In September 2012, the United States Center for Disease Control and Prevention traced a widespread outbreak of fungal meningitis to fungal contamination in three lots of methylprednisolone acetate, a common steroid administered by epidural injection. This medicine was packaged and marketed by the New England Compounding Center (NECC), a now-defunct compounding pharmacy in Framingham, Massachusetts.
In all, 793 patients in 20 states were diagnosed with a fungal infection after receiving preservative-free methylprednisolone injections manufactured by NECC. More than 100 people died as a result. This outbreak represents the largest public health crisis ever caused by a contaminated pharmaceutical drug.
Although no cases of infection were associated with any other medication, all medications distributed by NECC were recalled in separate actions by regulators and the company.
Fallout from NECC Disaster
Following this disastrous outbreak, NECC filed for Chapter 11 bankruptcy in December 2012. Eleven former owners, executives, and employees of NECC have since been convicted of federal crimes, as the outbreak was linked to the company's disregard for safety and quality protocols.
As reported by the FDA, the NECC produced its drugs in an unclean environment using expired ingredients, failing to sterilize its drugs properly and performing sterility tests. NECC also refused to wait for sterility test results before sending its drugs out to patients and hid the fact that certain batches of drugs were being mixed by an unlicensed pharmaceutical technician.
In the wake of this incident, Congress passed the Drug Quality and Security Act of 2013, granting the FDA oversight over certain compounded drugs and leading to the formation of 503A compounding facilities and 503B outsourcing facilities. These new designations have resulted in more stringent standards and restrictions being placed on compounding pharmacies, ensuring that they maintain high levels of safety and quality.
It has now been over ten years since the events caused by NECC. The compounding industry has never been safer, with major industry players like AIS Healthcare showing a continued commitment to high-quality standards and an immense level of safety.
AIS Healthcare's Industry's Leadership Over the Past 10 Years
AIS Healthcare is the leading provider of medications used in targeted drug delivery (TDD) and infusion care systems in the United States. From AIS Healthcare's two 503A compounding facilities, the company prepares and ships medication to over 34,000 patients nationwide. AIS Healthcare has never had any issue with any of the medications it has sent to patients. Given the complexity of producing patient-specific intrathecal medications, AIS Healthcare has made significant investments to ensure its medications exceed industry standards in terms of quality, sterility, and patient safety.
AIS Healthcare CEO Simon Castellanos describes these investments, saying, "Enhanced contamination-control procedures are in place, including two fully redundant, state-of-the-art facilities in Dallas, Texas, and Ridgeland, Mississippi. AIS Healthcare also uses advanced quality aseptic processing and sterilization techniques, including putting every syringe through a proprietary terminal sterilization system that uses a steam heat autoclave to enhance sterility assurance levels for patients."
AIS Healthcare's sterilization process has a 1 in 1,000,000 assurance level, meaning the chance of finding an unsterilized unit is one in a million.
AIS Healthcare's pharmacies were built to promote and ensure pristine levels of cleanliness. The inside of both 503A facilities contain non-porous, easily cleanable surfaces, allowing for high levels of disinfection during each routine cleaning. AIS control rooms throughout the two pharmacies exceed required ISO standards for cleanliness and air quality, with all ISO-classified rooms being third-party certified every three months (twice as often as industry requirements). Any air used for terminal sterilization is first run through medical-grade air systems using seven different filters.
For additional quality assurance, AIS Healthcare requires that 100% of its stock solutions be third-party tested for pH, sterility, potency, endotoxins, and particulate matter.
AIS Healthcare has also been accredited by the Accreditation Commission for Health Care's (ACHC) compounding accreditation division, PCAB, and received URAC accreditation. URAC is an independent nonprofit organization that accredits healthcare services like pharmacies, providers, and healthcare plans. The URAC specialty pharmacy accreditation received by AIS Healthcare is considered the gold standard and represents a continued adherence to rigorous standards that exceed industry requirements.
To receive these accreditations, AIS Healthcare had to demonstrate excellence in a variety of categories. One category, pharmaceutical dispensing operations, included the review of prescription processing, intake, utilization review, verification, preparation, and administration.
While many find NECC's disregard for patient safety difficult to forget even a decade later, compounders like AIS Healthcare seek to strengthen and preserve patients' trust in the industry. AIS Healthcare's continued focus on patient safety has attracted a loyal client base, with the majority of the company's 34,000 TDD patients being with them for over five years.
