BACKGROUND: On May 28th, 2013, Main Street Family Pharmacy (MSFP) of Tennessee recalled all lots of sterile compounded products manufactured since December 1, 2012. On June 7, 2013, the Food and Drug Administration reported bacterial and fungal growth from two separate lots of unopened 80mg/mL, 10mL vials of preservative-free methylprednisolone acetate (pf-MPA) from MSFP. As of June 27, 2013 the Centers for Disease Control and Prevention (CDC) reported 26 individuals in four states had an infection suspected to be associated with exposure to recalled MSFP products. The investigation objective was to identify injection-site abscesses and quantify risk factors from injections with subsequently recalled MSFP’s pf-MPA 10 mL single-dose (not labeled as such) vials administered to multiple patients at a single clinic in Florida.
METHODS: Medical records were abstracted for individuals identified with an adverse event and for all individuals recorded as exposed to pf-MPA lots: 011413dan and 120612dan. Facility records from July 2006 to August 2013 were reviewed for ICD-9 CM 682.5 (abscess of the buttocks) and 680.5 (carbuncle of the buttocks) codes to identify additional adverse events. Univariate analysis and logistic regression were performed to identify risk factors for adverse events and to control for demographic factors andco-morbidities.
RESULTS: Sixteen of 307 exposed individuals developed soft tissue abscesses at the injection site (attack rate = 5.2%). Twelve patients required incision and drainage of their abscesses. Most patients received injections for symptoms related to allergic rhinitis or an acute upper respiratory infection. Four of the abscesses were cultured and Klebsiella pneumonia (n=4) and Enterobacter cloacae (n=2) were identified. Increasing Body Mass Index (BMI) (odds ratio (OR)=1.17; CI=1.04-1.33), age of vial at injection (OR=1.13; CI=1.00-1.27), and an 11-day injection period (OR=10.01; CI=1.49-67.11) were significant factors associated with adverse events. Review of ICD-9 CM codes identified two additional patients that received an injection with MPA prior to diagnosis of abscess of the buttocks.
CONCLUSIONS: Healthcare providers should consider BMI and potential fat pad depths for intramuscular injections to reach the muscle, and alter needle length and gauge to reach the intended injection location. A written protocol for the pf-MPA injections, including needle size and gauge, should be created and training on this protocol provided to staff administering injections. Preservative-free compounded products should only be used when absolutely necessary and should be considered single-dose products. Healthcare practitioners should be reminded to report any adverse events from pharmaceuticals to Medwatch.