Editorial: Afraid to take responsibility?
One thing about compounding and/or dispensing is that one knows who must take responsibility for what is dispensed or compounded. The individual pharmacist must take responsibility that everything associated with the compounding and/or dispensing of a prescription is correct and signs off on it or initials it. All the legal and pharmaceutical "t's" must be crossed and the "i's" must be dotted. It is engrained into our daily functions that "the buck stops here" and we must answer if errors are made.
However, there has been a change in the way a lot of the pharmacy students are being trained that is associated with the clinical roles of pharmacy that has seemed to alter this "responsibility" function. For example, I occasionally get calls or e-mails from clinical faculty or practitioners that ask about compounding and they state that they cannot support anything that has not been published in the peer-reviewed literature and has demonstrated "safety and efficacy" and studies showing that blood levels have been achieved with these compounded preparations.
It is very disappointing to hear these "pharmacists?" say this because it basically shows that they do not want to take any responsibility but only do or recommend something based on someone else's work; a shift of the responsibility to the authors of the reports. Meanwhile, the patient is left with only manufactured drugs and pharmacists that don't really seem to care about going the extra mile to take care of their patients needs. Let's look at some of the issues here.
First, being a pharmacist means taking on responsibility, the same that physicians, nurses, and other health care practitioners do. We can't expect everything to be published and simply recite the journal, volume and page number and think that we are practicing pharmacy or good patient care. A librarian or computer program can provide us with published material. Pharmacy means taking the patients as they are and working with the physicians to optimize drug therapy. Note that it doesn't say "optimize manufactured drug therapy" or "optimize drug literature published drug therapy". True, there are decisions that must be made and they need to be made based on science and clinical/evidence-based medicine, not based solely on what is found on a MEDLINE search.
Second, one will not find a lot of clinical studies based on compounded prescriptions. Why? There is not enough financial support to conduct full-scale clinical studies on about 10,000 different compounded formulations. Pharmaceutical companies obviously will not support the studies. Individual pharmacists or physicians cannot support all these studies. Basically, there is not a "return on the investment" if one puts out the money to conduct the study. What then, do we do? We simply base our judgment with the physician's judgment and look at the clinical evidence; so-called, evidence-based medicine. If a compounded prescription has been written tens of thousands of times by physicians all over the U.S. (and even the world), does it not seem logical that that prescription apparently works? That provides the evidence for its continued use. I am sure glad that these "practitioners" were not around back in the 1960s and 1970s before bioavailability and therapeutic drug monitoring (TDM) became popular. After all, how can one make a decision if they don't "know the numbers"? However, one must be aware that there are a lot of approved medications that don't "have the numbers" and they are still used all the time. Many drugs, vitamins, vaccines, etc. do not have TDM numbers associated with them. Also, what does one do with the patients that have the correct TDM numbers but still do not respond to therapy? What about bioavailability? What level is the minimum? The FDA has approved drugs with bioavailabilities of less then 1% (Yes, less the one per cent). So where do we draw the line; 1%,10%, 25%, 50%, 75%, 90%? Is it even important if the clinical results are being obtained in a consistent manner with consistent doses?
Third, and last, it is very hypocritical to say that one does not support compounded medications and yet be involved in preparing intravenous admixtures that have not been studied in their specific combinations and reported on in the literature nor are they "approved by the FDA"; they are in the same category as all the other compounded medications.
In summary, I think too many practitioners take the irresponsible road and deny their patients the benefits of individually prepared medications. However, these individuals need to consider the future that may involve biotechnology and nanotechnology derived pharmaceuticals where compounding may play a central role. I'm not sure that these new pharmaceuticals are going to have TDM numbers; but, they will have clinical results!
I'm certainly not for taking unnecessary chances or putting patients at risk. However, I think it is a sad day when "pharmacists" refuse to compound a preparation that has been prescribed by a physician because "they don't see the numbers". I don't think the patients care about the numbers; I think they care about results.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief | 
