Fast Facts

The Drug Enforcement Administration collects industry-reported data on the sale and purchase of controlled substances and prescription drugs, including opioids. The data supports DEA’s investigations into whether drugs have been diverted to the illegal marketplace.

DEA’s systems don’t provide real-time analysis, but more robust analysis is possible. For example, DEA could use computer algorithms to proactively identify patterns and trends in drug distribution—e.g., to see when unusual volumes of drugs are disposed of vs. sold.

Better using algorithms to analyze and identify patterns in drug transaction data is among our recommendations to DEA.

Pills and medication bottles on a table

Pills and medication bottles on a table

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Highlights

What GAO Found

The Drug Enforcement Administration (DEA) collects industry-reported data on the sale and purchase of controlled substances and prescription drugs, including opioids. It uses these data to support ongoing investigations into the diversion of such substances into the illegal market place and to identify investigative leads for its field division offices.

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GAO identified deficiencies associated with DEA's drug diversion efforts, including the following:

Limited proactive and robust analysis of industry-reported data. While DEA's current data systems are not designed to conduct real-time analysis, and it conducts some analyses of industry-reported data, such as in response to requests from its field division offices, DEA could conduct more analyses using automated computer algorithms to help identify questionable patterns in the data. For example, DEA could analyze data to identify unusual volumes of deleted transactions or unusual volumes of drugs that were disposed of rather than sold. It could also analyze data to identify trends in distribution or drug purchases in a given geographic area. Other analysis DEA could perform is to look for unusual patterns when comparing drug orders in one geographic area with other nearby areas. These analyses could potentially help DEA proactively identify suspicious activities or registrants that may warrant investigation.

No data governance structure to manage all drug transaction data. Although DEA has guidance, policies and procedures for the use of some information systems, it has not established a formal data governance structure to manage all data it collects and maintains, which are integral to its diversion control activities. A data governance structure is defined as an institutionalized set of policies and procedures for providing data governance throughout the life cycle of developing and implementing data standards. Industry and technology councils, domestic and international standards-setting organizations, and federal entities endorse the use of a governance structure to oversee the development, management, and implementation of data standards, digital content, and other data assets. While DEA began efforts to develop a governance structure, it is in the early stages of development and does not have additional details or documentation of its efforts. An effective data governance structure could help DEA ensure its important data assets are consistently and fully utilized.

Why GAO Did This Study

Since 1999, more than 700,000 people have died of a drug overdose in the United States, with about 48,000 dying of an opioid overdose in 2017 alone. The DEA administers and enforces the Controlled Substances Act as it pertains to ensuring the availability of controlled substances, including certain prescription drugs, for legitimate use while limiting their availability for abuse and diversion.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, enacted in 2018 included a provision for GAO to study the reporting of suspicious opioid orders on a real-time basis nationally using computer algorithms. This report examines, among other things, how DEA obtains and uses industry-reported data to identify and address suspicious opioid orders and opportunities for DEA to improve these efforts, such as using computer algorithms or real-time reporting. GAO analyzed program documentation and DEA data, and interviewed DEA and industry officials as well as officials from national associations representing distributors, investigators, state boards of pharmacy, and other federal and state agencies.

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Recommendations

GAO is making four recommendations related to DEA's collection and use of industry-reported data. DEA agreed with three of the four recommendations, and neither agreed nor disagreed with the fourth.

Recommendations for Executive Action

Agency Affected Recommendation Status
Drug Enforcement Administration
Priority Rec.
This is a priority recommendation.
The DEA Administrator should develop and implement additional ways to use algorithms in analyzing ARCOS and other data to more proactively identify problematic drug transaction patterns. (Recommendation 1)
Open
DOJ agreed with this recommendation and has made significant progress in addressing this recommendation. For example, in February 2021, DOJ deployed a new platform that facilitates user identification of, among other things, geographical trends and outliers in opioid and stimulant drug sale patterns. In addition, DEA's built-in algorithms track increases in the number of thefts, locations, and drug type and. DEA is working to further develop and use algorithms to more proactively identify and alert DEA's field divisions of problematic drug transactions. Once implemented, the agency will need to provide documentation and demonstrate their implementation to fully address this recommendation.
Drug Enforcement Administration
Priority Rec.
This is a priority recommendation.
The DEA Administrator, in coordination with the department-wide efforts on data strategy, should establish and document a data governance structure to ensure DEA is maximizing its management of industry-reported drug transaction data. (Recommendation 2)
Closed - Implemented
DOJ agreed with this recommendation and, in July 2020, reported that it had developed a data strategy to strengthen its data management practices. While the strategy addresses the first part of our recommendation, it does not provide the details on how it will help DEA manage its collection and use of data that supports the Diversion Control Division's mission and manage its industry-reported drug transaction data. To fully meet this recommendation, DEA will need to provide further documentation that demonstrates how its development of a data governance structure helps it to maximize its management of industry-reported drug transaction data. The intent of this recommendation is for DEA to establish a formalized data governance structure to manage its collection and use of data used to support the Diversion Control Division's mission. In July 2021, DEA provided further documentation describing the Diversion Control Division staff's roles and responsibilities for managing industry-reported data and how the Diversion Control Division will communicate and collaborate with other divisions in managing and analyzing data across DEA. The agency's actions demonstrate how its data governance structure helps it support the Diversion Control Division's mission and helps it maximize its management of industry-reported drug transaction data.
Drug Enforcement Administration
Priority Rec.
This is a priority recommendation.
The DEA Administrator should establish outcome-oriented goals and associated measurable performance targets related to opioid diversion activities, using data it collects, to assess how the data it obtains and uses supports its diversion control activities. (Recommendation 3)
Open
DOJ neither agreed nor disagreed with this recommendation. In July 2020, DEA reported that it anticipated being able to set measureable performance targets that are based on the number of leads that result in either the initiation of a new case or supplement an existing investigation. In February 2021, DEA established an automated portal that sends fully developed investigative leads and pointers to field personnel; however, the metrics that DEA identified are output measures, not outcome-oriented goals, and measurable performance targets. To address this recommendation, DEA needs to provide documentation demonstrating linkage of these goals and targets to their diversion control program efforts and activities. This would help DEA demonstrate how it plans to determine whether it is meeting its goals within the newly established system. Our recommendation is intended to ensure that DEA can demonstrate the usefulness of the data it collects and uses to support its opioid diversion control activities.
Drug Enforcement Administration
Priority Rec.
This is a priority recommendation.
The DEA Administrator, in consultation with industry stakeholders, should identify solutions to address the limitations of the ARCOS Enhanced Lookup Buyer Statistic Tool, to ensure registrants have the most useful information possible to assist them in identifying and reporting suspicious orders to DEA. (Recommendation 4)
Closed - Implemented
DOJ agreed with this recommendation, and, in April 2021, reported that it had addressed all but one of the limitations GAO identified in our report related to the ARCOS Lookup Buyer Statistic Tool. For example, DEA engaged in ongoing consultations with industry stakeholders to identify solutions to address the tool's limitations. In May 2021, DEA provided documentation demonstrating it addressed this last limitation. The agency's actions in addressing all of the limitations GAO identified in our report help ensure registrants have more useful information at their disposal when evaluating whether an order is suspicious.

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