Prenatal Drug Use and Newborn Health: Federal Efforts Need Better Planning and Coordination
Published: 2015-02-10T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The prenatal use of opioids, including heroin and opioids prescribed for pain management, can produce a withdrawal condition in newborns known as NAS. A recent study found that cases of NAS have tripled over the last decade and that treatment costs for newborns with NAS—most of which are paid by Medicaid—are more than five times the cost of treating other newborns at birth.
GAO was asked to provide information on how federal agencies have addressed prenatal opioid use and NAS. In this report, GAO examines (1) federally funded research, federal programs, and other federal agency efforts related to prenatal opioid use or NAS; (2) gaps identified by federal agency officials and experts in efforts to address prenatal opioid use or NAS; and (3) how federal efforts to address prenatal opioid use or NAS are planned and coordinated. GAO analyzed information from federal agencies, including documents and data, on research, programs, and other agency efforts; interviewed federal agency officials and experts about gaps; and interviewed federal agency officials about planning and coordination of federal efforts.
section_title: What GAO Found
paragraphs: Federally funded research mostly focused on neonatal abstinence syndrome (NAS), and federal programs and other agency efforts made services available or conducted activities to address prenatal opioid use or NAS. From fiscal years 2008 through 2014, federal agencies obligated almost $21.6 million for 18 research projects related to prenatal opioid use or NAS, most of which focused on preventing, understanding, or treating NAS. Fourteen federal programs on substance abuse, health, and welfare—12 of which were administered by agencies within the Department of Health and Human Services (HHS)—made direct services available (such as screening and referral for treatment) or conducted other activities (such as training or technical assistance) to address prenatal opioid or NAS in fiscal years 2013 or 2014 as part of broader objectives. Outside of research and programs, 11 federal agencies made direct services available through their health systems or engaged in other efforts during fiscal years 2008 through 2014.
The gaps in efforts to address prenatal opioid use and NAS most commonly cited by federal agency officials and experts were related to the treatment of prenatal opioid use and NAS. With regard to research, the most commonly cited gaps were inadequate research on treatment of prenatal opioid use and the long-term effects of prenatal opioid exposure on children. Reasons cited for these research gaps included difficulties in conducting research, such as identifying and retaining pregnant women with substance use disorders for studies, and prenatal opioid use and NAS not being as high a priority as other research areas. With regards to programs, agency officials and experts most commonly cited the lack of available treatment programs for pregnant women and newborns with NAS, including the availability of comprehensive care and enabling services, such as transportation and child care. Reasons cited for these program gaps included the stigmatization and criminalization of pregnant women who use drugs. In addition to research and program gaps, other gaps cited by agency officials and experts included a lack of guidance on criminalization policies for states, screening and treatment practices, and opioid prescribing.
The Office of National Drug Control Policy (ONDCP)—the agency responsible for coordinating drug control efforts across federal agencies—plans and coordinates with other agencies by sharing information and developing national action items to address prenatal opioid use and NAS. However, ONDCP does not document its process for developing action items, including the information considered or discussions with agency officials. Within HHS—which has nine agencies that address prenatal opioid use or NAS—the department relies on its agencies to plan and coordinate individual efforts, and also has established a council that identifies activities that may influence, but are not targeted specifically at, prenatal opioid use and NAS. However, HHS lacks a focal point to lead planning and coordination of efforts related specifically to prenatal opioid use or NAS across the department. These limitations in planning and coordination by ONDCP and HHS may limit the effectiveness of federal efforts to reduce prenatal opioid use among pregnant women and rates of NAS. Additionally, there is a risk that federal efforts may be duplicated, overlapping, or fragmented.
section_title: What GAO Recommends
paragraphs: GAO recommends that ONDCP document the process for developing action items on prenatal opioid use and NAS and that HHS designate a focal point to lead departmental planning and coordination on these issues. ONDCP and HHS concurred with GAO's recommendations and provided technical comments that GAO incorporated as appropriate.

section_title: Letter
paragraphs: Opioid abuse, including the increasing use of heroin and abuse of opioids  prescribed for pain management, has been recognized by the federal  government, states, researchers, and others as a burgeoning problem in  the United States. The prenatal use of opioids by pregnant women— including opioid abuse, opioids prescribed for pain management, and  treatment for opioid addiction—can produce a withdrawal condition in  newborns known as neonatal abstinence syndrome (NAS). Though other  drugs may cause NAS, opioids are considered the primary cause. NAS  symptoms range from excessive crying and irritability to difficulties with  breathing and feeding. The incidence of NAS in the United States has  nearly tripled over the past decade. A recent study showed that cases of  NAS increased from a rate of 1.2 per 1,000 hospital births per year in the  year 2000 to 3.4 per 1,000 hospital births in 2009.
Newborns with NAS require specialized care—often in a neonatal  intensive care unit—which results in longer hospital stays and increased  costs. The same recent study found that treatment costs for newborns  with NAS are, on average, more than five times the costs of treating other  newborns at birth. Newborns with NAS stayed in the hospital an average  of 16 days and incurred average hospital charges of about $53,000,  compared with an average of 3 days and $9,500 for all other hospital  births, according to data from 2009. cases identified in the study were paid for by Medicaid, the federal-state  program that provides health insurance coverage for certain low-income  individuals.
Patrick et al., “Neonatal Abstinence Syndrome,” p. 1937.
The Office of National Drug Control Policy (ONDCP) within the Executive  Office of the President is the agency responsible for coordinating drug  control efforts across the federal government. As part of its efforts,  ONDCP highlighted maternal addiction and NAS as emerging and critical  issues in its 2013 and 2014 annual National Drug Control Strategy  reports, and noted that these issues, together with ongoing efforts to  reduce rates of prescription drug misuse more broadly, require  coordinated action from public health and safety leaders at the federal,  state, local, and tribal levels. ONDCP also published its prescription drug  abuse prevention plan in 2011, which focused primarily on prescription  opioid abuse and included actions in education, monitoring, proper  disposal, and enforcement to reduce prescription drug abuse in the  United States.
Given the health and cost concerns associated with prenatal opioid use  and NAS, you requested that we provide information on how federal  agencies have addressed these issues. This report examines (1) federally  funded research, federal programs, and other federal agency efforts  related to addressing prenatal opioid use or NAS; (2) gaps identified by  federal agency officials and experts in efforts to address prenatal opioid  use or NAS; and (3) how federal efforts to address prenatal opioid use or  NAS are planned and coordinated.
We then requested and analyzed information,  information on research projects, including data on funding  obligations, from agencies that reported having conducted or funded  research at any time during fiscal years 2008 through 2014;  information gathered using a Web-based questionnaire on federal  programs, including data on funding obligations, from agencies that  reported administering a program in operation during fiscal years  2013 and 2014; and  information on other efforts conducted outside of research and  programs by any agency during fiscal years 2008 through 2014.
To identify gaps in efforts to address prenatal opioid use or NAS, we  analyzed information gathered from interviews of federal agency officials  and experts about research, program, and other gaps that may generally  exist and were not only specific to federal efforts.federal efforts to address prenatal opioid use or NAS are planned and  coordinated, we analyzed information from documents provided by and  interviews of officials from ONDCP and the Office of the Secretary for the  Department of Health and Human Services (HHS). We asked ONDCP  officials about planning and coordination with agencies across the federal   To examine how  government and HHS officials about planning and coordination across its  department since nine of its agencies address prenatal opioid use or  NAS. As part of our work, we reviewed the data provided by agency  officials for any outliers, checked for errors and asked for supporting  documentation as appropriate, and determined that the data were  sufficiently reliable for our purposes.
We conducted this performance audit from January 2014 to February  2015 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives. (See appendix I for a  more detailed description of our methodology.)
subsections: section_title: Background
subsections: section_title: Prenatal Opioid Use
paragraphs: Prenatal opioid use can take various forms, including (1) using  prescriptions for pain management, such as fentanyl and oxycodone;   (2) medication-assisted treatment for opioid addiction, such as use of  methadone and buprenorphine; (3) prescription misuse or abuse (such as  using without a prescription, using a different dosage than prescribed, or  continuing to use a drug when no longer needed for pain); and (4) illicit  opioid use, such as heroin. These types of prenatal opioid use are not  mutually exclusive. Women can use opioids in different ways during the  course of a pregnancy. A recent study of heroin-dependent individuals in  treatment showed most people reported their first regular opioid was a  prescription drug. Two recent studies also found that 14 percent of  pregnant private health insurance beneficiaries, and almost 22 percent of  pregnant Medicaid beneficiaries filled a prescription for opioids during  their pregnancy.
Medication is considered the standard of care for pregnant women with  opioid use disorders. Medications used for such addiction treatment are  typically other opioids, such as methadone and buprenorphine, used off- label as neither is approved for use during pregnancy. administered daily as part of a registered, comprehensive substance  abuse treatment program that can include prenatal care, counseling,  family therapy, nutrition counseling, and other supportive services.  Buprenorphine is the only opioid approved for the treatment of opioid use  disorders for which physicians can write a prescription outside of a  licensed treatment program. It is generally associated with a lower risk of  overdose and fewer drug interactions than methadone and does not  require daily visits to a treatment program.
Experts consider NAS to be an expected and treatable result of pregnant  women’s prenatal opioid use. Newborns with NAS may exhibit withdrawal  signs and symptoms such as irritability, high-pitched crying, stiffness,  sweating, vomiting, diarrhea, poor feeding, seizures, and respiratory  distress. NAS is also associated with premature birth and lower birth  weight, and can interfere with the mother-infant bonding process.  Symptoms of NAS usually develop within 72 hours of birth, but may  develop anytime in the first 2 weeks of life, including after hospital  discharge. Providers predominantly diagnose NAS using the Finnegan  Neonatal Abstinence Scoring Tool, which calculates a score based on a  variety of central nervous, metabolic, respiratory, and gastro-intestinal  symptoms that might be observed.
Off-label use refers to the prescription of a medication for uses other than what the Food  and Drug Administration has approved. the infant into a dark and quiet environment, swaddling, rooming with the  mother, and providing high-calorie nutrition, among other things.  Medication, such as methadone or morphine, may be necessary only for  the relief of moderate to severe signs of NAS. Regardless of the type of  treatment, a recent study found inconsistency in treatment both across  and within particular settings of care. Specifically, the study found that the  medications primarily used to treat NAS from 2004 to 2011 varied across  hospitals, and that the type of medication used was associated with  variations in length of treatment, length of stay, and hospital charges.  Even within hospitals, only 5 of the 14 hospitals examined used the same  treatment more than 80 percent of the time.
section_title: Federally Funded Research Mostly Focused on NAS, and Federal Programs and Other Agency Efforts Made Services Available or Conducted Activities to Address Prenatal Opioid Use or NAS
paragraphs: Fourteen out of 18 federally funded research projects included a focus on  NAS prevention, understanding, or treatment. Fourteen federal programs  made direct services available or conducted other activities to address  prenatal opioid use or NAS as part of broader program objectives. Eleven  federal agencies also addressed prenatal opioid use or NAS through their  health systems or other efforts outside of research or programs.
subsections: section_title: Federally Funded Research Projects Mostly Focused on Prevention, Understanding, or Treatment of NAS
paragraphs: From fiscal years 2008 through 2014, federal agencies obligated almost  $21.6 million for 18 research projects related to prenatal opioid use or  NAS, 14 of which included a focus on prevention and understanding of  NAS, treatment of NAS, or both, as individual projects sometimes   focused on more than one research area.$13.6 million for eight projects that included a focus on prevention and   Federal agencies obligated   understanding of NAS and $6 million for seven projects that included a  focus on treating NAS. Other topics covered by these 18 projects  included the treatment of prenatal opioid use (4 projects), incidence or  prevalence of NAS, incidence or prevalence of prenatal opioid use, and  costs related to NAS (3 projects each). No projects focused on the  prevention or understanding of prenatal opioid use or any costs  associated with such use. (See fig. 1.) All of the 18 projects were funded  by agencies within HHS. Specifically, 14 of the 18 projects were funded  by the National Institutes of Health (NIH) and the remaining 4 were  funded by the Centers for Disease Control and Prevention (CDC) and the  Food and Drug Administration (FDA). (See appendix II for descriptions  of all 18 projects.)
Projects that included a focus on prevention and understanding of NAS  examined, for example, the transfer of drugs from the mother to the fetus  or how different drugs used to treat addiction in the mother affected the  newborn. Projects that included a focus on treatment of NAS examined,  for example, different approaches to treatment such as gentle stimulation  of newborns or comparisons of different medications to treat NAS. The  project that was provided the largest amount of funds (nearly $4.6 million  during the period we reviewed) was the Maternal Opioid Treatment:  Human Experimental Research (MOTHER) study, which included a focus  on prevention and understanding of NAS as well as treatment of NAS.  This eight-site randomized clinical trial compared the effects of pregnant  women’s use of buprenorphine to methadone on the severity and duration  of NAS. It found that newborns born to women who received  buprenorphine for opioid addiction treatment during pregnancy required  significantly less morphine to treat withdrawal symptoms, had significantly  shorter hospital stays, and required a significantly shorter duration of  treatment for NAS, compared to newborns born to women who received  methadone during pregnancy.
section_title: Federal Programs Made Direct Services Available or Conducted Other Activities to Address Prenatal Opioid Use or NAS as Part of Broader Objectives
paragraphs: Agency officials identified 14 federal programs on substance abuse  prevention or treatment, maternal and child health, or family and child  welfare services that addressed prenatal opioid use or NAS in fiscal years  2013 or 2014 as part of broader program objectives. Through a Web- based questionnaire, officials from 8 of these 14 programs reported  making direct services available to women, infants, or their families, and  11 reported conducting other activities such as public education or  providing technical assistance, with 5 reporting both. (See fig. 2.) These  14 programs were run by five different agencies, with 12 of these  programs administered by agencies within HHS. Nine of the 14 programs  had been in existence for more than 5 fiscal years.more details on these programs.)
section_title: Federal Agencies also Addressed Prenatal Opioid or NAS through Their Health Systems or Other Efforts Outside of Research and Programs
paragraphs: Outside of research and programs, officials from 11 federal agencies— mostly within HHS— reported that their agencies made direct services  available through their health systems or engaged in other efforts that  addressed prenatal opioid use or NAS during fiscal years 2008 through  2014. Four of the 11 agencies reported making relevant direct services  available through their health systems and 10 agencies reported  engaging in other efforts, such as provider education and knowledge- sharing groups, while three agencies reported doing both. (See fig. 4.)
Officials from four of the 11 agencies—the Indian Health Service (IHS)  within HHS, the Bureau of Prisons (BOP) within the Department of Justice  (DOJ), the Department of Defense (DOD), and the Department of  Veterans Affairs (VA)—reported that their health systems made direct  services available to women who use opioids, their newborns, or their  families, as part of each agency health system’s broader efforts to provide  care to its beneficiaries.abuse screening and referral, medication-assisted treatment for opioid  use disorders, behavioral treatment services, and case management or  recovery support services may be available through their health systems,  among other services.
The State Children’s Health Insurance Program is a federal-state program that provides  coverage to low-income children whose household incomes are above the threshold for  Medicaid eligibility. which include guidance for DOD and VA health care providers on  screening for drug use and offering treatment during pregnancy. Some  agencies also published relevant reports or fact sheets that included  information on prenatal opioid use or NAS. For example, SAMHSA  recently published a fact sheet on pregnant teenagers admitted to  substance abuse treatment facilities that, in part, discusses opioid use.(See appendix V for more information on agency efforts to address  prenatal opioid use or NAS outside of research and programs.)
section_title: Most Commonly Cited Gaps Were Related to Treatment of Prenatal Opioid Use or NAS
paragraphs: The research and program gaps most commonly cited by federal agency  officials and other experts were related to treatment of pregnant women  with opioid use disorders or newborns with NAS. Research gaps cited  focused on treatment of opioid use during pregnancy, including the  effectiveness of various drugs, and the long-term effects of prenatal  opioid exposure on children. The program gap most frequently cited was  the lack of available treatment programs for both pregnant women and  newborns with NAS. Other gaps cited included a lack of guidance and  coordination in efforts to address prenatal opioid use or NAS.
subsections: section_title: Research Gaps Cited Included Treatment of Prenatal Opioid Use and Long-Term Effects of Prenatal Opioid Exposure on Children
paragraphs: Agency officials and other experts we interviewed most often cited  research gaps on treatments of opioid use during pregnancy and  understanding the long-term impact on children exposed to opioids  prenatally. Specific research gaps related to the treatment of prenatal  opioid use included a lack of knowledge about best practices for initiating  medication-assisted treatment during pregnancy, and an understanding of  the barriers to accessing opioid use disorder treatment for pregnant  women. Agency officials and experts said that there has not been  adequate research comparing different types of treatment approaches  and that research is needed on how best to treat a pregnant woman with  an opioid use disorder so that the treatment is most effective for the  woman while offering minimal risk to the fetus. The other research gap  most frequently cited by agency officials and experts was research on the  long-term effects of prenatal drug exposure, which officials and experts  said is needed to understand the impact of prenatal exposure to opioids  on children through adolescence. Other research gaps cited by agency  officials and experts were related to studies of the treatment of NAS,  screening and diagnosis of NAS, and understanding of NAS, such as the  impact of opioid exposure on infants and severity of NAS. For example,  officials and experts noted that the Finnegan Neonatal Abstinence  Scoring Tool, which is used by health care providers to screen for and  diagnose NAS, can be long and complex, and that a more objective NAS  screening tool is needed. They also noted that there is not enough  information to know what medications work best for what kinds of patients  when behavioral therapies do not work for newborns with NAS. Agency  officials and experts told us that as a result of these research gaps,  providers often do not know how best to treat patients, which in turn leads  to variation in the length and quality of treatment. (See table 1.)
Agency officials and other experts cited several reasons for these  research gaps, some of which are similar to those we have found for  other public health issues. The most frequently cited reasons were
Difficulty conducting research. Agency officials and experts noted  difficulties in identifying and retaining pregnant women with substance  use disorders for research studies due to the low number of such  women and their reluctance to participate in such studies, sometimes  out of fear of criminal charges or other repercussions from their use of  opioids. Further, due to the use of multiple substances and variation in  the expression of NAS, studies on this topic require a large number of  participants, according to agency officials and experts.
Research priorities. Agency officials and experts told us that  prenatal opioid use and NAS had not been prioritized compared to  other areas of research. For example, one expert suggested that  there is a priority now on studying marijuana use and pregnancy.
Lack of funding. Agency officials and experts cited a lack of research  funds in general and specifically for NAS-related studies. They  commented that there are many competing priorities for limited  research funds.
Funding structure. Research funding is typically provided for a  limited time period, such as 5 years, making research on the long- term effects of prenatal opioid use particularly challenging according  to experts. Experts also noted that funding for individual studies is  often capped at a level too small to conduct the multi-site studies  necessary in this area since it is difficult to find enough study  participants at a single research site.
Lack of capacity to conduct research. Agency officials and experts  expressed concern that there may not be adequate expertise in this  area to conduct this type of research.
section_title: Program Gaps Cited Included Lack of Available Treatment Programs and Provider Education
paragraphs: When asked about program gaps related to prenatal opioid use or NAS,  agency officials and other experts we interviewed most frequently cited  the lack of available programs, including treatment programs for pregnant  women and for newborns with NAS. Such gaps in treatment programs  included a lack of comprehensive care (i.e., the coordinated provision of  obstetric care and addiction treatment), culturally appropriate care  (particularly for the tribal community), and enabling services (e.g.,  transportation and child care). For example, agency officials and experts  said that there were not enough services available that allow women to  keep their children with them while in residential substance abuse  treatment. They also cited program gaps in provider education—such as  how to recognize substance abuse in patients, and how to appropriately  prescribe and dispense opioids to prevent addiction—noting that many  health care providers receive only limited training on these topics. Agency  officials and experts told us that these program gaps can result in women  not getting the addiction treatment they need while pregnant and the  continuation of substance use during pregnancy. This may result in poor  health outcomes for infants because they may be exposed to more than  one substance or at risk for increased severity of NAS, according to  agency officials and experts. (See table 2.)
Agency officials and other experts cited several reasons for these  program gaps, some of which are similar to those we have found for other  public health issues. The most frequently cited reasons were
Stigma and criminalization of pregnant women who use drugs.
Some state laws require health care providers to report substance use  during pregnancy to state or local officials, which officials and experts  said could result in women not getting substance abuse treatment or  prenatal care out of fears of criminal charges, their children being  taken away, or being stigmatized as a drug user. Officials told us that  providers are reluctant to recommend screening, treatment, or  counseling when there are serious potential legal consequences, and  as a result, pregnant women may not have access to appropriate  programs that do not present legal consequences.
Gaps in current research. Agency officials and experts attributed  program gaps to the limited evidence base specific to prenatal opioid  use or NAS, particularly around screening and medication safety  during pregnancy. Officials and experts told us, for example, that  because of the gaps in scientific knowledge, there is limited training  for providers on how to treat substance use or prescribe pain  medication during pregnancy.
Awareness of NAS as a public health problem. Officials noted that  the development of treatment programs lags behind the awareness of  the existence of a problem, and issues such as prenatal opioid use  and NAS have become more critical in the last 5 to 10 years.
Lack of funding. Agency officials and experts said that funding for  programs to address prenatal opioid use or NAS is challenging for  many states and localities. This may result in a lack of available  treatment programs.
section_title: Other Gaps Cited Included Lack of Guidance and Coordination of Efforts to Address Prenatal Opioid Use or NAS
paragraphs: In addition to research and program gaps, agency officials and other  experts cited other gaps in guidance, particularly around “safe harbor”  laws for states, issues of treatment of prenatal opioid use and NAS,  prescription drug monitoring programs, and development of Medicaid  reimbursement policies. For example, agency officials and experts noted  that there is no national or federal guidance for states on how to best draft  laws and policies that would remove the possibility of criminalization so  that pregnant women could more freely obtain needed treatment without  facing the risk of criminal penalties or removal of their children from the  home. They also cited a lack of national or federal guidance for health  care providers in approaches to screening and treatment of prenatal  opioid use and NAS. Specifically, they noted that there are not a lot of  data to inform best practices, so there are no standards for care.  Similarly, they cited a lack of federal guidance to assist states in the  regulation and oversight of opioid use and prescribing through  prescription drug monitoring programs, which also vary across states.  They noted that while most states have prescription drug monitoring  programs, their capacity and utility vary. Agency officials and experts  noted that one effect of these other gaps is that states have varying  policies related to prenatal opioid use or NAS. For example, officials and  experts have noted that state policies on criminalization can result in  women not having access to appropriate programs. In addition, agency  officials and experts said some states have not seen much success with  their prescription drug monitoring programs, possibly because they are  not used by providers. One official commented that without effective  prescription drug monitoring programs, it is difficult to catch “doctor  shopping,” which is when a patient obtains controlled substances (such  as opioids prescribed for pain management) from multiple health care  providers without the providers’ knowledge of other similar prescriptions.  (See table 3.)
Agency officials and other experts did not frequently cite reasons for  these other gaps. Among the few reasons cited, one official said that one  reason for these gaps is that some states may have more established  programs with a greater financial investment, particularly regarding  prescription drug monitoring programs.
section_title: ONDCP and HHS Plan and Coordinate to Address Prenatal Opioid Use and NAS, but More Documentation and a Departmental Focal Point Are Needed
paragraphs: ONDCP plans and coordinates by sharing information and developing  national action items to address prenatal opioid use and NAS, but does  not document the development of these action items. HHS relies on its  agencies to plan and coordinate individual efforts, and has established a  council that identifies activities that may influence, but are not targeted  specifically at, prenatal opioid use and NAS. However, HHS lacks a focal  point to lead planning and coordination of efforts related to prenatal opioid  use or NAS across the department.
subsections: section_title: ONDCP Shares Information Government- Wide, but Does Not Document Development of National Action Items on Prenatal Opioid Use and NAS
paragraphs: As part of ONDCP’s efforts to plan and coordinate the federal  government’s approach to prenatal opioid use and NAS, officials told us  that they have shared information on these issues with federal agencies,  states, and other organizations and experts. ONDCP officials told us  that the office has been both a leader and participant at various  conferences and meetings that focus on sharing information in this area.For example, officials told us that ONDCP gave presentations on NAS in May 2012, July 2014, and August 2014  as part of a webinar hosted by the Association for State and Territorial  Health Officials and other organizations. hosted a leadership meeting in August 2012 that brought together  scientists and policymakers to share knowledge on these issues.  ONDCP shared the results of this leadership meeting at a subsequent  September 2012 meeting that included federal agency officials as well  as the American Academy of Pediatrics and the American Congress  of Obstetricians and Gynecologists. participated in the April 2014 annual National Rx Drug Abuse Summit,  where ONDCP officials led a presentation entitled, “Solutions  Discussion Impacting Neonatal Abstinence Syndrome.”  led a June 2014 White House Summit on the Opioid Epidemic which  focused on heroin and prescription drugs, and during which NAS was  briefly discussed. helped SAMHSA plan its August 2014 Prescription Drug Abuse Policy  Academy, which included presentations on prenatal opioid use and  NAS.
Officials told us that ONDCP also shares information through two  interagency groups—the Prescription Drug Abuse Prevention Interagency  Working Group and the Treatment Coordination Group—comprising  officials from at least 15 federal agencies. These interagency groups are  broad in scope, but may raise prenatal opioid use or NAS during group  meetings. Specifically, the Prescription Drug Abuse Prevention  Interagency Working Group coordinates implementation of ONDCP’s  2011 prescription drug abuse prevention plan, and officials told us group  members have discussed presentations on prenatal opioid use and NAS.  The Treatment Coordination Group is focused on evidence-based  substance abuse treatment services and ONDCP officials told us that  members are working to plan and implement three to five activities aimed  at improving access to medication-assisted treatment for people with  opioid use disorders. Officials said that in discussing medication-assisted  treatment, prenatal opioid use or NAS may have been raised. ONDCP  officials also told us that the agency plans to develop an informal  subgroup of the Prescription Drug Abuse Prevention Interagency Working  Group that will focus specifically on NAS, but had not done so as of  November 2014. They said that the purpose of this subgroup will be for  staff from agencies involved in NAS-related issues to meet periodically  and exchange information on the subject.
In addition to these interagency working groups, ONDCP officials told us  that in September 2014 they initiated the process and are coordinating  with federal agencies to develop national action items related to prenatal  opioid use and NAS for inclusion in the 2015 National Drug Control  Strategy report, which outlines the federal government’s action items  aimed at reducing illegal drug use and drug-related health consequences,  among other goals.use and NAS as emerging issues in its 2013 and 2014 National Drug  Control Strategy reports, but officials said that they had not yet developed  action items, in part, because it is challenging to determine goals and  targets in the absence of extensive research on NAS. Officials also said  that they plan to follow the same method used to develop all action items  by consulting with federal officials, state and local governments, health  experts, and other stakeholders, and that federal agencies would be  identified to take the lead on implementing and monitoring the action  items once they are developed. Officials told us they anticipate having  three to five action items related to prenatal opioid use and NAS that will  be finalized by the end of 2014 in order to be included in the 2015  National Drug Control Strategy.
ONDCP had previously identified prenatal opioid  While developing these action items could potentially help the federal  government address issues related to prenatal opioid use and NAS,  ONDCP did not provide information on the potential action items being  considered, the content of the discussions with federal agencies in  developing these action items, or potential agency leads for  implementation. Officials said they used information gathered from  meetings and conversations with federal, state, and local officials and  experts on prenatal opioid use or NAS to identify potential action items  and have had separate discussions with officials from various federal  agencies to develop specific action items and discuss any issues with  implementation. However, ONDCP does not formally document the  information used or the discussions with federal agency officials, including  the extent to which gaps were considered, to develop specific action  items. ONDCP officials said they do not document this information since  the process followed in developing action items is generally informal.Additionally, ONDCP officials told us that the agency has not examined  issues of duplication, overlap, or fragmentation related to prenatal opioid  use or NAS. ONDCP officials told us that they believe that there is little  risk of duplication in federal efforts in this area, but have not conducted a  systematic review of federal efforts.
Given the large number of federal agencies and stakeholders with whom  ONDCP coordinates on prenatal opioid use and NAS, ONDCP’s lack of  documentation of items such as meeting discussions and potential issues  with implementation as they develop action items related to prenatal  opioid use and NAS could limit its ability to systematically and effectively  plan and coordinate these activities. Specifically, ONDCP may be less  effective in ensuring clarity in the steps agencies need to take to  implement the action items. Furthermore, as the challenges of prenatal  opioid use and NAS are unlikely to be resolved in one year,  documentation of the process—including information considered and  discussions used to develop the action items—will be helpful as ONDCP  considers modifying existing action items or adding additional action  items in the future.
section_title: Within HHS, Agencies Plan and Coordinate on Individual Efforts to Address Prenatal Opioid Use and NAS, but Do Not Have A Focal Point to Lead Efforts Department- Wide
paragraphs: HHS officials told us that those HHS agencies that conduct or fund  research, administer programs, or conduct other efforts related to  prenatal opioid use or NAS, plan and coordinate on individual efforts  when working toward broad goals and objectives related to opioid abuse  and overdoses. For example, SAMHSA officials told us that they have a  long partnership with the Administration for Children and Families (ACF)  to address issues of prenatal substance exposure, including opioids.  Additionally, officials from the Office of the Assistant Secretary for Health  (OASH) said they plan to convene an ad hoc workgroup of  representatives from OASH offices to identify resources and opportunities  for dissemination and expansion of public health awareness, education,  and prevention efforts to address prenatal opioid use and NAS. As of  November 2014, officials told us that the group will meet to identify key  strategic initiatives that will take place within the next 18 months, but the  first meeting was in the planning stages and no members had been  identified.
HHS officials also told us that the department broadly plans and  coordinates across the department on opioid abuse through its Behavioral  Health Coordinating Council (BHCC), which identifies activities that may  influence, but are not are specifically targeted to address, prenatal opioid  use or NAS. The Office of the Secretary—which oversees the activities of  HHS—established the BHCC to coordinate departmental activities related  to mental health and substance use and abuse. HHS officials told us  that one of the subcommittees of the BHCC, the prescription drug and  opioid abuse subcommittee, identifies activities to address the overall  prescription opioid epidemic and reduce the rates of death and other  adverse public health effects, which may include prenatal opioid use and  NAS. HHS officials told us that the activities the BHCC identifies can  influence the use and abuse of opioids by pregnant women, which is the  primary cause of NAS. For example, HHS officials said one such activity  is FDA’s requirement for manufacturers of certain opioid analgesics to  make training on proper prescribing practices available to health care  professionals that prescribe these medications, including the potential risk  of NAS.
We have previously reported that identification of a leader is a key feature for successful  collaboration. See GAO-12-1022. not other HHS agencies.plan and coordinate department-wide on efforts specifically related to  prenatal opioid use or NAS. The lack of a focal point may limit HHS’s  ability to efficiently and effectively plan and coordinate efforts across the  nine HHS agencies that conduct or fund research, administer programs,  or conduct other agency efforts related to prenatal opioid use or NAS.  Additionally, there is risk of duplication, overlap, or fragmentation of  HHS’s research, programs, and other agency efforts to address these  issues. HHS officials also indicated that they had not reviewed any  potential gaps in existing efforts at this time.
section_title: Conclusions
paragraphs: Federal agencies have recognized prenatal opioid use and NAS as  emerging public health issues facing pregnant women and newborns and  have several ongoing efforts to address these issues. Specifically, we  found that federal agencies fund research projects focused primarily on  NAS; administer programs or have health systems that make direct  services available to women who use opioids and newborns with NAS;  and engage in other efforts, such as provider education and knowledge- sharing groups. However, federal agency officials and experts we  interviewed cited several gaps in efforts to address prenatal opioid use  and NAS, most commonly gaps related to treatment, as well as lack of  guidance to states and health care providers. While ONDCP is  coordinating with federal agencies to develop action items to address  prenatal opioid use and NAS, improved documentation could help make  the process more systematic and effective. Further, HHS does not have a  focal point to lead planning and coordination of efforts across its nine  agencies that address these issues. These limitations in planning and  coordination by ONDCP and HHS may limit the effectiveness of federal  efforts to reduce prenatal opioid use among pregnant women and rates of  NAS. Additionally, there is a risk that efforts may be duplicated,  overlapping, or fragmented. Given the increasing use of heroin and abuse  of opioids prescribed for pain management, as well as the increased rate  of NAS in the United States, it is important to improve the efficiency and  effectiveness of planning and coordination of federal efforts on prenatal  opioid use and NAS.
section_title: Recommendations
paragraphs: In order to ensure that efforts to address prenatal opioid use and NAS are  systematically and effectively planned and coordinated across the federal  government, the Director of ONDCP should document the process,  including discussions held and information considered, of developing  action items on prenatal opioid use and NAS. This may include  documenting gaps that were considered in developing action items.
In order to ensure that efforts to address prenatal opioid use and NAS are  systematically and effectively planned and coordinated across HHS’s  agencies, the Secretary of HHS should designate a focal point, such as  the BHCC or another entity, to lead departmental planning and  coordination related to prenatal opioid use and NAS, including  consideration of gaps in research, programs, and other efforts.
section_title: Agency Comments
paragraphs: We provided a draft of this report to ONDCP, HHS, DOJ, USDA, DOD,  and VA. ONDCP and HHS concurred with our recommendations and  provided written comments, which are reprinted in appendixes VI and VII,  respectively. In its written comments, ONDCP noted its efforts in working  with federal agencies, states, and other stakeholders to focus attention on  opioid addiction and NAS, and concurred with our recommendation that  ONDCP document its process for developing action items on prenatal  opioid use and NAS. In its written comments, HHS stated that it has  focused efforts on reducing opioid use disorders with some emphasis on  special populations, including pregnant women, and concurred with our  recommendation that HHS designate a focal point to lead departmental  planning and coordination related to prenatal opioid use and NAS. HHS  noted that it plans to conduct a departmental review to designate such a  focal point. ONDCP and HHS also provided technical comments, which  we incorporated as appropriate. In addition, USDA provided one technical  comment, which we incorporated.
We are sending copies of this report to the Director of the Office of  National Drug Control Policy, the Secretary of the Department of Health  and Human Services, the Attorney General, the Secretary of the  Department of Agriculture, the Secretary of the Department of Defense,   the Secretary of the Department of Veterans Affairs, and other interested  parties. In addition, the report is 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  dsouzav@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this report.  Major contributors to this report are listed in appendix VIII.
section_title: Appendix I: Scope and Methodology
paragraphs: Our objectives were to examine (1) federally funded research, federal  programs, and other federal agency efforts related to prenatal opioid use  or neonatal abstinence syndrome (NAS); (2) gaps identified by federal  agency officials and experts in efforts to address prenatal opioid use or  NAS; and (3) how federal efforts to address prenatal opioid use or NAS  are planned and coordinated.
To examine federally funded research, federal programs, and other  federal agency efforts related to prenatal opioid use or NAS, we first  identified federal departments or agencies (collectively referred to as  agencies) that reported having research, programs, or other agency  efforts related to prenatal opioid use or NAS through fiscal year 2014. To  identify these agencies, we created a list of preliminary agencies based  on a review of our recent work, as well as a review of the 2013 Catalog of  Federal Domestic Assistance (CFDA) and discussion with officials from  the Office of National Drug Control Policy (ONDCP), which is responsible  for coordinating federal drug control efforts. We then screened these  agencies to identify those with research, programs, or other agency  efforts related to prenatal opioid use or NAS. Based on our screening, we  identified 15 relevant agencies that we included in our review. (See   table 4.)
To examine federally funded research, each of the 15 agencies in our  review identified whether they had conducted or funded research on  prenatal opioid use or NAS during fiscal years 2008 through 2014 through  our initial screening. We selected these timeframes in order to provide  information on the body of research funded in recent years. Three of the  15 agencies in our review—the Centers for Disease Control and  Prevention, Food and Drug Administration, and National Institutes of  Health—reported that they had funded or conducted relevant research  during this time period. Using a data collection instrument, we collected  information from these three agencies on the details of this research— such as the target populations, focus of the research, and funding  obligations data by fiscal year. We received completed responses from  the three agencies and followed up to clarify the agencies’ responses if  their responses were unclear or incomplete. In addition, to assess the  reliability of the obligations data, we requested information on the  agencies’ data systems and if there were any limitations to reporting the  data. We also conducted internal checks to identify any outliers, and  followed up with agency officials as appropriate. We determined that the  research data provided by the agencies were sufficiently reliable for our  purposes.
To examine federal programs that addressed prenatal opioid use or NAS,  we took a two-part approach. We first identified potentially relevant  federal programs by reviewing the 2013 CFDA and the Department of  Health and Human Services (HHS) Federal Program Inventory for fiscal  year 2013, the latest available data at the time of our review, and by  interviewing federal agency officials. We then requested that each of the  15 agencies in our review confirm if the programs that we initially  identified addressed prenatal opioid use or NAS, and if they were in  operation in fiscal years 2013 or 2014. We selected these time frames to  provide information on current programs that address these issues, and  we included fiscal year 2013 because it was the most recent fiscal year  for which complete program data were available. We also asked each  agency to identify any additional programs that we had not identified that  were relevant to prenatal opioid use or NAS. As a result, seven federal  agencies identified a total of 22 federal programs that addressed prenatal  opioid use or NAS in fiscal years 2013 or 2014.
We then developed and administered a Web-based questionnaire to  collect information on each of these 22 programs—such as types of direct  services made available and other activities conducted related to prenatal  opioid use or NAS—and used the information provided to determine if  each of the programs met our definition for addressing prenatal opioid  use or NAS. We defined a program as addressing prenatal opioid use or  NAS if (1) the program made relevant direct services available— regardless if these services were actually provided—or (2) the program  conducted other activities that were relevant to prenatal opioid use or  NAS. We also collected other types of information on each program,  such as the program description and objectives, number of years in  operation, funding mechanisms, funding obligations, and whether  available services and activities were required to be evidence-based.  During the development of our questionnaire, we pretested it with federal  agency officials representing four programs across three agencies to  ensure that our questions and response choices were clear, appropriate,  and answerable. To obtain a variety of perspectives on our questionnaire,  we selected the four programs for pretesting based on the types of  services offered or activities conducted, funding mechanisms, and federal  agency responsible for program administration. We then made changes  to the content of the questionnaire based on feedback obtained from the  pretests. We administered the questionnaire from June 2014 through  October 2014. Officials from all 22 programs completed the  questionnaire.
The results from our questionnaire are not subject to sampling error  because we sent the questionnaire to the universe of potential  respondents. However, the practical difficulties of conducting any  questionnaire may introduce errors, commonly referred to as  nonsampling errors. For example, difficulties in how a particular question  was interpreted, in the sources of information that were available to  respondents, or in how the data were entered into a database or were  analyzed could introduce unwanted variability into the questionnaire  results. We encountered instances of nonsampling error in analyzing the  questionnaire responses, such as respondents providing conflicting,  vague, or incomplete information. We generally addressed these errors  by performing automated checks to identify inappropriate answers, and  also contacted agency officials for clarification and to request additional  documentation as appropriate. However, we did not independently verify  all of the information and data provided by the questionnaire respondents.  In addition, to assess the reliability of obligations data reported in the  questionnaire, we requested supporting documentation, and incorporated  questions about the programs’ data systems and if there were any  limitations to reporting the data. On the basis of our application of  recognized survey design practices and follow-up procedures, we  determined that the data provided by the agencies on programs were  sufficiently reliable for our purposes.
To examine other agency efforts that addressed prenatal opioid use or  NAS in recent years outside of research and programs, we used a data  collection form through which the 15 agencies in our review identified any other agency efforts that took place from fiscal years 2008 through 2014.We received completed responses from all 15 agencies. In some  instances, respondents provided conflicting, vague, or incomplete  information. We generally addressed these errors by contacting agency  officials for clarification and requesting additional information or  documentation as appropriate. However, we did not independently verify  all of the information provided by the respondents. We determined that  the data provided by the agencies on other agency efforts were  sufficiently reliable for our purposes.
To examine gaps in efforts to address prenatal opioid use or NAS, we  obtained testimonial evidence from federal agency officials and experts  on any research, program, and other gaps that exist in efforts to address  prenatal opioid use or NAS. Specifically, we requested information from  federal officials representing the agencies that had funded or conducted  research in fiscal years 2008 through 2014, the agencies with relevant  programs in fiscal years 2013 or 2014, and ONDCP. In addition, we  selected experts (comprising expert organizations as well as individual  researchers and clinicians) in order to include perspectives from health  care professionals, advocates, and researchers with expertise in women’s  health, pediatric health, and addiction. We obtained testimonial evidence  from officials representing nine federal agencies and six experts from  which we requested information. We then conducted preliminary content  analyses of the information provided by agency officials and experts on:  (1) research, program, and other gaps; (2) the reasons for these gaps;  and (3) the effects of these gaps. We created preliminary categories  based on these analyses. Two GAO analysts then independently  conducted formal analyses, reviewed each other’s work, and discussed  any discrepancies to ensure that both agreed on the assigned  categorization of all information provided by agency officials and experts.  For reporting purposes, we counted each federal agency and each expert  (whether an individual or an expert organization) as one unit in our  analysis. The results of this analysis are not generalizable because we  selected the agency officials and experts from whom we obtained  testimonial information. We did not independently verify the information  provided by agency officials and experts.
To examine how federal efforts to address prenatal opioid use or NAS are  planned and coordinated, we collected documents and interviewed  officials from ONDCP about planning and coordination across the federal  government. We also collected documents and interviewed officials from  HHS’s Office of the Secretary about planning and coordination across  HHS’s nine agencies that fund research, conduct programs, or engage in  other agency efforts to address prenatal opioid use or NAS.
We conducted this performance audit from January 2014 to February  2015 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
section_title: Appendix II: Federally Funded Research Projects on Prenatal Opioid Use or Neonatal Abstinence Syndrome
paragraphs: Federal agencies obligated almost $21.6 million for 18 research projects  that focused on prenatal opioid use or neonatal abstinence syndrome  (NAS) from fiscal year 2008 through 2014. The six research projects that  were provided the highest amount of funding each received more than   $2 million from fiscal years 2008 through 2014, with five of these projects  including a focus on prevention and understanding of NAS or treatment of  NAS. Additionally, half of the 18 projects were completed by May 2014,  while the remaining half were ongoing. All but three of the 18 projects  were funded for extramural research, which were grants, contracts, or  cooperative agreements awarded to universities, medical schools,  research organizations, and private companies. Fourteen of the 18  projects were funded by the National Institutes of Health (NIH) and the  remaining four were funded by the Centers for Disease Control and  Prevention (CDC) and the Food and Drug Administration (FDA). (See  table 5.)
section_title: Appendix III: Federal Programs that Addressed Prenatal Opioid Use or Neonatal Abstinence Syndrome
paragraphs: Federal agency officials identified 14 programs that addressed prenatal  opioid use or neonatal abstinence syndrome (NAS) in fiscal years 2013 or  2014 by making relevant direct services available or conducting other  activities as part of broader programs on substance abuse prevention and treatment, maternal and child health, or family and child welfare services.Officials from four of these 14 programs reported specifically addressing  prenatal opioid use or NAS as part of their program objectives: (1) the  Maternal, Infant, and Early Childhood Home Visiting Program, run by the  Health Resources and Services Administration (HRSA); (2) the Services  Grant Program for Residential Treatment for Pregnant and Postpartum  Women, run by the Substance Abuse and Mental Health Services  Administration (SAMHSA); (3) the National Center on Substance Abuse  and Child Welfare, run by SAMHSA and the Administration for Children  and Families (ACF), all within the Department of Health and Human  Services; and (4) the Family Drug Court Program within the Department  of Justice’s Office of Justice Programs. (See table 6.)
section_title: Appendix IV: Direct Services Made Available and Program Activities Conducted by Federal Programs
paragraphs: Officials from eight of the 14 programs that addressed prenatal opioid use  or neonatal abstinence syndrome (NAS) in fiscal years 2013-2014  reported that their programs made various direct services available to  women who used opioids, such as women in medication-assisted  treatment for opioid use disorders; those who misused, abused, or were  addicted to opioids; and/or those who were prescribed opioids for pain  management. Some programs also made services available to newborns  who had been exposed to opioids during pregnancy, to family members  of pregnant women who used opioids, or to family members of opioid- exposed newborns. (See fig. 6.) Officials from 11 of the 14 federal  programs that addressed prenatal opioid use or NAS reported that the  programs had conducted activities relevant to these issues, other than, or  in addition to, direct services. All of these programs reported providing  training or technical assistance that addressed prenatal opioid use or  NAS to various stakeholders, most frequently health care providers,  officials from state or local health departments or behavioral health  agencies, and nonprofit organization staff. In addition to training and  technical assistance, officials from five programs reported that their  programs conducted public education or outreach related to prenatal  opioid use or NAS. (See fig. 7.)
section_title: Appendix V: Other Agency Efforts to Address Prenatal Opioid Use or Neonatal Abstinence Syndrome
paragraphs: Officials from 10 out of 11 federal agencies reported engaging in other  efforts outside of research and programs to address prenatal opioid use  or neonatal abstinence syndrome (NAS) from fiscal years 2008 through  2014. These 10 agencies most frequently reported conducting provider  education or participating in relevant knowledge-sharing groups, such as  working groups or expert panels. (See fig. 8.)
section_title: Appendix VI: Comments from the Office of National Drug Control Policy
section_title: Appendix VII: Comments from the Department of Health and Human Services
section_title: Appendix VIII: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
paragraphs: Vijay A. D’Souza, (202) 512-7114 or dsouzav@gao.gov.
section_title: Staff Acknowledgments
paragraphs: In addition to the contact name above, Rashmi Agarwal, Assistant  Director; Sarah Abou-El-Seoud; Jennie Apter; Carolyn Fitzgerald;   Linda Galib; Jackie Hamilton; Carolyn Feis Korman; and Hannah Locke  made key contributions to this report.
section_title: Related GAO Products
paragraphs: Office of National Drug Control Policy: Office Could Better Identify  Opportunities to Increase Program Coordination, GAO-13-333  (Washington, D.C.: Mar. 26, 2013).
Drug Control: Initial Review of the National Strategy and Drug Abuse  Prevention and Treatment Programs, GAO-12-744R (Washington, D.C.:  July 6, 2012).
Prescription Pain Reliever Abuse: Agencies Have Begun Coordinating  Education Efforts, but Need to Assess Effectiveness, GAO-12-115  (Washington, D.C.: Dec. 22, 2011).
Methadone-Associated Overdose Deaths: Factors Contributing to  Increased Deaths and Efforts to Prevent Them, GAO-09-341  (Washington, D.C.: Mar. 26, 2009).
Prescription Drugs: OxyContin Abuse and Diversion and Efforts to  Address the Problem, GAO-04-110 (Washington, D.C.: Dec. 23, 2003).
Drug Exposed Infants: A Generation at Risk, HRD-90-138 (Washington,  D.C.: June 28, 1990).