Prescription Drugs: More DEA Information about Registrants' Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access
Published: 2015-06-25T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: The Centers for Disease Control and Prevention (CDC) has declared that  the United States is in the midst of an epidemic of prescription drug  overdose deaths. In 2013, more than 22,000 Americans died from drug  overdoses attributable to prescription drugs, and most of those deaths— more than 16,000—were attributable to prescription opioid pain relievers.  While these prescription drugs have legitimate purposes and are safe  when taken as directed, they also can be misused, and pose a potential  for abuse and addiction as well as being diverted for illicit uses. In 2012,  an estimated 6.8 million Americans reported being current nonmedical  users of prescription drugs, according to the National Survey on Drug Use  and Health. About 70 percent of these people reported that they got the  drug from a friend or family member, while about 22 percent got the drug  from a doctor. Abuse of prescription drugs results in significant social,  public health, and economic consequences for the United States. For  example, economic costs include workplace costs (e.g., lost productivity),  health care costs (e.g., abuse treatment), and criminal justice costs. One  study estimated that opioid pain reliever abuse costs health insurers  alone up to $72.5 billion per year.
Multiple federal agencies have responsibility for addressing the misuse,  abuse, and diversion of prescription drugs through prevention, treatment,  and enforcement activities. In particular, the Department of Justice’s Drug  Enforcement Administration (DEA) has a key role as it enforces the  Controlled Substances Act (CSA). The CSA was enacted in 1970 to  regulate and facilitate the use of controlled substances, including certain  prescription drugs such as opioid pain relievers, for legitimate medical,  scientific, research, and industrial purposes while preventing them from  being diverted for illegal uses. DEA’s Office of Diversion Control is  responsible for administering and enforcing the provisions of the CSA as  they pertain to ensuring the availability of controlled substances for  legitimate uses while limiting their availability for abuse and diversion.  Various CSA provisions require persons who handle controlled  substances to register with the DEA, including businesses that import,  export, manufacture, or distribute controlled substances; health care  practitioners, such as physicians, licensed to dispense, administer, or  prescribe them; and pharmacies authorized to fill prescriptions. These  DEA registrants have certain responsibilities under the CSA and its  implementing regulations for preventing abuse and diversion of controlled  substances. For example, practitioner registrants must ensure that  prescriptions for controlled substances are issued for legitimate medical  purposes. To monitor registrants’ compliance with the CSA, DEA can  conduct investigations into instances of potential diversion, and can  initiate a variety of enforcement actions for violations of the CSA and its  implementing regulations. DEA also conducts educational activities and  provides guidance to its registrants regarding their roles and  responsibilities under the CSA.
Because the problem of prescription drug abuse is complex and multi- faceted, a federal report has noted that an effective response to the  problem requires a multi-pronged approach that can only be achieved  through a coordinated effort among public health, clinical medicine, public  safety, and other stakeholders. Accordingly, in addition to its work with  registrants, DEA interacts with other governmental and nongovernmental  stakeholders, such as state public health and law enforcement agencies,  and national associations representing various interests, on efforts related  to reducing prescription drug abuse and diversion. However, questions  have been raised about how and the extent to which DEA interacts with  its registrants and other nonfederal stakeholders on issues related to  reducing prescription drug abuse and diversion, as well as whether DEA’s  enforcement actions have struck the right balance between reducing  diversion and ensuring access for legitimate medical needs.
You asked us to review registrants’ interactions with DEA related to their  responsibilities under the CSA, DEA’s coordination of efforts with  nonfederal stakeholders to reduce prescription drug abuse and diversion,  and the effect of enforcement actions on abuse and diversion and access  to prescription drugs. This report examines (1) how and to what extent  selected registrants interact with DEA related to their responsibilities for  preventing prescription drug abuse and diversion under the 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. For the  purposes of this report, the stakeholders whose perspectives we obtained  include DEA registrants (distributors, pharmacies, and practitioners), state government officials in four states, and officials from 26 national  associations and other nonprofits representing various interests.
To address our first and third objectives, we administered four web-based  nationally representative surveys to the following three types of DEA  registrants: distributors, pharmacies, and practitioners. Using DEA’s CSA  registrant database as of January 2014 to create listings of these  populations, we split the pharmacy population into two—“individual”  pharmacies and “chain pharmacy corporate offices.” We defined the  individual pharmacies as being individually registered pharmacy locations  that were either independently owned or part of a corporation with less  than 50 registered pharmacy locations, and we defined the chain  pharmacy corporate offices as having 50 or more registered pharmacy  locations. We surveyed generalizable random samples of 200   The 304  distributors, 304 individual pharmacies, and 400 practitioners. individual pharmacies were asked to respond to the survey on behalf of  their single pharmacy location that was selected in our sample,  regardless of its ownership status. We also surveyed all of the corporate  offices of the 38 chain pharmacies we identified, using DEA’s CSA  database, as having 50 or more registered pharmacy locations.38 chain pharmacy corporate offices were asked to respond to the survey  on behalf of all of their registered pharmacy locations. We conducted our  surveys between July 2014 and October 2014. The response rates for   These  each registrant sample were as follows: 86 percent of distributors,   63 percent of individual pharmacies, and 55 percent of practitioners.  Among the chain pharmacy corporate offices we surveyed, 84 percent  (32 of 38) responded. We selected these categories of registrants  because they are the primary DEA registrants in the prescription drug  supply chain and are more likely to be the focus of DEA enforcement  actions than other categories of registrants such as researchers or drug  importers. We surveyed registrants about how they have interacted with  DEA since 2012, and their perspectives about those interactions. We also  surveyed registrants about their perspectives on how DEA enforcement  actions, or the possibility of actions against registrants, have affected their  business practices, or the business climate in which they operate, as well  as their perspectives on whether enforcement actions have had an effect  on reducing abuse and diversion and on limiting patients’ access to  prescription drugs for legitimate medical needs. We analyzed survey  responses and compared them to federal internal control standards  related to information and communication and the standards in DEA’s  Office of Diversion Control Customer Service Plan for Registrants.
To further address all three objectives, we interviewed government  officials at 16 agencies within four states (California, Florida, Kentucky,  and New York) and officials at 26 national associations to obtain  information about interactions with DEA, their perspectives about those  interactions, and their views about the effects of DEA enforcement  actions on abuse and diversion and access to legitimate prescription  medication. We selected these four states based on several criteria,  including that they (1) have varied levels of prescription drug overdose  deaths, (2) have received federal grant funds relevant to reducing  prescription drug abuse and diversion, and (3) represented different  geographic regions of the country (as represented by DEA field divisions).  We interviewed officials at 16 state agencies within these four states,  including state regulatory authorities such as pharmacy and medical  boards, law enforcement, and agencies that oversee the state’s  prescription drug monitoring program. Although the perspectives we  obtained during the interviews with state agencies and national  associations are not generalizable, the interviews provided insights  regarding how these types of entities interact with DEA as well as  common areas of concern.
We also obtained documents from and interviewed DEA Office of  Diversion Control officials who have oversight responsibility for DEA  registrants and are engaged in addressing prescription drug abuse and  diversion issues to learn about how DEA interacts with its registrants and  other nonfederal stakeholders, and to obtain DEA’s perspectives on  information we obtained from our survey results and interviews with  nonfederal stakeholders. In addition, in each of the four states where we  conducted interviews with state agency officials, we also interviewed  officials from DEA field divisions, such as supervisors overseeing both  diversion investigators and special agents. We compared DEA’s  responses regarding its interactions with registrants and nonfederal  stakeholders to federal internal control standards related to information  and communication and the standards in DEA’s Office of Diversion   Finally, to help address  Control Customer Service Plan for Registrants.our third objective, we reviewed data on DEA’s enforcement actions from  fiscal year 2009 through fiscal year 2013 that were taken against DEA  registrants in the three categories that we included in our surveys  (distributors, pharmacies, and practitioners) to identify any trends in  DEA’s enforcement actions over a recent time period. We determined that  the data were sufficiently reliable for purposes of our report. (See app. I  for a detailed discussion of our scope and methodology.)
We conducted this performance audit from August 2013 to June 2015 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: Prescription opioid pain relievers are safe and effective when used as  directed, but these highly addictive substances can pose serious risks of  addiction or death if they are abused, misused, or diverted. Opportunities  for abuse or diversion can occur as drugs flow through the prescription  drug supply chain. DEA is responsible for ensuring the availability of  controlled substances for legitimate uses while preventing their diversion  through its administration and enforcement of the CSA and its   States also play a role in regulating controlled  implementing regulations.substances and the practices of medicine and pharmacy within their state  boundaries. Additionally, national associations representing stakeholders  such as distributors, pharmacies, and practitioners work on behalf of their  members to support efforts to reduce prescription drug abuse and  diversion.
subsections: section_title: Legitimate Use of Prescription Drugs, Drug Supply Chain, and Opportunities for Abuse and Diversion
paragraphs: When taken as directed for legitimate medical purposes, prescription  drugs are safe and effective. Pain, which affects millions of Americans, is  a health problem for which prescription drugs are often used. Pain can be  characterized in terms of intensity—mild to severe—and duration—acute  or chronic. According to the Institute of Medicine, more than 100 million  Americans are affected by chronic pain.treatment of pain varies, some patients are prescribed prescription pain  relievers, such as opioids, to treat pain. These may include hydrocodone,  oxycodone, and morphine, among other opioids. Prescription opioid pain  relievers can be used effectively as a short-term treatment for a variety of  acute or chronic pain conditions, such as severe pain following trauma,   While the appropriate medical  and for patients with painful terminal diseases such as cancer. However,  opioids are sometimes used in a manner other than as prescribed—that  is, they are abused and misused. Because opioids are highly addictive  substances, they can pose serious risks when they are abused and  misused, which can lead to addiction and cause death.
The prescription drug supply chain is the means through which  prescription drugs are ultimately delivered to patients with legitimate  medical needs. Although there can be many variations in the flow of  prescription drugs through the supply chain, in a common example,  prescription drugs are produced by manufacturers; are purchased and  stored by distributors, who take orders and deliver them to customers  such as pharmacies; and ultimately are dispensed by pharmacies to  patients who have a prescription from a practitioner. (See fig. 1.) Although  prescription drugs are intended for legitimate medical uses, the  prescription drug supply chain may present opportunities for the drugs to  be abused and diverted as the drugs move through the various  components of the supply chain. For example, an individual may visit  multiple practitioners posing as a legitimate patient, referred to as a  doctor shopper, to obtain prescriptions for drugs for themselves or others.  In an example of diversion, criminal enterprises may rob distributors and  pharmacies of prescription drugs to sell to others for a profit.
section_title: DEA’s Office of Diversion Control and the CSA
paragraphs: Through its Office of Diversion Control, DEA administers the Diversion  Control Program whose mission is to prevent, detect, and investigate the  diversion of controlled substances from legitimate sources while ensuring  an adequate and uninterrupted supply is available for legitimate medical,  commercial, and scientific needs. In addition to investigations, the Office  of Diversion Control conducts a variety of activities such as establishing  quotas on the total amount of each basic class of controlled substance  that can be manufactured, promulgating regulations for handling  controlled substances, regulating handlers of controlled substances, and  monitoring the production and distribution of certain controlled  substances, among other things.
The CSA requires businesses, entities, or individuals that import, export,  manufacture, distribute, dispense, conduct research with respect to, or  administer controlled substances to register with the DEA. As of  December 2014, along with other registrants, there were over 1.5 million  registered distributors, pharmacies, and practitioners. (See table 1.)
DEA registrants must comply with a variety of requirements imposed by  the CSA and its implementing regulations. For example, a registrant must  keep accurate records and maintain inventories of controlled substances,  among other requirements, in compliance with applicable federal and  state laws. Additionally, all registrants must provide effective controls and  procedures to guard against theft and diversion of controlled substances.  Examples of some of the specific regulatory requirements for distributors,  pharmacists, and practitioners include the following:
Distributors: Registrants must design and operate a system to  disclose suspicious orders of controlled substances, and must inform  the DEA field division office in the registrant’s area of suspicious  orders when the registrant discovers them.
Pharmacists: While the responsibility for proper prescribing and  dispensing of controlled substances rests with the prescribing  practitioner, the pharmacist who fills the prescription holds a  corresponding responsibility for ensuring that the prescription was  issued in the usual course of professional treatment for a legitimate  purpose.
Practitioners: Practitioners are responsible for the proper prescribing  and dispensing of controlled substances for legitimate medical uses.  A prescription for a controlled substance must be issued for a  legitimate medical purpose by an individual practitioner acting in the  usual course of that person’s professional practice.
As part of the registrant monitoring process and to ensure compliance  with the CSA and its implementing regulations, DEA conducts three types  of investigations—regulatory, complaint, and criminal.
Regulatory investigations: DEA conducts different types of  regulatory investigations, including scheduled, or cyclic, investigations  (inspections) of DEA registrants.conducted at a frequency depending on the registrant’s business  activity, and occur every 2, 3 or 5 years. Registrants such as  physicians—with the exception of physicians permitted to treat  narcotic dependence—generally do not receive scheduled  investigations by the DEA. These registrants may be regularly  investigated by the states in which they conduct business.
Complaint investigations: Complaint investigations are started on  the basis of information or a tip provided to DEA or state regulators, or  other information DEA has regarding the diversion of controlled  substances. The origin of the information could be from any number of  sources, such as a state or local official or citizen who observed  something suspicious, employees of a registrant, the identification by  DEA of unusual purchasing trends by a registrant such as a pharmacy  that is tracked through DEA’s Automation of Reports and  Consolidated Orders System (ARCOS), or a report to DEA of a loss of  controlled substances by a registrant.
Criminal investigations: DEA also conducts investigations into  criminal activities involving diversion of controlled substances that  may involve DEA registrants or nonregistrants, such as an undercover  purchase of a controlled substance from an individual who is not a  registrant.
Within its 21 field divisions, DEA utilizes a variety of personnel (including  diversion investigators, special agents, and task force officers) to carry  out these investigative responsibilities.
Following an investigation, DEA can initiate a variety of enforcement  actions for violations of the CSA or its implementing regulations— administrative, civil, and criminal. The type(s) of action initiated is within  DEA’s discretion and is typically driven by the severity of the offense(s)  and whether a registrant was the subject of any previous actions. The  penalties associated with different enforcement actions likewise vary in  severity.
Administrative actions: Administrative actions are handled primarily  by DEA and can include (1) a letter of admonition to advise the  registrant of any violations and necessary corrective action, (2) a  memorandum of agreement which outlines things the registrants  agree to do to become compliant and obligations of DEA when  violations are corrected or not corrected, (3) an order to show cause  that can initiate revocation or suspension of a DEA registration, and  (4) an immediate suspension order that is issued when violations  pose an imminent threat to public health or safety, and deprive the  registrant of the ability to handle controlled substances upon service  of the suspension order.
Civil penalties: Civil penalties generally include monetary fines.
Criminal penalties: Criminal penalties generally include incarceration  and fines.
section_title: States’ Roles in the Regulation of Controlled Substances and Health Care
paragraphs: Each state has a role in regulating controlled substances and health care  within its jurisdiction. For example, as of December 2014, 49 states and  one U.S. territory (Guam) have operational prescription drug monitoring  programs, which collect data from dispensers and report information to  authorized users, including practitioners and pharmacists. Prescription  drug monitoring program information can assist law enforcement and  health care providers such as practitioners and pharmacists in identifying  patterns of prescribing, dispensing, or receiving controlled substances  that may indicate abuse or diversion. State prescription drug monitoring  programs vary in numerous ways, including what information they collect;  what drugs they cover; who has access to, or who is required to use, the  prescription drug monitoring program; and which state agency oversees  and administers the program.
States also govern the use of controlled substances through their own  state controlled substances acts, and through the regulation of the  practices of medicine and pharmacy. In general, to legally dispense a  prescription drug, a pharmacist licensed by the state and working in a  pharmacy licensed by the state must be presented a valid prescription  from a licensed practitioner. The regulation of the practice of pharmacy is  rooted in state pharmacy practice acts and regulations enforced by state  boards of pharmacy. The state boards of pharmacy also are responsible  for routinely inspecting pharmacies, ensuring that pharmacists and  pharmacies comply with applicable laws, and investigating and  disciplining those that fail to comply. All states also require that physicians  practicing in the state be licensed to do so and state medical practice  laws generally outline standards for the practice of medicine and delegate  the responsibility of regulating physicians to state medical boards. Each  state’s medical board also defines the elements of a valid patient-provider  relationship, and grants prescribing privileges to physicians and other  practitioners.
section_title: National Associations’ Roles in Efforts to Reduce Prescription Drug Abuse and Diversion
paragraphs: National associations also play a role in efforts to reduce prescription  drug abuse and diversion. National associations represent the interests of  their members or constituents, which can include DEA registrants, such  as pharmacies, practitioners, and distributors; various state governmental  agencies or employees, such as state regulatory boards and law  enforcement entities; and patient groups, among others. These national  associations may support their members in various ways, such as  providing guidance and training to help educate members about abuse  and diversion; commenting on proposed legislation, such as proper  disposal of prescription drugs; and lobbying on behalf of their members or  constituents to federal agencies and members of Congress.
section_title: 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
paragraphs: 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. Of those registrants that reported that they had interacted with  DEA since January 1, 2012, most were generally satisfied. However,  some distributors, individual pharmacies, and chain pharmacy corporate  offices reported that they want additional guidance from, and  communication with, DEA.
We surveyed registrants about three primary methods for interacting with  DEA—direct communication with DEA headquarters or field office staff;  participation in DEA conferences, initiatives, or training; and utilization of  DEA resources, such as guidance. Our survey results show that  registrants interact with DEA through these methods to varying degrees,  and that many registrants are not aware of DEA conferences and  resources.
Communication with DEA headquarters or field office staff. Based on  our surveys, we found that the most common type of interaction between  DEA and its registrants is direct communication with DEA headquarters or  field office staff about registrants’ roles and responsibilities under the  CSA. Most distributors and chain pharmacy corporate offices  communicate with DEA headquarters or field office staff, while few  individual pharmacies or practitioners do so. (See table 2.) Registrants  that reported that they had no communication with DEA headquarters or  field office staff (outside of conferences, initiatives, or training) were  asked to explain why not. Of those that offered a response, one common  explanation was that the registrant did not feel any communication was  necessary.
Of those registrants that had communicated with DEA headquarters or  field office staff, the frequency of communication was typically less than  once a quarter, although we estimate that some distributors (22 percent)  and some chain pharmacy corporate offices (22 percent or 6 of 27) have  communicated with DEA field office staff at least once a month since  January 1, 2012. (See app. II, tables 12 and 13, for a complete listing of  the numbers of registrants reporting various frequencies of  communication with DEA headquarters and field office staff.) We did not  survey registrants about the content of these communications with DEA  headquarters or field office staff. However, the responses distributors,  chain pharmacy corporate offices, and individual pharmacies offered to  open-ended questions in these sections of our surveys suggest that the  substance of this communication is wide ranging. For example,  registrants cited communication with DEA ranging from inquiries about  regulatory responsibilities to questions about suspicious customers and  reporting of thefts. The most common methods of communication  reported across registrant types generally were telephone or e-mail  communication, although we estimate that most distributors (76 percent)  also have in-person communication with DEA field office staff. (See   app. II, table 14, for a complete listing of numbers of registrants reporting  various methods of communication with DEA headquarters and field  office staff.)
The reasons for greater communication with DEA among distributors and  chain pharmacy corporate offices may be related to the nature of their  relationship with DEA. For example, distributors are required to renew  their DEA registration annually, and are subject to scheduled, cyclical  regulatory investigations. Conversely, pharmacies and practitioners only  have to renew their DEA registration every three years, and are not  subject to scheduled, cyclical regulatory investigations. Because the  chain pharmacy corporate offices we surveyed represent 50 or more  individual pharmacies, it follows that they might have more regular  communication with DEA on behalf of those pharmacies.
Participation in conferences, initiatives, or training. Results from our  surveys show that smaller percentages of DEA registrants have  interacted with DEA via conferences, initiatives, or training (see table 3),  although many registrants are not aware of these opportunities.
DEA periodically hosts events such as conferences or meetings for  various components of its registrant population during which the agency  provides information about registrants’ CSA roles and responsibilities for  preventing abuse and diversion. DEA is also often a presenter at various  conferences at the national, state, or local level, which registrants may  attend. DEA places information about upcoming conferences that it is  hosting on its website, and DEA officials said that to further publicize  them DEA has sent emails or letters to registrants about these events, but  also relies on state regulatory boards and national associations to  promote them. Distributors were asked whether representatives of their  facility attended DEA’s 2013 Distributor Conference, and individual  pharmacies and chain pharmacy corporate offices were asked whether  they or other representatives of their pharmacy (or pharmacy chain) had  attended a Pharmacy Diversion Awareness Conference (PDAC).
Based on our surveys, we estimate that 27 percent of distributors and   17 percent of individual pharmacies have participated in the DEA-hosted  events, while 63 percent (20 of 32) of chain pharmacy corporate offices  we surveyed had participated in a PDAC. Of the large percentages of  distributors and pharmacies that did not participate in these conferences,  many cited lack of awareness as the reason. For example, an estimated  76 percent of individual pharmacies that had not attended a PDAC and   35 percent of distributors that had not attended the 2013 Distributor  Conference cited lack of awareness as a reason for not participating.  (See app. II, table 15 and table 16, for additional reasons reported by  distributors and pharmacies for not participating in these conferences.)  While it is possible that some individual pharmacies are not aware of  PDACs because one has not yet been scheduled or publicized in its  state, the 76 percent of individual pharmacies that cite lack of awareness  as a reason for not participating is a matter of concern since PDACs have  been held in 21 states since 2011.
Some distributors have also interacted with DEA through its Distributor  Initiative briefings, which are intended to educate and inform distributors  of their responsibilities under the CSA.12 percent of distributor facilities reported participating in these briefings  since January 1, 2012, of those that reported that they had not attended,  an estimated 12 percent said that a briefing had been attended by  corporate or other company staff, and 4 percent said they participated in  a briefing prior to 2012. (See app. II, table 15, for additional reasons  distributors reported for not participating in these briefings.)
We also asked all registrants whether they had participated in any other  DEA conferences, initiatives, or training since January 1, 2012, and small  percentages of registrants indicated that they had done so. (See table 3.)  In the open-ended responses offered about the other DEA events they  had attended, registrants across all four surveys cited, for example, DEA  presentations at various professional association conferences or  meetings they had attended.
Utilization of DEA resources. DEA also has created various resources,  such as guidance manuals and a registration validation tool, which  registrants may utilize to understand or meet their roles and  responsibilities under the CSA; however, based on our surveys, we found  that many registrants are not utilizing these resources because they are  not aware that they exist. (See table 4.) For example, DEA has created  guidance manuals for pharmacists and practitioners to help them  understand how the CSA and its implementing regulations pertain to  these registrants’ professions. These documents are available on DEA’s  Office of Diversion Control’s website. In terms of guidance for distributors,  in 2011 DEA released a document containing suggested questions a  distributor should ask customers prior to shipping controlled substances  (referred to as the Know Your Customer guidance). Additionally, DEA  offers a registration validation tool on its website so that registrants, such  as distributors and pharmacies, can determine if a pharmacy or  practitioner has a valid, current DEA registration.
However, as shown in table 4, our survey results suggest that many  registrants are not utilizing these resources that could help them better  understand and meet their CSA roles and responsibilities because they  are unfamiliar with them. For example, of particular concern are the  estimated 53 percent of individual pharmacies that are not aware of either  DEA’s Pharmacist’s Manual or the registration validation tool, and the   70 percent of practitioners that are not aware of DEA’s Practitioner’s  Manual, and are therefore not utilizing these resources.
In addition to the resources listed above, we also asked registrants  whether there were “any other DEA guidance, resources, or tools (e.g.  DEA’s Office of Diversion Control website or DEA presentations available  online)” that they had used to understand their roles and responsibilities.  We estimate that while nearly half of distributors (42 percent) and chain  pharmacy corporate offices (47 percent or 15 of 32) have used other DEA  resources, only small percentages of individual pharmacies (15 percent)  or practitioners (7 percent) have done so. Of those distributors and chain  pharmacy corporate offices that offered responses about what other DEA  resources they have used, usage of DEA’s website was the most  common response, with some distributors noting that they also refer to  published DEA regulations, and some chain pharmacy corporate offices  noting that they have referred to presentations from past DEA  conferences.
The lack of awareness among registrants of DEA resources and  conferences suggests that DEA may not have an adequate means of  communicating with its registrant populations. While DEA’s website  contains information and links for specific guidance, tools, and  conferences, if registrants are unaware that these types of resources  exist, they will not know to search DEA’s website for them. And although  DEA officials told us that many registrants should be familiar with DEA’s  website because that is where they renew their registration, a DEA official  estimated that about 14 percent of registrants register by paper, and  registration renewal is only required once every three years for  pharmacies and practitioners. Also, many of the registrants we surveyed  reported that they had not used other DEA resources such as DEA’s  website to understand their roles and responsibilities under the CSA. For  example, we estimate that 69 percent of individual pharmacies and   46 percent of distributors have not used other DEA resources such as  DEA’s website for this purpose. Therefore, while most registrants are  using DEA’s website to renew their registration, it is likely that registrants  responding to our survey did not consider this usage of DEA’s website an  activity that helped them understand their CSA roles and responsibilities.
Furthermore, while DEA has promoted some conferences via email, the  agency does not have current, valid email addresses for all of its  registrants. DEA reports that email addresses are not required  information for registrants, and that mailed correspondence to a  registrant’s address is the official method of communication. A DEA  official told us that while DEA has email addresses for the approximately  86 percent of registrants that renew their registration online, not all of  these email addresses may be current or valid. For example, the official  noted that because pharmacies and practitioners are only required to  renew their registration every three years, the email addresses for those  groups may be less accurate, as the registrant’s email address may have  changed during that time.
The standards in DEA’s Office of Diversion Control Customer Service  Plan for Registrants state that DEA will provide guidance regarding the  CSA and its regulations. Additionally, federal internal control standards  state that management should ensure there are adequate means of  communicating with stakeholders who may have a significant impact on  the agency achieving its goals. Despite the lack of awareness we found  that existed among registrants, DEA officials have indicated that they do  not believe they need to take any additional steps to improve  communication or raise registrants’ awareness of the agency’s  conferences and resources.
Other federal agencies use practices that may be useful to DEA to  increase registrants’ awareness of agency resources. For example, an  additional method for communicating with stakeholders that other federal  agencies, such as the Centers for Medicare & Medicaid Services (CMS)  and National Institutes of Health, have used is a listserv—an electronic  mailing list through which external stakeholders sign up to receive  information on various topics of interest. For example, the bottom right  corner of any page on CMS.gov has a link through which interested  parties can sign up to receive e-mail updates from CMS on a wide variety  of topics. DEA could examine the use of these or other communication  methods to help keep relevant registrant populations informed about  upcoming conferences, new or revised resources, or other materials or  activities that inform registrants about their responsibilities regarding the  CSA and its implementing regulations.
With so many registrants unaware of DEA’s conferences and resources,  DEA lacks assurance that registrants have sufficient information to  understand and meet their CSA responsibilities. If registrants do not meet  their CSA responsibilities, they could be subject to DEA enforcement  actions. However, since DEA officials reported that the agency’s goal is to  bring registrants into compliance rather than take enforcement actions  against them, additional communication with registrants about DEA’s  conferences and resources may help the agency better achieve this goal.
subsections: section_title: Most Registrants That Interacted with DEA Are Generally Satisfied, Although Some Distributors and Pharmacies Want Additional Communication and Guidance
subsections: section_title: Most Registrants That Interacted with DEA Were Generally Satisfied
paragraphs: Our survey results showed that while many registrants, particularly  individual pharmacies and practitioners, did not report any interaction with  DEA since 2012, most of those that did interact with DEA were generally  positive about those interactions. For example, of the registrants that  communicated with DEA headquarters or field office staff, most reported  that the communication was very or moderately helpful. (See table 5.)  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. However, some registrants reported dissatisfaction  with DEA communication. For example, 6 of 26 chain pharmacy corporate  offices that reported communicating with DEA field offices said that staff  were slightly or not at all helpful.
Similarly, when asked about DEA’s performance relative to certain  customer service standards, most of the registrants that reported  communicating with DEA headquarters or field office staff were positive  about their interactions with staff. DEA’s Office of Diversion Control  Customer Service Plan for Registrants has standards for interacting with  registrants, which include the following expectations:
Courteous and professional treatment from DEA personnel;
Responses to: written, electronic, or telephone inquiries; concerns  and criticisms; and complaints and suggestions to improve DEA  service, procedures, and performance; and
Discretion in handling sensitive information.
When asked about their interactions with DEA relative to these standards,  generally most registrants that communicated with DEA headquarters or  field office staff reported that staff were very or moderately responsive,  very or moderately courteous and respectful, and showed great or  moderate discretion when handling sensitive information. For example,  we estimate that 93 percent of distributors and 77 percent of individual  pharmacies found DEA field office staff very or moderately responsive to  their inquiries. (See app. II, table 17 through table 19, for a complete  listing of the number of registrants reporting perspectives on both DEA  headquarters and field office staff on these three standards.) Ratings  were similarly positive for both DEA headquarters and field office staff,  although distributors and chain pharmacy corporate offices more often  reported having made inquiries to DEA field office staff than DEA  headquarters staff.
Finally, related to DEA conferences, initiatives, or training, while most  registrants other than chain pharmacy corporate offices had not attended  such events, the most frequent response among registrants that reported  attending was that these events were very or moderately helpful for  understanding their CSA roles and responsibilities. (See app. II, table 20.)
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. Similarly, many distributors (29 of 40) that  reported attending DEA’s October 2013 Distributor Conference said that it  was very or moderately helpful, although a smaller but notable number of  distributors (11 of 40) that attended reported that the conference was  slightly or not at all helpful. Criticisms of the 2013 Distributor Conference  that were offered by distributors in their open-ended responses included  the presentation of outdated or previously shared information, and that  the information shared was too general and did not provide the specific  guidance registrants were expecting.
section_title: Some Distributors Want Additional Guidance and More Communication
paragraphs: Some survey responses indicate that additional guidance for distributors  regarding suspicious orders monitoring and reporting, as well as more  regular communication, would be beneficial. For example, while DEA has  created guidance manuals for pharmacists and practitioners, the agency  has not developed a guidance manual or comparable document for  distributors. As noted previously, standards in DEA’s Customer Service  Plan for Registrants include providing guidance regarding the CSA and its  regulations, and internal control standards for federal agencies state that  management should ensure there are adequate means of communicating  with stakeholders that may have a significant impact on the agency  achieving its goals.
In response to an open-ended question in our survey about how DEA  could improve its Know Your Customer document, the guidance  document DEA has provided to distributors, half of distributors (28 of 55)  that offered comments said that they want more guidance from DEA.  Additionally, just over one-third of distributors (28 of 77) reported that  DEA’s Know Your Customer document was slightly or not at all helpful.(See app. II, table 21 for a complete listing of registrant responses on the  helpfulness of various DEA resources.) Furthermore, in response to an  open-ended question about what additional interactions they would find  helpful to have with DEA, more than half of the distributors that offered  comments (36 of 55) said that they needed more communication or  information from, or interactions with, DEA. Some of the specific  comments noted that distributors would like more proactive  communication from DEA that is collaborative in nature, rather than being  solely violation- or enforcement-oriented. Some of the additional  communication and interactions proposed by distributors included  quarterly meetings with the local field office and more training or  conferences related to their regulatory roles and responsibilities.
DEA officials told us that they believe the information in agency  regulations is sufficient for distributors to understand their CSA  responsibilities for suspicious orders monitoring and reporting. DEA  officials said that they have not created guidance manuals for distributors  similar to what they have done for pharmacies and practitioners because  they meet routinely with distributors and distributors have fewer  requirements compared to those other registrant types and officials don’t  believe such guidance is necessary. Additionally, DEA officials said that  while distributors want specific instructions on how to avoid enforcement  actions, DEA cannot do that because circumstances that lead to  enforcement actions (e.g., individual business practices) vary. DEA  officials said that distributors must make informed business decisions  regarding customers that are diverting prescription drugs, and that DEA  cannot tell distributors not to ship to specific customers. Officials told us  that they would advise distributors to know their customers and their  typical orders so that they’ll be able to identify unusual or suspicious  orders or purchasers. DEA officials also suggested that distributors  should refer to the enforcement actions against distributors that are  described on DEA’s website in order to learn “what not to do.” Regarding  their communication with registrants, DEA officials also indicated that they  do not think they need to make any changes in their practices. They said  that they believe that they are accessible to any registrant, and that  registrants can contact either DEA headquarters or field office staff if they  have questions.
A guidance document for distributors similar to the one offered for  pharmacies and practitioners could help distributors further understand  and meet their roles and responsibilities under the CSA for preventing  diversion, though the document may not need to be as detailed.  Specifically, although DEA may not be able to provide guidance that will  definitively answer the question of what constitutes a suspicious order or  offer advice about which customers to ship to, DEA could, for example,  provide guidance around best practices in developing suspicious orders  monitoring systems. DEA could also enhance its proactive  communication with distributors—which could be done, for example, via  electronic means if additional in-person outreach would be cost  prohibitive. Such steps are key to addressing distributors’ concerns, as  without sufficient guidance and communication from DEA, distributors  may not be fully understanding or meeting their roles and responsibilities  under the CSA for preventing diversion. Additionally, in the absence of  clear guidance from DEA, our survey data show that many distributors   are setting thresholds on the amount of certain controlled substances that  can be ordered by their customers (i.e., pharmacies and practitioners),  which can negatively impact pharmacies and ultimately patients’ access.  For example, we estimate that 62 percent of individual pharmacies do  business with distributors that put thresholds on the quantity of controlled  substances they can order, and we estimate that 25 percent of individual  pharmacies have had orders cancelled or suspended by distributors.
section_title: Some Pharmacies Want Improved Guidance and More Communication from DEA
paragraphs: Responses to our surveys also show that some pharmacies want updated  or clearer guidance, as well as more communication and information,  from DEA. The agency has provided a guidance manual for pharmacists,  and of the pharmacies that were aware of DEA’s Pharmacist’s Manual,  most said that it was helpful. For example, most individual pharmacies  (54 of 68) that were aware of the manual found it very or moderately  helpful. (See app. II, table 21.) However, DEA’s Pharmacist’s Manual was  last updated in 2010, and since that time DEA has levied large civil fines  against some pharmacies; some pharmacy associations reported these  fines have caused confusion in the industry about pharmacists’ CSA roles  and responsibilities. As noted previously, DEA’s customer service plan  standards call for the agency to provide guidance regarding the CSA and  its regulations, and federal internal control standards call for adequate  communication channels with stakeholders. In their responses to an  open-ended question in our survey about DEA’s Pharmacist’s Manual,  some chain pharmacy corporate offices (7 of 18) said that the manual  needed updates or more detail, some chain pharmacy corporate offices  (5 of 18) reported other concerns with the manual, and some individual  pharmacies (13 of 33) said that the manual needed improvement, such as  more specifics. For example, several chain pharmacy corporate offices  commented that the manual needed to be updated to reflect changes in  DEA enforcement practices or regulations (e.g., the rescheduling of  hydrocodone from a schedule III to a schedule II drug).
The need for clearer guidance for pharmacists was also suggested by  some chain pharmacy corporate offices’ responses to a question about  DEA field office consistency. Specifically, when asked how consistent the  responses of staff in different field offices have been to their inquiries  about pharmacists’ roles and responsibilities, nearly half of chain  pharmacy corporate offices (8 of 19) that had contact with multiple DEA  field offices said that staff responses were slightly or not at all consistent.  (See app. II, table 22.) In an open-ended response to this question, one  chain pharmacy corporate office noted that in its interactions with different  DEA field offices throughout the country it has received different, widely  varying interpretations of DEA requirements that affect the chain’s day-to- day operations, such as requirements for theft/loss reporting of controlled  substances and requirements for prescribers to be reported when the  prescriber fails to provide a written prescription. These responses from  chain pharmacy corporate offices about field office inconsistencies  suggest that the existing pharmacy guidance may not be clear even to  some DEA field office officials.
Additionally, the desire for more or clearer guidance and more  communication from DEA was a common theme in the responses offered  from both individual pharmacies and chain pharmacy corporate offices to  the open-ended questions in our survey related to DEA interactions. For  example, in response to an open-ended question about what additional  interactions they would find helpful to have with DEA headquarters or field  office staff, nearly all of the chain pharmacy corporate offices that offered  comments (15 of 18) said that they wanted more guidance or clearer  interpretation of the guidance from DEA, more communication with DEA,  or a more proactive, collaborative relationship with DEA. In addition,  nearly a third of individual pharmacies (18 of 60) that offered open-ended  answers to a question about any new guidance, resources, or tools that  DEA should provide to help them understand their roles and  responsibilities said that they would like more proactive communication  from DEA through methods such as a newsletter or e-mail blast. Some  chain pharmacy corporate offices (7 of 17) and individual pharmacies (11  of 33) also offered comments expressing a desire to receive up-to-date  information on data or trends in diversion of prescription drugs from DEA.  The majority of pharmacy registrants that reported having seen DEA data  on trends in prescription drug abuse and diversion found the information  to be very or moderately helpful for understanding how to identify  common abuse and diversion tactics (43 of 57 individual pharmacies and  23 of 25 chain pharmacy corporate offices), suggesting that information of  this kind could be very helpful to pharmacy registrants if it was more  widely distributed. (See app. II, table 21.)
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.  DEA officials said that registrants can write, call, or e-mail DEA  headquarters or field offices if they have questions. Officials also said that  the agency has reached out to pharmacy registrants via their PDACs;  however, because DEA had held only 44 PDACs in 21 states between  2011 and 2014, many pharmacy registrants had not had the opportunity  to attend these conferences. Additionally, in their open-ended responses  to questions in the section of our survey about DEA conferences, several  individual pharmacies also cited their distance from the cities in which  training is often held as their reason for not attending, with one individual  pharmacy suggesting that a web-based training option would be helpful.
Regarding the concern about inconsistencies in responses among DEA  field offices related to inquiries about pharmacies’ roles and  responsibilities under the CSA, DEA headquarters officials said that they  have heard this concern in the past, but when they ask for specific  examples of the conflicting information, registrants do not provide  specific, actionable details. DEA officials acknowledged that  interpretations can vary among different investigators and said that they  have provided training to their staff to ensure consistent interpretation of  regulations, including an annual conference and training of every  diversion investigator, to address this concern.
As indicated in the concerns expressed by some pharmacy registrants,  without clear guidance or adequate communication with and information  from DEA, these registrants may not fully understand or meet their  responsibilities for preventing abuse and diversion under the CSA.  Furthermore, without adequate communication with pharmacy registrants,  DEA may not fully understand registrants’ needs and how best to address  them. Additionally, in the absence of clear guidance from DEA, some  pharmacies may be inappropriately delaying or denying filling  prescriptions for patients with legitimate medical needs. For example, we  estimate that 22 percent of practitioners have had pharmacies delay filling  the prescriptions they wrote, and 13 percent of practitioners have had  pharmacies deny filling certain prescriptions for controlled substances.
section_title: State Agencies and National Associations Interact with DEA through Joint Task Forces or Meetings, and While Generally Satisfied, Some Associations Want Improved Communication
paragraphs: Officials from state agencies we interviewed told us that they interact with  DEA through law enforcement activities, such as joint task forces, and  other activities, while officials from national associations we interviewed  said that they most often interact with DEA by hosting and participating in  meetings. Nearly all state agencies and more than half of the national  associations told us that they were generally satisfied with their  interactions with DEA; however, some national associations wanted  improved communication with DEA.
subsections: section_title: State Agencies Interact with DEA through Law Enforcement Activities, Attending Joint Events, and Sharing Data, and Nearly All Were Satisfied with Their Interactions
paragraphs: Among the 16 state agencies we interviewed, 14 reported interacting with  DEA, most commonly through law enforcement activities (including joint  task forces, investigations, and inspections), meetings and presentations,  and sharing prescription drug monitoring program and other types of data  to help reduce prescription drug abuse and diversion. Nearly all state  agencies that reported interacting with DEA indicated that they were  satisfied with those interactions.
Methods of interaction with DEA. Of the 14 state agencies that  interacted with DEA, the most common method reported to us was  through law enforcement-related activities such as working together  during investigations, or collaborating on joint task forces to reduce  prescription drug abuse and diversion (11 of 14). For example, officials  from a state medical board reported that the board collaborated with DEA  on an investigation against a physician involving fraud and questionable  prescribing practices which resulted in several patients’ deaths.  Additionally, officials from eight state agencies we interviewed reported  working with DEA and other law enforcement agencies in a task force  setting such as with DEA Tactical Diversion Squads to investigate  criminal prescription drug diversion cases.
Most of the state agencies (11 of 14) also reported interacting with DEA  through attending the same conferences, meetings, presentations, or  workshops related to reducing prescription drug abuse and diversion.  Specifically, officials from three state agencies reported that they invited  DEA to present at an agency meeting; officials from another three state  agencies reported that they were invited to speak at DEA sponsored  events; and officials from three more state agencies reported they held  general meetings with DEA to discuss trends and best practices. Officials  from three state agencies also reported that their agencies jointly hosted  a conference related to prescription drug abuse and diversion with DEA.  Officials from some of the boards of pharmacy we interviewed reported  that their boards collaborated with DEA on the agency’s PDACs, such as  by sending emails about the PDACs to their pharmacists to encourage  participation, and by joining DEA in presentations about pharmacists’  corresponding responsibilities.
More than half of the state agencies (9 of 14) reported interacting with  DEA through sharing data, including sharing state prescription drug  monitoring program data and other data about suspicious prescribers,  pharmacies, or distributors. For example, an official from one state  prescription drug monitoring program noted that the program responded  to a request from DEA for its data related to a physician’s prescribing  history in order to support DEA’s investigation into a prescription fraud  ring in which the physician’s DEA registration number had been used.  Another state agency official reported that DEA shares its registrant  information with the state agency when information is needed for  investigative purposes.
A few state agencies (4 of 14) reported interacting with DEA through  promoting DEA’s prescription drug take-back events. According to DEA,  the purpose of its National Take-Back events is to provide a safe,  convenient, and responsible means of disposing prescription drugs, while  educating the public about the potential for abuse and diversion of  controlled substances. DEA has partnered with others such as state and  local law enforcement agencies to help with their take-back events. For  example, officials from one state agency reported that they conduct  outreach among local agencies about DEA’s prescription drug take-back  days and encourage participation from drug task forces in their state.  Furthermore, officials representing a state board of pharmacy and a state  law enforcement agency reported that they posted information about  DEA’s take-back events on their website, including locations collecting  the unwanted, unused medications.
Satisfaction with DEA interactions. Nearly all state agencies (13 of 14)  that reported interacting with DEA indicated that they were satisfied with  those interactions. For example, officials at some state agencies who  reported that they participated in DEA’s Tactical Diversion Squads or  other investigative activities with DEA found those interactions to be  positive and helpful—particularly as DEA provided access to additional  investigative tools and resources and intelligence they would not  otherwise have had access to. Furthermore, four state agencies we  interviewed stated that they are easily able to exchange information or  data with DEA, and officials have no problems in communicating and  collaborating with DEA. Officials from two state agencies noted that they  meet with DEA on a monthly or quarterly basis for presentations and to  discuss updated information. Officials said that during these meetings  they exchange recommendations and best practices for how to reduce  prescription drug abuse and diversion. Furthermore, officials from two  state agencies—both pharmacy boards—reported that DEA’s education  outreach efforts through its PDACs were positive and provided invaluable  information. Officials from one state board suggested that because the  PDACs held in their state have been so valuable, pharmacists should be  required to attend these conferences, and that they would encourage  DEA to offer more PDACs in their state.
One state board reported dissatisfaction with its interactions with DEA  related to DEA enforcement actions against pharmacists in the state, and  differences in how DEA field office staff and the state pharmacy board  interpret laws and regulations affecting pharmacists. Specifically, officials  from that state board said that while there is value in DEA enforcement  actions such as preventing harmful drugs from being diverted to illegal  sales, DEA enforcement actions have created fear among some  pharmacists, causing them to be overly cautious when dispensing  prescription drugs (e.g., by denying a prescription). Regarding the  different interpretation of laws and regulations, the state board officials  explained that there was inconsistent interpretation of laws and  regulations among DEA field offices, which caused confusion among the  board and pharmacists. The board officials said that they contacted DEA  for clarification, but this has not resolved the issue.
section_title: Many National Associations Interact with DEA, Mostly through Meetings, and While More than Half Were Satisfied Some Want Improved Communication
paragraphs: Of the 26 national associations we interviewed, 24 reported interacting  with DEA most commonly through hosting or participating in meetings,  providing input and comments on regulations, and supporting federal drug  disposal efforts to help reduce prescription drug abuse and diversion.  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.
Methods of interaction with DEA. Of the 24 national associations that  interacted with DEA, many reported that they participate in meetings with  DEA to obtain and share information related to prescription drug abuse   Specifically, more than half (15 of 24) of the national  and diversion.associations that interacted with DEA reported that they have hosted  meetings in which DEA was invited to be a speaker or participated in  meetings where DEA was present. For example, officials from six national  associations reported that they invited DEA to their meetings to discuss  issues such as changes in regulations or trend data on prescription drug  abuse. National associations also interact with DEA as part of larger,  national meetings. For example, officials from four national associations  reported interacting with DEA by attending the same meetings such as  the National Prescription Drug Abuse Summit and Pain Care Forum,  where DEA was a presenter. They reported that during these meetings  DEA officials discussed such things as best practices for reducing  prescription drug abuse and diversion, legitimate prescribing, and patient  access to legitimate drugs.
National associations also reported that they have interacted with DEA by  providing input or comments on proposed regulations. For example,  officials from six national associations we interviewed reported interacting  with DEA by providing comments or feedback on DEA’s proposed drug  disposal rule.(12 of 24) we interviewed reported supporting or participating in DEA’s  prescription drug take-back events. According to officials from four of  these national associations, they helped promote the take-back events by  publicizing the events on their website for their members and two  associations arranged for the collection of unwanted medication from the  public.
Additionally, officials from half of the national associations  Satisfaction with DEA interactions. While some national associations  (7 of 24) did not comment on whether they were satisfied with how they  interact with DEA, most of those that did indicated that they were  generally satisfied with those interactions. Specifically, of the 17 national  associations that commented about their satisfaction with their  interactions with DEA, 10 indicated that they were generally satisfied,  while 7 indicated that they were generally dissatisfied.
Of the national associations that indicated they were generally satisfied,  some noted that the information shared by DEA officials during meetings,  particularly about trends in prescription drug abuse and diversion, has  been helpful, as were DEA’s prescription drug take-back events.  According to officials from three national associations we interviewed, the  trend information they receive from DEA has been helpful in  understanding what is happening in different regions related to  prescription drug abuse and diversion. Regarding DEA’s prescription drug  take-back events, officials from a national association reported that the  take-back events help to reduce the number of drugs in people’s  medicine cabinets, which may reduce potential misuse or abuse. One  national association that indicated it was generally satisfied with its  interactions with DEA also said that it would like to have more  communication from DEA. For example, an official from this national  association reported that it would be helpful if DEA would provide some  type of communication and information that could serve as a checklist of  things the association and its members should be aware of, such as tips  and trends related to transporting pharmaceuticals.
Among the concerns cited by the seven national associations that were  generally dissatisfied with their DEA interactions was insufficient  communication and collaboration from DEA. For example, officials from  five national associations reported that as prescription drug abuse has  increased, DEA has been less collaborative, and officials from two  associations noted that DEA refused to meet with them to clarify issues  related to their members’ CSA responsibilities. DEA officials told us that  they did not believe the agency had turned down any requests from  associations that wanted to meet, though they acknowledged they were  aware that one national association in particular has not been satisfied  with DEA and has said that DEA has cut off communications. DEA  officials said that the agency communicates with the registrants that this  particular association represents, and these registrants should contact  DEA directly about any questions related to their roles and  responsibilities. Nonetheless, because 4 of the 7 dissatisfied associations  indicated that the additional communication they want to have with DEA  relates to the CSA roles and responsibilities of their members, improved  communication with and guidance for registrants may address some of  these associations’ concerns.
section_title: Many Stakeholders Believe DEA Enforcement Actions Have Helped Decrease Prescription Drug Abuse and Diversion, but May Also Have Limited Legitimate Access
paragraphs: Many of the DEA registrants we surveyed and other stakeholders we  interviewed reported that they believe DEA enforcement actions have  helped decrease prescription drug abuse and diversion. Nonetheless,  over half of DEA registrants reported changing certain business practices  as a result of DEA enforcement actions or the business climate these  actions may have created, and many of these registrants reported that  these changes have limited access to prescription drugs for patients with  legitimate medical needs.
subsections: section_title: Many Stakeholders Believe DEA Enforcement Actions Have Helped Decrease Abuse and Diversion, Although Some Are Uncertain about Effects
paragraphs: While the majority of DEA registrants have not had DEA enforcement  actions taken against them, we estimate that between 31 and 38 percent  of registrants that we surveyed, depending on the registrant group,  believe DEA enforcement actions have been very or moderately helpful in  decreasing abuse and diversion. However, 53 percent of chain pharmacy  corporate offices (17 of 32) believe DEA enforcement actions were  slightly or not at all helpful and other registrants reported not knowing  whether DEA’s efforts had an effect, such as practitioner registrants  where we estimate that 47 percent don’t know the effect of enforcement   actions. (See table 6.)
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. For example, an official from a state law enforcement  agency said that DEA’s enforcement efforts had been very helpful in that  state, particularly as DEA provided the state with additional resources and  worked with local law enforcement. In addition, an official from a national  association said that the association has heard from its members how  helpful DEA has been in working with some of the statewide and local  task forces on diversion-related investigations. An official from another  national association said that DEA’s enforcement actions have caused  some companies to make changes to their corporate practices that have  a positive effect on decreasing abuse and diversion. While several of the  national associations and state agencies we interviewed said that DEA  enforcement actions may be reducing prescription drug abuse and  diversion, some are concerned about a resulting substitution of other  illegal drug use. For example, officials from one state law enforcement  agency said that they are seeing evidence of the reemergence of heroin  usage as the availability of prescription drugs has gone down and their  cost has gone up.
In addition to obtaining stakeholders’ perspectives on how DEA  enforcement actions have affected abuse and diversion of prescription  drugs, we reviewed data on DEA enforcement actions and investigations  from fiscal year 2009 through fiscal year 2013 to identify any trends in  DEA activities. Our analyses showed that certain types of administrative  enforcement actions—administrative enforcement hearings, letters of  admonition, and memoranda of agreement—increased across all  registrants during this time period while other administrative enforcement  actions—orders to show cause and immediate suspension orders— decreased. Scheduled regulatory investigations also increased during this  time period for diversion-related cases, particularly for pharmacy and  practitioner registrants. (See app. III for data on DEA enforcement actions  and investigations.) Officials from DEA’s Office of Diversion Control told  us that DEA shifted its work plan in 2009 to put more emphasis on  regulatory investigations with the goal of bringing registrants into  compliance with the CSA. The officials said the increase in DEA’s  scheduled regulatory investigations during this period may have helped  identify areas in which registrants needed to improve and make changes  to be in compliance with their responsibilities under the CSA. They also  said that the increase in letters of admonition explains why there was not  an increase of orders to show cause or immediate suspension orders,  which are more severe penalties. Officials said that DEA considers letters  of admonition as a way to help registrants comply with CSA requirements,  and if registrants comply, this may help reduce diversion. The officials  added that this increase shows that DEA’s enforcement efforts are being  resolved cooperatively with its registrants, and that as a result DEA has  less need to impose harsher penalties on its registrants. However, data  are not available to show any direct link between DEA enforcement  actions or investigations and decreases in abuse and diversion. In a  previous report, we recommended that DEA enhance its performance  measures to better track and report on the results its enforcement actions  had on reducing diversion of prescription drugs.stated that it is impossible to measure the lack of diversion, and that  enforcement actions help to prevent future diversion, among other things.
section_title: Many Registrants Have Changed Certain Business Practices as a Result of DEA Enforcement Actions and Reported These Changes Have Limited Legitimate Access
paragraphs: 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   71 percent of individual pharmacies increased the number of contacts  made to prescriber’s offices to verify legitimate medical need for  prescriptions, and 75 percent of these pharmacies attributed this change  to a great or moderate extent to DEA enforcement actions or the business  climate those actions have created. (See app. II, tables 23 through 26 for  complete data for all four registrant types.)
Some business practice changes may help reduce prescription drug  abuse and diversion. For example, in their open-ended responses,  several practitioners said that they appreciated getting phone calls from  pharmacies verifying the legitimacy of prescriptions because it helped  make the practitioner more aware of potential abuse. However, many  registrants reported that some of these changes had limited access to  prescription drugs for patients with legitimate medical needs. (See table 7  below, and app. II, tables 27 through 30 for additional data.) 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. Regarding specific enforcement actions that DEA  has taken, in 2011, three distributors agreed to pay fines totaling more   than $58 million and, in 2013, two distributors agreed to pay fines totaling  more than $80 million, which some registrants and one national  association suggested could be influencing distributors’ decisions to place  thresholds on orders. (See app. III for additional data on civil fines.) 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. (See table 7.)
In their open-ended responses to our survey, some registrants expanded  upon how DEA enforcement actions have affected their business  practices, and subsequently affected patient access. A chain pharmacy  corporate office reported that pharmacists are afraid of being the target of   DEA enforcement actions even if they fill a prescription in good faith and  with good judgment. Instead of erring on the side of a patient when  considering filling a prescription, the chain pharmacy corporate office said  that pharmacists are taking actions to try to protect their DEA registration  that come at the expense of the patient. For example, one individual  pharmacy reported that it turned away patients without taking steps to  verify whether a controlled substance prescription was legitimate because  the pharmacy could not serve new controlled substance patients without  risking being cut off by its distributor. This pharmacy said that DEA has  clearly stated that it is not calling for distributor cutoffs (i.e., thresholds),  but their distributors have communicated that these changes are made  because of fear of DEA enforcement actions, which has led many  pharmacies to refuse to fill legitimate prescriptions. A distributor reported  it refuses to distribute large volumes of controlled substances to  prescribers or pharmacies that specialize in pain management, even if it  has no evidence that the prescribers or pharmacies are engaged in  diversion. This distributor said that DEA has stated that the agency would  hold distributors accountable for diversion that occurs at the prescriber  and pharmacy level. Therefore, according to this distributor, supplying a  large volume of controlled substances to customers with a pain  management practice creates too great a risk of being the target of a DEA  enforcement action for them to continue to service such requests.  Further, several individual pharmacies expressed concern in their open- ended responses that certain business practices, such as distributors  placing thresholds on their orders for controlled substances, have  affected their ability to care for patients by limiting access to these drugs.
A few national associations also spoke of indirect effects resulting from  the business climate that enforcement actions have created, which could  ultimately result in limiting access for legitimate needs. For example, one  national association said that following a large DEA fine against one  distributor, and in the absence of clear DEA guidance, distributors  became concerned about how to determine that an order is suspicious.  Therefore, distributors elected to arbitrarily set thresholds for the amount  of controlled substances pharmacies could order. In addition, an official  from another national association said that prescribers find it difficult to  address the questions from pharmacists about patients’ need for certain  prescription medication and this affects the prescriber’s time in providing  care to the patients and could affect patient access to certain medication.
Of the national associations and state agencies we interviewed that  offered a perspective on the potential for limited access, more than half  (19 of 28) expressed concern that DEA’s enforcement actions have  limited access to these drugs for legitimate medical needs. For example,  officials from one state agency said that DEA has taken actions against  pharmacists in that state that has caused concerns among some  pharmacists resulting in instances where legitimate patients with a  legitimate prescription are being denied access to prescription drugs.
However, DEA officials in the four DEA field office divisions we spoke with  said that they generally did not think that their enforcement actions have  had a negative effect on access, and headquarters officials from DEA’s  Office of Diversion Control indicated that they did not believe their  enforcement actions had any bearing on access issues. DEA field office  officials said that they have rarely heard about any access concerns,  although neither DEA field office nor headquarters officials indicated that  they have taken steps to obtain any information about the extent of  access issues. DEA headquarters officials said that they could not tell a  distributor that a pharmacy is ordering too many controlled substances;  there are no federal quotas on these orders. Additionally, DEA  headquarters officials said that if access is limited the patient should  contact his or her state pharmacy association and explain the situation  and that the state pharmacy board could intervene. DEA headquarters  officials also told us that if a pharmacy is unable to fill a prescription  because distributor thresholds have limited the amount of drugs the  pharmacy has available to fill prescriptions, that pharmacy should help  the patients find another pharmacy where they can get the medications,  as they should in any case in which the pharmacy could not fill a  prescription. However, while DEA’s recommendation may be valid for  some patients, it does not take into account that certain patients could  experience hardships in trying to find another pharmacy to get their  prescription filled. For example, patients living in rural areas may have a  limited number of pharmacies nearby, and some patients, such as those  with cancer, may be too ill to travel to different pharmacies for their  medications.
As previously noted, internal control standards for federal agencies state  that management should ensure there are adequate means of  communicating with stakeholders that may have a significant impact on  the agency achieving its goals. If access issues to prescription drugs for  patients with legitimate medical needs are resulting from DEA registrants  being unclear about their roles and responsibilities under the CSA, and  registrants have not proactively raised concerns about access issues  directly with DEA, more regular communication with its registrants, as  previously discussed, could provide the agency with more opportunities to  obtain registrants’ input regarding concerns about access issues. Further,  more regular communication between DEA and its registrants, including  clearer guidance, could help to mitigate registrants’ fears of taking actions  that would make them targets of DEA enforcement actions and  investigations, and help registrants make business decisions that balance  ensuring that patients have access to needed medications with controlling  abuse and diversion.
section_title: Conclusions
paragraphs: The magnitude of the prescription drug abuse problem, including high  rates of overdose deaths, requires a response from all levels of  government, industry, and other stakeholders. And while many federal  agencies have important responsibilities in addressing prescription drug  abuse and diversion, DEA plays a key role because it administers and  enforces the CSA, and in doing so interacts with a wide range of  nonfederal entities that are stakeholders in the prescription drug supply  chain. 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. More  DEA communication with registrants could help improve their awareness  of various DEA resources, as well as help DEA better understand  registrants’ information needs, such as their need for improved guidance.  While providing additional guidance to registrants—particularly  distributors and pharmacies—about their CSA roles and responsibilities  cannot ensure that registrants are meeting them, by doing so DEA will  have a greater assurance that registrants understand their CSA  responsibilities. Additionally, DEA has stated that its goal is bringing  registrants into compliance rather than taking enforcement actions, and  DEA can move closer towards this goal by improving its communication  and information sharing with registrants, consistent with federal internal  controls standards.
section_title: Recommendations for Executive Action
paragraphs: 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, we recommend that  the Deputy Assistant Administrator for the Office of Diversion Control take  the following three actions:  Identify and implement means of cost-effective, regular  communication with distributor, pharmacy, and practitioner registrants,  such as through listservs or web-based training.
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.
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.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft copy of this report to the Department of Justice for its  review and DEA’s Office of Diversion Control provided written comments,  which are reproduced in full in appendix IV. 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.
In addition to providing comments on the recommendations, DEA also  commented on other aspects of our draft report, including some of the  results and conclusions from our surveys, and referred to some survey  results as anecdotal data. Because our surveys were designed and  conducted to produce reliable and generalizable estimates, we are  confident that our survey results accurately represent the perspectives of  registrants about their interactions with DEA and their concerns about  their roles and responsibilities under the CSA. We are also confident that  the conclusions we drew from the survey results were reasonable and  appropriate.
Regarding our first recommendation to identify and implement means of  cost-effective, regular communication with distributor, pharmacy, and  practitioner registrants, DEA agreed that communication from DEA to the  registrant population is necessary and vital. The agency stated that it is in  the planning stages of developing web-based training modules for its  registrant population, to include training for pharmacists on their  corresponding responsibilities and potential training for manufacturers  and distributors to include ARCOS reporting and how to request a quota.  While DEA did not specifically mention developing training for distributors  on suspicious orders monitoring in its comments, our survey results  suggest that this type of training for distributors would also be helpful.  DEA also stated that it is considering implementing a listserv to  disseminate information on various topics to its registrants, including  information on cases involving diversion of controlled substances, and will  continue to explore other means of cost-effective communication with its  registrants. Additionally, while DEA agreed that communication with its  registrants is necessary and vital, it also suggested that registrants that  are not in frequent communication with the agency do not deem such  communication to be necessary and noted that its registrant community  has not broached the subject of additional guidance or communication.  However, our survey data show that registrants are not fully aware of  DEA conferences and resources and want additional guidance from, and  communication with, the agency. Therefore, we continue to believe that it  is DEA’s responsibility to reach out to its registrants, and believe that  doing so will help DEA better understand registrants’ information needs.
DEA raised concerns about our second recommendation to 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. DEA  stated that short of providing arbitrary thresholds to distributors, it cannot  provide more specific suspicious orders guidance because the variables  that indicate a suspicious order differ among distributors and their  customers. Instead, DEA highlighted regulations that require distributors  to design and operate systems to disclose suspicious orders. However,  according to DEA’s Customer Service Plan for Registrants, DEA is  responsible for developing guidance for registrants regarding the CSA  and its regulations, and the agency was able to create such guidance for  pharmacy and practitioner registrants. DEA also noted that it has steadily  increased the frequency of compliance inspections of distributors in  recent years. DEA stated that this has enabled the agency to take a more  proactive approach in educating its registrants and ensuring that  registrants understand and comply with the CSA and its implementing  regulations. While we agree that inspections provide registrants with an  opportunity for communication with DEA and may provide specific  information related to compliance with the CSA, we do not believe that  formal inspections provide registrants with a neutral educational setting in  which to obtain a better understanding of their CSA roles and  responsibilities. DEA also provided examples of how the agency has  provided additional information related to suspicious orders monitoring to  distributor registrants who participate in its Distributor Initiative briefings  and its distributor conferences. Therefore, we continue to believe that  DEA could provide additional written guidance for distributors that could  be more widely accessible to all distributor registrants. DEA did not  comment on whether it plans to solicit input from distributors, or  associations representing distributors, on developing additional distributor  guidance, and we continue to believe that obtaining input from these  parties would help DEA better understand distributors’ needs related to  their CSA roles and responsibilities.
With regard to our third recommendation to 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, DEA described actions it would take to  partially address the recommendation. Specifically, DEA stated that it  would work to update the Pharmacist’s Manual to reflect two subject  matter area changes made since the manual was last updated in 2010—  (1) the rescheduling of hydrocodone from schedule III to schedule II and  (2) the new rules on disposal of controlled substances. However, DEA did  not comment about providing any additional guidance to pharmacists  related to their roles and responsibilities in preventing abuse and  diversion under the CSA. Because our survey results showed that this  was a primary area of concern for individual pharmacies and chain  pharmacy corporate offices, we believe any updates to the Pharmacist’s  Manual should also include additional information specific to pharmacists’  corresponding responsibilities under the CSA. DEA also did not comment  on whether it plans to solicit input from pharmacists, or associations  representing pharmacies and pharmacists, on updating and revising  guidance for pharmacists; however, we continue to believe such input  would be beneficial for DEA to better understand its pharmacy registrants’  needs and how best to address them.
As agreed with your office, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies of this report to the Attorney  General, the Administrator of DEA, and other interested parties. In  addition, the report will be available at no charge on GAO’s website at  http://www.gao.gov.
If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or at kohnl@gao.gov. Contact points for our Office  of Congressional Relations and Office of Public Affairs can be found on  the last page of this report. Other major contributors to this report are  listed in appendix V.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: 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.
To address our first and third objectives, we administered four web-based  nationally representative surveys to the following three types of DEA  registrants: drug distributors, pharmacies, and practitioners. To further  address all three objectives we interviewed government officials from 16  agencies in four states (California, Florida, Kentucky, and New York),  officials at 26 national associations and nonprofit organizations (referred  to as “national associations” throughout this report), and officials at both  DEA headquarters and selected field offices. Finally, to help address our  third objective, we reviewed data on DEA’s enforcement actions from  fiscal year 2009 through fiscal year 2013 that were taken against DEA  registrants in the three categories that we included in our surveys  (distributors, pharmacies, and practitioners) to identify any trends in  DEA’s enforcement actions over a recent time period.
subsections: section_title: 2014 Surveys of Distributors, Individual Pharmacies, Chain Pharmacy Corporate Offices, and Practitioners
paragraphs: 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. The survey  was designed to collect detailed reports from registrants and make  generalizable estimates of the nature and extent of their interaction with  DEA programs and staff related to registrant responsibilities under the  CSA. The survey was also designed to measure registrant perceptions of  the impact of DEA enforcement actions on: their own business practices,  or the business climate in which they operate, as well as their  perspectives on whether enforcement actions have had an effect on  reducing abuse and diversion or on limiting patients’ access to  prescription drugs for legitimate medical needs.
Of the approximately 1.5 million DEA registrants as of January 2014, the  target populations for our survey were restricted to distributors,  pharmacies, and practitioners in specific business activity categories. We  selected these categories of registrants because they are the primary  DEA registrants in the prescription drug supply chain and are more likely  to be the focus of DEA enforcement actions than other categories of  registrants such as researchers or drug importers. Our target populations  were also restricted to those with an active registration status; eligible to  distribute, dispense, administer, or prescribe either Schedule II or III  drugs; and located in the continental United States. We used DEA’s CSA  Master File, as of January 13, 2014, to define the target populations, and  to create the listings from which we drew our survey samples. Our target  populations also excluded additional identifiable registrants outside the  scope of our review such as federal government registrants, veterinarians  or veterinary-oriented businesses, and research-oriented academic  registrants.
Distributors in our target population were restricted to those registrants  with the DEA business activity code F and subcode 0. Pharmacies were  restricted to those with activity code A and subcodes 0 (“Retail  Pharmacies”), 1 (“Central Fill Pharmacies”—later excluded from being  included in the survey sample if not part of a chain pharmacy  corporation), or 3 (“Chain Pharmacies”). Practitioners in our target  population were restricted to those with activity codes and subcodes  listed in table 8.
The total number of registrants in the DEA CSA Master File database that  we received, and the total number of registrants initially designated as  eligible for the target populations, prior to sampling, are listed in table 9.
In our interviews with national pharmacy associations and in our survey pretests with  selected chain pharmacies, we learned that the corporate offices of the larger chain  pharmacies generally interact with federal agencies and other groups on issues related to  prescription drug abuse and diversion as opposed to their individual pharmacy locations.  Therefore, we sent a separate survey to the corporate offices for the chain pharmacies  that we identified as having 50 or more registered stores so that the chain pharmacies  could answer our survey on behalf of all of their stores. practitioner registrants who were primarily in academic, federal  government, or veterinary practice, and those practitioners or distributors  that were no longer prescribing, administering, storing or handling  controlled substances. The resulting four target populations were:  distributors, individual pharmacies, chain pharmacy corporate offices, and  practitioners.
From the four target population lists, we drew simple random samples of  sufficient sizes (see table 11) to account for reductions due to  nonresponse, additional ineligibility, and the variability introduced by  sampling, to yield percentage estimates from survey questions  generalizable to each of the four populations with confidence intervals  (sampling error, or the margin of error) no wider than ±10 percentage  points at the 95 percent level of confidence. This planned level of  precision applied only to questions to be asked of the entire sample;  questions asked of only a subset of the sample would produce estimates  with wider confidence intervals.
We designed and tested four questionnaires, asking parallel questions  tailored to each of the four populations. We consulted with subject matter  experts in professional trade associations and survey methodologists,  and reviewed past surveys of these populations and subjects. We also  conducted cognitive interview pretests of draft versions of the  questionnaires with registrants from each population (three practitioners,  two distributors, one individual pharmacy, and two chain pharmacy  corporate offices), and obtained a quality review by a separate GAO  survey methodologist. Based on these developmental and evaluation  activities, we made changes to the four draft questionnaires before  administering them.
Each questionnaire focused on four primary topic areas, made up of  questions appropriate for the population:  1.  awareness, use, and rating of DEA guidance, resources, and tools for  understanding registrant responsibilities related to the CSA;  2.  nature, extent, and ratings of interactions with DEA headquarters or  field staff related to CSA responsibilities through DEA conferences,  initiatives, training, and other communication;  3.  interaction with other federal agencies; and  4.  impact of DEA enforcement actions on registrant business practices,  including opinions on the effect of DEA enforcement actions on drug  abuse and diversion and legitimate access to controlled substances.
Individual pharmacies were asked to respond to the survey on behalf of  their single pharmacy location that was selected in our sample,  regardless of its ownership status. Chain pharmacy corporate offices  were asked to respond to the survey on behalf of all of their registered  pharmacy locations.
The surveys were administered using a mixed-mode approach. Web  questionnaire format was the primary mode, and each of the surveys  used an initial data collection attempt using emailed username, password,  and link to a questionnaire website. When email addresses were not  available, or found to be nonworking, mail or phone contacts were made  to obtain emails, to direct registrants to the website, or, as a secondary  mode of response for practitioners and individual pharmacies, to fax or  mail paper versions of the questionnaires. For practitioners, of the 208  usable responses, 47 were received in paper format. For individual  pharmacies, of the 170 usable responses, 20 were received in paper  format.
A variety of contacts were made with each sample during survey  fieldwork. For practitioners and individual pharmacies, an advance letter  was mailed to all sampled registrants in late June and early July of 2014.  Telephone contacts were made before and during fieldwork to obtain  missing or incorrect contact information, encourage response, and  determine final outcomes such as ineligibility or refusal. Paper  questionnaires were mailed to nonresponding practitioner and individual  pharmacy registrants; letters with web survey login information were  mailed to distributors during the follow-up period. GAO staff made direct  contacts with chain pharmacy corporate offices to manage survey  administration. The key steps and dates of data collection are described  in table 10.
After the survey fieldwork period closed, the outcomes of the original  samples drawn were tallied. (See table 11.)
Each questionnaire, except for those sent to chain pharmacy corporate  offices, began with a filter question to determine whether the sampled  registrant had prescribed, dispensed administered, stored or handled  controlled substances in the approximately two years prior to the survey  (or, in the case of individual pharmacies, “currently”). This was known  with certainty for the chain pharmacy corporate offices, but some of the  respondents in the other registrant samples had not performed this  activity: 14 percent of practitioners, 11 percent of distributors, and   4 percent of individual pharmacies reported that they had not performed  this activity in the last two years, or currently. These respondents were  not asked the rest of the survey questions, which were only applicable to  the subset of 179 practitioners, 152 distributors, and 162 individual  pharmacies that had performed these activities recently.
We statistically adjusted, or weighted, survey results to multiply the  contribution of each responding member of the sample, to produce  estimates that represented the entire population. Weights greater than  one were applied to all but the chain pharmacy corporate office survey  results, which were not based on a sample, as that survey included all   38 members of the target population as we defined, each contributing a  weight of one.
Because we followed a probability procedure based on random  selections, our samples are only three of a large number of samples that  we might have drawn. As each sample could have provided different  estimates, we express our confidence in the precision of our particular  samples’ results as 95 percent confidence intervals (e.g., from x to   y percent). This is the interval that would contain the actual population  value for 95 percent of the samples we could have drawn. As a result, we  are 95 percent confident that each of the confidence intervals based on  our survey includes the true values in the sample population. Throughout  this report, the confidence intervals surrounding our estimates are no  more than plus or minus 10 percentage points, unless otherwise noted.
In addition to sampling error, questionnaire surveys are subject to other  potential errors: failure to include all eligible members in the listing of the  population, measurement errors when administering the questions,  nonresponse error from failing to collect information on some or all  questions from those sampled, and data processing error. We took steps  to limit each type of error. The DEA CSA Master File database we used to  create our listings of the populations was assessed as reliable and likely  the most comprehensive listing of DEA registrants. Our manual screening  and presurvey contacts with the original oversamples mitigated this  potential source of error. Our survey design, testing and evaluation steps  were intended to reduce measurement error. Because response rates for  practitioners and individual pharmacies fell below 80 percent, a level  generally accepted as an indicator of potentially increasing risk of bias  due to missing data, we performed nonresponse bias analyses to  determine whether those not responding would have answered in a  fundamentally different way on key questions we asked. Based on the  information available to us to compare respondents to nonrespondents,  we found no evidence of a difference on a characteristic that might  reasonably be expected to determine the propensity or nature of  response. Finally, all data processing and analysis programming was  verified by a separate data analyst, and sample and response tracking  datasets were independently reviewed.
We analyzed survey responses and compared them to federal internal  control standards related to information and communication and the  standards in DEA’s Office of Diversion Control Customer Service Plan for  Registrants.
section_title: Interviews with Officials in State Government Agencies, National Associations, and DEA
paragraphs: To further address our objectives, we interviewed government officials at  16 agencies in four states (California, Florida, Kentucky, and New York)  and officials at 26 national associations to obtain information about  interactions with DEA, their perspectives about those interactions, and  their views about the effects of DEA enforcement actions on abuse and  diversion and access to legitimate prescription medication. We selected  these four states based on the following criteria: (1) had varied drug  overdose death rates per 100,000 people based on 2010 CDC data,   (2) received federal grants for their prescription drug monitoring programs  in 2012 and 2013 from the Department of Justice’s Bureau of Justice  Assistance, and the Department of Health and Human Services’  Substance Abuse and Mental Health Services Administration,   (3) represented different geographic regions of the country (as  represented by DEA domestic field divisions), and (4) were among states  that were mentioned by national associations during our interviews as  having unique or innovative initiatives to address prescription drug abuse  and diversion. In each of the four states, we interviewed officials that  represented the state’s Controlled Substances Authority, pharmacy  board, medical board, law enforcement agency, and the agency that  oversees the state’s prescription drug monitoring program, for a total of  16 state agencies. The 26 national associations represented patients,  practitioners, pharmacies and pharmacists, distributors, state regulatory  authorities, state and local law enforcement, and drug manufacturers,  among other relevant stakeholder types. Although the perspectives we  obtained during the interviews with state agencies and national  associations are not generalizable, the interviews provided insights  regarding how these types of entities interact with DEA as well as  indicating common areas of concern.
We also obtained documents from and interviewed DEA Office of  Diversion Control officials who have oversight responsibility for DEA  registrants and are engaged in addressing prescription drug abuse and  diversion to learn about how DEA interacts with its registrants and other  nonfederal stakeholders, and to obtain DEA’s perspectives on information  we obtained from our survey results and interviews with nonfederal  stakeholders. In addition, we interviewed officials in DEA field offices in  each of the four states in our study, such as supervisors overseeing both  diversion investigators and special agents, to obtain their views about  engaging with state agencies on efforts related to reducing prescription  drug abuse and diversion. We interviewed officials in the following four  DEA field offices: the Miami Division, the San Francisco Division, the  Kentucky District Office, and the New York Division. We compared DEA’s  responses regarding its interactions with registrants and nonfederal  stakeholders to federal internal control standards related to information  and communication and the standards in DEA’s Office of Diversion  Control Customer Service Plan for Registrants.
section_title: Review of DEA Investigations and Enforcement Actions Data
paragraphs: To further address our third objective, we reviewed data on DEA  investigations and enforcement actions from fiscal year 2009 through  fiscal year 2013 that were taken against the DEA registrant categories  that we included in our survey. We examined the data to determine if  there were any trends over a recent time period. Investigations included  regulatory investigations (i.e., scheduled investigations or inspections  conducted every 2, 3, or 5 years), complaint investigations, and criminal  investigations. Enforcement actions included administrative actions (e.g.,  formal administrative hearings, letters of admonition to advise registrants  of any violations, and orders to show cause to initiate revocation or  suspension of a registration), civil actions, where penalties generally  include monetary fines, and criminal actions, where penalties generally  include incarceration and fines. We determined that the data were  sufficiently reliable for purposes of our report.
We conducted this performance audit from August 2013 to June 2015 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
section_title: Appendix II: Drug Enforcement Administration (DEA) Registrant Survey Data
paragraphs: Tables 12 through 30 contain selected data from our surveys of DEA  registrants. Between July 30, 2014 and October 14, 2014, we surveyed  generalizable random samples of distributors, individual pharmacies, and  practitioners, and we surveyed all of the corporate offices of the 38 chain  pharmacies we identified using a DEA database. Percentages that are  cited are weighted to represent the population. Generally, actual numbers  of responses are cited when the number of responses for any registrant  type in a particular table fell below 100.
section_title: Appendix III: Drug Enforcement Administration (DEA) Investigations and Enforcement Actions Data
paragraphs: Tables 31 through 38 show data on DEA investigations and enforcement  actions from fiscal year 2009 through fiscal year 2013, focusing in  particular on data related to DEA-registered distributors, pharmacies, and  practitioners (including mid-level practitioners). As of September 2013,  there were nearly 1.5 million registered distributors, pharmacies, and  practitioners. DEA conducts investigations of its registrants as part of the  registrant monitoring process and to ensure compliance with the  Controlled Substances Act (CSA) and its implementing regulations.  Following an investigation, DEA can initiate a variety of enforcement  actions for violations of the CSA or its implementing regulations.
section_title: Appendix IV: Comments from the Department of Justice
section_title: Appendix V: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Staff Acknowledgments
paragraphs: In addition to the contacts above, Karen Doran, Assistant Director;   Kristy Love, Assistant Director; Amy Andresen; Willie Commons III;  Christine Davis; Justin S. Fisher; Sally Gilley; Cathleen Hamann;  Catherine Hurley; Eileen Larence; Kirsten Lauber; Lisa A. Lusk;   Carl M. Ramirez; Christina Ritchie; and Monica Savoy made key  contributions to this report.