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NEWS FROM
CAMBRIDGE HEALTH ALLIANCE
October 6, 2008
Free Drug Samples Carry Risks for Children
First of its Kind Study Finds Safety Hazards in Frequently Distributed
Samples
Cambridge, MA...Free prescription drug samples distributed
to children may be unsafe, according to a study by physicians from
Cambridge Health Alliance and Hasbro Children's Hospital. The national
study, the first to look at free drug sample use among children,
appears in the October 2008 issue of Pediatrics.
The authors, also researchers at Harvard Medical School and the
Warren Alpert Medical School of Brown University, found that children
commonly receive free drug samples from their doctors. One out of
every 20 American children received free drug samples in 2004. Among
children who took at least one prescription drug in that year, nearly
one in 10 got free samples.
The U.S. Food and Drug Administration identified significant new
safety concerns for four of the top 15 most frequently distributed
samples in 2004. These four medications acquired new black box warnings
or had significant revisions to existing black box warnings issued
since 2004. In addition, two of the top 15 sample medications given
to children were schedule II controlled substances (drugs controlled
and monitored by the Drug Enforcement Agency due to high potential
for abuse). Distribution of these medications, Strattera (atomoxetine)
and Adderall (amphetamine/dextroamphetamine), carries risk, especially
when drug sample closets in physician's offices (or home medicine
cabinets) are not strictly monitored.
Although some physicians support the use of free drug samples as
a way of getting medications to indigent patients, lead author Dr.
Sarah Cutrona and her colleagues found that few free samples in
their study go to needy children. More than 80 percent of children
receiving samples were insured all year. Conversely, approximately
16 percent were uninsured for all or part of 2004, and less than
one-third had low family incomes (under $38,000 for a family of
four). Minority children were less likely to receive free samples
than white non-Hispanic children, and free sample receipt was positively
associated with markers reflecting access to health care. The authors
concluded that free sample distribution does not equalize medication
access for needy children.
Dr. Cutrona, a physician at Cambridge Health Alliance and an instructor
in medicine at Harvard Medical School, commented, "New medications
are frequently released before their safety profile is fully understood,
and samples tend to be newer medications. Free samples encourage
the casual use of medications in our children before enough is known
about potential harm. As a mother of young children, I find that
very concerning."
Senior author Dr. Neal LeLeiko, director of pediatric gastroenterology
and nutrition at Hasbro Children's Hospital and a professor of pediatrics
at the Warren Alpert Medical School of Brown University, added,
"Previous findings in adults strongly suggest that free drug
samples serve as a marketing tool. Our study shows that samples
can pose a serious and unappreciated risk to our children."
The study used data on 10,295 US children and adolescents from
the 2004 Medical Expenditure Panel Survey (MEPS), an annual federal
survey. Dr. Cutrona's work was supported under a National Research
Service Award to Harvard Medical School.
Sarah L. Cutrona, MD, MPH, is a hospitalist at Cambridge Health
Alliance. She also serves as an instructor in medicine at Harvard
Medical School. Dr. Cutrona conducts research on access to health
care and medications. She earned her medical degree at Columbia
College of Physicians and Surgeons and completed her training at
Rhode Island Hospital and Harvard Medical School.
"Free Drug Samples in the United States: Characteristics of
Pediatric Recipients and Safety Concerns" published by Pediatrics.
October 2008; 122 (4). Authors: Cutrona, SL, Woolhandler, SJ, Lasser,
KE, Bor, DH, Himmelstein, DU, Shrank, WH, LeLeiko, NS.
Hasbro Children's Hospital (www.hasbrochildrenshospital.org)
in Providence, RI, is the premier pediatric facility for southeastern
New England. As the pediatric division of Rhode Island Hospital
it is part of the largest teaching hospital of The Warren Alpert
Medical School of Brown University. A private, not-for-profit hospital,
Hasbro Children's Hospital is a member of the Lifespan health system.
Cambridge Health Alliance is an innovative, award-winning
health system that provides high quality care in Cambridge, Somerville,
and Boston's metro-north communities. It includes three hospital
campuses, more than 20 primary care and specialty practices, the
Cambridge Public Health Dept., and the Network Health plan. CHA
is a Harvard Medical School teaching affiliate and is also affiliated
with Harvard School of Public Health, Harvard School of Dental Medicine,
and Tufts University School of Medicine.
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Media Contact
David Cecere
Media Relations Manager
Phone: 617-503-8428
Cell: 617-921-9613
Pager: 617-546-1879
dcecere@challiance.org
Nancy Cawley
Hasbro Children's Hospital
Phone: 401-444-4039 ncawley@lifespan.org
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