Category: surgery

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 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.

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.

Ten Gripes of Buprenorphine Doctors

I recently gave a lecture to medical students about opioid dependence and medication assisted treatment using buprenorphine, methadone, or naltrexone. I was happy to see their interest in the topic, in contrast to the utter lack of interest in learning about buprenorphine shown by practicing physicians. In case someone from the latter group comes across this page, I’ll list a few things to do or to avoid when caring for someone on buprenorphine (e.g. Suboxone).

1. Buprenorphine does NOT treat acute pain, so don’t assume that it will. Patients are fully tolerant to the mu-opioid effects of buprenorphine, so they do not walk around in a state of constant analgesia. Acute pain that you would typically treat with opioids should be treated with opioids in buprenorphine patients. Patients on buprenorphine need higher doses of agonist, usually 2-3 times greater than other patients. Reduce risk of overuse/overdose by providing multiple scripts with ‘fill after’ dates. For example if someone needs opioid analgesia for 6 days, use three prescriptions that each cover two days, each with the notation ‘fill on or after’ the date each will be needed.

2. Don’t say ‘since you’re an opioid addict I can’t give you anything’. There are ways to provide analgesia safely. If you do not provide analgesia when indicated, your patient will only crave opioids more, and may seek out illicit opioids for relief. Unfortunately nobody will criticize you for leaving your patient in pain, but they should!

3. Don’t blame the lack of pain control on laws that don’t exist, for example “I’d like to help you but the law won’t let me.” Patients deserve honesty, even when the truth makes us uncomfortable. We get paid ‘the big bucks’ for tolerating the discomfort that sometimes comes from frank discussions with our patients.

4. Don’t assume your patient can or cannot control pain medications. If a patient has been stable on buprenorphine for years, he/she may have a partner or family member who you can trust to control pain medications. Some patients stable on buprenorphine can control agonists used for acute pain, but I wouldn’t stake my life, or theirs, on that ability. A useful compromise is to prescribe enough pain medication to cover 1-2 days of analgesia on each of several prescriptions, each with a ‘fill after’ date, to reduce the amount of agonist controlled by the patient at one time.

5. Don’t tell your patients that ‘opioids don’t work for chronic pain.’ I see stories on such great medical sources as the ‘Huffington Post’ explaining that ‘opioids never help chronic pain’. In reality, your patients know that opioids DO treat chronic pain, so they will consider you a liar or an idiot if you clam they don’t. The challenge is explaining the risk/reward equation to your patients, and explaining why treating chronic pain with opioids often leads to greater problems, as the risk/benefit equation is changed by tolerance.

6. I know this will cause heads to explode, but don’t assume that chronic pain is always less severe than acute pain. What if your patient’s chronic pain is worse than the typical pain after cholecystectomy or ACL repair? Most doctors would gasp at the idea of recovering from major surgery without opioids. What if the pain from failed back syndrome is worse?! I have had a few patients who, I’m certain, experience a great deal of suffering, and have gone so far as to have brain or spinal cord implants to get relief. I’m not arguing that we treat chronic pain in the same way as acute pain. But we shouldn’t jump to the conclusion that chronic pain isn’t severe enough to warrant opioids in order to dismiss those complaints more easily.

7. Don’t tell your patient to stop taking buprenorphine unless you’ve talked with the doctor who is prescribing that medication, and realize that the doctor you are calling knows more about buprenorphine and addiction than you do.

8. Don’t ask patients ‘how long are you going to take that stuff’ or criticize patients’ use of buprenorphine medications. Likewise psychiatrists shouldn’t tell patients scheduled for knee arthroscopy that the procedure is controversial, or talk patients out of hernia surgery.

9. Don’t assume that the doctor prescribing buprenorphine knows what YOU are doing. Too often patients will tell me about surgery that they failed to discuss in advance, even calling about pain hours after getting home from a procedure they failed to mention. Some people seem to believe that doctors regularly collaborate on their care, even though the opposite is closer to the truth.

10. Don’t assume that unusual or atypical symptoms come fromo buprenorphine. One truism of medicine is that doctors tend to blame unexplained symptoms on whatever medication they know the least about. Fevers of unknown origin, mental status changes, or double vision are not ‘from the buprenorphine!’

Those are the gripes at the top of my list. Did I miss one of yours? Or for patients, have you suffered from breakdowns in the system?

Addendum: 11. When treating post-surgical pain in buprenorphine patients, choose one opioid and stick with it. What often happens is that doctors will use one opioid, say morphine… and when nurses call a few hours later to say the patient is still screaming, they change to a different opioid, then another after that. As a result, the patient is placed on insufficient doses of several opioids, rather than an adequate dose of one medication.

There are two critical issues in treating such patients effectively. First, providing pain relief comes down to competition at the mu receptor. A certain concentration of agonist in the brain and spinal fluid will out-compete buprenorphine and provide analgesia. You cannot get there by adding other opioids together. If you use oxycodone for an hour and then change to dilaudid, you are starting over. Instead, choose one drug, preferably something that can be given intravenously, and stick with it. Morphine is not a good option btw, because of the low potency and histamine releasing properties of that drug.

Second, remember that analgesia and respiratory depression travel together, both mediated by the mu receptor. Anesthesiologists know this principle well… opioid medication can be titrated to respiratory rate, providing that the medication is given IM or IV. If a patient is breathing 28 times per minute, he/she is in pain. If the patient is breathing 6 times per minute, pain is not a problem, and the patient should be monitored for respiratory depression and possible overdose. When treating pain, doctors should aim for a respiratory rate of 14-18 breaths per minute, making sure that the medication is actually getting into the bloodstream (the risk comes when patients are given SQ injections or oral doses of narcotic that enter the bloodstream later, causing toxic blood levels).

Post-op Pain on Suboxone

Many patients on Suboxone or buprenorphine eventually require pain treatment, just like people who aren’t on buprenorphine products.  I’ve written about post-op pain control several times, but I continue to get emails from patients who haven’t seen my comments and who view an upcoming surgery with the same fear experienced by patients before the early 1900’s, when the OR was correctly seen as a horror-chamber.
These patients are often torn between following the treatment plan vs. doing what they have learned may work better.  In all cases, I tell patients that they cannot act in ways counter to what their physician prescribes.  But I often support their intent to ask their doctors to clarify or modify their treatment plans.

Patients write about ‘the look’– the way doctors, nurses, and pharmacists react when patients ask about pain control.  As a recovering addict myself, I know what they are referring to.   Doctors encourage other patients to discuss concerns about pain control, and as long as they have no piercing or tattoos, patients will usually be comforted with assurances that their doctors will take their pain seriously.  But people on buprenorphine often see their doctors roll their eyes, or even say that the opposite is true– that if they have pain, they had better not bother the doctor about it!    Doctors who act that way are asses, of course, and I urge patients to avoid them if possible.  This post is not for those doctors, as they are not likely to ‘get it’ after reading the comments of another doctor— if they would ever read them in the first place!

I’m writing for the doctors who are open to hearing about new ways to help their patients.  I intend to use this post, going forward, to answer the emails from patients about this topic   If you are a physician who received this from a patient, please consider my comments– as I have found the approach described below far more helpful for surgical patients on buprenorphine products than the alternatives described elsewhere.  There was an NIH consensus paper a few years ago for example that described several alternatives, but mostly focused on discontinuing buprenorphine before surgery, then restarting buprenorphine at some point through a standard induction that includes 24 hours of withdrawal in patients already weakened by surgery.  Standard doses of opioid agonists were recommended for pain.  That approach was also described in a flashy article in one of the throw-away journals a month or two ago (i.e. Autumn of 2015).

There are so many problems with that approach:

  • Patients forced to stop buprenorphine before surgery and enter surgery dehydrated and weakened (IF they even managed to stop, as many patients end up staying on buprenorphine covertly– NOT a good situation for surgery.)
  • Buprenorphine discontinuation not an option for emergency surgeries;
  • Constant opioid levels are necessary to avoid withdrawal, before even considering pain control;
  • Buprenorphine is erroneously considered gone, when the long half-life actually assures that buprenorphine is still present;
  • Patients fret and argue over pain control every time the nurses change shifts;
  • Buprenorphine re-induction at some point after surgery, requiring patients to go through withdrawal symptoms;
  • Agonist treatment alone causes tolerance to rise very rapidly, requiring high doses of narcotic at hospital discharge;
  • An increased risk of overdose from narcotic pain medication in patients off buprenorphine;
  • And many other reasons.  Using the ‘discontinuation’ approach, patients end up on a Hellish roller-coaster ride where pain is grossly under-treated and withdrawal symptoms are only 4 hours away, day after day.

I’ve read emails from people whose buprenorphine doctors recommended taking more buprenorphine for post-op pain, or dosing more often.  I’ve read about suggestions to use Tramadol for pain after major surgery(!)
Earlier today I sent a letter in response to a woman who is planning a series of painful procedures.  I’ll share that letter to spare myself some time:

Dear A,

You’ve been through enough misery, and I hope you convince your physician to consider a different approach to your pain. I’ve had patients on buprenorphine go through many surgeries including thoracotomy, nephrectomy, open cholecystectomy, total knee replacement, and rotator cuff repair– all very painful surgeries.  My experience as an anesthesiologist piques my interest in post-op pain control.

My favored approach is very simple.  Maintain buprenorphine, and use oxycodone or other agonists to out-compete buprenorphine at the mu receptor as needed for pain relief. The benefits of the approach are obvious once the prescriber opens his/her mind to the realities of ligand competition.  There is no need to go through withdrawal, no need for ‘comfort meds’ to tolerate the withdrawal, and no need to enter surgery in an already-weakened state. As you know, even minor withdrawal causes people to feel very depressed, lose their appetites, stop sleeping…. is that really any way to go into surgery?

As an aside,  buprenorphine alone does not provide ‘real’ pain control in patients who take chronic buprenorphine.   Yes, buprenorphine seems to reduce pain in people with minor pain issues.  But it is of no use for the pain of major surgery.  Of course in theory, why would buprenorphine treat chronic pain in patients with complete mu tolerance to a medication with a ceiling effect?

A few years ago, an NIH consensus paper described a few approaches to acute pain in patients on buprenorphine. I don’t know who was on that panel, but the paper suggested stopping buprenorphine for several days before surgery and then using agonists. The panel mentioned the approach that I favor near the end of the paper.   I also described my favored approach at an annual meeting of ASAM, in a talk that was very-well received. I was optimistic that the discussion would open enough minds among prescribers to follow the neurochemistry, instead of focusing on the misplaced fear of combining an agonist and a partial agonist.   There are other papers out there– and book chapters– about the effects gained by combining an agonist with a partial agonist. You can find my ASAM slides at www.slideshare.net by searching for ‘junig’ and ‘uncoupling analgesia’.
The ‘uncoupling’ part BTW is what makes my favored approach so valuable, but that gets into the area of chronic pain, which is not entirely relevant to this discussion.  In short, opioid analgesia has always been limited by tolerance and dependence.  I believe that those limits can be removed by combining mu receptor agonists with partial agonists, allowing for pain relief from agonists while partial-agonists prevent euphoria and anchor tolerance at a lower level.

My approach is to reduce buprenorphine to about 4 mg per day.   Higher doses in my experience get in the way of pain control.  I then treat post-op pain as I would in any patient, but using 4 times more agonist (warning– see * below).  I typically prescribe oxycodone, 15 mg tabs,* and direct patients to take one tab every 4 hours as needed. When patients no-longer needs narcotic analgesia, I stop the agonist and have them resume their regular doses of buprenorphine. That’s it.  No tapering, and no withdrawal… just treating patients as I would any other patients, but realizing that mu receptors are competitively blocked, and effective doses of oxycodone must out-compete buprenorphine.

Dilaudid or fentanyl are not necessary. You could approach post-op pain in a very elegant way in a hospital using sublingual buprenorphine, fentanyl infusion, and PCA, but that gets a bit complicated. Oxycodone works fine.   In rare cases my patients required higher doses of oxycodone, but I’ve never had reason to use more than 30 mg.   Oxycodone is typically used every 4 hours.  My buprenorphine patients have found good pain relief from total daily doses of 60-120 mg of oxycodone.  The patients who went to a hospital where I couldn’t control their analgesia, who were told to stop buprenorphine, ended up on much higher doses of oxycodone at discharge.

Advantages of Combined Approach:

There are many advantages to maintaining buprenorphine throughout the perioperative period. The entire process is much simpler, and the patient’s experience is better because there is no euphoria, and no warm rush from oxycodone to rekindle addiction. The pain is relieved, but the reinforcing effects of oxycodone are eliminated.  I assume the that the limits on mu effects by buprenorphine are like a ‘governor’ that limits the speed of fleet vehicles. You can get only so much opioid effect in the presence of buprenorphine, and not enough to cause a ‘high.’

The combined approach also prevents tolerance, which is a greater issue with chronic pain than with post-operative pain. Buprenorphine anchors tolerance at the level yielded by the ceiling effect, allowing agonist effects to continue over time. I’ve treated people with the combination of buprenorphine and oxycodone for over 2 years, and the combination continues to work as well as it did on the first day.

Some prescribers and pharmacists worry about ‘precipitated withdrawal’, but that is not an issue as long as buprenorphine is continued every day. The only way to precipitate withdrawal would be to stop buprenorphine for at least a few days, boost tolerance higher with an agonist, and then give buprenorphine– which would ‘yank’ tolerance back down again. Patients who stay on buprenorphine can add agonists without fear of precipitated withdrawal.

I’ve convinced a few doctors to try this approach, and I’ve received a number of positive reports about the approach.   I’ve described the idea to several pharmaceutical companies as an approach that would revolutionize pain treatment.  Can you imagine pain relief without addiction, without tolerance, and without euphoria?   I realize that the large number of deaths caused by opioid overdose limits interest in opioid analgesia.  But I suspect that a product that combines buprenorphine and an agonist would go a long way to reducing opioid dependence, providing that the two medications were irreversibly bonded together in a combination product.  I have some thoughts about how to do that… but that’s for another day.

It is NEVER safe to prescribe one’s self opioids or other controlled substances, so this discussion is intended to provoke discussion between patients and their doctors.  Patients must realize that there are many things that go into decisions about post-operative analgesia, and NO approach is the right approach for everyone.  Any individual patient may have features to his/her history that make the combination approach inappropriate, or even dangerous.

*Doses described in this post are intended as approximations for consideration by trained and licensed medical professionals.  Doses described may not be safe in some patients, including patients at the extremes of age, patients with respiratory or other chronic illness, patients with central nervous system disorders, or patients on other respiratory depressant medications.

NEVER use opioids except as directed by your own physician.

Opioid Analgesia Without Addiction

I don’t have pull with the addiction-related organizations out there.  I’m never been a joiner, and I tend to notice the problems caused by medical societies over the good things that they supposedly accomplish.    For example PROP, or ‘Physicians for Responsible Opioid Prescribing’, have a specific mission.  Once a group has a mission, any considerations about individual patients go out the window.  PROP has propagated the message that opioids are NEVER beneficial for patients with chronic pain.

Legislators with no knowledge of clinical medicine hear that message, and respond by passing draconian laws that interfere with any considerations of individual patients.  I would guess that the people of PROP pat themselves on the back for encouraging laws that remove physician autonomy.  I’m sure they figure that they are smarter than all the family practice docs out there.  But in reality, they are only destroying the control of doctors over patient care, and handing that care over to politicians.  Way to go, PROP.

In the same way, the societies that hold meetings about meetings, that elect Secretaries who become Vice Presidents who become Presidents, get to publish the articles that describe clinical protocols.  The doc who spends every day talking with patients has no access to these sources, and little ability to influence those protocols.  Sometimes the societies and organizations get things right… and sometimes they get things wrong.  The latter is the case with post-op pain control in patients on buprenorphine products.

I’ve written about this before, as regular readers know.  Over the past 8 years I’ve had dozens, if not hundreds, of patients on buprenorphine undergo surgery.  The surgeries include coronary bypass, thoracotomy, rotator cuff repair, C-section, nephrectomy, total knee or hip replacement… and a host of minor surgeries with scopes and lasers.  I’ve treated these patients in a number of ways, in part because hospitals that provide emergency care have different ways of dealing with post-op analgesia.  I rarely have control over what they do acutely– but I almost-always take over pain control when patients are discharged.

In the past few months there have been several ‘articles’ stating that the best way to handle surgery, in people on buprenorphine products, is to stop the buprenorphine before surgery, and treat pain using opioid agonists.  This opinion is not supported by any data.  It is someone’s opinion– usually someone who has a title, i.e. someone who spends at least some of his/her time in society meetings.  That time is removed from the amount of time that could be spent treating and speaking with patients.  Frankly, the ‘higher’ a doctor is in society circles, the less time they spend in patient care.  That comment will anger the docs who it applies to.  I can hear them now– saying I’m only full of ‘sour grapes’. But maybe those same docs should look in the mirror, and wonder how they ended up as ‘President’ of a society.

I’ve used the approach claimed as best practice in the society journals– i.e stopping buprenorphine before surgery– and the same thing always happens.  Tolerance to opioid agonists rises very rapidly in the post-op period.  Patients are discharged on huge doses of opioid agonists.  And at some point, agonists must be discontinued for 24 hours to allow for re-induction with buprenorphine agents.  I’ve had several recent patients go through this exact process– and my frustration motivates this post.  One guy shot himself in the femur, and the bullet also passed through his lower leg.  He needed fasciotomy to avoid losing the leg. His Suboxone was discontinued at admission, and ten days later he was discharged on 30 mg of oxycodone every 2-3 hours– i.e. over 200 mg per day.  The other person was in a serious car accident, and had multiple fractures—  femur, pelvis, ribs, wrist– as well as internal injuries.  After 3 weeks he was released on over 300 mg of oxycodone per day!

On the other hand, I’ve had many patients go through the surgeries listed earlier while maintained on buprenorphine, 4-8 mg per day.  In ALL cases, they had excellent analgesia with lower doses of oxycodone than in the people who stopped buprenorphine.  Most patients did well on 15 mg of oxycodone every 3-4 hours– a max of 120 mg of oxycodone per day.  In a few cases– i.e. in the most painful operations, in the most sensitive patients– I had to use 30 mg of oxycodone every 4 hours.

The most amazing thing about the combination of buprenorphine and opioid agonists is the absence of tolerance to agonists, when buprenorphine is present.  I’ve had patients with recurrent injuries that required repeated surgeries, including a woman who tore her rotator cuff and the surgical repair THREE times over three months.  She took the same amount of opioid agonist for three months, with no noticeable decrease in efficacy.  After the final operation, after three months on significant amounts of opioid agonist, she simply stopped the agonist and resumed her full dose (16 mg) of buprenorphine.  She had no withdrawal, and not other complications.  She simply stopped the agonist and resumed buprenorphine treatment.

I’ve come to realize that buprenorphine effectively ‘anchors’ tolerance when patients take opioid agonists, as long as the buprenorphine is continued.  Patients always say the same thing:  that the pain was reduced by the agonist, but that it didn’t ‘feel’ like the agonist they used to take.  In fact, patients who could never control pain pills found that they COULD control agonists if they stayed on buprenorphine.

A couple years ago I presented these findings at an annual meeting of ASAM.  The slides can be found here.  I believe that some day, combinations of buprenorphine and opioid agonists will be the standard approach to pain treatment.  The combination allows for opioid analgesia without tolerance, without euphoria, and with little or no risk of addiction.  If THAT doesn’t piqué your interest, you have no business reading about opioid dependence!

I picture combinations of buprenorphine and fentanyl… especially since both are now FDA-approved as transdermal patches.  Or perhaps a combination of fentanyl lozenges and sublingual buprenorphine.  The possibilities are endless.  Throughout history, the miracle of opioid analgesia has been cursed by the attachment to tolerance, dependence, and addiction.

Imagine if that curse was lifted from opioid analgesia.    Can you even dare to imagine that world?  I’m telling you… it is closer than you think—- and there for the taking.

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.

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

Codeine Never Works for Me

Originally published 10/29/2012
The FDA recently released a Drug Safety Announcement about the use of codeine in young children after tonsillectomy/adenoidectomy surgery for obstructive sleep apnea.  I was somewhat surprised to see a safety announcement on a medication that has been in use for decades, but the release underscores our improved knowledge of drug metabolism, and the broadening demographics of the United States.
Codeine has little activity at opioid receptors.  The analgesic effects of codeine are actually caused by morphine, after the conversion of codeine to morphine at the liver.  The conversion is catalyzed by an enzyme called CYP2D6, part of the cytochrome system of enzymes that are involved in the metabolism of a number of compounds.
I have written about the addictiveness of narcotic pain medications.  People addicted to opioids often go to significant lengths to obtain prescriptions for narcotic pain relievers from healthcare practitioners.  Emergency room physicians and nurses become aware of the efforts of ‘narcotic-seekers’, which range from faking pain symptoms or dental injuries to self-catheterization and instilling blood into the bladder to fake kidney stones.  Distinguishing those with real pain from those who are addicted and not experiencing pain is a serious situation, but doctors roll their eyes at some of the more-typical presentations.  One such situation is the patient who reports an ‘allergy’ to all of the weaker narcotics, and claims that ‘the only drug that works is (insert Dilaudid, morphine, oxycodone, or another potent opioid here).
Codeine is one drug that is commonly rejected as ‘ineffective’ as part of a request for something stronger.  When I was a medical student, we assumed that requests for something other than codeine were disingenuous.  But at some point, maybe 15 years ago, I remember reading an article that described the conversion of codeine to morphine by the liver.  The article reported that the enzyme that performs the conversion exists in varying forms across the population, with some ethnic groups having more active forms of the enzyme than others.  Some people have very low levels of CYP2D6, and so get very little analgesia from codeine.  In other words, some of the people who claimed that ‘codeine never works for me’ were probably less disingenuous than doctors thought!
The latest FDA warning describes three deaths in children between the ages of 2 and 5.  The effected children were ‘ultra-rapid CYP2D6 metabolizers’ who were given typical doses of codeine for post-operative pain control, who converted the codeine to morphine more efficiently than expected.  The respiratory depressant effects of morphine, combined with some degree of post-operative respiratory obstruction, caused the death of those children and the near-death of a fourth.
About 6% of the people in the US are ultra-rapid metabolizers.  About the same number are poor metabolizers and have a reduced analgesic response to codeine.  In some ethnic groups there are greater numbers of rapid metabolizers, particularly people from Greek or African/Ethiopian ancestry.  If you are someone who gets little pain relief from codeine or on the other hand if you get a very strong effect from codeine, you may want to look into G6PD testing, which can be ordered by physicians.  The enzyme activity is heritable to some extent, so your own enzyme activity may bear relevance to the activity of the enzyme in your children.
Expect similar issues to arise with other medications, as we learn more and more about how our bodies metabolize medications, and about the effects of those metabolites on enzyme systems.  The lesson also reminds doctors that there is wisdom to be gained by listening to our patients.

Post-op Pain on Suboxone

I often receive emails from patients on buprenorphine (or Suboxone) who are preparing for surgery or other painful medical procedures. Ideally in such cases, the surgeon would have a discussion with the person prescribing buprenorphine, in order to coordinate the plan for treating postoperative pain. In practice such discussions don’t seem to take place, leaving patients to scramble for effective pain control after surgery– when it is too late to take the steps necessary for a smooth perioperative course.
I am familiar with an NIH article that describes pain control in people who take buprenorphine. I’ve also prepared a handbook that describes the issues that must be considered in such patients; the handbook can be found easily-enough by searching for the User’s Guide to Suboxone.
Even with those descriptions ‘out there,’ I’ll get requests for a short, ‘just-the-facts’ note that patients can give to their surgeons. I realize that unfortunately, the average surgeon will not sit down for an in-depth discussion of post-op pain control, so I have prepared a few paragraphs that lay out the issues. People on buprenorphine who are having surgery are welcome to copy the paragraphs below and give them to their surgeons, in order to facilitate discussion.
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 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 post-operatively. 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.
Quick Notes:
Patients taking maintenance doses of buprenorphine do NOT receive surgical analgesia from the medication, as they are completely tolerant to the mu-opioid effects of buprenorphine after the first week or so on the medication.
Discontinuation of high dose buprenorphine or Suboxone treatment results in significant opioid withdrawal symptoms within 24-48 hours.
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 on buprenorphine. Initiating buprenorphine WILL cause withdrawal in someone who is tolerant to opioid agonists, unless the person is in physical 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.

My Book

Ah yes…. another post about my book…
Over the past few years, I’ve taken posts from this blog, posts from other sources that I’ve written, some sections of a ‘memoir’ that I have not gotten around to writing… and combined them in a book about addiction. The book does not hold together as well as it should, and it is way too long– so instead of a ‘sit and read’ book it is more like a reference, similar to the blog itself. If you like this blog, you’ll like it; I’ve taken the more important posts and cleaned them up and organized them. I’ve added some new material as well, including a section about my own background. If you have a loved one on Suboxone, or have an interest in the medication yourself, you will know as much about the buprenorphine as anyone should you finish this book– particularly about the use of buprenorphine by addicts, the controversy over buprenorphine, the relationship between buprenorphine and methadone, etc.
There are some chapters that are dated– i.e. where my opinion has changed or softened over the years. I was much more ‘anti-methadone’ when I wrote most of the book; now I see methadone as something that some people simply need in order to survive. I am not a fan of how some clinics are run– but that is a topic that I don’t get into in this book.
Finally, you’ll notice how I have changed over the years; in early posts I would become angry and sarcastic with some writers. In part, that is because I was being attacked on a daily basis by the ‘anti-sub’ movement– which has largely disappeared. But I think I have also aged a bit, and I now tend to pick my battles more carefully.
The book (note- this is an e-book) goes for $14.99, and runs around 250 pages– long enough to occupy most of your summer! Proceeds continue to support this blog, and SuboxForum as well.
Thank you very much, to those of you who purchase it and check it out. I would be most grateful if you would leave comments about it– for me, and also for others– by writing them in response to this post. At some point I will get a page set up, and tranfer this promo and the comments to that page.
The book is called ‘Dying to be Clean’– and can be purchased using the links at the left of this page– or right below this post.
NOTE: Because I don’t want it simply passed around freely at this point, you need a code to open it– and it cannot be printed. The code will be included with the download link. Please understand why I take those actions.
Thanks again,
Jeff J
Buy Now