In the News Over 70 Health Care Experts Call On FDA to Make Naloxone Nasal Spray “Over the Counter”

Oregon Pain Guidance

Monday, September 10, 2018

PRESS RELEASE
For Immediate Release
Contact: Mark Kantor
Phone: 541-787-0162

Increasing access to Naloxone will help save lives as the nation battles the Opioid Epidemic

Medford, Ore – Over 70 health care experts from Oregon are petitioning the Food & Drug Administration (FDA) to make Naloxone nasal spray available without a prescription. Naloxone is a fast acting drug that can prevent the death of people who are experiencing an opioid drug overdose.

The petition was posted on www.regulations.gov on September 6th. This begins the FDA review process to make Naloxone Nasal Spray an Over the Counter (OTC) drug.

“Oregon state naloxone data shows a lack of availability of naloxone in our communities,” said Dr. Jim Shames, Health Officer at Jackson County HHS.  “This is a simple step that could save thousands of people a year.”

These health care experts point to research that Naloxone is safe, effective and easy to use because it is a nasal spray. Researchers found few differences between trained and untrained overdose rescuers when it comes delivering the drug, and increased naloxone availability does not increase drug use.

“Over the counter availability of naloxone will complement the efforts of community distribution programs to get naloxone into the hands of every person and every household that needs it.” said Julia Pinsky, Executive Director of Max’s Mission, a non-profit which provides naloxone and overdose education in Southern Oregon.

Over the Counter drug products are drugs that are available to consumers without a prescription and have these general characteristics:

  • Their benefits outweigh their risks
  • The potential for misuse and abuse is low
  • Consumer can use them for self‐diagnosed conditions
  • They can be adequately labeled
  • Health practitioners are not needed for the safe and effective use of the product

“Naloxone Nasal Spray meets the requirements to be moved to over the counter,”  said pharmacist Mark Kantor.  “There is clearly a need in our communities; now is the time for FDA to make it happen,”

The Oregon Pain Guidance (OPG) is a diverse group of health care professionals from Jackson and Josephine Counties. OPG engages health care professionals and community partners in understanding the nature of the current opioid problem, teaches best practices for managing complex chronic non-cancer pain (CCNP), and help bring best practices into standardized, general use all around Oregon.  To learn more visit: oregonpainguidance.org