The Trump administration on Thursday proposed reducing the production quotas for six of the most misused and most commonly prescribed opioids by an average of 10% in 2019 when compared with 2018 quotas.
Background: DEA lowers opioid production quotas; hospitals face shortages
Drug Enforcement Administration (DEA) sets a quota for the amount of Schedule I and Schedule II drugs produced annually. The agency sets production thresholds intended to ensure that enough Schedule I and Schedule II drugs are produced to meet research and medical needs, but also to ensure that the supply of such drugs is limited to prevent misuse. DEA in 2013 increased the production threshold for Schedule II opiate and opioid drugs by 25% to avoid potential shortages, but the agency in 2017 reduced production quotas for almost every Schedule II opiate and opioid drug by between 22% and 66%. DEA at the time said the reduction reflected a drop in demand for prescription opioids and would reverse the 25% production increase the agency ordered in 2013.
But DEA earlier this year increased production quotas for certain drugmakers to alleviate a shortage of injectable opioids that has plagued providers since the summer. 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—which include morphine, Dilaudid, and fentanyl—are intended to treat pain in patients who are undergoing major surgery or are experiencing severe pain due to trauma or cancer.
Industry experts largely have attributed the shortage to manufacturing issues at Pfizer. Pfizer, which holds at least 60% of the injectable opioids market, scaled down production of the drugs in June 2017 while upgrading a plant in Kansas, according to Pfizer spokesperson Steve Danehy. The company in March also said it had encountered "technical and process issue[s]" with an unnamed third-party supplier. Pfizer has resumed some of its production, but the company does not expect to resume its full production volume until the second quarter of next year.
The combination of a manufacturing shortage and DEA's opioid quota reductions has had significant effects on hospitals and health systems. Providers have scrambled to find ways to conserve their supplies of injectable opioids and use alternatives when possible.
The American Hospital Association and other industry stakeholders convinced DEA to grant partial approvals for Fresenius Kabi and West-Ward Pharmaceuticals—as well as a smaller, unidentified drugmaker—to ease production quotas and manufacture the ingredients used in making the needed drugs. But observers say health care providers are not yet in the clear.
DOJ, DEA propose reducing opioid production quotas
Despite the shortage, the Department of Justice (DOJ) and DEA on Thursday proposed cutting by 7% to 15% the production quotas in 2019 for:
- Oxycodone; and
DOJ and DEA in a statement said the proposed reduction would help further President Trump's effort to cut the number of opioid prescriptions filled in the United States by one-third within three years. "This significant drop in prescriptions by doctors and DEA's production quota adjustment will continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine," DEA Acting Administrator Uttam Dhillon said.
DEA said it will send the proposed quotas to state attorneys general for review. The proposal also is open for public comments for 30 days (Wang, Inside Health Policy, 8/16 [subscription required]; Ahmann, et al., Reuters, 8/16; Hellmann, The Hill, 8/16).
Your top resources for combatting the opioid epidemic—in one place
The opioid epidemic is a complex, multi-dimensional public health problem. Use this list of helpful resources on how hospitals and health systems can play a role to treat opioid addiction and prevent further increase in opioid abuse.
- Tool: Opioid Population Profiler
- Infographic: 9 imperatives for hospital and health system executives to confront the opioid epidemic
- Upcoming Webconference: What you need to know to stay on top of the opioid epidemic
- Report: Get 15 best practices to reduce unwarranted opioid prescribing