AHA comments on DEA’s proposed rule on controlled substances quotas

May 4, 2018

Re: Docket No. DEA-480, Controlled Substances Quotas; Notice of Proposed Rulemaking (Vol. 83, No. 76), April 19, 2018.

We concur with the DEA that setting quotas for the production of opioid medications can be an effective step in “preventing the accumulation of controlled substances in amounts exceeding legitimate need,” and therefore reduce the chance that these powerful medications will be diverted for non-medical illicit purposes. However, opioids are commonly administered in hospitals to relieve the pain of significant trauma, surgery, cancer that has metastasized to the bone or invaded the brain, severe burns and other significant diseases or disorders.

Given its commitment to addressing injectable opioid shortages, the AHA strongly recommends that the DEA amend its proposed rule to ensure that, in addition to diversion, that drug shortages be considered when aggregate production quotas are set and adjusted.

We also recommend that the DEA routinely consult with the Food and Drug Administration’s drug shortage staff, which collects and publishes relevant data on all national drug shortages, when establishing and adjusting quotas.

Read the full comment letter below.

Related Resources

In its fiscal year 2019 inpatient prospective payment system final rule, the Centers for Medicare & Medicaid Services (CMS) updated federal gui
Press Releases
Bibliography/Link Page
The AHA is involved with Advocacy work on opioid legislation. These are resources to other advocacy and policy documents on opioids.
Bibliography/Link Page
Ending the opioid epidemic requires a coordinated community response. Hospitals and health systems are actively partnering with organizations and people in…
Bibliography/Link Page
The resources below are guidelines to help prevent against diversion in hospitals and communities.
Bibliography/Link Page
According to the CDC, each day more than 1,000 people are treated in emergency departments for misusing prescription opioids. Even though patients may be…