Member only content: This article appears in the August issue of Patient Safety Monitor Journal.
No physician or nurse injects medicine into a patient’s blood planning to make the patient sicker. Sadly, that’s exactly what happened to scores of providers back in 2012. This June, the former president of a Boston compounding pharmacy was sentenced to nine years in prison for racketeering and mail fraud after his company’s products caused a fungal meningitis outbreak, infecting 778 patients nationwide and killing 76.
Many hospitals, clinics, and pharmacies compound their own medicines for a variety of reasons. Sometimes the medicine patients need isn’t available commercially. Sometimes they’re mixed together so the patient only needs one IV instead of having two. Commonly, medicines are mixed into large-volume solutions. And while the Boston case was exceptionally horrific in scope, every compounding facility runs the same risks when trying to compound safe, sterile drugs.
Joint Commission and USP
In January, The Joint Commission unveiled a Medication Compounding Certification (MCC) program that’s open to all compounding pharmacies, not just those accredited by The Joint Commission. The accreditor also called upon healthcare providers to work toward the elimination of medication compounding-related infections (MCRI) like the meningitis outbreak.
“The health care community, including The Joint Commission, recognize that as the need for compounded medications continues to grow it is more important than ever to ensure safe polices and procedures are being appropriately and effectively implemented to prevent patient harm,” wrote Robert Campbell, PharmD, Joint Commission field surveyor, in a blog post.
Meanwhile, the U.S. Pharmacopeial Convention’s (USP) chapter<800>will become fully enforceable by regulators on July 1, 2018. Its regulations aim to protect the 8 million American healthcare workers who are potentially exposed to other extant chapters on sterile compounding, such as Chapters<797>and<795>.
Complexity and Risk
Kurt Patton, MS, RPh, former director of accreditation services for The Joint Commission and founder of Patton Healthcare Consulting in Naperville, Illinois, says the big risk of compounding IV products is failing to maintain the products sterility. When that happens, bacteria or molds could be introduced into the patient’s system.
“To try and make a sterile product you can deliver intravenously is not as easy as making an oral product,” he says. “Keeping or maintaining sterility is the difficult challenge, but it’s essential when you’re talking about a product going directly into the bloodstream. If you or I ate a product that contained some contaminanation, once it got into the GI tract, to a large extent our GI tract helps protect us. But if you deliver that same bacteria into the bloodstream, you don’t have that same level of protection.”
“When not mixed in sterile conditions, compounded medications can cause multiple types of infections, including bacterial bloodstream infections and cases of fungal meningitis,” he adds.