Compounding Pharmacy Shutdown In Massachusetts: Matters of Public Health and Regulation
Key Takeaways:
- Infusion Resource, a compounding pharmacy in Massachusetts, voluntarily surrendered its license following an investigation that exposed conditions potentially jeopardizing the sterility of their products.
- This case follows exposure of unsanitary practices at another Massachusetts pharmacy, New England Compounding Center, which is linked to a massive ongoing meningitis outbreak caused by contaminated steroid injections.
- Poor maintenance and failure to adhere to sterility practices, such as neglecting to run the air conditioner in the clean room overnight, were found during the investigations.
- These incidents raise concerns around the need for more stringent regulatory control over compounding pharmacies, which are not subject to the same level of oversight as conventional drug manufacturers.
- Due to these negligent practices, 25 individuals have died and 354 have fallen ill across 19 states due to fungal meningitis. Symptoms can take up to a month to appear post injection.
Officials in Massachusetts have sealed off a second compounding pharmacy following an abrupt investigation last week. The investigation exposed conditions potentially jeopardizing the sterility of their products.
Pharmacy Voluntarily Surrenders License
The compounding pharmacy based in Waltham, Massachusetts, known as Infusion Resource, voluntarily relinquished its license after the investigation identified noteworthy issues about the environment where medications were being created. The critical information was shared by Dr. Madeleine Biondolillo, the director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department.
Without detailing the findings of the inspection, Dr. Biondolillo mentioned that the pharmacy was administrating intravenous medications to patients on location, which is a direct breach of state law.
Link to Previous Unsanitary Conditions
The pharmacy’s closure follows exposure of unsanitary practices at the New England Compounding Center facility in Framingham, Massachusetts, which is at the heart of a massive ongoing meningitis outbreak. Federal inspectors revealed the discovery of strange “greenish-black” matter in some vials of the steroid suspected to be the cause of the widespread illness.
Detailed Investigation Enquiries
Federal authorities shared that a hundred or so vials of the steroid, presumed to be a sterile injectable drug, had a greenish-black foreign substance and white fibrous material inside. Investigations also pointed out that the pharmacy failed in maintaining cleanliness in their “clean room.” This specific room is designed to control the environment with low levels of airborne particles and surface contaminants.
The company was found to be neglecting to run the air conditioner in the clean room overnight, a universal practice to balance the room temperature and humidity. Previously, the company itself identified mold and bacteria within the clean room.
Offences and Violations
State officials confirmed that a criminal investigation was initiated against New England Compounding Center, which operated more as a drug manufacturer than meeting specific individual prescriptions, contradicting its state license terms.
Furthermore, the compounding facility faced issues as early as 2006, with recorded evidence indicating insufficient contamination control, lack of standard operating procedures for using equipment, among other complications.
Role and Regulation of Compounding Pharmacies
Compounding pharmacies, such as Infusion Resource and New England Compounding Center, alter or mix ingredients to create drugs catering to specific individual needs. However, unlike conventional drug manufacturers, they are not subject to the same level of FDA oversight. This has raised concerns around the need for more stringent regulatory control.
Meningitis, a potentially fatal inflammation of the lining around the brain and spinal cord, has been associated with the pharmacy’s steroid injections. The steroid, methylprednisolone acetate, is usually used for treating back and joint pain.
National Health Impact
As a result of the pharmacy’s negligent practices, 25 individuals have died and 354 have fallen ill across 19 states due to fungal meningitis infections. Majority of patients identified with fungal meningitis are believed to be injected with methylprednisolone acetate medication from the Massachusetts pharmacy.
Health officials anticipate more cases as symptoms can take up to a month or more to manifest. Infected patients generally start showing symptoms one to four weeks after receiving their injection.
If you have had a steroid injection since July and experience symptoms like worsening headache, fever, increased sensitivity to light, stiff neck, new weakness or numbness in any part of your body, or slurred speech, it is advised to talk to your doctor immediately. Infected patients need to be treated with intravenous drugs in a hospital.
Additional Information
The U.S. National Library of Medicine provides more information about back pain injections here.
