Public Release:  Free drug samples carry risks for children

First of its kind study finds safety concerns in frequently distributed samples

Lifespan

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, who also serve as 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 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 of 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."

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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 of 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. Visit us online at www.challiance.org.

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