According to the PEW Charitable Trusts study of 2013 there were 20 compounding pharmacy errors that resulted in 87 deaths in the years following 2001. The study points to contamination of sterile products as the most common error. These contaminations also caused various adverse reactions among those affected including instances of fungal meningitis, blindness, bacterial bloodstream infections and systemic inflammatory response syndrome.
In September of 2012, a fungal infection was spread by tainted epidural steroid injections produced and packaged by the New England Compounding Center in Framingham, Massachusetts. These doses were distributed to to 75 medical facilities in 23 states and administered to more than 13,000 patients between May and September of that year. As of March 2013, 749 cases of fungal meningitis had been linked to the contamination resulting in 63 deaths across 20 states. Though the NECC recalled the remaining lots of medication, subsequent findings showed contamination in other lots.
Because the consequences of these contaminations can be so injurious and their effects so widespread, compounding pharmacy sanitation remains the most important factor in pharmacy cleanrooms, the FDA remains vigilant in identifying contamination sources and citing those pharmacies that do not comply with USP 797 and other regulations. As late as May 2013, the FDA identified another case of bacterial and fungal contamination in unopened vials of steroid injections at Main Street Pharmacy in Newbern, Tennessee. This contamination lead to several adverse events including one case of fungal infection.
At TCA we strive to make sure that every single aspect of our USP 797 clean rooms are designed and built to exacting standards and are guaranteed in writing to meet USP 797 guidelines. Knowing that what we do has far-reaching implications, we stop at nothing to make sure that we do our part in keeping people safe when constructing modular clean rooms for your compounding pharmacy.