A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy.
BACKGROUND
In contrast to pharmaceutical manufacturers, compounding pharmacies adhere to different quality-control standards, which may increase the likelihood of undetected outbreaks. In 2005, the Centers for Disease Control and Prevention received reports of cases of Serratia marcescens bloodstream infection occurring in patients who underwent cardiac surgical procedures in Los Angeles, California, and in New Jersey. An investigation was initiated to determine whether there was a common underlying cause.


METHODS
A matched case-control study was conducted in Los Angeles. Case record review and environmental testing were conducted in New Jersey. The Centers for Disease Control and Prevention performed a multistate case-finding investigation; isolates were compared using pulsed-field gel electrophoresis analysis.


RESULTS
Nationally distributed magnesium sulfate solution (MgSO(4)) from compounding pharmacy X was the only significant risk factor for S. marcescens bloodstream infection (odds ratio, 6.4; 95% confidence interval, 1.1-38.3) among 6 Los Angeles case patients and 18 control subjects. Five New Jersey case patients received MgSO(4) from a single lot produced by compounding pharmacy X; culture of samples from open and unopened 50-mL bags in this lot yielded S. marcescens. Seven additional case patients from 3 different states were identified. Isolates from all 18 case patients and from samples of MgSO(4) demonstrated indistinguishable pulsed-field gel electrophoresis patterns. Compounding pharmacy X voluntarily recalled the product. Neither the pharmacy nor the US Food and Drug Administration could identify a source of contamination in their investigations of compounding pharmacy X.


CONCLUSIONS
A multistate outbreak of S. marcescens bloodstream infection was linked to contaminated MgSO(4) distributed nationally by a compounding pharmacy. Health care personnel should take into account the different quality standards and regulation of compounded parenteral medications distributed in large quantities during investigations of outbreaks of bloodstream infection.
Centers for Disease Control and Prevention, Arizona Dept. of Health Services, 150 N. 18th Ave., Ste. 150, Phoenix, AZ 85007, USA. Sunensr@azdhs.gov
Rebecca H
RH
Sunenshine
Esther T
ET
Tan
Dawn M
DM
Terashita
Bette J
BJ
Jensen
Marilyn A
MA
Kacica
Emily E
EE
Sickbert-Bennett
Judith A
JA
Noble-Wang
Michael J
MJ
Palmieri
Dianna J
DJ
Bopp
Daniel B
DB
Jernigan
Sophia
S
Kazakova
Eddy A
EA
Bresnitz
Christina G
CG
Tan
L Clifford
LC
McDonald
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016470:Bacteremia / Q000453:epidemiology* / Q000382:microbiology; D006348:Cardiac Surgical Procedures; D002317:Cardiovascular Agents / Q000009:adverse effects*; D002487:Centers for Disease Control and Prevention, U.S. / Q000706:statistics & numerical data; D003428:Cross Infection / Q000453:epidemiology / Q000382:microbiology; D004196:Disease Outbreaks; D004339:Drug Compounding / Q000009:adverse effects / Q000592:standards; D004340:Drug Contamination; D005260:Female; D006801:Humans; D015141:Los Angeles / Q000453:epidemiology; D008278:Magnesium Sulfate / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009515:New Jersey / Q000453:epidemiology; D012307:Risk Factors; D016868:Serratia Infections / Q000453:epidemiology / Q000209:etiology*; D012706:Serratia marcescens / Q000302:isolation & purification / Q000472:pathogenicity*; D014481:United States
D002317:Cardiovascular Agents; D008278:Magnesium Sulfate