Shortages of Drugs Containing Controlled Substances

As we have previously discussed, in the last decade, Thumbnail Health Careshortages of prescription drugs have increased nationwide. In recent years, the number of new shortages reported has declined, but the number of active shortages of drugs containing controlled substances—a subset of prescription drugs such as narcotics, stimulants, and sedatives—remains high. Today’s WatchBlog explores what’s behind the shortages of prescription drugs containing controlled substances.

What Are the Risks?

Prescription drugs containing controlled substances, such as pain relievers, have the potential for abuse and psychological and physical dependence. However, shortages of these drugs can
•    delay or deny needed care for patients,
•    cause patients to use less effective or more risky medications, and
•    burden both patients and providers in other ways.

Our podcast further explains the public health threats associated with drug shortages:


DEA Oversight and Quotas

The Controlled Substance Act requires the Drug Enforcement Agency (DEA) to establish limits—known as quotas—on the amounts of certain controlled substances available for use each year in the United States. These quotas are supposed to limit controlled substances because of the potential for their abuse, while ensuring an adequate and uninterrupted supply for medical, research, and other uses.

In addition, DEA works with the Food and Drug Administration (FDA) to prevent and mitigate shortages of drugs that contain certain controlled substances.

Coming Up Short

We found that DEA did not effectively administer its quota process for controlled substances. For example, from 2001 through 2014, DEA didn’t meet its own time frames for setting quotas.

We also found that DEA lacked the management oversight that would ensure the quotas it sets meet estimated needs. For example, DEA is missing policies, procedures, and performance measures related to setting quotas.

Additionally, we found that DEA and FDA couldn’t share proprietary information from drug manufacturers—including information that could help identify or address drug shortages. Since our report was released, DEA and FDA have signed an agreement that allows the agencies to share information about drug shortages.

We offered multiple recommendations to improve DEA’s management of the quota process and its coordination with FDA to reduce drug shortages.

Still want to know more about drug shortages? Check out this recording of our live question-and-answer session:


  • Questions on the content of this post? Contact Marcia Crosse at crossem@gao.gov.
  • Comments on GAO’s WatchBlog? Contact blog@gao.gov.
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