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.
The New England Compounding Pharmacy was shipping thousands of medicines across the nation. The difference in what Brooks is doing is that she knows who the medicine is for and is filling a prescription specific to one person.
“We individualized each person's medication, we compound it from scratch, package it, dispense it, and it goes out,” Brooks said.
Compounding pharmacies provide a wide range of drugs to their clients. These pharmacies fill prescriptions for hormone replacement therapy, pain relief, skin conditions and veterinary clinics, just to name a few.
There's a door inside the aseptic room that leads to the pharmacy's sterile room. To maintain good air quality in the room, no one is allowed in other than trained staff. Brooks will enter this room three or four times a day. Each time before she enters, she must use an iodine scrub and put covers on her shoes and wear a mask, apron, arm sleeves and gloves, among other things.
“Nothing on me is going to get in their product,” Brooks said.
It's no coincidence that Oklahoma has both tough compounding restrictions and is home to the International Journal of Pharmaceutical Compounding headquarters in Edmond.
Loyd Allen, the journal's editor-in-chief, has been a pharmacist for about 50 years and has played an integral role in shaping Oklahoma's compounding pharmacy laws.
Oklahoma was one of the first states to require pharmacists to take continuing education courses before they renew their license each year. That requirement was put in place 40 years ago.
At compounding pharmacies, pharmacists must monitor air quality. An Oklahoma compounding pharmacy's clean room must meet higher standards than a hospital operating room, Allen said. Compounding pharmacies in Oklahoma also must monitor the number of microorganisms found in certain parts of the facility. These are just a few of the requirements a compounding pharmacy in Oklahoma must meet, and for good reason, Allen said.
But it's not just regulations that must be in place. The state's pharmacy board has inspectors who visit most, if not all, Oklahoma pharmacies every year. Regulations have to be enforced to be worth anything.
“There's no reason why the FDA should not have closed the New England Compounding Center back in 2006,” Allen said. “They should have closed them down, no question about that, and they had the authority to.”
Before there was Pfizer or GlaxoSmithKline or Merck or Bayer, there was a local pharmacist compounding. In the 1700s and 1800s, everything was made through compounding.
In the early 2000s, as pharmaceutical companies were merging, they were dropping the number of medicines they made, Allen said.
There are more than 8,000 prescription and nonprescription drugs that pharmaceutical companies have discontinued — not because they were not safe, but because they weren't profitable, Allen said.
“Compounding has continued to grow to meet individual patient needs that the pharmaceutical industry is not meeting right now,” Allen said.
Last year, there were about 270 drugs facing shortages. Whenever there's a drug shortage, a compounding pharmacy is allowed to make that drug to help increase access.
Allen said this is an example of the role compounding pharmacies play in the nation's health care.
“Bottom line is if you couldn't compound, doctors could not practice health care today because they're so dependent on it,” Allen said. “You cannot do surgery without compounded medications. You can't feed kids tablets and capsules — so where are they going to get their medications?”