Intranasal Naloxone for At-home Opioid Rescue
Naloxone is a well-tested antidote for reversing often-fatal respiratory depression due to opioid overdose poisoning. So, the prescription of naloxone for at-home intranasal administration, along with complete instructions for its emergency use, may be the best antidote for stemming rising rates of prescription-opioid overdoses and fatalities in the United States population. Yet, there are some major obstacles to be overcome.
The Rx-Opioid Overdose Crisis
The annual incidence of opioid-overdose-associated mortality on a nationwide scale has been difficult to assess due to incomplete reporting systems, inadequate forensic determinations at autopsy, and other factors. According to the 2007 Annual Report of the American Association of Poison Control Centers, analgesics of all types were the most frequently involved agents in human-exposure calls for help (about 312,000 calls), and opioids were the second most frequently associated with fatalities; coming after sedatives, hypnotics, and antipsychotic agents.1
Data from the U.S. Centers for Disease Control indicate that accidental drug overdose deaths nationwide escalated by more than 800% between 1980 and 2005 — in 2005 there were about 22,500 accidental drug overdose fatalities2 and 8,541 deaths were associated specifically with prescription-opioid analgesics.3 Another report, from the National Center for Health Statistics, notes that from 1999 through 2006, the number of fatal poisonings involving opioid analgesics more than tripled, rising from 4,000 to 13,800 deaths. Opioid analgesics were involved in nearly 40% of all poisoning deaths in 2006, with persons aged 35 to 54 years at greatest risk.4 While the data vary somewhat depending on the source, today’s opioid overdose crisis clearly touches the lives of a great many American individuals and families, regardless of age, social class, ethnicity, or gender.
Individual states have reported data reflecting increasing concerns about opioid-related overdose fatalities. For example, in 2006, there were 275 opioid-involved fatalities in West Virginia representing 93.2% of all deaths attributed to pharmaceuticals in that state.5 In 2007, 2,328 people in Florida died from accidental opioid-analgesic overdose.6 Also in 2007, there were 637 opioid overdose fatalities in Massachusetts, surpassing motor vehicle injury deaths.7
Similarly, alarming reports have come from Maine, North Carolina, Tennessee, Washington, Ohio, and other states. In 2006, Utah, New Mexico, Louisiana, Kentucky, Oklahoma, West Virginia, and Nevada had the highest rates of opioid-analgesic-related fatalities in the United States, ranging from 14.2 to 19.4 per 100,000 population compared to a national average of 9.14.4,8 Reported opioid overdoses may be associated with the misuse or diversion of opioid analgesics as well as with illicit street drugs like heroin; however, most accidental opioid overdose fatalities today are linked to prescribed opioid analgesics.2
Life-threatening opioid overdose takes place over time—it is not a sudden catastrophic event—it usually occurs while other persons are present or in the vicinity and it can be averted with proper monitoring and care.8,9 In one investigation of opioid-related deaths, the majority of fatalities (65%) occurred within one week of a change in medication dose and most decedents were discovered in the morning at home in bed.10 In most cases, other persons were likely present in the home and might have saved the victim had they been armed with proper knowledge and an antidote.
The Naloxone Solution
Fortunately, there is an antidote that acts rapidly, effectively, and safely—naloxone. This agent was FDA-approved in 1971 and has been used for decades by emergency medical services (EMS) personnel for reversing opioid overdose and reviving victims who otherwise would have died. Naloxone is an opioid antagonist, meaning that it temporarily displaces opioids from their receptors in the brain and protects the person for a period of time from further action by the opioids.
Naloxone is an unscheduled drug with no abuse potential and a very favorable safety profile. On rare occasions, nausea, vomiting, hypertension, pulmonary edema, tachycardia, or arrhythmia have been reported following naloxone administration11,12; however, it is often unclear whether such effects were due to naloxone, the ingested opioid and/or other drugs, or the victim’s prior physical condition. The only contraindication is hypersensitivity to naloxone or any component of the formulation.13 If administered to a person who has not taken opioids, naloxone simply has no pharmacological effect and naloxone itself has no overdose potential.2,14
Besides its use by EMS teams worldwide, some harm-reduction organizations—starting in Europe, then in Australia, England, and the United States— have provided prescription naloxone directly to addicted intravenous-drug users (IVDUs; most often heroin users). To help curtail opioid overdose deaths, these individuals have been provided training in recognizing overdose, basic life-support techniques (e.g., rescue breath-ing, recovery position, etc.), and how to administer naloxone. Participants are typically provided a container of naloxone and one or more needle-tipped syringes for intramuscular injection of the drug. They are encouraged to share this information with drug-using peers so they can assist each other during an overdose emergency.
To date, naloxone-distribution programs focusing on IVDUs have been initiated in 17 states and several cities (New York, Baltimore, Boston, San Francisco, and Chicago).15 Although these programs were somewhat controversial at first, successes have been well-documented. Ac-cording to one report, as of 2007 a program started in Chicago in 1998 had trained and distributed naloxone to 10,211 participants resulting in 1,011 documented episodes of life-saving overdose reversal with naloxone.2
Overall, as of 2008 in the U.S., about 21,000 persons at risk were trained on rescue naloxone and 2,600 overdose reversals were reported9—more than a 10% return in lives saved by the investment in naloxone training and distribution. A study by the Overdose Prevention and Reversal Program at the Lower East Side Harm Reduction Center in New York City concluded that naloxone is “undeniably advantageous for individuals to effectively revive an overdosing friend or family member, instead of resorting to potentially harmful and less effective methods of resuscitation.”2
Some European countries are promoting increasingly unrestricted naloxone access for more effective overdose prevention. The United Kingdom added naloxone to its list of emergency medications— such as adrenaline and glucagons—that may be administered by anyone in a life-saving situation and has initiated community-based naloxone distribution programs.16 Naloxone has been available over-the-counter in Italy since 1998,9 and advocates in the United States have suggested the drug should be changed from prescription-only to OTC status.2