Opioid Crisis: USP’s Comments to the FDA | Quality Matters | U.S. Pharmacopeia Blog
 // January 23, 2018

Opioid Crisis: USP’s Comments to the FDA

Opioid Crisis: USP’s Comments to the FDA
Contributors:

As government agencies consider solutions to the growing opioid crisis, the Food and Drug Administration (FDA) recently sought public comment about ways to best address this national emergency. USP was pleased to provide our perspective about how public standards might help support the agency’s efforts, and to report on our recent discussions with stakeholders and the standards being considered by USP’s Healthcare Quality Expert Committee.  

Similar to FDA, USP relies on feedback from stakeholders as we develop public quality standards to improve public health. In the past several months, USP convened representatives of leading government agencies, as well as organizations representing healthcare practitioners, patients, academics and industry to gain their insights and feedback regarding opportunities to develop public standards to address some of the core factors contributing to opioid abuse. 

While we came to these discussions with concepts for this cross-section of the community to consider, we also gained new insights and ideas of how standards could make a positive impact. USP is extremely thankful to the many organizations and individuals who provided their time and expertise to help us play our part in addressing the opioid crisis. As Chair of the Council of Experts who oversees all of USP’s standard-setting work, I am acutely aware of how invaluable this feedback is to our Healthcare Quality Expert Committee as they work to develop standards over the next few months. 

In the comments we provided to the FDA in late December, we gave an overview of the approaches USP is considering, which include standards related to:

  • Safe storage and disposal of opioids to help prevent accidental exposure and unauthorized access by others in the home, as well as to decrease the volume of excess opioids in the community through effective disposal;

  • Patient-centered labeling of prescription opioid containers so patients have consistent and useful information about safe opioid use;

  • Consumer-directed and consistent instructions for naloxone administration for this life-saving antidote in cases of overdose; and

  • A framework for counseling about opioids to support discussions between healthcare practitioners and patients about appropriate use, storage and disposal and other important related issues.

These approaches will be illustrated further in a white paper that will accompany our proposed standards when they are published for public comment. All of the proposed new or revised standards will be open to public comment and we welcome additional perspectives from a broad base of interested parties.

USP deeply appreciates our partnership with FDA and is hopeful that we can develop public standards that will compliment FDA’s essential work to combat the crisis.