Partnership Between FDA, UK, UNC Will Shape Opioid Regulatory Decisions

December 13, 2018

 

headshot_Slavova-Svetla_new.jpgThe U.S. Federal Drug Administration has awarded a four-year $3.3 million contract to researchers at the UK College of Public Health and the University of North Carolina at Chapel Hill (UNC) to conduct studies to help the agency evaluate emerging technologies and provide information vital to making regulatory decisions.

 

Dr. Svetla Slavova, associate professor of Biostatistics and faculty researcher with the Kentucky Injury Prevention and Research Center (KIPRC), will lead work that includes 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. Her team will continue to develop electronic linkages of prescribing, mortality, and toxicology data in Kentucky.

 

"The data will then be used to provide the FDA with improved monitoring of emerging medication risks," Slavova said. “The timeliness of data availability could revolutionize our concept of what can be learned about newly marketed drugs.”

 

Faculty at UK and UNC will conduct research to help the FDA better understand the use of opioid therapies and products designed to prevent abuse – and the impact of the products on use, overdose and fatalities. The research will increase the FDA’s knowledge of data systems and methods used in studying the impact of new medications as well as develop new data resources and methods that will be available as open-source research tools.

 

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. 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.

 

“We will develop a panoramic portrait of the opioid crisis, rather than a series of isolated data snapshots,” said Dr. Nabarun Dasgupta, 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.”

 

“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 UKCPH Dean Donna K. Arnett. “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.”

 

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The University of Kentucky College of Public Health is a catalyst of positive change for population health, with a mission to develop health champions, conduct multidisciplinary and applied research, and collaborate with partners to improve health in Kentucky and beyond.