Contaminated Heparin Raises Questions About Drug Safety
- From: rpautrey2 <rpautrey2@xxxxxxxxx>
- Date: Wed, 14 Oct 2009 10:55:23 -0700 (PDT)
http://www.medpagetoday.com/InfectiousDisease/PublicHealth/16399
Contaminated Heparin Raises Questions About Drug Safety
By Chris Emery, Contributing Writer, MedPage Today
Published: October 12, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Lax compliance with federal regulations resulted in bacterial
bloodstream infections from contaminated heparin syringes in several
states, according to a new Centers for Disease Control and Prevention
report that has raised concerns about drug safety in an increasingly
complex pharmaceutical industry.
Responding to reports of outbreaks of Serratia marcescens bloodstream
infections between October 2007 and February 2008, CDC investigators
traced the infections to syringes of the blood thinner heparin
produced by a single company, according to the report published Oct.
12 in the Archives of Internal Medicine.
Inspection of the manufacturing facility revealed that the company
(which remained unnamed in the report) violated FDA Good Manufacturing
Practices, the comprehensive body of regulations that govern all
aspects of production.
However, it was hard for CDC to determine the source of the
contaminated syringes in the first place, since they moved through
multiple distributors before reaching patients and were not marked
with the name of the original manufacturer.
"Close collaboration among federal agencies, public health
authorities, and clinicians was critical to the identification of the
cause of this outbreak," David Blossom, of the Centers for Disease
Control and Prevention, and colleagues wrote.
"In the course of the investigation, we also identified several
challenges to medical product tracking that should be addressed
promptly so that disease outbreaks caused by exposure to contaminated
medications can be dealt with more efficiently in the future."
Beginning October 2007, the CDC received reports of 161 S. marcescens
infections among patients at medical centers in nine states.
Using information from facilities in Texas and Illinois, investigators
determined the infections were cause by syringes prefilled with
heparin and saline.
They ultimately traced the infections to asingle manufacturer. CDC
received 83 blood samples from infected patients and determined the
bacteria in 70 of the samples matched strains found in the prefilled
syringes from the manufacturing facility.
Soon after the CDC inspection, the company discontinued producing
medical products and issued a voluntary national recall of the
prefilled syringes.
The authors concluded that the incident highlights important issues
concerning the safety of pharmaceuticals.
Drug manufacturers must ensure that they are in full compliance with
the FDA requirements, they wrote, and distributors, healthcare
facilities, and pharmacies should keep track of the lot numbers of
products they distribute, so contaminated products can be traced to
their origins more rapidly.
Investigations of possible adverse drug events should include both
epidemiologic and laboratory components.
The authors noted that cases of infection from the syringes may have
been under-reported and that they were not always able to determine
exactly what patients were infected by which syringe lots.
In an accompanying editorial, William K. Hubbard, BA, MA, a former FDA
associate commissioner, wrote that the outbreak demonstrates the
important role the FDA plays in protecting the American public from
dangerous drugs.
This is particularly important as medicines are increasingly
manufactured abroad and travel through complex distribution networks,
he wrote.
He noted a recent case in which heparin produced at aChinese facility
described as a "primitive" pig farm is believed to have contributed to
dozens of deaths in the U.S.
"One might initially think this case is an anomaly, given that the
heparin was produced in China," he wrote. "But, unfortunately, it is
rapidly becoming the norm. Indeed, today, 80% of Americans'
pharmaceutical ingredients are imported."
"We simply must, as a nation, recognize that we cannot reverse this
trend toward globalization, that the solution to a safe drug supply is
a strong FDA, not reliance on foreign governments," he wrote.
He lamented that the FDA's annual budget has generally remained flat
or been in decline since the mid-1990s.
The agency lost about a 1,000 of its 9,000 staff between 1995 to 2007,
which he described as a "huge loss" for an agency tasked with
protecting "our foods, drugs, blood supply, medical devices, pet food,
cosmetics, dietary supplements, x-ray machines, cell phones, and many
other consumer products."
"Just as cities cannot educate their children without teachers,
extinguish fires without firefighters, and patrol their streets
without policemen," he wrote, "the FDA cannot protect this vast array
of products without the staff to do so."
The authors reported no outside sources of funding and no financial
conflicts of interest.
Primary source: Archives of Internal Medicine
Source reference:
Blossom D, et al "Multistate outbreak of Serratia marcescens
bloodstream infections caused by contamination of prefilled heparin
and isotonic sodium chloride solution syringes" Arch Intern Med 2009;
169: 1705-11.
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