With 438 infections and 32 deaths reported so far, the fungal meningitis crisis caused by the Massachusetts compounding pharmacy is prompting a stronger focus on patient safety. The New England Compounding Center, which is responsible for the contaminated steroid shots, is under scrutiny after an inspection by the Massachusetts Department of Public Health. However, one pharmacy in Tennessee is using the crisis to take necessary precautions in order to increase safety standards.
Compounding pharmacies create custom medications from scratch, so the need for a sterile environment is crucial in order to avoid contamination. Inspectors who went into NECC found a leaky boiler and visibly dirty floor mats near sterile drug mixing. Mold and bacteria were present in two supposedly sterile rooms, and NECC has also been accused of mislabeling sterile and non-sterile ingredients. “Green residue” and “yellow residue” were also noted in the inspectors’ report.
Surprise inspections are now conducted in other Massachusetts compounding pharmacies. But the issues with NECC are prompting compounding pharmacies in other states to focus on safety. Medical Center Compounding Pharmacy, based in Chattanooga, wants to ensure its customers that the conditions found at NECC are not representative of her pharmacy, or the industry as a whole.
Cindy Smith, the pharmacist-in-charge at Medical Center Compounding Pharmacy, read the NECC inspector report to the pharmacy staff to show them how their actions are instrumental to keep people safe. Smith states, “as we have seen, you can literally hold a patient’s life in your hands,” and emphasizes how that’s “a huge responsibility.”
In Smith’s pharmacy, customers can watch certified pharmacy technicians as they work behind several glass windows. The pharmacy is divided into sterile and non-sterile rooms, and the production process is detailed in a large three-ring binder. Technicians must print out the prescription label and then scan each necessary ingredient that the formula calls for. When all the ingredients are checked out, technicians can start to compound the medication, and they only work on one prescription at a time to avoid errors. All surfaces are white, so staff can visibly ensure that they’re clean, and the air-conditioner is set eight degrees below the maximum that is allowed to inhibit the growth of mold and mildew.
Out of an estimated 7,500 compounding pharmacies nationwide, only 166 pharmacies, like Smith’s, are accredited by the board. Accreditation takes time, money and effort to go beyond the mandated precautions, but after a crisis like the one NECC is facing, Smith notes how important it is for pharmacy staff to take extra precautions: “I wanted them to understand how really easy it is to get lazy, to get careless, and what the consequences are of that.”