Archive for the ‘Project Lazarus’ Category

Naloxone Controversy


It’s a misleading title, because most people support naloxone use. At this point…there’s not much controversy. Unless you live in Maine.

Their governor, Paul LePage, vetoed a bill, passed by their State House in 2013, that allowed naloxone to become more widely available. He called the life-saving medication and “escape,” and “An excuse to stay addicted.”

Naloxone is an escape in a way – an escape from death.

However, before learning about naloxone, I had some concerns too. For example, would having naloxone available for an overdose encourage people to use more illicit opioids? Would addicts be more likely to push then envelop of safety in the quest for the ultimate opioid high?

The answer appears to be no, at least according to some small studies. One of them was a study of intravenous heroin addicts in San Francisco, who received an eight-hour training in how to prevent heroin overdose, how to give CPR, and how to administer naloxone. [1]

These twenty-four study subjects were followed prospectively for six months. These addicts witnessed a total of twenty opioid overdoses. All of the overdose victims were said to be cyanotic, unresponsive, and have no respirations. The addicts in the study, who had received the eight hour training, administered naloxone to 75% of the overdose victims they encountered. They performed CPR on 80% of the overdose victims, and 95% of the overdose victims had one or the other of the two interventions performed. All of these overdose victims survived.

The study did not show an increase in the incidence of opioid overdose. In fact, the addicts in the study used less heroin over the study period, even though no part of the study was dedicated to encouraging the reduction of illicit opioid use or to entering addiction treatment.

Granted, the study participants had to be motivated in order to spend eight hours doing the training, so maybe they were already motivated to cut down or stop using drugs. But on the other hand, about half of these study subjects were homeless, a demographic many in our society would assume is poorly equipped or motivated to help anyone else. Yet they demonstrated a remarkable willingness and capability to help peers dying from overdoses.

Emergency medical services were called in only two of the overdoses. When study subjects were asked why they did not call emergency medical services, half said it was due to fear of police involvement and arrest. Twenty-five percent said no phone was available, and 25% said they didn’t see a need for EMS.

This information underscores the importance of Good Samaritan laws. In the broadest sense, Good Samaritan laws protect a person who tries to help another person from civil or criminal penalties.

Initially these laws were passed to protect doctors from being sued if they attempt to save the life of someone who is not a patient. For example, if I witness a man choking to death in a restaurant and I rush over to do the Heimlich maneuver, I can’t be sued if I break his ribs in my effort to get him to hack up the meatball wedged in his trachea.

Good Samaritan laws, as they apply to drug overdoses, give some degree of immunity to people who try to intervene to save another person’s life from drug overdose.

For example, in my state, our Good Samaritan law says if a person seeks medical assistance for an individual suffering from a drug overdose, that person will not be prosecuted for possession of less than one gram of cocaine or one gram of heroin. The bill has provisions for doctors to be able to prescribe naloxone to any person at risk of having an opioid-related overdose. Doctors can prescribe naloxone to the friends or family members of a person at risk for an overdose, even if that person is not a patient of the doctor. This is called third-party prescribing; the law hacks through red tape of previous regulations that said doctors could only prescribe naloxone for their own patients. And our Good Samaritan law says a private citizen can administer naloxone to an overdose victim, and so long as they use reasonable care, will be immune to civil or criminal liability.

Not all states allow third-party prescribing of naloxone or even Good Samaritan laws. Look on the map at the top of this blog, and if you live in a state that hasn’t yet passed these laws, write your congressmen. This is such an important issue, and naloxone needs to be more widely prescribed. (I don’t know why Maine is colored on the map as if they have naloxone laws).

Who should get a naloxone prescription? Opioid addicts should obviously receive kits, and the friends and family members of these addicts. I believe it should be considered for any patient prescribed opioids, including patients on opioids for chronic pain, and patients prescribed methadone or buprenorphine to treat opioid addiction.

Kits should certainly be provided for high-risk patients – opioid addicts recently released from jail or detox units.

I wish I could prescribe kits for all of my patients on methadone or buprenorphine now, but aside from the program where I work in Wilkes County, it’s not yet easily available.

But it will be soon. In April 2014, the FDA approved a commercially available naloxone auto-injector marketed under the name Evzio. This kit, which delivers .4mg of naloxone intramuscularly or subcutaneously, has both written and voice instructions. Each kit contains two doses, and it can be administered through clothing. This kit should be available in pharmacies this summer.

Until then, there are other options. Doctors can call a local pharmacy to see if they would be interested in making a kit for sale to patients. At a minimum, it would include one or two vials of naloxone, a needle and syringe, rubber gloves and alcohol wipes to cleanse skin prior to injecting. This would be a relatively cheap kit to make, but questions persist about who would pay for it: the patient, their health insurance company…
The Harm Reduction Coalition has been instrumental in providing intramuscular naloxone kits to anyone who wants one. They have contacted OTPs in my state to ask if they can hand out kits and other information, so that’s another possible source for a kit. If you are reading this article and want a naloxone kit for either yourself or a loved one, please contact either the Harm Reduction Coalition at:
This wonderful organization does other good works besides distributing naloxone kits, and it’s worth checking out their website.

At the opioid treatment program where I work in Wilkes County, NC, Project Lazarus has paid all or part of the cost of intranasal naloxone kits for our patients who enter treatment. Thus far I know of three lives saved by these kits. None of them were our patients; our patients used their kits to save other people.

I’ve written about Project Lazarus before in my blog. This organization, founded by Reverend Fred Brason, has implemented ongoing measures that reduced the opioid overdose death rates not only in Wilkes County, but probably statewide as well. Other states have started programs modeled on Project Lazarus. You can go to this website for more information: I know that in the past, Project Lazarus has been willing to send a naloxone kit to anyone who has a need for it, so that’s another possible source for a kit.

I predict it will become easier to get relatively cheap naloxone kits from pharmacies everywhere as the momentum behind naloxone availability grows.

1. Seal et al, “Naloxone distribution and cardiopulmonary resuscitation training for injection drug users to prevent heroin overdose death: A pilot intervention study,” Journal of Urban Health, June 2005; 82(2): 303-311.


The New Good Samaritan Law: Go ahead…Call 911

New Good Samaritan Law for North Carolina

New Good Samaritan Law for North Carolina

In an effort to reduce drug overdose deaths, North Carolina governor Pat McCrory approved a law earlier this month that limits legal consequences for people who call 911 to summon help for a friend who has overdosed. In the past, drug users have been reluctant to summon medical assistance for an overdosed companion, fearing police may arrive, and charge them with possession of drugs and/or paraphernalia. As a result, people die from overdoses due to a lack of timely medical care. In its place, the overdosed person’s companions may try an ineffective home remedy for overdose.

The new law doesn’t give a pass for all drug possession. It says that a person acting in good faith to seek medical assistance for an individual suffering a drug overdose will not be prosecuted for possession of less than one gram of cocaine or one gram of heroin. I don’t know if that means possession of larger amounts may still be prosecuted, but I suspect so. There is no mention of prescription drug possession specifically in the law, but I hope prescription opioids would be treated the same as heroin.

This new bill, called the Good Samaritan Bill, also says that if an underage drinker summons medical help for another person, the underage drinker will not be prosecuted by law enforcement, including campus police. The law says the underage drinker must use his own name when contacting authorities, reasonably believe he was the first to call for help, and must remain with the person needing medical help until it arrives to be covered by this law.

The bill has provisions for doctors to be able to prescribe an opioid antagonist such as naloxone to any person at risk of having an opioid-related overdose. Doctors can also prescribe this medication to the friend or family member of a person at risk for an overdose, even if that person is not a patient of the doctor. Also, a private citizen who possesses an overdose kit can administer it to another person who has had an overdose, so long as they use reasonable care. This law says the private citizen is immune to civil or criminal liability.

This is a great new law, and hopefully it will reduce witnessed overdose deaths. But the law won’t help unless addicts and their companions are aware of this law. Spread the word!

The Drug Czar Praises Project Lazarus

On Wednesday, August 22, the Drug Czar came to town.

Mr. Gil Kerlikowske, the director of the ONDCP (Office of National Drug Control Policy) gave the keynote speech at the Project Lazarus Symposium held in Wilkesboro, NC.

Being a drug czar isn’t as much fun as it sounds like it might be. It means Mr. Kerlikowske works hard helping to create the drug control strategy for the nation. His agency advises the president regarding drug-control issues, and sets the tone for the nation’s approach to drug addiction and treatment. For more information see my blog of April 20th, 2011. At the Project Lazarus Symposium in Wilkesboro, Mr. Kerlikowske gave the keynote speech and elaborated on these topics.

The Drug Czar came to Wilkesboro because of the impressive program Project Lazarus. Project Lazarus is a grass-root, non-profit organization established in 2008 in response to the very high rates of opioid overdose deaths in Wilkes County. That county had one of the highest drug overdose death rates in the entire nation, but over the last four years, those rates have dropped dramatically. For more data about these rates and about Project Lazarus, go to their website at:

The ONDCP has placed more emphasis on prevention and treatment, acknowledging that law enforcement efforts alone won’t fix our nations’ problems. During his keynote address, Mr. Kerlikowske praised Project Lazarus and said it should be used as a model for communities in other states facing the same problem of overdose deaths.

Project Lazarus’ founder and CEO, Fred Brason, gave an overview of the components of the program and most recent data. Then Mr. Kerlikowske spoke for about twenty minutes, explaining the ONDCP’s vision for drug control policy. Then came a roundtable discussion where parties from various agencies and organizations explained their role with the project.

I was invited to the roundtable because I am the medical director at Mountain Health Solutions, an opioid treatment program in North Wilkesboro that prescribes both buprenorphine and methadone to treat patients with opioid addiction. This OTP is now owned by CRC Health, but was started by Dr. Elizabeth Stanton nearly three years ago, in response to the need for medication- assisted treatment in Wilkes County. At first, her program prescribed only buprenorphine, but later she saw the need for methadone for those patients for whom buprenorphine didn’t work.

I started working there relatively recently. I’ve been amazed at the number of patients presenting for treatment for pain pill addiction, nearly all of whom live in this relatively small community. At present we have more than three hundred and fifty patients enrolled in treatment.

As part of Project Lazarus, all of our patients receive a prescription for (free) naloxone kit to prevent opioid overdose deaths. I was invited to the Project Lazarus Symposium because in my blog on March 28th, 2012, I described how a patient of our OTP clinic saved a relative’s life by using one of the kits.

At the roundtable, I said a few words about the effectiveness of medication-assisted treatment using buprenorphine and methadone, and then made a few comments about the overdose death that was prevented with the naloxone kit.

Next, during the roundtable discussion, representatives from many different organizations and locations across North Carolina described the role Project Lazarus plays in their missions. Representatives from such disparate populations as the Cherokee Nation and the military at Ft. Bragg described how they used Project Lazarus’ programs to keep patients safer. Several epidemiologists gave information about the lowered overdose death rates in Wilkes County. A local doctor explained how doctors have revised their prescribing of opioids in the Emergency Department. We also heard from several people connected with the Harm Reduction Coalition, and from the county’s sheriff.

Representatives from state organizations such as the Governor’s Institute on Substance Abuse, the North Carolina Medical Board, the NC Department of Health and Human Services, and the NC Division of Public Health, Injury and Prevention all explained how they worked with Project Lazarus. For example, a portion of Project Lazarus’ activity has been to encourage physicians to sign up for – and use – our states’ prescription monitoring program.

We heard about the Chronic Pain Initiative, a program developed with the help of Project Lazarus, which helps educate physicians about the best practices of opioid prescribing. Initially meant for Medicaid patients, the Chronic Pain Initiative is now available to help all patients.

This initiative helps reduce overdose deaths by providing physicians with, among other things, a toolkit for healthcare providers. It gives them everything from evidence-based information about safe opioid prescribing to a form that can be filled out to gain access to the NC CSRS. It contains worksheets, flow sheets, and addiction screening tools. It contains everything a doctor could want to keep patients on opioids as safe as is possible, while still making opioids available for patients who need them.

I’ve blogged about this program in the past. I knew there was more to Project Lazarus than distribution of naloxone rescue kits, but I didn’t know the full extent of the Projects activities in the state. At Wednesday’s program, I was impressed as professionals from organizations across the state explained how Project Lazarus helps them prevent, intervene, and treat opioid addiction, and reduce overdose deaths.

I was inspired with the depth of knowledge and commitment of all of these people, and by their collaborative spirit. People in all strata of the community cared enough about overdose deaths that they were trying to fix the problem before more lives are lost. These groups were cooperating, which is essential. Both Gil Kerlikowske and Fred Brason took pains to emphasize the importance of working together and not against each other.

In other words, naloxone kits aren’t enough to fix the epidemic of opioid overdose drug deaths. Law enforcement can’t arrest our way out of this problem. Prescription monitoring programs aren’t enough to stop all drug diversion. It takes the sustained efforts of people different segments of the community, working together, to get results. No one intervention is enough. That was the bottom line message I got from the Project Lazarus Symposium and the Drug Czar.

Information from the ASAM Conference: the CDC

At the recent ASAM conference, Dr. Ileana Arias, Deputy Director for the Centers for Disease Control and Prevention, spoke at a plenary session, explaining the public health impact of our epidemic of prescription drug abuse and addiction. She did a great job explaining how bad the problem of opioid addiction has become in the U.S. She also had some great slides. The above slide shows how by 2008, poisonings overtook motor vehicle accidents as the number one cause of death in the U.S. Overwhelmingly, the poisonings were drugs, and the vast majority of these drug overdose deaths involved opioids. Dr. Arias explained the ice berg phenomenon, where for each person who dies from opioid overdose death, an estimated 118 are estimated to meet the diagnosis for opioid abuse and dependency. She presented information showing that the amount of prescription opioids sold quadrupled between 1999 and 2010.

Dr. Arias spoke at our conference to encourage us and to let us know the CDC was committed to help solve our nation’s prescription opioid addiction problem.

She outlined some of the measures the CDC is taking to help prevent opioid addiction and overdose deaths.  She explained the new lock-in programs now being used by some insurance companies, where the patient can have only one doctor and one pharmacy to prescribe and fill medications. The CDC is advocating for all states to have prescription monitoring programs, and for those state programs to be linked, so that a doctor can access medications filled in other states.

Dr. Arias mentioned the progress being made in Florida, where pill mills are being shut down. Unfortunately, some pill mills have moved to other states like Georgia, Texas, Louisiana, Ohio, and – my favorote state to criticize – Tennessee.

She also spoke of the success of medication take-back days, where people drop off old medication for appropriate disposal so that it doesn’t fall into the wrong hands, and she described many other actions the CDC has started.

This was all great information, familiar to those of us treating opioid addiction over the past five to ten years. I’m grateful the CDC has joined the effort to quelch this problem. Their resources and experience can help a great deal. I just wish all doctors in the country could hear her message.

The addiction medicine doctors had a chance to make comments and further suggestions to the CDC through Dr. Arias, and I was pleased to see how carefully she listened.

One of the suggestions I liked the best addressed the expense of maintaining state prescriptoin monitoring programs. Apparently these can cost around a million dollars a year to administer. One doctor said why not have the pharmaceutical companies that make and sell controlled substances pay or help pay for the monitoring programs? These companies are the main entities that have benefitted from the sales and diversion of their products; why not ask them to bear at least some of the cost for detecting the problems they cause? Genius, though it would be hard to mandate the pharmaceutical companies to do this.

One doctor suggested that law enforcement personnel be educated about the types of treatment available to opioid addicts, so they can stop being barriers toward effective treatments, namely medication-assisted treatments using buprenorphine and methadone.

Another doctor suggested the CDC promote the naloxone programs that provide kits to reverse fatal opioid overdoses. Why not help fund these projects and/or help create more? The Harm Reduction Coalition estimates there are around 155 naloxone programs in the U.S. Some are government-funded and some are privately funded, but around 10,000 fatal opioid overdoses have been reversed. Like Project Lazarus in North Carolina, many of these programs started at a grass roots level because citizens got involved.

Another doctor made the extremely common sense suggestion that the best way to allow more patients into suboxone treatment would be to allow doctors to treat more than one hundred patients at a time. At present, suboxone doctors are allowed to have no more than thirty patients on buprenorphine in their first year prescribing, and no more than one hundred after the first year. This would cost next to nothing for the government to implement, and expand treament dramatically.

One of our past ASAM presidents endorsed mandatory physician education as a requirement for maintaining medical license.

One person compared the prescription opioid addiction to HIV infection in past years, and commended the CDC on its past efforts to reduce the stigma associated with having HIV. This person asked the CDC to make public service announcements to help reduce the stigma of addiction, and encourge people to get treatment.

Another doctor asked the CDC to produce public service announcements telling people to lock up their medications, to prevent medication diversion to a teen or other person for whom it was not prescribed. This doctor also said that patients need to know that not all pain conditions require prescription opioids. He recommended telling the general public the true risks of opioid addiction, which have been downplayed. In the past, pain medicine experts underestimated the incidence of addiction in patients prescribe opioids for chronic pain for more than three months.

The CDC representative, Dr. Arias, confirmed that the CDC already has plans to make PSAs about pain pills and pain pill addiction, much like their present (and very successful) anti-smoking television PSAs.

All great information, and now let’s get the word out to all physicians, and the public too.

Raising the Dead: Intranasal Naloxone and Project Lazarus

With help from the North Carolina Governor’s Institute, the doctors who work at opioid treatment programs in my state have a monthly telephone conference call. We discuss questions and problems, and discuss difficult cases. This month we talked about a proposal to prescribe a kit containing intranasal naloxone to each methadone patient, to prevent accidental methadone overdose deaths.

Naloxone is an opioid blocker. It attaches to opioid receptors, but doesn’t activate them, and it blocks other opioids from attaching to the receptors. This is maybe oversimplified, but will do for our purposes. Naloxone, better known under its brand name, Narcan, is administered intravenously by EMS personnel and emergency room doctors to reverse opioid overdoses. Naloxone throws opioids off the opioid receptors, reversing all opioid effects.

The effects are dramatic. I haven’t used naloxone since my Internal Medicine residency, but I remember the intense change seen in an overdosed patient. One minute the patient is lying unconscious, barely breathing, and literally the next minute they’re wide awake, actively moving around, and usually sick. I learned to step back quickly after giving naloxone, as vomiting is often seen as soon as the patient sits up. If the patient is an opioid addict whose body is accustomed to having a steady blood level of opioids, Narcan puts the patient into an immediate and severe opioid withdrawal.

Naloxone is used intravenously in the emergency department. This medication isn’t active if taken by mouth, since even if it is absorbed; the first-pass metabolism by the liver metabolizes most of it. The effect of one dose of naloxone lasts for about one hour. It can also be given subcutaneously and intramuscularly, though absorption into the bloodstream is more erratic with these methods. It may last a bit longer with intramuscular injection.

When learning ACLS (Advanced Cardiac Life Support) in my residency, we learned naloxone can be squirted down an endotracheal tube (breathing tube) if no intravenous access is immediately available, since it’s absorbed through the thin lining of the trachea.

Naloxone is also absorbed through the thin skin of the nasal mucosa, which is how this medication is being used around the country by ordinary citizens to “raise the dead.” The naloxone is mixed with a small amount of salt water and put into kits, so that the mixture is easy to squirt into the nostrils of an unconscious person, in order to reverse the effect of opioids. It’s a relatively large volume; usually it’s a 10cc mixture, half to be squirted up each nostril.

Does it work? Yes, it does. It may not quite as well as the intravenous route, but well enough so that people with no medical skills can save someone who has overdosed.

Project Lazarus, in Wilkes County, North Carolina, is a community-based, opioid overdose prevention initiative. This program recommends that all patients who are prescribed opioids, for any reason, be given a prescription for an intranasal naloxone kit. Since the patient taking opioids probably won’t be the one administering naloxone (since they will be unconscious), friends and family members are educated in how to give this potentially life-saving treatment.

On their website (, Project Lazarus implies their program has dramatically reduced opioid overdose deaths: fatal overdose deaths from opioids are down 82% in 2010 as compared to 2008. Besides distributing intranasal naloxone kits, this project also educated local doctors about opioid prescribing and urged the local hospital to change the opioid prescribing habits of emergency room physicians.

Did Project Lazarus really result in all of these positive changes? It’s possible, but just because one thing follows another in time doesn’t mean the first thing caused the second thing. I do support their initiative, but I think it’s far more likely that the opioid treatment center that opened in that county, as well as surrounding counties, had more influence. For the first time, opioid addicts could get evidence-based treatment, (not just reversal of overdoses), in Wilkes County. That clinic opened in 2010, and clinics in surrounding counties began operating a few years before that.

The North Carolina Medical Board has issued a statement that they support the Wilkes County Project Lazarus Initiative. As I’ve said, I support it too, but I really wish the North Carolina Medical Board would also issue a statement of support for a more evidence-based solution to opioid addiction and death: medication assisted therapy with methadone and buprenorphine.

But getting back to intranasal naloxone: what does the medical literature show? It shows naloxone can and has reversed potentially fatal opioid overdoses. It can be given effectively by a layperson, and is safe, effective, and works nearly as well as intravenous naloxone. Plus, there’s no risk of an accidental needle stick with the intranasal kit.

In my admittedly limited research, I found only one study that raised worrisome issues. In a San Francisco study, heroin addicts were questioned about their attitudes and opinions regarding the use of naloxone. (1) When asked if they would participate in a training program to learn how to use naloxone to reverse overdoses, an encouraging 87% said “yes.” However, 35% of the addicts said they might feel comfortable using greater amounts of heroin. Sixty-two percent said they would be less inclined to call 911 if they were able to use naloxone, and 30% said they would likely leave the person alone after the overdose was reversed. Interestingly, 46% said they may not be able to talk the addict whose overdose was reversed out of using heroin again, in order to stop the withdrawal induced by naloxone.

Other studies do show that concerns raised by these answers haven’t been seen in actual practice, but it’s worthwhile to analyze these concerns.

On our conference call, the doctors who work at opioid treatment programs in our state were discussing if we should recommend all methadone patients get a kit with intranasal naloxone to use in case of an overdose. With methadone, there are some drawbacks that aren’t seen with heroin and other shorter-acting opioids. Since methadone is very long acting, one dose of naloxone will reverse an overdose, but unless the patients is taken to the hospital, the patient will relapse back into unconsciousness and overdose later, because the patient’s methadone will long outlast the naloxone. So we know that naloxone, when used for a methadone overdose, is a temporary measure to save the patient until he can reach more definitive medical help.

What of the cost? We estimated a kit would cost about $50. Who should pay for these? Should clinic doctors give every patient a prescription for a naloxone kit, and let those who can afford them get them filled? Should the clinic bear the cost? If so, the cost will likely be shifted somehow to the patient, with higher treatment fees. What if that extra money kept a patient out of treatment? Would we be increasing the potential for harm in that case? Who will be responsible for teaching friends and family of the patients how to administer the naloxone?

We don’t have clear answers to these questions yet.

Overall, I like the idea of prescribing a naloxone kit to methadone patients. I actually called a local pharmacy to see if they stocked these kits, but they didn’t. Anything to reduce the risk of harm seems a good thing. However, it would be essential to stress that effect of naloxone would be only temporary for a person maintained on methadone, and that the person must come to the hospital for more definitive care.

I don’t think anyone believes naloxone alone is enough to treat our unfortunate wave of opioid addiction, but it’s one more tool we can use.

  1. Seal KH, Downing M, “Attitudes about prescribing take-home naloxone to injection drug users for the management of heroin overdose: a study of street-recruited injectors in the San Francisco Bay Area,” Journal of Urban Health, 2003, June;80(2):291-301.