This is the accessible text file for GAO report number GAO-12-115 
entitled 'Prescription Pain Reliever Abuse: Agencies Have Begun 
Coordinating Education Efforts, but Need to Assess Effectiveness' 
which was released on January 23, 2012. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as 
part of a longer term project to improve GAO products' accessibility. 
Every attempt has been made to maintain the structural and data 
integrity of the original printed product. Accessibility features, 
such as text descriptions of tables, consecutively numbered footnotes 
placed at the end of the file, and the text of agency comment letters, 
are provided but may not exactly duplicate the presentation or format 
of the printed version. The portable document format (PDF) file is an 
exact electronic replica of the printed version. We welcome your 
feedback. Please E-mail your comments regarding the contents or 
accessibility features of this document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

United States Government Accountability Office: 
GAO: 

Report to Congressional Requesters: 

December 2011: 

Prescription Pain Reliever Abuse: 

Agencies Have Begun Coordinating Education Efforts, but Need to Assess 
Effectiveness: 

GAO-12-115: 

GAO Highlights: 

Highlights of GAO-12-115, a report to congressional requesters. 

Why GAO Did This Study: 

The Centers for Disease Control and Prevention has declared that the 
United States is in the midst of an epidemic of prescription drug 
overdose deaths, with deaths associated with prescription pain 
relievers of particular concern. To address this issue, federal 
agencies are raising awareness by educating prescribers and the 
general public. In response to your request, GAO (1) described recent 
national trends in prescription pain reliever abuse and misuse, (2) 
described how federal agencies are educating prescribers, (3) assessed 
the extent to which federal agencies follow key practices for 
developing public education efforts, and (4) identified educational 
efforts that use similar strategies and assessed how agencies 
coordinate those efforts. 

GAO interviewed officials and reviewed documents and websites from 
seven agencies involved in federal drug control efforts and analyzed 
the most recent data from several data sources related to prescription 
pain reliever abuse and misuse. GAO also assessed the development of 
public education efforts and federal coordination efforts against key 
practices from prior GAO work. 

What GAO Found: 

Key measures of prescription pain reliever abuse and misuse increased 
from 2003 to 2009. The largest increases were in measures of adverse 
health consequences such as emergency department visits, substance 
abuse treatment admissions, and unintentional overdose deaths, though 
increases were not consistent across all measures. Federal officials 
suggested that increasing availability of prescription pain relievers 
and high-risk behaviors by those who abuse or misuse the drugs, such 
as combining prescription pain relievers with other drugs or alcohol, 
likely contributed to the rise in adverse health consequences, though 
data about the reasons for the increases are limited. 

The Food and Drug Administration (FDA), the National Institutes of 
Health (NIH), and the Substance Abuse and Mental Health Services 
Administration (SAMHSA) use a variety of strategies to educate 
prescribers about issues related to prescription pain reliever abuse 
and misuse, but officials told us that more education is needed. The 
strategies used include developing continuing medical education 
programs, requiring training and certification in order to prescribe 
certain drugs, and developing curriculum resources for future 
prescribers. The Office of National Drug Control Policy (ONDCP) is 
working to develop a legislative proposal to require education for 
prescribers registering with the Drug Enforcement Administration (DEA) 
to prescribe controlled substances. Officials from some agencies said 
such a requirement would ensure all prescribers were starting from the 
same baseline of knowledge. 

In their efforts to educate the public about prescription pain 
reliever abuse and misuse, DEA, FDA, NIH, ONDCP, and SAMHSA used 
almost all of the key practices for developing their consumer 
education efforts. Agencies varied in how they used the key practices 
when developing these efforts, which varied in size, scope, and 
duration. All agencies established metrics to monitor the 
implementation and functional elements of their educational efforts, 
but only two agencies have established or are planning to establish 
metrics to assess the impact of their efforts on audiences’ knowledge, 
attitudes, and behavior. Without outcome evaluations, federal agencies 
have limited knowledge of how effective their efforts are in achieving 
their goals—-in this case, reducing prescription pain reliever abuse 
and misuse. 

Among federal initiatives to educate prescribers and the public about 
prescription pain reliever abuse and misuse, GAO found several 
instances of agencies engaging in similar efforts, directed at similar 
target audiences and using similar mediums. Officials said that these 
similarities in public education efforts are beneficial in addressing 
prescription drug abuse and misuse because having multiple, 
reinforcing messages about the same subject is valuable in public 
health communications and because federal agencies provide slightly 
different perspectives on the issues surrounding prescription drug 
abuse and misuse. Likewise, the prescriber education programs GAO 
identified, though similar, are different in content and focus. Though 
these similar programs have the potential to be duplicative if not 
effectively coordinated, federal agencies have recently begun to 
coordinate their educational efforts. Nevertheless, federal agencies 
have missed opportunities to share lessons learned and pool resources 
among similar education efforts. 

What GAO Recommends: 

GAO recommends that the Director of ONDCP establish outcome metrics 
and implement a plan to evaluate proposed educational efforts, and 
ensure that agencies share lessons learned among similar efforts. 
ONDCP did not explicitly agree or disagree with GAO’s recommendations, 
but noted that it will continue to work for improved coordination of 
educational efforts and evaluation of outcomes. 

View [hyperlink, http://www.gao.gov/products/GAO-12-115]. For more 
information, contact Marcia Crosse at (202) 512-7114 or 
crossem@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

Key Measures of Prescription Pain Reliever Abuse and Misuse Have 
Increased Nationwide: 

Federal Agencies Are Using Various Strategies to Educate Prescribers 
about Issues Related to Prescription Pain Reliever Abuse and Misuse: 

Federal Agencies Generally Followed Key Practices When Developing 
Public Education Efforts: 

Federal Agencies Have Begun Coordinating Similar Public and Prescriber 
Education Efforts, but Have Missed Opportunities to Share Resources: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Abuse-Deterrent Formulations of Prescription Pain 
Relievers: 

Appendix II: DEA Quotas for Controlled Substances: 

Appendix III: Objectives, Scope, and Methodology: 

Appendix IV: Public Education Programs: 

Appendix V: Data from Key Measures of Prescription Pain Reliever Abuse 
and Misuse: 

Appendix VI: Comments from the Office of National Drug Control Policy: 

Appendix VII: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: Public Education Efforts about Prescription Pain Reliever 
Abuse and Misuse: 

Table 2: Efforts to Educate Prescribers about Issues Related to 
Prescription Pain Reliever Abuse and Misuse: 

Table 3: Key Practices for Developing Public Education Efforts: 

Table 4: Summary of Federal Efforts to Educate the General Public 
about Prescription Pain Reliever Abuse and Misuse: 

Table 5: Estimated Number of Emergency Department Visits Related to 
Abuse and Misuse of Prescription Pain Relievers by Age Groups with 
Confidence Intervals, 2004-2009: 

Table 6: Number of Admissions to Substance Abuse Treatment Facilities 
for Prescription Pain Reliever Abuse and Misuse by Age Groups, 2003-
2009: 

Table 7: Number of Unintentional Overdose Deaths Involving 
Prescription Pain Relievers by Age Groups, 2003-2008: 

Table 8: Estimated Number of Individuals Who Reported Abusing or 
Misusing Prescription Pain Relievers in the Past Year by Age Groups 
with Confidence Intervals, 2003-2009 (in Thousands): 

Figures: 

Figure 1: Measures of Adverse Health Consequences Related to Abuse and 
Misuse of Prescription Pain Relievers among the U.S. Population Aged 
12 and Older, 2003 to 2009: 

Figure 2: Agencies' Use of Key Practices for Developing Public 
Education Efforts: 

Figure 3: ONDCP and NIH Teen Websites: 

Figure 4: DEA Teen Website: 

Abbreviations: 

APQ: aggregate production quota: 

CDC: Centers for Disease Control and Prevention: 

CE: continuing education: 

CME: continuing medical education: 

DAWN: Drug Abuse Warning Network: 

DEA: Drug Enforcement Administration: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

HRSA: Health Resources and Services Administration: 

NIDA: National Institute on Drug Abuse: 

NIH: National Institutes of Health: 

NSDUH: National Survey on Drug Use and Health: 

NVSS: National Vital Statistics System: 

ONDCP: Office of National Drug Control Policy: 

REMS: Risk Evaluation and Mitigation Strategy: 

SAMHSA: Substance Abuse and Mental Health Services Administration: 

TEDS: Treatment Episode Data Set: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

December 22, 2011: 

The Honorable Darrell Issa: 
Chairman: 
Committee on Oversight and Government Reform: 
House of Representatives: 

The Honorable Mary Bono Mack: 
House of Representatives: 

The Honorable Edolphus Towns: 
House of Representatives: 

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, with such drugs involved in more overdose deaths than 
those involving heroin and cocaine combined. Further, according to 
CDC, recent increases in prescription drug overdose deaths overall are 
largely driven by deaths associated with prescription pain relievers, 
which include such drugs as OxyContin or Vicodin, among others. In 
2009, an estimated 12.4 million Americans reported using a 
prescription pain reliever in the past year without a prescription of 
their own or simply for the experience or feeling the drug caused, 
according to the National Survey on Drug Use and Health (NSDUH). 
Seventy percent of these people reported that they got the drug from a 
friend or family member, while another 19 percent got the drug from a 
doctor.[Footnote 1] Although specific regions of the country have been 
severely affected by this problem, recent media reports from across 
the United States suggest it is now a national issue. 

Multiple federal agencies have responsibility for addressing the abuse 
and misuse of prescription pain relievers through prevention, 
treatment, and enforcement activities. [Footnote 2,3] The Office of 
National Drug Control Policy (ONDCP) assists in setting national drug 
control priorities and helps to coordinate federal drug control 
efforts. One prevention activity ONDCP has identified as a focus area 
is raising awareness of the problem of prescription drug abuse and 
misuse through the education of parents, youth, patients, and health 
care providers. Accordingly, the Drug Enforcement Administration 
(DEA), the Food and Drug Administration (FDA), the Health Resources 
and Services Administration (HRSA), the National Institutes of Health’
s (NIH) National Institute on Drug Abuse (NIDA), the Substance Abuse 
and Mental Health Services Administration (SAMHSA), and ONDCP are 
engaged in various activities for educating the public and health care 
providers who prescribe pain relievers about issues related to abuse 
and misuse of these drugs. These federal agencies and ONDCP 
(hereinafter collectively referred to as “federal agencies”) have 
assisted in developing and implementing strategies specifically 
focused on preventing the inappropriate use of prescription pain 
relievers since the early 2000s, and our prior reports have documented 
some of their efforts.[Footnote 4] 

You asked us to update our prior work on OxyContin to reflect changes 
in oxycodone abuse trends and efforts aimed at stemming prescription 
drug abuse since our 2003 report. In response to that request, we (1) 
describe recent national trends in prescription pain reliever abuse 
and misuse, (2) describe how federal agencies are educating 
prescribers about prescription pain reliever abuse and misuse, (3) 
assess the extent to which federal agencies follow key practices for 
developing public education efforts about prescription pain reliever 
abuse and misuse, and (4) identify educational efforts that use 
similar strategies and assess how agencies coordinate those efforts. 
At your request, we also provide information on manufacturer-initiated 
efforts to develop abuse-deterrent formulations of prescription pain 
relievers (see appendix I) and DEA’s process for setting quotas for 
certain substances used in the manufacture of prescription pain 
relievers (see appendix II). 

To describe recent national trends in prescription pain reliever abuse 
and misuse, we interviewed officials from CDC, DEA, FDA, NIH, ONDCP, 
and SAMHSA; conducted a literature review to identify relevant data 
sources and explanations for trends in prescription pain reliever 
abuse and misuse; and analyzed data related to prescription pain 
reliever abuse and misuse from several data sources representative of 
the U.S. population aged 12 years and older. We included data in our 
review from the Drug Abuse Warning Network (DAWN), NSDUH, the National 
Vital Statistics System (NVSS), and the Treatment Episode Data Set 
(TEDS). We selected these four data sources because they are the data 
sources that the responsible agencies use for monitoring trends in 
prescription pain reliever abuse and misuse, and because they are 
nationally representative. We analyzed data for calendar years 2003 to 
2009, the most recent years for which data from at least three data 
sources were available. (See appendix III for more information about 
these data sources.) To assess the reliability of these data for our 
purposes, we reviewed related documentation and conducted interviews 
with knowledgeable agency officials from CDC and SAMHSA to learn about 
data collection, quality control, and any limitations of these data 
sources. We also conducted electronic and manual data testing to 
ensure the quality of the data. We determined that all data we 
assessed were sufficiently reliable to provide overall trends for the 
purposes of our review. 

To describe how federal agencies are educating prescribers about 
prescription pain reliever abuse and misuse, we reviewed documents and 
interviewed officials from FDA, NIH, and SAMHSA to identify and 
describe educational strategies used during fiscal year 2011. Because 
they are involved in federal prevention efforts, we also interviewed 
officials from DEA, HRSA, ONDCP, and the American Medical Association 
to gain their perspective on gaps in current prescriber education and 
efforts to fill these gaps. We excluded agencies that support their 
own health care systems, such as the Bureau of Prisons, Department of 
Defense, Indian Health Service, and Department of Veterans Affairs, 
from the scope of our review as they serve special populations, rather 
than the general public. We also excluded educational efforts related 
to drug abuse treatment, including education about the use of the 
prescription pain relievers methadone or buprenorphine for the 
treatment of opioid addiction. 

To assess the extent to which federal agencies follow key practices 
for developing public education efforts about prescription pain 
reliever abuse and misuse, we reviewed agency websites and interviewed 
officials from DEA, FDA, NIH, SAMHSA, and ONDCP to identify 
educational efforts. We then assessed the development of those 
educational efforts against key practices for developing consumer 
education efforts identified in our prior work.[Footnote 5] We limited 
our scope to efforts that target the general public, rather than 
special populations, such as educational efforts pursued by the 
Department of Veterans Affairs, Department of Defense, or Indian 
Health Service. We also focused on efforts that were being actively 
revised or disseminated in fiscal year 2011. Finally, we focused on 
efforts that craft targeted messages about abuse and misuse, rather 
than efforts that strictly provide factual information, such as a 
limited number of drug fact websites, since our criteria for 
developing consumer education efforts are only appropriate for efforts 
that seek to convey a particular message. 

To identify educational efforts that use similar strategies and assess 
how agencies coordinate those efforts, we first assessed the extent to 
which agencies targeted similar populations, provided similar 
information, and used similar educational strategies. We then 
interviewed officials from DEA, FDA, HRSA, NIH, SAMHSA, and ONDCP and 
reviewed agency documents in order to assess federal agencies’ 
coordination efforts against key practices for collaboration 
identified in our prior work.[Footnote 6] (See appendix III for a 
detailed discussion of our methodology.)[Footnote 7] 

We conducted this performance audit from December 2010 through 
December 2011 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. 

Background: 

Prescription Pain Relievers: 

Pain, which affects millions of Americans, can be characterized in 
terms of intensity--mild to severe--and duration--acute or chronic. 
[Footnote 8] While the appropriate medical treatment of pain varies 
according to these two dimensions, opioid analgesics can provide pain 
relief for some patients. These prescription pain relievers can be 
made in either immediate-release or extended-release formulations. 
Immediate-release pain relievers work for shorter periods of time, 
while extended-release pain relievers are designed to provide a longer 
period of drug release so that they can be taken less frequently. 
[Footnote 9] 

Prescription pain relievers are sometimes used in a manner other than 
as prescribed--that is, they are abused and misused. While federal 
agencies' definitions of abuse and misuse vary, they generally 
incorporate three types of inappropriate use. First, some individuals 
use prescription pain relievers with the intent to get high, whether 
or not they were prescribed the drugs. Second, some individuals use 
prescription pain relievers that they were not prescribed to relieve 
pain; for example, by borrowing a pill from a friend in order to treat 
a headache.[Footnote 10] Third, some individuals, while seeking pain 
relief, incorrectly use prescription pain relievers that were 
prescribed to them, such as by taking more than prescribed. 

Prescription pain relievers have serious risks when they are abused 
and misused. Abuse and misuse of prescription pain relievers can lead 
to addiction and severe respiratory depression, which can cause death. 
Depending on the amount taken, even a single dose could cause death if 
taken by an individual who does not regularly use such pain relievers 
and whose body is not accustomed to their effects. Also, using alcohol 
or other drugs with prescription pain relievers can increase the risk 
of dangerous side effects, including death. 

Preventing Prescription Pain Reliever Abuse and Misuse: 

Federal agencies use both regulatory and programmatic approaches in 
their efforts to prevent prescription pain reliever abuse and misuse. 
[Footnote 11] Because of their potential for abuse, prescription pain 
relievers are regulated under the Controlled Substances Act.[Footnote 
12] Prescribers, such as physicians, physician assistants, nurse 
practitioners, and dentists, must register with DEA to prescribe drugs 
regulated under the act, and prescribers serve a key role in reducing 
prescription drug abuse and misuse. 

However, federal agencies have noted gaps in prescriber education 
about issues related to prescription pain reliever abuse and misuse, 
including that most prescribers receive little training on the 
importance of appropriate prescribing and dispensing of prescription 
pain relievers, on how to recognize substance abuse in their patients, 
or on treating pain. A recent study on pain education in medical 
schools found that such education is limited, variable, and often 
fragmentary.[Footnote 13] Further, given the recent introduction of 
new pain relievers to the U.S. market and advances in pain management, 
prescribers who completed their medical training in prior years may 
not have received training in prescribing certain types of pain 
relievers, such as extended-release or long-acting formulations. While 
continuing education of current prescribers could help address this 
issue, according to an American Medical Association publication, as of 
September 2011 medical boards in only nine states had a continuing 
medical education (CME) requirement related to education on controlled 
substance prescribing or pain management for certain 
prescribers.[Footnote 14] A representative of the American Pain 
Foundation told us that the organization frequently receives reports 
from patients that, in some communities, prescribers have stopped 
prescribing prescription pain relievers because of a lack of knowledge 
about how to safely prescribe them. 

Federal public education efforts seek to educate patients and the 
general public of all ages about the appropriate use, secure storage, 
and disposal of prescription drugs, as well as the risks associated 
with prescription drug abuse and misuse (see appendix IV for 
descriptions of federal efforts to educate the general public about 
prescription pain reliever abuse and misuse). We have previously 
identified certain key practices that are important for the 
development of educational outreach efforts, motivating a target 
audience, and alleviating challenges, such as prioritizing limited 
resources.[Footnote 15] 

Federal Agencies Involved in Preventing Prescription Pain Reliever 
Abuse and Misuse: 

Multiple federal agencies play a role in preventing the abuse and 
misuse of prescription pain relievers. Within the Executive Office of 
the President, ONDCP establishes policies, priorities, and objectives 
for a national drug control program. ONDCP also oversees several 
programs related to curbing drug abuse and misuse, including an 
educational media campaign. 

In addition, Department of Health and Human Services (HHS) agencies, 
including FDA, HRSA, NIH, and SAMHSA, have various responsibilities 
and engage in activities related to preventing the abuse and misuse of 
prescription pain relievers. 

* FDA is responsible for ensuring the safety and effectiveness of 
drugs. FDA can require drug manufacturers to take measures to ensure 
the safety of their products, such as by providing patient and 
prescriber education materials. FDA also educates patients and 
providers about appropriate use and potential risks of drugs, 
including prescription pain relievers, in order to reduce preventable 
harm from these drugs. 

* HRSA operates the federal Poison Control Program, which provides 
funds for poison control centers that provide treatment 
recommendations for poisonings involving prescription drug abuse and 
misuse. This program also has a campaign that includes public 
education about the risks of poisoning from prescription pain 
relievers. 

* NIH, primarily through its component NIDA, provides strategic 
support for and conducts research on drug abuse and addiction. NIH's 
role also includes translating and disseminating this research into 
materials for public consumption. 

* SAMHSA seeks to direct substance abuse and mental health services to 
the people most in need and promote use of evidence-based practices in 
these areas in the general health care system. In particular, the 
agency seeks to educate the public and prescribers about issues 
related to substance abuse in an effort to prevent such abuse and 
reduce its prevalence. 

Finally, within the Department of Justice, DEA is responsible for 
enforcing the Controlled Substances Act and related regulations. One 
of DEA's roles is to control the quantity of schedule I and II 
controlled substances produced or procured each year in the United 
States, which it does by establishing annual quotas for U.S. 
manufacturers. (See appendix II for a description of DEA's process for 
setting quotas for controlled substances.) The agency also supports 
nonenforcement programs aimed at reducing the illicit use of 
controlled substances, including education about prescription drug 
abuse and misuse and diversion.[Footnote 16] 

Federal Data Sources Used to Monitor Prescription Pain Reliever Abuse 
and Misuse: 

To monitor trends in the extent of prescription pain reliever abuse 
and misuse, federal agencies rely on data obtained from four 
nationally representative data sources. Three of these data sources 
measure adverse health consequences related to abuse and misuse, and 
the fourth is a national household survey of drug use.[Footnote 17] 
Although these data sources do not directly measure abuse and misuse, 
when used together, they provide a more complete view of the problem 
of prescription pain reliever abuse and misuse than any of the data 
sources individually. Therefore, we refer to national data from these 
four data sources as key measures of prescription pain reliever abuse 
and misuse. The data sources used by federal agencies are: 

* DAWN, a public health surveillance system operated by SAMHSA, 
collects information on emergency department visits in the United 
States. DAWN staff review emergency department medical records from a 
nationally representative sample of hospitals to identify and gather 
information on visits in which drugs were involved, including visits 
where drugs were a direct cause and visits where drugs were a 
contributing factor. 

* TEDS, compiled by SAMHSA, gathers data from substance abuse 
treatment facilities in the United States on the demographic 
characteristics and substance abuse problems of those aged 12 or older 
admitted for treatment. 

* NVSS, operated by CDC, contains vital statistics data, including 
mortality data, such as causes of death, obtained from death 
certificates filed for every death from every jurisdiction in the 
United States. 

* NSDUH, an annual household survey sponsored by SAMHSA, gathers self-
reported information on the use of illicit drugs (including the 
"nonmedical use" of prescription drugs), alcohol, and tobacco in the 
civilian, noninstitutionalized population of the United States aged 12 
years old or older.[Footnote 18] 

See appendix III for more information about the data collection 
methodologies and limitations of these data sources. 

Key Measures of Prescription Pain Reliever Abuse and Misuse Have 
Increased Nationwide: 

Key measures of prescription pain reliever abuse and misuse increased 
from 2003 to 2009. The largest increases were in measures of adverse 
health consequences, though increases were not consistent across all 
measures. Federal officials suggested that increasing availability of 
prescription pain relievers and increasing high-risk behaviors by 
those who abuse or misuse the drugs, such as combining prescription 
pain relievers with other drugs or alcohol, likely contributed to the 
rise in adverse health consequences, though data about the reasons for 
the increases are limited. 

Key Measures of Prescription Pain Reliever Abuse and Misuse Increased 
from 2003 to 2009: 

Key measures of prescription pain reliever abuse and misuse increased 
from 2003 to 2009, though increases were not consistent across all 
measures. All three measures of adverse health consequences that we 
examined increased substantially in the U.S. population during the 
period we reviewed (see figure 1).[Footnote 19] The estimated number 
of emergency department visits annually related to prescription pain 
reliever abuse and misuse increased by 142 percent from 2004 to 2009, 
an estimated increase of 288,000 visits.[Footnote 20] Admissions to 
substance abuse treatment facilities annually for prescription pain 
reliever abuse and misuse increased by 131 percent, or 133,000 
admissions, from 2003 to 2009.[Footnote 21] The annual number of 
deaths resulting from unintentional overdoses of prescription pain 
relievers increased by 83 percent, equivalent to more than 5,000 
deaths, from 2003 to 2008.[Footnote 22] 

Figure 1: Measures of Adverse Health Consequences Related to Abuse and 
Misuse of Prescription Pain Relievers among the U.S. Population Aged 
12 and Older, 2003 to 2009: 

[Refer to PDF for image: 2 line graphs] 

National incidence: 

Year: 2003; 
Substance abuse treatment admissions: 101,193; 
Unintentional overdose deaths: 6,493. 

Year: 2004; 
Emergency department visits: 202,159; 
Substance abuse treatment admissions: 114,064; 
Unintentional overdose deaths: 7,541. 

Year: 2005; 
Emergency department visits: 249,156; 
Substance abuse treatment admissions: 131,049; 
Unintentional overdose deaths: 8,534. 

Year: 2006; 
Emergency department visits: 284,071; 
Substance abuse treatment admissions: 150,005; 
Unintentional overdose deaths: 10,986. 

Year: 2007; 
Emergency department visits: 333,748; 
Substance abuse treatment admissions: 171,925; 
Unintentional overdose deaths: 11,509. 

Year: 2008; 
Emergency department visits: 428,092; 
Substance abuse treatment admissions: 208,122; 
Unintentional overdose deaths: 11,877. 

Year: 2009; 
Emergency department visits: 489,951; 
Substance abuse treatment admissions: 234,244. 

Source: GAO analysis of SAMHSA and CDC data. 

Notes: Comparable emergency department visit estimates are not 
available for 2003 because changes were made that year to the data 
collection methodology. Unintentional overdose deaths data from 2009 
were not published in time for this report. See appendix V for the 
estimated number of emergency department visits, admissions to 
substance abuse treatment facilities, and unintentional overdose 
deaths for each year analyzed along with the corresponding confidence 
intervals, where applicable. 

[End of figure] 

While these measures of adverse health consequences increased 
substantially, according to NSDUH survey data, the percent increase in 
the estimated number of people nationwide who abused and misused 
prescription pain relievers--another key measure of prescription pain 
reliever abuse and misuse--was relatively slight during the period we 
reviewed.[Footnote 23] In 2003, an estimated 11.7 million people 
reported abusing or misusing prescription pain relievers at some point 
over the past year, and this number increased by 6 percent to 12.4 
million people in 2009.[Footnote 24] Appendix V shows data from the 
key measures by age group for each year that we reviewed. 

Increasing Availability and High-Risk Behaviors Likely Contributed to 
the Increases in Adverse Health Consequences: 

Although information about the reasons for the substantial increases 
in adverse health consequences is limited, agency officials suggested 
that increasing availability of prescription pain relievers, 
especially extended-release and long-acting pain relievers, and 
increasing high-risk behaviors by those who abuse or misuse the drugs 
were likely contributors to the increased adverse health consequences 
related to prescription pain reliever abuse and misuse from 2003-2009. 
Over this time period, the number of prescriptions dispensed from U.S. 
pharmacies for prescription pain relievers increased by 32 percent--
from 195 million prescriptions in 2003 to 257 million prescriptions in 
2009--which CDC, FDA, and NIH officials attributed to factors such as 
an increased focus on pain management.[Footnote 25] Officials from a 
number of agencies noted, however, that while most prescription pain 
relievers are used as prescribed, a fraction of all prescribed pain 
relievers are abused and misused.[Footnote 26] Available data do not 
allow officials to determine what fraction of prescription pain 
relievers are abused and misused. 

Officials from multiple agencies suggested that adverse health 
consequences may also be increasing because more individuals who abuse 
or misuse prescription pain relievers may be abusing or misusing 
extended-release and long-acting pain reliever formulations, though 
data from which to draw this conclusion are limited. Because extended-
release and long-acting formulations are designed to release their 
ingredients and relieve pain over an extended period of time, they may 
have more pain-relieving ingredients in each dose than immediate-
release drugs. Prescriptions dispensed for these extended-release and 
long-acting formulations increased by 56 percent from 2003 to 2009--an 
even higher rate than the increase for prescription pain relievers 
overall.[Footnote 27] FDA officials said that, because of their 
potency, when extended-release and long-acting drugs are abused and 
misused, they are more likely to cause harm than when immediate-
release pain relievers are abused. For example, an FDA analysis found 
that extended-release and long-acting pain relievers are more often 
involved in emergency department visits than immediate-release pain 
relievers, when adjusted for number of prescriptions.[Footnote 28] In 
addition, a 2009 analysis by a panel of experts associated methadone, 
a long-acting pain reliever, with a high number of deaths compared 
with other prescription pain relievers, when adjusted for the total 
number of prescriptions dispensed.[Footnote 29],[Footnote 30] 
Officials from most of the agencies we interviewed said that they are 
most concerned about extended-release and long-acting pain relievers, 
but they noted that immediate-release pain relievers are also abused 
and misused. Officials from multiple agencies noted, however, that 
data on what drug formulations are being abused and misused are 
limited because most measures of abuse and misuse do not gather 
information on the particular drug formulation involved in a case of 
an adverse health consequence or self-reported abuse and misuse. 

A second factor that officials from several agencies said likely 
contributed to the increases in adverse health consequences is that 
more individuals may be engaging in high-risk behaviors when they 
abuse or misuse prescription pain relievers, though data on the extent 
of high-risk behaviors are limited. One high-risk behavior officials 
pointed to was combining prescription pain relievers with other 
substances, such as another prescription pain reliever, alcohol, or 
other drugs. Taken together, the interactions of such substances can 
lead to increased risk of life-threatening conditions. From 2004 to 
2009, the number of emergency department visits that involved 
combining prescription pain relievers with other substances increased 
by an estimated 200,000 visits, while the number of emergency 
department visits involving a prescription pain reliever alone 
increased by an estimated 88,000 visits.[Footnote 31] However, 
officials from several agencies told us that their understanding of 
how drugs are used in combination is limited by the available data. 
For example, NSDUH, which reports estimates of abuse and misuse based 
on a nationwide survey, does not ask survey respondents which 
substances they use in combination. In addition, NVSS data on 
unintentional overdose deaths are limited by the amount of detail 
listed on death certificates. Not all substances involved in a death 
may be listed on a death certificate, especially when a toxicology 
report is not used to determine the cause of death. CDC officials said 
that whether a toxicology report is used to determine the cause of 
death varies by jurisdiction, and currently, the number of postmortem 
examinations, which may include toxicology reports, is declining. 

Officials from multiple agencies said that another high-risk behavior 
that may be leading to increased adverse health consequences is 
inhaling or injecting the drugs, rather than taking them orally as 
prescribed. From 2003 to 2009, the percentage of admissions to 
substance abuse treatment facilities where the admitted individual 
reported usually abusing or misusing prescription pain relievers 
through inhaling the drugs increased from 9 percent to 16 percent of 
cases. The percent of admissions where the admitted individual 
reported using the drugs orally decreased from 72 to 69 percent of 
cases, while the percent of admissions using the drugs in other ways 
was stable. NIH has reported that inhaling and injecting drugs is more 
dangerous than taking them orally as prescribed. Inhaling or injecting 
the drugs delivers drugs more quickly to the brain and can increase 
the risk of addiction and overdose. 

Federal Agencies Are Using Various Strategies to Educate Prescribers 
about Issues Related to Prescription Pain Reliever Abuse and Misuse: 

FDA, NIH, and SAMHSA are using a variety of strategies to fill the 
gaps federal agencies have identified in prescriber education related 
to treating pain, prescribing opioids appropriately, and identifying 
substance abuse in their patients, but officials told us that more 
education is needed. Strategies that these agencies pursued in fiscal 
year 2011 include developing CME programs, requiring training and 
certification in order to prescribe certain drugs, organizing 
physician mentoring networks, and developing curriculum resources for 
future prescribers. 

First, FDA, NIH, and SAMHSA are using voluntary CME programs to 
educate prescribers about issues related to prescription pain reliever 
abuse and misuse. CME programs are educational activities which serve 
to maintain, develop, and increase the knowledge, skills, and 
professional performance and relationships physicians use to provide 
services to patients. Many state medical boards require prescribers to 
complete a certain number of CME credits for license re-registration. 
FDA is requiring manufacturers to develop a CME or continuing 
education (CE) course for prescribers as part of a Risk Evaluation and 
Mitigation Strategy (REMS) for extended-release and long-acting 
prescription pain relievers.[Footnote 32],[Footnote 33] While 
completion of the course, which is expected to be implemented in early 
2012, will be voluntary, FDA is requiring manufacturers to propose 
performance goals for the percentage of prescribers who complete it. 
NIH is undertaking a different approach to using CME programs to 
educate prescribers about identification of substance abuse in their 
patients, reaching out to prescribers at medical conferences across 
the country. Using a live theater CME format, NIH uses a dramatic 
reading of a portion of the play Long Day's Journey into Night that 
focuses on a character's morphine addiction, an expert panel reaction, 
and a facilitated audience discussion to highlight issues like 
incorporating screening, brief intervention, and referral to treatment 
into primary care settings. Finally, SAMHSA developed a CME course on 
prescribing opioids for chronic pain and partners with local host 
organizations, such as local medical organizations and state agencies, 
to offer it across the United States. The course is targeted at 
physicians, dentists, and other prescribers and can be modified to 
reflect the needs of the local host organization. 

Another strategy FDA uses is requiring prescribers of certain 
prescription pain relievers to be trained and certified in order to 
prescribe them. As of October 2011, all five marketed transmucosal 
immediate-release fentanyl products had REMS with prescriber training 
and certification components due to unique concerns associated with 
these products.[Footnote 34] In order to become certified to prescribe 
these drugs for outpatient use, prescribers must review written 
materials, successfully complete a knowledge assessment, and register 
with the manufacturer of the drug by completing a prescriber 
enrollment form, which includes a commitment to complete a patient-
prescriber agreement with each new patient.[Footnote 35] Prescribers 
are required to become recertified every 2 years. 

A third strategy NIH and SAMHSA are pursuing is providing funding to 
develop physician clinical support systems, which provide educational 
resources and free, nationwide mentoring services related to 
prescribing prescription pain relievers. As of October 2011, two 
physician clinical support systems had been funded: one to assist 
practicing physicians interested in implementing substance abuse 
screening in their practices and one related to the appropriate use of 
prescription pain relievers for the treatment of chronic 
pain.[Footnote 36] Each system links physicians to trained clinical 
advisors who can provide telephone or e-mail responses to specific 
questions and offer support using the educational resources. 

The final strategy NIH and SAMHSA are using is developing curricula 
for future prescribers, including medical students and residents, 
about issues related to prescription pain reliever abuse and misuse. 
NIDA's Centers of Excellence for Physician Information, located in 
eight medical schools, are developing curriculum resources--including 
lectures, faculty workshops, and web modules--to help train medical 
students and residents to screen, treat, and refer patients with 
substance use disorders. As of October 2011, the medical schools had 
developed 10 curriculum resources, 5 of which are specific to 
prescription drug abuse and misuse. In addition, NIDA is taking the 
lead on a project with participation from more than 10 institutes and 
centers within the NIH to establish the NIH Pain Consortium Centers of 
Excellence in Pain Education. These Centers of Excellence aim to 
develop curricula that will educate medical students about best 
practices in the treatment of pain by fiscal year 2014. SAMHSA is also 
facilitating the development of curricula for training medical 
residents. Through its Screening, Brief Intervention, Referral and 
Treatment Medical Residency Program, medical residency programs are 
developing curricula and clinical training for identifying substance 
use disorders, including training about issues related to prescription 
drug abuse and misuse, and incorporating the curricula and clinical 
training into 16 residency programs.[Footnote 37] The curriculum 
resources for these programs are designed to be transferable to 
medical schools and residency programs nationwide. 

Despite various ongoing strategies to educate current and future 
prescribers about issues related to prescription pain reliever abuse 
and misuse, officials from each of the federal agencies we spoke with 
told us that more prescriber education is necessary. ONDCP officials 
indicated that they--with technical assistance from DEA, FDA, and 
SAMHSA--are working to develop a legislative proposal to require that 
all prescribers who request DEA registration to prescribe controlled 
substances be trained on the appropriate and safe use, proper storage, 
and disposal of prescription pain relievers as a precondition of 
registration. Currently, in order to register with DEA to prescribe a 
controlled substance, prescribers must hold a valid state license. 
[Footnote 38] Officials from many of the agencies we spoke with 
expressed support for mandatory prescriber education, with some noting 
that this would ensure that all prescribers were starting from the 
same baseline of knowledge. Officials from one agency expressed 
support for promoting the education of all prescribers through other 
means, such as working with state medical boards. Officials from 
several agencies explained that more prescriber education is necessary 
because the majority of educational strategies that federal agencies 
are currently pursuing are voluntary and may not reach the majority of 
either current or future prescribers. Because training could help 
prescribers feel more comfortable prescribing these drugs, ONDCP 
officials also explained that mandatory prescriber education could 
improve access to prescription pain relievers for patients with a 
legitimate need for pain relief. Officials from ONDCP also noted that 
by mandating education for all prescribers, rather than only for those 
who prescribed extended-release and long-acting prescription pain 
relievers, they could avoid a possible situation in which some 
prescribers would be unable to prescribe certain pain relievers 
because they had chosen not to take the training. Representatives of 
the American Medical Association told us that they, along with a 
number of other associations representing prescribers, favored the use 
of positive incentives--such as a reduction in the $551 fee 
prescribers pay to DEA when registering to prescribe controlled 
substances--to encourage prescribers to complete voluntary education 
about these issues, rather than mandating such education. The American 
Medical Association representatives noted that the contribution that 
poor prescribing practices or fraudulent activity on the part of 
prescribers makes to the supply of prescription pain relievers that 
are diverted for abuse and misuse is unknown. As a result, they told 
us that it is unclear whether mandatory prescriber education would 
have an effect on prescription pain reliever abuse and misuse. 

Federal Agencies Generally Followed Key Practices When Developing 
Public Education Efforts: 

All federal agencies used almost all of the key practices for 
developing consumer education efforts, which varied in size, scope, 
and duration. Agencies also varied in how they used key practices when 
developing these efforts. All agencies established metrics to monitor 
the implementation and functional elements of their educational 
efforts, but only two agencies have established or are planning to 
establish metrics to assess the impact of their efforts on audiences' 
knowledge, attitudes, and behavior. 

All Agencies Followed Almost All Key Practices; Efforts Varied in Size 
and Approach: 

All federal agencies used almost all of the key practices for 
developing consumer education efforts when developing the efforts that 
we reviewed to educate the general public about prescription pain 
reliever abuse and misuse. In fiscal year 2011, five agencies operated 
nine educational efforts targeted at the general public, ranging from 
websites to brochures to a museum exhibit (see appendix IV for full 
descriptions of the educational efforts). Our prior work outlines key 
practices that agencies should engage in when developing public 
education efforts: define key goals and objectives of the educational 
effort; analyze the situation, including identifying competing voices 
or timing considerations; identify stakeholders and clarify their 
roles; identify resources; research target audiences, including 
identifying audience characteristics and motivators; develop clear, 
consistent messages; identify credible messenger(s); design a mix of 
media, including method and frequency of delivery; and establish 
metrics to measure success (for further description of these key 
practices, see appendix III).[Footnote 39] Our review of initiatives 
to educate the general public about prescription pain reliever abuse 
and misuse shows that all of the agencies used almost all of these 
practices when developing their initiatives (see figure 2). For 
instance, FDA relied on seven of nine key practices when developing 
outreach materials for its Opioid Public Service Announcements. Other 
agencies used more key practices when developing their education 
efforts; ONDCP relied on all nine key practices for developing 
consumer education efforts when it developed the prescription drug 
content for the National Youth Anti-Drug Media Campaign. 

Figure 2: Agencies' Use of Key Practices for Developing Public 
Education Efforts: 

[Refer to PDF for image: illustrated table] 

Agency: DEA; 
Education effort: Just Think Twice[A]; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Agency: DEA; 
Education effort: Get Smart About Drugs[A]; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Agency: DEA; 
Education effort: Take Back Initiative[B]; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Agency: DEA; 
Education effort: Good Medicine, Bad Behavior; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Agency: FDA; 
Education effort: Opioid Public Service Announcements; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Empty]; 
Identify resources: [Check]; 
Research target audiences: [Empty]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Agency: NIH; 
Education effort: Heads Up: Real News About Drugs and Your Body[A]; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Agency: NIH; 
Education effort: NIDA for Teens[A]; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Check]. 

Agency: ONDCP; 
Education effort: National Youth Anti-Drug Media Campaign[A]; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Check]. 

Agency: SAMHSA; 
Education effort: Not Worth The Risk; Even if it's Legal; 
Define goals and objectives: [Check]; 
Analyze the situation: [Check]; 
Identify stakeholders: [Check]; 
Identify resources: [Check]; 
Research target audiences: [Check]; 
Develop consistent, clear messages: [Check]; 
Identify credible messenger(s): [Check]; 
Design media mix: [Check]; 
Establish metrics to measure success: 
Process metrics: [Check]; 
Outcome metrics: [Empty]. 

Source: GAO analysis of information from DEA FDA, NIH, ONDCP, and 
SAMHSA. 

[A] Efforts are broader than prescription drugs. We limited our 
analysis to the prescription drug-related components of these efforts. 

[B] According to DEA officials, the primary purpose of the Take Back 
Initiative is to collect and dispose of unwanted and unused 
prescription drugs. Public education about prescription drug storage 
and disposal is a secondary goal. We limited our analysis to the 
public education materials associated with the Take Back Initiative. 

[End of figure] 

Agencies varied in how they used the key practices for developing 
public education efforts. For instance, SAMHSA used the key practice 
of developing consistent, clear messages by convening Project Advisory 
Teams composed of external stakeholders and subject matter experts. 
The teams met several times during the development of two phases of 
Not Worth the Risk; Even if it's Legal and gave input to SAMHSA about 
effective messaging and distribution channels for the program's target 
audiences, which include teens, college students, and "student 
influencers" (e.g, parents, teachers, health care providers). FDA used 
a different approach for the same key practice of developing 
consistent, clear messages for its Opioid Public Service 
Announcements--which include information about appropriate use, 
storage, and disposal of medications--relying on internal discussions 
between staff in its Office of Communications and the Office of New 
Drugs. 

Although all agencies used many of the same key practices to develop 
their educational efforts, the resulting initiatives are different in 
terms of size, scope, and duration, and agencies dedicated varying 
amounts of resources to developing their efforts. For instance, NIH's 
Heads Up: Real News About Drugs and Your Body provides classroom 
materials--including magazine articles, student worksheets, and lesson 
plans--to students and teachers about a range of topics related to 
drug abuse and misuse, including but not limited to prescription 
drugs, and has done so each school year since 2002. By contrast, DEA 
began collecting and disposing of unused prescription drugs through 
its Take Back Initiative in 2010.[Footnote 40] The agency developed 
outreach materials to raise awareness of the event and the materials--
including brochures and billboards--are specific to prescription 
drugs. There is also significant variation in terms of the resources 
different agencies used for program development. For instance, the 
budget for the National Youth Anti-Drug Media Campaign in fiscal year 
2011 was approximately $35 million, whereas Not Worth the Risk; Even 
if it's Legal cost about $80,000 for the last phase of the brochure 
series.[Footnote 41] Many programs we reviewed cost less than $150,000 
for program development and dissemination in a fiscal year. 

All Agencies Followed the Key Practice of Establishing Process Metrics 
but Most Did Not Assess Program Outcomes: 

While all agencies established metrics to monitor the implementation 
and functional elements of their educational initiatives, only two 
agencies have established or planned to establish metrics to assess 
the impact of their initiatives on audiences' knowledge, attitudes, 
and behavior with regard to prescription pain reliever abuse and 
misuse. The former, known as process metrics, monitor the operational 
elements of educational efforts, such as the quantity or volume of 
outreach efforts. The latter, known as outcome metrics, are used to 
assess the impact of the initiative on the desired health or behavior 
outcome. Our prior work and other guides for developing consumer 
education efforts note that establishing both process and outcome 
metrics are critical elements of program development.[Footnote 42] 

All federal agencies followed the key practice of establishing process 
metrics for the public education efforts we reviewed. For instance, 
DEA tracks the amount of activity and use across the different 
features and content pages on its websites, Just Think Twice and Get 
Smart About Drugs, including the most popular search terms and amount 
of time spent on the components of the websites. DEA also monitors the 
number of visitors to its museum exhibit about prescription drug abuse 
and misuse, Good Medicine, Bad Behavior, and records the number of 
group visits by category (e.g., schools, universities, or senior 
citizens). 

ONDCP and NIH were the only agencies that followed the key practice of 
establishing outcome metrics for their education efforts. ONDCP 
measures outcomes from its National Youth Anti-Drug Media Campaign 
(the Campaign) on a weekly basis through ongoing tracking studies. The 
tracking studies survey 100 teens each week about awareness of the 
Campaign and their attitudes, beliefs, and intentions regarding drug 
use, including where and how teens interact with the Campaign's 
website, and attitudes after interacting with the website.[Footnote 
43] ONDCP also awarded a contract to evaluate the Campaign's 
contribution to preventing drug abuse among young people in the United 
States, in particular by assessing the Campaign's impact on knowledge, 
attitudes, beliefs, and behavioral intention about drug use.[Footnote 
44] However, ONDCP indicated that, as of September 2011, the contract 
was being terminated because the Campaign has not been funded for 
fiscal year 2012. NIH plans to evaluate outcomes for its NIDA for 
Teens website by surveying students and teachers about students' 
knowledge acquisition and attitude change after exposure to NIDA for 
Teens, as well as teachers' opinions on the utility of the website. 
Although officials from agencies that did not establish outcome 
metrics told us that they recognize the importance of evaluating 
public education efforts, they cited challenges measuring the impact 
of such efforts and lack of financial resources as reasons for not 
assessing program outcomes. For instance, one official explained that 
an outcome evaluation for his agency's drug education program would 
cost more than developing and implementing the program itself. 

Beyond the key practices for developing public education efforts, our 
prior work notes that using existing evidence to inform public health 
communications, such as research on teen messaging or evaluations of 
related efforts, can also be helpful in analyzing the effectiveness of 
educational efforts in addition to establishing outcome metrics. 
[Footnote 45] When developing their public education efforts, agencies 
incorporated evidence-based strategies when possible, but limited 
evidence exists about how to successfully educate the public about 
prescription pain reliever abuse and misuse. For instance, research 
shows that teens may mistakenly believe that prescription pain 
relievers are safer than illicit drugs. As a result, officials from 
several agencies told us that they seek to dispel this misperception 
in their educational efforts. In addition, NSDUH data also indicate 
that most people who abuse or misuse prescription pain relievers get 
the drugs from a friend or family member. Thus, DEA officials told us 
that they have sought to educate the public about proper drug storage 
and disposal in order to limit the amount of drugs that are available 
to be diverted from medicine cabinets for abuse and misuse. 

However, officials from multiple agencies explained that because there 
are distinct challenges when designing educational efforts about 
prescription pain reliever abuse and misuse compared to other drug 
prevention efforts, more research is needed in order to understand how 
to craft effective messages, particularly for teens. Officials said 
that education about prescription pain reliever abuse and misuse 
requires a more nuanced approach because there are legitimate medical 
uses for these products. In addition, officials from several agencies 
noted that educational efforts should avoid inadvertently alerting 
people to the possibility of using these drugs to get high. The 
motivations for abusing and misusing prescription drugs can also be 
different than the motivations for using illicit drugs, such as self-
medicating for pain relief, and understanding how to effectively 
target the variety of reasons people abuse and misuse prescription 
drugs is another area that requires more research, according to agency 
officials. The Surgeon General, with support from other federal 
agencies, is currently developing a Call to Action on youth 
prescription drug abuse that will discuss available evidence to 
support prevention strategies, including educational efforts.[Footnote 
46] An official from the Office of the Surgeon General told us that 
the Call to Action, which is anticipated for release in February 2012, 
will also identify gaps in existing research related to youth 
prescription drug abuse prevention strategies and call for further 
research to be conducted to fill these gaps. 

Federal Agencies Have Begun Coordinating Similar Public and Prescriber 
Education Efforts, but Have Missed Opportunities to Share Resources: 

There are several similarities among agencies' efforts, target 
audiences, and mediums across the nine public education initiatives 
and nine prescriber education programs we identified. Officials said 
that these similarities in public education efforts are beneficial in 
addressing prescription drug abuse and misuse because having multiple, 
reinforcing messages about the same subject is valuable in public 
health communications and because federal agencies provide slightly 
different perspectives on the issues surrounding prescription drug 
abuse and misuse. Likewise, the prescriber education programs we 
identified, though similar, are different in content and focus. 
Although these similar programs have the potential to be duplicative 
if not effectively coordinated, federal agencies have recently begun 
to coordinate their educational efforts. Nevertheless, federal 
agencies have missed opportunities to pool resources--a key practice 
for effective coordination--among similar education efforts, which may 
have resulted in lost opportunities to obtain additional benefits 
through coordination. 

Federal Agencies Operate Similar Public and Prescriber Education 
Programs: 

Among all nine federal initiatives to educate the general public about 
prescription pain reliever abuse and misuse that we reviewed, there 
are several instances of agencies engaging in similar efforts (see 
table 1). Officials told us that it is beneficial to have similar 
education efforts about prescription pain reliever abuse and misuse 
because of the complex nature of this problem and the fact that 
agencies provide different but reinforcing messages about the issue. 

Table 1: Public Education Efforts about Prescription Pain Reliever 
Abuse and Misuse: 

Primary target audience: Teens; 
Agency: DEA; 
Program: Good Medicine, Bad Behavior; 
Medium: Museum exhibit. 

Primary target audience: Teens; 
Agency: DEA; 
Program: Just Think Twice[A]; 
Medium: Website. 

Primary target audience: Teens; 
Agency: NIH; 
Program: Heads Up: Real News About Drugs and Your Body[A]; 
Medium: Classroom materials. 

Primary target audience: Teens; 
Agency: NIH; 
Program: NIDA for Teens[A]; 
Medium: Website. 

Primary target audience: Teens; 
Agency: ONDCP; 
Program: National Youth Anti-Drug Media Campaign[A]; 
Medium: Website. 

Primary target audience: Teens; 
Agency: SAMHSA; 
Program: Not Worth the Risk; Even if it's Legal; 
Medium: Brochures and posters. 

Primary target audience: Parents; 
Agency: DEA; 
Program: Get Smart About Drugs[A]; 
Medium: Website. 

Primary target audience: Parents; 
Agency: ONDCP; 
Program: National Youth Anti-Drug Media Campaign[A]; 
Medium: Website. 

Primary target audience: Parents; 
Agency: SAMHSA; 
Program: Not Worth the Risk; Even if it's Legal; 
Medium: Brochures and posters. 

Primary target audience: College students; 
Agency: SAMHSA; 
Program: Not Worth the Risk; Even if it's Legal; 
Medium: Brochures and posters. 

Primary target audience: Teachers; 
Agency: NIH; 
Program: Heads Up: Real News About Drugs and Your Body[A]; 
Medium: Classroom materials. 

Primary target audience: Teachers; 
Agency: SAMHSA; 
Program: Not Worth the Risk; Even if it's Legal; 
Medium: Brochures and posters. 

Primary target audience: Public; 
Agency: DEA; 
Program: Take Back Initiative; 
Medium: Posters, brochures, advertisements. 

Primary target audience: Public; 
Agency: FDA; 
Program: Opioid Public Service Announcements; 
Medium: Audio, slides. 

Source: GAO analysis of information from NIH, SAMHSA, FDA, DEA, and 
ONDCP. 

Notes: See appendix IV for detailed program descriptions. 

[A] Efforts are broader than prescription drugs. We limited our 
analysis to the prescription drug-related components of these efforts. 

[End of table] 

For example, three initiatives--Just Think Twice, NIDA for Teens, and 
the National Youth Anti-Drug Media Campaign--use the same medium to 
target teens with similar messages about prescription drug abuse and 
misuse. These efforts provide web-based information and interactive 
features to educate teens about prescription drug abuse and misuse. 
(See figure 3 and figure 4 for examples of web-based efforts to 
educate teens about prescription drug abuse and misuse.) Officials 
working on these efforts noted that they chose to focus on teens 
because drug abuse typically starts during teen years. NIH officials 
told us that prescription and over-the-counter medications account for 
most of the drugs commonly abused by 12th graders as well, after 
alcohol, tobacco, and marijuana. Teens are also more vulnerable to the 
negative effects of drug use since their brains are still developing. 

Figure 3: ONDCP and NIH Teen Websites: 

[Refer to PDF for image: depiction of 2 websites] 

Source: ONDCP, NIH, GAO. 

[End of figure] 

Figure 4: DEA Teen Website: 

[Refer to PDF for image: depiction of website] 

Source: DEA, GAO. 

[End of figure] 

There are also two initiatives--DEA's Get Smart About Drugs and 
ONDCP's National Youth Anti-Drug Media Campaign--that use the same 
medium to target parents with similar messages about prescription drug 
abuse and misuse. For instance, both use websites that have 
interactive features that show parents where teens commonly access 
prescription drugs in the home. Both sites also include tips for 
parents about how to talk to teens about drugs and about how to 
identify signs of abuse. 

Officials acknowledged these instances of similar goals and similar 
strategies to reach the same audience among educational efforts. 
However, officials said that these similarities are beneficial in 
addressing prescription drug abuse and misuse. Officials from NIH, 
FDA, DEA, and ONDCP noted that having multiple, reinforcing messages 
about the same subject is valuable in public health communications, 
particularly about an issue as complex as prescription drug abuse and 
misuse. The National Council on Patient Information and Education also 
told us that repetition and frequent delivery of information supports 
message reinforcement. Second, federal agencies have their own 
constituencies and each approaches prescription drug abuse and misuse 
from a slightly different perspective. For instance, NIDA for Teens 
provides a science-based perspective and includes information about 
how prescription drugs affect the brain. Specifically, the "Mind Over 
Matter" series on the NIDA for Teens website explains how prescription 
drugs mimic neurotransmitters to alter the brain's chemistry. DEA's 
Just Think Twice, on the other hand, provides more information about 
the legal consequences of abusing drugs, such as losing federal 
student loans, and the culture of drug abuse, including images of 
drugs and true stories of youth overdose deaths. NIH officials told us 
that both perspectives are important as some members of the public may 
go to NIH's NIDA for information about these issues, while others may 
go to DEA. Officials also said that they cross-reference each other's 
information when appropriate. For instance, ONDCP links to 
publications from NIH's NIDA on one of the National Youth Anti-Drug 
Media Campaign websites. 

In addition to the similarities among the nine targeted educational 
efforts we reviewed, agencies are engaged in additional efforts 
outside the scope of our review which, taken together, may present 
areas of potential duplication.[Footnote 47] These additional efforts 
include posting materials from retired initiatives online, planning 
future efforts, and providing factual information about prescription 
pain relievers. For instance, FDA and SAMHSA have brochures and 
posters for teens and the elderly with messages about prescription 
pain reliever abuse and misuse that are no longer actively 
disseminated, but are still available on their websites. HRSA and, 
contingent on available resources, DEA are also planning to launch new 
or update existing educational initiatives in the next fiscal year, 
targeted at the elderly and parents, respectively. ONDCP is also 
planning to work with agencies and external stakeholders to develop 
and implement national public education campaigns on prescription drug 
abuse and misuse and drug storage and disposal, by April 2013. ONDCP 
officials told us that, as of October 2011, they were still 
considering various options and working to identify resources for 
these campaigns. Finally, three federal agencies have prescription 
drug fact pages on their main websites and FDA oversees the 
dissemination of drug information to patients through tools such as 
medication guides that are provided with some prescription drugs. 
Given the number of agencies involved in educating the public about 
prescription pain reliever abuse and misuse and the number of efforts 
currently under way, these additional efforts represent areas where 
there may be the potential for duplicative programming, if such 
efforts are not effectively coordinated. 

There are also similar target audiences and mediums among the nine 
prescriber education programs we identified, although the content and 
focus of these programs is different (see table 2). For example, two 
CME courses, SAMHSA's Prescribing Opioids for Chronic Pain course and 
FDA's requirement for prescriber education through its extended-
release and long-acting opioid REMS, are both targeted at current 
prescribers. Though these courses have some similar content about 
patient selection and monitoring, FDA officials noted that prescriber 
education through REMS will focus on extended-release and long-acting 
products, whereas the SAMHSA course includes information on both 
extended-release and immediate-release pain relievers. They also noted 
that the SAMHSA course is more focused on addiction and treatment than 
the REMS materials will be. As a result, prescribers are being 
educated about the full range of issues related to prescription pain 
reliever abuse and misuse, including treating pain, appropriate 
prescribing, and recognizing substance abuse in their patients. 

Table 2: Efforts to Educate Prescribers about Issues Related to 
Prescription Pain Reliever Abuse and Misuse: 

Target audience: Current prescribers; 
Program (Agency): Extended-release and long-acting opioid REMS (FDA); 
Medium: CME/CE course; 
Content of training: Appropriate prescribing[A]. 

Target audience: Current prescribers; 
Program (Agency): Addiction Performance Project (NIH)[B]; 
Medium: CME course; 
Content of training: Screening, brief intervention, and referral to 
treatment[C]. 

Target audience: Current prescribers; 
Program (Agency): Prescribing Opioids for Chronic Pain (SAMHSA); 
Medium: CME course; 
Content of training: Appropriate prescribing. 

Target audience: Current prescribers; 
Program (Agency): Transmucosal immediate-release fentanyl REMS (FDA); 
Medium: Written materials; 
Content of training: Appropriate prescribing. 

Target audience: Current prescribers; 
Program (Agency): Physician Clinical Support System - Primary Care 
(NIH)[B]; 
Medium: Written materials, screening tools, mentoring; 
Content of training: Screening, brief intervention, and referral to 
treatment. 

Target audience: Current prescribers; 
Program (Agency): Prescriber's Clinical Support System for the 
Appropriate Use of Opioids in the Treatment of Pain and Opioid-related 
Addiction (SAMHSA); 
Medium: Written materials, mentoring, webinars; 
Content of training: Appropriate prescribing[A]. 

Target audience: Future prescribers; 
Program (Agency): NIDA Centers of Excellence for Physician Information 
(NIH)[B]; 
Medium: Curricular resources, including lectures, case studies, and 
web-based training; 
Content of training: Appropriate prescribing; 
screening, brief intervention, and referral to treatment. 

Target audience: Future prescribers; 
Program (Agency): NIH Pain Consortium Centers of Excellence in Pain 
Education (NIH); 
Medium: Curricular resources; 
Content of training: Treating pain[A]. 

Target audience: Future prescribers; 
Program (Agency): Screening, Brief Intervention, Referral and 
Treatment Medical Residency Program (SAMHSA)[B]; 
Medium: Curricular resources, including lectures, web-based training, 
and role plays, and clinical training, including practice with 
simulated patients; 
Content of training: Screening, brief intervention, and referral to 
treatment. 

Source: GAO. 

Notes: The Addiction Performance Project, Physician Clinical Support 
System--Primary Care, and Centers of Excellence for Physician 
Information are all part of the NIDAMED physician outreach initiative, 
designed to provide tools and resources to assist physicians in 
addressing substance abuse (including prescription drug abuse) in 
their practices. Another component of this initiative is NIH's Drug 
Use Screening Tool, a web-based interactive screening tool for use in 
primary care practices that specifically captures information on 
patient prescription drug abuse. 

[A] Content is anticipated as materials have not yet been developed. 

[B] Programs are broader than prescription drugs. We limited our 
analysis to the prescription drug-related components of these programs. 

[C] According to NIH officials, the primary goal of the Addiction 
Performance Project is to help break down the stigma associated with 
addiction. Educating prescribers about screening, brief intervention, 
and referral to treatment is a secondary goal. 

[End of table] 

Federal Agencies Coordinate Their Educational Efforts through Three 
Main Mechanisms and Have Increasingly Relied on Key Practices for 
Coordination: 

Federal agencies use three main mechanisms--two mechanisms that are 
overseen by ONDCP, the National Drug Control Strategy and the 
Prescription Drug Abuse Prevention Plan, and one mechanism within HHS, 
the HHS Behavioral Health Coordinating Committee's Subcommittee on 
Prescription Drug Abuse--to coordinate their educational efforts. The 
agencies have also begun using key practices for coordination that we 
have identified in prior work on practices that help enhance and 
sustain collaboration.[Footnote 48] ONDCP releases the National Drug 
Control Strategy (the Strategy) on an annual basis and it outlines the 
administration's goals and priorities for reducing the rate of drug 
abuse and misuse and the associated consequences. The Strategy, which 
outlines drug control policies and programs for illicit and 
prescription drugs, serves as a coordination mechanism for drug 
control agencies and incorporates several key practices for 
interagency collaboration. For instance, the Strategy defines and 
articulates a common outcome by establishing the administration's 
goals for reducing drug abuse and misuse. The Strategy also provides a 
means for agencies to agree on roles and responsibilities by listing 
specific actions for agencies to take, including identifying lead and 
partnering agencies for each action item. For example, "Enhance 
Healthcare Providers' Skills in Screening and Brief Intervention" is 
an action item in the 2010 Strategy and it specifies that SAMHSA is 
the lead agency, with NIH's NIDA, HRSA, and the Indian Health Service 
listed as partnering agencies. Finally, the Strategy provides a means 
to monitor, evaluate, and report on results for collaborative efforts. 
Agencies developed objectives and 1-and 2-year milestones for the 
action items in the 2010 Strategy and they submit regular progress 
reports to ONDCP. 

The Prescription Drug Abuse Prevention Plan (the Plan) was recently 
released by ONDCP and complements the Strategy by outlining the 
administration's approach to addressing prescription drug abuse and 
misuse, in particular. As a result, it serves as a second interagency 
coordination mechanism for agencies addressing prescription drug abuse 
and also reflects the key practices for collaboration that we 
previously identified. The Plan establishes mutually reinforcing or 
joint strategies by identifying four priority areas for federal 
efforts to reduce prescription drug abuse and misuse--education, 
monitoring, proper disposal, and enforcement--and it aligns agencies' 
activities around these four areas. For instance, the Plan calls for 
federal agencies and private stakeholders to work together to develop 
evidence-based public education campaigns about appropriate use, 
secure storage, disposal, and abuse of prescription drugs. Like the 
Strategy, the Plan also provides a means to monitor, evaluate, and 
report on results. ONDCP asked agencies to submit implementation plans 
with objectives and 1-and 2-year milestones and to provide progress 
reports on a quarterly basis. The Plan also calls for the 
establishment of a Federal Council on Prescription Drug Abuse to 
coordinate implementation of the Plan. 

Finally, the HHS Behavioral Health Coordinating Committee's 
Subcommittee on Prescription Drug Abuse provides a third coordination 
mechanism for HHS agencies and demonstrates use of the key practices 
for collaboration as well. For instance, the Subcommittee defines a 
common outcome for HHS agencies by identifying five goals related to 
prescription drug abuse and organizing its activities around these 
goals.[Footnote 49] The Subcommittee also provides a means to monitor 
and report on progress to HHS leadership. Agency officials report on 
their activities related to prescription drug abuse and misuse to the 
Subcommittee co-chairs, who then provide updates to HHS leadership. 

Agencies have begun using these coordination mechanisms, or augmenting 
existing coordination efforts, within recent years. Beginning in 2009, 
ONDCP began using a more collaborative process for developing the 
Strategy, convening a Demand Reduction Interagency Working Group. The 
working group brought together subject experts from drug control 
agencies to provide input on the development of the Strategy and DEA, 
FDA, HRSA, NIH, and SAMHSA all participated. Officials from multiple 
agencies indicated that this process was more interactive than in 
years past. The 2010 Strategy also utilized a new approach by 
outlining specific action items and developing a system to monitor 
agency progress toward objectives. ONDCP also released the Plan in 
April 2011 and agency officials described the process for developing 
the Plan as collaborative. One official described the amount of 
brainstorming between ONDCP and agencies in order to develop the Plan 
as "unprecedented." Finally, the Subcommittee on Prescription Drug 
Abuse was formed in the summer of 2010. Officials explained that the 
Subcommittee provides a more regular and formal means of coordination, 
whereas prior efforts to coordinate within HHS were more irregular and 
informal. For instance, the Subcommittee helped institutionalize 
relationships among officials who work on prescription drug abuse and 
misuse across HHS. Officials noted that although they were previously 
aware of subject experts at other agencies, they now work together on 
related tasks through the Subcommittee and therefore have formal 
working relationships which they can draw on to work through issues. 
Subcommittee members added that they use their meetings to share 
programming information. For instance, prior to convening the 
Subcommittee, NIH officials told us that they were not fully aware of 
all of the prescriber education efforts across HHS agencies. Now, 
officials have created a group through the Subcommittee to catalogue 
related prescriber education programs. 

While officials from each agency we spoke with said that these 
coordination mechanisms were working well, ONDCP and other agency 
officials indicated that they were aware of the potential for creating 
too many coordinating bodies. Though the Strategy's Demand Reduction 
Interagency Working Group, the Plan's new Federal Council on 
Prescription Drug Abuse, and the HHS Subcommittee on Prescription Drug 
Abuse may have membership from many of the same agencies, officials 
said that they felt that they had not reached the point of too much 
coordination, noting that current coordination efforts were effective 
in terms of facilitating information sharing and avoiding overlapping 
programming among agencies. 

Federal Agencies Have Missed Opportunities to Leverage Resources among 
Efforts with Similar Goals: 

Although agencies have increased their coordination efforts in recent 
years, they have missed opportunities to leverage resources--a key 
practice for effective coordination--among similar education efforts 
targeting teens, which may have resulted in lost opportunities to 
obtain additional benefits through coordination. At least four teen 
initiatives--Just Think Twice, NIDA for Teens, the National Youth Anti-
Drug Media Campaign, and Not Worth the Risk; Even if it's Legal--have 
obtained feedback from teens and other stakeholders about the features 
of and messages for educational efforts about prescription drug abuse 
and misuse that was not shared. For instance, NIH formed a Teen 
Advisory Group to pretest their messages and also seeks input from 
local high school students, including groups such as Students Against 
Destructive Decisions. These focus groups revealed information that 
could be useful to other teen education efforts, addressing topics 
such as web and materials design, video content, language and 
terminology, and messaging. For instance, one focus group revealed 
that trying to imitate the layout of social networking sites (e.g., 
MySpace or Facebook) did not make sites more appealing to teen users. 

DEA, ONDCP, and SAMHSA also get feedback on their teen education 
efforts. DEA gets feedback from the Drug Abuse Resistance Education--
D.A.R.E.--Youth Advisory Board on content for Just Think Twice and 
also gets feedback from DEA field staff who give presentations to 
teens about drug abuse. DEA officials told us that the feedback on the 
website that they received from field staff often varies depending on 
the part of the country in which the field staff give presentations in 
schools, with field staff in San Diego reporting different successful 
approaches than those in Miami. ONDCP also pretests content and 
features with teens. One lesson derived from ONDCP's pretesting 
efforts is that teens liked the option to view content posted by their 
peers on the website, such as photos or stories. Finally, SAMHSA gets 
input from professional and student groups through its Project 
Advisory Team for Not Worth the Risk; Even if it's Legal. For 
instance, the Project Advisory Team advised SAMHSA on a number of 
issues related to addressing prescription drug abuse and misuse among 
teens, including the importance of acknowledging and validating common 
stressors teens face in order to establish credibility and to create 
an opportunity to address alternative coping skills. 

While each of these agencies obtained feedback on the messages for and 
features of similar initiatives, agencies did not share the results of 
their feedback sessions or pretesting efforts with officials from 
other agencies who work on similar programs. Officials said they did 
not share the feedback they received for two reasons. First, NIH, DEA, 
and SAMHSA officials said that they were never asked to do so by other 
agencies with similar education efforts. Second, ONDCP officials said 
that they felt that the results of their pretesting would not be 
useful for other educational efforts. Nonetheless, one official 
acknowledged that sharing findings from pretesting efforts and other 
feedback sessions could have been useful when developing the content 
and messages for their educational effort. 

NIH officials said that there are two coordination mechanisms through 
which they could share information among agencies involved with 
educational efforts in the future. In addition to its Subcommittee on 
Prescription Drug Abuse, the HHS Behavioral Health Coordinating 
Committee also has a Communications Subcommittee and NIH officials 
said that they can use the Communications Subcommittee to share 
information about the development of educational efforts among HHS 
agencies. NIH officials said that they also have the opportunity to 
share information with agencies outside of HHS through weekly phone 
calls that ONDCP facilitates with communications staff from DEA, NIH, 
ONDCP, and SAMHSA, among other agencies. 

Conclusions: 

Abuse and misuse of prescription pain relievers is a large and growing 
public health problem in the United States. Although DEA, FDA, NIH, 
ONDCP, and SAMHSA are engaged in multiple efforts to educate the 
public about prescription pain reliever abuse and misuse, there is 
limited evidence about how to craft effective messages about this 
issue. The agencies agree that education about prescription drug abuse 
and misuse requires a different approach than other drug prevention 
efforts, but there is a lack of proven strategies and messages on 
which agencies can model their own educational efforts to ensure that 
such efforts will have the desired outcome. In the absence of a strong 
evidence base, establishing outcome metrics is an especially important 
key practice to incorporate into the development of educational 
efforts because outcome metrics provide feedback on the effectiveness 
of agencies' efforts at preventing prescription pain reliever abuse 
and misuse. However, seven of the nine public education efforts that 
we reviewed did not assess program outcomes. This leaves federal 
agencies with limited knowledge as to whether such efforts are 
effective. 

Given these challenges, there is much to be gained from continued and 
robust coordination among similar education efforts about prescription 
pain reliever abuse and misuse. In its role as a coordinating body for 
federal drug control efforts, ONDCP is uniquely situated to ensure 
that federal educational efforts are not duplicative and are 
effectively coordinated. DEA, NIH, SAMHSA, and ONDCP operate similar 
educational initiatives--including three websites and a brochure 
series--targeting teens. While agency officials told us that the 
similar educational efforts we reviewed are reinforcing, it is 
important that agencies continue to coordinate their efforts as 
additional planned educational efforts are implemented in order to 
avoid duplicative programming. Although agencies involved in educating 
the public have recently increased their coordination efforts, they 
have missed opportunities to share the results of teen and stakeholder 
feedback among similar efforts--a key practice for effective 
coordination. In developing their educational efforts, DEA, NIH, 
ONDCP, and SAMHSA obtained feedback from their target audience and 
other stakeholders that could be useful for other agencies to consider 
in relation to their own efforts. Although each educational effort has 
unique features, comments from focus group participants and other 
stakeholders could produce lessons that other agencies could have 
drawn on if summaries of those comments had been made available to 
other agencies to review. As additional public education efforts are 
developed agencies will need to leverage resources, including sharing 
lessons learned from the development and implementation of existing 
educational efforts, to ensure that they make the best use of limited 
resources. 

Recommendations for Executive Action: 

In order to ensure that federal efforts to prevent the abuse and 
misuse of prescription pain relievers are an effective and efficient 
use of limited government resources, we recommend that the Director of 
ONDCP take the following three actions: 

* Establish outcome metrics and identify resources for conducting 
outcome evaluations for the national education campaigns about 
prescription drug abuse and safe storage and disposal proposed in the 
Prescription Drug Abuse Prevention Plan. 

* Develop and implement a plan to evaluate outcomes from the proposed 
national education campaigns. 

* Ensure that federal agencies undertaking similar educational efforts 
leverage available resources and use coordination mechanisms to share 
information on the development of their efforts. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to ONDCP, the Department of 
Justice, and HHS for their review and comment. In written comments, 
reproduced in appendix VI, ONDCP did not explicitly agree or disagree 
with our recommendations, but noted that it will continue to work for 
improved coordination of prescription drug abuse educational efforts 
and evaluation of outcomes. ONDCP also stated that the prescription 
drug abuse educational efforts that we reviewed target different 
populations and address different messages, and suggested that we 
explain the differences among these efforts in our report. We revised 
our report to include an additional reference to our detailed 
descriptions of the various educational efforts we reviewed, which 
explain the scope, target audiences, and mediums used among the 
educational efforts. We also included additional information about the 
size and scope of ONDCP's National Youth Anti-Drug Media Campaign. 
ONDCP, DEA, and HHS also provided technical comments, which we have 
incorporated as appropriate. 

As agreed with your offices, 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 Director of the Office of National Drug Control Policy, the 
Attorney General, and the Secretary of Health and Human Services. In 
addition, the report will be available at no charge on the GAO website 
at [hyperlink, http://www.gao.gov]. 

If you or your staff have any questions about this report, please 
contact me at 202-512-7114 or crossem@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. GAO staff who made key contributions to 
this report are listed in appendix VII. 

Signed by: 

Marcia Crosse: 
Director, Health Care: 

[End of section] 

Appendix I: Abuse-Deterrent Formulations of Prescription Pain 
Relievers: 

In order to help address the abuse and misuse of prescription pain 
relievers, drug manufacturers are developing formulations of these 
drugs that are specifically designed to deter abuse.[Footnote 50] We 
are presenting information on different types of abuse-deterrent 
formulations of prescription pain relievers, whether they are being 
used in fiscal year 2011, and challenges related to these products. 
This appendix is based on our review of scientific literature and Food 
and Drug Administration (FDA) and manufacturer documents, as well as 
interviews with FDA officials and representatives of Purdue Pharma 
L.P., the manufacturer of OxyContin. 

Manufacturers of prescription pain relievers have long sought to 
achieve a balance between creating drugs that are effective for 
therapeutic use while minimizing their potential for abuse. The 
scientific articles noted that, in general, abusers seek out drugs 
that can be smoked, snorted, or taken intravenously, thus providing a 
more rapid onset of the effects of the drug. Therefore, some 
manufacturers of prescription pain relievers have focused on making 
their products tamper resistant, so that the physical or chemical 
makeup or delivery system of the drug cannot be altered, with the goal 
of preventing users from accessing and abusing the active ingredient. 

Types of Abuse-Deterrent Formulations: 

[Side bar: 
Example of an Abuse-Deterrent Formulation: Embeda: 

Embeda is a prescription pain reliever that was designed from 
inception to be abuse-deterrent. Embeda employs an agonist-antagonist 
combination in which the antagonist-—a substance that counteracts the 
opioid (in this case, naltrexone)-—is embedded within the center of 
the active ingredient, or agonist (in this case, morphine). 

[Figure: illustration of above description] 

Source: Alpharma Pharmaceuticals, LLC, a subsidiary of Pfizer. 

[End of figure] 

When administered orally, as prescribed, the naltrexone remains 
pharmacologically inert and the morphine provides pain relief for up 
to 24 hours. If the capsule is chewed, crushed or dissolved, the 
naltrexone is activated, inhibiting the psychoactive effect of the 
morphine and thus making it less
attractive to abusers. 

Source: GAO and Alpharma Pharmaceuticals, LLC. 
End of side bar] 

There are five different types of abuse-deterrent formulations 
manufacturers have developed to reduce tampering and abuse of their 
products, though some drugs may incorporate multiple types. Some of 
these abuse-deterrent formulations are already being utilized in 
prescription pain relievers, others are being incorporated into pain 
relievers that are in the process of being developed, and others have 
been used in other types of products, but not prescription pain 
relievers. In general, the different classifications include:[Footnote 
51] 

* Physical/Chemical Barriers - Such barriers impart physical or 
chemical properties to a drug so that it resists manipulation via 
chewing, grinding, and mixing with alcohol or other common solvents, 
thus making extraction of the active ingredient difficult. A 
reformulated version of the prescription pain reliever OxyContin that 
is currently marketed uses this type of barrier to deter abuse. 

* Agonist/Antagonist Combinations - Combinations of agonists and 
antagonists, which mitigate, block, or reverse the effect of the 
agonist (the opioid), if manipulated. Two prescription pain relievers 
that were marketed in fiscal year 2011 use this barrier to deter 
abuse: Talwin Nx and Embeda (see sidebar).[Footnote 52] 

* Aversion - A combination of substances designed to produce an 
unpleasant effect if a tampered form is ingested or a higher dosage 
than directed is used. For example, one formulation designed in the 
past added niacin to a prescription pain reliever to dissuade abusers 
because, in high doses, niacin causes headache, sweating, chills, 
flushing, and general discomfort. While at least one manufacturer has 
designed prescription pain relievers using the aversion method of 
abuse-deterrence in the past, FDA officials told us that no such 
prescription pain relievers are currently marketed.[Footnote 53] 

* Delivery System - The method of delivery or drug release design can 
be used as an abuse deterrent. For example, a depot injection--an 
injection that releases its active ingredient over a sustained period--
or subcutaneous implant can be more difficult to tamper with. FDA 
officials told us that they were not aware of any prescription pain 
relievers currently marketed that were designed to be abuse-deterrent 
by way of a delivery system. 

* Prodrug - Prodrug compounds must undergo biotransformation to 
activate the active ingredients. For example, they may be formulated 
so that they are only activated if they are metabolized in the 
digestive system, so that the drug will not be activated if, for 
example, it is taken intravenously. FDA officials told us that they 
were not aware of any prescription pain relievers currently marketed 
that were designed to be abuse-deterrent by way of a prodrug design. 

Challenges Related to Abuse-Deterrent Prescription Pain Relievers: 

Manufacturers face a number of challenges related to abuse-deterrent 
formulations of prescription pain relievers. First, there are 
technical challenges in developing formulations of prescription pain 
relievers that deter abuse, but still have the intended effect of 
providing pain relief. For example, it took Purdue Pharma L.P. 
approximately 9 years to develop a reformulated version of OxyContin 
that both effectively provided pain relief and displayed abuse-
deterrent properties. Another challenge for manufacturers relates to 
the extent to which they will be allowed to market their new products 
as reducing or deterring abuse. FDA officials told us that until 
postmarketing studies demonstrate a product's effectiveness in 
reducing abuse in the general population, manufacturers cannot market 
their products accordingly, but they are allowed to make marketing 
claims based on the product's abuse-deterrent features as demonstrated 
in clinical trials. For example, Embeda's label includes information 
on the results of clinical trails testing its abuse-deterrent 
features, but also states that the abuse-deterrent characteristics of 
the product "have not been shown to reduce the abuse liability of 
Embeda." Finally, a manufacturer indicated that insurers may be 
reluctant to provide coverage for abuse-deterrent formulations of 
drugs when less expensive, nondeterrent alternatives are available and 
that this could minimize their usage and ultimately, their impact on 
abuse in the general population. 

FDA faces a number of challenges related to approving and assessing 
the safety and effectiveness of abuse-deterrent formulations of 
prescription pain relievers. According to FDA officials, one of these 
challenges is balancing the abuse-deterrent properties of a drug with 
its safety in the general patient population. Another challenge for 
FDA is developing standards and methods for determining if the 
products are, in fact, abuse deterrent. FDA officials told us that the 
agency is currently developing guidance for manufacturers on the 
development of abuse-deterrent formulations and on the postmarket 
assessment of their performance. However, officials told us that 
standard guidance is difficult to develop because potential types of 
abuse-deterrent formulations are so varied that the criteria used to 
evaluate one drug may not be applicable for another. FDA indicated 
that it requires manufacturers of prescription pain relievers that 
want to make abuse-deterrent claims about their products to conduct 
postmarket epidemiological studies to assess the effectiveness of 
their drugs in deterring abuse in the general population. However, in 
developing methods for assessing the effectiveness of a particular 
drug on deterring abuse, FDA officials told us that they, like 
manufacturers, are challenged by limitations in available data. FDA 
officials said that consistent and clear definitions of abuse across 
data sources are lacking and that most data sources with information 
on prescription pain reliever abuse do not distinguish between 
products from different manufacturers, which can make it difficult to 
assess the effectiveness of a specific drug in deterring abuse. For 
example, data sources that measure abuse and its consequences may not 
distinguish between OxyContin and other drugs that contain oxycodone. 
Further, FDA is challenged in determining what degree of decrease in 
some measurable outcomes of abuse would be sufficient to label a drug 
as being able to reduce actual abuse. 

Finally, there are inherent challenges related to abuse-deterrent 
formulations of prescription pain relievers and their overall impact 
on abuse. First, a drug that deters one type of abuse might not 
necessarily deter another type of abuse. For example, the new 
formulation of OxyContin is designed to deter abuse via injection or 
snorting (see sidebar), but is not a deterrent for those who abuse the 
product via oral ingestion of whole tablets. A related challenge is 
that while technology may deter the abuse of one particular 
prescription pain reliever, an abuser may instead seek another 
prescription pain reliever (either a different formulation of the same 
pain reliever or a different pain reliever altogether) that is not 
designed to be abuse deterrent. An abuser may even seek out another 
opioid, such as heroin. 

[Side bar: 
Example of an Abuse-Deterrent Formulation: OxyContin: 

OxyContin is a prescription pain reliever that was reformulated to be 
abuse deterrent. The extended-release mechanism of the original 
formulation of OxyContin could be overcome by crushing the tablet to 
release a large amount of oxycodone. Purdue Pharma L.P. reformulated 
OxyContin to use physical/chemical barriers to deter abuse by mixing 
the active ingredient—oxycodone—with polyethylene oxide, increasing 
the hardness of the tablet and rendering it more difficult to crush. 

[Figure: 2 photographs] 

Source: Purdue Pharma L.P. 

[End of figure] 

If the tablet is successfully physically altered through crushing and 
mixing with a liquid, the result is a viscous gel that is difficult to 
take up in a syringe. 

[Figure: 2 photographs] 

Source: Purdue Pharma L.P. 

Note: According to the manufacturer, the reformulated OxyContin on the 
right cannot be drawn up into a syringe. 

[End of figure] 

FDA officials told us that only limited, preliminary data about the 
impact of the reformulated OxyContin on abuse are available (the 
reformulated OxyContin has only been in widespread use since late 
2010). These preliminary data have been promising, but officials were 
uncertain as to whether any decreases in OxyContin abuse would hold 
over the long term. 

Source: GAO and Purdue Pharma L.P. 
End of side bar] 

[End of section] 

Appendix II: DEA Quotas for Controlled Substances: 

As part of its responsibilities related to enforcing the Controlled 
Substances Act, the Drug Enforcement Administration (DEA) sets limits, 
called quotas, on the quantity of schedule I and II controlled 
substances that may be produced in the United States in any given 
calendar year.[Footnote 54] Quotas are a component of the closed 
system of distribution that exists under the Controlled Substances 
Act. In this appendix, we present an overview of the closed system, as 
well as information on the three types of quotas: aggregate production 
quotas (APQ), bulk manufacturing quotas, and procurement quotas. The 
information in this appendix is based on our review of DEA documents 
and interviews with DEA officials. 

Closed Distribution System: 

Under the Controlled Substances Act, DEA maintains a closed system 
requiring any person who manufactures, dispenses, imports, exports, or 
conducts research with controlled substances to register with DEA 
(unless exempt),[Footnote 55] periodically inventory all stocks of 
controlled substances,[Footnote 56] provide effective security 
controls,[Footnote 57] and maintain records to account for all 
controlled substances manufactured, imported, exported, received, 
distributed, or otherwise disposed of.[Footnote 58] DEA officials said 
that the closed system, including quotas, is designed to reduce the 
amount of pharmaceuticals that are diverted for illicit purposes, 
while also ensuring an adequate and uninterrupted supply of controlled 
substances for legitimate medical needs. They said that both 
legitimate and illegitimate users of prescription pain relievers often 
acquire the drugs from the same source--from doctors or other 
practitioners who prescribe or dispense them. For example, diversion 
of prescription pain relievers may occur through methods such as 
doctor shopping, thefts from medicine cabinets, improper prescribing, 
and forged prescriptions. 

According to DEA, quotas are a tool used at the beginning of the 
closed system to manage and prevent diversion of controlled 
substances, such as the substances used to make prescription pain 
relievers, during their legitimate scientific, medical, and industrial 
applications. While DEA is authorized to control the overall amount of 
controlled substances available, according to DEA officials, it is 
ultimately for practitioners and their regulating bodies to ensure 
that these substances are prescribed appropriately. While officials 
said that they do seek to account for known diversion when setting 
APQs, they said that establishing quotas based on known diversion for 
the purpose of reducing the availability of prescribed drugs will not 
appreciably affect diversion at the retail level and may prevent 
legitimate patients from having access to medication for legitimate 
medical needs. 

Aggregate Production Quotas: 

DEA officials said that the APQ is the first type of quota that DEA 
sets for each year.[Footnote 59] The APQ specifies the maximum amount 
of each basic class of controlled substance listed in schedule I or II 
that can be produced for specified needs in the United States in a 
given year, thus limiting the amount of bulk raw materials available 
for use in the manufacture of prescription pain relievers. For 
example, methadone is a controlled substance that is used in the 
manufacture of drugs for addiction treatment as well as in the 
manufacture of the prescription pain relievers Dolophine and 
Methadose, and multiple generic equivalents. In 2010, DEA set the 
final APQ for methadone at 20,000,000 grams. Therefore, this is the 
maximum amount of methadone that could be available for manufacturing 
addiction treatment drugs and prescription pain relievers that use 
this substance, as well as for other authorized uses, in the United 
States in 2010. 

DEA officials said that they consider data from many sources when 
determining the APQ, including estimates of the legitimate medical 
need for each substance from FDA, estimates of retail consumption 
based on prescriptions dispensed from IMS Health, companies' 
production history and forecasts, data from DEA's own internal system 
for tracking controlled substances transactions, and past quota 
histories for each substance.[Footnote 60] DEA officials said that DEA 
scientists draw on their professional expertise and experience when 
considering all available data to recommend the appropriate APQ for a 
substance. DEA then publishes the proposed APQ for each substance for 
the following calendar year in the Federal Register, and, after 
receiving and reviewing comments, DEA publishes a final order 
determining the APQ for that year. DEA can revise the APQ midyear if 
legitimate changes in U.S. manufacturing requirements, such as 
increased sales or exports, new manufacturers entering the market, new 
product development, or product recalls, warrant a change. For 
example, in 2010, DEA revised the APQ for methadone, decreasing it 
from an initial APQ of 25,000,000 grams to the revised APQ of 
20,000,000 grams. 

Officials said that when determining the APQ they also consider losses 
of controlled substances that occur through diversion activities by 
considering known and reported thefts and losses, case seizures, and 
information from national databases of drug evidence, such as analysis 
from DEA and other forensic laboratories and law enforcement entities. 
DEA can reduce the APQ based on the quantity of seized or diverted 
material. The APQ may also be decreased because of DEA enforcement 
actions that impact sales data, such as by shutting down rogue pain 
clinics, thus reducing the amount of controlled substances purchased 
by such entities. DEA officials said that because sales data are one 
factor considered in determining APQ, these actions may ultimately 
lead to a reduction in the APQ. DEA said that in rare instances the 
APQ may also be increased as a result of diversion activities. For 
example, if a large quantity of a controlled substance is stolen from 
a manufacturer, the APQ may need to be raised to ensure that 
sufficient quantities of that substance will be available to meet the 
nation's ongoing legitimate medical needs. When determining the 
following year's APQ, DEA considers such circumstances to ensure that 
the APQ remains at an appropriate level to meet legitimate need and 
may reduce the APQ in relation to the previous year's to account for 
the known diversion. 

Bulk Manufacturing Quotas and Procurement Quotas: 

In addition to the APQ, DEA sets two types of quotas for individual 
companies: bulk manufacturing quotas[Footnote 61] and procurement 
quotas.[Footnote 62] Bulk manufacturing quotas limit the amount of a 
basic class of schedule I or II controlled substance that an 
individual company can extract or synthesize from plant material or 
other controlled substances. According to DEA officials, once the 
initial APQ for a substance for a calendar year is set by DEA, 
individual companies apply to DEA for bulk manufacturing quotas for 
specific controlled substances to produce the bulk raw materials that 
are used in prescription pain relievers for that same year. Officials 
said that separate quotas are issued for each DEA-registered facility 
that manufactures a controlled substance, even if the same company 
operates multiple manufacturing facilities. In 2010, five facilities 
received bulk manufacturing quotas for methadone. The quota levels 
ranged between 4 grams at the low end and 12,000,000 grams at the 
highest levels. The sum of the bulk manufacturing quotas for all 
companies for a particular controlled substance cannot exceed the APQ 
for that substance in a given year. 

DEA officials said that they use a variety of data sources--including 
internal DEA data, IMS Health data, and data provided by the company-- 
to determine the bulk manufacturing quota for a company. DEA's Office 
of Diversion Control also reviews the company for any pending 
administrative, civil, or criminal action. DEA officials said that DEA 
scientists draw on their professional expertise and experience when 
considering all available data to recommend an appropriate bulk 
manufacturing quota, which is then issued to the company by letter. 
Bulk manufacturing quotas can be revised through a process similar to 
that used in setting the initial quotas, in that a company submits an 
application to revise its quota and must include supporting 
documentation. DEA officials said that DEA does not generally initiate 
changes to bulk manufacturing quotas on its own. 

DEA also establishes procurement quotas, which limit the amount of a 
basic class of schedule I or II controlled substance that an 
individual company can procure from a manufacturer of bulk raw 
materials in order to manufacture individual dosage units of a 
medicine, such as a prescription pain reliever. Individual companies 
must apply to DEA for procurement quotas for each specific basic class 
of controlled substance, and DEA officials told us that separate 
quotas are issued for each facility that procures a controlled 
substance. For example, according to DEA data, 52 facilities received 
procurement quotas for methadone in 2010. The quota levels ranged 
between 1 gram at the low end and 9,000,000 grams at the highest 
levels. Sometimes an individual company may be engaged in both bulk 
manufacturing and procurement activities for the same controlled 
substance. In this case, the company will apply for both a bulk 
manufacturing quota and a procurement quota. DEA officials said they 
use the same process and data sources, as described above, to 
determine appropriate levels for procurement quotas as for bulk 
manufacturing quotas. 

Officials said that DEA does not always set a company's bulk 
manufacturing quota or procurement quota at the level the company 
requested. For example, if a registrant is suspected of unlawfully 
diverting controlled substances, DEA will take this factor into 
consideration when determining whether to grant or deny the quota 
request. In addition, DEA may set the quota lower than requested if a 
company has set its quota request based on projected sales figures, 
which can inflate the quantity of quota requested, rather than on 
actual sales figures. DEA officials said that the agency uses actual 
sales and inventory figures in their evaluation of bulk manufacturing 
or procurement quota applications, and they grant quotas in line with 
legitimate medical need. In the past, we have reported that DEA cited 
difficulties in determining an appropriate level for quotas to ensure 
that adequate quantities are available for legitimate medical need, as 
there are not direct measures available to establish legitimate 
medical need. DEA officials said that, based on the available 
prescription and sales data, there is no method to calculate which 
prescriptions are issued for a legitimate medical purpose by a 
practitioner acting in the usual course of professional practice and 
which are not. They noted that if DEA were to reduce a quota level by 
some percentage to account for estimated illegitimate prescriptions or 
to otherwise reduce a quota by an amount estimating how much of the 
substance is abused and misused, the action would only reduce the 
total amount of substance available for dispensing, and would not 
affect to whom or in what quantities the drugs are prescribed or 
dispensed. Therefore, DEA officials said that a reduction in the 
supply of a drug based upon estimated illegitimate prescriptions or 
abuse and misuse could result in a shortage of the substance for 
legitimate purposes, while not affecting illicit demand for the 
substance at all. As a result, officials said that the agency does not 
use the quota process as a tool to reduce demand or to help prevent 
abuse and misuse of prescription pain relievers. 

[End of section] 

Appendix III: Objectives, Scope, and Methodology: 

This report (1) describes recent national trends in prescription pain 
reliever abuse and misuse, (2) describes how federal agencies are 
educating prescribers about prescription pain reliever abuse and 
misuse, (3) assesses the extent to which federal agencies follow key 
practices for developing public education efforts about prescription 
pain reliever abuse and misuse, and (4) identifies educational efforts 
that use similar strategies and assess how agencies coordinate those 
efforts. To conduct this work we interviewed officials and reviewed 
documents, as described below for each objective. In addition, to gain 
context on the challenge of addressing the problem of abuse and misuse 
of prescription pain relievers while ensuring access to these pain 
relievers for legitimate medical use, we interviewed officials from 
the American Pain Foundation, and Purdue Pharma L.P., the manufacturer 
of the prescription pain reliever OxyContin. 

To describe recent national trends in prescription pain reliever abuse 
and misuse, we interviewed officials from the Centers for Disease 
Control and Prevention (CDC), DEA, FDA, the National Institutes of 
Health's (NIH) National Institute on Drug Abuse (NIDA), the Office of 
National Drug Control Policy (ONDCP), and the Substance Abuse and 
Mental Health Services Administration (SAMHSA). We also conducted a 
literature review to identify relevant data sources and explanations 
for trends in prescription pain reliever abuse and misuse and analyzed 
data related to prescription pain reliever abuse and misuse from 
several data sources representative of the U.S. population aged 12 
years and older. We included data in our review from the Drug Abuse 
Warning Network (DAWN), the National Vital Statistics System (NVSS), 
the Treatment Episode Data Set (TEDS), and the National Survey on Drug 
Use and Health (NSDUH). We selected these four data sources because 
they are the data sources that the agencies we interviewed use for 
monitoring trends in prescription pain reliever abuse and misuse, and 
because they are nationally representative.[Footnote 63] We analyzed 
data for calendar years 2003-2009, the most recent years for which 
data from at least three data sources were available. 

DAWN, a public health surveillance system operated by SAMHSA, provides 
annual national estimates of drug-related emergency department visits, 
including visits involving the abuse or misuse of prescription pain 
relievers.[Footnote 64] These national estimates are produced from 
data DAWN collects from a national sample of general, nonfederal 
hospitals operating 24-hour emergency departments. For each sample 
hospital, a trained DAWN reporter conducts a retrospective review of a 
random sample of emergency department medical records to identify 
emergency department visits that involved recent drug use. The number 
of visits may not directly represent the number of individuals who 
have visited emergency departments in a given year, since some 
patients may have more than one visit in a year. Emergency department 
medical records may vary in specificity and detail. For example, 
prescription pain reliever abuse and misuse may be overreported if the 
medical record is unclear about whether an individual was abusing or 
misusing a prescription pain reliever, or taking it as prescribed 
while abusing or misusing another drug. Conversely, prescription pain 
reliever abuse and misuse may be underreported if the abuse or misuse 
of a regularly prescribed prescription pain reliever is not recognized 
or documented by the clinician. Because of changes to the DAWN 
methodology for 2004, we were not able to look at trends in DAWN data 
prior to that year. 

NVSS, operated by CDC, receives and compiles data from all death 
certificates filed in the United States each year, including deaths 
involving prescription pain relievers. The causes of death section of 
the death certificates are completed by local medical examiners, 
coroners, or attending physicians, and the information is then coded 
by the states, or in some cases by CDC, and submitted to CDC, where it 
is further processed and coded, if necessary.[Footnote 65] NVSS data 
on overdoses includes both the mechanism of injury leading to death 
(such as poisoning by certain substances) and the manner or intent, 
including unintentional, suicide, homicide, undetermined, and legal 
intervention or war. Although CDC sometimes reports on all manners of 
overdose deaths combined, we focused only on unintentional deaths 
because it matches most closely with our definition of abuse and 
misuse.[Footnote 66] CDC officials said that some jurisdictions may 
undercount unintentional overdose deaths involving prescription pain 
relievers because of inconsistent use of toxicological lab tests, 
which may result in listing a death as a drug overdose death with no 
drugs specified on the death certificate, and other inconsistencies 
among jurisdictions, such as how they determine whether deaths are 
unintentional.[Footnote 67] NVSS data for 2009 were not published in 
time for inclusion in this report. 

TEDS, compiled by SAMHSA, gathers data on admissions to substance 
abuse treatment facilities nationwide, including data about the 
substances being abused by the person being admitted to treatment, 
such as prescription pain relievers. TEDS does not include all 
admissions to substance abuse treatment. It includes admissions at 
facilities that are licensed or certified by the state substance abuse 
agency to provide substance abuse treatment (or are administratively 
tracked for other reasons). In general, facilities reporting TEDS data 
are those that receive state alcohol or drug agency funds (including 
federal block grant funds) for the provision of alcohol or drug 
treatment services. Data about admissions are initially gathered by 
the facilities themselves and then collected by states and transmitted 
to a national data center. The number of admissions does not directly 
represent the number of individuals who have been admitted to 
treatment in a given year, because an individual admitted to treatment 
twice within a calendar year would be counted as two admissions. While 
treatment facilities included in TEDS account for a significant 
portion of treatment admissions nationwide, SAMHSA officials told us 
that no nationwide estimates are available of admissions to private, 
for-profit facilities or on the number of individuals being treated 
for substance abuse by physicians who have been approved to 
independently treat opioid addiction in an office-based setting. 
Therefore, SAMHSA officials told us that TEDS data underreport the 
number of individuals seeking treatment for prescription pain reliever 
abuse and misuse in the United States, especially among populations 
that have the resources to seek treatment from private facilities or 
physicians. In addition, the facilities and populations included in 
the data each state reports to TEDS are affected by state regulations 
and funding priorities. For example, some states report data from 
hospital-and prison-based treatment facilities, while others do not. 
Finally, some states may target certain populations, such as 
teenagers, with their limited funds for addiction treatment, meaning 
that these populations may be more heavily represented in the data 
from those states. 

NSDUH, an annual survey sponsored by SAMHSA, provides annual national 
estimates about the use of illicit drugs, alcohol, and tobacco in the 
civilian, noninstitutionalized population of the United States aged 12 
years old or older, including estimates about the abuse and misuse of 
prescription pain relievers.[Footnote 68] These national estimates are 
produced from data NSDUH collects through a national household survey, 
which involves in-person interviews with sampled respondents. SAMHSA 
officials reported that NSDUH may underestimate the extent of drug 
use, including prescription pain reliever abuse and misuse, both due 
to underreporting by surveyed individuals and because the sample may 
not include some individuals at high risk for drug use. We have 
reported on these limitations in the past.[Footnote 69] While NSDUH 
incorporates strategies intended to increase respondents' cooperation 
and willingness to report honestly and accurately, such as use of 
computer-assisted interviewing methods, it is not possible to know the 
extent of underreporting within NSDUH data. However, SAMHSA officials 
told us that when looking at trended data, underreporting is not a 
problem because it is assumed constant. 

To assess the reliability of these data for our purposes, we reviewed 
related documentation and conducted interviews with knowledgeable 
agency officials from CDC and SAMHSA to learn about data collection, 
quality control, and any limitations of these data sources. We also 
conducted electronic and manual data testing to ensure the quality of 
the data. We determined that all data we assessed were sufficiently 
reliable to provide overall trends for the purposes of our review. 

To describe how federal agencies are educating prescribers about 
prescription pain reliever abuse and misuse, we reviewed the 2010 
National Drug Control Strategy and interviewed officials involved with 
federal prevention efforts to identify strategies used to educate 
prescribers during fiscal year 2011. We then interviewed officials 
from FDA, NIH, and SAMHSA and reviewed agency websites and documents 
to describe educational strategies used by these agencies. Because 
they are involved in federal prevention efforts, we also interviewed 
officials from DEA, the Health Resources and Services Administration 
(HRSA), ONDCP, and the American Medical Association about gaps in 
current prescriber education efforts and efforts to fill these gaps 
through mandatory prescriber education. We excluded agencies that 
support their own health care systems, such as the Bureau of Prisons, 
Department of Defense, Indian Health Service, and Department of 
Veterans Affairs, from the scope of our review as they serve special 
populations, rather than the general public. We also excluded 
educational efforts related to drug abuse treatment, including 
education about the use of the prescription pain relievers methadone 
or buprenorphine for use in the treatment of opioid addiction. 

To assess the extent to which federal agencies follow key practices 
for developing public education efforts about prescription pain 
reliever abuse and misuse, we reviewed the 2010 National Drug Control 
Strategy and interviewed officials involved with federal prevention 
efforts to identify efforts to educate the general public during 
fiscal year 2011. We then interviewed officials from DEA, FDA, NIH, 
ONDCP, and SAMHSA and reviewed agency websites and documents to gather 
evidence about how agencies developed public education efforts and 
then compared the development of these educational efforts against key 
practices for developing consumer education efforts from our prior 
work, Digital Television Transition: Increased Federal Planning and 
Risk Management Could Further Facilitate the DTV Transition (see table 
3).[Footnote 70] We also consulted the Department of Health and Human 
Services (HHS) publication, Making Health Communications Programs 
Work, for additional information about best practices for developing 
public education initiatives.[Footnote 71] We also contacted the 
National Council on Patient Information and Education to gain 
information about best practices for public health education. 

Table 3: Key Practices for Developing Public Education Efforts: 

Key practice: Define goals and objectives; 
Description: Define the goals of the communications campaign, e.g., to 
increase awareness or motivate a change in behavior. Define the 
objectives that will help the campaign meet those goals. 

Key practice: Analyze the situation; 
Description: Analyze the situation, including any competing voices or 
messages, related market conditions, and key dates or timing 
constraints. Review relevant past experiences and examples to identify 
applicable "lessons learned" that may help to guide efforts. 

Key practice: Identify stakeholders; 
Description: Identify and engage all the key stakeholders who will be 
involved in communications efforts. Clarify the roles and 
responsibilities of each stakeholder, including which entity or 
entities will lead overall efforts. 

Key practice: Identify resources; 
Description: Identify available short-and long-term budgetary and 
other resources. 

Key practice: Research target audiences; 
Description: Conduct audience research, such as dividing the audience 
into smaller groups of people who have relevant needs, preferences and 
characteristics, as well as measuring audience awareness, beliefs, 
competing behaviors, and motivators. Also, identify any potential 
audience-specific obstacles, such as access to information. 

Key practice: Develop consistent, clear messages; 
Description: Determine what messages to develop based on budget, 
goals, and audience research findings. Develop clear and consistent 
audience messages; test and refine them. 

Key practice: Identify credible messenger(s); 
Description: Identify who will be delivering the messages and ensure 
that the source is credible with audiences. 

Key practice: Design media mix; 
Description: Plan the media mix to optimize earned media (such as news 
stories or opinion editorials) and paid media (such as broadcast, 
print, or Internet advertising). Identify through which methods (e.g., 
advertising in newsprint ads), how often (e.g., weekly or monthly) and 
over what duration (e.g., 1 year) messages will reach audiences. 

Key practice: Establish metrics to measure success; 
Description: Establish both process and outcome metrics to measure 
success in achieving objectives of the outreach campaign. Process 
metrics assure the quality, quantity, and timeliness of the 
contractor's work. Outcome metrics evaluate how well the campaign 
influenced the attitudes and behaviors of the target audience(s) that 
it set out to influence. 

Source: GAO. 

Note: See GAO, Digital Television Transition: Increased Federal 
Planning and Risk Management Could Further Facilitate the DTV 
Transition, [hyperlink, http://www.gao.gov/products/GAO-08-43] 
(Washington, D.C.: Nov. 19, 2007). 

[End of table] 

We limited our scope to efforts that target the general public, rather 
than specific populations, such as educational efforts pursued by the 
Department of Veterans Affairs, the Department of Defense, or the 
Indian Health Service. We also focused on efforts that were being 
actively revised or disseminated during fiscal year 2011. We focused 
on programs that craft targeted messages about abuse and misuse, 
rather than efforts that strictly provide factual information, such as 
drug fact websites and medication guides that come with prescription 
drugs, since our criteria for developing consumer education efforts 
are only appropriate for efforts that seek to convey a particular 
message. 

To identify educational efforts that use similar strategies and assess 
how agencies coordinate those efforts, we interviewed officials from 
DEA, FDA, HRSA, NIH, ONDCP, and SAMHSA and reviewed documents about 
efforts to coordinate public and prescriber education initiatives. We 
then assessed these coordination activities against key practices for 
collaboration identified in our prior work.[Footnote 72] We also 
assessed the extent to which agencies targeted similar populations, 
provided similar information, and used similar strategies to educate 
the general public and prescribers about prescription pain reliever 
abuse and misuse. 

We conducted this performance audit from December 2010 through 
December 2011 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. 

[End of section] 

Appendix IV: Public Education Programs: 

We identified nine efforts in fiscal year 2011 to educate the general 
public about prescription pain reliever abuse and misuse (see table 4). 

Table 4: Summary of Federal Efforts to Educate the General Public 
about Prescription Pain Reliever Abuse and Misuse: 

DEA: 

Take Back Initiative; 
To promote DEA's drug collection program (National Take Back Day) and 
educate the public about drug disposal, DEA created web buttons, 
posters, brochures, billboards, and banners. 

Get Smart About Drugs; 
A website for parents and caregivers to learn about drug abuse and to 
give them the tools to talk to their children about drugs. The website 
includes a downloadable booklet, Prescription for Disaster: How Teens 
Abuse Medicine, and educational PowerPoint presentations for community 
groups. 

Just Think Twice; 
A website to educate teens about the dangers of drug abuse. It is 
intended to talk to teens in "their language" and give them the 
information they need to make informed decisions about drugs. The 
website also includes a teacher's guide that provides lesson plans and 
classroom activities about drug abuse. 

Good Medicine, Bad Behavior; 
A museum exhibit that provides information on the history of 
prescription drug abuse and diversion in the United States and efforts 
to combat the problem through time, including the effects of 
prescription drugs on the body and the dangers of misuse. 

FDA: 

Opioid Public Service Announcements; 
In-store broadcast announcements and a slide presentation shown in 
physician waiting rooms over a 4-week period. The announcements and 
slides contain messages about how to properly use, store, and dispose 
of prescription medications. 

NIH: 

Heads Up: Real News About Drugs and Your Body; 
Heads Up is a drug education series from Scholastic and NIH for 
teachers and 11-to 15-year-old students with materials about drugs' 
effects on the brain and body. The series includes inserts in 
Scholastic magazines and a presence on the Scholastic website and 
includes materials such as teacher guides and posters. 

NIDA for Teens; 
Launched in 2003, NIDA for Teens provides teens with science-based 
information about the harmful effects that prescription drug abuse and 
addiction have on the brain and body through a website and hard copy 
materials. PEERx is the prescription drug abuse component within the 
NIDA for Teens website. 

ONDCP: 

National Youth Anti-Drug Media Campaign; 
Aims to prevent and reduce youth drug abuse across the nation through 
a mass-media campaign. The Campaign targets youth, their parents and 
other caregivers, and community organizations through two primary 
brands: Above the Influence is the Campaign's teen brand and Parents. 
The Anti-Drug is the Campaign's brand aimed at parents, other 
caregivers, and community organizations. In fiscal year 2011, the 
Campaign targeted parents and teens with messages about prescription 
drug abuse and misuse on its websites. 

SAMHSA: 

"Not Worth the Risk; Even if it's Legal"; 
A series of posters and brochures released in three phases targeting 
teens, college students, and teen influencers with information about 
the dangers of prescription drug abuse. 

Source: GAO review of information from DEA, FDA, NIH, ONDCP, and 
SAMHSA. 

[End of table] 

[End of section] 

Appendix V: Data from Key Measures of Prescription Pain Reliever Abuse 
and Misuse: 

To determine recent trends in prescription pain reliever abuse and 
misuse, we analyzed trends from 2003 to 2009 in four key measures used 
to monitor prescription pain reliever abuse and misuse. These measures 
include emergency department visits (see table 5), admissions to 
substance abuse treatment facilities (see table 6), and unintentional 
overdose deaths (see table 7) involving prescription pain relievers, 
as well as the number of individuals who reported abusing or misusing 
prescription pain relievers in the past year (see table 8). 

Table 5: Estimated Number of Emergency Department Visits Related to 
Abuse and Misuse of Prescription Pain Relievers by Age Groups with 
Confidence Intervals, 2004-2009: 

12-15 years: Estimate; 
2004: 3,517; 
2005: 2,983; 
2006: 3,669; 
2007: 3,967; 
2008: 5,904; 
2009[A]: 3,271. 

12-15 years: Confidence Interval[B]; 
2004: 1,980-5,054; 
2005: 1,653-4,313; 
2006: 2,147-5,191; 
2007: 1,974-5,961; 
2008: 1,111-10,696; 
2009[A]: 1,391-5,151. 

16-19 years: Estimate; 
2004: 12,536; 
2005: 13,283; 
2006: 17,401; 
2007: 20,330; 
2008: 23,439; 
2009[A]: 27,385. 

16-19 years: Confidence Interval[B]; 
2004: 8,994-16,079; 
2005: 9,636-16,930; 
2006: 14,117-20,685; 
2007: 14,143-26,517; 
2008: 16,195-30,682; 
2009[A]: 19,923-34,846. 

20-29 years: Estimate; 
2004: 43,912; 
2005: 60,074; 
2006: 70,763; 
2007: 81,318; 
2008: 117,744; 
2009[A]: 134,682. 

20-29 years: Confidence Interval[B]; 
2004: 31,501-56,322; 
2005: 45,911-74,237; 
2006: 56,519-85,007; 
2007: 62,892-99,744; 
2008: 65,024-170,463; 
2009[A]: 79,592-189,771. 

30-39 years: Estimate; 
2004: 50,875; 
2005: 52,656; 
2006: 58,193; 
2007: 68,229; 
2008: 85,801; 
2009[A]: 102,939. 

30-39 years: Confidence Interval[B]; 
2004: 40,974-60,776; 
2005: 41,247-64,064; 
2006: 48,767-67,620; 
2007: 53,924-82,533; 
2008: 66,713-104,889; 
2009[A]: 67,083-138,796. 

40-49 years: Estimate; 
2004: 51,542; 
2005: 63,789; 
2006: 71,742; 
2007: 81,724; 
2008: 95,991; 
2009[A]: 98,454. 

40-49 years: Confidence Interval[B]; 
2004: 39,342-63,742; 
2005: 50,548-77,029; 
2006: 63,385-80,099; 
2007: 66,827-96,621; 
2008: 74,972-117,010; 
2009[A]: 78,221-118,686. 

50-59 years: Estimate; 
2004: 24,827; 
2005: 37,867; 
2006: 39,993; 
2007: 50,778; 
2008: 59,287; 
2009[A]: 77,368. 

50-59 years: Confidence Interval[B]; 
2004: 18,353-31,301; 
2005: 28,792-46,942; 
2006: 33,819-46,166; 
2007: 41,885-59,670; 
2008: 47,981-70,593; 
2009[A]: 63,016-91,720. 

60+ years: Estimate; 
2004: 14,950; 
2005: 18,505; 
2006: 22,310; 
2007: 27,403; 
2008: 39,928; 
2009[A]: 45,852. 

60+ years: Confidence Interval[B]; 
2004: 9,777-20,123; 
2005: 12,911-24,099; 
2006: 16,812-27,809; 
2007: 21,284-33,521; 
2008: 30,285-49,571; 
2009[A]: 36,776-54,929. 

Total (12+ years): Estimate; 
2004: 202,159; 
2005: 249,156; 
2006: 284,071; 
2007: 333,748; 
2008: 428,092; 
2009[A]: 489,951. 

Total (12+ years): Confidence Interval[B]; 
2004: 159,527-244,791; 
2005: 199,241-299,070; 
2006: 246,132-322,011; 
2007: 277,696-389,800; 
2008: 314,570-541,614; 
2009[A]: 358,177-621,724. 

Source: Drug Abuse Warning Network (DAWN), Substance Abuse and Mental 
Health Services Administration (SAMHSA). 

Notes: SAMHSA defines emergency department visits related to abuse and 
misuse of prescription pain relievers broadly to include all visits 
involving nonmedical use of a prescription pain reliever (such as when 
a patient exceeded prescribed or recommended dose, used drugs 
prescribed for another individual, or was administered a drug by 
another person for a malicious purpose) or use of a prescription pain 
reliever in combination with alcohol or illicit drugs. DAWN data 
represent visits, not unique individuals; thus, an individual who 
visits an emergency department twice within a calendar year would be 
counted as two visits. Comparable emergency department visit estimates 
are not available for 2003 because changes were made that year to the 
data collection methodology. 

[A] The change from 2004 to 2009 is statistically significant at the 
95 percent confidence level for all age groups except for the 12-15 
years age group. 

[B] This table presents the lower and upper bounds of a 95 percent 
confidence level for each estimate. 

[End of table] 

Table 6: Number of Admissions to Substance Abuse Treatment Facilities 
for Prescription Pain Reliever Abuse and Misuse by Age Groups, 2003-
2009: 

12-15 years: 
2003: 1,308; 
2004: 1,406; 
2005: 1,513; 
2006: 1,489; 
2007: 1,847; 
2008: 2,440; 
2009: 2,786. 

16-19 years: 
2003: 6,653; 
2004: 8,041; 
2005: 8,825; 
2006: 9,717; 
2007: 11,367; 
2008: 15,213; 
2009: 18,322. 

20-29 years: 
2003: 32,132; 
2004: 39,518; 
2005: 48,882; 
2006: 59,880; 
2007: 71,522; 
2008: 89,485; 
2009: 104,650. 

30-39 years: 
2003: 28,612; 
2004: 30,250; 
2005: 33,604; 
2006: 37,232; 
2007: 42,251; 
2008: 50,525; 
2009: 56,474. 

40-49 years: 
2003: 24,575; 
2004: 25,827; 
2005: 27,512; 
2006: 29,402; 
2007: 30,630; 
2008: 33,378; 
2009: 34,059. 

50-59 years: 
2003: 6,998; 
2004: 7,975; 
2005: 9,500; 
2006: 10,952; 
2007: 12,752; 
2008: 15,170; 
2009: 15,820. 

60+ years: 
2003: 915; 
2004: 1,047; 
2005: 1,213; 
2006: 1,333; 
2007: 1,556; 
2008: 1,911; 
2009: 2,133. 

Total (12+ years): 
2003: 101,193; 
2004: 114,064; 
2005: 131,049; 
2006: 150,005; 
2007: 171,925; 
2008: 208,122; 
2009: 234,244. 

Source: Treatment Episode Data Set (TEDS), Substance Abuse and Mental 
Health Services Administration. 

Note: Admissions for prescription pain reliever abuse and misuse 
include all admissions where methadone (not prescribed for the 
individual) or other non-heroin opioids were reported as primary, 
secondary, or tertiary substances of abuse at the time of admission. 
TEDS data represents admissions, not unique individuals; thus, an 
individual admitted to treatment twice within a calendar year would be 
counted as two admissions. 

[End of table] 

Table 7: Number of Unintentional Overdose Deaths Involving 
Prescription Pain Relievers by Age Groups, 2003-2008: 

12-15 years: 
2003: [A]; 
2004: 37; 
2005: 29; 
2006: 32; 
2007: 51; 
2008: 36. 

16-19 years: 
2003: 207; 
2004: 269; 
2005: 248; 
2006: 350; 
2007: 361; 
2008: 366. 

20-29 years: 
2003: 1,053; 
2004: 1,341; 
2005: 1,547; 
2006: 2,154; 
2007: 2,314; 
2008: 2,291. 

30-39 years: 
2003: 1,566; 
2004: 1,633; 
2005: 1,874; 
2006: 2,394; 
2007: 2,464; 
2008: 2,469. 

40-49 years: 
2003: 2,448; 
2004: 2,777; 
2005: 2,983; 
2006: 3,581; 
2007: 3,519; 
2008: 3,541. 

50-59 years: 
2003: 1,001; 
2004: 1,217; 
2005: 1,510; 
2006: 2,083; 
2007: 2,338; 
2008: 2,612. 

60+ years: 
2003: 218; 
2004: 267; 
2005: 343; 
2006: 392; 
2007: 462; 
2008: 562. 

Total (12+ years): 
2003: 6,493[B]; 
2004: 7,541; 
2005: 8,534; 
2006: 10,986; 
2007: 11,509; 
2008: 11,877. 

Source: GAO analysis of National Vital Statistics System multiple 
cause of death mortality files, Centers for Disease Control and 
Prevention. 

Notes: Deaths resulting from unintentional overdoses of prescription 
pain relievers are defined as those with an underlying cause of death 
of poisoning (International Classification of Diseases, Tenth Revision 
(ICD-10) code of X40-X49) and any mention of ICD-10 codes T40.2, 
T40.3, or T40.4 as a multiple cause. These data do not include deaths 
in which drugs are present but the cause of death was determined to be 
something other than poisoning, such as cancer or motor vehicle 
traffic crashes. Data represents U.S. residents only. Unintentional 
overdose deaths data from 2009 were not published in time for this 
report. 

[A] Fewer than 20 deaths. Does not meet standards of reliability or 
precision. 

[B] The total for 2003 does not include deaths of individuals aged 12-
15 years, because there were fewer than 20 deaths in this age group. 

[End of table] 

Table 8: Estimated Number of Individuals Who Reported Abusing or 
Misusing Prescription Pain Relievers in the Past Year by Age Groups 
with Confidence Intervals, 2003-2009 (in Thousands): 

12-15 years[A]: Estimate; 
2003: 927; 
2004: 933; 
2005: 797; 
2006: 879; 
2007: 786; 
2008: 750; 
2009: 772. 

12-15 years[A]: Confidence Interval[B]; 
2003: 851-1,008; 
2004: 855-1,017; 
2005: 725-875; 
2006: 803-963; 
2007: 712-868; 
2008: 679-829; 
2009: 701-850. 

16-19 years: Estimate; 
2003: 2,152; 
2004: 2,136; 
2005: 2,169; 
2006: 2,151; 
2007: 2,095; 
2008: 1,981; 
2009: 2,005. 

16-19 years: Confidence Interval[B]; 
2003: 2,025-2,285; 
2004: 2,009-2,269; 
2005: 2,044-2,300; 
2006: 2,025-2,283; 
2007: 1,964-2,233; 
2008: 1,853-2,116; 
2009: 1,887-2,130. 

20-29 years[A]: Estimate; 
2003: 3,797; 
2004: 3,804; 
2005: 3,943; 
2006: 4,341; 
2007: 4,049; 
2008: 4,136; 
2009: 4,306. 

20-29 years[A]: Confidence Interval[B]; 
2003: 3,560-4,048; 
2004: 3,563-4,060; 
2005: 3,690-4,212; 
2006: 4,062-4,637; 
2007: 3,802-4,309; 
2008: 3,874-4,413; 
2009: 4,031-4,597. 

30-39 years: Estimate; 
2003: 2,128; 
2004: 1,923; 
2005: 2,107; 
2006: 2,151; 
2007: 2,293; 
2008: 1,962; 
2009: 2,135. 

30-39 years: Confidence Interval[B]; 
2003: 1,869-2,421; 
2004: 1,686-2,192; 
2005: 1,843-2,405; 
2006: 1,897-2,437; 
2007: 2,007-2,617; 
2008: 1,710-2,249; 
2009: 1,870-2,436. 

40-49 years: Estimate; 
2003: 1,815; 
2004: 1,703; 
2005: 1,566; 
2006: 1,974; 
2007: 1,767; 
2008: 1,792; 
2009: 1,645. 

40-49 years: Confidence Interval[B]; 
2003: 1,541-2,135; 
2004: 1,468-1,973; 
2005: 1,329-1,843; 
2006: 1,701-2,288; 
2007: 1,536-2,031; 
2008: 1,552-2,067; 
2009: 1,410-1,917. 

50-59 years[A]: Estimate; 
2003: 514; 
2004: 590; 
2005: 876; 
2006: 882; 
2007: 1,070; 
2008: 759; 
2009: 1,193. 

50-59 years[A]: Confidence Interval[B]; 
2003: 350-754; 
2004: 419-830; 
2005: 641-1,195; 
2006: 671-1,157; 
2007: 796-1,435; 
2008: 558-1,030; 
2009: 921-1,543. 

60+ years: Estimate; 
2003: 338; 
2004: 167; 
2005: 358; 
2006: 272; 
2007: 406; 
2008: 506; 
2009: 349. 

60+ years: Confidence Interval[B]; 
2003: 192-593; 
2004: 97-289; 
2005: 221-580; 
2006: 159-462; 
2007: 258-639; 
2008: 337-757; 
2009: 225-539. 

Total (12+ years): Estimate; 
2003: 11,671; 
2004: 11,256; 
2005: 11,815; 
2006: 12,649; 
2007: 12,466; 
2008: 11,885; 
2009: 12,405. 

Total (12+ years): Confidence Interval[B]; 
2003: 11,096-12,273; 
2004: 10,695-11,844; 
2005: 11,233-12,426; 
2006: 12,063-13,263; 
2007: 11,861-13,100; 
2008: 11,319-12,479; 
2009: 11,788-13,052. 

Source: National Survey on Drug Use and Health, Substance Abuse and 
Mental Health Services Administration. 

Notes: These estimates are based on the number of survey respondents 
who reported using a prescription pain reliever not prescribed for the 
respondent or used only for the experience or feeling it caused in the 
past 12 months prior to the survey being conducted. The survey results 
are weighted to represent the U.S. civilian, noninstitutionalized 
population. 

[A] The change from 2003 to 2009 is statistically significant at the 
95 percent confidence level for only the 12-15 years, 20-29 years, and 
50-59 years age groups. 

[B] This table presents the lower and upper bounds of a 95 percent 
confidence level for each estimate. 

[End of table] 

[End of section] 

Appendix VI: Comments from the Office of National Drug Control Policy: 

Executive Office of The President: 
Office of National Drug Control Policy: 
Washington, D.C. 20503: 

December 7,2011: 

Gene L. Dodaro: 
Comptroller General: 
Government Accountability Office: 
Washington, D.C. 20548: 

Re: Prescription Pain Reliever Abuse - GA0-12-115: 

Dear Mr. Dodaro: 

Thank you for the opportunity to review a draft copy of your report 
concerning prescription pain reliever abuse and the Administration's 
coordinated efforts to alleviate the associated problems. I especially 
appreciate your laudatory comments about the Prescription
Drug Abuse Prevention Plan which ONDCP established in 2011 and 
recognition of the "unprecedented" amount of brainstorming that 
occurred between ONDCP and other drug control agencies in developing 
it. 

The draft report presents an informative review of the various drug 
control agencies' prescription drug abuse educational efforts, and 
describes how these efforts work in concert. Nonetheless, portions of 
the report suggest that efforts by different agencies arc overlapping 
when they in fact target different populations or address different 
messages. Most of these agency efforts have very small budgets. As a 
result, the reader may misperceive that there is greater potential for 
duplication than actually exists. 

I believe the report could benefit from explaining in greater detail 
the differences between each agency's prescription drug abuse 
education efforts such as the specific target audiences, the number of 
people reached, the specific media used, and the amount of money spent 
on each effort. For example, the $35 million Congress appropriated to 
the National Youth Anti-Drug Media Campaign funded a generalized 
message about substance abuse, Two independent, peer-reviewed studies 
released in 2011 — one in Prevention Science and another in the 
American Journal of Public Health - have shown this approach to be 
effective in reducing the initiation of youth drug use. The draft 
report did not clearly explain that only a small portion of the 
Campaign's total funds were directed solely to messages dealing with 
prescription drug abuse education. 

I appreciate the dedication and hard work or your staff, and ON1l)CP 
will continue to work for improved coordination of prescription drug 
abuse educational efforts and evaluation or outcomes. 

Sincerely, 

Signed by: 

R. Gil Kerlikowske: 
Director: 

[End of section] 

Appendix VII: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Marcia Crosse, 202-512-7114 or crossem@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Thomas Conahan (Assistant 
Director), Katherine L. Amoroso, Emily Binek, George Bogart, Cathleen 
Hamann, Regina Lohr, and Leslie Powell made key contributions to this 
report. 

[End of section] 

Related GAO Products: 

Medicare Part D: Instances of Questionable Access to Prescription 
Drugs. [hyperlink, http://www.gao.gov/products/GAO-11-699]. 
Washington, D.C.: September 6, 2011. 

Prescription Drug Control: DEA Has Enhanced Efforts to Combat 
Diversion, but Could Better Assess and Report Program Results. 
[hyperlink, http://www.gao.gov/products/GAO-11-744]. Washington, D.C.: 
August 26, 2011. 

Medicaid: Fraud and Abuse Related to Controlled Substances Identified 
in Selected States. [hyperlink, http://www.gao.gov/products/GAO-09-
957]. Washington, D.C.: September 9, 2009. 

Methadone-Associated Overdose Deaths: Factors Contributing to 
Increased Deaths and Efforts to Prevent Them. [hyperlink, 
http://www.gao.gov/products/GAO-09-341]. Washington, D.C.: March 26, 
2009. 

Anabolic Steroid Abuse: Federal Efforts to Prevent and Reduce Anabolic 
Steroid Abuse among Teenagers. [hyperlink, 
http://www.gao.gov/products/GAO-08-15]. Washington, D.C.: October 31, 
2007. 

ONDCP Media Campaign: Contractor's National Evaluation Did Not Find 
That the Youth Anti-Drug Media Campaign Was Effective in Reducing 
Youth Drug Use. [hyperlink, http://www.gao.gov/products/GAO-06-818]. 
Washington, D.C.: August 25, 2006. 

Internet Pharmacies: Some Pose Safety Risks for Consumers. [hyperlink, 
http://www.gao.gov/products/GAO-04-820]. Washington, D.C.: June 17, 
2004. 

Prescription Drugs: OxyContin Abuse and Diversion and Efforts to 
Address the Problem. [hyperlink, 
http://www.gao.gov/products/GAO-04-110]. Washington, D.C.: December 
23, 2003. 

Prescription Drugs: State Monitoring Programs Provide Useful Tool to 
Reduce Diversion. [hyperlink, http://www.gao.gov/products/GAO-02-634]. 
Washington, D.C.: May 17, 2002. 

[End of section] 

Footnotes: 

[1] According to NSDUH data from 2009, 17 percent of these people 
reported that they got the drug from one doctor and 2 percent reported 
that they got the drug from more than one doctor. 

[2] In this report the term "prescription pain relievers" refers to a 
class of pain relievers known as opioid analgesics. While multiple 
classes of pain relievers are used in the United States, opioid 
analgesics, such as fentanyl, hydrocodone, methadone, morphine, and 
oxycodone, are the most commonly abused and misused pain relievers. In 
addition to relieving pain, they can cause feelings of euphoria or a 
sense of well being among some people who take them, which may lead to 
their abuse and misuse. 

[3] No standard definitions of prescription pain reliever abuse or 
prescription pain reliever misuse are used by the federal agencies 
dealing with these issues. In this report, we use the term "abuse and 
misuse" to collectively refer to the three types of inappropriate use 
most often included in the agencies' definitions: using a prescription 
pain reliever with the intent to get high, with or without a 
prescription of one's own; using a prescription pain reliever for pain 
relief, but without a prescription of one's own; or using a 
prescription pain reliever for pain relief, with a prescription of 
one's own, but in ways other than as prescribed, such as by taking 
more than prescribed. 

[4] GAO, Methadone-Associated Overdose Deaths: Factors Contributing to 
Increased Deaths and Efforts to Prevent Them, [hyperlink, 
http://www.gao.gov/products/GAO-09-341] (Washington, D.C.: Mar. 26, 
2009) and Prescription Drugs: OxyContin Abuse and Diversion and 
Efforts to Address the Problem, [hyperlink, 
http://www.gao.gov/products/GAO-04-110] (Washington, D.C.: Dec. 23, 
2003). For more GAO reports on this topic, see the Related GAO 
Products page at the end of this report. 

[5] GAO, Digital Television Transition: Increased Federal Planning and 
Risk Management Could Further Facilitate the DTV Transition, 
[hyperlink, http://www.gao.gov/products/GAO-08-43] (Washington, D.C.: 
Nov. 19, 2007). 

[6] GAO, Results-Oriented Government: Practices that Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 21, 
2005). 

[7] Other activities at the federal level are beyond the scope of our 
review, including prevention activities like supporting state 
prescription drug monitoring programs--programs that collect 
information on prescription drugs that are prescribed or dispensed in 
a state in order to detect and prevent the abuse and misuse of these 
drugs--and enabling safe disposal of prescription drugs; federal 
efforts to expand access to addiction treatment; and federal law 
enforcement activities, such as taking action against "pill mills" 
where prescription pain relievers can be obtained without a legitimate 
medical need. 

[8] A report from the Institute of Medicine stated that more than 100 
million Americans are affected by chronic pain. Institute of Medicine, 
Relieving Pain In America: A Blueprint for Transforming Prevention, 
Care, Education, and Research (Washington, D.C.: The National 
Academies Press, 2011). 

[9] There are also particular prescription pain relievers, such as 
methadone, that are referred to as long-acting, rather than extended-
release, because they deliver drugs to the body for a longer period of 
time due to inherent characteristics of the drug substance, rather 
than because of being specially formulated for an extended period of 
drug release. 

[10] Some individuals may also abuse or misuse prescription pain 
relievers by using pain relievers that were not prescribed to them in 
order to prevent drug withdrawal symptoms, which may occur if an 
individual stops or dramatically reduces use of prescription pain 
relievers after heavy and prolonged use. 

[11] DEA officials told us that in addition to federal laws and 
regulations, state laws and medical practice standards govern the 
prescribing of prescription drugs. These state laws and standards may 
include requiring tamper-resistant prescribing pads and restricting 
who can prescribe controlled substances. 

[12] Pub. L. No. 91-513, 84 Stat. 1242 (1970) (codified at 21 U.S.C. 
§§ 801 et seq. as amended). Under the Controlled Substances Act drugs 
are placed into one of five schedules based on their accepted 
medicinal uses and potential for abuse and dependence. Schedule I and 
II drugs have the highest potential for abuse and dependence, and 
schedules III through V have progressively lower potential for abuse 
and dependence. See 21 U.S.C. §812. All drugs in schedules II through 
V are available to the public with a prescription. See 21 U.S.C. §829. 
In addition, some schedule V drugs may be available to the public 
without a prescription, but subject to certain other restrictions. 

[13] L. Mezei and B.B. Murinson, "Pain Education in North American 
Medical Schools," Journal of Pain (2011). 

[14] According to the American Medical Association publication State 
Medical Licensure Requirements and Statistics, 2012 the states in 
which medical boards required CME related to education on controlled 
substance prescribing or pain management for certain prescribers were 
California, Florida, Massachusetts (for license renewals after January 
1, 2012), Oklahoma, Oregon, Rhode Island, Tennessee, Texas, and West 
Virginia. 

[15] [hyperlink, http://www.gao.gov/products/GAO-08-43]. These key 
practices include: define key goals and objectives; analyze the 
situation; identify stakeholders; identify resources; research target 
audiences; develop clear, consistent messages; identify credible 
messenger(s); design a mix of media; and establish metrics to measure 
success. For further description of these key practices, see appendix 
III. 

[16] Diversion is the channeling of pharmaceuticals for illegal 
purposes or abuse. Diversion can involve illegal sales of prescription 
drugs by physicians, patients, or pharmacists, as well as obtaining 
controlled substances from Internet pharmacies without a valid 
prescription. Diversion can also involve such activities as "doctor 
shopping" by individuals who visit numerous physicians to obtain 
multiple prescriptions, prescription forgery, and pharmacy theft. For 
more on federal efforts to address the diversion of prescription drugs 
for illegal purposes or abuse, see GAO, Medicare Part D: Instances of 
Questionable Access to Prescription Drugs, [hyperlink, 
http://www.gao.gov/products/GAO-11-699] (Washington, D.C.: Sept. 6, 
2011); and Prescription Drug Control: DEA Has Enhanced Efforts to 
Combat Diversion, but Could Better Assess and Report Program Results, 
[hyperlink, http://www.gao.gov/products/GAO-11-744] (Washington, D.C.: 
Aug. 26, 2011). 

[17] DEA, NIH, ONDCP, and SAMHSA officials told us that they also use 
data from Monitoring the Future, an annual national survey supported 
by a grant from NIH's NIDA and administered to nationally 
representative samples of public and private secondary school students 
throughout the United States. (Monitoring the Future also includes 
surveys following high school students into adulthood.) We did not 
include this data source in our analysis because it primarily focuses 
on youth and young adults, and is thus not nationally representative 
at all age levels. 

[18] NSDUH defines "nonmedical use" of a prescription drug as use 
without a prescription of the individual's own or simply for the 
experience or feeling the drugs caused. Such use would be included in 
our use of the term "abuse and misuse," though it only represents two 
of the three scenarios within that definition. It does not represent 
individuals who incorrectly use prescription pain relievers for pain 
relief, with a prescription of one's own, but in ways other than as 
prescribed, such as by taking more than prescribed. 

[19] See appendix V for the estimated number of emergency department 
visits, admissions to substance abuse treatment facilities, and 
unintentional overdose deaths for each year analyzed along with the 
corresponding confidence intervals, where applicable. 

[20] In 2004, according to DAWN, there were an estimated 202,000 
emergency department visits related to prescription pain reliever 
abuse and misuse and an estimated 490,000 such visits in 2009. 
Comparable emergency department visit estimates are not available for 
2003 because changes were made that year to the data collection 
methodology. 

[21] In 2003, according to TEDS, there were about 101,000 admissions 
to substance abuse treatment facilities for prescription pain reliever 
abuse and misuse and about 234,000 such visits in 2009. 

[22] In 2003 there were approximately 6,500 deaths resulting from 
unintentional overdoses of prescription pain relievers and 
approximately 11,900 such deaths in 2008. NVSS unintentional overdose 
deaths data from 2009 were not published in time for this report. The 
determination of intentionality in an overdose death is made by the 
attending physician, medical examiner, or coroner responsible for 
completing the causes of death section of the death certificate. 

[23] National estimates of the number of people who abused and misused 
prescription pain relievers represent only two of the three scenarios 
that we defined as abuse and misuse. Estimates do not represent 
individuals who incorrectly use prescription pain relievers for pain 
relief, with a prescription of one's own, but in ways other than as 
prescribed, such as by taking more than prescribed. In addition, 
estimates do not differentiate between individuals who abused or 
misused a pain reliever with the intent to get high and those who 
abused or misused a pain reliever to relieve pain. 

[24] The increase from 2003 to 2009 in the estimated number of people 
in the U.S. population aged 12 and older who abused and misused 
prescription pain relievers as reported in NSDUH is not statistically 
significant at the 95 percent confidence level. See appendix V for the 
estimates for each year analyzed along with the corresponding 
confidence intervals. 

[25] The estimates represent the number of prescriptions dispensed 
from U.S. outpatient retail pharmacies for non-injectable opioid 
analgesics, rounded to the nearest million. These estimates were 
obtained from FDA, based on its analysis of data from the SDI, Vector 
One®:National database, which measures retail dispensing of 
prescriptions based on a sample of retail pharmacies throughout the 
United States. The data were extracted from the database in June 2010. 

[26] According to NSDUH, among persons aged 12 or older in 2009 who 
abused or misused a pain reliever in the past year, 19 percent got the 
drug that was most recently abused or misused as a prescription from a 
doctor. In addition, 55 percent got the drug they most recently abused 
or misused from a friend or relative for free, 11 percent bought the 
drug from a friend or relative, and 4 percent took the drug from a 
friend or relative without asking. 

[27] From 2003 to 2009, prescriptions for extended-release and long-
acting pain relievers increased from approximately 15 million to 23 
million. Estimates of dispensed prescriptions are from FDA's analysis 
of SDI, Vector One®:National, extracted June 2010. 

[28] FDA estimated that in 2008, there were 106.8 emergency department 
visits involving abuse or misuse of extended-release oxycodone for 
every 10,000 retail prescriptions, in contrast to 14.3 emergency 
department visits involving abuse or misuse of immediate-release 
oxycodone for every 10,000 retail prescriptions. FDA developed these 
estimates based on an analysis of data from DAWN and SDI, Vector One®: 
National, extracted June 2010. 

[29] Methadone has unique pharmacological properties that make it 
different from other opioids, and as a result, when it is used without 
adequate knowledge or when it is used for a purpose other than that 
for which it was prescribed, it can lead to adverse health 
consequences, including death. [hyperlink, 
http://www.gao.gov/products/GAO-09-341]. 

[30] L.R. Webster et al., "An Analysis of the Root Causes for Opioid-
Related Overdose Deaths in the United States," Pain Medicine, vol. 12 
(2011). 

[31] According to DAWN, in 2004, there were an estimated 63,000 
emergency department visits involving a prescription pain reliever 
alone and an estimated 140,000 visits with both a prescription pain 
reliever and alcohol or other drugs. In 2009 these figures were 
estimated at 151,000 and 340,000, respectively. 

[32] According to FDA, the course will be provided by organizations 
accredited to provide CME to physicians or by organizations that 
provide CE to health care professionals other than physicians. 

[33] See Food and Drug Administration Amendments Act of 2007, Pub. L. 
No., 110-85, § 901, 121 Stat. 823, 922 (codified in pertinent part at 
21 U.S.C. §§ 355(p), 355-1) (conditioning authority to market a drug 
on compliance with an approved REMS, where determined necessary to 
ensure the benefits outweigh the risks). A REMS is a risk management 
plan that FDA can require a manufacturer to develop to manage serious 
risks associated with a drug. Prescription pain relievers subject to 
the extended-release and long-acting class-wide REMS include extended-
release products containing buprenorphine, fentanyl, hydromorphone, 
morphine, oxycodone, oxymorphone, and tapentadol, and products 
containing the long-acting prescription pain reliever methadone. 

[34] As the five products are highly potent and designed for 
transmucosal absorption they are only indicated for use in adults with 
breakthrough cancer pain who are already routinely taking another 
prescription pain reliever around the clock. However, FDA officials 
told us that in studying the postmarket data, they became concerned 
that these drugs were being used in patients who were not already 
routinely taking another prescription pain reliever. Because these 
products have a very high risk of death if administered incorrectly or 
if taken by patients who were not already routinely taking another 
prescription pain reliever, FDA has also placed special restrictions 
on the dispensing of these products through REMS. 

[35] Patient-prescriber agreements are documents signed by the patient 
and prescriber that outline patient and prescriber responsibilities, 
including, in the case of transmucosal immediate-release fentanyl 
products, documenting that the patient is regularly taking another 
prescription pain reliever and has been counseled on the risks, 
benefits, and appropriate use of these drugs. 

[36] SAMHSA also funds two additional physician clinical support 
systems related to the use of methadone and buprenorphine in addiction 
treatment, which are outside the scope of our review. 

[37] SAMHSA also provided funding to one additional medical residency 
program, but officials told us that the curriculum resources that 
residency program is developing do not include information about 
prescription drug abuse and misuse. 

[38] See 21 U.S.C. § 823(f). 

[39] [hyperlink, http://www.gao.gov/products/GAO-08-43]. 

[40] In September 2010 DEA conducted a National Prescription Drug Take 
Back Day to provide a venue for the disposal of unwanted and unused 
prescription drugs. DEA held a second Take Back Day in April 2011 and 
a third in October 2011. A DEA official told us that such events are a 
short-term measure until the agency can implement regulations for the 
Secure and Responsible Drug Disposal Act of 2010, which will allow for 
authorized entities to collect and dispose of controlled substances. 

[41] The National Youth Anti-Drug Media Campaign (the Campaign) is a 
mass-media campaign, including paid advertising and public 
communications outreach. In fiscal year 2011, the Campaign targeted 
parents and teens with messages about prescription drug abuse and 
misuse on its websites, rather than through paid advertising. The 
budget for the Campaign includes funding for all aspects of the 
Campaign. Only a small portion of the overall budget was spent on 
programming about prescription drug abuse. 

[42] U.S. Department of Health and Human Services, National Institutes 
of Health and National Cancer Institute, Making Health Communication 
Programs Work: A Planner's Guide (2004). 

[43] The tracking studies also evaluate teen awareness and memory of 
the Campaign's advertisements. However, there were no advertisements 
about prescription drug abuse and misuse being broadcast during fiscal 
year 2011. 

[44] ONDCP awarded the evaluation contract to Westat, Inc. in July, 
2010. We have previously reported on a prior Westat evaluation of the 
National Youth Anti-Drug Media Campaign; see GAO, ONDCP Media 
Campaign: Contractor's National Evaluation Did Not Find that the Youth 
Anti-Drug Media Campaign Was Effective in Reducing Youth Drug Use, 
[hyperlink, http://www.gao.gov/products/GAO-06-818] (Washington, D.C.: 
Aug. 25, 2006). 

[45] GAO, Program Evaluation: Strategies for Assessing How Information 
Dissemination Contributes to Agency Goals, [hyperlink, 
http://www.gao.gov/products/GAO-02-923] (Washington, D.C.: Sept. 30, 
2002). 

[46] A Call to Action is a science-based document to stimulate action 
nationwide to solve a major public health problem. 

[47] We have previously defined "duplication" as occurring when two or 
more agencies or programs are engaged in the same activities or 
provide the same services to the same beneficiaries. GAO, 
Opportunities to Reduce Potential Duplication in Government Programs, 
Save Tax Dollars, and Enhance Revenue, [hyperlink, 
http://www.gao.gov/products/GAO-11-318SP] (Washington, D.C.: Mar. 1, 
2011). 

[48] These key practices are (1) defining and articulating a common 
outcome; (2) establishing mutually reinforcing or joint strategies; 
(3) identifying and addressing needs by leveraging resources; (4) 
agreeing on roles and responsibilities; (5) establishing compatible 
policies, procedures, and other means to operate across agency 
boundaries; (6) developing mechanisms to monitor, evaluate, and report 
on results; (7) reinforcing agency accountability for collaborative 
efforts through agency plans and reports; and (8) reinforcing 
individual accountability for collaborative efforts through 
performance management systems. See [hyperlink, 
http://www.gao.gov/products/GAO-06-15]. 

[49] The five goals are (1) improve the federal surveillance capacity 
for pharmaceutical abuse; (2) improve clinical outcomes for substance 
abusers by increasing access to prescription drug monitoring program 
data by clinicians in a timely manner and across state boundaries; (3) 
reduce the number of opioid overdose deaths by identifying and 
implementing effective secondary prevention strategies; (4) 
collaborate on the development of educational materials for health 
care providers, patients, parents, and communities at large to address 
the appropriate use of prescription pharmaceuticals and reduce their 
misuse and abuse; and (5) implement standards for electronic medical 
records to increase the identification of pharmaceutical abuse 
routinely in medical care. 

[50] Throughout this report we use the term "abuse and misuse" to 
collectively refer to the three types of inappropriate use that are 
most frequently incorporated into agencies definitions. However, in 
this appendix, because the literature we reviewed used the term 
"abuse," we use that term alone. 

[51] To develop the list of types of abuse-deterrent formulations, we 
conducted a literature review. The following articles were 
particularly useful in defining the five types of abuse-deterrent 
formulations, and challenges associated with them, referenced here: 
J.J. Coleman, C.R. Schuster, and R.L. DuPont, "Reducing the Abuse 
Potential of Controlled Substances," Pharmaceutical Medicine, vol. 24, 
no. 1 (2010); J.J. Coleman, P.B. Bensiger, M.S. Gold, D.E. Smith, R.P. 
Bianchi, and R.L. DuPont, "Can Drug Design Inhibit Abuse?" Journal of 
Psychoactive Drugs, vol. 37, no. 4 (2005); N. Katz, "Abuse-deterrent 
Opioid Formulations: Are They a Pipe Dream?" Current Rheumatology 
Reports, vol. 10 (2008); J.P. Schneider, M. Matthews, and R.N. 
Jamison, "Abuse-Deterrent and Tamper-Resistant Opioid Formulations: 
What is their Role in Addressing Prescription Opioid Abuse?" CNS 
Drugs, vol. 24, no. 10 (2010); L. Webster, "Update on Abuse-Resistant 
and Abuse-Deterrent Approaches to Opioid Formulations," Pain Medicine, 
vol. 10, supplement 2 (2009); and N. P. Katz et. al., "Challenges in 
the Development of Prescription Opioid Abuse-deterrent Formulations," 
Clinical Journal of Pain, vol. 23, no. 8 (2007). 

[52] One additional product, Suboxone, uses an agonist/antagonist 
combination to deter abuse, but this drug is indicated for the 
treatment of opioid dependence, not the treatment of pain. In 
addition, though it was marketed earlier in the year, in March 2011 
Embeda was voluntarily recalled because a prespecified stability 
requirement was not met during routine testing. As of October 2011 the 
recall was still in effect, but Pfizer officials said they hope to 
return the product to market once the stability issue has been 
resolved. 

[53] Though no prescription pain relievers that use aversion alone are 
currently marketed, in June 2011 FDA approved the prescription pain 
reliever Oxecta, which Pfizer officials said is designed to use a 
combination of physical/chemical barriers and aversion to deter abuse. 

[54] Controlled substances used in the manufacture of prescription 
pain relievers include codeine, fentanyl, hydrocodone, hydromorphone, 
methadone, morphine, oxycodone, and oxymorphone. 

[55] 21 C.F.R. § 1301.11(a) (2011) (researchers are defined as 
manufacturers for purposes of this provision) (exemptions, such as 
institutions operated by the U.S. military, provided for at 21 C.F.R. 
§§ 1301.22 et seq. (2011)). 

[56] See 21 C.F.R. §§ 1304.3, 1304.11 (2011). 

[57] See 21 C.F.R. § 1301.71 (2011). 

[58] See 21 C.F.R. § 1304.22 (2011). 

[59] See 21 C.F.R. § 1303.11(a) (2011). 

[60] DEA obtains data from the IMS Health National Prescription Audit. 
IMS Health is a private company that provides market information to 
the pharmaceutical and health care industries. 

[61] See 21 C.F.R. § 1303.21 (2011). Although this regulation uses the 
term "individual manufacturing quotas," DEA officials refer to them as 
"bulk manufacturing quotas." Accordingly, we use the term "bulk 
manufacturing quotas" throughout our discussion. 

[62] See 21 C.F.R. § 1303.12 (2011). 

[63] Although all of these data sources are nationally representative, 
they represent slightly different populations. For example, active 
military personnel are included to different extents in each of the 
data sources. NSDUH excludes active military personnel from its sample 
population. NVSS includes deaths of active military personnel, though 
it does not include overseas military deaths. DAWN and TEDS do not 
explicitly exclude active military personnel, though emergency 
department visits and treatment admissions at military-funded 
facilities are not included in these data sets. A DAWN official said 
that he therefore expects the number of individuals in the military 
included in these data to be low because these individuals likely use 
military-funded services. SAMHSA reports also note that the excluded 
populations may have different rates of prescription pain reliever 
abuse and misuse than the general public as a whole. 

[64] Data on emergency department visits related to abuse and misuse 
may include cases of malicious poisoning, which is not included in our 
definition of abuse and misuse. However, SAMHSA officials told us that 
there are very few cases of malicious poisoning each year. 

[65] NVSS data are coded in accordance with the International 
Classification of Diseases, Tenth Revision. 

[66] Data on unintentional overdose deaths may include deaths that are 
not related to abuse and misuse, such as cases of unintentional 
ingestion of a prescription pain reliever. However, a CDC official 
said that these cases likely comprise only a small portion of 
unintentional overdose deaths. 

[67] According to CDC analyses, in 2006, more than 20 percent of all 
drug overdose deaths did not specify the drugs involved. 

[68] Specifically, NSDUH gathers information on the nonmedical use of 
prescription pain relievers, which it defines as the use of 
prescription pain relievers without a prescription of the individual's 
own or simply for the experience or feeling the drugs caused. 

[69] GAO, Drug Use Measurement: Strengths, Limitations, and 
Recommendations for Improvement, GAO/PEMD-93-18 (Washington, D.C.: 
June 25, 1993). 

[70] [hyperlink, http://www.gao.gov/products/GAO-08-43[. 

[71] U.S. Department of Health and Human Services, National Institutes 
of Health and National Cancer Institute, Making Health Communication 
Programs Work: A Planner's Guide (2004). 

[72] In our prior work, we identified key practices that help enhance 
and sustain collaboration. These key practices are (1) defining and 
articulating a common outcome; (2) establishing mutually reinforcing 
or joint strategies; (3) identifying and addressing needs by 
leveraging resources; (4) agreeing on roles and responsibilities; (5) 
establishing compatible policies, procedures, and other means to 
operate across agency boundaries; (6) developing mechanisms to 
monitor, evaluate, and report on results; (7) reinforcing agency 
accountability for collaborative efforts through agency plans and 
reports; and (8) reinforcing individual accountability for 
collaborative efforts through performance management systems. See 
[hyperlink, http://www.gao.gov/products/GAO-06-15]. 

[End of section] 

GAO’s Mission: 

The Government Accountability Office, the audit, evaluation, and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the 
performance and accountability of the federal government for the 
American people. GAO examines the use of public funds; evaluates 
federal programs and policies; and provides analyses, recommendations, 
and other assistance to help Congress make informed oversight, policy, 
and funding decisions. GAO’s commitment to good government is 
reflected in its core values of accountability, integrity, and 
reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO’s website [hyperlink, http://www.gao.gov]. Each 
weekday afternoon, GAO posts on its website newly released reports, 
testimony, and correspondence. To have GAO e mail you a list of newly 
posted products, go to [hyperlink, http://www.gao.gov] and select “E-
mail Updates.” 

Order by Phone: 

The price of each GAO publication reflects GAO’s actual cost of 
production and distribution and depends on the number of pages in the 
publication and whether the publication is printed in color or black 
and white. Pricing and ordering information is posted on GAO’s 
website, [hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or 
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card, 
MasterCard, Visa, check, or money order. Call for additional 
information. 

Connect with GAO: 

Connect with GAO on facebook, flickr, twitter, and YouTube.
Subscribe to our RSS Feeds or E mail Updates. Listen to our Podcasts.
Visit GAO on the web at [hyperlink, http://www.gao.gov]. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 
Website: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]; 
E-mail: fraudnet@gao.gov; 
Automated answering system: (800) 424-5454 or (202) 512-7470. 

Congressional Relations: 

Ralph Dawn, Managing Director, dawnr@gao.gov, (202) 512-4400
U.S. Government Accountability Office, 441 G Street NW, Room 7125
Washington, DC 20548. 

Public Affairs: 
Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800
U.S. Government Accountability Office, 441 G Street NW, Room 7149 
Washington, DC 20548.