Risky Business – Is Price Dictating Your Decision?

Quality in your compounded sterile products (CSPs) is something you should never take for granted.  While this has always been true, the tragic events of last fall have made everyone look at sterile compounding quality with renewed focus.  As healthcare providers, no one sets out to buy an inferior product but many do not know what is involved in maintaining a quality pharmacy environment and compounding a safe compounded product.  As I talk with customers about how to vet their compounder, I typically share the fact that a pharmacist could have graduated from pharmacy school yesterday and opened a sterile products compounding pharmacy today.  However, I doubt you would want that person compounding your high risk sterile medications.   Experience in sterile products compounding is of paramount importance and you should demand a pharmacy that has an impeccable safety record.  I recently read an article that was lamenting the lack of emphasis the pharmaceutical industry places on quality.  The authors of this article (FDA staffers) are of the opinion that a lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing investments in quality. They claim that, although today’s buyers may now be more aware of quality problems with sterile injectables, buyers appear to generally discount quality concerns and to focus principally on obtaining the lowest prices possible.  This behavior is likely based on a belief that all marketed products are of equivalent quality. 

While the aforementioned article was referring to commercial manufacturers, I think some people have the same opinions regarding compounded products.  I have two concerns with this focus on the lowest price and the belief that all products are equivalent.  First, do you really want to use the compounding pharmacy that competes solely by offering the lowest price?  The customers I speak with want a sterile compounder that is accredited by the Pharmacy Compounding Accreditation Board (PCAB) and one that meets or exceeds the United States Pharmacopeia (USP) 797 requirements.  They want a compounding pharmacy they can trust to make sure their patients receive the best care possible.  Secondly, it appears that not all products undergo the same sterility, endotoxin and potency testing.  Ask your compounder for their policy and procedure on testing sterile products.  Does your compounding pharmacy test per USP 797 guidelines?  They should, but the recent dramatic increase in the number of test samples sent in to analytical labs appears to indicate that not every pharmacy follows USP 797. I recently spoke with one of our independent testing laboratories and they said their business tripled in the two months following the deadly meningitis outbreak caused by contaminated compounded steroids.  That seems to indicate that not everyone was testing properly prior to the tragedy. 

Now is the time for you to take critical look into your compounding pharmacy.  Ask the tough questions of your high risk sterile compounding pharmacy.  Make sure you have all the documentation you need not only to give you peace of mind but also to satisfy your regulatory auditors.

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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