Prescription Drugs: More DEA Information about Registrants' Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access
Highlights
What GAO Found
GAO's four nationally representative surveys of Drug Enforcement Administration (DEA) registrants showed that these registrants vary in the extent of their interaction with DEA related to their roles and responsibilities for preventing prescription drug abuse and diversion under the Controlled Substances Act (CSA). Specifically, GAO found that distributors and chain pharmacy corporate offices interacted with DEA more often than individual pharmacies or health care practitioners. The surveys also showed that many registrants are not aware of various DEA resources. For example, GAO estimates that 70 percent of practitioners are not aware of DEA's Practitioner's Manual. Of those registrants that have interacted with DEA, most were generally satisfied with those interactions. For example, 92 percent of distributors that communicated with DEA field office staff found them “very” or “moderately” helpful. However, some distributors, individual pharmacies, and chain pharmacy corporate offices want improved guidance from, and additional communication with, DEA about their CSA roles and responsibilities. For example, 36 of 55 distributors commented that more communication or information from, or interactions with, DEA would be helpful. DEA officials indicated that they do not believe there is a need for more registrant guidance or communication. Federal internal control standards call for adequate communication with stakeholders. Without more registrant awareness of DEA resources and adequate guidance and communication from DEA, registrants may not fully understand or meet their CSA roles and responsibilities.
Officials GAO interviewed from 14 of 16 state government agencies and 24 of 26 national associations said that they interact with DEA through various methods. Thirteen of 14 state agencies and 10 of 17 national associations that commented about their satisfaction with DEA interactions said that they were generally satisfied; however, some associations wanted improved DEA communication. Because the additional communication that four associations want relates to their members' CSA roles and responsibilities, improved DEA communication with and guidance for registrants may address some of the associations' concerns.
Among those offering a perspective, between 31 and 38 percent of registrants GAO surveyed and 13 of 17 state agencies and national associations GAO interviewed believe that DEA enforcement actions have helped decrease prescription drug abuse and diversion. GAO's survey results also showed that over half of DEA registrants have changed certain business practices as a result of DEA enforcement actions or the business climate these actions may have created. For example, GAO estimates that over half of distributors placed stricter limits on the quantities of controlled substances that their customers (e.g., pharmacies) could order, and that most of these distributors (84 percent) were influenced to a “great” or “moderate extent” by DEA's enforcement actions. Many individual pharmacies (52 of 84) and chain pharmacy corporate offices (18 of 29) reported that these stricter limits have limited, to a “great” or “moderate extent,” their ability to supply drugs to those with legitimate needs. While DEA officials said they generally did not believe that enforcement actions have negatively affected access, better communication and guidance from DEA could help registrants make business decisions that balance ensuring access for patients with legitimate needs with controlling abuse and diversion.
Why GAO Did This Study
The DEA administers and enforces the CSA 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 CSA requires those handling controlled substances to register with DEA.
GAO was asked to review registrants' and others' interactions with DEA. This report examines (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants' perspectives on those interactions, (2) how state agencies and national associations interact with DEA, and their perspectives on those interactions, and (3) stakeholders' perspectives on how DEA enforcement actions have affected prescription drug abuse and diversion and access to those drugs for legitimate needs. GAO administered nationally representative web-based surveys to DEA-registered distributors, individual pharmacies, chain pharmacy corporate offices, and practitioners. GAO also interviewed officials from DEA, 26 national associations and other nonprofits, and 16 government agencies in four states representing varying geographic regions and overdose death rates.
Recommendations
GAO recommends that DEA take three actions to improve communication with and guidance for registrants about their CSA roles and responsibilities. DEA described actions that it planned to take to implement GAO's recommendations; however, GAO identified additional actions DEA should take to fully implement the recommendations.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Deputy Assistant Administrator for the Office of Diversion Control | In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should identify and implement means of cost-effective, regular communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training. |
DEA agreed that communication with its registrant population was necessary and vital, and has provided regular updates on its progress on implementing this recommendation. In February 2018, DEA reported that the agency had addressed this recommendation by developing a subscription based process that allows all DEA registrants to receive notification when DEA posts important information to its website, as well as the option to opt-in to Federal Register notifications. DEA reported that it had activated this process on August 3, 2017, and that as of February 2018, it had enrolled 1.73 million registrants in this process. Improving regular communication with registrants will help improve their awareness of various DEA resources, as well as help DEA registrants better understand their CSA roles and responsibilities.
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| Deputy Assistant Administrator for the Office of Diversion Control |
Priority Rec.
In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting. |
In September 2019, DEA told us that the agency had refocused its efforts on revising draft regulations in line with the SUPPORT for Patients and Communities Act. On November 2, 2020, DEA published a notice of proposed rulemaking entitled Suspicious Orders of Controlled Substances. DEA reports that the proposed rule (1) codifies existing legal obligations related to due diligence and suspicious order monitoring and reporting; and (2) provides additional guidance regarding the nature and timing of the reporting requirement. The proposed rule provided an opportunity for the public, including distributors, to submit comments to DEA. Since 2021, DEA has provided us with periodic updates on the rule's status and estimated publication dates for the final rule. However, as of February 2024, DEA reported that the suspicious orders regulation remained in the internal deliberative process, as DEA was still addressing questions from the Department of Justice's Office of Legal Policy. DEA provided a goal date of July 31, 2024 for publishing the final rule. While DEA has reported taking some action to address this recommendation, as noted above, until the regulations are finalized, we cannot determine if these changes will fully address the recommendation. We will continue to monitor DEA's progress in addressing our recommendation.
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| Deputy Assistant Administrator for the Office of Diversion Control | In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly. |
In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In February 2018, DEA reported that following input from pharmacists, and representatives of pharmacies and pharmacists, it had revised its existing Pharmacist's Manual. DEA published the updated Pharmacist's Manual on DEA's public website on October 8, 2020, and that same day, sent a notice of publication to pharmacists and associations representing them. The revised manual provides updated, additional information that can help reduce uncertainty among pharmacists regarding appropriately meeting their Controlled Substances Act roles and responsibilities. We believe that DEA's actions have satisfied the intent of our recommendation and we consider this recommendation implemented.
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