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Palo Alto Medical Foundation Newsroom


New Study Investigates Underuse of Generic Drugs

FDA taps PAMF Research Institute & Johns Hopkins Medicine study team

Generic drugs can save millions in health care costs, while providing the same quality, safety and efficacy as brand medications. Yet many doctors still prescribe brand-name treatments for their patients. Why?

To find out, the Food and Drug Administration (FDA) has tapped a team at the Palo Alto Medical Foundation Research Institute (PAMFRI) and Johns Hopkins Medicine for a two-year study that will analyze factors that contribute to the underuse of generic drugs.

Robert Romanelli, Ph.D., MPH

Robert Romanelli, Ph.D., MPH

“The FDA is interested in understanding why certain generic drug classes may be underutilized,” said Robert Romanelli, Ph.D., MPH, health services researcher and project director at PAMFRI. “One goal of this project is to use electronic medical record data from Sutter Health to understand provider and patient barriers to generic drug use.”

The study, “Effect of Therapeutic Class on Generic Drug Substitutions,” will analyze drug use both at Sutter Health and in the U.S. by therapeutic class. It will also examine patient-reported concerns about generic drugs to identify reasons patients might ask their doctors to prescribe brand-name drugs. Based on this data, the study will identify predictors to help determine when generic or brand medications are more likely to be used by patients. In addition, the study will develop a method to prioritize drug classes that would benefit from the development of generic drugs.

Generic drugs cost significantly less than brand-name drugs for both patients and insurance companies. In 2013, 86 percent of drugs prescribed in the United States were generic, according to the FDA, yet generic drugs accounted for just 29 percent of the nation’s prescription drug costs. Branded drugs accounted for 71 percent of U.S. prescription drug costs, or $232 billion. “If the societal goal is to allow patients to access worthy medications while containing costs within the health care system, we need to understand why there is differential acceptance of generic drugs,” said Jodi Segal, M.D., study principal investigator and associate professor of medicine at the Johns Hopkins School of Medicine.

Researchers will analyze electronic medical records from Sutter Health and insurance claims data from Truven Health Analytics. These large data sets will yield information about written and pharmacist-filled prescriptions, providing insights into the drugs that are prescribed as well as the ones patients actually used. In particular, investigators will look at differences in generic usage rates between different classes of therapeutic drugs, including medications for heart disease, epilepsy or asthma. They will also take into consideration such factors as the age and socioeconomic class of the patient.

The researchers will also analyze data from the FDA Adverse Event Reporting System, which collects patient-based complaints about drug-related adverse events. Investigators will focus on reports that discuss adverse results from switching to a generic product.

The final step in the study will be to convene a panel of colleagues and experts, including representatives of large generic drug manufacturing companies, to work together to develop a system for identifying and prioritizing drugs that are suitable for investment and development of a generic substitute, said Segal.

PAMFRI’s Romanelli is conducting the research in partnership with a team at Johns Hopkins, which includes Dr. Segal, study principal investigator and associate professor of medicine, and Sonal Singh, co-investigator and assistant professor of Medicine, Health, Policy and Management.

The  two-year study will be conducted with a grant of $400,000 from the FDA. (Grant # U01FD005267-01)