With the sentencing of Glenn Chin the supervisory pharmacist at the now closed New England Compounding center to 8-years in prison, hopefully the NECC nightmare comes to a close. Previously Barry Cadden co-owner of NECC was sentenced to 9 years in prison.
As reported by the Center for Disease Control, In September 2012, the Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free MPA steroid injections from the New England Compounding Center in Framingham, Massachusetts.
The investigation includes fungal meningitis (a form of meningitis that is not contagious), localized spinal or paraspinal infections, such as epidural abscess and arachnoiditis, and infections associated with injections in a peripheral joint space, such as a knee, shoulder, or ankle.
The predominant fungus identified in patients is Exserohilum rostratum. One patient, the index case, had a laboratory-confirmed Aspergillus fumigatus infection. These fungi are common in the environment, however fungal infections are not transmitted from person to person.
Distribution of these medications led to a total case count of 753 sickened individuals and ultimately the deaths of 64 individuals. The case map from CDC is shown below:
The quality failures at NECC which led to the distribution of fungal contaminated sterile medicines directly led to the passage of the Drug Quality and Security Act (DQSA), the implementation of 503B outsourcing facility category and increased FDA oversight of non-traditional pharmacy operations.
In FDA Commissioner Gottlieb’s, testimony before the Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives. Commissioner Gottlieb stated (p.3):
We [FDA] have conducted close to 500 inspections of 503A and 503B facilities
between the passage of DQSA and the end of fiscal year 2017. We have observed problematic conditions during the vast majority of these inspections and have overseen more than 150 recalls of compounded drugs and issued more than 180 warning letters. We also have worked in close coordination with our Federal and state partners, sending more than 70 referral letters to state regulatory authorities for follow up on certain inspectional findings and working with the Department of Justice on civil and criminal enforcement actions.
In closing remarks Commissioner Gottlib stated (p. 5):
These and similar violations have led to many cases of serious patient harm. Despite a heightened level of oversight activity, FDA has received a steady stream of reports of serious adverse events related to compounded drugs since 2012, mostly associated with pharmacies regulated under section 503A.
Pharmacies operating under 503A and B exemptions have the potential to provide a valid needed service to the community, to the health care systems, and ultimately to the patients. But, only if the medicines compounded by these facilities are safe, effective, and pose no additional risk to the patient.