US hospitals struggling with prolonged shortage of injected opioids | Live Well CV: Health and Wellness

Medical groups urge regulators to help, saying that some people undergoing surgery, fighting cancer or suffering from severe burns. They also say that shortages frequently lead to drug changes that could lead to fatal errors.

Earlier this month, the American Medical Association said that drug shortages would constitute a public health crisis. perhaps designate medicine factories as a critical infrastructure.

Injected opioid shortages occurred before, in 2001 and 2010, but they were not 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 severe I have seen in tracking drug shortages for 17 years," says Erin Fox, pharmacist at the University of Utah. She tracks drug shortages and recalls two patients who died due to medication errors during the 2010 shortage.

These shortages take time away from patient care, increase hospital costs and affect approximately all services, operating rooms, emergencies and anticancer clinics. . Doctors sometimes find opioids missing from emergency trolleys and surgical trays "borrowed" by colleagues who need them for other patients.

Shortages began to hit hospitals last summer, after the Food and Drug Administration reported infertility and other serious problems. factory in Kansas. The company, which makes 60% of the opioids injected, had to reduce its production to solve the problems.

In January, shortages were such that hospitals began to build teams to manage their supplies, said Michael Ganio, director of pharmacy. The April survey of 343 hospital pharmacists found that 98% of them had faced moderate or severe shortages of key opioids to treat the condition. severe pain: morphine, fentanyl and hydromorphone, better known as dilaudid. Many hospitals were completely at least one.

The shortages of generic drugs injected became normal. Since profit margins are minimal, only a few companies manufacture them and none can significantly increase production when a competitor ceases to manufacture.

Opioid shortages persist and hospitals and medical groups have established guidelines for supply, including the transfer of injected analgesics. Michael Cohen, president of the Institute for Safe Medication Practices, an independent group that compiles voluntary error reports, says that errors also occur in some cases.

when nurses or pharmacists replace unfamiliar analgesics or those with different concentrations of 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.

Hospitals are also struggling with a shortage of regional anesthesia – local injections of lidocaine, bupivacaine and a third painkiller for eye surgery, orthopedic procedures and knee replacement and the hip. Ruth Landau, director of obstetric anesthesia at the Columbia University Medical Center in New York, said the maternity homes have been suffering for several months from a critical shortage of the fast-acting version of bupivacaine.

It's risky because if a woman starts to bleed. baby is not getting enough oxygen, obstetricians need to 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 Anesthesiology Obstetrics and Perinatology

At the Massachusetts General Hospital emergency of 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 because the nurses were free to do it and he was not in pain anymore" , remembers 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 time, the patient is suffering Longer".

This is not an option for many patients hospitalized sedated, intubated, vomiting or too fragile to swallow pills. And because pills can take 45 minutes to start working, they are a poor choice for patients with fractures, internal infections and stab wounds.

Often, patients require an opioid dose slightly greater than that of a vial.

"Having to choose between under-dosing the patient or having no medication to treat another patient later in the day is incredibly frustrating," says Dr. Raja. Centered in Houston, Dr. Ishwaria Subbiah, palliative care specialist, is now spending more time choosing painkillers as availability changes. She says that patients with advanced cancer already in distress need to be reassured when they are forced to remove them from an injected analgesic that works.

"Cancer pains can be atrocious, more than what a pill can handle. 19659003] At Intermountain Health Care, outpatient surgery facilities and cancer clinics in Salt Lake City are also affected as well as acute care services, and the rarest analgesics vary constantly, says Sabrina, director of pharmacy. Cole. The shortages caused by Pfizer's problems could improve slightly over the next few months.

The three smaller opiate manufacturers injected – Fresenius Kabi, West Ward and Akorn – began to do more. They impose overtime on factory workers, add more shifts, and turn some less-essential drug lines into injectable opioids.

The FDA is accelerating the approvals needed to manufacture more opioids, including allowing new formulations. 19659003] The agency also let Pfizer dispense pre-filled opioid glass syringes that were withheld due to possible contamination of particles and cracks in the corks. Hospital pharmacists must examine each syringe closely and then filter the contents into a complex, multi-step process.

Meanwhile, Pfizer Inc. does not anticipate that most of its injectable opiates will be fully available before the first quarter. 2019, says John Kelly, head of quality manufacturing.

The New York-based company acquires the McPherson, Kansas plant, buying the manufacturer Hospira in 2015. To solve the problems, Pfizer decides to replace the production lines and other technologies, in especially the huge equipment sterilization machines called autoclaves that can take two years to build, install and test. 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, Kelly said. He says that production is increasing somewhat each week.