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ICA at Pain Care Forum

Last week, ICA staff attended the monthly meeting of the Pain Care Forum to hear the guest speaker, Douglas C. Throckmorton, MD, Deputy Director for Regulatory Programs, part of the FDA’s Center for Drug Evaluation and Research (CDER). CDER is working to provide appropriate access to pain treatments for patients, including opioid drugs, and to reduce the misuse and abuse of prescription opioids. To meet those two goals, the FDA is working to improve drugs used to treat pain, specifically, abuse-deterrent formulations (ADF) of opioids, which are new classes of pain drugs that lack abuse risk. According to Dr. Throckmorton, the FDA is also working to advance the safe use of opioids through education of prescribers and patients, as well as supporting research into the best approaches to pain treatments, including opioids, and getting approval of the Naloxone autoinjector, used to treat opioid overdoses.

A representative of the Patient-Centered Outcomes Research Institute (PCORI) also spoke at the Pain Care Forum. She presented PCORI’s proposal, “Patient-centered Comparative Effectiveness of Long-term Opioid Treatment for Chronic Pain: Real-world Research over 20 Years and 200,000 Patients,” which seeks to:

  • Provide chronic pain patients, their healthcare providers, and policy makers with real-world, long-term clinical evidence to assess the risk/benefit of opioids and non-opioid alternative treatments to control pain over time.
  • Compare the pain control effectiveness of opioids over long periods of time to previous and alternative non-opioid medications and alternative treatments.
  • Compare the physical and mental health impacts of inadequately controlled chronic pain with the investigated treatment options.
  • Identify subsets of patients for whom the risk of negative outcomes related to opioids may be considered by the patient to be greater than the pain control benefit.
  • Measure the impact of new formulations and changes in policy/regulation on patient access to effective treatment.
  • Disseminate research findings to collaborating stakeholder groups, their networks, providers, health systems and regulators for use in care planning and policy making.

This research is potentially significant because it will be the first and only, real-world, longitudinal study of complete electronic health records, spanning 20 years, in a large population, to examine actual patient-centered, pain control and adverse event outcomes of long-term opioid treatments for chronic pain compared with alternatives.