Meningitis outbreak raises concerns about drug mixing methods
Who knew of the role “compounding pharmacies” play in supplying clinics, hospitals and doctors with custom-mixed medicines?
Many Americans didn’t. Certainly the lack of oversight of these laboratories by the Food and Drug Administration was not widely known. It’s known now. As of Tuesday, it was known that 119 people had been sickened by a rare and deadly meningitis outbreak. Eleven had died. It was known that Tennessee is the hardest hit of the 10 states where 39 cases were reported. The state’s death toll stood at six.
It could get worse. As many as 13,000 people with back pain received epidural steroid injections that are blamed for the fungal meningitis outbreak. Investigators have pointed to a specialty pharmacy in Massachusetts New England Compounding Center as the source of the medication.
Thanks to an alert Tennessee physician, the danger posed by the disease now is common knowledge. More precisely, thanks to Dr. April Pettit. Pettit is an infectious diseases specialist at Vanderbilt University. The lack of improvement of a meningitis patient of hers who was not responding normally to medication incited her to investigate.
When a lab found the fungus in the patient’s spinal fluid, Pettit asked questions and learned the patient recently had steroid injections in his spine. The ongoing investigation highlights a serious problem facing U.S. hospitals and doctors — and, of course, their patients.
A national shortage of many drugs has forced doctors to seek custom-made alternatives to the usual first-choice treatments. The steroid identified in the current outbreak has been in short supply. To fill the need for hard-to-get drugs, the compounding pharmacies get certain drugs from manufacturers and mix them to meet demand.
Compounding pharmacies often obtain drugs from manufacturers and then split them into smaller doses, or mix ingredients sold in bulk. Any of those steps can easily lead to contamination if sterile conditions aren’t maintained. For example, the fungus suspected in the current meningitis outbreak can spread in the air.
These compounding pharmacies mix solutions, creams and other medicines used to treat everything from menopause symptoms and back pain to vision loss and cancer.
Unlike manufactured drugs, these products are not subject to approval by the Food and Drug Administration. The Associated Press reported other dangerous drug-mixing contaminations have occurred, including two people blinded in Washington, D.C., in 2005. Earlier this year, 33 people in seven states had fungal eye infections. In 2009, 21 polo horses died in Florida.
The U.S. has a choice. Tighten up the operation of these compounding pharmacies or live — or die — with the consequences.