The U.S. Food and Drug Administration (FDA) has for the first time advocated considering the distribution of the naloxone, an overdose antidote, as a way to curb the rising toll of overdose deaths in America.
The federal agency stated its position at a press briefing on Wednesday held jointly with the drug czar’s office, the Centers for Disease Control and Prevention and the Drug Enforcement Administration (DEA) to announce the agencies’ strategies to fight prescription drug misuse and report on new analyses of data on the sources of misused prescription drugs. In the U.S., 15,000 people die of opioid overdose — from prescription drugs including Oxycontin and Vicodin — each year.
FDA Commissioner Dr. Margaret Hamburg noted at the press conference that “last week, the FDA convened an important public meeting on naloxone,” referring to the agency’s hearing on whether to make naloxone, a prescription drug, widely available to all over-the-counter. (I covered that hearing here.)
Naloxone (sold under the brand name Narcan) is a nontoxic, non-addictive drug that can reverse potentially fatal opioid overdose. The drug is currently available without a prescription only through certain channels: namely through small, community-based distribution programs that put the life-saving drug in the hands of people at high risk and their families. These programs have dispensed 50,000 doses of naloxone since 1996 and have reported 10,000 cases of overdose reversal.
(MORE: A Lifesaving Overdose Antidote Should Be Made More Widely Available)
The director of the National Institute on Drug Abuse, Dr. Nora Volkow, has said that the drug should be available without a prescription.
Contacted for follow up after the briefing on Wednesday, an FDA representative said in an emailed statement that the meeting “was the beginning of what we expect to be many discussions to look at naloxone and the broader regulatory issues, including the potential health, social and legal concerns, as well as future research needs. FDA believes that it has an important role to play in stimulating discussions like this.”
The statement further noted that:
At the meeting, FDA also laid out in detail the pathways to greater legal availability of naloxone, whether as a new formulation (e.g., intranasal) or as an over-the-counter medication. We hope that by laying out the pathways and signaling our interest in working with groups interested in these issues, FDA can help to improve appropriate use and access to naloxone.
Whether there is sufficient commercial interest in developing the drug as an over-the-counter product remains to be seen, but it is clear that thousands of Americans who are currently taking prescription opioid painkillers — whether they are using them legitimately for pain or are misusing them without a doctor’s supervision — could potentially be saved from accidental overdose by having wider access to the antidote.
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New research presented at the press conference on Wednesday confirmed earlier findings about the most common sources of misused drugs. The vast majority of nonmedical users of prescription pain relievers — 71% — get their drugs for free from friends and family, not from doctors. Although many observers have claimed that many cases of prescription drug addiction or misuse start with legitimate pain treatment, the research shows repeatedly that this is not typical. Most people who start misusing these drugs were in fact never pain patients to begin with; many have had previous drug problems.
The data also show that new and infrequent nonmedical users of painkillers are more likely to get their drugs free from friends and family than are regular or addicted users. For obvious reasons, those who are addicted turn to dealers, paying friends and family for drugs or resort to doctor-shopping once the free and easy sources have been exhausted.
At the press conference, the DEA also announced that it will hold its fourth annual National Take Back Initiative on Saturday, April 28, 2012, so that people can dispose of unwanted prescription medications safely and prevent them from getting into the hands of those who might misuse them. To find a local site, click here.
MORE: Are Doctors Really to Blame for the Overdose Epidemic?
Maia Szalavitz is a health writer at TIME.com. Find her on Twitter at @maiasz. You can also continue the discussion on TIME Healthland’s Facebook page and on Twitter at @TIMEHealthland.