The U.S. Food and Drug Administration has tapped researchers at Johns Hopkins University and the Palo Alto Medical Foundation Research Institute for a two-year study that will analyze factors that determine underuse of generic drugs.
The study, Effect of Therapeutic Class on Generic Drug Substitutions, will analyze drug use in the U.S. by therapeutic class and create predictors to help determine when generic or brand-name medications are more likely to be used by patients. The research will also make use of patient-reported concerns about generic drugs, by therapeutic class, to identify reasons patients might ask their doctors to prescribe generic drugs. It also will develop a method for prioritizing drug classes that would benefit from generic drug development.
Researchers will analyze electronic health records from Sutter Health and insurance claims data from Truven Health Analytics. These data sets will yield information about written and pharmacist-filled prescriptions, providing insights into the drugs that are prescribed and the ones patients actually had filled.
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 patients age and socioeconomic class.
Also, researchers will analyze data from the FDA Adverse Event Reporting System, which collects patient-based complaints about drugs. Investigators will focus on reports that discuss adverse results after switching to a generic product.
The final step 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.
If the societal goal is to allow patients to access worthy medications while containing costs within the healthcare system, we need to understand why there is differential acceptance of generic drugs, said Johns Hopkins-based lead investigator Jodi Segal, M.D.
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