Do the Due Diligence!
As interventional pain management physicians, you understand the important role that your sterile compounding pharmacy plays in providing you with your intraspinal infusions.
Make sure to partner with a compounding pharmacy that demonstrates competence and exerts great effort to provide the highest quality sterile preparations, starting with an aggressive quality assurance program.
What to Look For
What is quality assurance? It’s a broad term, and the details can range from the very superficial, down to borderline obsessive. Think of it as the aggregate of the steps and processes put in place to obtain a consistent level of quality. How consistent and how high the level of quality, depends entirely on the quality of the steps and processes.
There are many questions you should ask when vetting a prospective sterile compounding pharmacy. This is a brief discussion, and the goal of this article is help you ask the right questions. With that said, you’ll want to be sure to address key areas such as the following: environmental monitoring, staff training, and ongoing staff assessment.
Does your compounding pharmacy have a dedicated room for making sterile preparations, known as a clean room? They should. If they do, then environmental monitoring will detail the management and maintenance of this area? For example, how clean, exactly, is the clean room? How is this room disinfected, and how often? What air-quality controls are in place? How many times over does the air in this room change, each hour? Think of the this space as a sort of high-volume kitchen. How well-kept is that kitchen? Would you consume what comes out of it? If not, then maybe your patients shouldn’t either?
Compounding Personnel: Training
If the clean room is the kitchen, then the compounding staff are the chefs. Can they prepare a high quality “meal”? What does the onboarding training process look like for new staff? Don’t hesitate to request a detailed briefing of training procedures, from gowning to hygiene to aseptic technique, because these are the people responsible for making the very sensitive medications your patients depend on. You have to be confident in their abilities and knowledge. Do you feel they’re qualified? Would you consume what they’re producing? If not, then maybe your patients shouldn’t either?
Compounding Personnel: Ongoing Assessment
So, how do you know your compounding pharmacy is persistently sharp? This is where ongoing staff evaluations come in. Not many guidelines exist for ongoing staff assessment, but it’s important to know what is done, after each staff member is trained, to ensure the continued integrity of the product? Does staff undergo further evaluation? How so? Does this evaluation happen regularly? How regularly? Does your compounding pharmacy’s staff meet industry standards, or exceed them? This is that obsessive territory we talked about earlier in this article. However, these “extra” protocols and procedures are how sterile compounders separate themselves and demonstrate, again, that…
Not All Compounding Pharmacies Are the Same!
Utilizing intrathecal drug delivery systems is a sophisticated method for treating chronic pain. Be sure to work with a sterile compounding pharmacy that is equally sophisticated. Perform due diligence; it’s that important. And, when you’re conducting your research, remember to ask yourself: Would you eat what they’re cooking?