Prescription Pain Reliever Abuse: Agencies Have Begun Coordinating Education Efforts, but Need to Assess Effectiveness
Published: 2011-12-22T00:00:00

Fast Facts:

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

section_title: Letter
paragraphs: The Centers for Disease Control and Prevention (CDC) has declared that  the United States is in the midst of an epidemic of prescription drug  overdose deaths, 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. Although specific  regions of the country have been severely affected by this problem,  recent media reports from across the United States suggest it is now a  national issue.
Multiple federal agencies have responsibility for addressing the abuse  and misuse of prescription pain relievers through prevention, treatment,  and enforcement activities. 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.
You asked us to update our prior work on OxyContin to reflect changes in  oxycodone abuse trends and efforts aimed at stemming prescription drug  abuse since our 2003 report. In response to that request, we (1) describe  recent national trends in prescription pain reliever abuse and misuse,   (2) describe how federal agencies are educating prescribers about  prescription pain reliever abuse and misuse, (3) assess the extent to  which federal agencies follow key practices for developing public  education efforts about prescription pain reliever abuse and misuse, and  (4) identify educational efforts that use similar strategies and assess how  agencies coordinate those efforts. At your request, we also provide  information on manufacturer-initiated efforts to develop abuse-deterrent  formulations of prescription pain relievers (see 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,  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. We limited our scope to efforts that target the general public,  rather than special populations, such as educational efforts pursued by  the Department of Veterans Affairs, Department of Defense, or Indian  Health Service. We also focused on efforts that were being actively  revised or disseminated in fiscal year 2011. Finally, we focused on efforts  that craft targeted messages about abuse and misuse, rather than efforts  that strictly provide factual information, such as a limited number of drug  fact websites, since our criteria for developing consumer education efforts  are only appropriate for efforts that seek to convey a particular message.
To identify educational efforts that use similar strategies and assess how  agencies coordinate those efforts, we first assessed the extent to which  agencies targeted similar populations, provided similar information, and  used similar educational strategies. We then interviewed officials from  DEA, FDA, HRSA, NIH, SAMHSA, and ONDCP and reviewed agency  documents in order to assess federal agencies’ coordination efforts  against key practices for collaboration identified in our prior work. (See  app. III for a detailed discussion of our methodology.)
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.
subsections: section_title: Background
subsections: section_title: Prescription Pain Relievers
paragraphs: Pain, which affects millions of Americans, can be characterized in terms  of intensity—mild to severe—and duration—acute or chronic. While the  appropriate medical treatment of pain varies according to these two  dimensions, opioid analgesics can provide pain relief for some patients.  These prescription pain relievers can be made in either immediate- release or extended-release formulations. Immediate-release pain  relievers work for shorter periods of time, while extended-release pain  relievers are designed to provide a longer period of drug release so that  they can be taken less frequently.
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. Third,  some individuals, while seeking pain relief, incorrectly use prescription  pain relievers that were prescribed to them, such as by taking more than  prescribed.
Prescription pain relievers have serious risks when they are abused and  misused. Abuse and misuse of prescription pain relievers can lead to  addiction and severe respiratory depression, which can cause death.  Depending on the amount taken, even a single dose could cause death if  taken by an individual who does not regularly use such pain relievers and  whose body is not accustomed to their effects. Also, using alcohol or  other drugs with prescription pain relievers can increase the risk of  dangerous side effects, including death.
section_title: Preventing Prescription Pain Reliever Abuse and Misuse
paragraphs: Federal agencies use both regulatory and programmatic approaches in  their efforts to prevent prescription pain reliever abuse and misuse.  Because of their potential for abuse, prescription pain relievers are  regulated under the Controlled Substances Act.
Prescribers, such as  physicians, physician assistants, nurse practitioners, and dentists, must  register with DEA to prescribe drugs regulated under the act, and  prescribers serve a key role in reducing prescription drug abuse and  misuse.
However, federal agencies have noted gaps in prescriber education about  issues related to prescription pain reliever abuse and misuse, including  that most prescribers receive little training on the importance of  appropriate prescribing and dispensing of prescription pain relievers, on  how to recognize substance abuse in their patients, or on treating pain. A  recent study on pain education in medical schools found that such  education is limited, variable, and often fragmentary. 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. A  representative of the American Pain Foundation told us that the  organization frequently receives reports from patients that, in some  communities, prescribers have stopped prescribing prescription pain  relievers because of a lack of knowledge about how to safely prescribe  them.
Federal public education efforts seek to educate patients and the general  public of all ages about the appropriate use, secure storage, and disposal  of prescription drugs, as well as the risks associated with prescription  drug abuse and misuse (see 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  important for the development of educational outreach efforts, motivating  a target audience, and alleviating challenges, such as prioritizing limited  resources.
section_title: Federal Agencies Involved in Preventing Prescription Pain Reliever Abuse and Misuse
paragraphs: Multiple federal agencies play a role in preventing the abuse and misuse  of prescription pain relievers. Within the Executive Office of the President,  ONDCP establishes policies, priorities, and objectives for a national drug  control program. ONDCP also oversees several programs related to  curbing drug abuse and misuse, including an educational media  campaign.
In addition, Department of Health and Human Services (HHS) agencies,  including FDA, HRSA, NIH, and SAMHSA, have various responsibilities  and engage in activities related to preventing the abuse and misuse of  prescription pain relievers.
FDA is responsible for ensuring the safety and effectiveness of drugs.
FDA can require drug manufacturers to take measures to ensure the  safety of their products, such as by providing patient and prescriber  education materials. FDA also educates patients and providers about  appropriate use and potential risks of drugs, including prescription  pain relievers, in order to reduce preventable harm from these drugs.
HRSA operates the federal Poison Control Program, which provides  funds for poison control centers that provide treatment  recommendations for poisonings involving prescription drug abuse  and misuse. This program also has a campaign that includes public  education about the risks of poisoning from prescription pain relievers.
NIH, primarily through its component NIDA, provides strategic support  for and conducts research on drug abuse and addiction. NIH’s role  also includes translating and disseminating this research into  materials for public consumption.
SAMHSA seeks to direct substance abuse and mental health services  to the people most in need and promote use of evidence-based  practices in these areas in the general health care system. In  particular, the agency seeks to educate the public and prescribers  about issues related to substance abuse in an effort to prevent such  abuse and reduce its prevalence.
Finally, within the Department of Justice, DEA is responsible for enforcing  the Controlled Substances Act and related regulations. One of DEA’s  roles is to control the quantity of schedule I and II controlled substances  produced or procured each year in the United States, which it does by  establishing annual quotas for U.S. manufacturers. (See 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.
section_title: Federal Data Sources Used to Monitor Prescription Pain Reliever Abuse and Misuse
paragraphs: 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. Although these data  sources do not directly measure abuse and misuse, when used together,  they provide a more complete view of the problem of prescription pain  reliever abuse and misuse than any of the data sources individually.  Therefore, we refer to national data from these four data sources as key  measures of prescription pain reliever abuse and misuse. The data  sources used by federal agencies are:
DAWN, a public health surveillance system operated by SAMHSA,  collects information on emergency department visits in the United  States. DAWN staff review emergency department medical records  from a nationally representative sample of hospitals to identify and  gather information on visits in which drugs were involved, including  visits where drugs were a direct cause and visits where drugs were a  contributing factor.
TEDS, compiled by SAMHSA, gathers data from substance abuse  treatment facilities in the United States on the demographic  characteristics and substance abuse problems of those aged 12 or  older admitted for treatment.
NVSS, operated by CDC, contains vital statistics data, including  mortality data, such as causes of death, obtained from death  certificates filed for every death from every jurisdiction in the United  States.
NSDUH, an annual household survey sponsored by SAMHSA,  gathers self-reported information on the use of illicit drugs (including  the “nonmedical use” of prescription drugs), alcohol, and tobacco in  the civilian, noninstitutionalized population of the United States aged  12 years old or older.
See appendix III for more information about the data collection  methodologies and limitations of these data sources.
section_title: Key Measures of Prescription Pain Reliever Abuse and Misuse Have Increased Nationwide
paragraphs: 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.
subsections: section_title: Key Measures of Prescription Pain Reliever Abuse and Misuse Increased from 2003 to 2009
paragraphs: 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). 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. 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.  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.
While these measures of adverse health consequences increased  substantially, according to NSDUH survey data, the percent increase in  the estimated number of people nationwide who abused and misused  prescription pain relievers—another key measure of prescription pain  reliever abuse and misuse—was relatively slight during the period we  reviewed. 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.Appendix V shows data from the key measures by age group for each  year that we reviewed.
section_title: Increasing Availability and High-Risk Behaviors Likely Contributed to the Increases in Adverse Health Consequences
paragraphs: Although information about the reasons for the substantial increases in  adverse health consequences is limited, agency officials suggested that  increasing availability of prescription pain relievers, especially extended- release and long-acting pain relievers, and increasing high-risk behaviors  by those who abuse or misuse the drugs were likely contributors to the  increased adverse health consequences related to prescription pain  reliever abuse and misuse from 2003-2009. Over this time period, the  number of prescriptions dispensed from U.S. pharmacies for prescription  pain relievers increased by 32 percent—from 195 million prescriptions in  2003 to 257 million prescriptions in 2009—which CDC, FDA, and NIH  officials attributed to factors such as an increased focus on pain  management. Officials from a number of agencies noted, however, that  while most prescription pain relievers are used as prescribed, a fraction of  all prescribed pain relievers are abused and misused.not allow officials to determine what fraction of prescription pain relievers  are abused and misused.
From 2003 to 2009, prescriptions for extended-release and long-acting pain relievers  increased from approximately 15 million to 23 million. Estimates of dispensed  prescriptions are from FDA’s analysis of SDI, Vector One®:National, extracted June 2010. the total number of prescriptions dispensed.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.
Officials from most of the  A second factor that officials from several agencies said likely contributed  to the increases in adverse health consequences is that more individuals  may be engaging in high-risk behaviors when they abuse or misuse  prescription pain relievers, though data on the extent of high-risk  behaviors are limited. One high-risk behavior officials pointed to was  combining prescription pain relievers with other substances, such as  another prescription pain reliever, alcohol, or other drugs. Taken together,  the interactions of such substances can lead to increased risk of life- threatening conditions. From 2004 to 2009, the number of emergency  department visits that involved combining prescription pain relievers with  other substances increased by an estimated 200,000 visits, while the  number of emergency department visits involving a prescription pain  reliever alone increased by an estimated 88,000 visits.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   However,  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.
section_title: Federal Agencies Are Using Various Strategies to Educate Prescribers about Issues Related to Prescription Pain Reliever Abuse and Misuse
paragraphs: FDA, NIH, and SAMHSA are using a variety of strategies to fill the gaps  federal agencies have identified in prescriber education related to treating  pain, prescribing opioids appropriately, and identifying substance abuse  in their patients, but officials told us that more education is needed.  Strategies that these agencies pursued in fiscal year 2011 include  developing CME programs, requiring training and certification in order to  prescribe certain drugs, organizing physician mentoring networks, and  developing curriculum resources for future prescribers.
First, FDA, NIH, and SAMHSA are using voluntary CME programs to  educate prescribers about issues related to prescription pain reliever  abuse and misuse. CME programs are educational activities which serve  to maintain, develop, and increase the knowledge, skills, and professional  performance and relationships physicians use to provide services to  patients. Many state medical boards require prescribers to complete a  certain number of CME credits for license re-registration. FDA is requiring  manufacturers to develop a CME or continuing education (CE) course for  prescribers as part of a Risk Evaluation and Mitigation Strategy (REMS)  for extended-release and long-acting prescription pain relievers.completion of the course, which is expected to be implemented in early  2012, will be voluntary, FDA is requiring manufacturers to propose  performance goals for the percentage of prescribers who complete it. NIH  is undertaking a different approach to using CME programs to educate  prescribers about identification of substance abuse in their patients,  reaching out to prescribers at medical conferences across the country.  Using a live theater CME format, NIH uses a dramatic reading of a portion  of the play Long Day’s Journey into Night that focuses on a character’s  morphine addiction, an expert panel reaction, and a facilitated audience  discussion to highlight issues like incorporating screening, brief  intervention, and referral to treatment into primary care settings. Finally,  SAMHSA developed a CME course on prescribing opioids for chronic  pain and partners with local host organizations, such as local medical  organizations and state agencies, to offer it across the United States. The  course is targeted at physicians, dentists, and other prescribers and can  be modified to reflect the needs of the local host organization.
Another strategy FDA uses is requiring prescribers of certain prescription  pain relievers to be trained and certified in order to prescribe them. As of  October 2011, all five marketed transmucosal immediate-release fentanyl  products had REMS with prescriber training and certification components  due to unique concerns associated with these products. 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.required to become recertified every 2 years.
A third strategy NIH and SAMHSA are pursuing is providing funding to  develop physician clinical support systems, which provide educational  resources and free, nationwide mentoring services related to prescribing  prescription pain relievers. As of October 2011, two physician clinical  support systems had been funded: one to assist practicing physicians  interested in implementing substance abuse screening in their practices  and one related to the appropriate use of prescription pain relievers for   Each system links physicians to trained  the treatment of chronic pain. clinical advisors who can provide telephone or e-mail responses to  specific questions and offer support using the educational resources.
SAMHSA also funds two additional physician clinical support systems related to the use  of methadone and buprenorphine in addiction treatment, which are outside the scope of  our review. 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. The curriculum resources  for these programs are designed to be transferable to medical schools  and residency programs nationwide.
Despite various ongoing strategies to educate current and future  prescribers about issues related to prescription pain reliever abuse and  misuse, officials from each of the federal agencies we spoke with told us  that more prescriber education is necessary. ONDCP officials indicated  that they—with technical assistance from DEA, FDA, and SAMHSA—are  working to develop a legislative proposal to require that all prescribers  who request DEA registration to prescribe controlled substances be  trained on the appropriate and safe use, proper storage, and disposal of  prescription pain relievers as a precondition of registration. Currently, in  order to register with DEA to prescribe a controlled substance,  prescribers must hold a valid state license.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   Officials from many of the  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.
section_title: Federal Agencies Generally Followed Key Practices When Developing Public Education Efforts
paragraphs: 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.
subsections: section_title: All Agencies Followed Almost All Key Practices; Efforts Varied in Size and Approach
paragraphs: 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  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). 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.
Agencies varied in how they used the key practices for developing public  education efforts. For instance, SAMHSA used the key practice of  developing consistent, clear messages by convening Project Advisory  Teams composed of external stakeholders and subject matter experts.  The teams met several times during the development of two phases of  Not Worth the Risk; Even if it’s Legal and gave input to SAMHSA about  effective messaging and distribution channels for the program’s target  audiences, which include teens, college students, and “student  influencers” (e.g, parents, teachers, health care providers). FDA used a  different approach for the same key practice of developing consistent,  clear messages for its Opioid Public Service Announcements—which  include information about appropriate use, storage, and disposal of  medications—relying on internal discussions between staff in its Office of  Communications and the Office of New Drugs.
Although all agencies used many of the same key practices to develop  their educational efforts, the resulting initiatives are different in terms of  size, scope, and duration, and agencies dedicated varying amounts of  resources to developing their efforts. For instance, NIH’s Heads Up: Real  News About Drugs and Your Body provides classroom materials— including magazine articles, student worksheets, and lesson plans—to  students and teachers about a range of topics related to drug abuse and  misuse, including but not limited to prescription drugs, and has done so  each school year since 2002. By contrast, DEA began collecting and  disposing of unused prescription drugs through its Take Back Initiative in  2010. 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.for program development and dissemination in a fiscal year.
section_title: All Agencies Followed the Key Practice of Establishing Process Metrics but Most Did Not Assess Program Outcomes
paragraphs: 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.
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.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   ONDCP also awarded a  behavioral intention about drug use.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.
However, ONDCP indicated that,  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. developing their public education efforts, agencies incorporated evidence- based strategies when possible, but limited evidence exists about how to  successfully educate the public about prescription pain reliever abuse and  misuse. For instance, research shows that teens may mistakenly believe  that prescription pain relievers are safer than illicit drugs. As a result,  officials from several agencies told us that they seek to dispel this  misperception in their educational efforts. In addition, NSDUH data also  indicate that most people who abuse or misuse prescription pain relievers  get the drugs from a friend or family member. Thus, DEA officials told us  that they have sought to educate the public about proper drug storage  and disposal in order to limit the amount of drugs that are available to be  diverted from medicine cabinets for abuse and misuse.
GAO, Program Evaluation: Strategies for Assessing How Information Dissemination  Contributes to Agency Goals, GAO-02-923 (Washington, D.C.: Sept. 30, 2002).
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.  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.
section_title: Federal Agencies Have Begun Coordinating Similar Public and Prescriber Education Efforts, but Have Missed Opportunities to Share Resources
paragraphs: There are several similarities among agencies’ efforts, target audiences,  and mediums across the nine public education initiatives and nine  prescriber education programs we identified. Officials said that these  similarities in public education efforts are beneficial in addressing  prescription drug abuse and misuse because having multiple, reinforcing  messages about the same subject is valuable in public health  communications and because federal agencies provide slightly different  perspectives on the issues surrounding prescription drug abuse and  misuse. Likewise, the prescriber education programs we identified,  though similar, are different in content and focus. Although these similar  programs have the potential to be duplicative if not effectively  coordinated, federal agencies have recently begun to coordinate their  educational efforts. Nevertheless, federal agencies have missed  opportunities to pool resources—a key practice for effective  coordination—among similar education efforts, which may have resulted  in lost opportunities to obtain additional benefits through coordination.
subsections: section_title: Federal Agencies Operate Similar Public and Prescriber Education Programs
paragraphs: 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.
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.
There are also two initiatives—DEA’s Get Smart About Drugs and  ONDCP’s National Youth Anti-Drug Media Campaign—that use the same  medium to target parents with similar messages about prescription drug  abuse and misuse. For instance, both use websites that have interactive  features that show parents where teens commonly access prescription  drugs in the home. Both sites also include tips for parents about how to  talk to teens about drugs and about how to identify signs of abuse.
Officials acknowledged these instances of similar goals and similar  strategies to reach the same audience among educational efforts.  However, officials said that these similarities are beneficial in addressing  prescription drug abuse and misuse. Officials from NIH, FDA, DEA, and  ONDCP noted that having multiple, reinforcing messages about the same  subject is valuable in public health communications, particularly about an  issue as complex as prescription drug abuse and misuse. The National  Council on Patient Information and Education also told us that repetition  and frequent delivery of information supports message reinforcement.  Second, federal agencies have their own constituencies and each  approaches prescription drug abuse and misuse from a slightly different  perspective. For instance, NIDA for Teens provides a science-based  perspective and includes information about how prescription drugs affect  the brain. Specifically, the “Mind Over Matter” series on the NIDA for  Teens website explains how prescription drugs mimic neurotransmitters  to alter the brain’s chemistry. DEA’s Just Think Twice, on the other hand,  provides more information about the legal consequences of abusing  drugs, such as losing federal student loans, and the culture of drug  abuse, including images of drugs and true stories of youth overdose  deaths. NIH officials told us that both perspectives are important as some  members of the public may go to NIH’s NIDA for information about these  issues, while others may go to DEA. Officials also said that they cross- reference each other’s information when appropriate. For instance,  ONDCP links to publications from NIH’s NIDA on one of the National  Youth Anti-Drug Media Campaign websites.
In addition to the similarities among the nine targeted educational efforts  we reviewed, agencies are engaged in additional efforts outside the  scope of our review which, taken together, may present areas of potential   These additional efforts include posting materials from  duplication.retired initiatives online, planning future efforts, and providing factual  information about prescription pain relievers. For instance, FDA and  SAMHSA have brochures and posters for teens and the elderly with  messages about prescription pain reliever abuse and misuse that are no  longer actively disseminated, but are still available on their websites.  HRSA and, contingent on available resources, DEA are also planning to  launch new or update existing educational initiatives in the next fiscal  year, targeted at the elderly and parents, respectively. ONDCP is also  planning to work with agencies and external stakeholders to develop and  implement national public education campaigns on prescription drug  abuse and misuse and drug storage and disposal, by April 2013. ONDCP  officials told us that, as of October 2011, they were still considering  various options and working to identify resources for these campaigns.  Finally, three federal agencies have prescription drug fact pages on their  main websites and FDA oversees the dissemination of drug information to  patients through tools such as medication guides that are provided with  some prescription drugs. Given the number of agencies involved in  educating the public about prescription pain reliever abuse and misuse  and the number of efforts currently under way, these additional efforts  represent areas where there may be the potential for duplicative  programming, if such efforts are not effectively coordinated.
There are also similar target audiences and mediums among the nine  prescriber education programs we identified, although the content and  focus of these programs is different (see table 2). For example, two CME  courses, SAMHSA’s Prescribing Opioids for Chronic Pain course and  FDA’s requirement for prescriber education through its extended-release  and long-acting opioid REMS, are both targeted at current prescribers.  Though these courses have some similar content about patient selection  and monitoring, FDA officials noted that prescriber education through  REMS will focus on extended-release and long-acting products, whereas  the SAMHSA course includes information on both extended-release and  immediate-release pain relievers. They also noted that the SAMHSA  course is more focused on addiction and treatment than the REMS  materials will be. As a result, prescribers are being educated about the  full range of issues related to prescription pain reliever abuse and misuse,  including treating pain, appropriate prescribing, and recognizing  substance abuse in their patients.
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. ONDCP releases the National Drug  Control Strategy (the Strategy) on an annual basis and it outlines the  administration’s goals and priorities for reducing the rate of drug abuse  and misuse and the associated consequences. The Strategy, which  outlines drug control policies and programs for illicit and prescription  drugs, serves as a coordination mechanism for drug control agencies and  incorporates several key practices for interagency collaboration. For  instance, the Strategy defines and articulates a common outcome by  establishing the administration’s goals for reducing drug abuse and  misuse. The Strategy also provides a means for agencies to agree on  roles and responsibilities by listing specific actions for agencies to take,  including identifying lead and partnering agencies for each action item.  For example, “Enhance Healthcare Providers’ Skills in Screening and  Brief Intervention” is an action item in the 2010 Strategy and it specifies  that SAMHSA is the lead agency, with NIH’s NIDA, HRSA, and the Indian  Health Service listed as partnering agencies. Finally, the Strategy  provides a means to monitor, evaluate, and report on results for  collaborative efforts. Agencies developed objectives and 1- and 2-year  milestones for the action items in the 2010 Strategy and they submit  regular progress reports to ONDCP.
The Prescription Drug Abuse Prevention Plan (the Plan) was recently  released by ONDCP and complements the Strategy by outlining the  administration’s approach to addressing prescription drug abuse and  misuse, in particular. As a result, it serves as a second interagency  coordination mechanism for agencies addressing prescription drug abuse  and also reflects the key practices for collaboration that we previously  identified. The Plan establishes mutually reinforcing or joint strategies by  identifying four priority areas for federal efforts to reduce prescription drug  abuse and misuse—education, monitoring, proper disposal, and  enforcement—and it aligns agencies’ activities around these four areas.  For instance, the Plan calls for federal agencies and private stakeholders  to work together to develop evidence-based public education campaigns  about appropriate use, secure storage, disposal, and abuse of  prescription drugs. Like the Strategy, the Plan also provides a means to  monitor, evaluate, and report on results. ONDCP asked agencies to  submit implementation plans with objectives and 1- and 2-year milestones  and to provide progress reports on a quarterly basis. The Plan also calls  for the establishment of a Federal Council on Prescription Drug Abuse to  coordinate implementation of the Plan.
Finally, the HHS Behavioral Health Coordinating Committee’s  Subcommittee on Prescription Drug Abuse provides a third coordination  mechanism for HHS agencies and demonstrates use of the key practices  for collaboration as well. For instance, the Subcommittee defines a  common outcome for HHS agencies by identifying five goals related to  prescription drug abuse and organizing its activities around these goals.The Subcommittee also provides a means to monitor and report on  progress to HHS leadership. Agency officials report on their activities  related to prescription drug abuse and misuse to the Subcommittee   co-chairs, who then provide updates to HHS leadership.
Agencies have begun using these coordination mechanisms, or  augmenting existing coordination efforts, within recent years. Beginning in  2009, ONDCP began using a more collaborative process for developing  the Strategy, convening a Demand Reduction Interagency Working  Group. The working group brought together subject experts from drug  control agencies to provide input on the development of the Strategy and  DEA, FDA, HRSA, NIH, and SAMHSA all participated. Officials from  multiple agencies indicated that this process was more interactive than in  years past. The 2010 Strategy also utilized a new approach by outlining  specific action items and developing a system to monitor agency progress  toward objectives. ONDCP also released the Plan in April 2011 and  agency officials described the process for developing the Plan as  collaborative. One official described the amount of brainstorming between  ONDCP and agencies in order to develop the Plan as “unprecedented.”  Finally, the Subcommittee on Prescription Drug Abuse was formed in the  summer of 2010. Officials explained that the Subcommittee provides a  more regular and formal means of coordination, whereas prior efforts to  coordinate within HHS were more irregular and informal. For instance, the  Subcommittee helped institutionalize relationships among officials who  work on prescription drug abuse and misuse across HHS. Officials noted  that although they were previously aware of subject experts at other  agencies, they now work together on related tasks through the  Subcommittee and therefore have formal working relationships which  they can draw on to work through issues. Subcommittee members added  that they use their meetings to share programming information. For  instance, prior to convening the Subcommittee, NIH officials told us that  they were not fully aware of all of the prescriber education efforts across  HHS agencies. Now, officials have created a group through the  Subcommittee to catalogue related prescriber education programs.
While officials from each agency we spoke with said that these  coordination mechanisms were working well, ONDCP and other agency  officials indicated that they were aware of the potential for creating too  many coordinating bodies. Though the Strategy’s Demand Reduction  Interagency Working Group, the Plan’s new Federal Council on  Prescription Drug Abuse, and the HHS Subcommittee on Prescription  Drug Abuse may have membership from many of the same agencies,  officials said that they felt that they had not reached the point of too much  coordination, noting that current coordination efforts were effective in  terms of facilitating information sharing and avoiding overlapping  programming among agencies.
section_title: Federal Agencies Have Missed Opportunities to Leverage Resources among Efforts with Similar Goals
paragraphs: Although agencies have increased their coordination efforts in recent  years, they have missed opportunities to leverage resources—a key  practice for effective coordination—among similar education efforts  targeting teens, which may have resulted in lost opportunities to obtain  additional benefits through coordination. At least four teen initiatives— Just Think Twice, NIDA for Teens, the National Youth Anti-Drug Media  Campaign, and Not Worth the Risk; Even if it’s Legal—have obtained  feedback from teens and other stakeholders about the features of and  messages for educational efforts about prescription drug abuse and  misuse that was not shared. For instance, NIH formed a Teen Advisory  Group to pretest their messages and also seeks input from local high  school students, including groups such as Students Against Destructive  Decisions. These focus groups revealed information that could be useful  to other teen education efforts, addressing topics such as web and  materials design, video content, language and terminology, and  messaging. For instance, one focus group revealed that trying to imitate  the layout of social networking sites (e.g., MySpace or Facebook) did not  make sites more appealing to teen users.
DEA, ONDCP, and SAMHSA also get feedback on their teen education  efforts. DEA gets feedback from the Drug Abuse Resistance Education— D.A.R.E.—Youth Advisory Board on content for Just Think Twice and  also gets feedback from DEA field staff who give presentations to teens  about drug abuse. DEA officials told us that the feedback on the website  that they received from field staff often varies depending on the part of the  country in which the field staff give presentations in schools, with field  staff in San Diego reporting different successful approaches than those in  Miami. ONDCP also pretests content and features with teens. One lesson  derived from ONDCP’s pretesting efforts is that teens liked the option to  view content posted by their peers on the website, such as photos or  stories. Finally, SAMHSA gets input from professional and student groups  through its Project Advisory Team for Not Worth the Risk; Even if it’s  Legal. For instance, the Project Advisory Team advised SAMHSA on a  number of issues related to addressing prescription drug abuse and  misuse among teens, including the importance of acknowledging and  validating common stressors teens face in order to establish credibility  and to create an opportunity to address alternative coping skills.
While each of these agencies obtained feedback on the messages for  and features of similar initiatives, agencies did not share the results of  their feedback sessions or pretesting efforts with officials from other  agencies who work on similar programs. Officials said they did not share  the feedback they received for two reasons. First, NIH, DEA, and  SAMHSA officials said that they were never asked to do so by other  agencies with similar education efforts. Second, ONDCP officials said that  they felt that the results of their pretesting would not be useful for other  educational efforts. Nonetheless, one official acknowledged that sharing  findings from pretesting efforts and other feedback sessions could have  been useful when developing the content and messages for their  educational effort.
NIH officials said that there are two coordination mechanisms through  which they could share information among agencies involved with  educational efforts in the future. In addition to its Subcommittee on  Prescription Drug Abuse, the HHS Behavioral Health Coordinating  Committee also has a Communications Subcommittee and NIH officials  said that they can use the Communications Subcommittee to share  information about the development of educational efforts among HHS  agencies. NIH officials said that they also have the opportunity to share  information with agencies outside of HHS through weekly phone calls that  ONDCP facilitates with communications staff from DEA, NIH, ONDCP,  and SAMHSA, among other agencies.
section_title: Conclusions
paragraphs: Abuse and misuse of prescription pain relievers is a large and growing  public health problem in the United States. Although DEA, FDA, NIH,  ONDCP, and SAMHSA are engaged in multiple efforts to educate the  public about prescription pain reliever abuse and misuse, there is limited  evidence about how to craft effective messages about this issue. The  agencies agree that education about prescription drug abuse and misuse  requires a different approach than other drug prevention efforts, but there  is a lack of proven strategies and messages on which agencies can  model their own educational efforts to ensure that such efforts will have  the desired outcome. In the absence of a strong evidence base,  establishing outcome metrics is an especially important key practice to  incorporate into the development of educational efforts because outcome  metrics provide feedback on the effectiveness of agencies’ efforts at  preventing prescription pain reliever abuse and misuse. However, seven  of the nine public education efforts that we reviewed did not assess  program outcomes. This leaves federal agencies with limited knowledge  as to whether such efforts are effective.
Given these challenges, there is much to be gained from continued and  robust coordination among similar education efforts about prescription  pain reliever abuse and misuse. In its role as a coordinating body for  federal drug control efforts, ONDCP is uniquely situated to ensure that  federal educational efforts are not duplicative and are effectively  coordinated. DEA, NIH, SAMHSA, and ONDCP operate similar  educational initiatives—including three websites and a brochure series— targeting teens. While agency officials told us that the similar educational  efforts we reviewed are reinforcing, it is important that agencies continue  to coordinate their efforts as additional planned educational efforts are  implemented in order to avoid duplicative programming. Although  agencies involved in educating the public have recently increased their  coordination efforts, they have missed opportunities to share the results  of teen and stakeholder feedback among similar efforts—a key practice  for effective coordination. In developing their educational efforts, DEA,  NIH, ONDCP, and SAMHSA obtained feedback from their target  audience and other stakeholders that could be useful for other agencies  to consider in relation to their own efforts. Although each educational  effort has unique features, comments from focus group participants and  other stakeholders could produce lessons that other agencies could have  drawn on if summaries of those comments had been made available to  other agencies to review. As additional public education efforts are  developed agencies will need to leverage resources, including sharing  lessons learned from the development and implementation of existing  educational efforts, to ensure that they make the best use of limited  resources.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to ONDCP, the Department of Justice,  and HHS for their review and comment. In written comments, reproduced  in appendix VI, ONDCP did not explicitly agree or disagree with our  recommendations, but noted that it will continue to work for improved  coordination of prescription drug abuse educational efforts and evaluation  of outcomes. ONDCP also stated that the prescription drug abuse  educational efforts that we reviewed target different populations and  address different messages, and suggested that we explain the  differences among these efforts in our report. We revised our report to  include an additional reference to our detailed descriptions of the various  educational efforts we reviewed, which explain the scope, target  audiences, and mediums used among the educational efforts. We also  included additional information about the size and scope of ONDCP’s  National Youth Anti-Drug Media Campaign. ONDCP, DEA, and HHS also  provided technical comments, which we have incorporated as  appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time we will send copies of this report to the Director  of the Office of National Drug Control Policy, the Attorney General, and  the Secretary of Health and Human Services. In addition, the report will  be available at no charge on the GAO website at 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.
section_title: Appendix I: Abuse-Deterrent Formulations of Prescription Pain Relievers
paragraphs: 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. We are presenting  information on different types of abuse-deterrent formulations of  prescription pain relievers, whether they are being used in fiscal year  2011, and challenges related to these products. This appendix is based  on our review of scientific literature and Food and Drug Administration  (FDA) and manufacturer documents, as well as interviews with FDA  officials and representatives of Purdue Pharma L.P., the manufacturer of  OxyContin.
Manufacturers of prescription pain relievers have long sought to achieve  a balance between creating drugs that are effective for therapeutic use  while minimizing their potential for abuse. The scientific articles noted  that, in general, abusers seek out drugs that can be smoked, snorted, or  taken intravenously, thus providing a more rapid onset of the effects of  the drug. Therefore, some manufacturers of prescription pain relievers  have focused on making their products tamper resistant, so that the  physical or chemical makeup or delivery system of the drug cannot be  altered, with the goal of preventing users from accessing and abusing the  active ingredient.
subsections: section_title: Types of Abuse- Deterrent Formulations
paragraphs: There are five different types of abuse-deterrent formulations  manufacturers have developed to reduce tampering and abuse of their  products, though some drugs may incorporate multiple types. Some of  these abuse-deterrent formulations are already being utilized in  prescription pain relievers, others are being incorporated into pain  relievers that are in the process of being developed, and others have  been used in other types of products, but not prescription pain relievers.  In general, the different classifications include:
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).
Aversion – A combination of substances designed to produce an  unpleasant effect if a tampered form is ingested or a higher dosage  than directed is used. For example, one formulation designed in the  past added niacin to a prescription pain reliever to dissuade abusers  because, in high doses, niacin causes headache, sweating, chills,  flushing, and general discomfort. While at least one manufacturer has  designed prescription pain relievers using the aversion method of  abuse-deterrence in the past, FDA officials told us that no such  prescription pain relievers are currently marketed.
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.
section_title: Challenges Related to Abuse-Deterrent Prescription Pain Relievers
paragraphs: Manufacturers face a number of challenges related to abuse-deterrent  formulations of prescription pain relievers. First, there are technical  challenges in developing formulations of prescription pain relievers that  deter abuse, but still have the intended effect of providing pain relief. For  example, it took Purdue Pharma L.P. approximately 9 years to develop a  reformulated version of OxyContin that both effectively provided pain  relief and displayed abuse-deterrent properties. Another challenge for  manufacturers relates to the extent to which they will be allowed to  market their new products as reducing or deterring abuse. FDA officials  told us that until postmarketing studies demonstrate a product’s  effectiveness in reducing abuse in the general population, manufacturers  cannot market their products accordingly, but they are allowed to make  marketing claims based on the product’s abuse-deterrent features as  demonstrated in clinical trials. For example, Embeda’s label includes  information on the results of clinical trails testing its abuse-deterrent  features, but also states that the abuse-deterrent characteristics of the  product “have not been shown to reduce the abuse liability of Embeda.”
Finally, a manufacturer indicated that insurers may be reluctant to provide  coverage for abuse-deterrent formulations of drugs when less expensive,  nondeterrent alternatives are available and that this could minimize their  usage and ultimately, their impact on abuse in the general population.
FDA faces a number of challenges related to approving and assessing  the safety and effectiveness of abuse-deterrent formulations of  prescription pain relievers. According to FDA officials, one of these  challenges is balancing the abuse-deterrent properties of a drug with its  safety in the general patient population. Another challenge for FDA is  developing standards and methods for determining if the products are, in  fact, abuse deterrent. FDA officials told us that the agency is currently  developing guidance for manufacturers on the development of abuse- deterrent formulations and on the postmarket assessment of their  performance. However, officials told us that standard guidance is difficult  to develop because potential types of abuse-deterrent formulations are so  varied that the criteria used to evaluate one drug may not be applicable  for another. FDA indicated that it requires manufacturers of prescription  pain relievers that want to make abuse-deterrent claims about their  products to conduct postmarket epidemiological studies to assess the  effectiveness of their drugs in deterring abuse in the general population.  However, in developing methods for assessing the effectiveness of a  particular drug on deterring abuse, FDA officials told us that they, like  manufacturers, are challenged by limitations in available data. FDA  officials said that consistent and clear definitions of abuse across data  sources are lacking and that most data sources with information on  prescription pain reliever abuse do not distinguish between products from  different manufacturers, which can make it difficult to assess the  effectiveness of a specific drug in deterring abuse. For example, data  sources that measure abuse and its consequences may not distinguish  between OxyContin and other drugs that contain oxycodone. Further,  FDA is challenged in determining what degree of decrease in some  measurable outcomes of abuse would be sufficient to label a drug as  being able to reduce actual abuse.
Finally, there are inherent challenges related to abuse-deterrent  formulations of prescription pain relievers and their overall impact on  abuse. First, a drug that deters one type of abuse might not necessarily  deter another type of abuse. For example, the new formulation of  OxyContin is designed to deter abuse via injection or snorting (see  sidebar), but is not a deterrent for those who abuse the product via oral  ingestion of whole tablets. A related challenge is that while technology  may deter the abuse of one particular prescription pain reliever, an  abuser may instead seek another prescription pain reliever (either a  different formulation of the same pain reliever or a different pain reliever  altogether) that is not designed to be abuse deterrent. An abuser may  even seek out another opioid, such as heroin.
section_title: Appendix II: DEA Quotas for Controlled Substances
paragraphs: 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.
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.
subsections: section_title: Closed Distribution System
paragraphs: 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), periodically inventory all stocks of controlled  substances, provide effective security controls, and maintain records to  account for all controlled substances manufactured, imported, exported,  received, distributed, or otherwise disposed of. DEA officials said that the  closed system, including quotas, is designed to reduce the amount of  pharmaceuticals that are diverted for illicit purposes, while also ensuring  an adequate and uninterrupted supply of controlled substances for  legitimate medical needs. They said that both legitimate and illegitimate  users of prescription pain relievers often acquire the drugs from the same  source—from doctors or other practitioners who prescribe or dispense  them. For example, diversion of prescription pain relievers may occur  through methods such as doctor shopping, thefts from medicine cabinets,  improper prescribing, and forged prescriptions.
According to DEA, quotas are a tool used at the beginning of the closed  system to manage and prevent diversion of controlled substances, such  as the substances used to make prescription pain relievers, during their  legitimate scientific, medical, and industrial applications. While DEA is  authorized to control the overall amount of controlled substances  available, according to DEA officials, it is ultimately for practitioners and  their regulating bodies to ensure that these substances are prescribed  appropriately. While officials said that they do seek to account for known  diversion when setting APQs, they said that establishing quotas based on  known diversion for the purpose of reducing the availability of prescribed  drugs will not appreciably affect diversion at the retail level and may  prevent legitimate patients from having access to medication for  legitimate medical needs.
section_title: Aggregate Production Quotas
paragraphs: DEA officials said that the APQ is the first type of quota that DEA sets for   The APQ specifies the maximum amount of each basic class  each year.of controlled substance listed in schedule I or II that can be produced for  specified needs in the United States in a given year, thus limiting the  amount of bulk raw materials available for use in the manufacture of  prescription pain relievers. For example, methadone is a controlled  substance that is used in the manufacture of drugs for addiction treatment  as well as in the manufacture of the prescription pain relievers Dolophine  and Methadose, and multiple generic equivalents. In 2010, DEA set the  final APQ for methadone at 20,000,000 grams. Therefore, this is the  maximum amount of methadone that could be available for manufacturing  addiction treatment drugs and prescription pain relievers that use this  substance, as well as for other authorized uses, in the United States in  2010.
DEA officials said that they consider data from many sources when  determining the APQ, including estimates of the legitimate medical need  for each substance from FDA, estimates of retail consumption based on  prescriptions dispensed from IMS Health, companies’ production history  and forecasts, data from DEA’s own internal system for tracking  controlled substances transactions, and past quota histories for each  substance.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.
DEA officials said that DEA scientists draw on their  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.
section_title: Bulk Manufacturing Quotas and Procurement Quotas
paragraphs: In addition to the APQ, DEA sets two types of quotas for individual  companies: bulk manufacturing quotas and procurement quotas. Bulk  manufacturing quotas limit the amount of a basic class of schedule I or II  controlled substance that an individual company can extract or synthesize  from plant material or other controlled substances. According to DEA  officials, once the initial APQ for a substance for a calendar year is set by  DEA, individual companies apply to DEA for bulk manufacturing quotas  for specific controlled substances to produce the bulk raw materials that  are used in prescription pain relievers for that same year. Officials said  that separate quotas are issued for each DEA-registered facility that  manufactures a controlled substance, even if the same company  operates multiple manufacturing facilities. In 2010, five facilities received  bulk manufacturing quotas for methadone. The quota levels ranged  between 4 grams at the low end and 12,000,000 grams at the highest  levels. The sum of the bulk manufacturing quotas for all companies for a  particular controlled substance cannot exceed the APQ for that substance  in a given year.
DEA officials said that they use a variety of data sources—including  internal DEA data, IMS Health data, and data provided by the company— to determine the bulk manufacturing quota for a company. DEA’s Office of  Diversion Control also reviews the company for any pending  administrative, civil, or criminal action. DEA officials said that DEA  scientists draw on their professional expertise and experience when  considering all available data to recommend an appropriate bulk  manufacturing quota, which is then issued to the company by letter. Bulk  manufacturing quotas can be revised through a process similar to that  used in setting the initial quotas, in that a company submits an application  to revise its quota and must include supporting documentation. DEA  officials said that DEA does not generally initiate changes to bulk  manufacturing quotas on its own.
DEA also establishes procurement quotas, which limit the amount of a  basic class of schedule I or II controlled substance that an individual  company can procure from a manufacturer of bulk raw materials in order  to manufacture individual dosage units of a medicine, such as a  prescription pain reliever. Individual companies must apply to DEA for  procurement quotas for each specific basic class of controlled substance,  and DEA officials told us that separate quotas are issued for each facility  that procures a controlled substance. For example, according to DEA  data, 52 facilities received procurement quotas for methadone in 2010.  The quota levels ranged between 1 gram at the low end and 9,000,000  grams at the highest levels. Sometimes an individual company may be  engaged in both bulk manufacturing and procurement activities for the  same controlled substance. In this case, the company will apply for both a  bulk manufacturing quota and a procurement quota. DEA officials said  they use the same process and data sources, as described above, to  determine appropriate levels for procurement quotas as for bulk  manufacturing quotas.
Officials said that DEA does not always set a company’s bulk  manufacturing quota or procurement quota at the level the company  requested. For example, if a registrant is suspected of unlawfully diverting  controlled substances, DEA will take this factor into consideration when  determining whether to grant or deny the quota request. In addition, DEA  may set the quota lower than requested if a company has set its quota  request based on projected sales figures, which can inflate the quantity of  quota requested, rather than on actual sales figures. DEA officials said  that the agency uses actual sales and inventory figures in their evaluation  of bulk manufacturing or procurement quota applications, and they grant  quotas in line with legitimate medical need. In the past, we have reported  that DEA cited difficulties in determining an appropriate level for quotas to  ensure that adequate quantities are available for legitimate medical need,  as there are not direct measures available to establish legitimate medical  need. DEA officials said that, based on the available prescription and  sales data, there is no method to calculate which prescriptions are issued  for a legitimate medical purpose by a practitioner acting in the usual  course of professional practice and which are not. They noted that if DEA  were to reduce a quota level by some percentage to account for  estimated illegitimate prescriptions or to otherwise reduce a quota by an  amount estimating how much of the substance is abused and misused,  the action would only reduce the total amount of substance available for  dispensing, and would not affect to whom or in what quantities the drugs  are prescribed or dispensed. Therefore, DEA officials said that a  reduction in the supply of a drug based upon estimated illegitimate  prescriptions or abuse and misuse could result in a shortage of the  substance for legitimate purposes, while not affecting illicit demand for the  substance at all. As a result, officials said that the agency does not use  the quota process as a tool to reduce demand or to help prevent abuse  and misuse of prescription pain relievers.
section_title: Appendix III: Objectives, Scope, and Methodology
paragraphs: This report (1) describes recent national trends in prescription pain  reliever abuse and misuse, (2) describes how federal agencies are  educating prescribers about prescription pain reliever abuse and misuse,  (3) assesses the extent to which federal agencies follow key practices for  developing public education efforts about prescription pain reliever abuse  and misuse, and (4) identifies educational efforts that use similar  strategies and assess how agencies coordinate those efforts. To conduct  this work we interviewed officials and reviewed documents, as described  below for each objective. In addition, to gain context on the challenge of  addressing the problem of abuse and misuse of prescription pain  relievers while ensuring access to these pain relievers for legitimate  medical use, we interviewed officials from the American Pain Foundation,  and Purdue Pharma L.P., the manufacturer of the prescription pain  reliever OxyContin.
To describe recent national trends in prescription pain reliever abuse and  misuse, we interviewed officials from the Centers for Disease Control and  Prevention (CDC), DEA, FDA, the National Institutes of Health’s (NIH)  National Institute on Drug Abuse (NIDA), the Office of National Drug  Control Policy (ONDCP), and the Substance Abuse and Mental Health  Services Administration (SAMHSA). We also conducted a literature  review to identify relevant data sources and explanations for trends in  prescription pain reliever abuse and misuse and analyzed data related to  prescription pain reliever abuse and misuse from several data sources  representative of the U.S. population aged 12 years and older. We  included data in our review from the Drug Abuse Warning Network  (DAWN), the National Vital Statistics System (NVSS), the Treatment  Episode Data Set (TEDS), and the National Survey on Drug Use and  Health (NSDUH). We selected these four data sources because they are  the data sources that the agencies we interviewed use for monitoring  trends in prescription pain reliever abuse and misuse, and because they  are nationally representative.2009, the most recent years for which data from at least three data  sources were available.
We analyzed data for calendar years 2003- 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.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.
These national estimates are produced from  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. 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. 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.inclusion in this report.
NVSS data for 2009 were not published in time for  TEDS, compiled by SAMHSA, gathers data on admissions to substance  abuse treatment facilities nationwide, including data about the substances  being abused by the person being admitted to treatment, such as  prescription pain relievers. TEDS does not include all admissions to  substance abuse treatment. It includes admissions at facilities that are  licensed or certified by the state substance abuse agency to provide  substance abuse treatment (or are administratively tracked for other  reasons). In general, facilities reporting TEDS data are those that receive  state alcohol or drug agency funds (including federal block grant funds)  for the provision of alcohol or drug treatment services. Data about  admissions are initially gathered by the facilities themselves and then  collected by states and transmitted to a national data center. The number  of admissions does not directly represent the number of individuals who  have been admitted to treatment in a given year, because an individual  admitted to treatment twice within a calendar year would be counted as  two admissions. While treatment facilities included in TEDS account for a  significant portion of treatment admissions nationwide, SAMHSA officials  told us that no nationwide estimates are available of admissions to  private, for-profit facilities or on the number of individuals being treated for  substance abuse by physicians who have been approved to  independently treat opioid addiction in an office-based setting. Therefore,  SAMHSA officials told us that TEDS data underreport the number of  individuals seeking treatment for prescription pain reliever abuse and  misuse in the United States, especially among populations that have the  resources to seek treatment from private facilities or physicians. In  addition, the facilities and populations included in the data each state  reports to TEDS are affected by state regulations and funding priorities.  For example, some states report data from hospital- and prison-based  treatment facilities, while others do not. Finally, some states may target  certain populations, such as teenagers, with their limited funds for  addiction treatment, meaning that these populations may be more heavily  represented in the data from those states.
NSDUH, an annual survey sponsored by SAMHSA, provides annual  national estimates about the use of illicit drugs, alcohol, and tobacco in  the civilian, noninstitutionalized population of the United States aged   12 years old or older, including estimates about the abuse and misuse of  prescription pain relievers. 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. While NSDUH incorporates strategies  intended to increase respondents’ cooperation and willingness to report  honestly and accurately, such as use of computer-assisted interviewing  methods, it is not possible to know the extent of underreporting within  NSDUH data. However, SAMHSA officials told us that when looking at  trended data, underreporting is not a problem because it is assumed  constant.
To assess the reliability of these data for our purposes, we reviewed  related documentation and conducted interviews with knowledgeable  agency officials from CDC and SAMHSA to learn about data collection,  quality control, and any limitations of these data sources. We also  conducted electronic and manual data testing to ensure the quality of the  data. We determined that all data we assessed were sufficiently reliable  to provide overall trends for the purposes of our review.
To describe how federal agencies are educating prescribers about  prescription pain reliever abuse and misuse, we reviewed the 2010  National Drug Control Strategy and interviewed officials involved with  federal prevention efforts to identify strategies used to educate  prescribers during fiscal year 2011. We then interviewed officials from  FDA, NIH, and SAMHSA and reviewed agency websites and documents  to describe educational strategies used by these agencies. Because they  are involved in federal prevention efforts, we also interviewed officials  from DEA, the Health Resources and Services Administration (HRSA),  ONDCP, and the American Medical Association about gaps in current  prescriber education efforts and efforts to fill these gaps through  mandatory prescriber education. We excluded agencies that support their  own health care systems, such as the Bureau of Prisons, Department of  Defense, Indian Health Service, and Department of Veterans Affairs, from  the scope of our review as they serve special populations, rather than the  general public. We also excluded educational efforts related to drug  abuse treatment, including education about the use of the prescription  pain relievers methadone or buprenorphine for use in the treatment of  opioid addiction.
To assess the extent to which federal agencies follow key practices for  developing public education efforts about prescription pain reliever abuse  and misuse, we reviewed the 2010 National Drug Control Strategy and  interviewed officials involved with federal prevention efforts to identify  efforts to educate the general public during fiscal year 2011. We then  interviewed officials from DEA, FDA, NIH, ONDCP, and SAMHSA and  reviewed agency websites and documents to gather evidence about how  agencies developed public education efforts and then compared the  development of these educational efforts against key practices for  developing consumer education efforts from our prior work, Digital  Television Transition: Increased Federal Planning and Risk Management  Could Further Facilitate the DTV Transition (see table 3). 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.Information and Education to gain information about best practices for  public health education.
section_title: Appendix IV: Public Education Programs
paragraphs: We identified nine efforts in fiscal year 2011 to educate the general public  about prescription pain reliever abuse and misuse (see table 4).
section_title: Appendix V: Data from Key Measures of Prescription Pain Reliever Abuse and Misuse
paragraphs: 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).
section_title: Appendix VI: Comments from the Office of National Drug Control Policy
section_title: Appendix VII: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.
section_title: Related GAO Products
paragraphs: 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.