Suboxone Talk Zone - Buprenorphine and Other Medication-Assisted Treatments %

Suboxone Forum Upgrade

Regular readers know that I’m a psychiatrist and addiction doc – not a computer guy. When I started writing about Suboxone and buprenorphine twelve years ago, there were few other people writing about the medication. Of course heroin addiction was just taking off, and fentanyl was confined to operating rooms.

I put together a couple sites that skyrocketed in readers. The most-used was SuboxForum, where we discussed controversial issues like ‘is Suboxone a drug for a drug’, and ‘do the films hurt your teeth?’

I did not work on SEO stuff, because (in case I didn’t say) I’m a psychiatrist. I watched my sites fall below sites that had almost no content, that only advertised spa-like treatment programs that have been proven not to work for treating opioid addiction. Many web sites ‘scraped’ my posts and content, or took feeds from the forum, and posted them as content on their own sites – that scored above the native sites.

Google always says ‘don’t worry about SEO; just have good content and we’ll find you!’ I can attest that in this corner of the internet, they don’t do a good job of separating the posers and scammers from real content.

There are a couple other forums out there that were big in the past, and now sit dormant or dead. They still rank for questions about buprenorphine. I’ve decided that I need a hobby, so I’m going to try to get the numbers up at SuboxForum. If you haven’t been there for a while, stop by! We are still at the same place, with some software upgrades… but we have many of the same people you knew years ago. Our main mission, of course, is to help the newcomer learn about an important medication… so if you’re wondering how the medication works or other questions, stop by.

I’m a psychiatrist (if I didn’t say that before). So I don’t collect info and sell it to spammers. The software needs you to give your email to sign up, but get a free anonymous one and use that.

Hope to see you there.

Tapering off Buprenorphine or Suboxone, Pt 2

In the last post we discussed some of the misconceptions about tapering off opioids. Today we will discuss a couple basic principles, and then describe the approach I recommend for my patients tapering off buprenorphine.
Opioids act at receptors that normally bind endorphins, which are released by neurons in response to a range of stimuli including trauma and rewarding behaviors such as eating a good meal or using addictive drugs. Endorphin pathways elevate mood, reduce sensation of pain, and impact urine production, immune function, intestinal motility, and other bodily functions. Endorphin pathways have a certain baseline activity or ‘opioid tone’ that is directly related to opioid tolerance. When opioid stimulation is greater than one’s tolerance, opioid tone is increased. When opioid stimulation drops below one’s tolerance, opioid tone is reduced, causing withdrawal symptoms.

The goal of any taper off opioids is to recover original or native opioid tolerance. Some people focus on getting rid of the opioid, and even use substances or behaviors to ‘flush buprenorphine from the body’. Products marketed as detox agents have minimal impact on the clearance of buprenorphine or other substances. And even if they could increase the rate of clearance, they would only make detox harder by increasing the severity of withdrawal symptoms. The relatively slow metabolism and clearance of buprenorphine provides a cushion by slowing the loss of opioid tone.

Prolonged use of any opioid changes opioid receptors. The changes are not fully understood but include a decrease in number of receptors and changes in binding properties that reduce receptor sensitivity to opioids, including endogenous opioids (endorphins). Recovery from a state of tolerance takes 2-3 months, and is initiated by reduced opioid tone. Withdrawal symptoms reflect the reduced opioid tone that provokes eventual recovery of native tolerance.

Recovery of native tolerance is the rate-limiting step when tapering off any opioid, including buprenorphine. When the dose of buprenorphine is reduced, the amount of buprenorphine at opioid receptors decreases over the next 5 days and then stabilizes at a lower level. In response, opioid tone (the summation of current flow through opioid receptors) drops below normal. If the dose of buprenorphine is maintained at that level, opioid tone will recover to normal in about 2-3 months. If buprenorphine is suddenly and completely discontinued, opioid tone will decrease to very low levels and cause severe withdrawal that lasts for 2-3 months. If buprenorphine dose decreases more slowly, opioid tone will decrease more slowly, lessening the severity of withdrawal. But it still takes 2-3 months for opioid tone to return to normal. So for any taper, patients must decide whether to decrease their dose quickly and be done in 2-3 months, at the cost of greater withdrawal, or instead to taper more slowly to reduce the severity of withdrawal.

The relationship between buprenorphine dose and opioid activity is linear up to about 2-6 mg. Beyond that point further increases in dose have less impact on opioid tone. The reverse occurs when tapering, so that opioid tone decreases only slightly as dose is reduced from 16 mg per day to 4 mg per day. The non-linear dose/response relationship allows for rapid decreases in dose early in the taper process with limited or no physical withdrawal symptoms. Since the early challenge is mostly psychological, I use the early part of a taper to help assess whether a patient is truly ready to take on the tapering process.

I like to have patients lead the way in tapering off buprenorphine. I’ve found that if I lead and reduce the amount of prescribed buprenorphine for the next month, patients often fail to make reductions and end up out of medication before the end of the month. So instead I ask patients to tell me when they are certain that they are ready to stay at the lower dose.
During a taper, I recommend dosing buprenorphine twice per day. Patients start by removing 2 mg from the evening dose. After at least two weeks 2 mg can be removed from the morning dose. This sequence is repeated at intervals of at least 2 weeks until the total dose is 4 mg per day. In my experience patients who get to that point are usually in a good mental position to begin the second, more difficult part of the taper.

Most people will be able to continue working when opioid dose is reduced by 5% or less every 2 weeks, or 10% every month. That number is a good general guideline when deciding how fast to taper. Suboxone film makes tapering relatively easy. Patients purchase a weekly med organizer, and start the week by opening and stacking 7 films. A scissors or razor is used to cut a millimeter from the end of the stack, and one film is placed in each compartment of the organizer for that day’s dose. When the patient is comfortable with that dose, slightly more is removed for the next week. The process continues every 2-4 weeks, eventually changing to the 2 mg films. I recommend that patients continue tapering until the dose is 300 micrograms (0.3 mg) per day or less before stopping buprenorphine completely. It is fairly easy to guesstimate where to cut the film in order to reduce by 10%; just measure half, then half of that, then half of that.

Buprenorphine tablets, of course, are much harder to divide. Zubsolv did people a favor by coming out with a range of doses, and hopefully other brand and generic manufacturers will eventually follow suit. For now I usually have patients use the tablets to taper as far as possible, using the 2 mg tablets in the lower dose range, and then pay the extra cost for the film for the final month or so. A 12 mg film can be divided into 24 half-milligram pieces without too much effort, so the cost doesn’t have to be prohibitive.

I have had many patients taper successfully off buprenorphine. Fear is common and normal for a number of reasons, but the fear usually gives way to a sense of confidence and optimism when a taper is done correctly.
Things to keep in mind:

Be patient. Tapering by too much, or too quickly, causes withdrawal symptoms that lead to ‘yo-yos’ in dose.
Buprenorphine products are very potent. A sliver of Suboxone Film may contain enough buprenorphine to harm or kill an animal or small child. Take care to divide the medication in a well-lit setting, and clean up very carefully.
Buprenorphine is used to treat pain in microgram doses. If you jump from 1 mg, you will have considerable withdrawal symptoms.
If you are still running out of medication early, it is not time to taper off the medication.
People on buprenorphine for a year or less have rates of relapse over 90%. In my experience patients are more successful tapering off buprenorphine if they have been on the medication for 2-5 years or more.
If you struggle in tapering down to 8 mg, consider going back to your stable dose, waiting 6 months, and trying again.
People addicted to opioids often substitute other drugs for their drug of choice. Do not start a new addictive substance in order to get off buprenorphine.

Good luck!

Tapering Off Buprenorphine or Suboxone pt. 1

Many patients taking buprenorphine live in fear of a dark world around the corner where they will have to taper off the medication. They see horror stories on YouTube posted by people who, for some reason, abruptly stopped the medication and kept a video log of their experiences. My own patients sometimes ask, nervously, if I plan to retire some day. Some have asked what they should do if I ever, say, drop dead.

It needn’t be all that bad. Yes, sudden discontinuation of a typical dose of buprenorphine will result in withdrawal symptoms. But if you taper correctly, your body will slowly reset your tolerance without putting you through the wringer. In this post I’ll describe my typical approach to helping a person through that process. But first we should correct some of the misconceptions about buprenorphine and opioid dependence.

It does NOT get harder and harder to stop buprenorphine the longer you take the medication. I have heard that idea over and over in one form or another, and I presume it comes from the experience people have with active addiction where use tends to grow with time, and other facets of life gradually fade away. But the opposite occurs in patients treated with maintenance agents like buprenorphine or methadone, where use of the medication does not trigger a reward or relieve the ‘punishment’ of withdrawal. The conditioning that occurred during active addiction is slowly extinguished, and most people gradually lose the desire to use opioids. I’ve witnessed this process literally hundreds of times over the past 12 years in patients on buprenorphine or methadone. Patients of successful treatment also develop interests and accomplishments that help them avoid returning to opioids. And after a few years away from ‘using friends’, people no longer see themselves as part of the using scene. Patients get to a point where they have too much to lose to get close to that world again.

Opioid withdrawal has physical and psychological dimensions. During short-term detoxes, minor physical symptoms trigger fears that magnify the perception of those symptoms. A bead of sweat on the neck signals that hot flashes, diarrhea, and depression are on the way. Patients who have been away from the cycle of using and withdrawal don’t seem to have as many emotions about their physical symptoms. I see the change very clearly in methadone-assisted treatment, where the minor withdrawal at the end of the day is a big deal to people starting treatment, but a minor inconvenience in patients tapering off methadone after several years of treatment.

Does buprenorphine ‘get in your bones’? YES, of course! Bones are living tissue, so anything in the bloodstream gets in the bones. Glucose gets in your bones. Aspirin gets in your bones. But so what? When you taper off buprenorphine, the buprenorphine in your body will be metabolized and removed. It does not accumulate or stay in bones or other tissues beyond what occurs with other fat-soluble molecules.

Is buprenorphine or Suboxone ‘the hardest opioid to stop’? No. The brain keeps no record of the molecules that pushed opioid tolerance higher. The challenge during a taper is that opioid receptors have become down-regulated by opioid stimulation, resulting in reduced endorphin tone as the opioid is removed. Opioids that leave the body quickly tend to have more-intense discontinuation effects than those that leave more slowly because the latter mimics a taper, where opioid activity decreases over time. The longer half-life of buprenorphine also slightly extends the total period of withdrawal by a few days.

I’ve heard people claim that ‘heroin was much easier to stop’, and rather than tell people what they should think I’ll let them have their opinions on the issue. But that opinion is not supported by studies comparing withdrawal from different opioids. Usually the claim is followed by the comment that ‘with heroin I was fine after 4 days’ or something along that line. But it takes longer for tolerance to reset, after ANY opioid. I suspect that perception comes from the severity of early heroin withdrawal, making subsequent weeks easier by comparison. Again, the brain doesn’t care which opioid you used to take; it only cares that the opioid stimulation that was there is now gone.

In a few days I’ll share the approach I recommend to patients tapering off buprenorphine.

Addiction Treatment, Science, and Dead Rats

In my last post I teased that I would write about fake science. I’ll try to make it interesting.

The internet allows everyone to do research about symptoms and treatments for any condition. If not for need for prescriptions, people could act as their own doctors. But a huge dose of caution is necessary before anyone takes that path.

Realize first that doctors don’t treat themselves or even their family members. The saying that ‘a person representing himself in court has a fool for a lawyer’ applies double in healthcare. Treating someone close to one’s self introduces a bias that is hard to explain, but easy to notice. As an example, I see a doctor annually to monitor a progressive condition that threatens my vision. I would like to know the answer to a simple question: how bad is it? If I have a patient with that condition I can look at images of his/her retina and have an immediate, rough sense about what the person is facing. But when I look at my own images and test results I sense nothing beyond fear or relief. The problems with self-assessment are of course greater in the field of psychiatry and addiction. After my relapse in 2001 I was told I needed treatment, and my assessment called for a brief refresher course on the twelve steps. Three months later, still in residential treatment, I recognized how wrong I was.

A larger problem is that research on the internet is nothing like the research used by doctors or scientists. There are a few sites that offer true research, such as Pub Med, where you can search my name and see the articles from my PhD work in the 1980s. Doctors at academic hospitals or institutions often have access to an electronic database including thousands of peer-reviewed journals. In grad school I spent time each morning in the library, reading the Science Citation Index for new stories about vasopressin and then searching the stacks for the article (medical libraries have so many journals that they take up 4 or 5 floors or more of a large building, with narrow halls between floor-to-ceiling shelves). In the stacks I sometimes realized I was standing amidst the results of the hard work of millions of scientists over the past 50 years.

The information on the internet is useful because it helps patients ask the right questions. But it is a mistake to consider it as research, or even to assume it is correct. Doctors and scientists (and any good health practitioners) rely only on peer-reviewed literature. And even then, a good scientist gathers a sense, over time, of the better peer-reviewed journals vs. the ones with less credence. What is peer review? When a scientist submits research for publication, the article is sent to 3 or 4 independent reviewers who work in the same field but have no connection to the author of the study. I am a peer-reviewer for a couple of journals. When I receive an invitation to review a study I have to disclose any bias or connection to the study or authors. If I accept the invitation I have several weeks to carefully review the study, noting if the findings are valuable, whether the groups were sufficiently randomized and blinded, whether the statistics are correct or if a statistician should be involved, and whether the findings support the conclusions. I then tell the journal editor my opinion, including whether the study should be accepted, rejected, or accepted with certain revisions. Peer reviewers are not paid; they provide the service because they recognize that the process is necessary and valuable.

The FDA regulates medications based on the results of research studies. Some of the studies reviewed by the FDA are already published, and some may never end up in a formal publication. But their process for evaluating medications is similar to the work of a peer-reviewer in that they determine whether the science is ‘good’ – double blinded, properly randomized, good statistics, etc. Any claims about a medication MUST be deemed accurate by the FDA.

This post was inspired by an ad for Declinol, a supplement marketed to ‘treat’ alcoholism. Supplements are not medications, and not subject to the same rules. Read the FAQ on the Declinol web site and note the answer about FDA approval. Declinol is not subject to FDA approval because it is a nutrient, not a medication. The FDA allows greater latitude for promotional claims about nutrients, but even makers of supplements are not allowed to lie. The acrobatics of marketers of such products are sometimes funny, at least to us nerds, and Declinol is a classic example. Note that the web page doesn’t say that it treats alcoholism or cravings; it is a ‘SUPPORT for physical cravings, calmness, and overall well-being’. What is a ‘support’? Your guess is as good as mine.

Instead of making claims that can be found to be false, nutrients often show quotes by ‘satisfied customers’. If the FDA believes that the quotes are misleading, that’s on ‘Bob from California’, not on the marketer of the nutrient. Instead of describing how the nutrient works, nutrient marketers provide citations about the nutrient that support whatever the marketers want you to think. So with Declinol we see ingredients like folic acid, with broad generalizations about the value of that substance. Yes, Folic acid is valuable. You can’t live without it. But that’s a far cry from saying that taking extra folic acid has any value, let alone value in reducing alcohol intake. We give folate to alcoholics in detox because they sometimes have dietary deficiencies caused by consuming nothing but alcoholic beverages. If you eat meals a couple of times per day you almost surely have plenty of folic acid in your body, and any extra is metabolized and excreted.

Must nutrient ‘treatments’ or supplements contain a blend of vitamins. It is very easy to write reassuring and positive statements about vitamins because by definition, vitamins (the term comes from ‘vital amines’) are molecules critical to normal function. But many studies have shown that a typical diet provides adequate amounts of vitamins, even if that diet includes fast food.

Many nutrient ‘treatments’ also contain a couple special ingredients we’ll call ‘secret sauce’. One secret sauce in Declinol is Kudzu, and support for Kudzu in reducing alcohol consumption can be found on Pub Med. Like similar products, Declinol’s marketers take a finding about a substance and grossly generalize the findings to create an impression that was never part of the original finding. According to the study about Kudzu, 20 people in a ‘natural settings laboratory’ (is that an oxymoron?) were given water, juice, and up to six beers, and told to drink at will. And (wow) when people were given 2 grams of Kudzu first, they drank beer more slowly, and opened fewer bottles.

A couple of problems, though, in concluding relevance to treating alcoholism. Were the 20 subjects alcoholics? It doesn’t say, but I would guess not because I don’t know if a study giving beer to alcoholics would pass the ethical review board. Beyond that, WHY did they drink less alcohol? If I gave you syrup of ipecac, you would probably drink less alcohol. If I gave you a tablet of oxycodone, you would probably drink less alcohol. That doesn’t mean that the substances are useful in treating alcoholism or alcohol cravings. Why did the Kudzu group drink less alcohol? Did it truly reduce interest in alcohol in a study with very few subjects who may or may not have alcohol problems? Or did it leave a nasty taste in their mouths or destroy their taste buds? Did it cause nausea or dizziness that made alcohol less enticing? Did it reduce vision so they couldn’t find the beer bottles as easily?

As for the title of this post, when I researched vasopressin one hot idea was that vasopressin enhanced learning and memory. We measured that improvement in studies using ‘passive avoidance.’ We placed rats in a cage that had dark cubbies in one corner, and when rats invariably went into a certain cubby they received an electric shock. We repeated the task with or without putting vasopressin into the rats’ brains and some rats ‘learned’ to avoid the electric cubby, supposedly by remembering the shock better than other rats. There is a major flaw in the study that can often be applied to other ‘experiments’, including the one I cited about Kudzu: the best performer in a passive avoidance task is a dead rat.

I have no idea whether Declinol reduces cravings or generates ‘well being’, whatever that is. But nothing on their website pushes me toward that conclusion. I hope readers will keep some of these comments in mind when the next big cure comes along.

Buprenorphine, Not Subbies

I’ve been writing longer and longer posts on SuboxForum so maybe I need to write more here. This blog archives twelve years of frustration over the ignorance toward buprenorphine, at least until I ran out of steam a year ago. I grew used doctors refusing to treat people addicted to heroin and other opioids. I became used to the growth of abstinence-based treatment programs, even as relapse rates and deaths continued to rise. It isn’t all bad news; I enjoyed the past couple meetings of AATOD, where people openly spoke about medication-assisted treatments without hushed voices. I feel like I’m the conservative one at those meetings!

I don’t remember where I heard first – maybe in an interview with some reporter about addiction- that I was an ‘influencer’ with buprenorphine. The comment surprised me, because from here I don’t see the influence. My supposed influence is from this blog, although I may have changed a couple of minds in my part of my home state among my patients, who had to sit across from me and hear me talk. For an ‘influencer’ I’m not very happy about how many buprenorphine-related things have gone over the years. I still see the same reckless spending of resources, for example. A couple million people in the US abuse opioids, and only a fraction receive treatment.

Those are big things, and anyone reading my blog knows all the big things. I want to write about the little things. The easiest way to have influence is to write about the things that nobody else writes about. After all, that’s what made me an influencer in the first place, back when I had the only buprenorphine blog out there. Here’s what I want to influence: If you’re trying to leave opioid addiction behind, do not call buprenorphine ‘subs’ or subbies.

On the forum I try to keep things real – not in a cool way, but in a medical or scientific way. I want people to use . I know I sound like some old guy frustrated by all of the new words and acronyms on social media. YES, dammit, I AM frustrated by those things! But communication has become so…. careless in the era of Twitter and texting. Find an old book and notice the words and phrases used by educated people 100 years ago. Or look in the drawer at your mom’s house where she kept letters from your dad, or from her friends. Does anyone communicate in sentences anymore?

I’m not crazy (always pay attention when you catch yourself saying that!), so I realize this isn’t the start of a wave (what color would THAT one be?) But I might show a couple people how loose language is used to take advantage of healthcare consumers. In the next post I’m going to show an example of ‘fad-science’ masquerading as alternative medicine, promoting substances that avoid FDA scrutiny by identifying as nutrients and not drugs. Some large scams benefit from the informal attitudes toward health and medicine; attitudes that might encourage more discussion about health, but also lead people to think that medical decisions are as easy as fixing a faulty indicator on the dashboard with the help of a YouTube video. As in ‘I can treat it myself if I can find the medicines somewhere.’

The point is that common talk about medicines is helpful unless it isn’t.
Many people in my area addicted to opioids treat themselves with buprenorphine, either now and then or in some cases long-term. Is ‘treat’ the right word? From my perspective I’d say yes in some cases, and no in others. Last year I took on 4 patients who were taking buprenorphine medications on their own, paying $30/dose, for more than a year. They said (and I believe them) that they hadn’t used opioid agonists for at least that long. I’ve also taken on patients who used buprenorphine but also used heroin, cocaine, and other illicit substances. There is a big difference between the two groups in regard to level of function, employment, relationship status, emotional stability, dental and general health status, and finances. Another difference between them is that people in the first group talk about taking buprenorphine or Suboxone or Zubsolv. Those in the second group talk about finding subbies.

I also have patients in my practice to whom I prescribe buprenorphine, who sometimes talk about subbies, or subs, or ‘vives’, or addies. I correct them and tell them that I have a hard time trusting patients who talk that way. After all, those are street terms. A pharmacist doesn’t say ‘here’s your subs!’

So here’s the rub. Should I discharge these patients? Should I assume from their language that they are part of the street scene, and maybe selling medication I’m prescribing? Or should I just watch them closer and be more suspicious, doubling the drug tests and pill counts? Should I tell the police?
No, of course not. I took it that far to make a point about slippery slopes, and the struggle to find a foothold while sliding.

But I will continue to correct them, and let them know that their words create a certain impression. Getting that point across would be enough influence for one day!

Help for Heroin Addiction

A couple comments for regular readers… first, watch for an upcoming change to a new name. For years I’ve debated whether to adopt a name centered on ‘buprenorphine’, rather than the more-recognizable ‘Suboxone’. I believe that time has come. Second, I’m going to ‘reset’ with some introductory comments about the proper approach to treating heroin addiction, intended for those who are seeking help – starting with this post.
I’m addicted to heroin. Which treatment should I use?

I’ve treated heroin addiction in a range of settings, including abstinence-based programs and medication-assisted treatment with buprenorphine, naltrexone, and methadone. My education prepared me for this type of work, and my personal background created empathy for people engaged in the struggle to leave opioids behind.

The first barrier to success is on you. Are you ready to leave opioids behind? How ready? Are you so ready that you will be able to end relationships with people who use? Are you ready to stop other substances, especially cocaine and benzodiazepines? You will find help during treatment and you don’t have to take these steps entirely on your own. But you must at least have the desire to get there.

If you’re ready, the next step is deciding the treatment that is likely to help you. Many people see abstinence-based treatment as a ‘gold standard’ – the ultimate way to escape opioids. Unfortunately, that belief has fueled many deaths over the past ten years, as desperate people paid large sums of money for themselves or loved ones expecting programs to alter personality over the course of three months. It doesn’t work that way for most people!
During several years working in abstinence-based programs, I helped fix people who were broken by addiction. After a couple months, people left treatment with healthier bodies, cleaner complexions, and better hair. But over 90% of those people returned to opioid use, some within a few days. Some of them died because of their new lack of tolerance to opioids. In each case, counselors said the same thing: ‘he/she didn’t really want it’. But I remembered that they DID ‘want it’ when they were in treatment. In fact, some were considered star patients! At some point we must hold treatments responsible if they fail over 90% of the time.

My perspective changed. Now I wonder, why does anyone expects those treatments to work? A person is removed from a life of scrambling and drug connections and poverty, placed in a box and shined up for a few months, then put right back in the same using world and expected to act differently?
I eventually learned about medications that treat opioid addiction. I realized that opioid addiction truly is a medical illness that should be treated like any medical illness. Think about it – we treat high blood pressure, asthma, and diabetes over time. We don’t cure any of them. In fact, the only illnesses that we can cure are infectious diseases, and even that accomplishment is fading as organisms develop resistance to current medications. Given that we can’t really cure anything, why do we expect anyone to cure addiction – in 12 weeks?!

Medication-based treatments for addiction represent a transition to normalcy. Doctors and nurses were removed from treating addictive disorders decades ago because of historical events that I’ll eventually write about. Clearly, it’s time for health professionals to take a role in treating addiction. In the next article I’ll discuss the medications currently available, and the reasons that one might work better than another for certain individuals.

In the meantime please check out my youtube videos under the name ‘Suboxdoc’, where I discuss the use of medications, primarily buprenorphine, for treating addiction to heroin and other opioids.

The Other Opioid Crisis: Hospital Shortages Lead To Patient Pain, Medical Error

I came across this public-accesss story, and wanted to share the perspective:

Pauline Bartolone, Kaiser Health News
Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.

The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.

As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.
In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which can be up to 10 times more powerful than fentanyl, the ideal medication for that situation.
In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can. Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases. Other patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.

The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.

Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.

The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.

In a Feb. 27 letter to the U.S. Drug Enforcement Administration, a coalition of professional medical groups — including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists — said the shortages “increase the risk of medical errors” and are “potentially life-threatening.”

In addition, “having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients,” the group wrote.

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.

Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.

Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.

Marchelle Bernell (Courtesy of Marchelle Bernell)
Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.
Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.

“The system has been set up safely for the drugs and the care processes that we ordinarily use,” said Dr. Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women’s Hospital in Boston. “You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”

Dr. Beverly Philip (Courtesy of the American Society of Anesthesiologists)
Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.

“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.”

During the last major opioid shortage in 2010, two patients died from overdoses when a more powerful opioid was mistakenly prescribed, according to the institute. Other patients had to be revived after receiving inaccurate doses.

The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.

A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kan. The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.

That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.

Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.
At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.
“DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances,” the agency said in August.

When the coalition of health groups penned its letter to the DEA last month, it asked the agency to loosen the restrictions for liquid opioids to ease the strain on hospitals.

The shortages are not being felt evenly across all hospitals. Dr. Melissa Dillmon, medical oncologist at the Harbin Clinic in Rome, Ga., said that by shopping around for other suppliers and using pill forms of the painkillers, her cancer patients are getting the pain relief they need.

Dr. Shalini Shah, the head of pain medicine at the University of California-Irvine health system, pulled together a team of 20 people in January to figure out how to meet patients’ needs. The group meets for an hour twice a week.

Dr. Shalini Shah (Courtesy of University of California-Irvine)
The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.

“We essentially have to ration to patients that are most vulnerable,” Shah said.

Two other California hospital systems, Kaiser Permanente and Dignity Health in Sacramento, confirmed they’re experiencing shortages, and that staff are being judicious with their supplies and using alternative medications when necessary. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
At Helen Keller Hospital’s emergency department in Sheffield, Ala., earlier this month, a 20-year-old showed up with second-degree burns. Dr. Hamad Husainy said he didn’t have what he needed to keep her out of pain.
Sometime in January, the hospital ran out of Dilaudid, a drug seven times more potent than morphine, and has been low on other injectable opioids, he said.

Because Husainy’s patient was a former opioid user, she had a higher tolerance to the drugs. She needed something strong like Dilaudid to keep her out of pain during a two-hour ride to a burn center, he said.
“It really posed a problem,” said Husainy, who was certain she was in pain even after giving her several doses of the less potent morphine. “We did what we could, the best that we could,” he said.

Bernell, the St. Louis nurse, said some trauma patients have had to wait 30 minutes before getting pain relief because of the shortages.
Dr. Howie Mell (Courtesy of Howie Mell)

“That’s too long,” said Bernell, a former intensive care nurse who now works in radiology.

Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl.

Mell, who is also a spokesman for the American College of Emergency Physicians, said some emergency departments are considering using nitrous oxide, or “laughing gas,” to manage patient pain, he said.
When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.

“But they didn’t,” he said.

Missing the Point of Buprenorphine Treatment

A forum reader wrote about concerns over a partner on buprenorphine. Her concerns pointed out a common misperception about the goals of treatment of opioid use disorder using buprenorphine, or using methadone for that matter.

Her question, amended for privacy:
I married the love of my life. He is still he love of my life but has been an addict for 15 of them. Our children have been greatly affected by his addiction. He made promise after promise that he was clean, and I dove back in with complete faith time after time only to get burned.

His addiction started with recreational pills increasing over time, but now he is abusing Suboxone. He was taking up to 12 mg depending on the day, but no pain pills for the last year. I suggested a Suboxone doctor and a plan to get off, and my husband called one and was able to get right in.

At the visit the doctor did a half ass intake and called in a prescription for an 8 mg tab for induction. After induction they called in prescription for 20 mg/day. My husband stayed with 4 mg once a day and was “blah” in the afternoon and irritable but not physically sick. On his next visit to the doctor he was proud, but when he told the doctor he had only take 4mg in the mornings she got angry. She told him she wouldn’t see him anymore if that’s what he was going to do. He asked how long he would be on it and she wouldn’t give any kind of answer. I asked again before we left and she snapped at me.

I see a profound change in him after each time we see her and she tells him to take more. We walked away last time with another prescription for 16 mg a day which is just about double what he’s been taking for the last year and a half. So my question is, how does it make sense to treat someone taking 8 mg as their addiction with the same medication at double the dosage? Since seeing her he has decided he needs to take it more than once a day as well as up the dosage. Is this right? Is it right to treat Suboxone addiction with Suboxone? A heroin addict isn’t treated with more heroin and a pill addict isn’t treated with more pills. While I understand the concept of treating his original pill addiction with Suboxone, I am having a very hard time wrapping my head around what’s happening.

Me again…
The writer raises interesting questions. Regarding the ‘drug for a drug’ questions, buprenorphine has significant pharmacologic differences from heroin or pain pills. Those differences, including the long half-life and ceiling on agonist effects, allow the medication to create a level degree of mu-receptor agonism across the dosing interval. Tolerance to that level mu agonism allows patients on the medication to feel ‘normal’ throughout the day, or at least normal from an opioid standpoint.

But her broader point provides an example of the basic misunderstanding many people have about medication assisted treatment, in focusing on the same short-term goals that their addicted loved ones have focused on: controlling the dose of opioid and tapering off. That goal is natural, of course; anyone who loves a person addicted to opioids wishes and hopes that the person will reverse the using behavior and climb down from opioid use. Those hopes are bolstered by ads for rapid detox, even as studies show that detox is mostly useless.

My response to her:
I would not be concerned about increasing the dose of buprenorphine, because there is no increase in effect after a dose of about 8 mg per day. A higher dose might reduce mild withdrawal symptoms at the end of the dosing interval, and sometimes provides a reduction in cravings through a placebo effect.

So why increase? Because the goal with buprenorphine treatment is to put cravings into remission for a considerable length of time. If your husband is still having cravings as he gets by on 8 mg, then his dose is not high enough. Buprenorphine is a safe medication that is used as a tool to extinguish the conditioning that was part of your husband’s addiction.

One of my patients saw a different buprenorphine physician for years, and her dose was constantly lowered over the past year. She would run out of medication after 24 days each month and then go without for 6 days, craving opioids and experiencing wtihdrawal during that time. In some ways, her entire time in treatment was a waste. She could boast, I suppose, that she was prescribed less buprenorphine over time. But in most ways she is just as far from stopping opioids as when she entered treatment, still lying to her husband, lying to her doctor, and feeling ashamed of herself. All of those things keep her addiction in the dark, where it stays active.

When I started treating her my goal was to promote legitimate behavior. I increased her dose to 12 mg per day, from 8 mg. After a month she still ran out early, So I raised the dose to 24 mg per day. Now, after 6 months, she has taken the medication as prescribed. Her focus on buprenorphine is going down, as we want it to do. She isn’t lying, and she isn’t craving pain pills or buprenorphine. My goal is for her to take the medication like she would take a vitamin or blood pressure pill, without any special attention or interest.

How long will we do this? I can’t say now. We know from research that the longer a person stays on medication, the less risk of relapse after stopping. I don’t like to push anyone off buprenorphine, because I’ve seen so many people who have relapsed after being pushed off by their former doctors. I find that many people eventually decide that the time has come to taper off buprenorphine, and those efforts are usually successful. From my perspective, people forced to taper off buprenorphine do not generally do well. That perspective is just an opinion, but an opinion based on treating 800 people with buprenorphine over the past 11 years.

Opinions aside, the goal is not about getting off opioids as fast as possible. Your husband can accomplish that in a couple weeks with a remote hotel room and a bottle of clonidine, or a couple weeks in jail. But those experiences rarely lead to prolonged abstinence, and they sometimes precede overdose, when people return to using with a lower tolerance.

I can’t tell whether your husband’s doc is on the right track or not– but she might be. She is a better doctor telling you that she can’t give a time estimate, than a doctor telling you he will be off in 3 months. Ideally, your husband will be in a state of ‘remission’– on a dose of buprenorphine that virtually eliminates interest in opioids– for a year or more. He can taper for some of that time, but the taper should be slow enough that he doesn’t return to using. If he returns to active use, he starts over in many ways.

Try to drop the focus on ‘how much’ or ‘how long’. Those things are not important; what is important is to get his interest back on you and the family, not on buprenorphine or other opioids. That will be easier if you let him know that he has your support, even if he takes a medication, and even if he needs that medication for a long time. You would want the same from him if you ever needed a medication for hypertension, diabetes, or anything else.

Brandeis and CDC Wrong on Buprenorphine PDMP Data

I’ll share an interesting story about the data used for the prescription drug database in Wisconsin and other states. I’ve been holding back on writing about this issue in hopes that the reason for the story would be corrected, and I would have no story to tell. But that hasn’t happened.

A new law in Wisconsin requires all prescribers to check the prescription drug database when prescribing any controlled substance. I’m surprised that no privacy advocates have complained about the database, which tells prescribers about the controlled substances used by their patients over the past 5 years, the pharmacies their patients used, and any suspicions of law enforcement about their patient in regard to controlled substances. The database, or PDMP, is a significant tool for preventing doctor-shopping and diversion. But the PDMP provides a great deal of information about activities by patients that they rightfully believed to be private just a few years ago.

But this story isn’t about privacy. I’ll leave that for another day. This story is about the information provided by experts at the CDC, the top health agency in the world, about buprenorphine. A mountain of nonsense about buprenorphine permeates healthcare, law enforcement agencies, and addiction treatment programs. But one could optimistically expect the CDC to get it right. Right?

When a prescriber follows the new law and looks up a patient on the PDMP, the web page includes a graph that displays the patient’s use of opioids over the past three months, displayed as the oral morphine equivalence. The graph has a blue line on the graph that represents 50 mg of oral morphine per day, and a red line that represents 90 mg of morphine per day. Another line represents the patient’s daily opioid dose, and the entire graph is shaded red during the time that the patient also used benzodiazepines. Neat!
For most patients, the red and blue lines are clearly visible, and the patient’s opioid use is displayed in relation to those lines. But for patients on buprenorphine, the red and blue lines are pushed against the bottom of the graph by the line that shows the patient’s opioid usage. Why? Because according to the PDMP, a patient on 16 mg of a buprenorphine medication is taking the equivalent of 900 mg of morphine per day!

Anyone with a basic understanding of buprenorphine knows about the ceiling effect of the drug. Unlike with opioid agonists, the opioid potency of addiction-sized dosages of buprenorphine cannot be directly extrapolated from the potency at lower dosages. With oxycodone, 10 mg of the drug is ten times stronger than 1 mg of the drug. With buprenorphine, 2 mg of the drug is about as potent as 8 mg, which is about as potent as 24 mg. The PDMP, though, shows 16 mg of buprenorphine to be 16 times stronger than 1 mg of buprenorphine.

When I noticed the error in the data I emailed the people who developed the Wisconsin PDMP. They responded and wrote that they appreciated the information, but Brandeis University provided the data about opioid dose equivalency, so Brandeis was responsible for the accuracy (or lack of accuracy) of the data.

So I wrote to the folks at Brandeis who provided the information for Wisconsin and other states’ PDMPs. They responded that THEIR information comes from the CDC, and so the CDC was ultimately responsible for the dosage conversion data. They also said that doctors shouldn’t use the information for opioid dose conversions, and there was no danger to that effect because of the fine print at the bottom telling doctors to avoid using the information in that way.

I wrote to the CDC, cc’ing everyone and their cousins to make certain that the right person received my email. I wrote, respectfully, what I’ve written here—that the information about buprenorphine failed to take the ceiling effect into account, and that the misinformation could potentially lead to patient harm, if a doctor did what doctors tend to do, i.e. use the most readily available information about dose equivalency and trust that information, especially if it comes from an official site like their state’s Prescription Drug Database.

The CDC replied with a form-email. Given that a genuine response takes about one minute, I can’t believe that the person who received my email saved a significant amount of time by searching out that reply, but I suppose we citizens would become spoiled if the government responded personally! The form email thanked me for my interest in the CDC, and provided a link where I could read more about the great work they do.

I admit that I get worked up about things sometimes. And yes, I was annoyed to get a form email providing a link to more information from the CDC, after writing to correct their wrong information. So I sent an email expressing that annoyance to everyone in the story up to this point. I’m sure that at least a few of the people in the ‘to’ box had a good laugh, and I suspect that I annoyed a few more. Whatever.

A couple weeks later I noticed a new paragraph under the dose-equivalence graph, telling doctors to avoid using the opioid dose-conversion information to actually convert opioid dosages. The small print at the bottom of the page was made larger, and placed higher in the page, directly below the display of morphine equivalents. I don’t know if the change had anything to do with my emails or was only a coincidence.

But then yesterday I received an email from one of my patients, after he consulted with his surgeon about an upcoming operation. The patient wrote about that doctor, paraphrasing a bit: “she showed me a graph that said my tolerance is equal to 900 mg of morphine. I don’t know what that means exactly but she will need to give me a high dose of pain medicine without killing me.” I eventually spoke with that doctor. Guess where the graph came from?!

This the punchline by the way, in case you’re skimming the story. The patient wrote that his doctor used the PDMP to convert the amount of morphine he would need after surgery, in spite of the ‘warning’ on the web site. What a shock!

I shared my patient’s email with the people at the WI PDMP, Brandeis University, and the CDC, letting them know that even though they added a paragraph to their data telling doctors that their data was nonsense, doctors STILL used that data in a way that could kill somebody.

Should they be proud of that misplaced trust? I have no idea. But why don’t they just USE THE CORRECT DATA??!!

Is Suboxone Potent?

We get about 5000 readers of SuboxForum per day who ask question, provide answers, or share their experiences with buprenorphine medications. If you’re a patient on buprenorphine, consider joining us. It is free, and you’ll find help for starting buprenorphine, tapering off the medication, and everything in between. Or if you’re a buprenorphine prescriber consider joining to see what patients are doing and thinking, and to help answer their questions!

Yesterday someone wrote about the high potency of buprenorphine. He also wrote that it is hard to get off buprenorphine medications. I ended up writing more than I intended, which occurs often and keeps me up too late most evenings. I decided to share my anwer, as the issue comes up often on the forum and in my practice treating patients on buprenorphine medications (Suboxone, buprenorphine, Zubsolv, Bunavail, etc.)

My answer, partially edited:

Yes, buprenorphine is ‘potent’, but that potency is limited. Buprenorphine has strong opioid effects in microgram amounts, which is one aspect of potency. But the potency of buprenorphine is limited to a certain maximum effect, and in that regard buprenorphine is not potent at all. No matter how many milligrams, grams, or pounds of buprenorphine a person ingests, injects, or absorbs sublingually, the medication is NOT more potent than one 80 mg tablet of Oxycontin or five 10 mg tablets of methadone.
Likewise, an adult human cannot typically overdose on buprenorphine alone, even if that person has never used opioids. But it is very easy for adults to overdose from oxycodone or fentanyl. So from the danger standpoint, buprenorphine is not potent at all.

As for the difficulty stopping buprenorphine, the brain has NO idea which opioid drug or medication you are stopping. The brain (more accurately, the neurons in your endorphin pathways) only know that your opioid receptors have a high tolerance, and the activity in those endorphin pathways will come to a halt until tolerance returns to normal.

The degree of misery caused by stopping any opioid is a function of only two things: the degree of tolerance and the rapidness that exogenous opioids are removed. Buprenorphine cannot raise tolerance higher than the effect of 40 mg of methadone, which limits the severity of withdrawal. Almost every heroin addict I’ve met over the past 2 years– about 300 people coming in as new patients in a methadone program– have tolerances much higher than 40 mg of methadone. The average, in my best guess, is 3-4 times higher, judged by the very small effect that 40 mg of methadone has on their withdrawal symptoms.

The severity of withdrawal comes up often, and the reality is very simple. The problem is the change in mu receptors, not anything specific to buprenorphine.

Buprenorphine has features that make it easier to ‘come off’. We always use long-acting agents to taper medications. People coming off Xanax are changed to clonazepam, for example. It is not really possible to taper off something that has a blood level that goes up and down throughout the day. Tapering requires a stable blood level, and that blood level is then slowly decreased. With oxycodone, the blood level goes from very high to zero in 4 hours; with heroin in 8 hours. Medications administered by patch, such as transdermal fentanyl, can be tapered because of the constant blood level that patches provide.

As for the length of withdrawal, it takes 6-12 weeks off exogenous opioids for opioid receptors to return to normal, no matter the opioid. People always remember it differently, not surprising given how memory works. Think back about how long you had pain after your last surgery, or how long you had a bad cough after you had the flu. Unless the memory is pegged to something (like days off work), nobody remembers those types of things. We all have ‘impressions’, formed by what we’ve said or what we’ve read from others. But human memory is not good at remembering how long something happened. That’s probably why women go through pregnancy over and over. They wouldn’t more than once if they remembered the entire experience better!

Thanks for reading, as always. And again, I hope to see you at the Forum!