Abstract

Objective: Identify injection-site abscesses and quantify risk factors from injections with subsequently recalled preservative-free Methylprednisolone acetate (pf-MPA) from Main Street Family Pharmacy (MSFP).

Design: Outbreak investigation and retrospective cohort study.

Setting: Private primary healthcare facility.

Patients: Three hundred and seven patients that received pf-MPA injections manufactured by MSFP from December 1, 2012 through February 28, 2013.

Methods: Medical records were abstracted for individuals with an adverse event and individuals with known exposure to pf-MPA lots 011413dan and 120612dan. Records were analyzed for factors related to injection-site adverse events using logistic regression. Facility records from 2006 through 2013 were queried for International Classification of Diseases, 9th edition, Clinical Modification (ICD-9-CM) diagnosis codes 682.5 and 680.5 to identify additional adverse events. Results: Sixteen of 307 injected individuals (attack rate = 5.2%) were identified with adverse events consisting of soft tissue infections at the injection site. 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 date of injection (OR=10.01; CI=1.49-67.11) were associated with adverse events.

Conclusion: Risk of soft tissue infections following injection of recalled MSFP pf-MPA was greater among persons with higher BMI, receiving older product, and receiving injections from February 5 through February 15, 2013. Appropriate needle length was not used for patients with a greater BMI. A written protocol for pf-MPA injections including needle length and gauge should be created and trainings on this protocol provided to staff administering injections. Compounded pharmaceuticals, especially preservative-free formulations, should not be utilized for multiple injections.