Regulate compounding pharmacies to prevent future outbreaks
Posted on Oct 25, 2012 in Opinion
Steroid injections given in the spine, also known as lumbar epidural steroid injections, are used to treat lower back pain. The most common reason for this back pain is having a herniated disk, a condition in which one or more of the disks in the spine protrude. The backbone consists of 26 vertebrae, and in between these lie the disks. The protrusion of a disk causes the disk to pinch nerves, which can cause not only back pain but also pain spreading through the legs. Because the nerves in your back travel to the legs, the pain can be debilitating.
CNN.com
I was diagnosed with a herniated disk when I was seventeen and the pain made it impossible for me to continue my regular life. As a result, I received a lumbar epidural steroid injection in August of 2011. I made a decent recovery and life was back to normal shortly thereafter. A few months before I left for college, my doctor and I thought it would be a good precautionary measure for me to have another injection before I left for college. I did not want to have even the smallest chance of letting the pain resurface. In August 2012, I received another injection a week before I left Memphis to come to UAB.
About three weeks ago, a headline on CNN caught my eye: Spinal steroid injections linked to meningitis outbreak. Nervously, I clicked on the article, which explained that many patients with lower back pain received steroid injections in the spine. I read on and it explained that several injections, given since May of 2012, were contaminated with fungal meningitis. The steroids, based in a compounding pharmacy in Massachusetts, were shipped to several states, including Tennessee, which is where I received my injection.
The news scared my entire family. Earlier that day I had told my mom that I had an awful headache and I felt like I was getting sick. Our fear at this point was, what if my headache and symptoms were a result of fungal meningitis. The disease travels from the spine straight to the brain, where it causes swelling and brain damage, but is not contagious. Symptoms include headaches, fever, stiffness in the neck, and sensitivity to light.
Fortunately, the next morning my doctor’s office confirmed that they did not buy their steroid medications from the manufacturer linked to the outbreaks and I did not have fungal meningitis. I was obviously relieved that there was nothing wrong with me, but what about the people infected? The latest statistics show that 271 people have been infected and 21 people have died.
This nightmare for patients with back problems happened because one manufacturer’s steroids were contaminated. The steroids were sent to 23 states. Federal health inspectors discovered foreign particles in unopened vials in the Massachusetts plant. These vials contained fungus.
However, no one knows how the actual contamination occurred. Questions are arising over the regulation that states impose over compounding pharmacies. Many doctors and hospitals buy drugs from compounding pharmacies because their prices are lower than those of the Food and Drug Administration. They are also regulated by the states, which have different guidelines, while drug companies are regulated by the Food and Drug Administration.
Hopefully, as a result of this deadly outbreak, regulation on compounding pharmacies will be as stringent as those on pharmaceutical companies, and future outbreaks will be prevented as a result.
Natasha Mehra
Contributor
nmehra16@uab.edu
In the past, I worked in a compounding pharmacy. They are regulated through State Boards of Pharmacy. Pharmacy inspections in my state are typically every six months to once a year. In contrast, drug manufacturers in the United States are inspected, on average, every 2.5 years. Many drugs are produced in foreign countries. The FDA inspects them, on average, every 11 years. In India and China, the rate of inspection is every 14 years. The more frequent inspection of compounding pharmacies is the reason why it has been extremely rare for problems to occur with compounding as opposed to manufacturing of drugs.