DEA Allowing More Production of Opioids
/By Pat Anson, PNN Editor
Faced with growing concerns about drug shortages, the U.S. Drug Enforcement Administration has increased the production quotas for some opioid pain medications and other controlled substances.
The move is in response to reports that hospitals are experiencing shortages of injectable fentanyl, morphine and hydromorphone, which are used as analgesics to keep COVID-19 patients comfortable while on ventilators.
“DEA is committed to ensuring an adequate and uninterrupted supply of critical medications during this public health emergency,” acting DEA Administrator Uttam Dhillon said in a statement. “This will ensure that manufacturers can increase production of these important drugs, should the need arise.”
The emergency order signed by Dhillon increases 2020 production quotas by 15 percent for some Schedule II controlled substances, including fentanyl, morphine, hydromorphone, codeine, ephedrine and pseudoephedrine, as well as other drugs used in their manufacture.
Although some of those drugs have been listed for years on an FDA database of drug shortages, the DEA said as recently as three weeks ago that it was “unaware of any shortages of controlled substances at this time.”
In addition to pain medication, Dhillon’s order increases the annual production quota (APQ) for methadone, which is used primarily to treat opioid addiction. The order also raises the amount of Schedule III and IV controlled substances that can be imported into the United States, including ketamine, diazepam, midazolam, lorazepam and phenobarbital, which are also used to treat patients on ventilators.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of these substances as the country moves through this public health emergency,” Dhillon said in the order.
“Although the existing 2020 quota level is sufficient to meet current needs, DEA is acting proactively to ensure that — should the public health emergency become more acute — there is sufficient quota for these important drugs.”
Shortages Began Before Coronavirus
The DEA began aggressively cutting the supply of opioids in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.
As recently as last December, the agency reduced 2020 production quotas for hydrocodone by 19 percent and oxycodone by 9 percent. The supply of hydromorphone, oxymorphone and fentanyl was also cut.
Some health officials warned months ago – before the coronavirus outbreak -- that the cuts went too far.
“Some of these medicines, injectable fentanyl and hydromorphone specifically, have been subject to recent and frequent shortages, hindering the ability of doctors and hospitals to conduct critical surgeries and essential patient care,” Corey Brown, Executive Director of Government Affairs for Sanford Health, which operates 44 hospitals in the Midwest, warned in an October 14 letter to the DEA.
“There remains a legitimate need to assure that patients needing surgery and those with short-term or chronic pain in hospitals (or hospice) have monitored access to pain management medications. We are concerned that additional reductions in quotas of these vital medicines may further impact the ability of medical professionals across the country to provide needed care and comfort to patients in a hospital or hospice setting.”
Last week the DEA issued an order allowing drug manufacturers to increase their inventory of Schedule II controlled substances. But no increase in the production quota was made at the time. A senior DEA official told Reuters the quotas were “completely sufficient” to meet high demand.
The agency changed course after receiving a joint letter from the American Medical Association, American Society of Anesthesiologists, Association for Clinical Oncology and the American Society of Health-System Pharmacists warning that injectable drug shortages were affecting the care of coronavirus patients.
“Injectable opioid medications such as these are vital for sedation, pain management, and interventional procedures. While oral dosage forms may be available, these are not clinically indicated for ventilation,” the letter said. “Without sufficient IV opioid supply, patients will suffer.”
Once the coronavirus emergency ends, DEA said it would “reevaluate demand and adjust APQ levels as needed.”
