Drug Shortages:

Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved

GAO-15-202: Published: Feb 2, 2015. Publicly Released: Mar 4, 2015.

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crossem@gao.gov

 

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What GAO Found

Shortages of prescription drugs containing controlled substances have increased sharply in recent years; of the 168 shortages reported from January 2001 through June 2013, nearly 70 percent began after 2007. Such shortages lasted for nearly a year, on average. Additionally, many shortages involved generic pain relievers and drugs where there was only one manufacturer.

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), and organizations representing patients and providers report that during shortages of drugs containing controlled substances, patients may receive less effective care, experience medication errors, or not receive treatment at all. They said providers are also affected as they spend time and resources mitigating the effects of shortages, rather than providing care.

The Drug Enforcement Administration (DEA), an agency within the Department of Justice (DOJ), has not effectively administered the quota process that limits the amount of controlled substances available for use in the United States. Each year, manufacturers apply to DEA for quota needed to make their drugs. DEA, however, has not responded to them within the time frames required by its regulations for any year from 2001 through 2014. DEA officials attributed this lack of compliance to inadequate staffing. Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs. Additionally, DEA's weak internal controls jeopardize the agency's ability to effectively manage the quota process. For instance, agency officials said that DEA does not conduct quality checks to ensure the accuracy of the data in its Year-End Reporting and Quota Management System (YERS/QMS). GAO estimates that 44 percent of YERS/QMS records in 2011 and 10 percent in 2012 had errors. DEA officials said that 2011 was the first year manufacturers applied for quota electronically and they expected data from 2012 and beyond to be more accurate. DEA also lacks critical management information because it does not have performance measures related to setting quotas, nor does it monitor data to assess its performance. Moreover, DEA does not have reasonable assurance that the quotas it sets are in accordance with its requirements and cannot ensure continuity of its operations, as it does not have protocols, policies, training materials, or other documentation to manage the quota process.

Despite statutory provisions requiring DEA and FDA to coordinate certain efforts to address shortages of drugs containing controlled substances, the agencies have not established a sufficiently collaborative relationship. For example, DEA and FDA disagree about what constitutes a shortage. DEA officials also said that they do not believe FDA appropriately validates or investigates the shortage information it posts on its website and that posting this information encourages manufacturers to falsely report shortages to obtain additional quota. However, FDA reports that it takes steps to investigate and confirm the shortages on its website. Given such barriers to coordination, DEA and FDA cannot effectively act to prevent or alleviate shortages. Although DEA and FDA have a memorandum of understanding (MOU) in place, it has not been revised since the 1970s and they have been working for more than two years to update it. Officials from both agencies said an updated MOU could facilitate information sharing and help prevent and mitigate future shortages of drugs containing controlled substances.

Why GAO Did This Study

In the last decade, shortages of prescription drugs containing controlled substances, such as narcotics and stimulants, have increased nationwide, preventing providers and patients from accessing essential medications for treatment. Controlled substances are regulated by DEA because of the potential for abuse and addiction. To prevent diversion of controlled substances, DEA sets quotas that limit the amount of certain substances that are available in the United States.

GAO was asked to examine shortages of drugs containing controlled substances. This report examines (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA's administration of the quota process, and (4) coordination between DEA and FDA to prevent and mitigate shortages. GAO analyzed data from 2001 through 2013 from the University of Utah Drug Information Service, which is generally regarded as the most comprehensive source of drug shortage data, and from 2011 and 2012 from YERS/QMS, which is the official record for the quota process. GAO interviewed officials from DEA, FDA, organizations representing patients and providers, and drug manufacturers. GAO reviewed relevant statutes, regulations, and documents.

What GAO Recommends

DEA should take five actions to improve its management of the quota process; DEA and FDA should quickly update their MOU and agree on steps each will take regarding drug shortages. HHS agreed with the applicable recommendations. DEA neither agreed nor disagreed, but raised multiple objections to this report.

For more information, contact Marcia Crosse at (202) 512-7114 or crossem@gao.gov.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In June 2016, DEA stated it had implemented a series of system-generated flags in YERS/QMS to verify the information manufacturers enter into their quota applications and identify entries made by DEA staff that warrant further review by the agency. For example, when DEA staff grant a greater quantity of quota than is requested by the manufacturers, the entry is flagged for review and explanation. Further, the agency conducted a comparison of a random sample of 146 manufacturers' applications and DEA's responses in YERS/QMS from March through May 2016 and found a nearly nonexistent error rate (0.1 percent). DEA officials said that they plan to continue to compare a random sample of manufacturers' applications and DEA's responses in YERS/QMS on a quarterly basis. With these additional controls in place and DEA checking to ensure that the controls are working, the agency now has reasonable assurance that the information in YERS/QMS, which serves as the official record of the quota process, is accurate.

    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should establish controls, including periodic data checks, to ensure that the YERS/QMS data accurately reflect both manufacturers' quota submissions and DEA's decisions.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  2. Status: Open

    Comments: In June 2016, DEA stated that developing performance measures specific to the quota process would not be feasible because actions affecting quotas are outside of the agency's control. Instead, DEA focused on training manufacturers about the quota process to improve the accuracy and quality of their quota applications by holding additional trainings in April 2016 and developing web-based training. While training is an important step in improving the information being submitted to DEA, it is also important that DEA establish measures to assess its performance in achieving its mission of ensuring an adequate and uninterrupted supply of controlled substances, as it does for its diversion-related mission. In July 2016, DEA officials agreed and said that they would implement performance measures for the quota process. DEA officials agreed to provide us with these performance measures once established.

    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should establish performance measures for DEA related to quotas and ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical use.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  3. Status: Open

    Comments: In June 2016, DEA stated that it streamlined its process for reviewing manufacturers' quota applications, which led to a significant reduction in the agency's response times. For example, DEA said that it is now responding to manufacturers' annual quota applications within the time frames required by the agency's regulations, and responding to supplemental quota applications in four to six weeks. As of July 2016, the agency plans to continue monitoring and analyzing the quality of the YERS/QMS data and DEA's timeliness in responding to quota applications on a quarterly basis. As of September 2016, we are currently awaiting documentation from DEA about its latest quarterly analysis and will update the status of this recommendation once documentation of this analysis is received.

    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should monitor and analyze YERS/QMS data to assess DEA's administration of the quota process.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  4. Status: Open

    Comments: In June 2016, DEA stated that it has established internal policies for the quotas process and is in the process of updating its training materials for new staff. These training materials include guidance on how the agency determines quotas for manufacturers. DEA officials clarified that these materials are different than the training materials that are publically available for industry. In July 2016, DEA officials said that they expect the updates to the new employee training materials to be completed in February 2017. DEA agreed to provide us with the training materials once completed.

    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should establish internal policies for processing quota applications and setting aggregate, annual, and supplemental quotas to ensure that staff conduct these activities consistently and in accordance with the Controlled Substances Act and agency's regulations.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  5. Status: Open

    Comments: In June 2016, DEA stated that the agency had met with FDA to determine the specific procedures by which information regarding drug shortages will be exchanged pursuant to the Food and Drug Administration Safety and Innovation Act. DEA stated it will include these procedures in the work plan being created in response to the updated memorandum of understanding signed by FDA and DEA in March 2015. DEA officials also said that they plan to include in the work plan time frames for which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications. DEA expects the work plan to be completed by December 2016.

    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should expeditiously establish formal policies and procedures to facilitate coordination with FDA as directed by the Food and Drug Administration Safety and Innovation Act, including a specific time frame in which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  6. Status: Closed - Implemented

    Comments: In March 2015, DEA and FDA signed a new memorandum of understanding (MOU) which may be helpful in preventing or addressing shortages of drugs containing controlled substances. Some of these drugs, such as narcotics and stimulants, play a vital role in health care. However, they are regulated by DEA because of the potential for abuse and addiction. We found that DEA and FDA did not have a sufficiently collaborative relationship, despite a requirement that they coordinate certain efforts to address shortages of drugs containing controlled substances. Although the agencies had an MOU in place, it had remained unchanged since the 1970s. Both agencies told us that they were subject to restrictions on exchanging the proprietary information they receive from drug manufacturers, which may be helpful to prevent or address these shortages. The agencies had therefore been working for more than 2 years to revise the MOU to facilitate the sharing of such information. The new MOU was finalized about a month after GAO's report was issued. The MOU establishes procedures regarding the exchange of proprietary and other sensitive information between FDA and DEA in both written and verbal communications. It also specifies that information must be shared in accordance with applicable laws, regulations, and policies, and safeguarded against improper use.

    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should promptly update the MOU between the two agencies.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  7. Status: Closed - Implemented

    Comments: In March 2015, DEA and FDA signed a new memorandum of understanding (MOU) which may be helpful in preventing or addressing shortages of drugs containing controlled substances. Some of these drugs, such as narcotics and stimulants, play a vital role in health care. However, they are regulated by DEA because of the potential for abuse and addiction. We found that DEA and FDA did not have a sufficiently collaborative relationship, despite a requirement that they coordinate certain efforts to address shortages of drugs containing controlled substances. Although the agencies had an MOU in place, it had remained unchanged since the 1970s. Both agencies told us that they were subject to restrictions on exchanging the proprietary information they receive from drug manufacturers, which may be helpful to prevent or address these shortages. The agencies had therefore been working for more than 2 years to revise the MOU to facilitate the sharing of such information. The new MOU was finalized about a month after GAO's report was issued. The MOU establishes procedures regarding the exchange of proprietary and other sensitive information between FDA and DEA in both written and verbal communications. It also specifies that information must be shared in accordance with applicable laws, regulations, and policies, and safeguarded against improper use.

    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should promptly update the MOU between the two agencies.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  8. Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. As of July 2016, FDA officials said that it has completed its section of the work plan related to sharing information about drug shortages. According to DEA the work plan is expected to be completed by December 2016.

    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

  9. Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. DEA expects the work plan to be completed by December 2016.

    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency Affected: Department of Justice: Drug Enforcement Administration

 

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