals? Would he or she need to be certified in nuclear pharmacy and compounding? Although a pharmacist compounding specialty may be good for the profession, it has a number of unintended consequences if we want to use this mechanism to prevent future tragedies from pharmacist-compounded medications.
Some might propose that accreditation of compounding pharmacies by the Pharmacy Compounding Accreditation Board (PCAB) be required to prevent these problems. At first, this seems to make sense because it assures more peer oversight of compounding pharmacies. But there is a cost to this activity and smaller operations, or those just getting started, may not have that capital, so it could keep some players from getting into the business or knock some operations out of the business. However, if compounded pharmaceuticals are important to meet patient needs, is it in the patient’s best interest to keep these types of programs out of the market?
You could make a case for either side, I believe, but I would come down on the side of not requiring accreditation by rules or statute. I think boards of pharmacy may want to recognize PCAB accreditation in lieu of board staff making unannounced inspections of a compounding pharmacy, or even a payer requiring accreditation to be eligible to bill for that service.
The area that is the most problematic for me is when there is a shortage of an essential manufactured drug. This is one of those unique aspects of pharmacy. Those drugs can be compounded locally during the shortage. This then becomes a gray area where it might be appropriate to prepare a bigger quantity in anticipation of future needs. It starts to become manufacturing instead of compounding, but everyone accepts that it probably is appropriate in this situation. If the pharmacists involved forget professional ethics, it can then lead to rationalizing that it is okay to continue doing this because the money is good and we are benefitting many people. Perhaps that’s what happened in the New England Compounding Center situation.
Perhaps there is a simple solution to the compounding pharmacy question, but I don’t think so. The real solution rests with the compounding pharmacists themselves. Are they following the law? Are they properly prepared to do this task? Are they following “best practices”? Accreditation of compounding pharmacies or even creating a pharmacist compounding specialty may help. But unless pharmacists practice ethically—remembering the public trust given to them—such a tragedy could happen again. This situation should be used by all pharmacists to reflect on their ethical obligations to patients and the pharmacist oath they took, and to recommit themselves to ethical practice.
Mr. Eckel is a professor emeritus at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He is past executive director of the North Carolina Association of Pharmacists.