Another Life Saved by Project Lazarus Naloxone Kit

Last week I talked to a young person, a patient at an opioid treatment program, who saved someone with her Project Lazarus naloxone kit. As you know if you read this blog regularly, Project Lazarus is a non-profit organization that started in Wilkes County, North Carolina, dedicated to reducing drug overdose deaths. As part of the project, Project Lazarus pays for naloxone kits for patients entering medication-assisted opioid addiction treatment. The patients are given a prescription for a kit that will be filled for free at a local pharmacy.

These kits are ingenious, because the naloxone is already packaged in a syringe with a spray attachment. There’s no needle. The person administering the drug pushes the plunger of the syringe to spray the medication into a nostril. Naloxone is absorbed through the skin of the nostril and into the bloodstream, reversing the effect of all opioids. In this way, naloxone immediately brings the person out of opioid-induced sedation or coma.

I talked to this person who used her kit, to get the full description of events. I’ve changed some details to prevent anyone from recognizing her.

Cindy said she was driving across town when she had the sudden urge to visit a relative, whom we will call Bob. Bob was on parole, and Cindy wanted to stop by and say hello. Bob isn’t an addict, but has occasionally experimented with illicit drugs, including opioids. When Bob opened the door for Cindy, his first words were, “I think I’ve just taken an overdose.” An acquaintance sold Bob some prescription opioid pills, and moments before Cindy stopped by he took all of them. Right away, he began to fear he’d taken too much.

Cindy wanted to take Bob to the hospital but he refused, fearing his parole officer would find out he’d used illegal drugs. Cindy agreed to stay with Bob, and warned him that if he passed out, she would call EMS, but Bob begged her not to do this.

At first they talked and watched TV, but within an hour Bob got sleepy and his head nodded. Initially Cindy could still wake him by shouting, but she was alarmed to see his breathing slow. She said his lips began to turn blue, and he was taking huge noisy breaths only a few times per minutes. She lived nearby, so she sent her boyfriend to get her naloxone kit. She pushed the plunger and sprayed the naloxone into Bob’s nostril. She said it took less than a minute for him to wake with a start. He even jumped out of his chair. He was standing up and breathing heavily. It was a few minutes before he felt like himself again. Cindy started to call 911 but Bob again pleaded with her not to do so because of his fears about what would happen with his parole situation.

Cindy was (correctly) worried the naloxone wasn’t going to last, so she sat with Bob through the whole night. Several hours after the first naloxone dose, she gave him a second dose, since he was again breathing slowly and heavily. It worked as well as the first. Thankfully, he was OK after that.

The next morning, Bob was grateful to Cindy for saving his life. He knew he had nearly died, and told Cindy he was never going to use drugs again. The event happened a week or so ago, and Cindy says as far as she know, Bob hasn’t used any drugs since.

Cindy saved Bob’s life because she had the Project Lazarus kit. I asked her what she would have done without it, and she said she would have called 911 even over Bob’s objections – she wasn’t going to watch him die.

This whole episode illustrates some of the problems that can contribute to overdoses. First, it isn’t only addicts who die from overdoses. Bob is a young adult who by Cindy’s report has only experimented with drugs. The trouble is that with opioids, your first experimentation can be the last thing you ever do. If Bob isn’t an addict, he may be able to stop using after this near disaster.

Second, it shows the new Good Samaritan law doesn’t go far enough. Bob was fearful about legal consequences of getting much-needed medical help. If Cindy hadn’t dropped by, this young man probably would have died. He had a brief period of time between realizing he may have taken an overdose and becoming so sedated he was unable to call for help, but he didn’t call, because he feared legal consequences. I think the Good Samaritan law should be broadened to include seeking help for oneself as well as for other people.

Third, would it have been better for Cindy to forget her kit and call the ambulance for Bob? Maybe, though not from Bob’s point of view. Stories like these travel fast along the drug addiction grapevine, so I’m hoping more people will get interested in having a kit that can reverse an overdose, if for no other reason than getting help without involving authorities.

I advocate making these kits available for anyone who wants one, if that’s financially possible. Over the period of a little more than a year, I’ve heard of two lives saved from opioid overdoses because other people used their naloxone kits. In both situations, the person saved was not the addict for whom the kit was prescribed, but a relative of that addict. This underlines the importance of getting these kits in the hands of friends and family members of all opioid users, even if the users are not addicts. Since the recent passage of the Good Samaritan law, it’s legal for physicians to prescribe naloxone for family member and friends of opioid addicts.

In the news last week we learned Project Lazarus of Wilkes County will get an infusion of $2.6 million over the next two years from both a private charity and government funds. The naloxone kits are only one part of the total program, and I hope to see funds for the kits expand so that any doctor can write a naloxone prescription for any opioid addict, friend or family of an addict that can be filled for free.

The New Good Samaritan Law: Go ahead…Call 911

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!

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.

The Big Sleep: Do Sleeping Pills Cause Premature Death and Cancer?

Adults who use sleeping pills are more than three times more likely to die prematurely compared to matched controls who don’t use sleeping pills, according to a recent study. (1)

I’ve never been a fan of sleeping pills, even the newer, first-line “Z” medications: zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta). I’ve seen all of them cause more harm than good in my patients, but that’s not surprising, since I treat patients with addictions.

These newer sleeping medications are touted by many as being safer and less addictive than older medication like temazepam (Restoril), triazolam (Halcion) or clonazepam (Klonipin). However, all of the “Z” medications are Schedule IV controlled substances, just like their benzodiazepine predecessors. This means they all have roughly the same potential to cause addiction, despite some enthusiastic and misleading marketing done by some drug companies.

But I know many people, without a history of addiction, can take sleeping pills without apparent problems, so I was surprised to read about this recent study. This relatively large study looked at the medical records of over 10,000 patients who were prescribed hypnotics for sleep, and compared their outcomes to over 23,000 matched control patients, similar except the controls weren’t taking sleeping pills.

The sleeping pills, also called “hypnotics” were associated with significant increases in mortality and  significant increases in cancer incidence.

The patients’ average age was 54, and they were followed for an average of 2.5 years. All were members of a large U.S. healthcare system in Pennsylvania. The data from the two groups were adjusted for age, gender, smoking status, prior cancer diagnoses, body mass index, ethnicity, and alcohol use.

Patients in the group taking prescribed hypnotics most frequently, defined as more than 132 doses per year, had  over five times increased risk of dying than patients not taking hypnotics. Even the group of patients taking hypnotics relatively infrequently (up to 18 doses per year) had a three times higher risk of death. These differences were statistically significant. The medications in the study included all of the “Z” medications, as well as temazepam (Restoril), barbiturates, and the sedating antihistamines, such as diphenhydramine (Benadryl).

Of note, eszopiclone (Lunesta) was associated with the highest risk of death. (This pill’s advertisement has a beautiful butterfly wafting in through an open window, and landing gently by a woman in bed, presumably  helping her sleep. I guess the butterfly seemed like a better commercial symbol that the grim reaper.)

The use of hypnotic medications was also associated with an increased risk of cancer, and reached statistical significance in patients taking the most hypnotics. Lung, colon, and prostate cancers were significantly more likely to occur in these hypnotic medication users, as well as lymphoma.

The author estimated that hypnotic medications are associated with 320,000 to 507,000 deaths in the U.S. over the year 2010.

This study raises some important questions, since hypnotic drugs are the most commonly prescribed drugs in the U.S., with an estimated 6 to 10% of the population being prescribed these medications.

This study really intrigued me. It’s the first I’ve read or heard about this association between sleeping pills and death, other than overdoses from mixing such drugs with opioids. After reading this article, my first thought was, “I wonder if more studies will show the same thing.” Then I started looking on the internet and found other studies that show an association between sleeping pills and increased risk of death. Many of these studies had flaws, but the overall impression is that this is a real correlation. The author of this current large study, Dr. Kripke, goes so far as to say the risks of hypnotic medications outweigh their benefits. He also admits his bias against hypnotics. (2)

Sleep medicine doctors say that correlation doesn’t mean causation, and we shouldn’t jump to conclusions. One sleep specialist pointed out that the study didn’t control for psychiatric illness, which could be a significant factor. Additionally, patients who are prescribed sleeping medications may be sicker overall, in ways the study didn’t control, and therefore a generally less healthy group. This could distort study findings.

Other scientists say that sleeping pills could make sleep apnea worse, and cause deaths in that way. Obesity increases the risk of sleep apnea, and with more adults becoming obese, perhaps sleeping pills make apnea worse and these people die in their sleep. Other scientists say sleeping pills slow reflexes, and perhaps patients taking these medications are more likely to be involved in car accidents and other accidents, increasing their death rates.

As for my patients, many of whom are prescribed methadone or buprenorphine, the risk of drug interaction and overdose with the hypnotics usually outweighs all of the benefits, and I recommend that patients do not mix these two types of medications.

So stay tuned. As time goes on, hopefully we’ll learn more about this correlation between sleeping pills and death. This current study is helpful because of its large size, and the author points out that 19 other studies have shown a relationship between hypnotics and increased risk for death.

Let’s also consider that sleeping medications bring in more than a billion dollars a year to the drug companies that sell them. I’ll be looking for more studies that are not funded by drug companies.

1. BMJ Open2012;2:e000850 doi:10.1136/bmjopen-2012-000850
2. http://www.medscape.com/viewarticle/759336

 

Project Lazarus Saves a Life

I’ve mentioned Project Lazarus in a previous blog entry. In that blog, I was cautiously supportive of this project, which provides kits to opioid addicts to reverse a life-threatening overdose with intranasal naloxone. Since that blog post, I’ve become a whole-hearted supporter of Project Lazarus, due to an incident in a community where I work. I’m going to change some of the details and circumstances of this occurrence so that the individuals involved can’t be recognized.

Last month, a young lady seeking admission to the opioid treatment program said she came for help because she’d almost died four days earlier. She said she’d injected a normal (for her) dose of opioids, and passed out. Her breathing either stopped or slowed dramatically, because her brother, an established patient at this clinic, found her unresponsive and blue. He couldn’t see her taking any breaths. Panicked, he called his counselor at the clinic, who told him to disconnect immediately so he could call 911, and then get his naloxone kit he’d been given when he entered treatment and started on methadone.

He followed those instructions precisely. After calling 911, he used his kit and shot the naloxone into his sister’s nose. He says the medication worked quickly, and she woke up within a minute or two. Though she had nausea and other opioid withdrawal symptoms, she was awake and alert by the time EMS personnel got to their house. Unfortunately, she refused to get in the ambulance to be taken for an evaluation at the emergency department, but her brother sat with her the rest of the day, and she had no further episodes of sedation.

Here she was, four days later, somberly considering how easily she could have died. “I’m not ready to die. I’m only 26 years old. I always thought people who died from drugs didn’t know how to do them right and took too much. But I took the same amount I’m used to taking. I don’t know why I overdosed that time. It made me see I’ve got to do something different if I want to stay alive. My brother was a worse addict than me, and I’ve seen him change his life since he’s been on methadone. I want that too.”

We discussed her treatment options and she agreed to try buprenorphine first. She started treatment that first day and so far has done very well. Every time I see her around the clinic, I’m reminded that she may not be alive today if not for her brother’s naloxone kit.

I now highly recommend these naloxone kits for any opioid addict. It’s not a treatment or permanent solution for addiction, but it can help keep an opioid addict alive long enough to find a treatment that works for him or her.

In Utah, Pain Medicine Specialists have the Highest Death-to-Prescription Rates

Of all fifty states in the U.S., Utah has the fourth highest opioid overdose death rate. In a study presented at this year’s American Academy of Pain Medicine conference, one researcher compared data from Utah’s prescription monitoring program with information regarding prescription opioid deaths in that state. She did this to discover which physician specialties have the highest death-to-opioid prescription rates. (1)

The results were somewhat surprising. Though pain medicine specialists wrote only 1% of all opioids prescribed in the state, their patients accounted for 3% of the state’s overdose deaths. Family practice physicians prescribed the highest amounts of opioids in Utah, but had half the death rates of pain medicine specialists. Other specialties with high death-to-prescription rates were anesthesiologists, physiatrists (physical medicine and rehabilitation doctors), and physician extenders (nurse practitioners and physicians’ assistants).

Specialties with the lowest risk were internal medicine doctors, orthopedic surgeons, emergency room doctors, and dentists.

Of course, pain medicine specialists correctly responded to this data by reminding us that association doesn’t prove causation. The pain medicine specialists say they care for the most complicated of patients, referred when primary care physicians feel they need expert help.

This is an important point. You have to look at the population being treated.

I’m reminded of a similar example in my region. A few years ago, a local suburban community hospital claimed that patients admitted to their hospital had the lowest complication rates of any hospital in the area. They were correct, but it was because they referred very sick patients to a nearby urban tertiary care hospital. That hospital, caring for the sickest of the sick, had a high complication rate for their inpatients. In other words, the data was accurate but still misleading, due to the marked differences in the patient population treated by each hospital.

In the same way, pain medicine experts aren’t likely to be caring for uncomplicated, easily treated patients. The tough, complicated cases will be referred to them from primary care doctors.

Pain medicine specialists also point out that dentists and primary care doctors may be prescribing for many patients with acute, short-term pain. This type of patient is likely at less risk than patients with chronic pain from serious illnesses. The amount and strength of opioids that dentists and primary care doctors prescribe is likely to be lower than the amount and strength of opioids prescribed by pain specialists. And we know that the higher the dose of opioids prescribed, the more likely the patient is to suffer an overdose death.

The author of the study acknowledged the difficulty in interpreting the data, but also said she felt this information indicated a need for education for all the state’s physicians. Adding support for her recommendation is a report released last fall that describes the results of a survey of pain medicine specialists. (2) Only 70% of these specialists answered questions correctly about opioid abuse and the FDA’s new Risk Evaluation and Mitigation Strategies. Thirteen percent say they don’t assess their pain patients for risk of opioid misuse, which is now the recommended standard of care for all patients receiving long-term opioid prescriptions.

Getting back to the Utah study: It’s important to note that even in this state with a high overdose death rate, only .475% of all opioid prescriptions were associated with fatalities

1.Drug and Alcohol Dependence News, Feb. 28, 2012, citing Porucznik C, et al, “Physician specialty and opioid prescribing in the Utah controlled substance database 2005-2009 AAPM; Abstract 201.

2. http://www.medscape.com/viewarticle/749713

Overdose Deaths: Opioids and Benzodiazepines

Any opioid, mixed with any benzodiazepine, alcohol, or barbiturate, can be deadly.

Part of our brainstem, the medulla, tells our bodies to breath while we sleep. Opioids inhibit the neurons (individual nerve cells) of this area of the brain, potentially interfering with this automatic breathing. This is how overdose deaths occur. People go to sleep, stop breathing, and die from lack of oxygen to main organs like the brain and the heart. Even a relatively small dose of opioid can kill a person who isn’t accustomed to taking them, and a larger dose can kill even those who are used to opioids. If you are wondering what constitutes a small or larger dose, that’s unanswerable, because of the considerable differences between individuals.

Benzodiazepines, alcohol, and barbiturates all also inhibit this same brain center, and have the potential to slow breathing, just like opioids. We don’t see many doctors prescribing barbiturates any more, with the possible exception of phenobarbital for seizures, and butalbital for headaches. Sometimes carisoprodol (Soma) is prescribed as muscle relaxant, and it gets metabolized to a barbiturate. We do see a great many people prescribed benzodiazepines, which can be dangerous for a person also taking opioids. And of course, alcohol flows freely in the U.S. society.

When a person with addiction mixes opioids with benzos, alcohol, or barbiturates, he often ends up taking more of the drug than he planned, making it easy to have a fatal overdose. Addiction is all about the loss of control. So for example, an addict may decide to take one Xanax with an opioid, but ultimately take three or four Xanax’s with the opioid. Compounding the problem, the effects of the two drugs together is usually more than would be expected, due to synergy. Synergy means that instead of 1+1=2, suddenly 1+1=4. There’s more of an effect than the person expected.

Some people are able to take both opioids and benzodiazepines without complications, but these people usually don’t have the disease of addiction, and are able to take their medication just as prescribed by their doctor. Even for these patients, benzodiazepines are rarely indicated for use for more than three months (fodder for a future blog).

But benzodiazepines can harm patients with addiction. Except for unusual circumstances, it’s a bad idea to mix any benzodiazepines with any opioid in people with addiction, because of the risk of overdose death. Rarely, a situation may arise that warrants use of benzodiazepines in a patient on opioids, but it’s for a short-term situation, and safer long-term treatments for anxiety usually can be found.

When my patients on methadone or buprenorphine (Suboxone) take benzodiazepines for anxiety, I get anxious. I worry those patients will die from an overdose. It’s a dilemma. Often, patients are clearly benefitting from methadone or buprenorphine, because they’re no longer using illicit opioids, but we now have the risk of an overdose death. So, the methadone or buprenorphine are helping them – unless it kills them… in which case it’s no longer helping.

What to do??

Some doctors say if the patient is benefitting even a small amount, because death rates are so high for opioid addicts who leave treatment, that patient should never be dismissed from a methadone clinic for using benzodiazepines.

I don’t agree with that. The first thing doctors learn in medical school is, “First, do no harm.” In other words, please try to kill as few patients as possible.

And yet, many of these patients can stop using benzodiazepines if they get the right kind of help. I ask my patients “Why do you use benzos?” and base my intervention of what they say. If they’re getting medication from a doctor, I’d like to talk to that doctor, and often a better long-term solution can be found. Benzodiazepines have very few indications for long-term use, because patients develop tolerance to the anti-anxiety properties of these medications fairly quickly. However, it’s dangerous to stop benzodiazepines suddenly in a patient who has been taking them for months or years, because of the risk of withdrawal seizures. We have to decide on the best way to handle the situation. If patients take benzos for the high it produces with methadone, they have to decide if it’s worth risking not only their treatment but their lives. If they take benzos for sleep, often I can prescribe a more suitable medication.

As long a patient has a willing spirit, and does not look like an overdose is imminent, I try to work with him or her. In each case, there are risks in stopping methadone treatment, and risks in continuing methadone treatment. The decision should be made by a physician who is well-educated and well-trained in addiction medicine. We make the best decision we can for the patient in front of us. We are the most qualified to make those – literally – life and death decisions.