no clue…

Posted on Tuesday 15 March 2016


Pharmalot
by Ed Silverman
March 15, 2016

After months of controversy, the Centers for Disease Control and Prevention today published prescribing guidelines to address the epidemic of deaths and overdoses attributed to opioid painkillers. The guidelines, which focus on chronic pain except for cancer and end-of-life care, arrive amid intensifying concern over the widely prescribed drugs. Every day, more than 40 Americans die from overdoses of opioid painkillers. And each year, 2 million people abuse or misuse the drugs.

Many state lawmakers have responded to the crisis by introducing bills to restrict prescribing. And the Food and Drug Administration is pushing drug makers to develop more tamper-resistant products. But the CDC guidelines, while voluntary, arguably represent the most sweeping effort to address the problem. “We don’t want people getting more opioids than needed,”  said Dr. Debra Houry, the director of the CDC’s National Center for Injury Prevention and Control. “So we hope this will give patients and health care providers help in assessing the risks and benefits.”

The guidelines are targeted at primary care physicians, in particular, since family doctors write the vast majority of prescriptions for painkillers. Notably, the agency recommends doctors prescribe opioids only after other therapies have failed and rely on the lowest possible doses. The CDC also suggests that short-term treatment — typically, just three days, but sometimes seven days — is far more preferable than long-term use. The overriding concern is that patients who take opioids for extended periods are much more likely to become addicted…
"I’m sorry, but I’m not someone to talk to about pain medications. Several years ago, I cancelled the part of my DEA license that has to do with narcotics and so I can no longer prescribe them. Narcotics are not a psychiatric medication, and I got so tired of being asked and not knowing what to do that I decided to eliminate the problem. The only other alternative was to stop working here." And that’s the truth. Most patients say, "I understand" and then go on to add "It’s a shame that the people who abuse medications make it so hard on those of us who genuinely need them." As a matter of fact, the ones that I’m sure are drug seeking and/or addicts also say that same thing. I have no clue what to do about the opiate problem. These guidelines sound mighty stringent to me, but maybe that’s what it takes. I fear that if they’re too prohibitive, the entrepreneurial cartels will expand even further to fill the void…

UPDATE: It didn’t really occur to me as I was writing this, but in retrospect, I don’t think I was totally forthcoming. One of the factors in how I dealt with this  surely had to do with my own experience. At age 37, half my life ago, my back went out – and it never came back. When it first happened, I was in the hospital and had pain medication of some kind. It was the days before CAT scans and MRIs, and I had a myelogram that was negative. So I left the hospital in a lot of pain with a large bottle of Percocet tablets. When I got home, I took the two that it said to take on the bottle. Within a short time, I had the thought "I can see why people get addicted!" and I never took another one. The euphoria was compelling and I guess it scared me. I’ve intermittently had a terrible time with my back ever since with two major fusions – one several years after it first started and another in my sixties when I had spinal stenosis from the scarring with temporary  paralysis. The only narcotic I took after leaving the hospital was hydrocodone after the surgeries for maybe two weeks. I’m no pain stoic, but I just knew if I took it as long as it felt like I needed it, it would’ve been extremely hard to stop. As it played out, even in that short time, I had mild withdrawal symptoms both times. So I’m hyper about people getting addicted. I’ve seen it happen a lot, and it’s not pretty…
  1.  
    James O'Brien, M.D.
    March 15, 2016 | 8:04 PM
     

    http://www.zerohedge.com/news/2016-03-15/why-do-americans-consume-80-percent-all-prescription-painkillers

    “We are a deeply unhappy nation that has been trained to turn to pills as a “quick fix” for our hurt and our pain.”

    “Yes, there are medical situations that call for prescription pain relievers. But what we are seeing in America today goes far, far beyond that. We are a nation of addicts that is always in search of a way to fill the gaping holes that we feel deep in our hearts. This prescription pain killer crisis is just another symptom of a much deeper problem.”

    I simply never ordered the triplicates so the issue is off the table for me.

  2.  
    Spencer
    March 16, 2016 | 6:33 PM
     

    Glad I found this blog. Thanks for spending time, consistently, on it. I’m a writer first and a psychiatry resident second and am considering starting my own blog, and this looks like a good mentoring blog to follow…

  3.  
    March 16, 2016 | 6:55 PM
     

    Thanks. I’m a psychiatrist first and not much of a writer, but I’ve found that writing the blog frequently has done what “the morning pages” in The Artist’s Way are intended to do. I no longer think much about writing and have learned to think on paper [screen], saving the revising until after the end instead of agonizing over sentences as they’re written. I write more blogs that I publish. It helps separate the writing from the reading and makes me less self conscious. I can’t seem to break the habit of using way too much underlining, bolding, and other “look at this” things. It’s an affliction, I guess. Anyway, good luck.

  4.  
    James O'Brien, M.D.
    March 16, 2016 | 10:25 PM
     

    Spencer M.D.,

    You’re way ahead of the pack if you’ve learned already not to believe everything force fed via Powerpoint and to be skeptical about the quality of research.

    One reason I trust older doctors in general is that they’ve learned not to believe everything they’re told. I was a natural skeptic in training and still I believed too much.

    To be clear, I’m not advocating cynicism, which is unhealthy, but a healthy skepticism.

  5.  
    Joseph Arpaia
    March 18, 2016 | 1:08 AM
     

    I think the guidelines are reasonable but what struck me was the lack of evidence for the most important question of whether opioids have long term benefit for chronic pain. There are NO studies of this. Which means after decades of using them we just don’t know. Absence of evidence is not evidence of absence. So maybe they are helpful, maybe not. Even the other recommendations are based largely on studies that seem to be rather weak. We apparently know very little about the real-world effects of chronic opioid use in real patients in real-world situations, except that they can be addicting, they are dangerous, and when combined with other sedatives they are much more dangerous. In the absence of numerous well-designed studies the guidelines seem reasonable.

    On the other hand I have had quite a number of people sent to me on opioids for chronic pain who absolutely insist that those medications make their lives bearable. While some may disagree, I usually find that those disagreeing have rarely suffered from chronic unremitting pain. Chronic pain is also associated with completed suicide. http://www.ncbi.nlm.nih.gov/pubmed/26860949

    So refusing to treat the pain with opioids because of the risk of overdose seems rather silly if it increases the risk of suicide. However, we don’t know the relative risks of either so the guidelines are not going to help the individual clinician in that dilemma. It takes a lot of work to get the opioid dose down when depression, poor socioeconomic conditions, loneliness and other factors are involved. Manualized CBT is not the answer either. It takes a lot of work building a relationship and reducing the dose over months or years, not weeks, unless you just don’t care if the person decompensates and ends up someone else’s problem. And some people can’t seem to get to zero, and having them buy pills off the street or use heroin doesn’t seem like harm reduction to me. Bup/nal is a good alternative, but insurers don’t seem to want to pay for it.

    Another factor that never seems to come up in the data is how often alcohol contributes to the overdose. A lot of people don’t seem to realize that if they have a couple of drinks or glasses of wine at a party or holiday dinner, they are playing Russian Roulette when they add that to their usual dose of pain medication. They are taking their medications as prescribed and they are not drinking excessively, and so they don’t think they are doing anything dangerous.

    Then there is the whole problem of overprescribing for acute non-surgical pain. My wife and and adult children have been given prescriptions for sore throats, ear infections, and a sprained wrist. They did not fill them and took Tylenol or ibuprofen or used ice for the sprain and were fine, but WTF, opioids for URI’s? a minor sprain? I have patients tell me they went to urgent care with a cough and were offered a prescription for Vicodin. So I was glad to see the guidelines look like they were advising against such. (In my day I had my wisdom teeth out with novocaine and then NSAIDS for pain relief. OK I also walked to school through foot high snow, uphill, both ways.) But really, people are tougher than they have been led to believe. Heck if some women can have a baby without opioid pain meds why is a 20 year old given a prescription of percoset for a sore throat.

    Finally there is the hysteria that seems typical of our species, or maybe its the subspecies Homo Americans. I have had a couple of patients yesterday come in whose well-meaning physician made them feel like an addict because their pain management specialist was prescribing opioids for chronic pain. One has been on 25 mg hydrocodone per day for the last 5 years with no increase in dose. Seriously, an addict??? We seem to have gone from one extreme “Here these pills will cure your pain and are as safe as M&M’s” to “Oh my God you’re on an opioid, that’s going to kill you!!” with no ability to actually think about the particular clinical presentation and short and long-term consequences of treatment on all aspects of the patient’s life, not just their pain. The guidelines seem to be advocating that above everything else and that will be a welcome addition of rationality.

  6.  
    James O'Brien, M.D.
    March 18, 2016 | 1:02 PM
     

    Maybe not an addict but what’s the point? If they’ve been taking Vicodin 25 mg for five years it’s not doing much anyway. And when something does come up like a surgery they’ll have to go higher.

    Opioid overprescription is not something most physicians do, but the ones who do go all out and their numbers of patients and dosages are off the chart. It’s not that hard to identify who they are. Every doc in the community knows it. If a DEA agent asked me for leads, I could instantly name five names that would lead to probable prosecutions after investigations. And I mean criminal not civil as they are starting to put away the worst offenders:

    http://www.latimes.com/local/lanow/la-me-ln-doctor-murder-overdose-drugs-sentencing-20160205-story.html

    The government will screw this up however. I know an ethical pain management doctor who has been raided by the DEA five times. Another pain mgmt. down the street who not only prescribed Norco/Soma/Xanax at high doses routinely for musculoskeletal conditions and then provides Waismann rapid detox for his own iatrogenic mess seems to skate untouched by the authorities.

  7.  
    Joseph Arpaia
    March 18, 2016 | 11:46 PM
     

    @Dr. O’Brien,
    Without having any information about a patient you are not able to judge if a particular regimen of treatment is having a benefit or not. Any statements such as “its not doing much anyway” are clear prejudices.

  8.  
    James O'Brien, M.D.
    March 19, 2016 | 10:42 AM
     

    With all due respect, you never explained what the purpose of the drug was when I asked the question. If you say the patient says it makes them feel better, that’s not evidence. I’ve never seen any evidence in general of the benefit of long term low dose opioids. My statement is just an reiteration of CDCs position and clinical experience which is not “prejudice”. Moreover it was phrased as a question, not a declaration.

  9.  
    James O'Brien, M.D.
    March 19, 2016 | 2:10 PM
     

    By the way, “what’s the point” is a question that should constantly be asked during any med recheck even if it is an ACE inhibitor for mild hypertension and especially the refill of any CNS drug. The inertia of the automatic unquestioned refill without critical examination is the source of many problems in management.

    In addition to the obvious CNS and GI effects, these meds contain Tylenol and can damage the liver. The “distinction” between physical dependence and addiction is not one that can be accurately made without talking to collateral sources. The refill seeker is not going to admit functional impairment.

    Assuming this med was for chronic musculoskeletal pain, my question was quite reasonable and one that every physician should ask.

    Now let’s try to answer the question without a personal attack or splitting doctors into good breasts and bad breasts. Mine wasn’t as I assumed you were not the prescriber in this case and even if you were it was a completely reasonable question.

  10.  
    Joseph Arpaia
    March 20, 2016 | 2:40 AM
     

    Dr. O’Brien, I was trying to point out what seemed to be some inconsistencies or over-reaching in your statements. This was not meant as a personal attack and I apologize if it came across that way. I was not challenging your question, but rather the statement that the medication “is not doing much anyway”.

    The CDC may not believe that long term opioid use has any benefit, but they have no evidence on that question. Their report lists zero studies on the topic. So any belief one way or the other is going to be personal opinion, which is perhaps a more politically correct synonym for prejudice. And I certainly don’t know either, and depending on the day my prejudice varies from yes to no.

    In this case II took over the prescribing from the patient’s neurologist as I see her more frequently, am an addictionologist and spend 45-60 minutes with her when we meet. He was under the impression that it was improving her quality of life to a significant degree and worth the risks, which she agreed with. I have concurred with his assessment thus far. We discuss her level of function and the non-pharmacologic methods she can use to improve that and deal with her depression as well as her pain. The pain scale I use with my patients is based on function, not feeling. 0=no pain; 1-3 = the pain is present but can be ignored; 4-6 = the pain cannot be ignored but does not interfere with important activities; 7-9 = the pain interferes with important activities; 10 = the pain prevents all important activities. The feedback I get from patients about this is that it makes much more sense to them than a scale based on feeling where 10 is the worst pain you ever felt. A patient can lie about their functioning, but its harder to keep the story straight from session to session and among different providers then simply stating how they feel.

    Physical dependence is not addiction as I am sure you realize. I have never seen an addict stay on a low dose of what they were addicted to. If a decrease in dose leads to significant increases in pain and decreases in function with no evidence of withdrawal, then something other than physical dependency or addiction is going on. That can often be a psychological dependence on the medication which is why I am often asked to take over the prescribing. I have more tools to address psychological dependency than other specialists. But that can take time and if the opioid dose is reasonably safe then it is better, IMHO, to take time and address other issues rather than continuing to drop the dose and have the person develop other, more serious problems. Note I just skimmed an article suggesting that if subjects in an acute pain study thought their IV remifentanil was turned off they experienced more pain and their brain activity changed. Its interesting in that it is evidence that negative expectancy causes observable changes in brain function, implying we can’t just ignore it.

    Found the link to full text article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4067746/

    My concerns are motivated by how little we really know about opioids and chronic pain and how the atmosphere seems saturated by rather dichotomous views, or overly simplistic case conceptualizations. I have had patients walk in on 300 mg oxycodone a day where it was quite clear that they had addiction and not pain. Those cases are rare, and its obvious what treatment is needed. However, most of my patients are being reasonably managed by the person prescribing opioids, (their dose of opioid is not excessive), and they have multiple medical and psychiatric and social issues in addition to pain, all of which are also affected by the opioid. These are the patients we need research for, and there simply aren’t enough high-quality studies to guide us.

    I realize that I have been thinking as I write and what I am coming to is this. The reaction from organizations and authorities seems focused on more urine drug testing, limited dosing, administering screening tests, clicking more buttons in the EHR, but nowhere is anyone being given more time to talk with their patient.

    I hope this comes across as a respectful presentation. I also thank Mickey for allowing me to take up so much space in his comments section.

  11.  
    EastCoaster
    March 20, 2016 | 1:49 PM
     

    I don’t want to overly politicize the blog, but I want to highlight the fact that Massachusetts has recently taken steps to address the opioid crisis here. I don’t know enough about them to address the merits, but I do know that the new legislation limits all new opioid prescriptions to a 7-day supply.

  12.  
    March 20, 2016 | 2:27 PM
     

    East Coaster,
    Thanks for “I don’t want to overly politicize the blog” – I don’t either. But if you find out how Massachusetts proposes to regulate things further, let us know.

    Joseph Arpaia,
    You remind us that the person on opioids is still a person.

  13.  
    James O'Brien, M.D.
    March 20, 2016 | 5:21 PM
     

    If the standard is that the skeptics have to prove a negative, then homeopathy is just as valid as EBM. For some reason the most developed and wealthiest country in the history of humanity finds it necessary to consume eighty percent of the world’s prescription opioids. Since there’s no proof that we are in more physical pain than people from Mozambique (and common sense would suggest the opposite), then there clearly are other issues at work.

    I’m not a Calvinist on this issue, but if opioids are being prescribed beyond a couple weeks for other than cancer and serious progressive pain. this choice needs to be reviewed. After years of 300 deaths per week form this, apparently the CDC has come to the same sensible conclusion. What was the underlying disorder? Big difference if it’s gastric cancer or fibromyalgia.

  14.  
    Joseph Arpaia
    March 20, 2016 | 7:40 PM
     

    I am having difficulty following the logic regarding the analogy with homeopathy. I can’t recall the exact articles but I do recall reading ones that claimed that homeopathy did not do better than placebo. That would tend to disprove the hypothesis that homeopathy is more effective than placebo.

    However, there are no such studies for the long-term effect of opioids in chronic pain. I am not asking for a negative to be proven. Support for the negative hypothesis would come from studies which tested the positive hypothesis (long-term opioid medication reduces chronic pain more than placebo) and yielded negative results. However, there do not seem to be any studies at all. I am therefore pointing out that there is no data. No data means no scientific conclusion can be reached. We can form hypotheses based on related evidence, but those hypotheses be quite wrong, hormone replacement therapy for example.

    I stated that I think the CDC guidelines are reasonable. The issue I have is that I am seeing less of the review that those call for, and more knee-jerk reactivity.

  15.  
    Joseph Arpaia
    March 20, 2016 | 8:01 PM
     

    I realized that my “knee-jerk reactivity” phrase might be misconstrued as referring to commenters here. That is absolutely not my meaning.

    I am referring to accounts that I am hearing from more and more of my patients who see pain management specialists in which they experience suspicion or a contemptuous attitude from other doctors who see an opioid on their medication list (which because of EHR hell may not even be accurate).

  16.  
    James O'Brien, M.D.
    March 21, 2016 | 12:29 AM
     

    You mean the EHR which lists the medication as “taking/discontinued” so you have no idea what the hell is going on? I’ve seen that hundreds of times.

    I know people in IT and they tell me the worst of the worst programmers end up in healthcare IT.

    But it’s nice being reminded that the patient does not smoke every three pages.

    Morons. But what are we if we put up with it?

  17.  
    James O'Brien, M.D.
    March 21, 2016 | 12:14 PM
     

    With all due respect, I’m still curious as to what the underlying medical disorder is.

    My point with homeopathy is you can’t prove it is not effective in an individual patient. A negative study on such a subject reaffirms the null hypothesis, it doesn’t disprove effectiveness in an individual. Just about anything can be effective in an individual.

  18.  
    EastCoaster
    March 21, 2016 | 12:20 PM
     

    Mickey – the law was just signed by Governor Baker. There should be write ups. Here’s this from the Globe.

    https://www.bostonglobe.com/metro/2016/03/14/baker-due-sign-opioid-bill-monday/EYWh7oJXvKCRguHErxrWhI/story.html

    On my phone. Apologies for the lack of a hyperlink.

  19.  
    March 22, 2016 | 6:57 AM
     

    EastCoaster,
    Thanks! I don’t know what I think about regulating opioid use by regulating doctors. But I don’t see alternatives either. That’s why I changed my DEA status. I wanted out of the loop altogether because it felt like living chronically in a double bind [which makes people nuts]. We’ll see how it goes…

  20.  
    James O'Brien, M.D.
    March 23, 2016 | 11:32 AM
     

    The foundation of my “prejudice”:

    http://www.fda.gov/downloads/Drugs/NewsEvents/UCM307887.pdf

    not to mention at least three friends and/or relatives who have trouble quitting after getting opioid/Xanax combos for non-cancer pain..so yes this is a bit personal for me too. I’m sure my version of their functional impairment is quite different from their self-reported when refill day comes up…

    in the age of the 15 minute medication visit and HIPAA, dependence v. addiction is a distinction without a difference…

    I am like Mickey, I took the issue off the table by not having the scripts

  21.  
    Catalyzt
    March 24, 2016 | 1:29 PM
     

    <>

    Thank you, Dr. Arpaia. This is exactly the point that is not addressed in Dr. O’Brien’s argument, which I found a little shrill and difficult to follow. (Despite my great respect for the vast majority of his posts here, which have been of great value and comfort through the more difficult days of finishing my internship and starting my practice.)

    And yes, I do have a strong personal bias. I have been taking 10 mg. of hydrocodone every day for over 10 years without increasing the dosage for chronic headaches caused by Mixed Connective Tissue Disorder.

    Going back to Dr. Arpaia’s question, what regimen of treatment might have served me better? Steroids? I did that as long as I could, maybe 5 years, with pericarditis I had no choice, discontinued as soon as I could, no bone or kidney damage that we can see yet. Cannabis might actually have helped if they had a version with no THC, but we don’t have enough research on that, either. DMARDs? Not such a great side-effect profile. (I am curious about the role they played in the death of Glenn Frey.) I may have to start them eventually, but I’m going to try to delay them as long as I can.

    Plaquenil’s side effects are often irreversible, even at low dosages, unlike Hydrocodone at low dosages. I take hydrocodone drug once a day, and I do not use a dose high enough to get rid of the pain– pain is part of being human. But I would like to have six hours a day when I only feel as much pain as most people my age– a few hours to do notes, a few hours with my wife and dogs. And obviously, I don’t take it when I’m seeing clients. For me, the tolerance curve has been very, very flat. The drug does exactly the same thing for me now as it did 10 years ago. I took dilaudid once for dry socket, and it stopped working almost completely by the third dose.

    There are so many patients with connective tissue disorders who have been pressured into taking DMARDs and do not seem to be doing as well as I am at my age. A few in my support group are doing fine at 45, but I wonder how well they will be doing ten years later when their immune system– the part they need– is totally shot to hell and they get pneumonia, which is something you don’t want to have when you have an illness where pulmonary hypertension is the leading case of death.

    There is an obvious and important difference between addiction and dependence, no matter what the DSM V says.

    Another important part of the equation that is rarely asked is not just “Scale the pain from one to 10” but “How long have you experienced this pain?” I understand and respect Dr. Mickey’s decision, but for me, 35 years was the limit. Age is another factor. Hydrocodone would have been a very bad choice when I was 25 years old, just as prednisone would probably be a bad choice now.

    I do not support the new FDA guidelines. I favor changing the cultural and social malaise that is a fertile breeding ground for addiction. I would not like to go back to the days when opioids were part of patent medicines sold over the counter, but I wonder if narcotics caused as much damage to the fabric of society a century ago.

    Thanks for listening.

  22.  
    March 24, 2016 | 1:45 PM
     

    Catalyzt,
    Thanks for telling!

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