Special Report: COVID deepens the other opioid crisis – a shortage of hospital painkillers – Reuters – Lisa Girion, Dan Levine, Robin Respaut – June 2020
The DEA, an agency of law enforcement without a medical purpose, controls the amount of opioid medication manufactured by giving several companies strict quotas to produce each year. Because the DEA has no ties to or knowledge of medicine, they react purely to police agency reports of illicit opioids.
They still don’t understand that overdoses are from street opioids, not medication, so they want to keep reducing the opioid medication supply in a misdirected effort to reduce overdoses from street drugs.
As opioid pills and patches fueled a two-decade epidemic of overdoses in the United States, hospitals faced chronic shortages of the same painkillers in injectable form – narcotics vital to patients on breathing machines.
For years, hospitals chased supplies, sometimes resorting to inferior substitutes. The shortfall grew so dire in 2018 that a drugmaker sent letters advising hospitals they could use batches of opioid syringes potentially containing hazardous contaminants – so long as they filtered each dose.
Then the novel coronavirus struck, and demand for injectable opioids exploded. By April, more than 16,000 COVID-19 patients a day were on ventilators, the University of Washington’s Institute for Health Metrics and Evaluation estimated.
After a highly public battle to secure enough ventilators, hospitals say they must scramble to obtain the powerful painkillers needed to use them. Opioids help keep patients in severe distress from reflexively ripping out the tubing that forces oxygen into their lungs.
Underlying the persistent shortages – and the present crisis – are the basic economics of the American drug industry. The market discourages production of low-margin hospital injectable opioids in favor of high-profit prescription versions.
Though deficiencies in the supply of injectable opioids had long been recognized, U.S. drugmakers, hospitals, regulators, and lawmakers failed to fix the problem and were caught unprepared for a pandemic that suddenly and dramatically escalated demand, Reuters found.
Demand for injectable opioids more than doubled between January and early April, rapidly depleting what hospitals and drugmakers had on hand
Orders for the commonly used injectable opioid fentanyl roughly tripled, but suppliers were able to ship only half of what hospitals asked for, said Amanda Forster, a spokeswoman for Premier Inc, another large hospital purchasing organization.
For injectables, the supply chain is slow and fragile. Aging plants operated by a small group of manufacturers chug along at nearly full capacity, with little room to ramp up production. The risk of a mechanical breakdown or contamination runs high, and adding another production line or opening a new plant can take a year or more, industry experts said.
The marketplace, Sherkow and others told Reuters, is hard-wired to reward innovation – new, ostensibly improved products – over older workhorse medications, no matter how vital.
Production of pills and other prescription opioids used outside hospitals began to explode in the late 1990s as drugmakers pursued new patients, patents and profits. By 2006, production of outpatient prescription opioids was at least nine times that of the low-margin injectable opioids most widely used by hospitals
Multiple government agencies, from the FDA to the Department of Defense, knew about the chronic shortages of injectable opioids and other critical care drugs well before the coronavirus pandemic, according to federal documents and interviews with public officials. Injectable opioids in syringes and various vial sizes, including fentanyl, have been on the FDA’s list of drugs in short supply at least since 2017.
The shortages have a direct impact on patients. Pharmacists, anesthesiologists and other frontline medical professionals told Reuters they have had to sub in less effective drugs, some with problematic side effects, or to inject crushed opioid tablets into feeding tubes.
The harm to patients is difficult to measure and most likely underestimated, the FDA-led task force found
Patients can have hallucinations and become agitated on a second-line drug, said Dr. Mangala Narasimhan, regional director of critical care at Northwell Health, a 23-hospital system in New York. “You can tell they are really uncomfortable.”
ONE DRUG, TWO MARKETS
Invented in 1960, fentanyl was long reserved for surgical, cancer and terminally ill patients. But in the late 1990s, drug companies and doctors launched a war on the chronic pain often experienced by outpatients.
The main weapons in this war were old, generic opioids manufactured in novel configurations that allowed their makers to win lucrative patents.
Cheap and easy to synthesize in the lab, fentanyl was refashioned in one newly patented form after another – as a lollipop, a fast-dissolving disc and a nasal spray.
After patents on prescription opioids elapsed, generic drugmakers have piled in to profit off volume sales.
Unlike the crowded marketplace for prescription opioids, the injectables sector is highly consolidated, with only a few companies producing the lion’s share of each narcotic. (For the most part, the companies making injectables are not making prescription opioids.)
Still, large hospital chains and purchasing groups have enough market power to drive hard bargains, the FDA-led drug task force found. Generic injectables are largely seen as interchangeable, so hospitals shop by price, not brand. For drugmakers, the report said, it’s “a race to the bottom.”
Despite bargain-basement prices, drugs injected directly into the bloodstream are more expensive and more difficult to make than pills, which are mass produced. Injectable drugs are made batch-by-batch, and the risks of contamination are greater.
“Manufacturing a sterile product requires a totally different investment,” said Siggi Olafsson, chief executive of Hikma Pharmaceuticals PLC, which makes 17% of generic injectables used in the United States.
He and other injectable manufacturers told Reuters they remained in the U.S. market because they believed it was the right thing to do. Hikma is still seeing sales growth, reporting that revenues from its injectables business rose 5% in the United States in 2019.
A SHAKY SUPPLY LINE
When the novel coronavirus landed in the United States, the supply line for hospital opioids was still recovering from a setback three years earlier.
In February 2017, Pfizer Inc, one of the nation’s biggest injectable drugmakers, received an FDA warning about several shoddy sterilization procedures. Pfizer warned of extended production delays as it sought to fix the problems. As a result, Pfizer’s output of injectable fentanyl, hydromorphone and morphine – three key hospital opioids – was thrown into disarray as other manufacturers were stepping away from the market.
In a February 2018 letter to U.S. drug regulators, hospital administrators warned that surgeries might be postponed or canceled. “In some cases, this could prove life-threatening,” they said.
The FDA requires manufacturers to update the agency on disruptions and shortages of necessary drugs. But those notices may be filed up to five days after a problem is identified – keeping the agency from taking action before a shortfal
Because drug companies hold information close to the vest, Woodcock said her agency had little visibility into what supplies companies had on hand or in production as the pandemic approached. She said the agency was encouraging – but couldn’t force – companies that once made injectable opioids to resume production.
But some manufacturers are plainly not interested in returning.
NO ‘EASY BUTTON’
As in the past, hospitals have been left to improvise.
It seems that anything to do with opioids is scrutinized for deletion because the public fears opioids, thanks to the media enabling the viral spread of anti-opioid messages containing falsehoods, like the familiar refrain “opioids cause addiction”.
Most of the news about opioids falls into the “fake news” category these days and, like real news, the correct information about opioids is submerged under the flood of public outrage stoked by anti-opioid PROPaganda.