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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.

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“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.

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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.

  • just after Thanksgiving I fell off a ladder and broke both my wrists and two fingers dislocated shoulder and broke 2 ribs. after my x-rays the doctor was ready to dismiss me and let me go and I said all I’ll need some pain medicine he said oh well wait a minute I’ll get you some ice chips and came back with two small paper cups filled with ice chips. he said oh we don’t give that stuff out anymore I said are you f****** kidding me he said no take some Aleve. I’m not a violent person but I wanted to just punch him in the face. What are we living in a third world country? This is totally unacceptable I spent 6 months and I’m still going through Major pain sleepless nights. The hospital I was in was one of the largest in southeast Wisconsin it was empty dirty unorganized and totally blew my mind that this is the way our Healthcare handled people when injured mind boggling I had to see it for myself. I’ll never go back there again. I’ll go to the local gas station and buy some bandages. I wouldn’t have believed this if I hadn’t seen it for my own two eyes. Oh they gave me a cortisone shot in my dislocated shoulder it made the pain 80% worse and help absolutely not at all. I still think I’m in a dream like I mean the Candid Camera. I just feel so sorry for anybody that’s worse off than I am so my suggestion to anyone out there I guess would be don’t get hurt. Or you’re up a creek. Have a feeling this is all about insurance and lawsuits if someone overdoses that’s what it’s all about. Nothing more nothing less.

  • just after Thanksgiving I fell off a ladder and broke both my wrists and two fingers dislocated shoulder and broke 2 ribs. after my x-rays the doctor was ready to dismiss me and let me go and I said all I’ll need some pain medicine he said oh well wait a minute I’ll get you some ice chips and came back with two small paper cups filled with ice chips. he said oh we don’t give that stuff out anymore I said are you f****** kidding me he said no take some Aleve. I’m not a violent person but I wanted to just punch him in the face. These other stories make total sense the only thing I could think about was what if I was in much worse shape and deal with more pain like some of these other people are. What are we living in a third world country? These Dirty son of a guns and don’t tell me that they’re having problems making the damn pills that is so simple it’s unbelievable it’s just an excuse for us and them to get more time. This is totally unacceptable I spent 6 months and I’m still going through Major pain sleepless nights. The hospital I was in was one of the largest in southeast Wisconsin it was empty dirty unorganized and totally blew my mind that this is the way our Healthcare handled people when injured mind boggling I had to see it for myself. I’ll never go back there again. I’ll go to the local gas station and buy some bandages. The follow-up visits with doctors were nothing more than patting his paycheck and if they think I’m paying anything for this shity service yeah that’s not going to happen they can go jump in a lake. I wouldn’t have believed this if I hadn’t seen it for my own two eyes. Oh they gave me a cortisone shot in my dislocated shoulder it made the pain 80% worse and help absolutely not at all. I still think I’m in a dream like I mean the Candid Camera. I just feel so sorry for anybody that’s worse off than I am so my suggestion to anyone out there I guess would be don’t get hurt. Or you’re up a creek. Have a feeling this is all about insurance and lawsuits if someone overdoses that’s what it’s all about. Nothing more nothing less. what I ask for pain medicine from some of these other doctors they freaked out.

  • I live with pain every day,yes some days not as bad as others, but neither the less I’m in constant pain, diagnosed with rheumatoid arthritis, sarcoidosis, fybromyalgia, degenerative disc disease, Osteoporosis, arthritis, Peripheral neuropathy,Costochondritis,and many more skeletal inflammation. My point is I need the option to have an opioid prescription or not. My pain is horrible most of the time, pain is always there. I can’t take Tylenol because of other meds and my liver. I can’t take ibuprofen because of my inflamed stomach. I need to have the choice, if I need to relieve my chronic pain, then I need to be able to get the prescription necessary to help me.

  • While the wall at the south border is big news. Everyday, lives are being ruined because of the painkiller crackdown. What point is there to have our country back if thousands won’t be around to enjoy it. Soon there won’t be any pain relief in hospitals or anywhere but the black market. Don’t put up the wall until the pain problem has been addressed. We might be needing the people who run the black market for some quality of life in the US.

  • Prescription pain medications are not the, “root of the nation’s opioid addiction crisis.” Naive propoganda pushing twats like this writer are the root of the nation’s opioid addiction crises!

    • I didn’t read the whole article, because it sounds like more of the BS that my doctor was using as an excuse not to be of help to me or anyone else. I will take Roberts word for it. VA doctors have decided with the help of the DEA that it is not necessary for me to walk anymore. By taking away my medicine and two years later they got their wish. To replace my legs they gave me a scooter and a lousy quality of life. Hope they get a chance to feel what some of the good people are going through, before their lives are over.

  • Why is government getting involved with doctors and hospitals and medications? It is not the business of government to decide what is good or bad or right or wrong with regard to treatment or medication. Just stay out!

  • Congratulations Bruce beaches! Your the moron of the day!
    There are 50 million disabled people in this country cutoff or severely cut down from thier long term opioids. Thier pain has come back with a vengeance. Over 20000 Have COMMITED suicide, millions are bedridden as they were before they had thier medication. You are the sheep of the day. These are real numbers. Not insurance company or REHAB center #s. There is a difference between pain.patients and drug addiction. Maybe your mom or daughter breaks thier back one day. Remember what you said. If your in a bad car accident and have a botched surgery and are in pain for life remember what you said. WE ARE living proof long term opioid medication works. Now we just get to watch life go by.

    • I totally agree also this is a real SOB and needs to be fired for writing such BS there are people that need long term pain medicine that would have a better quality of life if they could git a few extra pills a day for chronic pain I git tired of seeing people that needs medicine for pain and not getting what that need because doctor’s are afead of losing there license these are the people who were pushing big meds in the early 2000 for big pharma and I’m sure for kickbacks oxeyconton was every where but now are saying no now that is BS.Think about it.

  • Maybe if they would quit babying the drug addicts, with all these new centers that are opening up for them. I have already been taken down on my medicine, and I really need what I was getting. Oh no I’m not a drug addict, I am a person who has real pain. I have arthritis all over and fibromyalgia. But go ahead take the medicine from the ones who really need it.

  • Can we please consider that the current opioid crisis as well as the opioid shortage is an opportunity to expand the recommended use of multimodal approaches to pain management including Regional Anesthesia and the use of complementary techniques such as acupuncture, Auriculotherapy, hypnosis, biofeedback and many more.
    Every evidence support the concept that multimodal approaches are more effective, carry less side effects and do not carry the risk of addictions. Despite the evidence these techniques are still under prescribed because it is “cheaper” to prescribe opioids. At what point are we going to take a global approach to what is really cheap for the society.
    Is allowing hospital to promote for the use of cheap opioids really the best way to manage pain? Over 600 billion is spend on opioid addiction in this country. How much is save at the hospital level when an opioid is prescribe vs a peripheral nerve vs 600 billions?
    The hospital save money by still pushing for the use of opioids but that is OK because the society can pay for the consequences. We have much better use of the current 600 billion we presently use on opioid addiction.

    • If you think that Doctors don’t suggest other plans of treatment like acupuncture, PT,OT, Etc. you’re sadly mistaken. Writing out a script for pain medication is a last resort. Not to mention, what I just mentioned and what you mentioned doesn’t work for everybody and you can’t just assume it will. If a Dr. Writes for a pain medication, it has to be a pain management Dr. These Doctors are very strict, give minimal dose and frequency, and drug tests. What do you think a surgical patient should do the minute they open their eyes in recovery in horrible pain from being cut open? I don’t think they will want to hear, “We’re going to hypnotize you now” Terminal child with brain cancer…… I can go on and on. Opioid crisis has been going on for at least 40 years and NOW it’s become an issue. The real issue is Heroin and that isn’t prescribed!

    • LET ME GUESS, U R 1 OF THOSE PEOPLE WHO DONT HAVE SEVERE, LEGITIMATE PAIN? 1 OF THOSE WHO TALK ABOUT SOMETHING U KNOW NOTHING ABOUT. ACUPUNCTURE? PHYSICAL THERAPY? HYDROTHERAPY…..BLAH, BLAH, BLAH. I CANT STAND IT WHEN U PEOPLE TALK OUT OF YOUR ASSES. THE ONES WHO DONT HAVE A CLUE WHAT IT IS LIKE TO LIVE IN SEVERE CHRONIC PAIN EVERY DAY OF YOUR LIFE LIKE I DO. IM 48, BEEN ON DISABILITY NOW FOR 9 YEARS. GUESS WHAT, THE GOVT DOES NOT GIVE OUT SS DISABILITY TO ANYONE UNLESS ITS LEGIT. IM LIVING PROOF & HAVE TO TAKE MEDS TO LIVE. ITS PPL LIKE U WHO NEED TO WALK IN OUR SHOES FOR 1 DAY AND THEN SEE WHAT ITS LIKE NOW TRYING TO GET THE ADEQUATE MEDECINE THAT I NEED TO LIVE LIKE I HAD 2 YEARS AGO. I WISH U WOULD ALL SHUT THE HELL UP WHEN U HAVE NO CLUE WHAT THE REAL PAIN PATIENTS ARE GOING THROUGH NOW. STOP CODDLING THE DRUG ABUSERS AND ADDICTS. LET THEM OD ON THE CRAP IF THEY WANT. ENOUGH IS ENOUGH.

    • Wow Chelly Hacques you must be a very lucky person that has not been through the pain management system. Has 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. 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 could afford any treatment because my employer was push me to go 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 CELLEY 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.

  • A friend who is a nurse at major teaching hospital told me, she cries in the bathrooms and car, everyday now. Because NOONE is getting pain control, they are screaming, crying and having horrible physical and mental effects from being TORTURED at the hospital. Patients are spending days laying in bed screaming, moaning and crying, not because of a shortage BUT they are told to NOT provide pain control, other then Tylenol, Drs are ecnoring the cries. She said it’s almost to much to handle, seeing the absolute agony of people. People begging to have somone just kill them, YET not one patient is being treated properly for pain. They are told to just shut the door and encore calls for help. This is happening NOW

    • just after Thanksgiving I fell off a ladder and broke both my wrists and fingers dislocated shoulder and broken ribs and after my x-rays at the hospital the doctor was ready to dismiss me and let me go and I said all I’ll need some pain medicine he said oh well wait a minute I’ll get you some ice chips and came back with two small paper cups filled with ice chips. he said oh we don’t give that stuff out anymore I said are you f****** kidding me he said no take some Aleve I’m not a violent person but I wanted to just punch him in the face. These other stories make total sense the only thing I could think about was what if I was in much worse shape and deal with more pain like some of these other people are. What are we living in a third world country? These Dirty son of a guns and don’t tell me that they’re having problems making the damn pills that is so simple it’s unbelievable it’s just an excuse for us and them to get more time. This is totally unacceptable I spent 6 months and I’m still going through Major pain sleepless nights. The hospital I was in was one of the largest in southeast Wisconsin it was empty dirty unorganized and totally blew my mind that this is the way our Healthcare handled people when injured mind boggling I had to see it for myself. I’ll never go back there again. I’ll go to the local gas station and buy some bandages. The follow-up visits with doctors were nothing more than patting his paycheck and if they think I’m paying anything for this shity service yeah that’s not going to happen they can go jump in a lake. I wouldn’t have believed this if I hadn’t seen it for my own two eyes. Oh they gave me a cortisone shot in my dislocated shoulder it made the pain 80% worse and help absolutely not at all. I still think I’m in a dream like I mean the Candid Camera. I just feel so sorry for anybody that’s worse off than I am so my suggestion to anyone out there I guess would be don’t get hurt. Or you’re up a creek. Have a feeling this is all about insurance and lawsuits if someone overdoses that’s what it’s all about. Nothing more nothing less. what I ask for pain medicine from some of these other doctors they freaked out.

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