Meningitis Outbreak Due to Non-Sterile Conditions

Rachel Decker
The Paw Print

Ten years ago, a pharmacist named Sarah Sellers warned the US Congress about the non-sterile working environments she had witnessed. She explained that sterile regulations had not been upheld, and she assured the congress that if action was not taken, lives would be at stake.
Her warnings were dismissed, and now 137 cases and 12 confirmed fatalities are said to be linked to this gap in sterile security. The deaths are said to be caused by a noncontagious form of meningitis that has been linked to contaminated steroid injections.
Now, several lawmakers are proposing bills that will strengthen the Food and Drug Administration’s regulations on safety and sterility in workplaces that deal with medicine, and they will crack down on maintaining these guidelines.
However, it was discovered that many bills similar to the new ones being proposed have been in circulation since 2006, and they are “still in progress,” according to FDA spokeswoman Erica Jefferson.
Because these guidelines for safety are not taken seriously, many predict that this will lead to more outbreaks comparable to this, and that there is the possibility it could be more deadly.
“It is a serious possibility,” confirmed Jefferson. “We need to be more cautious, but many don’t feel the need for increased cleanliness and precaution.”
The suspected cause of the meningitis outbreak is being linked to carelessness at the New England Compounding Center (NECC). There have been multiple safety and sterility violations broke by them in the past, and they have been warned over again by the Massachusetts Department of Public Health since 2002.
Close by to the NECC is a garbage compactor and recycling center, and because there is no law that requires a minimum proximity between pharmacies and other establishments, there had been no action taken to prevent contamination.
“The New England Compounding Center can distribute thousands of doses of drugs and it doesn’t necessarily have to be accredited,” Dr. Sanjay Gupta, a chief medical correspondent, reported.
Originally, compounding pharmacies were never intended to produce the amount of pharmaceutical drugs that they do today. They had been created so that doctors and pharmacists would be able to make personalized amounts of custom medicine. Now, however, compounding is in charge of created 37 million drugs for the United States each year.
“Our investigation into NECC and the outbreak with our partners in Massachusetts are ongoing, so I can’t comment directly on how this factors in,” Jefferson explained. “There is the possibility that there may have been a violation for some organizations operating contrary to the licensing regulations, but that is part of the investigation.”
For now, sterility regulations will be enforced more strictly around pharmacy compounds to ensure that an outbreak such as this does not happen again. The FDA plans to do more frequent screening and tests to make sure that nothing slips through the cracks.
“Safety is essential when it comes to pharmaceuticals,” Jefferson assured. “And we’ll be doing everything we can to make sure something like this doesn’t happen again.” is powered by WordPress µ | Spam prevention powered by Akismet