The incident command system kicked in at Brigham and Women’s Hospital about a week ago. A large team of doctors, pharmacists, and nurses began assembling every morning to confront an emerging crisis with the potential to severely undermine care for patients.
The challenge was different than it was during the Boston Marathon bombing, another event that triggered the command response. This one wasn’t rushing toward caregivers as fast. But it was similarly daunting and logistically demanding: Amid a nationwide crisis caused by too-easy access to medical painkillers, hospitals are now struggling to find enough of that same class of drugs to keep their patients’ pain controlled.
That is the reality now facing Brigham and Women’s and other medical providers across the country. Production of injectable opioids has nearly ground to a halt due to manufacturing problems, creating a shortage of staple medications used to treat a wide array of patients. Alarms are now ringing at all kinds of medical providers, from sprawling academic hospitals to small hospice programs, and many are launching efforts to conserve injectable opioids and institute safeguards to prevent dosing errors that can result from rapid changes in medication regimens.
“Any shortage of these medicines has the potential to impact the ability to provide adequate pain management to patients admitted with painful conditions or patients undergoing surgeries,” said Dr. Charles Morris, associate chief medical officer at Brigham and Women’s. “We stood up this incident command response to make sure that this impact is not realized.”
These products, packaged in vials, patches, and syringes, are distinct from the prescription pills at the root of the nation’s opioid addiction crisis. They are distributed to hospitals and other medical providers that use them to treat patients undergoing major surgeries or those who are suffering from intense pain related to trauma or cancer.
The severity of the shortage, which has been brewing since last summer, only became clear in recent weeks after Pfizer Inc., the dominant manufacturer of injectable opioids, began notifying customers that it has halted production of some medicines and will not be able to fully restore its capacity until the first quarter of 2019. Some hospice providers in Florida, Maryland, and Hawaii are already reporting they have run out of some opioid products and are struggling to replenish supplies needed to help patients, according to the National Hospice and Palliative Care Organization.
Pfizer has attributed the shortage to a problem with a third-party manufacturer that produces the pre-filled syringes that contain various formulations of opioids, including morphine, hydromorphone, and fentanyl.
Scott Knoer, chief of pharmacy at the Cleveland Clinic, said the hospital system is carefully monitoring inventory and using alternative treatments whenever possible. That might include giving patients oral opioid medicines, or using IV Tylenol when their pain can be managed with a less potent drug. But the price of IV Tylenol has also tripled since 2014, to $37 per vial compared to $2 per vial for IV morphine. That carries a significant budget impact, in addition to extra costs for staff members to work overtime to manage the opioid shortage and receive additional training.
“There is a real cost to drug shortages,” Knoer said. “This month it’s opiates. It’s going to be something else next month. This revolving door means something is always going to be short. You’re never over it.”
Constant vigilance
Pharmacy leaders at Brigham and Women’s hospital expressed a similar weariness, noting that regulators have made limited headway in addressing shortages over the past decade.
In their incident command meetings, they discuss the volume of opioids available on a given day and how it might be impacted by the daily demands of surgery, emergency care, and other treatments.
So far, the shortage is not so severe that the hospital must scale back on services or consider rationing medicines. But its physicians, pharmacists, and administrators are also emphasizing the use of alternative pain medications and strategies to help conserve injectable opioids over the next year. The effort also involves regularly reaching out to wholesalers to make sure the hospital claims whatever additional supply becomes available.
“That is taking quite a bit of our purchasing resources to keep monitoring the situation to buy whatever release of product becomes available,” said Michael Cotugno, director of pharmacy services at Brigham and Women’s. “It’s constant vigilance to get your piece of the pie.”
He noted that the headlines about hospital drug shortages have hardly changed in 10 years. The type of drug subject to shortage might vary but the underlying cycle does not: A sudden blip in the supply chain halts production, and hospitals are left digging for basic medicines that can’t be found.
“The production margins are so thin that we’re vulnerable to a natural disaster, technology [problems], or a man-made disruption,” Cotugno said. “In this case, the production margins were so slim that one company undergoes modernization of their plants, and the whole system is in disarray.”
“There is a real cost to drug shortages. This month it’s opiates. It’s going to be something else next month. This revolving door means something is always going to be short.”
Scott Knoer, Cleveland Clinic chief of pharmacy
Pfizer, which controls about 60 percent of the U.S. market for injectable opioids, said a supplier responsible for making a component of its Carpuject and iSecure pre-filled syringes has experienced a “technical and process issue.”
“We recognize the importance of these medicines to patients and physicians and are committed to resolving these shortages as quickly as possible,” said a company spokesman, Steven Danehy. “To that end, we are exploring the feasibility of increasing capacity within the global Pfizer manufacturing network and potential third party suppliers.”
Strictures of DEA
Although the shortage was not directly caused by the opioid addiction crisis, the response to it is being impaired by some of the legal controls surrounding these drugs. In order to increase the supply of injectable opioids, the Drug Enforcement Administration, which regulates the distribution of controlled substances, must lift quotas on smaller manufacturers to allow them to make more.
But despite requests from these manufacturers and a wide array of hospital and patient groups, the DEA has not yet granted enough extra capacity to resolve the shortage.
“We’ve made multiple inquiries starting in January, and we just sent in more this week,” said Dan Motto, executive vice president for U.S. injectables at West-Ward Pharmaceutical Corp., the second-largest supplier of these opioids. He added that he did not know the reason for the delay, but that the “best solution is for everyone to work together to try to solve this.”
A spokeswoman for the DEA said the agency is working on the problem as quickly as it can. “We are communicating with those affected and are considering all possible solutions, including the adjustment of production quota,” said the spokeswoman, Katherine Pfaff. “DEA is confident these steps will avoid any shortages.”
Earlier this week, a group of U.S. senators filed legislation that would make it easier for the DEA to adjust its production quotas and respond to emerging problems. Though the bill focuses on helping the DEA to address the oversupply of opioids that contributed to the addiction crisis, it may also enable it to respond more swiftly to shortages.
But even if the legislation passes soon, it is unclear how quickly the DEA will act and whether smaller manufacturers of injectable opioids can ramp up production fast enough to alleviate the shortage.
No back-up plan
The problem is compounded by limited competition and the lack of redundant manufacturing capacity. Some medical organizations have pushed for regulatory or legislative solutions to help provide a more reliable supply of medicines.
“After this last round of shortages, I think it’s become pretty apparent there is still some work that needs to be done,” said Jillanne Schulte, director of regulatory affairs for the American Society of Health-System Pharmacists. The organization has pushed for changes to make reporting of shortages more timely and transparent, and ensure backup manufacturing capabilities are available for certain crucial medicines. “If you don’t have enough manufacturing capacity going, and something goes offline, you may be in a very uncomfortable position very quickly,” Schulte said.
But manufacturers say the issue is difficult to solve from a financial standpoint. Most operate with lean capacity because of tight profit margins on generic medications. Injectable opioids, while used in large volumes, cost only a few dollars a vial, so maintaining extra manufacturing capability doesn’t pencil out.
Motto said West-Ward will need to add more staff and facility space in order to increase production if the DEA does eventually allow it to produce more injectable opioids.
“It’s not like we have a plant that’s half empty and we can suddenly just use that extra space to make more product,” he said. “There’s a lot of work done to figure out how we fit these opioid products into the production schedule. It’s adding extra shifts and paying overtime and making capital investments.”
In the end, Motto said, no one in health care wins under the current system. “It’s bad for our industry. It’s bad for patients and it’s bad for the hospitals that now have to scramble,” he said. “We have every incentive to try to meet the needs of the customers.”
Correction: An earlier version of this story incorrectly reported the anticipated full recovery date for Pfizer’s production of its opioid products. The estimated time frame for recovery is the first quarter of 2019.
About the Author Reprints
Great article explaining the crisis that is impacting patient care across the country. Proud to be part of a team offering a solution, the Macy Catheter (https://www.businesswire.com/news/home/20180313006172/en/), which leverages readily available medication and a unique method of delivery appropriate for many patients.
For the youngsters here, ALL of this harkens back to the good ole War on Drugs. Good book to read, “Federal narcotics laws and the war on drugs: money down a rat hole.” By Thomas C Rowe it taught me a lot.
Opiates are the safest drugs for pain, check it out. Overdosing is not a side effect of anything. It’s something that addicts do who like to get high and mess up. Or not. Maybe they like the thrill of dodging death, who knows? Vioxx was a drug that many in pain found gave them relief without the stigma of opiates. Unfortunately, in their brilliance, the gov. decided it was too dangerous because some people had heart conditions or death from it. It was pulled from the market. Once again people suffering we’re forced back to the use of opiates. But unless one is taking opiates to get high rather than to treat pain, they are not dangerous at all. I have known people who have been on opiates for decades. They do not get high. They do not sell the drug. And most of them still have a level of pain with which they live. They understand the only true released from all of their pain is death. They have no desire for death. They just want to live a halfway normal life.
And honestly what is the big deal about being addicted anyway? People on ssris have terrible withdrawal at times and can get serotonin syndrome when trying to withdraw. If a drug helps somebody function and live a normal life, what does it matter that it’s an opiate versus some other medicine like blood pressure medicine or prosac or prilosec? Yes there is a question about tolerance, but doctors can explain that to patients who then can decide when they want to wean down a little and rather reset the response. Or, God forbid, maybe they should experiment with alternating drugs. Perhaps that would make a difference.
Just don’t tell people suffering and in pain that it is tough, Society is more worried about some dope that thinks it’s worth the risk to get high. As someone pointed out its people using heroin mixed with fentanyl that are buying the farm. I’m sorry they are so stupid. I’m sorry for their families. But I’m more concerned for the person left suffering who is being denied relief because of these stupid people.
The War on Drugs it’s ridiculous and hopeless and will never be any more successful than prohibition was.
The patients know and their doctors know that opioids allow their lives to carry on the best that they can. Most patients will say, without my pain meds, I have No quality of life.
Why are we taking away the one thing that will stop suicides?
This is what happens when you don’t have a logical plan to address a problem…. and we rush to judgment vs. critical thinking. #sad
Research has shown what research was paid to show, on the effectiveness of long term opioid use. For those who believe them. Wait until you need long term pain relief. Or someone you care for needs it. With that line of thinking, cancer patients should take aspirin and end of life pain patients should tough it out. Your time will come.
Stat should make an effort to eliminate meaningless comments. Most comments are being made by long-term opioid users who are upset because they cannot get as many opioids as they want. The article is about the delivery system for one type of opioids. These long-term users have ignored what is in the article, either because they don’t understand or because they don’t care.
The comments do demonstrate, however, that it’s important to avoid creating more drug addicts. Research has shown that opioids are not effective for treating long-term pain, and doctors should be required to prescirbe drugs that treat pain without causing addiction. I have a lot of sympathy for the addicts, but giving them more opioids will only make them worse off.
Bruce, you are a complete idiot
There is absolutely no evidence that says that opioids are not useful for managing long-term pain. This statement is unsupportable. Please try not to regurgitate nonsense you’ve read or heard. What we have is opinions on this topic, out the experience of millions. But there is no study that shows what you have claimed.
Bruce, wait until it’s your turn to go under the knife. Or you fall and break something. You will get your bag of ice and aspirin. I can hear you now. “What do you mean nothing for the pain”? Then you will be talking out of the other side of your face. It’s nice you have sympathy for addicts. The people asking for the long term help that have documented proof, aren’t the ones trying to chase the high. Or doing as much of the drug as they think they can handle. If the long term users have ignored what is in the article. It could be that all they see feel and expect from our wise leaders, and closed minded individuals, is a lifetime of pain and suffering in silence. It’s like comparing apples to oranges. Nothing to look forward to. Now shut up about something you know nothing about.
This is a very real issue confronting hospice and palliative care. We have had a shortage of staple medications we use at the end of life (morphine and Ativan) for those patients no longer able to swallow. My understanding is that it Is related to the vials manufacturered in Puerto Rico. While there are a few alternatives they are cost prohibitive.
Dr Dave
HOW DO YOU THINK THESE SHORTAGES HAPPENED. ALL DRS OF ALL TYPES SURGEONS TOO ARE AFRAID OF THE DEA. THIS CREATED A HUGE DECLINE IN DEMAND. THEREFORE THE PHARMA COMPANIES CUT SUPPLY AND CUT IT BIG. AS AN F.U. TO THE DEA. THE DEA HAS OVERSTEPPED THE LINE BY MILES. ITS TIME YOU RELIZE PHARMA IS NOT AT FAULT ANYMORE. THEY ARENT SELLING HEROIN OR FENTANYL ON THE STREETS. PAIN PATIENTS ARE SUFFERING AND NOBODY WILL HELP. HOSPITALS AND SURGEONS HAVE CUT ORDERS. OOPS. INSURANCE COMPANIES AND INSURANCE COMPANIES HOLD THE DOCTORS HOSTAGE. THERE IS NO PROBLEM WITH ANTDEVICES.STOP DEMORALIZING PAOPLE IN PAIN. YOU SURLY ARENT A DR I WOULD GO TO
Scott
Actually, you are 100% wrong. The “shortage” is NOT related to anything except a defect plastic manufacturing plant that makes the special syringes that the drugs are shipped in
The company is trying to redesign the plunger apparatus and get it to work but until it does the PhamarCos can’t put their liquid drugs into them
This is NOT about ANYTHING even remotely related to the 30 plus NONSENSICAL comments that have been made. It is NOT related to doctors abusing pain patients or neglecting pain patients or doing surgery without proper drugs it is SIMPLY an article describing that there is an issue with the IV drug DELIVERY system that affects ONLY Hospitals and Hospices since everyone uses oral drugs.
The comments simply show how people are willing to look foolish to post to ANY thread in order to be heard and Stat wonders why they can’t get enough people to pay for Stat Plus
I am NOT shelling out $30 per MONTH to read comments from people who can’t even read the thread and focus their point of view to the facts in the article
This “shortage” is NOT a drug shortage there are AMPLE stores of the various drugs the problem is we have shifted to automatic delivery systems in the hospitals and they ONLY take special syringes and there aren’t enough of them to go around
NO drug shortage but a delivery system shortage
READ THE ARTICLE FOLKS!!!!
Dr. Dave
Has ANYONE read this article?????
This has NOTHING to do with sick patients at home or chronic pain patients it is CLICK BAIT for STAT to get more clicks and more viewership!
This WHOLE article is about HOSPITALS not having enough “HOSPITAL type SELECTED narcotics” since the syringes they come in are defective and supply is short
This is NOT about the Gov NOT about Congress it is ALL about a technology that is not up to par and will take time to iron out
The issue is ALL about hospitals shifting to high tech and that technology failing to meet the need BUT since they no longer have the ability to revert BACK to low tech due to liability concerns they have to juggle
NO patients have been affected so far NO surgeries have been canceled and NO pain issues have gone untreated
Time you all read in detail BEFORE you start adding in your personal war stories so the world knows you are less than happy with your body and the healthcare system
Pathetic! Using this as a soapbox to change the topic is a waste of all readers time and energy
Stat has other articles about personal opioid regulations that you can vent all about your sciatica and chronic XYZ this isn’t one of them
Dr. Dave
Dr. Dave, I thought thee problem was Brigham Women in Boston was ‘running dry’ of REAL Rx pain meds. I have not only a CHRONIC condition, but a worsening one. I’m RESPONSIBLE (I have a teen, who I DON’T want getting the idea money could be made from or taking advantage of my meds for herself. I’m a responsible patient. (I have Levaquin Tendon Rupture) and have since Nov. 2010. Ironically, on Cape Cod (1hr out of Boston out town was ‘eaten alive’ by Heroin. (Not sure about this Chinese Fentanyl, issue, but ‘ve been on Rx Fentanyl and it sucks. THE WORST medicine delivery system ever hatched. Heroin HAS killed people I’ve KNOWN. And, I’v had a next door neighbor DEAL it (on Cape Cod, where not only have the elderly CHOSEN to be clueless, but gangs have formed, and shootings… gangland behavior is happening in Hyannis!) It started with states that have Doc/Dispersaries (Florida). In ANY other states there’s a filter of 4 stages of accountability. Vets, people like ME who are responsible are kept in check. I have a ‘Pain Contract’ and I adhere to it. I’m on disability and had the time to chase down (for the police) the trafficking routes. No one cared- THEN. Now I’m a bad guy for the meds I take (not that I have Levaquin Tendon Rupture. I AM (was) an Artist! A TRAINED artist! I PAID FOR MY OWN education! I WANT to DO what I’ve chosen my life-path to be. I’m NOT a welfare ‘queen’. I don’t make NEARLY what I did when I was working. I GET NO RESPECT from family or peers. My medical condition has left me humiliated. And now, I have to BEG a ccretin like Trump for the meager SSI-D ‘benefits (or Paul Ryan would call them entitlements), to LIVE. I’m humiliated. I’ve paid into Soc. Sec. since I was 16. I’m 52, and MADE to FEEL a burden. Did you know that folks on Disability are committing suicide at a higher rate (historically)? I FEEL like a burden. I’m TOLD I’m a burden, my family is starting to bite on Fox’s line. I was our top bread-winner. 5 minutes on a Levaquin IV burst my tendons and my chances of EVER being able to even be a ROOM MATE in someone’s house – or EAT, or SEE the cos on the Medicare I PAY for. If YOU have any pointers, I’d be glad… HAPPY
to hear them. Thank you. -CJ
Thanks, Dr. Dave. I see your point. As a Nurse/case manager, we are seeing challenges in all areas of resource management.
Why dont we put the people making these decisions go through the pain management system. I had a spinal stimulator put in to help with pain. Then the battery had to be replaced. That battery is inside me. It got infected because you have to charge these just like your cell phone and it gets hot. My pain management doctor is amazing he cares. I had another one put in to do all I can to stay away from meds. Force doctors not to be there for the patients make our world a miserable place. I wish the media would state more facts on those who need these meds. We follow every rule that is place on pain management. Then the media splashes OPIOD EPIDEMIC and OPIOD RELATED DEATHS all over. I’m so pissed when will the government and media start talking to someone that suffers and tell our stories. See our journey of following the rules. Many have not been through the process of disability. When you get so bad that you can’t work you have no income. End up homeless because you can’t pay for rent. Your employer sees the pain your in and lays you off. You no longer have money for insurance and can’t do anything 6 years go by until…if your lucky to be granted disability. You can only get help from pain management if you pay in cash. You do not get a script until all other methods have been attempted. I couldn’t afford any treatment because my employer was pushing me to go on disabilty. How in the hell do you think I can afford a script or even buy street drugs which i never will nor did I. But some how you think of people like me as an opioid addict. I have never used street drugs. If you have no family when your life falls apart your alone and sometimes family just don’t want to see you in pain and stop coming around. Did I cause what happened to me. NO and like many others that have there life, health and careers fall apart because I was driving to work and a 16 year old hit me with his damn truck and push me into oncoming traffic. Because he forgot his damn homework. Then back surgery with an artificial disc that your doctor said was perfect for me. Wake up with all my stomach muscles cut, can’t use your left leg because of a botched surgery. Said leg muscle from 2006 to now is hard like concrete. It’s like being ripped apart. Another surgery, blood tranfusions, then have your throat cut open not once but twice. From my ear to my collar bone at an Angle. Your saliva is like swallow acid. Every single one of my surgies I went back to work. No matter how much I f******* hurt and yes plenty of pt,biofeedback, acupuncture, yoga, hypnosis and 48 minor procedures of injections in my spine and so many other places. I still hurt so bad I can barely move some days. Cry and force myself to do what I can not to take an opioid. I work with my pain management team. If I feel I need less I tell them. I turn in anything I dont use and signed a contract. I take urine tests whenever I am asks. The thing that really burns me is when people know your taking them. Then they say don’t turn those in give them to me. Those are the people who are addicts the ones that OD. I am dependent on what I take to give me the ability to walk and sit. I am not an addict. I should be traveling and enjoying my life like many others out there suffering for real. My kids are grown and have watched me suffer since 2004. I am ashamed of you how dare you compare addiction to pain management. When will we the people that suffer and hate taking meds be put first and don’t judge or compare us to drug addicts. Also break a bone or shatter it on 2 tons of steel I rejected and meds. Woke up in the morning with pain running up my arm. Better yet get burned during a greae fire see how that feels. The air alone is enough to make you shake in agony. Big differnce between the opiod epademic and pain management. Not the same AT ALL. I turn in what I dont need so those that are addicts can’t get their hands on it. Have to lock it up also cuz you never know who may steal it from you. We need empathy for those who deserve it. If you leave those who are suffering out to fend for themselves. Suicides will rise and that’s on you who think the suffering should suffer and die because the pain is to much. While addicts keep pushing the limits and are “suffering” from addiction get all the help and empathy. They dont have to follow the rules. They mess up and those who really need it suffer and are cast out. REALLY I CANT BELIEVE YOU PEOPLE.
Debra, TAKE THE MEDS. They were made FOR YOU. Don’t let society tell you you aren’t a worthy person to accept help if you need it! Needing it is NOT weakness! I’m in the same boat. I’ve figured out HOW to deal with having a teen at home and management of my meds so they DON’T end up in the wrong hands. The LAST thing I’d want is my kid SELLING them or TAKING them. (In our old hometown, a (40 y.o.) nephew killed his aunt to get pain meds out of her bra. BUT, WE ARE NOT taking HEROIN. HEROIN is the #1 OPIATE KILLER. Don’t be talked into medication given by a doctor! Go ahead and SIGN the pain contract. THEY make sure you are taking them (if they give you a test and DON’T find the drug in your system (then you’ve been selling) -my assessment of how it works. They test you or count you pills. NO BIGGIE. I bring my pills to every appt. I take them… so TEST me. Without the drug, I’d be the WORST mother. Not able to get out of bed. NO able to interact with my kid. (I’ve even had side effects with the surgery to repair the damage done by (Levaquin). My DNA is forever changed to NEVER repair itself. I was MISERABLE. NO respect from my family/daughter. NOW, I can participate. (I used to be a professional artist -WHO doesn’t want to BE THAT- and PAID FOR SCHOOL MYSELF, busting my ass. I DON’T WANT to be demonized or told I’m a scourge on society. Lately people in our boat are committing suicide at a higher rate… but THEN what good am I? (I almost feel like they WANT you to off yourself- then they wouldn’t have to pay you.) I’ll be damned if they diminish me (working and contributing since 16). Big Pharma screwed me OVER and my future=over. I’ll be damned if they rob my CHILD… because SOMETHING THEY DID TO ME!