The United States Food and Drug Administration (FDA) has commissioned a set of visionary studies to answer critical questions about the opioid crisis in the U.S. The FDA’s four-year award of up to $6.6 million to the University of North Carolina at Chapel Hill (UNC) and the University of Kentucky (UK) will ensure FDA’s readiness to evaluate innovative emerging technologies in pharmacology.
Recent advances in pharmaceutical engineering have yielded new opioid medications that are more difficult to crush into powder. However, questions remain as to whether this feature deters injection and snorting – or whether the opiates’ new consistency may have unanticipated negative health consequences.
The opioid crisis is one of the United States’ defining public health challenges. For more than a decade, UNC and UK have been national leaders in generating rigorous and innovative science related to the crisis. Faculty at the universities will conduct research to help FDA leaders better understand the use of opioid products designed to deter inappropriate use – and those products’ impact on use, overdose and death in America’s communities.
The work also will increase the FDA’s understanding of data systems and methods available to study the impact of these new medications and will develop new data resources and methods to be disseminated as open-source research tools.
“We will develop a panoramic portrait of the opioid crisis, rather than a series of isolated data snapshots,” said Dr. Nabarun Dasgupta, University of North Carolina Gillings School of Global Public Health alumnus, senior research scientist at the UNC Injury Prevention Research Center and lead investigator on the project. “We’ll fundamentally improve the quality of information available to the FDA for regulatory decisions regarding opioids. At the same time, we will generate a new public research toolkit of modern epidemiologic methods that will be made widely available, with the expectation that opioid manufacturers and researchers can use these tools to improve the quality of studies that the FDA relies upon.”
Leveraging emerging advances in data connectivity, the first year of the project is focused upon clinical practice.
Dr. Svetla Slavova and her colleagues from the Kentucky Injury Prevention and Research Center are working in collaboration with the Kentucky All Schedule Prescription Electronic Reporting (KASPER) system, the Kentucky Office of Vital Statistics and the Office of the Chief Medical Examiner to pioneer an ongoing electronic linkage of prescribing, mortality and toxicology data in Kentucky. These data will provide the FDA with timely monitoring of emerging medication risks.
“The timeliness of data availability could revolutionize our concept of what can be learned about newly marketed drugs,” Dr. Slavova said.
The FDA also may add additional studies that would extend the scope of the research beginning in the second project year. These studies would engage scientists from RTI International and IBM Watson Health to explore further the themes of epidemiologic theory and methods and the lived experience of patients.
“This group of studies will leverage the expertise of some of the country’s leading opioid researchers to study the effects of novel drug formulations designed to help mitigate the opioid crisis,” said Dr. Barbara K. Rimer, dean of the UNC Gillings School. “This type of collaboration between government and academia ensures federal policy needs are addressed using the most innovative, up-to-date and rigorous science.”
“The project unites UK and UNC – both powerhouses of research and practice in the areas of injury prevention and opioid addiction – in our common goal of turning the tide of the opioid crisis,” said Dr. Donna K. Arnett, 1992 Gillings School epidemiology alumna and dean of the UK College of Public Health. “The work undertaken by this impressive group of researchers will develop new tools to support FDA decision-making on opioid deterrence, with the potential to greatly improve population health nationwide.”
The multidisciplinary project team includes pain management physicians, pharmacists, ethnographers, people who use drugs, people living with chronic pain, statisticians, epidemiologists, state government officials and policy makers.
Other partnering institutions include DePaul University, Sawbuck Productions, Urban Survivors Union, The UK College of Pharmacy’s Institute for Pharmaceutical Outcomes and Policy, and the University of Louisville.
Collectively, this carefully curated set of studies spans traditional, emerging and neglected information needs in opioid pharmacoepidemiology, with each raising the bar for scientific rigor, while producing ready-to-implement results. The suite of studies will develop novel research approaches to opioid data analytics and provide FDA with more reliable information on which to base regulatory decisions.
[Photo: Recent advances in pharmaceutical engineering have yielded new opioid medications that are more difficult to crush into powder. However, questions remain as to whether this feature deters injection and snorting – or whether the opiates’ new consistency may have unanticipated negative health consequences. Photo by Virginia Commonwealth University’s Capital News Service.]