Compounded Medications: A Cautionary Tale for Surgery Centers
A recent investigation involving postoperative Candida infections after cataract surgery is a good reminder for surgery centers to take a closer look at compounded sterile medications.
AAO alert: https://www.aao.org/education/headline/postoperative-candida-cluster-from-single-cataract
The current investigation has not established that the compounded medication caused the infections.
But it also shouldn't stop us from asking a larger question:
When we inject a medication into an eye, joint, spine or other sterile site, do we know exactly where that medication came from and how it was prepared?
Compounded medications have an important role, but they carry additional risk
It is a risk-benefit decision.
The FDA does not review each compounded drug for safety, effectiveness and manufacturing quality before it reaches the market. FDA continues to identify contamination, potency problems and insanitary conditions at compounding facilities that have resulted in serious patient harm.
Know your compounding pharmacy
When a center purchases sterile compounded medications, particularly medications intended for injection, I recommend knowing:
Is the medication actually necessary as a compounded preparation?
Who manufactures or compounds it?
Is the supplier an FDA-registered 503B outsourcing facility, when appropriate?
What does FDA's inspection, recall and enforcement history show for the specific facility producing your medication?
One important point: 503B registration is not an FDA seal of approval. FDA specifically states that registration does not mean the agency has determined that the facility is compliant with current good manufacturing practices. FDA recommends checking the inspection history of the actual facility supplying the medication. U.S. Food and Drug Administration
And be very careful about mixing medications yourself
Every additional manipulation creates another opportunity for error or contamination.
CDC recommends preparing injectable medications in a designated clean area away from sinks and other contamination sources, using aseptic technique and preparing injections as close as possible to administration.
CDC also recommends commercially manufactured prefilled syringes when available; another option is a prefilled syringe obtained from an FDA-registered outsourcing facility. CDC
ISMP goes even further: minimize sterile compounding outside of the pharmacy environment. Serious compounding errors have included incorrect concentrations, wrong ingredients and wrong diluents, errors that may be impossible for the person administering the medication to recognize. ECRI and ISMP
If your staff are combining, diluting, repackaging or batching injectable medications, stop and determine whether the activity constitutes sterile compounding and whether USP requirements apply.
One simple thing every center should do
Subscribe to FDA's Human Drug Compounding updates.
FDA publishes compounding risk alerts about adverse events, outbreaks and drug-quality concerns and specifically offers email notifications for compounding updates. U.S. Food and Drug Administration
Someone at every surgery center, pharmacy, nursing leadership, infection prevention or quality, should receive those alerts.
Don't wait for a vendor to tell you there is a problem.
The takeaway
Compounded medications aren't inherently bad. Sometimes they solve an important clinical problem.
But “we've always gotten it from this pharmacy” is not a medication-safety program.
Know why you are using a compounded medication. Know who made it. Minimize unnecessary manipulation in your facility. Follow FDA activity involving your suppliers. And when there is an alert, investigate first rather than either panicking or assuming everything is fine.
Sometimes the value of an outbreak investigation isn't only finding out what caused it.
It's finding the weak spots in our own systems before we have an outbreak of our own.
This information is provided for infection prevention and patient-safety education and is not a recommendation regarding the use or discontinuation of a specific medication. Medication selection and compounding decisions should be made by the facility's medical and pharmacy leadership based on the clinical indication, product information and applicable regulatory requirements.