Fungal Meningitis Outbreak: Who Oversees a Compounding Pharmacy?
Since the fungal meningitis outbreak last fall, more than 50 people have died, and roughly 700 are being treated for “persistent fungal infections”
August 26, 2013 -- About 17,000 vials of unregulated injectable corticosteroids were shipped to clinics and hospitals in the fall of 2012 from a pharmacy “clean room” found at the New England Compounding Center (NECC) - a “clean room” that harbored fungal contamination, as reported by CBS News 60 Minutes.
Compounding pharmacies are not regulated by the U.S. Food and Drug Administration (FDA) and do not undergo federal facility inspections or quality measures to assure sterility and quality control compliance; instead, State Boards of Pharmacy are tasked with the duty of inspecting the facilities. In addition, compounding pharmacies are required to receive an individual prescription written by a physician for a specific, legitimate patient each time they compound a requested medication. Compounding pharmacies are not large manufacturing facilities; they are not supposed to churn out thousands of drug doses stockpiled for unnamed patients -- but this is exactly what is happening in some parts of the country.
FDA’s Commissioner Dr. Margaret Hamburg admits that the FDA can no longer guarantee the safety of many drugs that are produced in compounding pharmacies. Yet she agrees that the FDA should have oversight for their operation. In April 2013, Dr. Hamburg made a statement to the House Subcommittee on Oversight and Investigations detailing “multiple situations where compounded products have caused deaths and serious injuries”. She notes products produced at some compounding pharmacies have been associated with a long-standing history of contamination, suffering and death. Over the last 20 years, compounding pharmacies have been linked with eye infections and blindness due to contaminated eye drops, excessive colchicine drug strengths leading to overdose and deaths, and tainted feeding solutions originally compounded to provide intravenous nutrition.
It appears the NECC far overstepped the requirement to compound for individual patients -- instead turning into a manufacturing facility of sorts that produced tens of thousands of doses of medications for fictitious patients. According to one salesman who was interviewed in the CBS program, close to 3,000 hospitals and clinics across the country had “become clients”. Pharmacy technicians that worked in the clean rooms admitted that the ability to maintain sterility was compromised with the level of drug they were manufacturing. One technician admitted mold was found a “dozen times” over a period of roughly three years in the clean room.
Since the fungal meningitis outbreak last fall, more than 50 people have died, and roughly 700 are being treated for “persistent fungal infections” from the contaminated methylprednisolone acetate steroid, as reported by 60 Minutes. These patients also report lingering pain from their infections and intolerable side effects from the anti-fungal medicines they must now receive. The Massachusetts State Board of Pharmacy previously inspected and passed the NECC facility in 2011; however, it had documented sterility issues in the past. The State Board had no idea to what extent the NECC was compounding sterile products -- mimicking that of a manufacturing facility.
In 1998, Congress exempted compounding pharmacies from FDA oversight. But after the NECC outbreak, FDA stepped up its oversight, even in the face of legal challenge. Steps were undertaken by the FDA, in conjunction with state authorities, to identify and inspect high-risk pharmacies known to be preparing sterile drug products. Dr. Hamburg noted in these inspections the FDA and state regulators have observed “lack of appropriate air filtration systems, insufficient microbiological testing, and other practices that create risk of contamination.”
Indeed, in this evolving industry, many hospitals are stocked with sterile products outsourced from supersized compounding pharmacies. If the current laws were applied, these pharmacies, many of which may be following adequate quality and sterility control, would need to apply to the FDA to manufacture “new drugs”, or get individual prescriptions for each patient. Shortages of these sterile products, which may not be accessible from other manufacturers, could occur around the country if the componding pharmacies were shut down across the board. Action is obviously needed to regulate an industry that has outgrown its current oversight.
Today, FDA is working towards protecting the public health from further incidents like the fungal meningitis outbreak linked to NECC. Federal regulation of compounding pharmacies that produce high-risk, large quantity, sterile products is a high priority. Dr. Hamburg outlined to the House Subcommittee a risk-based framework for FDA oversight of “non-traditional compounding” -- that is, compounding with higher risks but with a legitimate medical need. As noted by Dr. Hamburg, nontraditional “sterile products produced in advance of or without a prescription and shipped interstate should be subject to the highest level of controls, established by FDA and appropriate to the activity, similar to cGMP standards applicable to conventional drug manufacturers.”
CBS News. 60 Minutes. Lethal Medicine Linked to Meningitis Outbreak. Scott Pelley, Michael Radutzky, Oriana Zill de Granados, Michael Rey. Accessed August 11, 2013. http://www.cbsnews.com/8301-18560_162-57597470/lethal-medicine-linked-to-meningitis-outbreak/
U.S. Food and Drug Administration (FDA). News and Events. Statement of Dr. Margaret Hamburg. "A Continuing Investigation into the Fungal Meningitis Outbreak and Whether it Could Have Been Prevented" before the Subcommittee on Oversight and Investigations. House Committee on Energy and Commerce. U.S. House of Representatives. April 16, 2013. Accessed August 11, 2013. http://www.fda.gov/NewsEvents/Testimony/ucm348120.htm
Leigh Anderson, PharmD
Posted: August 2013