Registrants Vary in Extent of Interaction with DEA and Awareness of DEA Resources, and While Generally Satisfied, Some Want Additional Information Registrants Interact with DEA through Several Methods, but to Different Extents, and Many Are Not Aware of DEA Conferences and Resources

Results from our generalizable surveys of DEA registrants show that the  extent of registrants’ interaction with DEA varies. Our survey results also  show that many registrants are not aware of DEA conferences and  resources. However,  some distributors, individual pharmacies, and chain pharmacy corporate  offices reported that they want additional guidance from, and  communication with, DEA. Distributors that communicated with DEA field offices about their roles  and responsibilities under the CSA were particularly satisfied—we  estimate that 92 percent of distributors found the field office staff very or  moderately helpful. For example, most of the individual pharmacies and chain pharmacy  corporate offices that reported attending one of DEA’s PDACs found them  very or moderately helpful. Some Pharmacies Want Improved Guidance and More Communication from DEA

Responses to our surveys also show that some pharmacies want updated  or clearer guidance, as well as more communication and information,  from DEA. However, DEA officials indicated that they do not believe there is a need  for additional guidance for or communication with pharmacy registrants,  and that the current methods by which the agency helps pharmacy  registrants understand their CSA roles and responsibilities are sufficient. While some national associations did not comment directly on their  satisfaction with how they interact with DEA, more than half of those that  did indicated that they were generally satisfied with those interactions,  though others wanted better communication with the agency. Additionally, officials from half of the national associations  Satisfaction with DEA interactions. Of the national associations and state agencies we interviewed that  offered a perspective on this issue, most (13 of 17) reported that DEA  enforcement actions have helped to decrease abuse and diversion of  prescription drugs. Many Registrants Have Changed Certain Business Practices as a Result of DEA Enforcement Actions and Reported These Changes Have Limited Legitimate Access

On the basis of our generalizable surveys, we found that over half of  registrants have made changes to certain business practices that they  attribute in part to either DEA enforcement actions or the business climate  these actions may have created. For example,  we estimate that over half of distributors placed stricter thresholds, or  limits, on the quantities of controlled substances that their customers  (e.g., pharmacies and practitioners) could order, and that most of these  distributors were influenced to a great or moderate extent by DEA’s  enforcement actions. Many  individual pharmacies and chain pharmacy corporate offices reported that  these stricter thresholds have limited, to a great or moderate extent, their  ability to supply drugs to those with a legitimate need. DEA faces a significant challenge in simultaneously ensuring the  availability of controlled substances for legitimate use while limiting their  availability for diversion and abuse. Therefore, adequate DEA  communication with and guidance for its registrants are essential to help  ensure that registrants take actions that prevent abuse and diversion but  do not unnecessarily diminish patients’ access to controlled substances  for legitimate use because of their uncertainty about how to appropriately  meet their CSA roles and responsibilities. While many of the registrants, state government agencies, and national  associations that have interacted with DEA were generally satisfied with  these interactions, some of these stakeholders said they needed  improved communication and guidance regarding registrants’ roles and  responsibilities for preventing abuse and diversion under the CSA. In its comments, DEA stated  that it describes the actions that it plans to take to implement our three  recommendations. However, we identified additional actions DEA should  take to fully implement our recommendations. Other major contributors to this report are  listed in appendix V.

Appendix I: Objectives, Scope, and Methodology

This report examines (1) how and to what extent selected registrants  interact with the Drug Enforcement Administration (DEA) related to their  responsibilities for preventing prescription drug abuse and diversion  under the Controlled Substances Act (CSA), and registrants’ perspectives  on those interactions, (2) how selected state agencies and national  associations interact with DEA related to reducing prescription drug  abuse and diversion, and their perspectives on those interactions, and   (3) stakeholders’ perspectives about how DEA enforcement actions have  affected abuse and diversion of prescription drugs and access to those  drugs for legitimate medical needs. 2014 Surveys of Distributors, Individual Pharmacies, Chain Pharmacy Corporate Offices, and Practitioners

To address the first and third objectives, we surveyed samples of  practitioners, distributors, and pharmacies that were registered with the  DEA to prescribe, administer, or handle controlled substances about their  interactions with DEA and perspectives on DEA enforcement.
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.

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.

What GAO Recommends

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.