This story definitely falls into the category of “beware lest you get what you asked for”.
The DEA has restricted the production of opioids by 50% over the last four years without concern for their medical use. They seemed to believe that all opioids are the same, whether bought, cooked, and injected in the street or prescribed by a doctor.
In their opinion, there were “too many” legitimate opioids being manufactured, so they set out to curtail that by cutting production quotas.
They were successful. They got what they asked for, and now we don’t have enough medication during a crisis. And people are still overdosing just like before, with illicit opioids.
A yearslong crackdown on opioid production is having an unintended consequence during the coronavirus crisis: Many of these same drugs are essential for people on ventilators, and now there’s a shortage.
Low stocks of opioids in coronavirus hot spots — which have become dire enough for doctors to request that states divert death row supplies to hospitals instead — are compounded by the looming shortages of a range of other drugs, from antibiotics to inhalers, as hospitals struggle to cope with a massive wave of coronavirus patients.
The growing scarcity of these life-saving medications is just a hint of things to come as the U.S. outbreak progresses, said one senior official at the Department of Health and Human Services.
While the pandemic is unprecedented, such shortages are not. Health experts say the U.S. government has been slow to strengthen the drug supply chain, despite recent painful reminders of its vulnerabilities.
All that time, the Drug Enforcement Administration was tightening supply limits for a range of opioids.
Over five years, it halved production caps for drugs from fentanyl to morphine in response to the worsening opioid crisis nationwide. The agency this week relaxed some of those limits.
It’s sickening that drug enforcement agents–with badges and guns–are allowed to interfere with medical care like this. They have gone rogue.
But it’s not clear how quickly drugmakers can ramp up supplies — and hospitals in hot spots are dealing with shortages by the hour, their pharmacists say.
Bouts of scarcity are endemic to the U.S. drug supply chain, which affords little transparency about where drugs are made and stocks fluctuate due to production costs and small profits
Federal agencies have scrambled to loosen restrictions and ward off some of the expected crush. The DEA’s move this week lets drugmakers apply to boost production of fentanyl, morphine and hydromorphone by 15 percent, as hospital use soars to unprecedented levels to help intubated patients fighting the virus.
The agency has cut allowed production caps for those and other opioids by 54 percent since 2016, a senior DEA official said.
Wake up, folks! These are not street drugs used for recreation, they are critically needed medications.
A 50% reduction is frightening. Our population has grown, is aging, and needs more opioid medications than before, not less.
A further absurdity is that these restrictions causing so many probems are entirely misdirected. Prescription pills do not contribute much to overdoses.; those are usually from drug cocktails and contain deadly amounts of illicit fentanyl.
The DEA is aiming to reply to drugmakers’ requests within a day. Requests are likely to pour in: Besides increased demand from regular customers such as hospitals and cancer centers, manufacturers are fielding orders from the federal government and even some states, the DEA official said.
The FDA has pushed for years to have more oversight of the drug supply chain, in part by gaining the power to require earlier notice of shortages from drugmakers and details of the companies’ risk plans. The agency finally got its way on those two issues last month, as pieces of a bill by Smith and Maine Republican Susan Collins made their way into the $2 trillion stimulus package.
“While manufacturers are required to report certain information related to drug supply disruptions to FDA, they are not required to provide detailed information on their supply chain that be helpful for monitoring the drug supply,” an agency spokesperson said
“We rely on the cooperation of the drug companies in order to obtain accurate information as we proactively take steps to mitigate drug shortages.”
This so ridiculously naive I can’t believe even they believe themselves this is a plausible arrangement. When profit is the prime motive for any corporate decisions, no one wants to store much inventory. It’s expensive to hold on to things that aren’t “productive” while waiting to serve their purpose.
Why would a drug company ever provide any information that makes them look bad, like having shortages, when they are financially motivated to keep as little “spare” inventory as possible?
To minimize the time any goods are stored, we now have “just in time” inventory, a network of corporations supplying each other by coordinating their production of goods.
At its simplest, raw material flows into one end of the supply chain. Then some business uses the material to manufacture parts, which then flow to another business that assembles the parts into products, which then flow to another business that delivers products to stores, where they are quickly unpacked and sold to customers.
If it’s timed right, all inventory is in continuous motion. No one has inventory besides what they need right away. This is extremely efficient, but any disruption anywhere in the chain has wide-ranging effects, and changing any part of it can disrupt other supply chains.
Fifteen drugs needed to treat Covid-19 patients were in or close to shortages by the end of March, according to Premier, a group purchaser that supplies medicines to a range of hospital systems
While health care groups have largely applauded the DEA’s decision to ease limits on opioid production and Congress’s recent moves to boost FDA authority, many worry it is too little, too late for the current crisis.
It’s not like manufacturers can just change what they make by flipping a switch. They have to source different parts from different vendors and reconfigure their assembly lines… I think this would take months.