Washington, D.C.—Many of the drugs prescribed in primary care have not been tested in those settings, new research reports.

The study, published in the Journal of General Internal Medicine, raises concerns that primary care patients are being treated with drugs that have not been trialed among patients similar to them.

In addition to other issues, that might prevent the use of drugs that are equally effective but with possibly fewer side effects, suggests the study, conducted by researchers from Georgetown University Medical Center and Yale School of Medicine.

Conditions commonly treated in primary care settings, such as acne, hypertension, and diabetes, were included in the study.

The study team focused on 151 clinical studies—resulting in 129 published studies—of 40 different agents for all new drugs approved by the FDA between 2005 and 2012. None of the studies were conducted in primary care patients, researchers report, and only 8% included any primary care patients among participants. In those cases, the rest of the study patients were overseen by subspecialists or other nonprimary care physicians, and not in a primary care setting, they add.

“I think it is most important that the studies be done in primary care settings if they are to be used in this patient population,” explained Dan Merenstein, MD, of Georgetown’s Department of Family Medicine. “For example, studying an antibiotic for sinusitis in an ears, nose and throat specialty practice office is totally different than studying it in a primary care setting.”

Using sinusitis—the leading reason for outpatient antibiotic prescriptions—as an example, Merenstein points out that, by the time patients are referred to a subspecialist, they often have already received several courses of antibiotics and have a more severe bacterial disease. The patients seen in primary care offices for sinusitis often have viruses or less severe bacterial infections.

In another example, he said that, by the time diabetes patients see an endocrinologist, they are at a different severity level than primary care, explaining, “Therefore, the treatment will be very different.”

Results also indicate that as many as 70% of trials were either conducted outside of the United States or included only some U.S. patients. The researchers noted that almost 22% of the studies included no geographic information.

“The [National Institutes of Health] has funded only one very small study of sinusitis in a primary care setting, and family practitioners represent only 0.16% of NIH advisory committee members,” Merenstein said in a Georgetown press release. “I would like to see the FDA and NIH make it a priority to study conditions seen in primary care settings.”

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