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:


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.

Brandeis and CDC Wrong on Buprenorphine PDMP Data

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Where’s the Buprenorphine asked Mr. Obvious? Thanks, CDC!

A quick note tonight, hopefully with a longer post to follow this weekend…
I’ve been frustrated by the people behind the Wisconsin PDMP, or Prescription Drug Monitoring Program, for their mistakes related to buprenorphine. Whoever came up with the numbers made a rookie error when calculating the equivalent morphine dose of patients taking buprenorphine products. The error is easy to notice by anyone who works with the drug, but apparently difficult to grasp by anyone with the power to correct the database figures.

Those people include, by the way, the folks at Brandeis University who give the numbers to Wisconsin, and the people at the CDC who give them to Brandeis. I’ve written to all of them; the bright folks at the CDC skimmed my explanation of their error and responded with a form-email that provides a link to where I can get ‘answers to my questions’.
Thanks, CDC!

In short, the people doing the calculation take a low dose of buprenorphine– say 200 micrograms– and extrapolate out in a straight line to 16 mg, ignoring the ceiling effect of partial agonists like buprenorphine. The calculation causes the PDMP to display a graph showing that people on buprenorphine are on the equivalent of 1200 mg of morphine. Any physician who sees that data (and all WI physicians are required by law to use the PDMP effective April 1) will think that the buprenorphine patient needing post-op pain is on THAT dose of opioids. Talk about an April Fool’s joke– nothing like hypoxia in the recovery room to brighten everyone’s mood! Don’t worry though– in their email they pointed out the disclaimer in fine print that the site shouldn’t actually be used to compare or convert opioid doses.

Then why make the calculation and show the graph, asks Mr. Obvious?!
This is getting longer than I intended… Another annoying State tidbit is the series of letters to Wisconsin physicians warning about the severe risk of harm from prescribing benzodiazepines to patients on buprenorphine. I’ve written to those folks as well, pointing out that combinations of benzodiazepines with opioid agonists are much, much, much more dangerous than with buprenorphine. I’ve explained how somehow, sometime long ago, the phrase ‘buprenorphine can only cause death in adults if given to someone without opioid tolerance AND combined with a second respiratory depressant, to which the person also lacks tolerance’ (a true statement) was changed to ‘buprenorphine is dangerous when combined with benzodiazepines’ (mostly ‘fake news’).

I haven’t written as many letters over this second issue because I’m no big fan of benzodiazepines. But both issues annoy me greatly, maybe because the errors of logic in both cases are SO obvious. Even for government work!!
Speaking of government work, the Milwaukee County Common Council released figures about the surge in overdose deaths, including a breakdown by ethnicity, age, county region, and drugs found at autopsy. Mr. Obvious has a question for the people writing to doctors to tell them about the SEVERE risks from buprenorphine: ‘What drug is NOT on the list of the 8 most-common drugs found in toxicology tests of overdose patients?’ A hint: It starts with a ‘B’!

Congress Acts on Opioid Dependence (ugh)

I won’t weigh in on the upcoming election, for fear of being barraged with insulting tweets by one candidate or ‘offed’ by the other.  But the current opioid dependence crisis provides a great chance to learn whether you stand on the side of ‘limited government’ or the alternative.
The TREAT Act takes 5 minutes to read, that would have increased the cap on buprenorphine patients.  President Obama undermined the TREAT Act by announcing his own plans to raise the cap soon after the TREAT Act was presented in the Senate.  After 7 years without mentioning heroin or opioid addiction, it’s hard to believe Obama’s actions were a coincidence.   Only a master politician can ignore 200,000 deaths, and then claim to solve the problem single-handedly despite a do-nothing Congress!
As I wrote earlier, few doctors will make use of Obama’s lousy offer.  Today Congress approved a bipartisan bill that will reportedly signed ‘begrudgingly’  by President Obama– who complained that the Bill ‘doesn’t go far enough.’  I wonder how many pages HIS Bill would be.
I invite readers to check out the language of the TREAT Act in regard to the buprenorphine cap– and then read the language of the ‘Comprehensive Addiction and Recovery Act of 2016‘.  And then, please, tell me how many patients doctors will be able to treat with buprenorphine.  The new law will provide treatment authority for nurse practitioners and physician assistants– I think.  How?  When?  How many?  I see a number of details that are left to the HHS Secretary–  a post that changes a couple times during a 4-year Presidential term.
How do we set up practices based on rules that change every couple years?!
I’m no political scientist, so I’m just reading the Bill and trying to figure it out– and I encourage you to do the same.  Myself, I prefer the language of the TREAT Act, but hopefully the attorneys will get this new thing figured out and let us know how many people we get to help with buprenorphine.

Obama’s Lousy Suboxone Offer

I was reading more about Obama’s executive order over at Dr. Burson’s blog.  I guess she is a ‘competitor’ in the blogging world, but I have to admit that her blog has a lot more detail about the issue than I do.  If you haven’t been there yet, check it out.  Keep coming back here too of course!
She wrote recently about the rules that would be required by the Feds, in order for them t o allow us the ‘right’ to treat people with buprenorphine.   I wrote to Dr. Burson after reading her post that she is providing the facts, and I can’t help but provide the emotion.  And after reading the baggage tied up with the ‘right’ to treat heroin addicts, I am.. ‘pissed’!  I realize that isn’t a word that doctors should use.  But honestly… I just don’t have another one!
Dr. Burson wrote that according to the current proposal, Doctors begging the Federal Government to treat another 100 addiction patients must 1. Use electronic medical records; 2. Accept insurance for the treatment; and 3. Require counseling of patients treated with buprenorphine products.  There were other requirements as well, but these were the three that I remember for irritating me the most.
Dr. Burson goes through her reactions to the requirements, and mine are mostly the same.  As a solo psychiatrist, I don’t see the value of electronic records.  Many of my patients don’t WANT their addiction treatment in a database. They know the stigma that they face already every time they go to the pharmacy.  Some of them work for employers who would discriminate against people once-addicted to opioids.  Some of them know they would be accused of ‘impairment’ for taking buprenorphine.  Those of us who prescribe buprenorphine know that they are not impaired– and that they’ve worked at jobs for years with no problems should speak volumes.  BUT IT WON’T.  We all know that ‘impairment’ can be in the eye of the beholder– and once someone thinks it is there, it IS there.  Once accused, how do you prove you’re not impaired?
I realize that at first glance, accepting insurance sounds like a good deal.  But now, I am able to see at most 2 patients per hour.  I have accepted insurance in the past, and that’s a completely different business.  Insurance companies reimburse psychiatrists at a rate that anticipates seeing 4-5 patients per hour.  Medicaid reimburses far below that, expecting doctors to make up the difference through commercially insured patients.  But that doesn’t work when treating addiction, where the large majority of patients are on Medicaid.  The only way it works is if the doctor works for a network where knee replacements and MRI scans subsidize addiction treatment, or where care is ‘mass produced’ by a team that minimizes the time doctors spend with patients.
I LIKE seeing two patients per hour.  The Obama team says if that is the case, I can’t see more than 100 patients, no matter how much my home town needs my services..  How ironic… if I spend less time per patient, I can have MORE patients.
I’ve written about the counseling issue before.  The requirement is a nod toward the huge counseling/rehab industry that has tried to block medication-assisted treatment at every turn.  Shouldn’t something as personal as counseling be decided by each individual patient?  Is there any other illness that requires counseling in order for patients to receive medication?  Of course diabetics would benefit from nutritional counseling– but would we consider withholding insulin without it?!
Who will decide, by the way, if the counseling is adequate?  Will the doctor stop your medication if you miss too many sessions?  What if you have nothing to talk about– so you still have to go? How many times? What type of ‘counseling’ counts?  Can a person get a massage and call it ‘counseling’?  If I get my ears candled, is that good enough? Group therapy?  Music therapy?  I saw recently that Madison WI has practices offering ‘float therapy’– is that OK? What about equine therapy?
I think you get my point.
As I mentioned in an earlier post, the TREAT Act would have increased the cap and allowed doctors to decide the best course of action for each patient.  The doctor remained in charge of patient care– sort of like ‘if you like your health insurance, you can keep it.‘  President Obama stepped in front of the TREAT Act to offer something different.  I can almost hear him saying with a Bronx accent… ‘how can you turn down dis’ deal?’
With all the heroin deaths, he’s putting forward ‘an offer you can’t refuse’.   No thanks…. I’ll stay at 100.