For the first time, the drug czar has supported broadening access to naloxone, the life-saving prescription drug that immediately reverses overdoses of heroin and prescription painkillers.
Speaking on Wednesday at a North Carolina overdose-prevention program, the Obama administration’s drug czar Gil Kerlikowske called for increased action to prevent drug overdose deaths. Notably, Kerlikowske urged wider distribution of a medication called naloxone, an antidote to overdoses of opioid drugs, including prescription pain relievers and heroin, saying that “naloxone can be expanded beyond public health officials.”
Currently, naloxone is available only by prescription and is otherwise accessed easily only by health professionals and some law enforcement officers. Kerlikowske’s comments mark the first time the drug czar — who is more formally known as the director of the Office of National Drug Control Policy — has voiced support for broadening access to naloxone by addicted people, pain patients and their families. On Wednesday, he spoke with officials and others involved with Project Lazarus, a North Carolina program that pioneered wider distribution of the medication and is seen as a model prevention program for its comprehensive approach to fighting overdose and prescription drug misuse.
“As valuable as naloxone is, it’s only a small piece of the broad spectrum of drug use prevention,” Kerlikowske stressed, adding, “We’re very serious about removing the legal impediments that can mean the difference between life and death. The odds of surviving an overdose, much like the odds of surviving a heart attack, really depend on how quickly the victim receives treatment.”
To illustrate that point, Kerlikowske recounted the story of a young woman who survived an overdose thanks to the quick administration of naloxone. Her brother, who was enrolled in a drug treatment program participating in Project Lazarus, used the naloxone kit he had received from his treatment provider to save his 26-year-old sister’s life, when he found her “unresponsive and not breathing and her face was blue,” as Kerlikowske put it.
The man had initially called his counselor, who told him to hang up and dial 911 and use the naloxone. Within about a minute or two of receiving the drug, his sister woke up. Four days after “her near death experience,” Kerlikowske said, “she entered treatment. Without naloxone, she wouldn’t have had that choice.”
Naloxone, sold under the brand name Narcan, immediately reverses overdoses of heroin and prescription pain medications like Oxycontin, even if these opioids are combined with alcohol or other sedatives. The medication is non-addictive and does not cause harm if used in error, although it can induce non-life-threatening withdrawal symptoms in people who are dependent on opioids.
This spring, the FDA held a meeting to discuss making naloxone available over the counter, but such a move would require a manufacturer to seek approval to do so, which would in turn require expensive drug testing — that does not appear to be forthcoming. There are other regulatory paths to over-the-counter status that would bypass this hurdle, but it is not clear whether Obama administration officials will pursue them; neither Kerlikowske nor his office provided further specifics.
Dr. Nora Volkow, director of the National Institute on Drug Abuse, has supported broader distribution of the overdose antidote.
Earlier this month, a bill to provide federal grants to expand naloxone programs like Project Lazarus, known as the Stop Overdose Stat (SOS) Act, was introduced in the House by Rep. Mary Bono Mack (R-Calif.)* and Rep. Donna Edwards (D-Md.), with bipartisan support from two dozen other members, but its chances of passage and the amount of funding it would receive are also not known.
“I welcome Director Kerlikowske’s announcement today to expand the availability of naloxone, proven to be an effective treatment in reversing drug overdose,” Rep. Edwards said in an email. “This is a critical component of H.R. 6311, the Stop Overdose Stat (SOS) Act.”
On Wednesday, officials from Project Lazarus, which is based in Wilkes County, N.C., presented information on the program’s effectiveness and its collaborative, cross-disciplinary approach to overdose prevention. In addition to naloxone distribution, the program involves physician and widespread community education, law enforcement efforts to fight illegal prescribing, pill take-back days and use of the state’s prescription drug monitoring program. Unlike other efforts to reduce prescription drug misuse, it actively involves chronic pain patients and those who care for them.
Two years after Project Lazarus began, overdose death rates in Wilkes County dropped 67%, after having risen steadily for years, according to a presentation by Rev. Fred Brason, project director of the program. The program also appeared to reduce problem prescribing without harming legitimate pain patients: in 2008, 80% of overdose death victims had received at least one prescription for their medications from a local prescriber; in 2011, none did.
As a mother who lost her daughter to overdose said at Wednesday’s meeting, crying as she spoke, “If I had known there were things out there like naloxone, I could have helped her. I wouldn’t be here today talking to you all. I could have had my daughter.”
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