A compounding nightmare

Compounding is one of my favourite things to do in pharmacy. In particular, I enjoy non-sterile compounding. I know lots of technicians who prefer sterile compounding, but personally, I find it monotonous. With non-sterile compounding, I can work with one medication and prepare it 10 different ways, whereas with sterile compounding, I can work with 10 different medications but use the exact same processes and techniques—and with good reason.If you practise or have been trained in sterile prep, you will be all too familiar (hopefully!) with the NAPRA standards for sterile preparations and standards of conduct for those who are involved in sterile preparation and it’s a lot. It’s not terribly exciting reading (or maybe it is to you—I'm not judging) and it’s a lot of specifications and details. But again, with good reason.Read: A different kind of patientI just finished reading Kill Shot: A Shadow Industry, A Deadly Disease by Jason Dearen. The tag line on the front of the book reads “The untold story of the worst contaminated drug crisis in U.S. history.” This took place in 2012. Just slightly over 10 years ago and it’s touted as the “worst contaminated drug crisis” in the United States of America. I remember hearing about the New England Compounding Centre (NECC), but I can’t remember in what context. I don’t remember if it was related to this crisis or if it was about something else before this took place. Maybe you remember this story, or maybe you’re hearing about this for the first time.Kill Shot is about NECC dispensing (the term is used loosely in this case) thousands of vials of compounded methylprednisolone that were contaminated to hospitals and clinics in 23 states. The vials were contaminated with mold and fungi and injected into patients’ spines, causing the development of fungal meningitis in almost 800 patients, and resulting in more than 100 deaths. If you’re not familiar with this story, let that sink in for a moment. Sterile preparations contaminated with fungi. Injected into patients’ spine. Causing fungal meningitis. That is pretty scary. Scary to patients. Scary to doctors. Scary to me as a pharmacy technician who has compounded sterile preparations. How could this possibly happen and how do I make sure this does not happen when I am compounding? (Spoiler alert: following NAPRA standards is how to prevent it!).Read: Please help me help my patientsAs shocking as the story is, one of the most shocking things is that it was essentially caused by negligence. The owners of the pharmacy were very motivated to increase revenue and elected to not abide by USP . There were individuals involved (sales reps—yes, the pharmacy which was registered as a community pharmacy employed a team of sales reps—pharmacists, and pharmacy technicians) who brought several concerns to their supervisors, who then brought these concerns to the owners, who brushed them aside and, in some cases, lied. The pharmacy promoted itself as not only complying with USP , but in exceeding the standards. Hospitals and clinics across the U.S. were happy to be able to purchase sterile medications from them, freeing up their own pharmacy teams, and having access to medications that were otherwise on backorder. What were some of the issues identified and brought forward to management? Oil seeping in through the floor in the clean room. Dead insects in the clean room. Samples taken from the clean room showing growth of various pathogens. Not having the proper amount of product tested. Making up patient names. Making up Lot numbers. Compounding with expired drugs.The worst part of all of this (aside from patient harm) is that they knew. Management at the pharmacy realized that they were the source of the fungal meningitis outbreak before the doctors figured out what was happening, but they did nothing. They feared being caught. Being shut down. Losing revenue. And the cost was the lives of hundreds of patients. Even those who survived have lost their lives. Living with the side effects of the systemic antifungals, such as living with kidney or liver damage. Some requiring ongoing back surgeries to try to remove the fungus as it continues to grow in their spine (the fungus will travel through cerebrospinal fluid and attack blood vessels in the brain, causing strokes).There is so much more to this story than in my “Coles Notes” here, including information about legislation in the U.S. surrounding compounding and pharmacy assessments, as well as about the trials of some of the leadership team of the pharmacy. I highly recommend reading this book and would love to hear your thoughts. And, on an ending note, I feel grateful that we have regulatory bodies in Canada that have more oversight of pharmacies!

A compounding nightmare

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Blog Author

Sarah-Lynn Dunlop

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