The Drug Enforcement Administration is taking steps to permit increased production and importation of various medicines that are in short supply and needed for Covid-19 patients who are placed on ventilators.
The agency is increasing production quotas by 15% for several controlled substances, including fentanyl, morphine, hydromorphone, codeine, ephedrine, and pseudoephedrine, as well as certain so-called intermediates that are essential to producing these medicines. The DEA also plans to approve increased imports of ketamine, diazepam, midazolam, lorazepam, and phenobarbital (here is the order).
The move follows growing shortages of sedatives, anesthetics, painkillers, and muscle relaxants that health care providers need to place Covid-19 patients on ventilators. The drugs are used to help manage patient pain and comfort levels so they can benefit from mechanical ventilation, and the lack of medicines was compounding the inability of already strained hospitals to cope with the coronavirus.
As of last week, a 51% increase in demand was reported for several sedatives and anesthetics, but the fill rate — the rate that prescriptions were able to filled and shipped to hospitals — dropped from 100% at the beginning of the month to just 63% on March 24. Similarly, the demand for three analgesics — hydromorphone, fentanyl, and morphine — rose 67%, while the fill rate fell from 82% to 73%.
The reasons for the shortages vary. A spot check of shortages tracked by the American Society of Health-System Pharmacists found some companies no longer market certain medicines, while others experienced manufacturing problems. In some cases, there has been a tight market, according to Vizient, a group purchasing organization that works on behalf of hospitals and reported the data.
The issue now is whether pharmaceutical companies will be able to sufficiently ramp up production to meet demand that is expected to vary as different parts of the country experience a surge in Covid-19 patients at different times, according to Erin Fox, who tracks shortages and directs the drug-information service at University of Utah Health Care, which has four hospitals.
“This is great news — exactly what we needed,” she explained. “I don’t think we know how much of a difference it will make yet, but 15% is way better than zero. And now, the possibility exists that more patients can be treated. That possibility wasn’t here yesterday, so it offers a glimmer of hope in a really grim situation.”
The DEA actually started taking steps to alleviate the problem last week by issuing a temporary exception to its regulations so that manufacturers can increase their inventory of certain controlled substances. The agency also maintained that it reached out to manufacturers and has been expediting individual requests for increased quotas in order to meet production needs.