[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24137-24138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10735]
[[Page 24137]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICE
Substance Abuse and Mental Health Services Administration
Protecting Our Infants Act Report to Congress: Summary of Public
Comment and Final Strategy
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Substance Abuse and Mental Health Services Administration
(SAMHSA) in the Department of Health and Human Services (HHS) announces
the release of the ``Protecting Our Infants Act: Final Strategy'' in
response to sections 3(a)(2) and 3(b) of the Protecting Our Infants Act
of 2015 (POIA). The POIA mandated HHS to: conduct a review of planning
and coordination activities related to prenatal opioid exposure and
neonatal abstinence syndrome; develop recommendations for the
identification, prevention, and treatment of prenatal opioid exposure
and neonatal abstinence syndrome; and develop a strategy to address
gaps, overlap, and duplication among Federal programs and Federal
coordination efforts to address neonatal abstinence syndrome. The
Protecting Our Infants Act: Report to Congress which satisfied these
requirement was made available January 17, 2017, through February 21,
2017, for public comment in the following docket SAMHSA-2016-0004-0001.
As a result of the public comments, summarized below, several
recommendations were added to the original strategy and others
expanded. The Final Strategy can be read and downloaded at https://www.samhsa.gov/specific-populations/age-gender-based#poia.
FOR FURTHER INFORMATION CONTACT: Melinda Campopiano, MD, Chief Medical
Officer, Center for Substance Abuse Treatment, Substance Abuse and
Mental Health Services Administration, 5600 Fishers Lane, 13E49,
Rockville, MD, 20852. Email: [email protected]. Phone:
(240)276-2701
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments,
including any personally identifiable or confidential business
information that is included in a comment, received during the comment
period are available for viewing by the public in the public docket.
Background: The POIA mandated HHS to: (1) conduct a review of
planning and coordination activities related to prenatal opioid
exposure and neonatal abstinence syndrome (Section 2(a) of the Act);
(2) develop recommendations for the identification, prevention, and
treatment of prenatal opioid exposure and neonatal abstinence syndrome
(Section 3 of the Act); and (3) develop a strategy to address gaps,
overlap, and duplication among Federal programs and Federal
coordination efforts to address neonatal abstinence syndrome (Section
2(b) of the Act). The POIA is available at: https://www.congress.gov/114/plaws/publ91/PLAW-114publ91.pdf.
In response to the requirements of the POIA, ``The Protecting Our
Infants Act: Report to Congress'' was released January 17, 2017. The
report provided background information on prenatal opioid exposure and
neonatal abstinence syndrome (Part 1), summarized HHS activities
related to prenatal opioid exposure and neonatal abstinence syndrome
(Part 2), presented clinical and programmatic evidence and
recommendations for preventing and treating neonatal abstinence
syndrome (Part 3), and presented a strategy to address the identified
gaps, challenges, and recommendations (Part 4).
As required in Section 2(b) of POIA, public comment was sought on
``Part 4: Strategy to Protect Our Infants.'' All comments, including
any personally identifiable or confidential business information that
is included in a comment, received during the comment period are
available for viewing by the public in this docket. The comments and
corresponding changes to the strategy are summarized in this notice,
below. The Protecting Our Infants Act: Final Strategy can be read and
downloaded at https://www.samhsa.gov/specific-populations/age-gender-based#poia.
Summary of Public Comment: A total of 22 comments were received.
The majority were both favorable and relevant. This is a summary of the
relevant public comments. It is organized according to the same three
sections included in Part 4 of the report: Prevention, Treatment, and
Services. It also includes a brief section in which global comments are
reviewed. Examples of comments outside the scope of the original FRN
that are not included in this summary, include discussion of: The
statute itself, current unresolved policy issues related to health care
access, decriminalization of drug use, specific state policies or laws
outside the purview of the federal government, and comments on sections
of the report other than the strategy.
Prevention
Prevention-related comments were received on the topic of pain
management. These comments urged that education and awareness efforts
address opportunities to prevent and treat pain in preconception and
pregnancy. Commenters pointed out that the same types of barriers, such
as coverage limits and requirements for prior authorization that impede
access to substance use disorder treatment, also limit access to
alternative treatments for pain. The wider use of these alternatives
may ultimately reduce the numbers of opioid-exposed pregnancies and
neonatal opioid withdrawal syndrome (NOWS). The following language was
added to the programs and services section of the prevention strategy
(Table 11 of the final strategy) to address this comment: ``Provide
access to effective and alternative treatment options for pain prior to
conception and during pregnancy and breastfeeding.''
One comment urged exploration of primary prevention strategies of
benefit to women and infants at risk for NOWS and described important
elements of primary prevention strategies such as social determinants
of health, opioid prescribing practices, the need for care coordination
and increased capacity for behavioral, general medical, and gynecologic
health services. Language corresponding to this comment was not added
to the strategy because these comments, while relevant to opioid use
disorder (OUD) in general, are not directly related to opioid use
during pregnancy. Suggestions were provided on ways to strengthen data
collection and close existing gaps. Language capturing these
suggestions was not added to the document because similar activities
are currently underway within HHS, as described in Part 2 of the
report.
Treatment
Comments with regard to treatment urged that comprehensive,
integrated services be emphasized, that services such as smoking
cessation be tailored to pregnant women, and that all substance use
disorder (SUD) treatment continue for one year postpartum. The words
``from preconception through pregnancy and one year postpartum'' were
added to a recommendation in the programs and services section of the
treatment strategy (Table 12 of the final strategy) to reflect these
comments. The recommendation now reads: ``Support continuation of
treatment for SUD from preconception through pregnancy and one year
postpartum and tailor
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medication assisted treatment according to parental need.''
Commenters reaffirmed the need for research into pain management
during pregnancy for women either with or without OUD. One asked that
research into pain management during labor and delivery and postpartum
for women with OUD be conducted. A recommendation in the research
section of the treatment strategy (Table 12 of the final strategy) was
revised to reflect these comments. It now reads: ``Research effective
non-pharmacologic and non-opioid pharmacotherapies for pain management
during pregnancy, labor and delivery, post-partum care and
breastfeeding for women with chronic pain or opioid use disorder.''
Another commenter recommended the scope of the recommendation
``Determine the safety and effectiveness of naltrexone use during
pregnancy and breastfeeding'' be expanded to include naloxone in both
the strategies for prevention and treatment. Language was added to this
recommendation in the treatment strategy (Table 12 of the final
strategy) but not the prevention strategy. It was not included in the
prevention section because naloxone does not have a role in preventing
or reducing prenatal substance exposure. The recommendation now reads:
``Determine the safety and effectiveness of naltrexone and naloxone
when combined with buprenorphine use during pregnancy and
breastfeeding.''
Many commenters sought to reinforce specific elements of the
strategy, refine broad research recommendations with more specific
research questions, or inform how the recommendations might best be
carried out. For example, a group of commenters emphasized ``the need
for additional research into the impact on the fetus of drugs taken
during pregnancy . . . especially when exposure is concurrent with
opioids.'' There was a request for greater research on whether a
subgroup of women at sufficiently low risk of relapse could be
identified and detoxified safely and reliably and for more research on
the impact of detoxification on the fetus. There was also a request for
greater research on the most effective pharmacotherapy for infants with
neonatal abstinence syndrome (NAS) and or NOWS. These comments
reinforced or elaborated upon existing recommendations in the strategy
and therefore the strategy was not edited to reflect them.
Services
Several commenters raised concerns about criminal penalties
experienced by pregnant and parenting women with substance use disorder
and the uncertain benefit and unknown consequences of removing children
from their parents due to prenatal substance exposure. This comment
best summarizes the range of strategies suggested by the various
comments:
The current opioid epidemic is resulting in numerous referrals
to and removals by the child welfare system. . . . But, since the
primary purpose of the child welfare system is to investigate
reports of abuse and neglect, child welfare workers often lack the
appropriate training and resources to effectively address substance
use disorders. . . . more research and resources are needed to help
the child welfare system facilitate linkages to treatment and
promote recovery for mothers with addiction.
Another commenter pointed out that there is a ``non-evidence based
assumption that removing children from women who use substances during
pregnancy protects the child'' and several urged research into the
risks and benefits of child removal due to prenatal substance exposure
be added to the strategy. Two recommendations were added to the
services strategy (Table 13 of the final strategy). First, ``Collect
data on the welfare of substance exposed children who are removed from
their families versus those remaining with a mother receiving
supportive interventions'' was added to data collection. Second,
``Promote training and resources for child welfare workers to
effectively address SUD and prenatal substance exposure, facilitate
linkages to treatment, and promote recovery for mothers with SUD'' was
added to the education section.
General Comments
A group of commenters noted that the strategy would be improved by
greater synthesis of the recommendations and the definition of clear
goals with associated metrics. There are several reasons why goals and
metrics are not specified. First, the generally limited and
inconsistent data collection described in the report currently
precludes establishment of a national baseline upon which metrics can
be established. Second, the establishment of goals and metrics is
further complicated by the fact that for pregnant women with OUD, the
most effective intervention to promote optimal outcomes for both mother
and child is the provision of medication assisted treatment with an
opioid agonist, which itself carries a risk of NOWS. As a result,
reduction in the number of cases of NOWS is not a meaningful goal even
if NOWS, as distinct from NAS, could be measured accurately. As a
result, no changes were made to the strategy based on these comments.
Supporting and Related Material in the Docket: The information
provided includes:
(1) The Report
(2) The Final Strategy
(3) Public Comments
Summer King,
Statistician.
[FR Doc. 2017-10735 Filed 5-24-17; 8:45 am]
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