New Approach Needed To Prevent The Next Drug Abuse Crisis, FDA Officials Warn

Federal drug regulators say they have new plans that will help detect and prevent future drug abuse outbreaks, such as the opioid abuse epidemic that is currently gripping the country. 

The agency announced the new plan in an editorial published this week in the New England Journal of Medicine, which was written by top level FDA executives, including Scott Gottlieb, MD, commissioner of the FDA.

Opioid abuse has become a national epidemic, which has continued to worsen in recent years. Opioids account for two-thirds of drug overdose deaths in the U.S. and now outnumber breast cancer fatalities.

In response, the FDA officials said the agency is focused on multiple approaches. Those include approving better measures for treating opioid use disorder and preventing deaths from overdose, launching efforts to improve doctor prescribing habits, launching actions to reduce the amount of opioids available for abuse, and focusing on spurring development of new therapeutics to help patients.

While many of those approaches were taken largely after the crisis was well underway, FDA officials said the new approach focuses on a multicomponent system of pharmacovigilance which they hope will predict abuse patterns early. The FDA indicates this will help the agency intervene proactively in a way that may anticipate changes in drug use and abuse.

The announcement indicates that the agency will take a systematic approach to monitoring trends in the addiction landscape to help better protect the public from future risks. The FDA will use available technologies and research, including the Adverse Event Reporting System, to determine a drug’s effect on the population at large, as well as forthcoming trends.

The agency hopes this will help them better understand the changing patterns of prescription drug use.

Furthermore, the FDA plans to use social media to track conversations regarding opioids and other substances that may be abused in similar ways. This can help predict patterns of abuse before they become epidemic.

“Our assessment of changing patterns in drug use and abuse must be informed by an understanding of the complex social environment in which changing patterns of drug consumption occur,” wrote FDA officials.

The editorial used two examples where these practices are already being utilized to help predict and prevent abuse.

The FDA used healthcare databases, including the Adverse Event Reporting System, to assess the trends of use regarding over-the-counter loperamide, or Imodium. These anti-diarrheal medications are often used at high doses to treat opioid withdrawal at home. They are also taken to abuse the euphoric side effects.

Analyses of databases indicate serious Imodium side effects can occur when it is abused, including life-threatening heart problems and death. The FDA has called for a limit restricting the number of doses allowed in over-the-counter packages.

Another example is the recent widespread use of kratom, a botanical compound which is often advertised as a “cure” for some ailments. However, it is also widely abused because it has properties similar to opioid narcotics, posing the risk of abuse and death.

Kratom is not approved in the U.S., but widely discussed on social media as an alleged treatment of opioid pain. Poison centers recently reported that kratom exposure calls increased tenfold from 2010 to 2015.

The FDA used its focus on social media sites to spur awareness of the new opioid substitute.

“Our goal is to identify emerging trends earlier and intervene more quickly,” wrote FDA officials. “The agency will continue to use all tools available to assess shifts in patterns of substance use and protect the public from risks that may emerge as we combat our nation’s opioid problem.”