Free Drug Samples May Be a Health Risk for Children

Giving free samples of prescription drugs to pediatric patients can present serious health risks due to the development of a casual attitude toward such medications. In addition, some of the most frequently distributed samples may be unsafe and without proper warning on or in the packaging.

A group of researchers from Cambridge Health Alliance and Hasbro Children's Hospital found that 1 in 20 U.S. residents under the age of 18 received at least one free drug sample in 2004. Additionally, when counting just those who were prescribed medication, 1 in 10 received at least one free sample.
In the study, the researchers analyzed data on 10,295 U.S. residents under the age of 18 to examine the use of free drug samples in pediatric patients. The data was taken from a 2004 national survey regarding medical spending.

According to lead author Sarah Cutrona, an internist at Cambridge Health Alliance in Massachusetts, giving out free samples “encourages a casual attitude toward medications.” Cutrona also said that in distributing free samples, important safety checks done by pharmacists are bypassed and that samples do not include childproof caps or instructions regarding children’s doses and procedures for an accidental overdose.

The researchers also found that out of the 15 most commonly distributed free samples, 2 are medications for attention deficit hyperactivity disorder (ADHD). These medications, Strattera and Adderall, are controlled and monitored by the Drug Enforcement Agency due to high potential for abuse. Both drugs also carry the strongest possible safety warnings required by the U.S. Food and Drug Administration, called “black box” on their labels, as do two of the other commonly sampled medications known as Elidel, used for atopic dermatitis, and Advair, for asthma.

Also among the most widely distributed free samples were broad-spectrum antibiotics that are not used in the first line of treatment. Cutrona said that overuse of such drugs could contribute to the growing problem of antibiotic resistance. She noted that previous research has shown that free samples lead doctors to prescribe drugs that might not be the best choice. She went on to explain, “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.”

Although the prescription drug industry maintains that free samples fill an important role for poor or uninsured patients, the study found that these patients rarely receive the samples, as they do not have access to the doctors who distribute them. Of the children who received free samples, only 16 percent were uninsured for part or all of 2004, with less than one-third having low family incomes, which is defined as less than $38,000 for a family of four.

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, an industry group, responded to the study in a statement and said that free samples offer doctors “valuable firsthand experience with new treatment options and can also play a valuable role in fostering the appropriate use of medicines.” He also noted, “While it is true that poor and uninsured patients are not the only recipients of drug samples, a patient's financial situation is a factor physicians often consider when distributing such samples.”

The study was published in the October 2008 issue of Pediatrics.