This time around, more about BET (Bacterial Endotoxin Testing) and why we take it so seriously at Hartley Medical Pharmacy. By 2003, as a result of my professional journey through intrathecal drug therapy, I had amassed a great deal more knowledge of and experience with endotoxin testing. I purchased an instrument – PYROSKINETIX — manufactured by the aforementioned (BET, Part I) Associates of Cape Cod out of Falmouth Mass. We use it to determine the level of endotoxins in our parenteral compounded solutions.
Certainly one of the most sophisticated instruments available to our industry, Pyroskinetix has the ability to not only detect the presence of endotoxins in a sample or group of samples, but also to quantify the levels of endotoxin present. It is far more rigid than any of its predecessors, requiring a standard curve of six data points. And samples are again submitted in duplicate — both spiked and unspiked.
Although most contract labs that I work with own an instrument similar (in stated function) to Pyroskinetix. However, many pharmacists purchase endotoxin testing “kits”. These simplified kits are “knock off” or generic versions of the Pyroskinetix methodology. Most do not follow the US guidelines for endotoxin testing. It’s basically “shake and bake”…you put a small portion of your drug into a test tube, which is then placed in a heating device – one that may or may not necessarily conform to the test itself — and after a certain period of time, the pharmacist receives results indicating positive or negative for the presence orabsence of endotoxins.
Most compounding pharmacies are content to use these broader-based, far less refined generic methods. They will attest to performing BET regularly, yet are – by and large — seemingly unaware that the generic tests will frequently deliver a false negative.
There are those who would ask “Why? Why did I –– go that far…purchasing expensive equipment that wasn’t specifically required for me to purchase? Because it was the right thing to do. Bottom Line: this sophisticated testing tool gave me the ability to enhance my existing testing program. Because we have Pyroskinetix in place, we consequently test more frequently and more extensively and more effectively to verify that we’re operating well within the accepted safety standards. My first BET had a detection level of 0.03 Endotoxin Units (EU) per milliliter. My new BET detection level is .001.
I’m quite proud of my endotoxin testing program – as well as the hand-picked, extensively trained technician who runs it. With testing and staff and standards like that, Hartley Medical Pharmacy can safely say that our intrathecal drugs are carefully tested to ensure that they help everyone…without hurting anyone.