While the thoughts and prayers of everyone at the Lipscomb University College of Pharmacy are with those impacted by the fungal meningitis outbreak, I thought I would take this opportunity to assist the community in understanding what is occurring.
You may have heard a lot of talk about “compounding” since this outbreak started. Compounding is a core component of the art and science of pharmacy. It is simply the preparation and mixing of ingredients, assembling and/or packaging, and labeling of a drug or device. Compounding is specifically done in accordance with a licensed practitioner’s patient-specific prescription for a customized preparation.
The non-sterile form of compounding is done in your retail pharmacy every day to fill your prescriptions, and the sterile form of compounding is done in specialty sterile compounding pharmacies every time a patient requires an IV or any other type of drug. It is not a process that should cause patients concern.
While “compounding” is in the name of the New England Compounding Center that has come under scrutiny, it appears, based on news reports and Center for Disease Control announcements, that the process conducted by the New England center resulting in the tainted medication could have been manufacturing. The manufacturing of a drug is defined as the distribution of inordinate amounts of compounded preparations or the preparation of any quantity of a drug without a licensed prescriber, pharmacist and patient triad.
Manufacturing is not a process carried out by your local pharmacy, and when conducted legally, it is overseen and regulated by the Food and Drug Administration to ensure product integrity and patient safety.
If you are concerned about your medications, here are some questions to ask your local pharmacist:
- Is this a compounded or a commercially available product?
- Does this product require sterile technique for proper preparation?
- Has your prescriber explained the risk and benefits of this product?
These questions should be asked regarding any prescription you are given:
- Why are you taking this medication?
- What did the doctor tell you to expect from this product?
- What are the potential side effects or adverse reactions of this product?
- How am I to manage and respond to side effects or adverse reactions?
- How long am I to take this medication to achieve the outcome desired?