Opioid Report Recommends Coordinated Effort to Fight Epidemic

On July 13, 2017, the National Academies of Sciences, Engineering, and Medicine (NASEM) released a report on its findings regarding the opioid epidemic. FDA requested NASEM to provide the agency with an update on pain research, care, and education so the agency could develop a plan to respond to the situation. NASEM recommended a “sustained, coordinated” effort in fighting the opioid crisis and “a culture change in prescribing for chronic noncancer pain, aggressive regulation of opioids by the FDA, and multi-pronged policies by state and local governments.”

Four specific strategies are recommended in the report: restricting supply, influencing prescribing practices, reducing demand, and reducing harm. The report also recommends that FDA look at how the prescription and illegal drug markets are intertwined and strengthen the post-approval oversight of opioids. More research on pain should also be conducted, according to the report.

FDA Commissioner Scott Gottlieb, MD, has made addressing the opioid crisis a priority. Several initiatives have begun, and the agency has gone so far as to request the removal of an opioid from the market. The agency has also held workshops with experts to gain data on the impact of opioids.

One of the agency’s plans is to update and modify an existing Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioid analgesics, and include immediate-release opioid analgesic products in the modified REMS program.

“One of the areas in which we can have the greatest impact is in reducing the rate of new addictions by helping to make sure that only appropriately indicated patients are prescribed opioids, and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place. To do so, we must make sure that providers are properly informed about suitable prescribing and the risks and benefits associated with opioid drugs,” Gottlieb said in a statement. “We’re also continuously re-evaluating the safety of approved opioid products based on both post-market data the FDA has required from sponsors and additional sources of information as part of our safety surveillance. We will continue to consider what additional information is needed to ensure we have the right data to make important, science-based decisions.”

Source: FDA