Ensuring Generic Means Safe in Medication Choice

Generic drugs on a shelf in a pharmacy

February 20, 2018

AUBURN, Alabama – Nine out of every 10 prescriptions filled in the United States are for generic drugs, totaling roughly 3.9 billion prescriptions per year. While generics offer a less expensive option, researchers at the Harrison School of Pharmacy are investigating the safety of generic drugs, specifically when prescribed to special populations such as women, children, and older adults with multiple conditions.

Dr. Jingjing Qian, assistant professor in the Harrison School of Pharmacy’s Department of Health Outcomes Research and Policy, has received more than $1.15 million in funding from the Food and Drug Administration over the last three years to investigate generic drug safety.

The generic drug market continues to grow, increasing from 19% of total drug spending in 2006 to 26% of total drug spending in 2016. With the increased prevalence, Qian wants to ensure the drugs are just as safe and effective as the name brands, particularly when distributed to people who may be more vulnerable.

“With the increased presence of generic medicines on the market, the need exists to ensure the safety and effectiveness of the generic drugs,” said Qian. “In addition, the generic drug approval process is not universal to everyone, especially when it applies to special populations such as women, children, and older adults with multiple chronic conditions.”

When drug studies are being conducted, one of the main factors studied is bioequivalence, a process by which drugs are assed on their general equivalence to each other. Bioequivalence studies that compare a name-brand drug to a generic typically are conducted in healthy adult volunteers and occasionally are conducted in patients. Some populations have unique physical, biological, and physiological considerations that are not reflected by healthy volunteers or by the typical patient for whom a drug is indicated.

“Mixed evidence of the appropriateness of generic substitution and adverse events associated with generic drugs calls attention to the safety and efficacy profiles of generic drugs,” said Qian. “Furthermore, there is a scarce amount of evidence on barriers to and patterns of generic substitution in special populations whose experiences with a drug are not represented by those in whom bioequivalence studies are conducted.”

For these reasons, it is important to identify research needs, monitor, and improve generic drug substitution in special populations (i.e., pediatric patients, older adults who take multiple medications, women, racial/ethnic minorities, individuals with impaired kidney or liver function, and individuals residing in different geographic regions/settings).

“From the literature and medical guideline reviews, we have found that physical characteristics such as taste and smell of certain generic drugs and concerns of increased adverse events may influence generic drug substitution among patients,” said Qian. “Additionally, some medical guidelines disagree with generic substitution without physician and patient approval consent due to the risk of adverse or compromised clinical outcomes. Our analysis using large administrative claims data also found different generic substitution and switch patterns in subgroup populations by age, sex, and race and ethnicity among Medicare beneficiaries.”

The next step in the study is to analyze the impact of product, patient, and provider level factors on generic substitution and use among special populations.

“Our findings will create innovative evidence-based profiles that can be used to support FDA’s regulatory science efforts to monitor and ensure successful generic substitution for special populations, as well as to provide evidence on generic drug safety and effectiveness,” said Qian. “The expected outcomes of this study are provision of information to identify research needs and identification of strategies to improve monitoring of generic drug substitution in special populations, which can help to overcome barriers to generic drug use in the United States.”

Additionally, Qian and her team are looking for ways to educate groups who influence generic drug use. These groups include patients/caregivers, prescribers, pharmacists, insurance formulary managers, state health policy makers and pharmaceutical manufacturers. The intention is to put together information, strategies and educational materials to overcome barriers to generic drug use in the United States.

“The objective of the project is to understand roles of key groups and the extent of their influence on generic drug use in order to provide additional and effective educational outreach to meet their informational needs,” said Qian. “We develop educational materials tailored by different informational needs from stakeholders so that they have a better understanding of generic drugs, which, in turn, will help increase use of generic drugs in the country.”

Different stakeholders have different informational needs regarding generic drugs. In the study, seven domains of factors that influence generic drug utilization were identified: 1. patient-related factors; 2. formulary management or cost containment; 3. healthcare policies; 4. promotional activities; 5. educational initiatives; 6. Technology and 7. physician-related factors.

“Currently, we have pre-tested the tailored educational materials among different stakeholder groups and are ready for further testing among larger audiences,” said Qian.


About the Harrison School of Pharmacy

Auburn University’s Harrison School of Pharmacy is ranked among the top 20 percent of all pharmacy schools in the United States, according to U.S. News & World Report. Fully accredited by the Accreditation Council for Pharmacy Education (ACPE), the School offers doctoral degrees in pharmacy (Pharm.D.) and pharmaceutical sciences (Ph.D.) while also offering a master’s in pharmaceutical sciences. For more information about the School, please call 334.844.8348 or visit http://pharmacy.auburn.edu.

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Last Updated: February 20, 2018