The national fungal meningitis outbreak that has been linked to a Massachusetts compounding pharmacy, the New England Compounding Center, has resulted in hundreds of illnesses and many deaths. In order to ensure the safety and sterility of their products, compounding pharmacies must follow good pharmaceutical manufacturing practices and the U.S. Pharmacopecia Chapter 757 sterility guildelines. Failure to maintain sterility in these pharmacies can cause a serious threat to public safety, as this may result in dangerouos contaminants being contained in compounds that are injected directly into our bodies. The meningitis outbreak is linked to contaminated epidural steroid injections.
This meningitis outbreak is not the first example of how important it is for compounding pharmacies to make sure that contaminants do not make their way into the compounded products. In January, 2007, I blogged about another outbreak of deaths allegedly caused by vioations by another compounding pharmacy, Central Admixture Pharmacy Services (CAPS), of good pharmaceutical manufacturing practices and sterility guidelines. "Cardioplegia" is the term for the temporary paralyzation of the heart muscle during cardiac surgical procedures. CAPS manufactured a cardioplegic solution that was mixed with blood and infused directly into the coronary artery to paralyze the heart during surgery.
In or about 2005, a Virginia hospital experienced an outbreak of systemic inflammatory response syndrome (SIRS) cases following heart surgeries. My former lawfirm handled many of these cases, including multiple death cases. SIRS is a potentially deadly condition, which can result in inflammation throughout the whole body, organ death, and death of the patient. The CDC and the FDA linked the SIRS outbreak to contaminated cardioplegia, which had been compounded by CAPS, a subsidiary of B. Braun Medical, Inc. While inspecting CAPS's compounding facility, the agencies found several species of bacteria growing inside intact bags of cardioplegia, and in the areas where the cardioplegia was compounded.
The story in Massachusetts is alarmingly similar. The FDA inspectors who inspected the Massachusetts compounding pharmacy reported mold and bacteria in two "clean rooms" that were supposed to be sterile. They discovered labeling errors that made it difficult to tell sterile and non-sterile ingredients apart. They observed "yellow residue" and "green residue" and other unknown foreign substances on various pieces of equipment in areas that were supposed to be completely sterile. The result of this lax sterlity practice is the national meningitis crisis.
The FDA needs more resources to keep up with the task of protecting the country from unsafe food, drugs, and medical devices. There are simply some jobs that must be performed on the federal level, and the continuing problems caused by lax enforcement of and compliance with pharmaceutical sterility guildelines prove the point.