By Pat Anson, Editor
In response to a growing number of complaints about shortages of opioid pain medication in U.S. hospitals, the Drug Enforcement Administration is allowing some drug makers to increase their production of injectable opioids.
The shortages were first reported last summer but have intensified in recent months – leaving some hospitals scrambling to find morphine, fentanyl and other injectable opioids to treat patients suffering from acute pain after surgery or trauma. The shortages are largely due to manufacturing problems at Pfizer, which controls 60 percent of the market for injectable opioids.
“DEA is working closely with the U.S. Food and Drug Administration, drug manufacturers, wholesale distributors and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl,” the agency said in a statement.
The DEA said it gave permission to three other drugs makers to produce the injectable drugs after Pfizer “voluntarily surrendered” part of its quota allotment.
“It is important to note that an increase in DEA procurement quotas to various manufacturers cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products,” the agency said.
But critics say the DEA itself is partly responsible for the shortages. The agency may not control how companies manufacture drugs – but it has a big say on the amount. Under federal law, the DEA sets annual production quotas for each drug maker to produce opioids and other controlled substances.
Because of growing concerns about the overdose crisis, the DEA ordered a 25 percent reduction in opioid manufacturing in 2017 and an additional 20 percent cut in 2018. This year’s cuts were ordered despite warnings from three drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”
A group of 16 U.S. Senators – led by Illinois Democrat Dick Durbin – urged the DEA to make the production cuts.
“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the senators wrote in a September 2017 letter to then acting DEA administrator Chuck Rosenberg.
According to Kaiser Health News, shortages of injectable opioids have led to an increasing number of medical errors and left trauma patients suffering in pain. Some hospitals are rationing opioids like Dilaudid, and using nerve blocks, acetaminophen and muscle relaxants instead.
The DEA said it would make further adjustments to opioid quotas if they are needed and would “also consider other measures that may be necessary.”