This is a repost from my blog on PsychCentral:
There are changes afoot in the use of opioid agonists for chronic pain treatment. This blog has described the epidemic of opioid dependence that has killed tens of thousands of people across the country over the past few years, and the changes are directed toward reducing the harm caused by this epidemic.
A number of interventions have been proposed. Vicodin, the number one-selling medication in the country, contains the opioid hydrocodone combined with acetaminophen, the agent in Tylenol. Hydrocodone and Vicodin are currently ‘Schedule III’ medications, and will likely move to Schedule II, where oxycodone, Oxycontin, and Percocet are currently assigned. The change will have significant impact on the use of Vicodin and hydrocodone, since medications classified as Schedule II must be ordered on written prescriptions—i.e. they cannot be called in to the pharmacy. There are a number of other limitations on Schedule II medications; the prescriptions cannot have refills for example, and a maximum of 90 days of medication can be ordered at any one time. The laws that govern diversion of Schedule II medications are more strict as well, meaning that trading or selling Vicodin or hydrocodone to a friend or relative will carry significant risk of prosecution—and incarceration.
There are proposals for additional certification and training for doctors who prescribe pain medications, beyond the current DEA licenses that typically allow registrants to prescribe all of the controlled substances, without distinguishing between classes or uses of medications. These proposals anger the ‘pain treatment lobby,’ whose members claim that additional certification requirements will lessen the availability of pain medications. And they are correct—that is, after all, the whole point of the proposed changes.
There are a couple issues that merit discussion that have no clear right or wrong answer—at least in my opinion. First, in the debate over additional certification, there is little argument that such changes would reduce the number of doctors who prescribe opioids. Many doctors will decide that it is not worth the hassle and cost to obtain the special certification. Some others will see the requirement as a golden opportunity to leave the pain med prescribing to others, as they will be able to tell their patients ‘I’m sorry—I’m not allowed to prescribe them’—an easy way to avoid confrontation with patients asking for pain pills who doctors consider to have borderline indications for them.
We don’t know, though, whether other doctors will see the changes as business opportunities—growth in a new specialty of ‘pain pill prescribing’ for example—and fill the void left by less-frequent prescribers. And if there is a reduction in pain medication prescribing, will the reduction affect the people who don’t really NEED pain medications—i.e. the patients with mild lumbar strain, who would do much better using a heating pad and ibuprofen, and perhaps learn to lift without bending at the waist? Or will people with severe pain that truly warrants opioid medication find it impossible to have their pain adequately treated?
People should be aware that there are very significant differences in opinion over the proper use of opioid pain medications between physicians. For years, doctors were taught that people with ‘real pain’ rarely become addicted to pain medications. I was stunned when I read a study a couple years ago that claimed that less than 10% of patient who are prescribed pain medications develop opioid dependence. My clinical experience, after working for ten years in pain treatment and for about 20 years as a physician, suggest a number at least five times higher.
More and more doctors are realizing that for most people, opioid pain medications do little to increase function. People become tolerant to whatever dose of pain medication they are taking, and with that tolerance, the pain relief goes away—unless the dose is increased, which only repeats the cycle at a higher tolerance level. Patients become slaves to their medications, developing severe withdrawal from missing even one dose. Their high tolerance makes it difficult to treat pain from surgery, or from other painful conditions that the patient may develop. Finally, there is more and more evidence for the phenomenon of ‘opioid-induced hyperalgesia’ where pain symptoms are ultimately increased by opioid pain medications.
But patients still want pain medications when they are in pain, no matter how many lectures they hear about ‘decreased function,’ hyperalgesia, or tolerance. Doctors are placed in the position of giving patients what they ask for, even if it is ultimately bad for them— or protecting patients and standing up to their anger. Standing up to patient anger is not what many doctors signed up for when they went to medical school, and goes against their desire to help people—and to be liked for helping people.
And I don’t know if any course or certificate will help doctors deal with THAT.
Humana Health Insurance recently revised their guidelines to ultimately reduce the number of scripts for Suboxone that they will cover. I am in the process of writing the Humana Grievance Department a letter to regain coverage for a patient who was doing very well on the medication. To provide context, last week I learned of a former patient who had stopped buprenorphine for his own reasons, who passed away a few months later from on overdose of heroin. And then this morning a patient told me about her nephew, who at the age of 16 is in a coma after an overdose yesterday.
Buprenorphine has the power to prevent these and other deaths from opioid dependence. But patients must have access to the medication. Many barriers exist; doctors are reluctant to prescribe, afraid of their practices being open to random DEA audits, unwilling to take on the additional paperwork, or not interested in attracting an ‘unsavory element’ to their practices. And buprenorphine-based medications are too expensive. A cost of $6-$12 per day sound reasonable for a life-saving medication, but $360 per month is a large expense for someone with piles of debt, trying to make a new start.
Then there is insurance. This is a case where good policy from insurers will literally save thousands of lives. But Humana, by playing doctor, will do the opposite — i.e. cause the deaths of many people. I’m sure this sounds like an exaggeration– like I must be using scary words to make a point? I wish that were the case! Humana is playing with just enough knowledge of science to deny claims– and in THIS situation, make no mistake– the result will be dead teenagers. Don’t kid yourselves, Humana.
This gets a little complicated… and while I think of it, please consider forwarding this to your local newspaper, just in case somebody with access to the press wants to save some lives.
The patient of reference has been doing well on buprenorphine for a couple years. In January, Humana changed their policies such that the medication is no longer covered. The patient cannot afford to purchase the medication out-of-pocket– after all, that is why he pays for a good health insurance policy! Humana didn’t just remove buprenorphine completely, as that would have resulted in lawsuits that they would have clearly lost. Instead, they used various drug interactions to make people ineligible for the medication, under the guise of ‘good medicine.’ The problem with this approach is that we docs know that nowadays, virtually every medication out there interacts with other medications. We all have computer programs or reference texts to quickly sort out these interactions. And when interactions are found, we don’t just drop the medication; we use our knowledge of biochemistry and pharmacology to prescribe safely– sometimes with different medications, and sometimes with different dosages of the same medications. That is why medical school lasts four years!
The denial states ‘to meet medical necessity guidelines for coverage, the member must meet the following criteria: member is not concurrently using ANY narcotic painkillers, methadone, azole antifungals, protease inhibitors, macrolide antibiotics, benzodiazepines, cimetidine, or sodium oxybate. This coverage determination was based on the Humana Pharmacy and Therapeutics Buprenorphine Containing Products Coverage Policy.
I will paste my appeal letter to the insurer below; the letter will explain my problem with the insurer’s policy.
Dear Medical Director,
I am writing to appeal the denial of coverage for buprenorphine for maintenance treatment of opioid dependence for a patient in my psychiatric practice, Mr. XXXXXXX. Mr. XXXXXXX has been treated using buprenorphine for the past year, and has done well with this treatment, with no episodes of relapse.
The denial letter includes what is described as Humana’s Pharmacy and Therapeutics Buprenorphine-Containing Products Coverage Policy, but does not specifically identify the reason for my patient’s denial. For that reason, I will address several issues that are included under your stated policy, after first addressing an issue that is not part of the policy, i.e. length of treatment.
Length of coverage for buprenorphine maintenance
I assume that coverage is not being denied for reasons related the period of time for treatment with buprenorphine. More and more studies establish that buprenorphine should be considered as a maintenance medication. I personally am aware of several deaths of people with opiate dependence after their discontinuation of buprenorphine. I understand the temptation to think that at some point, people should do well without the medication. But research has clearly shown that opioid dependence is a chronic condition that warrants chronic treatment.
The Humana Pharmacy and Therapeutics Buprenorphine-Containing Products Coverage Policy
I am well-versed with treatment using buprenorphine. I understand the fear of respiratory depression from combining benzodiazepines and opioids. I am familiar with drug/drug interactions caused by effects of some medications on hepatic enzymes. These and other issues are commonly considered and managed when prescribing medications for other disease processes. I would hope that physicians are allowed the same discretion and clinical judgment when treating patients with addictions, as when treating other conditions. The issues of drug/drug interaction and additive respiratory effects should not be considered absolute contraindications—particularly given the lack of other effective treatments for opioid dependence, and the ease with which such issues can be managed by a knowledgeable physician.
The danger of combining benzodiazepines with buprenorphine occurs when a patient is not tolerant to the mu-receptor effects of buprenorphine, and is given an additional respiratory depressant. Once a person has become tolerant to buprenorphine, the danger from respiratory depression from benzodiazepines becomes the same as in a person not taking buprenorphine. I have testified in two cases of deaths from buprenorphine and benzodiazepines; in both cases the person had no tolerance to opioids or to benzodiazepines. Even in the absence of full tolerance, combined use requires consideration but is not an absolute contraindication.
I do not know if your policy considers zolpidem (Ambien) to be a benzodiazepine; the molecule has actions similar to benzodiazepines at GABA receptors, but zolpidem is not a benzodiazepine, as it lacks the benzene and diazepine rings that define the benzodiazepine class of molecules. At any rate, non-benzodiazepine GABA hypnotics can be used safely in people taking buprenorphine for the same reasons as described for benzodiazepines.
When considering using any potentially-addictive medication in a patient with a history of addiction, consideration must be given to the risk of cross-addiction. This consideration applies to the use of benzodiazepines and other sedative/hypnotics. Deliberations over the risk to benefit ratio in such circumstances has always been part of the work of physicians treating addictive and psychiatric disorders. This need for deliberation does not imply an absolute contraindication to concomitant use of buprenorphine and benzodiazepines.
Opioid Agonists and Pain
Your policy states that buprenorphine will not be allowed in patients receiving narcotic analgesics. But from time to time, patients on buprenorphine maintenance will require surgery, will suffer from trauma, or will have painful dental procedures. The treatment of acute and chronic pain in patients on buprenorphine has been studied extensively, and a significant body of literature supports the use of opioid agonists in people taking buprenorphine. As an aside, combining buprenorphine with opioid agonists works so well that I have no doubt that combination treatment using buprenorphine and agonists will eventually be recognized as the best way to administer opioid analgesia while reducing the risk of dependence.
Your buprenorphine policy allows no opioid analgesia for patients on buprenorphine who become injured or require surgery. What do the writers of your policy expect people on buprenorphine to do in the case of surgery? If a patient has pain that requires an opioid agonist, will that patient lose insurance coverage for the only truly effective treatment for opioid dependence?
I have treated post-surgical pain for patients on buprenorphine using opioid agonists as recommended in the literature. I have included an excellent review article that describes the technique. The article includes references for studies of combining buprenorphine with opioid agonists for pain management.
I do not plan to prescribe opioid agonists for Mr. XXXXXXX. But the writers of your buprenorphine policy should be aware that there are patients who require long-term opioid analgesia, who at the same time benefit from an anti-craving medication. It is simplistic and scientifically naïve to believe that one should automatically disqualify the other.
I ask for a resumption of coverage for the prescription for buprenorphine for Mr. XXXXXXX. If that coverage is not provided, I ask for the specific reason for disqualification. I will continue to aggressively advocate for Mr. XXXXXXX, and for his right for treatment under the terms of his policy. He is already struggling with a potentially fatal illness. At the very least, he deserves coverage for the one effective medication for his condition.
I’ll let readers know how things turn out.
I’ve been in more of a chatty mood lately, as regular readers have likely noticed. I find it interesting that weeks will pass when I have little or nothing to say… and at other times, I have all sorts of random thoughts to discuss.
Excuses first– I’ve been tinkering with ads for the past few days, and I apologize to those of you who tried to read a post while I was activating and deactivating Wordpress plug-ins. After experimenting with different colors I’ve decided that basic grayscale is the best. For those who don’t blog, ‘plug-ins’ are small, add-on programs that add a range of functions to a blog. There are literally thousands of them out there; some free, some for a small charge. A couple dozen plug-ins are designed to add the code for Google Adsense to a blog, with a range of features including adding ads randomly to old posts, etc. I’ve found that some work better than others; a couple of them really messed up the other blog functions, causing the top banner to appear at the bottom and vice versa. I THINK I have things working OK now; if you are having trouble, please send me an email (drj at Suboxonetalkzone dot com) and tell me the nature of the problen, and the browser and operating system you are using. Thanks!
Another neat feature of WordPress is that you can review a number of different statistics for a blog, including the keyword that each viewer searched for before arriving at the site. I see certain questions posted over and over; I presume those questions are about things that come up often in the lives of people on Suboxone. I used to do ‘questions and answers’ on a regular basis; I’ll try to get back to those now and then, using the most popular queries as starting points.
Yesterday, several people searched for phrases related to buprenorphine and workplace drug testing. I’ve received a number of questions by email about that same topic. People wonder if Suboxone (buprenorphine) shows up in drug testing, and whether they should disclose that they take the medication before the test. This is a very tough issue. I believe that people who take Suboxone properly are NOT impaired by the medication. There was an article from the Mayo Clinic Proceedings recently that claimed that people ARE impaired by Suboxone, and therefore certain occupations– notably physicians and nurses– should not work at those jobs, if taking Suboxone.
There were at least two things that made their conclusions… ridiculous. First, the authors wrote that doctors’ work is so uniquely difficult, that it challenges gray matter so much more heavily than other occupations, that doctors should avoid buprenorphine treatment. To that, I say that a recovering anesthesiologist taking Suboxone is much safer than a recovering anesthesiologist, holding fentanyl in his/her hand, not on Suboxone! Even if you take away the risk that the non-Suboxone doctor is using, one must consider the effects of cravings on vigilance. I’ll take the doc on Suboxone, who is placing all of his attention on ME, over the guy reciting the serenity prayer to himself and pondering the decision over what can be ‘changed’ and what can’t! Of course, that’s just me…
I was also impressed by the ego of the writers, who think that a pediatrician or radiologist has greater need for an ‘unmedicated brain’ than a jet pilot, or a welder ten stories up, or a long-haul trucker, or a nuclear physicist. Yes– doctor jobs are ‘uniquely’ difficult! (add sarcasm here).
The conclusions were deeply flawed in other ways. To determine the effects of Suboxone on performance, they looked at studies that gave people opioid agonists or buprenorphine, and concluded that the effects were similar. I mean really– people who are not on Suboxone regularly, without a tolerance to opioids, taking buprenorphine? OF COURSE the people were messed up! Suboxone has potent opioid effects; there is no argument to that point. But the unique ceiling effects of buprenorphine allow the subjective effects to go away, as tolerance is established. That’s the whole point of Suboxone treatment!
I’m off on a tangent, right? Back to drug testing… I do not think that people on Suboxone, who take it properly, are impaired in any way. So I do not believe that people should have to disclose their treatment, and their history, to their potential employers. But my opinions on the matter are irrelevant, unless the new/old President-elect appoints me as Attorney General… and odds are not in favor of that happening.
I can say that I’ve received 20-30 emails over the years, asking about employee drug testing. In each case I asked the writer to follow-up and let me know what happened. Some ended up disclosing that they were on Suboxone, and most did not. To date, nobody has written back to say that they were denied the job over the issue. I therefore conclude that most employers are ignoring buprenorphine, at least at this point. That’s the best answer I have; I can’t recommend any specific course of action.
Finally… today I came across an old post on my forum about a drug that was sweeping across Russia last year, called Krokodil. The drug apparently is made from over-the-counter codeine tablets, in a process that creates a cheap concoction of opioids in a toxic sludge. Users of the drug describe withdrawal more severe than opioid withdrawal, that includes seizures. And within days of starting a habit, users slough off large sections of skin and other tissue from their arms, legs, torso– even from the face. Not for the faint of heart— if you search the name of the drug under Google Images, you will find horrifying photographs of the damage inflicted on people addicted to the substance.
If anyone really thinks that drug addiction is a ‘choice,’ please tell me what, exactly, those tragic people were thinking.
More than ever, patients have easy access to information once read only by scientists and medical professionals. And at the same time, doctors have reduced the time spent with patients during appointments. The result has been an increase in internet-educated patients, who come to appointments armed with data from package inserts, information from internet health forums, and stacks of questions from net-savvy relatives.
There is a good side to this process, of course. Patients are wise to take greater interest in their personal health, and to be knowledgeable of medications that they are taking. And whether good or bad, the situation is necessary, given the abdication by many physicians of their roles as educators.
But there are downsides to the situation as well. Package inserts provide studies and odds ratios for the risks from medications, but interpreting the studies and odds ratios requires education and experience. Some data is reported in a way that a person without considerable education in statistics would have a hard time deciphering what is or isn’t relevant. Some patients struggle under the burden of calculating and weighing risks, and prefer to have a careful, caring doctor provide his/her opinion whether a medications is safe or not. Speaking from my role as physician, I am frustrated when patients choose to follow advice from an online forum over a recommendation based on medical knowledge or a careful literature search..
Doctors sometimes add to the problem. I am frustrated when doctors make claims that are not supported by best medical practice or by medical science. Distinctions between sources of information are blurred, so that some ‘facts’ are based on nothing but rumor. The process is like the old ‘telephone line’ game; a doctor reads a question about a medication or illness, and responds with his/her opinion. Another doctor then hears or reads that answer, adopts it as fact, and shares it with other doctors—who then reinforce the ‘factual’ nature of the information.
People tend to take information from physician educators/writers verbatim, as if the act of putting information online, in writing, guarantees that it to be true. People are confused when they read conflicting ‘facts’ or recommendations from people with comparable credentials.
I try, when writing here, to differentiate between facts, best medical practice, and personal opinion. If someone asks ‘how long should I stay on Suboxone?’, I’ll reply that several studies show high relapse rates in people who stay on Suboxone for less than 6 months (fact), that more and more physicians are keeping patients on the medication long-term (medical practice), and that in my opinion, many people are best off staying on the medication for an extended period of time. You get the idea.
I think it is because of my PhD training that I tend to take a closer look at things that everyone ‘knows’ and ask, ‘says who?’ History has given us many examples of things that everyone knew that turned out to be wrong—from the connection between autoimmune disease and breast implants that wasn’t, to global cooling, the impending disaster when I was a kid (read here)—and we all know how THAT turned out!
The treatment of opioid dependence with buprenorphine/Suboxone appears to be particularly vulnerable to misinformation. Some examples:
The naloxone in Suboxone prevents the person from getting ‘high’: Naloxone is not active orally or sublingually, and is added to Suboxone to prevent intravenous injection of the medication. Confusion comes in part from mistaking naloxone, an IV medication, with naltrexone, an orally-active medication that is NOT part of Suboxone.
People will abuse Subutex because it doesn’t have the opioid blocker in it: Subutex or the generic equivalent—buprenorphine—works just like Suboxone when taken correctly. Doctors and pharmacists are mistaken when they believe that buprenorphine is more addictive if naloxone is not included. In reality, the subjective effects of Suboxone and Subutex are identical. There IS a relatively low incidence of intravenous abuse of buprenorphine; Suboxone in theory causes withdrawal if injected because of the presence of naloxone. Realize, though, that the effects of buprenorphine or Suboxone are similar, whether injected or taken correctly. Injected buprenorphine has the same ‘ceiling effect’ as does sublingual buprenorphine, and so people on buprenorphine maintenance would NOT experience an opioid ‘high’ after injecting their medication—any more than they do when taking it sublingually.
The tablet should not be crushed or chewed: The package insert recommends that Suboxone tablets should be taken sublingually, without crushing the tablet. I am guessing that the recommendation comes out of an attempt to standardize the bio-availability of buprenorphine. Studies show that as little as 15% of a dose of buprenorphine is absorbed, and in my opinion, the high cost of the medication warrants efforts to reduce the amount that gets wasted. The bio-availability is affected by the concentration of buprenorphine in saliva, the surface area available for absorption, and the time that the medication is in contact with absorptive surfaces. Passage of buprenorphine through mucous membranes is the rate-limiting step for absorption–NOT dissolution of the tablet. In other words, crushing or chewing the tablet does NOT cause a ‘high’, and is NOT a sign of drug-seeking behavior. Neither does crushing or chewing hasten the onset time of a dose of Suboxone.
Discussions about chewing or crushing buprenorphine provide examples of the doublespeak that only confuses people. My own recent discussion with another Suboxone prescriber went like this: “I don’t want patients to crush or chew the tablet because that will make it get absorbed too quickly. In fact, I usually recommend the film, because it dissolves much more quickly than the tablet.” Say what? Do we want it to dissolve more quickly or not? The truth is that it really does not matter. The dissolving of buprenorphine— or the film– is the LONG part of the process.
The veins under the tongue absorb the drug in Suboxone. Actually, buprenorphine passes through all of the surfaces in the mouth, eventually entering capillaries under the surface. The veins under the tongue absorb little or no buprenorphine.
You must stop smoking cigarettes if you are on Suboxone: I have searched the literature and I have talked to folks at Reckitt Benckiser, and I can find no evidence to back up this claim. Scientifically, I cannot think of a reason that cigarette smoking would affect the absorption of buprenorphine, except perhaps to increase production of saliva, diluting the buprenorphine in solution and reducing diffusion into tissues. I doubt this would have any significant effect on the bio-availability of buprenorphine, and my clinical experiences backs that up. Patients in my practice who smoke have had normal responses to buprenorphine or Suboxone.
You can’t take pain pills if you are on Suboxone: Actually you can, but they will only reduce pain if the dose is sufficient. I often use this approach to treat people on buprenorphine who undergo surgery. But problems ARE caused if a person does things in the opposite order. In that case—if someone taking opioid agonists then takes buprenorphine– there is risk that the person will develope precipitated withdrawal, depending on the amount of opioid agonist that was being used.
The longer you are on Suboxone, the harder it is to stop: I have read no studies supporting this oft-read comment, and I can think of NO reason that it would be true. The tolerance to buprenorphine is set by the ceiling effect of the drug, and once tolerance develops, typically by several weeks on the medication, longer periods of time do not push tolerance higher.
The film formulation is safer than the tablet. Says who? If we are worrying about kids getting their hands on Suboxone, yes—the little orange tablets look like candy to a toddler. But little red strips of flavored material appear appetizing as well. ALL medications should be kept away from children. If the safety concerns are directed toward patients—for example one doctor told me he prescribes the film because it cannot be crushed—remember that crushing Suboxone is not a problem. I SUSPECT (only my opinion) that the change in formulation was a marketing ploy aimed toward preventing acceptance of generic buprenorphine tablets. Reckitt Benckiser apparently convinced the state of Wisconsin to cover the film exclusively, rather than allow addicts the choice of taking generic buprenorphine—a medication that works exactly the same as Suboxone, at about half the cost.
I think you get the idea. Whether thinking about Suboxone or another medication, I urge readers to always ask the question, ‘says who?’ There are MANY experts out there on the internet—and some exhibit more restraint in their comments than others. Ask yourself, what is the mechanism for what is being described? And if it doesn’t seem to make sense, consider that just perhaps, you’re the right one.