New England Compounding Center meningitis outbreak

New England Compounding Center meningitis outbreak was a significant public health crisis that occurred in 2012, involving the distribution of contaminated steroid injections by the New England Compounding Center (NECC), a compounding pharmacy located in Framingham, Massachusetts. This outbreak led to widespread meningitis infections, causing numerous illnesses and deaths across the United States. The incident highlighted critical issues in the regulation and oversight of compounding pharmacies and led to significant changes in laws and policies governing the pharmaceutical compounding industry.

Background

Compounding pharmacies, like the NECC, prepare medications tailored to meet the specific needs of patients, often by altering or combining drug ingredients. These pharmacies are supposed to operate under strict guidelines to ensure the safety and efficacy of their compounded medications. However, the NECC was found to have violated several safety standards, leading to the contamination of their products.

The Outbreak

The outbreak was traced back to methylprednisolone acetate, a steroid injection compounded by the NECC, which was contaminated with fungal pathogens. These injections are commonly used to treat back pain and joint issues. Patients receiving the contaminated injections developed fungal meningitis, a rare and severe form of meningitis. The outbreak affected over 750 individuals across 20 states, resulting in more than 60 deaths.

Investigation and Response

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) launched a comprehensive investigation into the outbreak. Their findings revealed significant lapses in the NECC's sterile compounding practices, including the use of expired ingredients, poor environmental monitoring, and inadequate testing of products for sterility. The investigation also uncovered that the NECC had been operating more like a drug manufacturer than a pharmacy, distributing large quantities of medications across state lines without patient-specific prescriptions, in violation of its pharmacy license.

Legal and Regulatory Outcomes

The outbreak led to criminal charges against several NECC employees, including its owners and supervising pharmacist, who were accused of multiple counts of racketeering, mail fraud, and the introduction of adulterated and misbranded drugs into interstate commerce with the intent to defraud and mislead.

In response to the outbreak, Congress passed the Drug Quality and Security Act (DQSA) in 2013, which aimed to strengthen the regulatory oversight of compounding pharmacies and enhance the safety of compounded medications. The DQSA created a new category of compounding pharmacies called "outsourcing facilities" that are subject to FDA oversight.

Impact

The NECC meningitis outbreak had a profound impact on public health, leading to increased scrutiny of compounding pharmacies and changes in regulatory oversight to prevent similar incidents in the future. It also raised awareness among healthcare providers and patients about the risks associated with compounded medications.

See Also

• Meningitis
• Compounding pharmacy
• Drug Quality and Security Act
• Centers for Disease Control and Prevention
• Food and Drug Administration