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TRENTON, NJ – Another opioid crisis is occurring in the United States, and this has nothing to do with the overdose epidemic: hospitals often lack widely used injected badgesics .
Manufacturing shortages are forcing many doctors and pharmacists to sometimes ration the opiates injected, reserving them for the most affected patients. Other patients have slower or less effective badgesics, alternatives with more side effects or even sedation.
Medical groups urge regulators to help, saying some people who have undergone surgery, fighting cancer or suffering severe burns get inadequate pain control. They also say that shortages frequently result in drug changes that could lead to fatal errors.
Earlier this month, the American Medical Association said the drug shortages constituted a public health crisis, saying it would urge federal agencies to consider the problem as a threat to national security and to designate drug factories as essential infrastructure.
Injected opioid shortages have already occurred in 2001 and 2010, but they have not been as acute and long-lasting, according to experts. This one started almost a year ago and should last until next year.
"It's certainly the most serious I've seen in tracking drug shortages for 17 years," says Erin Fox, pharmacist at the University of Utah. She is tracking drug shortages in the country and remembers two patients who died due to medication errors during the 2010 shortage.
These shortages waste patient care time, increase hospital costs, and affect virtually all services, including operating rooms, emergency departments, and cancer clinics. Doctors sometimes find opioids missing from emergency trolleys and surgical supply trays, "borrowed" by colleagues who need them for other patients.
Shortages began to hit hospitals last summer, after the Food and Drug Administration found sterility and other serious problems in a Pfizer plant in Kansas. The company, which manufactures 60% of the opioids injected into the country, had to reduce its production to solve the problems.
According to Michael Ganio, director of pharmacy practice at the 45,000-member American Society of Pharmacists of the Health System, the shortages of hospitals began to create teams to manage their supplies in January.
The group's April survey of 343 hospital pharmacists found that 98% of them had experienced moderate or severe shortages of key opioids to treat severe pain: morphine, fentanyl, and hydromorphone. , better known as Dilaudid. Many hospitals were completely out of at least one.
The shortages of generic injected drugs have become normal. Profit margins are minimal, so only a handful of companies manufacture them, and none can dramatically increase production when a rival stops making.
With persisting opioid shortages, hospitals and medical groups have established guidelines for stretching supplies, including the transfer of badgesics injected from large vials into smaller ones or syringes.
Some people worry about these workarounds invite errors.
Michael Cohen, president of the Institute for Safe Medication Practices, an independent group that compiles voluntary error reports, says that confusions also occur when nurses or pharmacists substitute for unfamiliar painkillers or concen- trations. different from normal.
Cohen recently received several reports from surgical patients who stopped breathing. Some had an overdose when fentanyl was not available and they mistakenly received the same amount of sufentanil much stronger. These patients were saved.
Hospitals are also facing shortages of regional anesthesia – local injections of lidocaine, bupivacaine and a third painkiller for eye surgery, orthopedic procedures and knee and hip replacements.
Dr. Ruth Landau, director of obstetrical anesthesia at the Columbia University Medical Center in New York, says the maternity wards have suffered for months from a severe shortage of the fast-acting version of bupivacaine.
It is risky because if a woman in labor starts to bleed or if her baby does not get enough oxygen, obstetricians must perform an emergency cesarean section. Anesthesiologists may have had to use a slower version of bupivacaine, which can delay childbirth and harm the mother or baby.
"We play with fire," worries Landau, vice president of the Society of Obstetric Anesthesia and Perinatology.
At the Mbadachusetts General Hospital's Emergency Department in Boston, Dr. Ali Raja recently received a patient with appendicitis who needed intravenous morphine or low dose Dilaudid. Instead, he had to resort to fentanyl, which dissipates rapidly, so additional doses were needed frequently.
"He was lucky, the nurses were free to do it, so he did not suffer any more," recalls Raja.
He tells patients that he will first try the pain pills and switch to intravenous medication if they do not work, but "at that point, the patient is suffering for a longer time ".
This is not an option for many hospitalized patients who are sedated, intubated, vomiting or too fragile to swallow pills. And because pills can take up to 45 minutes to start working, they are a poor choice for patients with fractures, internal infections and stab wounds or firearms.
Often, patients require an opioid dose slightly greater than that of a vial, but opening a second vial requires discarding the unused portion to avoid any contamination.
"Having to choose between under-dosing the patient or not having a medicine to treat another patient later in the day is incredibly frustrating," says Raja.
At the MD Anderson Cancer Center in Houston, Dr. Ishwaria Subbiah, palliative care specialist, is now spending more time choosing painkillers for changes in availability. She says that patients with advanced cancer already in distress need to be rebadured when they are forced to remove them from a rare injected badgesic that works.
"Cancer pain can be absolutely unsustainable, more than what a pill can handle," notes Subbiah.
At Intermountain Health Care in Salt Lake City, outpatient surgery services and cancer clinics are also affected as well as acute care services, and the rarest badgesics vary constantly, says pharmacy manager Sabrina Cole. .
Valerie Jensen, who is in charge of drug shortages at the FDA, says the shortages caused by Pfizer's problems could ease slightly over the next few months.
The three smaller injectable opioid manufacturers – Fresenius Kabi, West Ward and Akorn – have begun to do more. They impose overtime on factory workers, add more shifts, and turn some less-essential drug lines into injectable opioids.
The FDA has accelerated the approvals that companies need to manufacture more opioids, including allowing new product formulations.
The agency also let Pfizer dispense pre-filled opioid glbad syringes that were withheld due to possible contamination of particles and cracks in the caps. Hospital pharmacists must examine each syringe closely and then filter the contents into a complex, multi-step process.
Meanwhile, Pfizer Inc. does not expect most of its injectable opiates to be fully distributed before the first quarter of 2019, says John Kelly, Manufacturing Quality Manager at the manufacturer.
Pfizer has decided to replace production lines and other technologies, especially the huge equipment sterilization machines called autoclaves that can take two years. years to build, install and test. He has already spent more than $ 300 million.
The scheduled shutdowns last summer to start the upgrades have taken longer than expected, FDA inspectors have found other issues to resolve and the demand for products has increased, triggering shortages, explains Kelly. He says that production is increasing somewhat each week.
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