On May 22, 2013, the North Carolina
Division of Public Health (NCDPH) was notified by the US Food and Drug
Administration (FDA) of two adverse events reported to MedWatch, FDA’s Safety
Information and Adverse Event Reporting Program. Two patients had developed
soft tissue abscesses after receiving methylprednisolone acetate (MPA)
injections at the same clinic. The injections contained preservative-free (PF)
MPA 80mg/mL from 10mL vials compounded and distributed by Main Street Family
Pharmacy (MSFP) located in Newbern, Tennessee. Five similar adverse events associated
with the same MPA formulation from MSFP had been identified in April among
Illinois residents. Concerns about widespread use of a potentially contaminated
product led to a multi-state investigation.
As of
July 25, 2013, 81 facilities in 15 states administered any MPA product from
MSFP to their patients; national estimates of exposed patients were unavailable.
A total of 26 cases were reported from four states: Arkansas, Florida, Illinois
and North Carolina. All 26 illnesses were skin or soft-tissue abscesses at the
site of injection; no life-threatening infections were reported. Four case
patients had positive bacterial culture or histopathologic findings including Enterobacter cloacae, Klebsiella pneumonia, and
Aspergillus species.
In North Carolina, public health and
healthcare professionals partnered to mitigate further exposure and identify
any additional cases. The North Carolina Board of Pharmacy (NCBOP) identified five
clinics that received MPA products from MSFP and instructed clinics to
discontinue use and sequester any remaining MPA products. The NCBOP also
obtained the voluntary surrender of MSFP’s license in North Carolina. NCDPH and
affected county health departments worked with the five clinics to notify 1,045
patients who received MPA injections of their potential exposure and to assess
for any adverse events. No further cases were identified.
There
was strong evidence to support that the source of the outbreak was contaminated
PF MPA compounded at MSFP. FDA product testing of recalled, unopened MPA
products detected bacterial and fungal pathogens from two separate lots.
Pathogens included Acinetobacter ursingii, Alternaria species, Bacillus
cereus/thuringiensis/mycoides, Bacillus licheniformis, Bacillus pumilus,
Cladosporium species, Roseomonas gilardii and Penicillium species. Detailed information can be
found on the FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm355575.htm.
As a final note, this investigation
raised the following important issues. PF MPA products in 10mL vials were used
for multiple doses; however, as a preservative-free product it should have been
treated patient as a single-dose vial and used for one patient. Healthcare professionals
should be familiar with safe injection practices including appropriate use of
single-dose and multi-dose vials. For more information, visit the One and Only
Campaign website at http://www.oneandonlycampaign.org/. FDA’s MedWatch was a valuable tool for
identifying this multistate outbreak where few cases were dispersed throughout
the country. Healthcare providers and consumers may complete a MedWatch report (http://www.fda.gov/Safety/MedWatch/default.htm) when an adverse event to a
drug, product, or medical device is suspected.
