FDA should OK easier access to drug that reverses overdoses

Patrick Swanson / January 15,2023
  • Endnotes
  • The federal government appears to be on the verge of doing something right for a change—shocking, I know.

    The Food and Drug Administration (FDA) is mulling a proposal [1] to make certain naloxone products, which reverse drug overdoses, available over-the-counter.

    The FDA generally doesn’t take such actions lightly—and in fact has a reputation for its long delays. Yet in this case, there’s room for cautious optimism. The agency might do the right thing—easing the opioid epidemic in Georgia and across the country in the process.

    In 2020, there were over 68,000 opioid overdose-related deaths [2] in America—over 1,300 of which [3] happened in the Peach State. That number accounts for two thirds of Georgia’s overdose deaths, and trend lines show that the opioid epidemic will likely only get worse in the near future.

    “Opioid-involved overdose deaths have been rapidly increasing in Georgia since 2010, driven largely by increased use and misuse of prescription opioids (e.g., Oxycodone and Hydrocodone),” wrote the Georgia Department of Public Health [4]. “Beginning in 2013, illicit opioids such as heroin and fentanyl drove the sharp increase in opioid-involved overdose deaths.” Put simply, the opioid epidemic is very real and has sadly touched myriad families.

    Faced with mounting deaths, many public health professionals increasingly looked to naloxone to reverse opioid overdoses. First approved in 1971 [5], naloxone is now available in injectable and nasal spray forms, and it combats overdoses by restoring normal breathing. It works remarkably fast too—sometimes within 2-3 minutes [6]—and essentially poses no threat [7] to people who haven’t ingested opioids.

    As a result, states began taking the initiative [8] and allowing individuals to purchase naloxone directly from a pharmacist. In fact, Georgia is one such state that acted when the FDA would not. On March 6, 2019, the Gov. Brian Kemp administration approved a standing order for naloxone [9]—meaning people can bypass doctors and get it directly from a pharmacist who is empowered to dispense the drugs.

    Kemp also signed legislation last year—securing over $600 million for opioid addiction treatment and prevention. “Like every other state, the opioid crisis has hit Georgia communities and families hard and with lasting effect,” Kemp said in a press release [10]. “These funds will help us fight the good fight against the disease of addiction.” These were big steps forward, but more needs to be done.

    Unfortunately, states have few options available to them to further expand access to naloxone. Only the federal government has the authority to make it available over-the-counter. Doing so would be a boon in states like Georgia, given that the over-the-counter model is an improvement on the Peach State’s standing order.

    “Although pharmacy-initiated models have expanded naloxone access to areas where community-based harm reduction programs do not exist, factors such as stigma, insufficient awareness of naloxone standing orders and limited pharmacy operating hours still serve as barriers to accessing naloxone if it remains behind the pharmacy counter,” my colleague Chelsea Boyd wrote in her comments [11] to the FDA.

    “For example,” she continued,” 44 percent of North Carolina pharmacists surveyed reported dispensing naloxone less than once per month, and a survey of California pharmacists found that only 24 percent were aware that they could dispense naloxone without a prescription.”

    Approving naloxone for over-the-counter sales would help address these issues and expand access, which is needed. Reaching a critical mass of easily available naloxone to all walks of life is necessary to help stem the tide of the opioid epidemic. “Community saturation is important […] because the majority of overdoses are reversed by people who use drugs. A study using data from Massachusetts found that 87 percent of overdoses were reversed by people who also used drugs, were engaged in treatment or were in recovery,” wrote Boyd.

    Too often, pundits and policymakers show little sympathy for those who have overdosed—especially if it resulted from the use of illicit drugs. To be absolutely clear, not all overdoses result from illegal drug usage. Some are certainly due to accidental overdoses of pharmaceuticals that came from a doctors’ prescription.

    Nevertheless, people should not use illegal drugs or abuse any substances for that matter, but abstinence-only approaches have failed many Americans. Drug-use will continue, but these individuals deserve a chance to live and adopt healthier habits. More easily accessible naloxone could help this become a reality for many. Hopefully the FDA will act accordingly.


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