PRESCRIPTION PAIN 

RELIEVER ABUSE

Agencies Have Begun 

Coordinating 

Education Efforts, but 

Need to Assess 

Effectiveness

Report to Congressional Requesters

December 2011

GAO-12-115

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-115, a report to 

congressional requesters

December 2011

PRESCRIPTION PAIN RELIEVER ABUSE

Agencies Have Begun Coordinating Education 

Efforts, but Need to Assess Effectiveness

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 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.

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. 

View GAO-12-115. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov.
Page i GAO-12-115 Prescription Pain Reliever Abuse

Letter 1 

Background 5

Key Measures of Prescription Pain Reliever Abuse and Misuse 

Have Increased Nationwide 11

Federal Agencies Are Using Various Strategies to Educate 

Prescribers about Issues Related to Prescription Pain Reliever 

Abuse and Misuse 16

Federal Agencies Generally Followed Key Practices When 

Developing Public Education Efforts 20

Federal Agencies Have Begun Coordinating Similar Public and 

Prescriber Education Efforts, but Have Missed Opportunities to 

Share Resources 26

Conclusions 38

Recommendations for Executive Action 39

Agency Comments and Our Evaluation 39

Appendix I Abuse-Deterrent Formulations of Prescription Pain Relievers 41

Appendix II DEA Quotas for Controlled Substances 46

Appendix III Objectives, Scope, and Methodology 52

Appendix IV Public Education Programs 60

Appendix V Data from Key Measures of Prescription Pain Reliever Abuse 

and Misuse 61

Appendix VI Comments from the Office of National Drug Control Policy 65

Appendix VII GAO Contact and Staff Acknowledgments 66

Contents
Page ii GAO-12-115 Prescription Pain Reliever Abuse

Related GAO Products 67

Tables

Table 1: Public Education Efforts about Prescription Pain Reliever 

Abuse and Misuse 27

Table 2: Efforts to Educate Prescribers about Issues Related to 

Prescription Pain Reliever Abuse and Misuse 33

Table 3: Key Practices for Developing Public Education Efforts 58

Table 4: Summary of Federal Efforts to Educate the General Public 

about Prescription Pain Reliever Abuse and Misuse 60

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 62

Table 6: Number of Admissions to Substance Abuse Treatment 

Facilities for Prescription Pain Reliever Abuse and Misuse 

by Age Groups, 2003-2009 63

Table 7: Number of Unintentional Overdose Deaths Involving 

Prescription Pain Relievers by Age Groups, 2003-2008 63

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) 64

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 12

Figure 2: Agencies’ Use of Key Practices for Developing Public 

Education Efforts 22

Figure 3: ONDCP and NIH Teen Websites 29

Figure 4: DEA Teen Website 30
Page iii GAO-12-115 Prescription Pain Reliever Abuse

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

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Page 1 GAO-12-115 Prescription Pain Reliever Abuse

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.1

Multiple federal agencies have responsibility for addressing the abuse 

and misuse of prescription pain relievers through prevention, treatment, 

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.

 

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. 

 
 

Page 2 GAO-12-115 Prescription Pain Reliever Abuse

and enforcement activities.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.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

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, GAO-09-341 (Washington, D.C.: Mar. 26, 2009) and 

Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem, 

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.
 

Page 3 GAO-12-115 Prescription Pain Reliever Abuse

(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 app. I) and DEA’s process 

for setting quotas for certain substances used in the manufacture of 

prescription pain relievers (see app. 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 app. 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, 
 

Page 4 GAO-12-115 Prescription Pain Reliever Abuse

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.5

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 

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.

 

5

GAO, Digital Television Transition: Increased Federal Planning and Risk Management 

Could Further Facilitate the DTV Transition, GAO-08-43 (Washington, D.C.: Nov. 19, 

2007).
 

Page 5 GAO-12-115 Prescription Pain Reliever Abuse

against key practices for collaboration identified in our prior work.6 (See 

app. III for a detailed discussion of our methodology.)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.

Pain, which affects millions of Americans, can be characterized in terms 

of intensity—mild to severe—and duration—acute or chronic.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 immediaterelease 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.9

 

6

GAO, Results-Oriented Government: Practices that Can Help Enhance and Sustain 

Collaboration among Federal Agencies, 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. 

Background 

Prescription Pain Relievers
 

Page 6 GAO-12-115 Prescription Pain Reliever Abuse

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.10

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.

Third, 

some individuals, while seeking pain relief, incorrectly use prescription 

pain relievers that were prescribed to them, such as by taking more than 

prescribed.

Federal agencies use both regulatory and programmatic approaches in 

their efforts to prevent prescription pain reliever abuse and misuse.11

Because of their potential for abuse, prescription pain relievers are 

regulated under the Controlled Substances Act.12

 

10Some 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. 

Prescribers, such as 

11DEA 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.

12Pub. 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. 

Preventing Prescription 

Pain Reliever Abuse and 

Misuse
 

Page 7 GAO-12-115 Prescription Pain Reliever Abuse

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.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.14

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 app. 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 

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.

 

13L. Mezei and B.B. Murinson, “Pain Education in North American Medical Schools,”

Journal of Pain (2011). 

14According 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. 
 

Page 8 GAO-12-115 Prescription Pain Reliever Abuse

important for the development of educational outreach efforts, motivating 

a target audience, and alleviating challenges, such as prioritizing limited 

resources.15

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.

 

15GAO-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 

app. III.

Federal Agencies Involved 

in Preventing Prescription 

Pain Reliever Abuse and 

Misuse
 

Page 9 GAO-12-115 Prescription Pain Reliever Abuse

• 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 app. 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.16

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.17

 

16Diversion 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, 

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 

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, GAO-11-744 (Washington, D.C.: Aug. 26, 

2011). 

17DEA, 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.

Federal Data Sources Used 

to Monitor Prescription 

Pain Reliever Abuse and 

Misuse
 

Page 10 GAO-12-115 Prescription Pain Reliever Abuse

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.18

See appendix III for more information about the data collection 

methodologies and limitations of these data sources.

 

18NSDUH 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. 
 

Page 11 GAO-12-115 Prescription Pain Reliever Abuse

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, 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 fig. 1).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.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 2009.21

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 2008.22

 

19See app. 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.

20In 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. 

21In 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.

22In 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.

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
 

Page 12 GAO-12-115 Prescription Pain Reliever Abuse

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

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 app. 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.

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 
 

Page 13 GAO-12-115 Prescription Pain Reliever Abuse

reviewed.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 2009.24

Appendix V shows data from the key measures by age group for each 

year that we reviewed.

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 extendedrelease 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.25

 

23National 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.

Officials from a number of agencies noted, however, that 

while most prescription pain relievers are used as prescribed, a fraction of 

24The 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 

app. V for the estimates for each year analyzed along with the corresponding confidence 

intervals.

25The 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.

Increasing Availability and 

High-Risk Behaviors Likely 

Contributed to the 

Increases in Adverse 

Health Consequences
 

Page 14 GAO-12-115 Prescription Pain Reliever Abuse

all prescribed pain relievers are abused and misused.26

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 painrelieving 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.

Available data do 

not allow officials to determine what fraction of prescription pain relievers 

are abused and misused.

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.28

 

26According 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.

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 

27From 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.

28FDA 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 immediaterelease 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.
 

Page 15 GAO-12-115 Prescription Pain Reliever Abuse

the total number of prescriptions dispensed.29,30

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 lifethreatening 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.

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.

31

 

29Methadone 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. 

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 

GAO-09-341. 

30L.R. Webster et al., “An Analysis of the Root Causes for Opioid-Related Overdose 

Deaths in the United States,” Pain Medicine, vol. 12 (2011).

31According 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.
 

Page 16 GAO-12-115 Prescription Pain Reliever Abuse

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.

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) 

Federal Agencies Are 

Using Various 

Strategies to Educate 

Prescribers about 

Issues Related to 

Prescription Pain 

Reliever Abuse and 

Misuse 
 

Page 17 GAO-12-115 Prescription Pain Reliever Abuse

for extended-release and long-acting prescription pain relievers.32,33

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 

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.

 

32According 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.

33See 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.
 

Page 18 GAO-12-115 Prescription Pain Reliever Abuse

due to unique concerns associated with these products.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.35

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.

 Prescribers are 

required to become recertified every 2 years.

36

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 

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.

 

34As 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.

35Patient-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. 

36SAMHSA 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.
 

Page 19 GAO-12-115 Prescription Pain Reliever Abuse

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.37

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.

The curriculum resources 

for these programs are designed to be transferable to medical schools 

and residency programs nationwide.

38

 

37SAMHSA 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.

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 

38See 21 U.S.C. § 823(f). 
 

Page 20 GAO-12-115 Prescription Pain Reliever Abuse

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.

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 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 app. 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 

Federal Agencies 

Generally Followed 

Key Practices When 

Developing Public 

Education Efforts

All Agencies Followed 

Almost All Key Practices; 

Efforts Varied in Size and 

Approach 
 

Page 21 GAO-12-115 Prescription Pain Reliever Abuse

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 app. III).39

 

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 fig. 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. 

GAO-08-43. 
 

Page 22 GAO-12-115 Prescription Pain Reliever Abuse

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

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. 

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 
 

Page 23 GAO-12-115 Prescription Pain Reliever Abuse

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 

2010.40 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.41 Many programs we reviewed cost less than $150,000 

for program development and dissemination in a fiscal year.

 

40In 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. 

41The 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.
 

Page 24 GAO-12-115 Prescription Pain Reliever Abuse

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.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.43

 

42U.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).

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 

43The 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.

All Agencies Followed the 

Key Practice of 

Establishing Process 

Metrics but Most Did Not 

Assess Program Outcomes
 

Page 25 GAO-12-115 Prescription Pain Reliever Abuse

behavioral intention about drug use.44

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.

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.

45

 

44ONDCP 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, 

When 

developing their public education efforts, agencies incorporated evidencebased 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.

GAO-06-818 (Washington, D.C.: Aug. 25, 2006).

45GAO, Program Evaluation: Strategies for Assessing How Information Dissemination 

Contributes to Agency Goals, GAO-02-923 (Washington, D.C.: Sept. 30, 2002).
 

Page 26 GAO-12-115 Prescription Pain Reliever Abuse

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.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.

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 

 

46A Call to Action is a science-based document to stimulate action nationwide to solve a 

major public health problem. 

Federal Agencies 

Have Begun 

Coordinating Similar 

Public and Prescriber 

Education Efforts, but 

Have Missed 

Opportunities to 

Share Resources
 

Page 27 GAO-12-115 Prescription Pain Reliever Abuse

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.

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 Agency Program Medium

Teens DEA Good Medicine, Bad Behavior Museum exhibit

Just Think Twice Website a

NIH Heads Up: Real News About Drugs and Your Body Classroom materials a

NIDA for Teens Website a

ONDCP National Youth Anti-Drug Media Campaign Website a

SAMHSA Not Worth the Risk; Even if it’s Legal Brochures and posters

Parents DEA Get Smart About Drugs Website a

ONDCP National Youth Anti-Drug Media Campaign Website a

SAMHSA Not Worth the Risk; Even if it’s Legal Brochures and posters

College students SAMHSA Not Worth the Risk; Even if it’s Legal Brochures and posters

Teachers NIH Heads Up: Real News About Drugs and Your Body Classroom materials a

SAMHSA Not Worth the Risk; Even if it’s Legal Brochures and posters

Public DEA Take Back Initiative Posters, brochures, advertisements

FDA Opioid Public Service Announcements Audio, slides

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

Notes: See app. 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.

Federal Agencies Operate 

Similar Public and 

Prescriber Education 

Programs
 

Page 28 GAO-12-115 Prescription Pain Reliever Abuse

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 fig. 3 and fig. 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.
 

Page 29 GAO-12-115 Prescription Pain Reliever Abuse

Figure 3: ONDCP and NIH Teen Websites
 

Page 30 GAO-12-115 Prescription Pain Reliever Abuse

Figure 4: DEA Teen Website

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 
 

Page 31 GAO-12-115 Prescription Pain Reliever Abuse

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 crossreference 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.

47

 

47We 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, 

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 

GAO-11-318SP (Washington, D.C.: 

Mar. 1, 2011).
 

Page 32 GAO-12-115 Prescription Pain Reliever Abuse

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.
 

Page 33 GAO-12-115 Prescription Pain Reliever Abuse

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

Target audience Program (Agency) Medium Content of training

Current prescribers Extended-release and longacting opioid REMS (FDA)CME/CE course Appropriate prescribinga

Addiction Performance Project 

(NIH)

CME course b Screening, brief intervention, and 

referral to treatmentc

Prescribing Opioids for 

Chronic Pain (SAMHSA)

CME course Appropriate prescribing

Transmucosal immediaterelease fentanyl REMS (FDA)Written materials Appropriate prescribing

Physician Clinical Support 

System – Primary Care (NIH)

Written materials, screening tools, 

mentoring b Screening, brief intervention, and referral to treatment

Prescriber’s Clinical Support 

System for the Appropriate 

Use of Opioids in the 

Treatment of Pain and Opioidrelated Addiction (SAMHSA)

Written materials, mentoring, webinars Appropriate prescribing

Future prescribers

a

NIDA Centers of Excellence 

for Physician Information 

(NIH)

Curricular resources, including 

lectures, case studies, and web-based 

training b

Appropriate prescribing; screening, 

brief intervention, and referral to 

treatment

NIH Pain Consortium Centers 

of Excellence in Pain 

Education (NIH)

Curricular resources Treating paina

Screening, Brief Intervention, 

Referral and Treatment 

Medical Residency Program 

(SAMHSA)

Curricular resources, including 

lectures, web-based training, and role 

plays, and clinical training, including 

practice with simulated patients b

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 drugrelated 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.
 

Page 34 GAO-12-115 Prescription Pain Reliever Abuse

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.48

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 

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.

 

48These 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 GAO-06-15. 

Federal Agencies 

Coordinate Their 

Educational Efforts 

through Three Main 

Mechanisms and Have 

Increasingly Relied on Key 

Practices for Coordination
 

Page 35 GAO-12-115 Prescription Pain Reliever 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.49

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 

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.

 

49The 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.
 

Page 36 GAO-12-115 Prescription Pain Reliever Abuse

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.

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

Federal Agencies Have 

Missed Opportunities to 

Leverage Resources 

among Efforts with Similar 

Goals
 

Page 37 GAO-12-115 Prescription Pain Reliever Abuse

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 
 

Page 38 GAO-12-115 Prescription Pain Reliever Abuse

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.

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 

Conclusions 
 

Page 39 GAO-12-115 Prescription Pain Reliever Abuse

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.

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.

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 

Recommendations for 

Executive Action

Agency Comments 

and Our Evaluation
 

Page 40 GAO-12-115 Prescription Pain Reliever 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 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.

Marcia Crosse

Director, Health Care
Appendix I: Abuse-Deterrent Formulations of 

Prescription Pain Relievers

Page 41 GAO-12-115 Prescription Pain Reliever Abuse

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.1

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.

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.

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 

 

1

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. 

Appendix I: Abuse-Deterrent Formulations of 

Prescription Pain Relievers

Types of AbuseDeterrent 

Formulations 
Appendix I: Abuse-Deterrent Formulations of 

Prescription Pain Relievers

Page 42 GAO-12-115 Prescription Pain Reliever Abuse

been used in other types of products, but not prescription pain relievers. 

In general, the different classifications include:2

• 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).3

• 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 

 

2

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 abusedeterrent 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 TamperResistant 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).

3

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.
Appendix I: Abuse-Deterrent Formulations of 

Prescription Pain Relievers

Page 43 GAO-12-115 Prescription Pain Reliever Abuse

abuse-deterrence in the past, FDA officials told us that no such 

prescription pain relievers are currently marketed.4

• 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.

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.” 

 

4

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. 

Challenges Related to 

Abuse-Deterrent 

Prescription Pain 

Relievers 
Appendix I: Abuse-Deterrent Formulations of 

Prescription Pain Relievers

Page 44 GAO-12-115 Prescription Pain Reliever Abuse

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 abusedeterrent 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.
Appendix I: Abuse-Deterrent Formulations of 

Prescription Pain Relievers

Page 45 GAO-12-115 Prescription Pain Reliever 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.
Appendix II: DEA Quotas for Controlled 

Substances

Page 46 GAO-12-115 Prescription Pain Reliever Abuse

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.1

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.

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),2 periodically inventory all stocks of controlled 

substances,3 provide effective security controls,4 and maintain records to 

account for all controlled substances manufactured, imported, exported, 

received, distributed, or otherwise disposed of.5

 

1

Controlled substances used in the manufacture of prescription pain relievers include 

codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and 

oxymorphone. 

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.

2

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)). 

3

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

4

See 21 C.F.R. § 1301.71 (2011).

5

See 21 C.F.R. § 1304.22 (2011).

Appendix II: DEA Quotas for Controlled 

Substances 

Closed Distribution 

System 
Appendix II: DEA Quotas for Controlled 

Substances

Page 47 GAO-12-115 Prescription Pain Reliever Abuse

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.

DEA officials said that the APQ is the first type of quota that DEA sets for 

each year.6

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 

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.

 

6

See 21 C.F.R. § 1303.11(a) (2011).

Aggregate Production 

Quotas 
Appendix II: DEA Quotas for Controlled 

Substances

Page 48 GAO-12-115 Prescription Pain Reliever Abuse

substance.7

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.

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.

 

7

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. 
Appendix II: DEA Quotas for Controlled 

Substances

Page 49 GAO-12-115 Prescription Pain Reliever Abuse

In addition to the APQ, DEA sets two types of quotas for individual 

companies: bulk manufacturing quotas8 and procurement quotas.9

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.

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.

 

8

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.

9

See 21 C.F.R. § 1303.12 (2011).

Bulk Manufacturing 

Quotas and 

Procurement Quotas
Appendix II: DEA Quotas for Controlled 

Substances

Page 50 GAO-12-115 Prescription Pain Reliever Abuse

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 
Appendix II: DEA Quotas for Controlled 

Substances

Page 51 GAO-12-115 Prescription Pain Reliever Abuse

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.
Appendix III: Objectives, Scope, and 

Methodology

Page 52 GAO-12-115 Prescription Pain Reliever Abuse

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 

Appendix III: Objectives, Scope, and 

Methodology 
Appendix III: Objectives, Scope, and 

Methodology

Page 53 GAO-12-115 Prescription Pain Reliever Abuse

are nationally representative.1

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.

We analyzed data for calendar years 2003-

2009, the most recent years for which data from at least three data 

sources were available.

2 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.

 

1

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 militaryfunded 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.

2

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.
Appendix III: Objectives, Scope, and 

Methodology

Page 54 GAO-12-115 Prescription Pain Reliever Abuse

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.3 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.4 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.5

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 

NVSS data for 2009 were not published in time for 

inclusion in this report.

 

3

NVSS data are coded in accordance with the International Classification of Diseases, 

Tenth Revision. 

4

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.

5

According to CDC analyses, in 2006, more than 20 percent of all drug overdose deaths 

did not specify the drugs involved. 
Appendix III: Objectives, Scope, and 

Methodology

Page 55 GAO-12-115 Prescription Pain Reliever Abuse

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.6 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.7

 

6

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. 

While NSDUH incorporates strategies 

7

GAO, Drug Use Measurement: Strengths, Limitations, and Recommendations for 

Improvement, GAO/PEMD-93-18 (Washington, D.C.: June 25, 1993).
Appendix III: Objectives, Scope, and 

Methodology

Page 56 GAO-12-115 Prescription Pain Reliever Abuse

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 
Appendix III: Objectives, Scope, and 

Methodology

Page 57 GAO-12-115 Prescription Pain Reliever Abuse

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).8 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.9 We also contacted the National Council on Patient 

Information and Education to gain information about best practices for 

public health education.

 

8

GAO-08-43. 

9

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). 
Appendix III: Objectives, Scope, and 

Methodology

Page 58 GAO-12-115 Prescription Pain Reliever Abuse

Table 3: Key Practices for Developing Public Education Efforts

Key practice Description

Define goals and objectives 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.

Analyze the situation 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.

Identify stakeholders 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.

Identify resources Identify available short- and long-term budgetary and other resources.

Research target audiences 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.

Develop consistent, clear messages Determine what messages to develop based on budget, goals, and audience research 

findings. Develop clear and consistent audience messages; test and refine them.

Identify credible messenger(s) Identify who will be delivering the messages and ensure that the source is credible with 

audiences.

Design media mix 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.

Establish metrics to measure success 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, GAO-08-43 (Washington, D.C.: Nov. 19, 2007). 

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.
Appendix III: Objectives, Scope, and 

Methodology

Page 59 GAO-12-115 Prescription Pain Reliever Abuse

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.10

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.

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.

 

10In 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 GAO-06-15. 
Appendix IV: Public Education Programs

Page 60 GAO-12-115 Prescription Pain Reliever Abuse

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.

Appendix IV: Public Education Programs
Appendix V: Data from Key Measures of 

Prescription Pain Reliever Abuse and Misuse

Page 61 GAO-12-115 Prescription Pain Reliever Abuse

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).

Appendix V: Data from Key Measures of 

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

Prescription Pain Reliever Abuse and Misuse

Page 62 GAO-12-115 Prescription Pain Reliever Abuse

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

2004 2005 2006 2007 2008 2009

12-15 years

a

Estimate 3,517 2,983 3,669 3,967 5,904 3,271

Confidence Interval 1,980 - 

5,054

b 1,653 - 

4,313

2,147 - 

5,191

1,974 - 

5,961

1,111- 

10,696

1,391 - 

5,151

16-19 years Estimate 12,536 13,283 17,401 20,330 23,439 27,385

Confidence Interval 8,994 -

16,079

b 9,636 -

16,930

14,117 -

20,685

14,143 -

26,517

16,195 -

30,682

19,923 -

34,846

20-29 years Estimate 43,912 60,074 70,763 81,318 117,744 134,682

Confidence Interval 31,501 -

56,322

b 45,911 -

74,237

56,519 -

85,007

62,892 -

99,744

65,024 -

170,463

79,592 -

189,771

30-39 years Estimate 50,875 52,656 58,193 68,229 85,801 102,939

Confidence Interval 40,974 -

60,776

b 41,247 -

64,064

48,767 -

67,620

53,924 -

82,533

66,713 -

104,889

67,083 -

138,796

40-49 years Estimate 51,542 63,789 71,742 81,724 95,991 98,454

Confidence Interval 39,342 -

63,742

b 50,548 -

77,029

63,385 -

80,099

66,827 -

96,621

74,972 -

117,010

78,221 -

118,686

50-59 years Estimate 24,827 37,867 39,993 50,778 59,287 77,368

Confidence Interval 18,353 -

31,301

b 28,792 -

46,942

33,819 -

46,166

41,885 -

59,670 

47,981 -

70,593

63,016 -

91,720

60+ years Estimate 14,950 18,505 22,310 27,403 39,928 45,852

Confidence Interval 9,777 -

20,123

b 12,911 -

24,099

16,812 -

27,809

21,284 -

33,521

30,285 -

49,571

36,776 -

54,929

Total (12+ years) Estimate 202,159 249,156 284,071 333,748 428,092 489,951

Confidence Interval 159,527 -

244,791

b 199,241 -

299,070

246,132 -

322,011

277,696 -

389,800

314,570 -

541,614

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.
Appendix V: Data from Key Measures of 

Prescription Pain Reliever Abuse and Misuse

Page 63 GAO-12-115 Prescription Pain Reliever Abuse

Table 6: Number of Admissions to Substance Abuse Treatment Facilities for Prescription Pain Reliever Abuse and Misuse by 

Age Groups, 2003-2009

2003 2004 2005 2006 2007 2008 2009

12-15 years 1,308 1,406 1,513 1,489 1,847 2,440 2,786

16-19 years 6,653 8,041 8,825 9,717 11,367 15,213 18,322

20-29 years 32,132 39,518 48,882 59,880 71,522 89,485 104,650

30-39 years 28,612 30,250 33,604 37,232 42,251 50,525 56,474

40-49 years 24,575 25,827 27,512 29,402 30,630 33,378 34,059

50-59 years 6,998 7,975 9,500 10,952 12,752 15,170 15,820

60+ years 915 1,047 1,213 1,333 1,556 1,911 2,133

Total (12+ years) 101,193 114,064 131,049 150,005 171,925 208,122 234,244

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.

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

2003 2004 2005 2006 2007 2008

12-15 years 37 a 29 32 51 36

16-19 years 207 269 248 350 361 366

20-29 years 1,053 1,341 1,547 2,154 2,314 2,291

30-39 years 1,566 1,633 1,874 2,394 2,464 2,469

40-49 years 2,448 2,777 2,983 3,581 3,519 3,541

50-59 years 1,001 1,217 1,510 2,083 2,338 2,612

60+ years 218 267 343 392 462 562

Total (12+ years) 6,493 7,541 b 8,534 10,986 11,509 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.
Appendix V: Data from Key Measures of 

Prescription Pain Reliever Abuse and Misuse

Page 64 GAO-12-115 Prescription Pain Reliever Abuse

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)

2003 2004 2005 2006 2007 2008 2009

12-15 years Estimate a 927 933 797 879 786 750 772

Confidence 

Interval

851 - 

1,008 b 855 - 

1,017

725 - 

875

803 - 

963

712 - 

868

679 - 

829

701 - 

850

16-19 years Estimate 2,152 2,136 2,169 2,151 2,095 1,981 2,005

Confidence 

Interval

2,025 - 

2,285 b 2,009 - 

2,269

2,044 - 

2,300

2,025 - 

2,283

1,964 - 

2,233

1,853 - 

2,116

1,887 - 

2,130

20-29 years Estimate a 3,797 3,804 3,943 4,341 4,049 4,136 4,306

Confidence 

Interval

3,560 - 

4,048 b 3,563 - 

4,060

3,690 - 

4,212

4,062 - 

4,637

3,802 - 

4,309

3,874 - 

4,413

4,031 - 

4,597

30-39 years Estimate 2,128 1,923 2,107 2,151 2,293 1,962 2,135

Confidence 

Interval

1,869 - 

2,421 b 1,686 - 

2,192

1,843 - 

2,405

1,897 - 

2,437

2,007 - 

2,617

1,710 - 

2,249

1,870 - 

2,436

40-49 years Estimate 1,815 1,703 1,566 1,974 1,767 1,792 1,645

Confidence 

Interval

1,541 – 

2,135 b 1,468 - 

1,973

1,329 - 

1,843

1,701 - 

2,288

1,536 - 

2,031

1,552 - 

2,067

1,410 - 

1,917

50-59 years Estimate a 514 590 876 882 1,070 759 1,193

Confidence 

Interval

350 - 

754 b 419 - 

830

641 - 

1,195

671 - 

1,157

796 - 

1,435

558 - 

1,030

921 - 

1,543

60+ years Estimate 338 167 358 272 406 506 349

Confidence 

Interval

192 - 

593 b 97 - 

289

221 - 

580

159 - 

462

258 - 

639

337 - 

757

225 - 

539

Total (12+ years) Estimate 11,671 11,256 11,815 12,649 12,466 11,885 12,405

Confidence 

Interval

11,096 -

12,273 b 10,695 -

11,844

11,233 -

12,426

12,063 - 

13,263

11,861 - 

13,100

11,319 -

12,479

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.
Appendix VI: Comments from the Office of 

National Drug Control Policy

Page 65 GAO-12-115 Prescription Pain Reliever Abuse

Appendix VI: Comments from the Office of 

National Drug Control Policy
Appendix VII: GAO Contact and Staff 

Acknowledgments

Page 66 GAO-12-115 Prescription Pain Reliever Abuse

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

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.

Appendix VII: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 
Related GAO Products

Page 67 GAO-12-115 Prescription Pain Reliever Abuse

Medicare Part D: Instances of Questionable Access to Prescription 

Drugs. 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. 

GAO-11-744. Washington, D.C.: August 26, 2011.

Medicaid: Fraud and Abuse Related to Controlled Substances Identified 

in Selected States. GAO-09-957. Washington, D.C.: September 9, 2009.

Methadone-Associated Overdose Deaths: Factors Contributing to 

Increased Deaths and Efforts to Prevent Them. GAO-09-341. 

Washington, D.C.: March 26, 2009.

Anabolic Steroid Abuse: Federal Efforts to Prevent and Reduce Anabolic 

Steroid Abuse among Teenagers. 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. GAO-06-818. Washington, D.C.: August 25, 2006.

Internet Pharmacies: Some Pose Safety Risks for Consumers. 

GAO-04-820. Washington, D.C.: June 17, 2004.

Prescription Drugs: OxyContin Abuse and Diversion and Efforts to 

Address the Problem. GAO-04-110. Washington, D.C.: December 23, 

2003.

Prescription Drugs: State Monitoring Programs Provide Useful Tool to 

Reduce Diversion. GAO-02-634. Washington, D.C.: May 17, 2002.

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