The topic of medical compounding has been at the center of a debate over a U.S. meningitis outbreak that has killed 33 people and sickened 480.
Lack of oversight and action have been said to be reasons why the U.S. is experiencing the worst fungal meningitis outbreak in the nation's history.
Oklahoma pharmacy officials suggest that, at its core, the outbreak wasn't caused by compounding as much as it was people, people who didn't listen to warnings or follow the guidelines set forth by compounding regulation organizations.
“The more we find out about these guys, the more disappointing it is,” said Jerrod Roberts, owner of Flourish Integrative Pharmacy. “We had a bad apple in our industry. Every industry has it, and it appears to me they were warned, they were fully well aware that they were breaking state and federal regulations, but they continued to do so.”
Oklahoma has some of the strictest laws in the nation regarding compounding. Oklahoma is one of three states that require compounding pharmacies follow several guidelines written by the U.S. Pharmacopeial Convention, an organization that has developed medical purity standards used in more than 140 countries.
The current meningitis outbreak is thought to have been caused after the New England Compounding Center in Massachusetts shipped contaminated spinal steroid injections to 23 states, not including Oklahoma.
Oklahoma has not seen any cases of meningitis related to the current outbreak, and all products from the New England Compounding Center have been recalled.
The first case of meningitis connected to the outbreak was confirmed on Sept. 18 in Tennessee, according to documents from a federal congressional investigation.
There are multiple types of meningitis — viral meningitis, in which a virus causes inflammation in the brain and spinal cord; and bacterial meningitis, in which bacteria cause similar problems. Viral is more common than bacterial meningitis.
Fungal meningitis, which caused the outbreak, is extremely rare, according to the Centers for Disease Control and Prevention.
On Wednesday, U.S. Rep. Cliff Stearns, R-Fla., led a subcommittee of the House Energy and Commerce Committee investigating the meningitis outbreak.
“After a tragedy like this, the first question we all ask is: Could this have been prevented? After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration — the answer here appears to be yes,” Stearns said.
The compounding center had repeated problems with maintaining a sterile environment, receiving a warning letter from the FDA in 2006, according to oversight committee documents.
Was it clean enough?
Some argue that the New England Compounding Center was acting like a drug company, rather than a compounding pharmacy. It was making and shipping several drugs out of state, rather than making specific prescriptions for specific patients, which is at the heart of what compounding pharmacies do.
When you walk into Sherry's Drug, look to the right, and you'll see an enclosed room with small windows where you can see inside. This is the Edmond pharmacy's aseptic room, where compounding technicians fill prescriptions for patients.
On Friday morning, Jenny Brooks, a compounding pharmacy technician, is in that room, busy making a medicine to mail to Oklahoma residents who can't pick up their prescriptions at the pharmacy because of age, disability or distance from home.
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