The Drug Enforcement Administration (DEA) increased production quotas for certain drugmakers to help alleviate a shortage of injectable opioids that has plagued providers since the summer—but industry experts say relief is still several months away.
The shortage, which industry experts largely attribute to manufacturing issues at Pfizer, comes amid a federal push to reduce the use of prescription opioids. As part of that effort, DEA last year sought a 25% reduction in production of all opioids and a 20% additional reduction this year. DEA on Tuesday proposed a rule that would require the DEA administrator to consider a broader set of criteria when setting production quotas for drugmakers, including the extent to which the drugs, particularly prescription opioids, are being misused and contributing to overdose.
The opioids in short supply are not prescription pills but rather packaged vials, patches, and syringes that are distributed to hospitals and other medical providers. The medications are intended to treat pain in patients who are undergoing major surgery or are experiencing severe pain due to trauma or cancer. The specific medications include injectable morphine, Dilaudid, and fentanyl.
Pfizer spokesperson Steve Danehy said the shortage of clinical injectable opioids began in June 2017 when the company scaled down production of the drugs while upgrading a plant in Kansas. Pfizer, which holds at least 60% of the injectable opioids market, also said it is experiencing "technical and process issue[s]" with an unnamed third-party supplier, and is not currently distributing prefilled syringes "to ensure patient safety."
Although Pfizer has resumed some of its production, the company doesn't expect to be back to full production until the second quarter of next year, according to Modern Healthcare. In March, Danehy said the company was "exploring the feasibility of increasing capacity within the global Pfizer manufacturing network and potential third party suppliers."
Stakeholders call for quota boost
To help mitigate the shortage, the American Hospital Association and other industry stakeholders have asked DEA to ease quotas on opioid production for liquid opioids. Under current regulations, if a major drugmaker, such as Pfizer, hits a roadblock in production, smaller manufactures have to petition DEA to boost their own levels of production.
In the meantime, hospitals and health systems around the country have had to adopt multiple coping strategies, including inventory tracking and the use of opioid alternatives when feasible.
After delay, DEA raises quotas
According to Modern Healthcare, DEA received requests for additional raw ingredients on Jan. 1. However, the agency waited until mid-February and mid-March to grant partial approvals for Fresenius Kabi and West-Ward Pharmaceuticals—as well as a smaller, unidentified drugmaker—to manufacture the ingredients.
Modern Healthcare reports that while the agency can typically meet extra quota requests within four weeks, DEA in this case had to dispatch inspectors to facilities to reconcile drugmakers' inventory checks with their year-end reports to ensure there wasn't any drug diversion. According to DEA, the goal of such reviews is to make sure that manufacturers are not stockpiling raw ingredients that could be used to mitigate the shortage.
However, industry experts said the risk of drug diversion is minimal among manufacturing and inpatient settings—it's a greater risk among retail pharmacies. "The potential for diversion in the institutional setting versus the retail setting is infinitesimally small," William Larkin, EVP and chief pharmacy officer for Acurity said.
Providers and other stakeholders praised DEA for increasing the quotas, but they expressed concern about the delay—and noted that relief likely remains several months away, Modern Healthcare reports.
For instance, Scott Knoer, chief pharmacy officer at Cleveland Clinic, said there's typically an eight- to 12-week quarantine between when the opioids are manufactured and when they receive quality control approval necessary to ship the product—and then the products need a few more weeks to get through the wholesale distribution supply chain. "Bottom line, this is good news, but it will likely be summer before we have some relief and longer for full relief," Knoer said.
Similarly, Todd Ebert, CEO of the Healthcare Supply Chain Association (HSCA), said that HSCA was "encouraged" by the DEA's decision, but hopes that, in the future, "DEA will develop processes and procedures to recognize and respond to these market issues much more quickly … as three months seems to be too long."
Meanwhile, Daniel Motto, EVP of commercial and business development for West-Ward, said the company is "doing [its] best to meet the significant need that this shortage has presented for these important injectable medicines," but added that the company does "have limitations based upon the quota granted by the DEA." Motto said the company has asked for additional active pharmaceutical ingredients (Kacik, Modern Healthcare, 4/14; Wilber, Wall Street Journal, 4/17).
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