Anesthesia Archives - Suboxone Talk Zone

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.

Suboxone Patient Needs Surgery, Refused Pain Control

First Posted 10/21/2013
I have received MANY messages over the years from patients on buprenorphine/naloxone (Suboxone) who required surgery, but whose doctors refused to provide post-op analgesia. Those of you not on Suboxone– can you imagine having surgery, and being told that ‘it is too much hassle to give you any medicine for pain relief’?
Below is a comment to my last post, followed by my suggestion. I am usually not a fan of getting medical boards stirred up over other doctors’ business, but this type of situation is RIDICULOUS, and must be stopped.
The comment:
I’m scared to death!! I have been on Suboxone for over a year. Previous to that, I was on it for a couple of years before stopping its use. At that time I developed some gall stones and presented to the ER in pain I can not even begin to explain. Ultimately the stone passed but I need to have the gall bladder removed. I figured this was a good time to maybe get off of Suboxone. I knew I would be getting some standard opiates after surgery to manage pain so I thought it could manage the Suboxone withdrawal as well.
It was an awful experience and I eventually resumed Suboxone. It has been a little over a year now back on. About 8-12 mg/day. So about a couple of months ago, I needed shoulder surgery. Here we go again. I tapered back on the sub and went through with the labrum repair.   I did discuss it with my psychiatrist but he basically said he wanted NOTHING to do with the acute pain management portion of this surgery. And I actually experienced very little pain post-surgery and went almost immediately back on sub.
Now I have had complications mainly from scar tissue. Tremendous pain. My ortho recommended a surgical manipulation to clean out the scar tissue. So I went along and although the post surgical pain was much worse this time, I got through it OK and back on sub. Now I need to to go back to my psychiatrist for a refill on the sub. But, because I did not discuss THIS event with him (I already knew he didn’t want anything to do with it) he said he would not refill or treat me anymore. So now I am one year in on Suboxone and being told to take a flying you know what because of surgery I needed. I just feel that if I’m on Suboxone, I am at the mercy of whomever is treating me. It is like blackmail.
My response:
Shoulder surgery can be one of the most painful operations to endure. If patients have inadequate pain relief after surgery, they risk developing scar tissue formation because of inadequate movement and physical therapy. In other words, you second shoulder surgery might have been required BECAUSE you didn’t get pain meds after the first surgery.
Even if that is not exactly the case, people on Suboxone deserve pain relief after surgery. Can any of you non-Suboxone patients imagine having a surgeon say ‘you will need pain meds after surgery, but it is too much hassle so I’m not going to give you any’?
I suggest sending a letter to your medical licensing board and saying something like this:
I am prescribed buprenorphine/naloxone, an FDA-indicated treatment for opioid dependence, by Dr. Whatever.   That doctor is certified to prescribe buprenorphine and Suboxone, and so should be aware of the proper way to treat post-operative pain in patients on that medication (as described inthis article). I realize that there is a certain stigma for addiction even for those of us trying to do the right thing with appropriate medication— but refusing to treat post-operative pain is not consistent with the Hippocratic Oath.  Because my doctor simply refused to ‘get involved’ with treating my surgical pain, I was forced to endure the pain of surgery without any significant postoperative pain control– a level of care that would not be tolerate even for a family pet.   I wish to speak to someone at the board about the postoperative care that I did not receive.
Will it help? I have no idea. But the ONLY way things will change is if enough people start to complain. Good luck.

Buprenorphine Regulations and Unintended Consequences

First Posted 8/28/2013
I realize that I am halfway through a post called ‘Suboxone Abuse Part I’. This is poor form, but I am now going to get halfway through a second topic before finishing the first one. Sorry.
I recently came across a problem relating to the new healthcare law. I was thinking about writing ‘How the Affordable Care Act Is Killing a Few People’, but I figured that such an inflammatory title would chase away about half of my readership.   So I used the title I liked second-best.
I’ll first write about a couple background issues that are obvious to those of us who work in healthcare but less obvious to others. These things are important to know, in order to understand the second post. I won’t try to take one political stand or another, so hopefully the people who reflexively support or bash either side will take a chill pill, tune into the issue, and allow my perspective to filter into their knowledge base.
When I was in med school, I bought a brand new Hyundai for $3900. The car was a ‘loss leader’. Businesses owners use loss leaders to increase buzz about the business or to get people through the door, hoping to make up the loss by selling more profitable merchandise.
You may have noticed the disappearance of private doctor practices over the past 20 years. There are many reasons for the loss of private practices, but from the perspective of an owner of such a practice, a primary reason is because individual doctor visits, especially for primary care, have become loss leaders for healthcare systems. Patients attached to systems through loss leaders– primary care physicians– become sources of profit when they are admitted, have MRI’s or surgeries, or see specialists.
Look at the cost for different types of ‘health care.’ Your insurer pays less than $200 for a doctor to sit with you, 1:1, for 15-30 minutes. That same amount of time in an MRI costs your insurance ten times more, and an hour in the operating room costs $5,000-$20,000.
Health systems negotiate with insurers with an eye on the big picture. An orthopedic injury—say a torn ACL—brings an ER visit, X-rays, MRI, surgery, and physical therapy, with revenues well over $20,000. A patient with heart disease brings in $50,000 or more for EKGs, stress tests, cardiac ultrasound, angiogram, angioplasty, and bypass surgery. Cancer care can top $100,000 when surgeries, radiation therapy, and chemotherapy are included. Even a relatively common injury—lumbar disc herniation– requires MRI, PT, a variety of injections, and laminectomy or spinal fusion, with revenues up to and over $100,000.
While individual doctor visits are more common than heart surgery, the MRI suites and catheterization centers are the profit generators for health systems and the hot topics of insurance negotiations. To the big systems, whether the family practice doc is reimbursed $120 vs. $160 per visit is a minor consideration—just as we are more careful buying a home than a soda. But solo-practice docs must carefully consider the payments for office visits, since they are the ONLY revenue.   Independent docs are offered the discounted reimbursements that insurers pay the big healthcare systems, but unlike the systems, small practices have no high-revenue services to subsidize lower-revenue patient visits. With no high-revenue services to subsidize lower-revenue patient visits, independent physicians must be very careful in providing discounts to be part of insurance panels. Some types of payments—the $30 for a 20-30 minute office visit paid by Medicaid—won’t keep the lights on after malpractice, office staff, rent, and utilities are paid.
It is hard to run a business selling only loss leaders. That’s why the Hyundai dealer tried so hard to get me to test drive other cars. It wasn’t until I threatened to make a fuss about ‘bait and switch advertising’ that I was allowed to buy the $3900 car pictured in the newspaper ad. There was no profit in that sale, but the dealer knew that most people would turn away from the unwashed beater and consider other cars on the lot (he didn’t take into account how broke med students are!). Without bigger sales, the business can’t survive.
The second issue I need to cover is the shortage of doctors who prescribe buprenorphine, and the reason that buprenorphine prescribers are more likely to be independent or small-practice physicians.
To prescribe buprenorphine, doctors must take a short course and fill out some paperwork—not a big deal. A bigger deal is that buprenorphine-certified doctors must allow random inspections by the DEA without cause. Doctors who work for health systems get a paycheck each week, often regardless of the number of patient visits. For an employed doctor, does it make sense to take an extra course, file extra paperwork, and agree to random inspections, in order to see more people but for the same pay?
Patients in need of buprenorphine treatment have usually lost a great deal due to their addictions, and are not great ‘sources of revenue.’ I suspect that my own enjoyment treating addiction comes in part from my personal experiences ‘in the field’.    Beyond that type of interest, young doctors do not leave residency eager to take on patients who have been dishonest with other doctors, who early in treatment appear a bit ‘rougher’ than their other patients, and who have no disposable income!
The two issues must be understood and combined, in order to understanding the second half of the story (that I will get to eventually…). In review, the first point is that individual medical practices are disappearing because of a flawed business model. Fees charged for individual appointments are far lower than revenues from tests, procedures, and surgeries. Large systems can subsidize doctor visits with revenue from MRIs and surgery centers. Doctor visits are ‘loss leaders’ for more profitable services. One cannot make a ‘business’ from loss leaders, without the second half of the equation.
And second, doctors who prescribe buprenorphine are more likely to be independent practitioners with their own businesses. Another way to say it is that doctors who are employees of health care systems are less likely to obtain certification to prescribe buprenorphine. The extra patients that comes with buprenorphine certification cause more paperwork and more regulation, without an increase in pay. Beyond personal motivations, doctors have no incentive to treat addiction; in fact there are significant disincentives to becoming buprenorphine-certified.
Put the two together, and you have more and more communities where several large systems compete for patients, and nobody prescribes buprenorphine except for the one or two independent practices that haven’t closed yet.

Taking Buprenorphine, Having Surgery

Originally Posted 8/12/2013
I will get to ‘Part II’, but today I talked with a patient about something that happens too often, that deserves to be pointed out. The person was in the ER with an injury that resulted in tib/fib francture. The ER doc provided no analgesia, in the ER or at discharge, telling the patient “you would get sick if I gave you pain medicine because you are on Suboxone.”
I have a few paragraphs typed up that I send to dentists, surgeons, and other physicians when a patient on buprenorphine has a painful procedure. I am pasting it below so that it can be copied, printed, and given to physicians to encourage them to do a bit of continuing medical education on the topic. Those of you who are already enlightened, please leave comments if you see something that you would change. I have literature to back up this type of approach; send me an email if you’d like the reference.
Painful Procedures and Buprenorphine Patients
Buprenorphine is a partial opioid agonist that is used for several indications. In low doses—less than 1 mg/day—buprenorphine is used to treat pain (e.g. Butrans transdermal buprenorphine). In higher doses i.e. 4 – 24 mg per day, buprenorphine is used as a long-term treatment for opioid dependence and less often for pain management. At those higher doses, Buprenorphine has a unique ‘ceiling effect’ that reduces cravings and prevents dose escalation. Patients taking higher dose of buprenorphine, trade name Suboxone or Subutex, become tolerant to the effects of opioids, and require special consideration during surgical procedures or when treated for painful medical conditions.
There are two hurdles to providing effective analgesia for patients taking buprenorphine: 1. the high opioid tolerance of these individuals, and 2. the opioid-blocking actions of buprenorphine. The first can be overcome by using a sufficient dose of opioid agonist, on the order of 60 mg per day of oxycodone-equivalents or more. The second can be handled by either stopping the buprenorphine a couple weeks before agonists are required—something that most patients on the medication find very difficult or impossible to do—or by reducing the dose of buprenorphine to 4-8 mg per day, starting the day before surgery and continuing through the post-op period. Given the long half-life of buprenorphine, it is difficult to know exactly how much remains in the body after ‘holding’ the medication. That fact, along with the difficulty patients have in stopping the medication, leads some physicians (including myself) to use the latter approach- i.e. to continue 4 mg of buprenorphine per day throughout the postoperative period. People taking 4-8 mg of daily buprenorphine say that opioid agonists relieve pain if taken in sufficient dosage, but the subjective experience is different, in that there is less ‘euphoria.’
Important points:
Patients on daily maintenance doses of buprenorphine do NOT receive surgical analgesia from buprenorphine alone, as they are tolerant to the mu-opioid effects of buprenorphine.
The naloxone in Suboxone does not reach the bloodstream in significant amounts, and has no relevance to the issue of post-operative pain and Suboxone/buprenorphine.
Discontinuation of high dose buprenorphine/Suboxone results in opioid withdrawal symptoms within 24-48 hours, similar to the discontinuation of methadone 40 mg/day.
Normal amounts of opioid pain medication are NOT sufficient for treating pain in people on buprenorphine maintenance.
Opioid agonists will NOT cause withdrawal in people taking buprenorphine. Initiating buprenorphine WILL precipitate withdrawal in someone tolerant to opioid agonists, unless the person is in opioid withdrawal before initiating buprenorphine.
Non-narcotic pain relievers CAN and should be used for pain whenever possible in people on buprenorphine to reduce need for opioids. Note that Ultram has opioid and non-opioid effects; the opioid effects are blocked by buprenorphine.
I have had success in people taking 4 mg of buprenorphine/day, using oxycodone, 15-30 mg every 4 hours. Some patients can control their own intake of oxycodone while on buprenorphine, but some patients CAN’T. Overdose IS possible, if patients take excessive amounts of the opioid agonist. Consider providing multiple prescriptions with ‘fill after’ dates, each for a very short period of time (e.g. 2 days each) to that patients do not have access to large amounts of opioids at one time.
For longer post-operative periods I have used combinations of long and short-duration agonists, e.g. Oxycontin 20 mg BID plus oxycodone, 15 mg q4 hours PRN.
The risk of death is significant for opioid addicts not on buprenorphine. Buprenorphine/Suboxone has opioid-blocking effects that reduce risk of overdose and death. Asking a person to stop or ‘hold’ their Suboxone is introducing significant risk of injury. Opioid addicts are NOT generally able to stop Suboxone without replacing it with illicit opioids.
J Junig MD PhD

Post-Operative Pain in Suboxone Patients

Originally posted 12/19/2012
I’ve written about this topic a number of times, but I continue to receive emails from people on buprenorphine who describe inadequate pain control following surgery. I have prepared a document for my own patients to provide to surgeons, dentists, and ER staff to be used in the case of injury or surgery. A copy of that document can be found below, or can be downloaded here.
As with any of my comments, the information below must be used in consultation with your OWN buprenorphine-certified physician. Feel free to use my comments as a starting point for discussions about upcoming surgery or dental work. But do NOT use the information to treat yourself, for example using medication or substances that were not prescribed for you. Taking opioid agonists while treated with buprenorphine requires careful consideration, as the risks of opioid use include respiratory and cardiac arrest (i.e. death).
Re: Surgery in Patients on Buprenorphine
Buprenorphine is a partial opioid agonist that is used for several indications. In low doses—less than 1 mg—buprenorphine is used to treat pain (e.g. Butrans transdermal buprenorphine). In higher doses i.e. 4 – 24 mg per day, buprenorphine is used as a long-term treatment for opioid dependence and less often for pain management. At those higher doses, Buprenorphine has a unique ‘ceiling effect’ that reduces cravings and prevents dose escalation. Patients taking higher dose of buprenorphine, trade name Suboxone or Subutex, become tolerant to the effects of opioids, and require special consideration during surgical procedures or when treated for painful medical conditions.
There are two hurdles to providing effective analgesia for patients taking buprenorphine: 1. the high opioid tolerance of these individuals, and 2. the opioid-blocking actions of buprenorphine. The first can be overcome by using a sufficient dose of opioid agonist, on the order of 60 mg per day of oxycodone-equivalents or more. The second can be handled by either stopping the buprenorphine a couple weeks before agonists are required—something that most patients on the medication find very difficult to do—or by reducing the dose of buprenorphine to 4-8 mg per day, starting the day before surgery and continuing through the post-op period. Given the long half-life of buprenorphine, it is difficult to know exactly how much remains in the body after ‘holding’ the medication. That fact, along with the difficulty patients have in stopping the medication, leads some physicians to use the latter approach- i.e. to continue 4 mg of buprenorphine per day throughout the postoperative period. People taking 4-8 mg of daily buprenorphine report that opioid agonists relieve pain if taken in sufficient dosage, but the subjective experience is different, in that there is no feeling of euphoria.

Patients on daily maintenance doses of buprenorphine do NOT receive surgical analgesia from the medication, as they are completely tolerant to the mu-opioid effects of buprenorphine.
The naloxone in Suboxone does not reach the bloodstream in significant amounts, and has no relevance to the issue of post-operative pain and Suboxone/buprenorphine.
Sudden discontinuation of high dose buprenorphine/Suboxone results in opioid withdrawal symptoms within 24-48 hours, similar to the discontinuation of methadone 40 mg/day.
Normal amounts of opioid pain medication are NOT sufficient for treating pain in people on buprenorphine maintenance.
Opioid agonists will NOT cause withdrawal in people taking buprenorphine. Initiating buprenorphine WILL cause withdrawal in someone tolerant to opioid agonists, unless the person is in opioid withdrawal before initiating buprenorphine.
Non-narcotic pain relievers CAN and should be used for pain whenever possible in people on buprenorphine to reduce need for opioids.

Jeffrey T Junig MD PhD
For more information, I may be reached by email:
admin (at) suboxforum.com

Optimizing Absorption of Buprenorphine

I wrote this a couple years ago, and still get questions about the topic today. Studies show that a small fraction of the amount of buprenorphine in a tablet or film strip actually gets absorbed through mucous membranes; the rest is swallowed. The 15%-30% amount of absorption is referred to as the ‘bio-availability’ of the drug.
People who feel like they are not getting enough buprenorphine to remove cravings can review the principles below, to see if there are ways they can easily improve the absorption of buprenorphine. NOTE: improving absorption is NOT an ‘addictive’ behavior, for a couple reasons…. first, because of the ceiling effect, increasing the amount absorbed will NOT cause a ‘buzz’ or high, but will only make the medication last the full 24 hours without wearing off. Second, crushing a tablet will NOT cause a ‘rush’ or ‘high’ for two reasons– first, because of the ceiling effect as I just described, and second, because the rate-limiting step for absorption is the passage through tissue— NOT the dissolution of the tablet. This is why, by the way, the film does not cause a ‘rush’, even though it dissolves more quickly.
Read on:
I often answer questions about Suboxone that require the qualification ‘if it is being absorbed properly’. If a person asks how long it takes for Suboxone to wear off, or at what dose does the ceiling effect occur, I need to be sure that the person is taking it in a way that maximizes absorption; otherwise all bets are off. If a person simply swallows the tablet, for example, the level of buprenorphine in the bloodstream will be much lower than if it is taken correctly.
The usual instructions for taking Suboxone are to place a tablet under the tongue and let it dissolve. It is important that Suboxone be taken once per day, in the morning; this instruction is included in the course for physicians but is too often ignored. I will talk another time about the philosophy for dosing once per day; the basic reason is to extinguish the behavior that has been conditioned as part of the addiction. But the point of this post is the absorption of buprenorphine from the tablet into the bloodstream, and how to maximize that absorption. It is important to maximize absorption, particularly if one is trying to save money by reducing the daily dose of Suboxone.
From my experiences as an anesthesiologist, as an addict**, and as a PhD chemist, I recognize that three factors will maximize absorption. The first is the concentration of buprenorphine in the saliva, as the drug diffuses into tissue down a concentration gradient. This gradient is maximized by having a small volume of saliva. I recommend that a person start with a dry mouth, place the tablet in the mouth, and crush the tablet between the teeth until it is dissolved in a small volume of a concentrated solution.
The second factor that affects absorption is the amount of surface area. Buprenorphine is absorbed through all mucous membranes (the tissue lining the inside of the mouth), passing through the surfaces and entering capillaries, the route into the bloodstream. So the concentrated solution should be ‘painted’ repeatedly over all of the surfaces inside the oral cavity; the inside surface of the cheeks, the tongue, the roof of the mouth, under the tongue, the back of the throat… swished around in the mouth over and over, repeatedly bringing the concentrate into contact with new areas of mucous membranes.
The third factor is time– the longer period of time, the longer for the buprenorphine to make contact with the mucous membranes, attach to the surface, get absorbed into the tissue, and enter the capillaries. The initial process will be the saturation of the surfaces of the mucous membranes, and the slower process will be the passage into the tissue; that is why the amount of surface area has such an important effect on absorption. Fifteen minutes is probablysufficient for most of the absorption to occur; there may be drug remaining that is attached to the surface but not yet fully absorbed, and so I recommend avoiding eating or drinking within another fifteen minutes or so after swallowing the left-over saliva.
If you pay attention to these principles you will maximize absorption of the drug. The ceiling effect will occur under these conditions at a dose of about 2-4 mg; the long half-life of the drug will guarantee that if you take over 4 mg or so each morning, you won’t have any significant withdrawal for over 24 hours– allowing once-per-day dosing. Yes, early in treatment patients will feel as if they need to dose more frequently– but that is not because of too little buprenorphine, but rather because of conditioned behavior. A person early in Suboxone treatment will have feelings or minor withdrawal in the late afternoon or evening after dosing in the morning; those minor withdrawal sensations will go away in about 15 minutes if the person takes more Suboxone, and will also go away in 15 minutes if the person doesn’t take Suboxone. If the person takes more Suboxone, it will reinforce the sensations and the person will get stuck on dosing twice per day. If, on the other hand, the person uses distraction and avoids dosing, those minor withdrawal sensations will completely disappear in a week or two, as the conditioned behavior is extinguished.
**I mentioned my experience ‘as an addict’; for a period of time my preferred route of administration of lipid-soluble opioids was ‘trans-mucosal’ or ‘trans-buccal’. Since the amount of substance available was finite (albeit a fairly large finite amount!) I did all that I could to optimize absorption, including reading about diffusion of lipid-soluble molecules through mucous membranes.

I'm On Suboxone; Can I Have Surgery?

I recently resumed writing for the expert forum on addiction at MedHelp.Org. One result of writing for MedHelp is that I receive a number of e-mails from people with questions about specific issues related to buprenorphine. The most common questions are from people on buprenorphine undergoing surgery, asking about the safety of anesthesia and about postoperative pain control.
There are very significant problems with medical coverage for patients on buprenorphine undergoing surgery. Patients on buprenorphine will occasionally need surgery, and in such cases there are often no doctors willing and/or competent to manage postoperative pain. Psychiatrists, frankly, have little knowledge or experience in this area. Before psychiatry residency, medical school graduates generally complete a medical internship that provides little or no training in critical care or surgery. Making matters even worse, the medical students who go into psychiatry tend to be those who have the least interest in the surgical specialties.
And then there are surgeons. Where psychiatrists lack courage to provide effective pain relief for addicts, surgeons simply lack interest or concern. Surgeons enjoy being in the operating room, cutting things apart and sewing things together. The last thing they want to do is have a heart-to-heart talk about someone’s addiction to pain pills. To a surgeon’s way of thinking, addiction doesn’t even exist. You can’t cut it off or sew it on, so why even talk about it?
Hopefully, those of you who take buprenorphine will slip this article under the door of your psychiatrist to drop a hit about this problem. I cannot provide medical recommendations for people who I do not know, but I will at least provide some general information so that readers of my blog will know when they are being fed a line of nonsense.
Speaking of nonsense, the silliest and most potentially harmful advice that I hear about in e-mails is that buprenorphine will cover a person’s postoperative pain; that the person should simply take his/her normal dose of Suboxone and everything will be fine. Nonsense! People taking buprenorphine quickly become tolerant to the pain-relieving properties of buprenorphine, and therefore will not get adequate pain relief from buprenorphine for anything but the most minor surgical procedures. Buprenorphine has complex actions at opioid receptors, including partial agonism at mu receptors and mixed effects at kappa opioid receptors. The actions at kappa receptors are less subject to tolerance and provide some long-term effects on mood and analgesia, but these effects are not even close to what is required to cover postoperative pain.
There are several articles that have been published that describe various approaches for treating postoperative pain in patients on buprenorphine. I cannot post the articles here because of copyrights, but the general recommendation in the literature for treating post-op pain is to reduce the daily dose of buprenorphine starting several days before the surgery, and to use potent opioid agonists in addition to buprenorphine. Another option is to stop buprenorphine completely before surgery. But buprenorphine has a long half-life, and must be stopped for a week or more in order to significantly lower the level of buprenorphine in the body.
It is important to understand that there are two things that get in the way of pain relief in patients on buprenorphine; the antagonist actions of buprenorphine at the mu receptor, and the patient’s high tolerance to opioid agonists. Even if buprenorphine is stopped a week or two in advance of surgery, the person still has a high tolerance to opioids, and still requires significant doses of opioid agonists for adequate post-operative pain control. And if buprenorphine is stopped completely, the person must go through a period of withdrawal before eventually restarting buprenorphine in order to avoid precipitated withdrawal.
I have found it easiest to keep the person on a small dose of buprenorphine, perhaps 4 mg per day, throughout the entire operative period, until postoperative opioids are no longer needed. I’ve had good success treating post-operative pain with high doses of oxycodone while continuing buprenorphine, even after major surgeries. Interestingly, patients report good pain relief but the complete absence of the euphoria that they used to get from opioids. At the point after surgery when opioid agonists are no longer necessary, patients simply stop the agonists and resume their full dose of buprenorphine.
Whether or not buprenorphine is discontinued, high doses of opioid agonists are required to provide adequate pain relief for major surgery. An oxycodone equivalence of about 60 mg per day is required just to ‘break even’ with the tolerance of a typical person on buprenorphine maintenance. You can understand, then, why psychiatrists are wary of treating postoperative pain. Such high doses of oxycodone could easily cause fatal overdose in patients not taking buprenorphine. I am board certified in anesthesiology, but even I get nervous in such situations. But what is the alternative? I have had patients who required coronary bypass, hysterectomy, and total knee replacement, as well as minor surgeries. Dental work in particular is quite common in patients with a history of addiction. Should people on buprenorphine simply go without the necessary procedures that other people are allowed to have?
If psychiatrists or surgeons are unwilling to provide adequate postoperative analgesia for patients to take as outpatients, patients should allowed to stay in the hospital, even the intensive care unit, if that is what it takes for the doctor to feel safe providing adequate analgesia. Surgeons should provide adequate care, even if they have to fill out paperwork and battle insurers to obtain the necessary coverage for hospitalization. They would do the same for patients with brittle diabetes who need close monitoring following surgery. Opioid addicts are people too!
As for general anesthesia, buprenorphine does not pose significant problems, provided that the anesthesiologist is aware that the patient takes buprenorphine and has a high opioid tolerance. Opioids are often used during anesthesia to blunt changes in blood pressure and heart rate, and larger doses of opioids would be required for people taking buprenorphine. The amnesia component of an anesthetic is generally provided by medications not blocked by buprenorphine, such as anesthetic vapors or benzodiazepines.
Another reason that anesthesiologists must be made aware if a patient is taking buprenorphine is so that sufficient opioids are ‘on board’ when the patient awakes. As patients emerge from anesthesia, anesthesiologists often use respiratory rate to gauge whether sufficient doses of narcotics have been provided to cover postoperative pain. Without the knowledge that a patient is on buprenorphine, the anesthesiologist may be confused by the patient’s lack of response to narcotics, causing the anesthesiologist to give too little pain medication—meaning that the patient will awake with considerable pain.
Medications with combined actions (such as tramadol and the newer agent Nucynta) or of little value for post-operative pain control. These medications have actions at mu opioid receptors that are blocked by, and cross-tolerant with, buprenorphine– completely nullifying that component of their action. The other component of their action is through effects on serotonin or norepinephrine pathways, and these actions are insignificant for post-surgical pain. Because of mu receptor tolerance, Nucynta essentially becomes as useful for treating post-op pain as Cymbalta— i.e. worthless!
I must stress that everything I have written here is intended to serve as a basis for discussion between patients and their doctors. Every case has unique variables that must be taken into account, and so my comments must not be taken as medical recommendations or advice. Taking high doses of opioid agonists can be dangerous, particularly in combination with other respiratory depressants.
One final comment… I recently received letters from two different health insurers about ‘buprenorphine policies’ citing situations where Suboxone would not be covered. These situations have included cases where patients are prescribed opioid agonists. I want to point out that there are times when patients on buprenorphine require surgery, and every patient undergoing surgery deserves adequate pain control. There are also patients on buprenorphine maintenance who have chronic pain; pain that in some cases justifies the relief afforded by opioid agonists. I hope that those with the power to influence policy, including Reckitt-Benckiser, the American Society for Addiction Medicine, NIDA, and SAMHSA, will direct attention to this important gap in medical coverage.

Rapid Opioid Rip-Off

While I’m on the subject of rip-offs, I’ll mention an extreme form of ‘detox capitalism’; a process called rapid opioid withdrawal, rapid detox, or ‘the Waismann Method.’
The name of the process supposedly comes from a certain ‘Dr. Waismann’ who helped Israeli soldiers get off opioids after they were treated for various injuries. It sounds like a pretty exciting history, but to be honest there is nothing in the technique that takes a rocket scientist to figure out. The basic idea is to precipitate withdrawal using an opioid antagonist— something that is done many times over every day in emergency rooms across the U.S.—but to do it while the person is sedated with non-opioid medications.

I never expected to admit this back when it occurred, but I had the bright idea of putting myself through ‘rapid opioid detox’ shortly before entering treatment ten years ago, when I was desperately searching for a way to free myself from opioids.
Like any typical addict I wanted to do it entirely by myself, figuring that I knew as much about opioids and medicine as anyone else. I loaded up on naltrexone (an oral form of naloxone) thinking that the antagonist would block my receptors, lower my tolerance, and prevent me from using for as long as I took the naltrexone.
I simplified things a bit by omitting the sedation—a good idea since there was no other doctor monitoring me, but a bad idea because I experienced about a week of withdrawal condensed into several intensely-miserable hours. I remember being shocked at just how much sweat my body could produce in such a short time, as liquid beaded on my skin as fast as I could wipe it off!
After the real horrible period—the period that I would have slept through had I come up with $15,000 plus airfare—I remained quite ill for a matter of weeks. And of course that is what happened, since it takes weeks for tolerant mu receptors to be replaced by new, normal mu receptors. Until the receptors are replaced, the brain’s endorphin pathways remain quiet, causing hypersensitivity to pain—not to mention diarrhea, restless legs, cramping, gooseflesh, and depression.
There are several variations of rapid detox, but the principles are the same for all of them:
–          The addict is given a strong sedating medication or anesthetic
–          While heavily sedated, the addict is given an intravenous infusion of the opioid antagonist naloxone to precipitate withdrawal.
–          After a period of time that varies with the name of the facility, the addict wakes up; one day of withdrawal gone, and only two more months of withdrawal to go!
–          The process costs from five to ten thousand to tens of thousands of dollars.
–          Different options are tossed in for different programs, everything short of an extended warranty: amino acid cocktails, ‘vital nutrients,’ or long-term sedatives.
–          In some cases a chip of naltrexone is implanted that slowly releases over weeks, supposedly preventing a high from using—provided the addict doesn’t become desperate and use very high doses of heroin, or dig the implant from his/her body using a fork!
Web sites for the procedure point out that opioid dependence is a relapsing illness and that people who use Suboxone relapse when they stop Suboxone (no argument from me), but go on to claim a 70% one-year sobriety rate after their rapid-detox procedure—without any explanation for how they get better numbers than Suboxone patients. I have never seen peer-reviewed studies showing such success rates.
Speaking of peer-reviewed studies, I have seen a study of rapid detox showing what is intuitively obvious—that since it takes a number of weeks for the body to adjust to the lack of opioids, one day of sedation avoids only a tiny portion of the misery of withdrawal. Is it worth ten grand to avoid one day of withdrawal, knowing that several more weeks of withdrawal are yet to come? I suppose it depends on one’s checking account.
But the bigger issue is the poor long-term outcome for these people—a problem similar to what I described in my post about Sneetches. Early in the spiral of addiction, addicts and their families are under the mistaken belief that the hardest part of ‘kicking opioids’ is to get through physical withdrawal.
They eventually they learn that they are wrong, and that it is much more difficult and rare to STAY clean than it is to GET clean—but ‘rapid detox’ makes money off their ignorance in the meantime. Quitting opioids by rapid detox, amino acids, magic crystals, hypnosis, or a host of other expensive, highly-promoted methods reminds me of the story about the guy boasting about how easy it was to quit smoking—so easy that he’s done it over 20 times!

Is My Suboxone Dose Too High to Have Surgery?

Thanks, all of you who wrote comments to my last post. I remind everyone once again to consider taking your comments here and after writing them, also taking them to SuboxForum.com. I am going to put up a new category to discuss topics that were initiated here; it would be great to get a spirited, respectful ‘give and take’ on some of these topics. As I have mentioned before, the only thing that I will block on that site would be debating whether people on Suboxone are ‘in Recovery’– just because there are plenty of other sites for that, and I want the forum to be for people who have made their decision– and don’t want to be harassed over it. I will be upgrading that site shortly and changing the hosting account; hopefully I will pull it off without erasing everything!
OK, tonight’s topic: I am taking my post from a different forum and posting it here also to save wear and tear on my keyboard… I responded to a person who is taking 32 mg of Suboxone daily and who is concerned that the relatively high dose will raise her tolerance higher than she would like. She has surgery coming up, and is concerned that the high tolerance will get in the way during or after the surgery. My reply addresses the level of opiate tolerance in relation to dose of buprenorphine. Incidentally though I will quickly say that buprenorphine poses little problem during an anesthetic; it does not interfere to a large degree with general, epidural, or spinal anesthesia. But buprenorphine DOES interfere with the treatment of post-operative pain. I will also comment that I consider 32 mg of daily Suboxone to be a waste of money; my experiences treating people with Suboxone have only reinforced my opinion that there is no benefit, and often considerable harm, in taking more than 16 mg of Suboxone per day, and in dosing more than once per day. But that discussion will have to wait.
My Response:
I will talk about buprenorphine, the active medication in Suboxone, just to simplify things a bit– although Suboxone will have the same effects. First, when talking about the dose, it is important that the method one takes it is identified– as that is what determines how much active drug ends up in the bloodstream. I will assume that the person is taking steps to get maximal absorption of Suboxone; for example keeping it exposed to mucous membranes for a long-enough time, and not rinsing the mouth with liquid for at least 15 minutes after dosing, to avoid rinsing away drug that is attached to the lining of the mouth but not yet absorbed. As an aside, there is a post somewhere on this blog entitled ‘maximizing absorption of Suboxone’ for those who want more info.

When a person takes Suboxone, he is taking a ‘supra-maximal’ dose of buprenorphine. Buprenorphine is used to treat pain in microgram doses; the BuTrans patch is used in the UK to treat pain, and it releases buprenorphine at a rate of 5-20 MICROGRAMS per hour! One tablet of Suboxone containes 8000 micrograms! So whether a person is taking one, two, three, or more tabs of Suboxone per day, he is taking a very large dose of buprenorphine— a dose large enough to ascertain that he is up on the ‘ceiling’ of the dose/response curve. It is important to be on the ceiling, as this is the flat part of the curve (I know– a silly statement) so that as the level of buprenorphine in the bloodstream drops, the opiate potency remains constant, avoiding the sensation of a decreasing effect which would cause cravings.

I have read and heard differing opinions on the dose that gets one to the ‘ceiling’ but from everything I have seen the maximal opiate effect occurs at about 2-4 mg (or 2000-4000 micrograms), assuming good absorption of buprenorphine. I base this on watching many people initiate Suboxone; if a person with a low tolerance to opiates takes 2 mg of buprenorphine, he will have a very severe opiate effect; if he takes that dose for a few days and gets used to it, and then takes a larger dose, there is no significant increase in opiate intoxication– showing that once he is used to 2 mg, he is used to 16 mg— and is ‘on the ceiling’ by definition. I see the same thing in reverse; there is very little withdrawal as a person decreases the dose from 32-24-16-12-8 mg, but once the person gets below 4 mg per day, the real withdrawal starts. This again shows that the response is ‘flat’ at those high doses, and only comes down below about 4 mg of buprenorphine.

The flip side of all of this is that tolerance reaches a maximum at about 4 mg of buprenorphine, and further increase in dose of buprenorphine does not cause substantial increase in tolerance. Tolerance and withdrawal are two sides of the same coin; the lack of withdrawal going from 32 to 8 mg of buprenorphine is consistent with no significant change in tolerance across that range.

So in my opinion, being on 32 vs 4 mg of Suboxone doesn’t raise your tolerance. But in regard to upcoming surgery, there is an additional concern. One issue with surgery on buprenorphine is the high tolerance, but the second issue is blockade of opiate agonists by buprenorphine– and this effect is directly related to the dose of buprenorphine. A person on 32 mg of Suboxone will need much, much higher doses of agonist to get pain relief than will a person on 4 mg of Suboxone– not because of tolerance but because of the blocking effect, which is competitive in nature at the receptor. When people are approaching surgery I recommend that they lower their dose of Suboxone as much as possible– to 4-8 mg if possible. Because of the very long half-life (72 hours), this should be done at least a week before the surgery. Then I have them stop the Suboxone three days before the surgery; it usually takes 2-3 days for significant withdrawal to develop. I say all of this to give a general sense of the issues involved; people should discuss the issue with their physician rather than act on what I am describing here.

Drug Testing, Prescribed Opiates, and Employment

Im in a methadone maintenance program and am currently at 130 and I have pre-employment drug screen coming up in about a month. I wanted to see how low I could get off the methandone and switch to suboxone. if it is not detectable in a drug screen. Also, I have a prescription for methadone can they not hire me because a Dr, prescribes methadone.? Any thoughts, ideas?

My thoughts:
There are laws that prevent a person from being fired because of certain illnesses or disabilities, but those laws are complicated. Drug addiction is a ‘protected disability’, so theoretically you cannot be fired for being a RECOVERING drug addict. On the other hand, you can be fired you for any other reason, or for no reason at all! So except for the occasional boss who is a total idiot who says ‘I don’t like recovering addicts so I am firing you’, disability law is not involved.

In general you cannot be fired for having an illness… unless the illness interferes with your job. A surgeon can be fired for being HIV positive, as there are just some risks of transmitting the virus during surgery that cannot be TOTALLY avoided– an accidental needle stick during a frenzied attempt to get a suture around the splenic artery, for example. I used to be an anesthesiologist and miss those days– in the situation I’m referring to, a person came in with a ruptured spleen from a car accident. The blood pressure was stable, but in such a case the intra-abdominal pressure is often holding the spleen together, and as soon as the belly is opened the spleen will pour blood into the belly and the patient will crash… so the anesthesiologist gets several large-bore lines in the patient, hangs fluids and blood through blood-warmers, maybe even get an infusion of a pressor set up and at the ready to maintain the pressure as best one can when there is a large hole in the spleen… I loved that work but like the HIV-positive surgeon, it just was not the place for me anymore. How could I keep all of my attention on the patients under my care, when there were buckets of opiates right next to me under my control? I think that on Suboxone I would be OK– I think the cravings would be treated so that they would not be a distraction– but I understand, and accept, that I would never be able to convince an employer of that fact. Alas…. I miss that job, but I am surprised by how I enjoy being a psychiatrist in a different way, and the enjoyment grows as each year passes and I get to know my patients more and more. OK, enough about me– back to the letter: A person on methadone can be fired, regardless of getting it legally for pain or from an addiction program, if the job requires operating heavy machinery– because taking methadone, other opiates, sedatives, etc are simply not compatible with operating machinery. Yes, you might feel fine, and even be fine– but it would be so easy for an injured party to file a lawsuit and win by saying that ‘the company had a person taking these drugs, and it says right here on the bottle not to operate machinery!!’ So you will never win the ‘right’ to work while taking impairing medication.

As for drug tests, first realize that methadone shows up in tests for a LONG time– for weeks in some cases. Whether Suboxone will show up is hard to predict; it sometimes shows up and sometimes doesn’t, depending on the manufacturer of the test. I have many patients who have undergone drug testing, and none have come up as positive, but I have purchased test kits that have shown buprenorphine as positive for ‘opiates’. The problem is that you have to list your meds at the start of the test, and if you hide it and then it does happen to show, you are in trouble. One solution to that problem is to say you take Suboxone for chronic pain; that you use it because it causes less CNS effects (sedation, etc) and you want to be ‘super sharp for your job!!’. Of course you would need your doctor to verify that when he is called by your company.

If you are switching to Suboxone, do it sooner rather than later– get the methadone out of you as quick as you can. And in MOST cases, the Suboxone that you would take would not show up in any test. It isn’t the number of panels on the testing kit– it is the manufacturer of the kit, and there are many manufacturers. I have kits with many different panel set-ups– the companies will make whatever collection of tests that I ask for. I have kits that detect buprenorphine (suboxone), or OC, or methadone, or whatever. If a company wants to test for buprenorphine they could get a buprenorphine test strip for about 3 bucks. But the companies know that they would be challenged for ‘snooping’ into your personal medical history, rather than searching for active drug abuse– that is the only reason they don’t test for buprenorphine.

Wouldn’t it be nice if addiction was treated like any other illness, and you could explain to your employer that you ‘caught’ opiate dependence when your doctor prescribed high-potency narcotics for your back pain, and that now you are under treatment… and for that, you weren’t fired? Maybe some day.