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The U.S. Drug Enforcement Administration has announced plans to significantly reduce inventories of opioid pain medication and other controlled substances that drug manufacturers are allowed to maintain. The inventory reductions are in addition to cuts in the production of opioids that the DEA is seeking in 2020.
The proposed regulations, published this week in the Federal Register, would limit “excess quantities of medications” being stored in inventory that might be vulnerable to diversion. Other rule changes would tighten DEA oversight of the manufacturing and distribution of controlled substances.
Under current regulations, drug companies are allowed to keep inventories on up to 50% of their annual sales quota for Schedule I and II controlled substances. That would be reduced to 30% under the proposed rules.
“Practically speaking, this equates to a reduction from half of a year's sales supply allowed to be held as inventory to nearly four months,” the DEA said.
The agency said the smaller drug inventory “is not expected to increase the likelihood of drug shortages,” because more manufacturers are available to increase production if shortages develop.
“The DEA believes a reduction of inventory allowance to 30%, with flexibility to produce up to 45% at any given point in a year, would have minimal impact on registrants while continuing to provide adequate inventory for registrants to respond to fluctuations in demand in pharmaceutical markets,” the agency said.
Last year the DEA allowed drug manufacturers to increase the production of injectable opioids after shortages developed at U.S. hospitals. The shortages became so acute that some hospitals were forced to use acetaminophen and muscle relaxants to treat surgery and trauma pain.
The FDA still has morphine, hydromorphone and fentanyl solutions on its list of drug shortages and there are anecdotal reports of hospitals continuing to ration injectable opioids.
‘You Are Hurting Pain Patients’
The public has 60 days to comment on the DEA’s inventory proposal. The comments posted so far are mostly from pain patients critical of previous actions by the DEA.
“Why, why, why do you all keep taking meds from people? You are hurting the pain patients who need this medication. Start taking the drugs off the streets not from our doctors,” wrote Christy Ashford.
“The DEA has waged a war against the sickest and weakest members of American society,” wrote Kirsten Klang. “They know that almost all of the fatalities have to do with the integration of counterfeit fentanyl than any other chemical. Yet, the DEA clamps down where it's easy to do so... even if it's wrong... just because it's easy!”
“I would like to know why the DEA thinks it needs more power over the United States citizens. I mean really, don’t they think that they have tormented enough doctors and their patients through this so-called opioid crisis?” wrote Sheryl Cox. “They say that they have no control over the prescriptions that our doctors give us, and that is an outright lie. They do control our doctors by arresting them and prosecuting them needlessly, sending them to prison, and most do not deserve this kind of treatment and abuse.”
The DEA began cutting the supply of opioid medication in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third.
Last month, the DEA proposed further cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances. If approved, the 2020 production quotas would amount to a 60% decrease in the supply of hydrocodone and a 48% percent cut in the supply of oxycodone since 2016.
Cuts in the supply of prescription opioids have coincided with a sharp increase in overdoses from counterfeit medication. In recent months, hundreds of people have died after taking “Mexican Oxy” – counterfeit oxycodone pills made with illicit fentanyl – which are being trafficked in the U.S. from coast to coas
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