Protecting Our Infants Act Report to Congress 
Protecting Our Infants Act Neonatal Abstinence Syndrome Noenatal Opioid Withdrawal Opioid Use Disorder Pregnancy Prenatal Opioid Exposure
2017-01-27 2017-01-31 2017-02-06 2017-01-23 2017-02-14 2017-01-27 2017-02-21 2017-01-25 2017-01-25 2017-02-16
SAMHSA-2016-0004-0007 SAMHSA-2016-0004-0009 SAMHSA-2016-0004-0010 SAMHSA-2016-0004-0004 SAMHSA-2016-0004-0014 SAMHSA-2016-0004-0008 SAMHSA-2016-0004-0021 SAMHSA-2016-0004-0006 SAMHSA-2016-0004-0005 SAMHSA-2016-0004-0015
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https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0007 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0009 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0010 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0004 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0014 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0008 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0021 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0006 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0005 https://api.regulations.gov/v4/comments/SAMHSA-2016-0004-0015
Anonymous Janice Ericka Dawn Dara Richard Regan Anonymous Joyeal Sierra
Anonymous Meinert Lear Goodman-martin Fruchter Fein Ward-allen Anonymous Hunter Lacivita
Stop infant circumcision.  Women need supports in addition to services, while pregnant and after their child is born.  Babies exposed to drugs in utero are often fussy, difficult to soothe infants and children.  It would be wonderful if the administration could find a way to tap into the compassionate individuals who are Pro-Life to volunteer their services to these families in need.  Perhaps hospitals, clinics and treatment programs could be funded to advertise for volunteers and pay for child abuse and other appropriate clearances and provide training to the volunteers.  Magee-Womens Hospital in Pittsburgh, PA has a program in their neonatal unit for volunteers to hold and rock babies.  The waiting list is so long they no longer take names for volunteers.  Programs like this across the country would be wonderful. As a former methadone patient who gave birth to 3 children while in treatment, I would like to see national standards advocating the use of split dosing upon confirmation of pregnancy.  Maintaining an even level of medication in the system is essential to avoid learned withdrawal response in infants and can reduce symptom severity or prevent neonatal abstinence syndrome. There was no document or public study available concerning pregnancy while in methadone treatment.  I had to do the research myself and present the studies to the clinic doctor in order to Split dose for the duration of my pregnancy and while breastfeeding.  None of my children experienced NAS due to my diligence and willingness to fight for the healthiest outcome for them. Not all clinics are willing to allow for split dose.  In my time as an advocate for patients, there were multiple occasions where despite the research, the clinic refused the patient split dose simply due to inconvenience, which is not a proper response in an evidence-based setting. Setting national standards, giving a clinic the proper method for administering medication during pregnancy, would benefit both mother and child and would reduce the severity of NAS in this population. Additionally, having a website where patients could easily read the potential complications and outcomes of opioid use in pregnancy is necessary.  There is no one place where these women could read the studies, learn the potential for NAS symptoms in babies, and educate themselves on the effect of use and ways to lessen the potential for these effects on their children.  Knowledge is instrumental in assisting these women.  Part 4 Section 2(b) of the Act:I believe a strong emphasis should be encouraged for the rooming in interventions and others that would allow the mother and infant bonding time.  This would allow for practical education for the mother with the child at the oversee of the medical staff.  I support the development of family friendly relapse prevention and recovery strategies and feel that there should be some thought put into the most appropriate community based program that is not driven by each states Division of Child and Family Services.  In a rural area, this will send a message of criminalization to the affected childs family. Under education, a wider societal educational role needs to be placed with more preventative attempts with the childbearing population. It would be beneficial going forward to encourage further research specifically into Suboxone and Subutex  management. In the field results are indicating much better long term results than methadone for both baby and mother. I live in Massachusetts, and have been volunteering in a special care nursery as a cuddler for more than seven years. Almost all of the newborns I have cuddled are drug exposed in utero, and are in the special care nursery going through withdrawal, experiencing Newborn Abstinence Syndrome (NAS). After spending hundreds of hours holding babies who are suffering with the challenging symptoms associated with newborn withdrawal, observing how caregivers and families interact, and on my own time, learning about newborn brain development, I believe the process of caring for and protecting our infants born drug exposed begins by investing in and using a model of care in our hospital nicus and special care nurseries, and beyond, that supports healthy newborn brain development...what I have come to think of as brain sensitive care.Science teaches that immediately following birth, rapid brain development occurs, and the way a newborn brain develops is closely connected to environment. If NAS newborns going through withdrawal are cared for in nicus and/or special care environments designed to support healthy newborn brain development, along with doctors, nurses, caregivers, and families, educated in developmental care, with their focus on the baby first, there may be tremendous opportunity for positive, lifelong outcomes for this population of infants, and their families.Over the past several years, as I have looked for professional direction and validation around what I have observed in my volunteer role, I have reached out to a handful of medical pioneers and leaders in the field of newborn behavior and developmental care, several of whom are based in Boston, MA. In 2014, I have had the privilege of attending a training workshop at The Brazelton Institute in Boston to learn about a specific model of newborn care. The workshop, entitled, The Newborn Behavioral Obseravtion (NBO) System for At-Risk Infants introduced an approach to me that I have come to believe could be key in the long-term health of this population of babies and their families. Located in Boston, based in the division of Developmental Medicine, Boston Childrens Hospital, the Institute is founded on the ground-breaking work of Dr. T. Berry Brazelton. I think that those reporting to Congress, advising on public policy and best practices around caring for these infants, have a responsibility to consult with the Institutes leaders, including Dr. Joshua Sparrow, Director, Brazelton Touchpoints Center, Boston Childrens Hospital and President Brazelton Touchpoints Foundation, to learn how the Institutes developmental care research and this model of care may create an important and much needed stance within hospitals, and beyond, for supporting the well-being of NAS babies, parents, and families dealing with the disease of addiction. Dear Panel,My hope is that, in addressing the problems of opiate dependent children, we will begin to address the much larger problem of opiate dependent parents. My feeling is hat this has to be addressed in conjunction with any attempt to reduce the incidence of opiate dependency in pre- and post-natal infants. Lack of insurance is probably the largest institutional limitation to access to care. Education of children through adolescents about the dangers of drugs is also important.A genuine attempt by society to understand the drug addicts poverty, upbringing, and lack of education will go a long way towards restoring these people to functioning members of our communities.I hope you can address some of these concerns, as I dont hold out much hope for your initiative without them.Thank you, Richard Fein, D.O. Nearly 7 million people in the U.S. had used OUD related to prescription opioids or heroin in the last 30 days.  This number is not only shocking but unacceptable. I do not personally associate myself with anyone that does drugs, but I know people that I went to high school with that used opioids while pregnant and I have family members who adopted a child that was born with NAS.  It is not beyond reach that everyone knows or knows of someone who had a baby that was exposed to opioids. This is a trend that must be stopped. I know this act focuses on the impact that holds for unborn babies and the impact once they are born but to me it seems the recommendations provided to congress have a major blind spot. As a law student whos area of interest is education law, it seems most of your recommendations are to educate women about the best options for the child once they become pregnant and the fetus is exposed to the drugs. Education should start in middle school health class. Students are educated about drugs and the process of reproduction. An in depth analysis of what happens when the two are mixed should be provided. The actual effects are not portrayed in a way that provides the gruesome reality. Women who are prescribed opioids as a form of pain management should be educated about the risks of becoming pregnant while using opioids when they begin their treatment instead of when they become pregnant. Prescribing doctors should also prescribe a contraceptive.  Opioid use should never be a choice that is made without knowing the impact it could hold on the future of the user and that includes their future children. More emphasis needs to be placed on providing a comfortable forum for a woman who becomes pregnant while using opioids to disclose this and provide proper medical assessment.  It is in recommendations from the report, but still no specific plan has been made to overcome the deterrents. In 2012 with nearly 5.8 per 1,000 hospital births having an incidence of NAS, it is essential that the proper treatment be given from the first time a woman visits her doctor. The education of medical professionals should go beyond understanding what to do if your patient is using opioids while carrying a baby. There should be specialized doctors. We have specialists for every body part and most diseases. With the dramatic amount of infants born with NAS, there should be OBGYNs that these women can go to and know that they will receive the best care for their situation. If all of the women seeing this specialized OBGYN were dealing with the same issues associated with opioid use, it would provide a comfortable environment for them to seek help and not feel singled out as the bad woman on drugs while pregnant.   Additionally, the report continuously mentions the needs for collective data to avoid overlaps and receive more conclusive statistics. There is no direct plan suggested of how to accomplish this. Defining the specific data that would be the most beneficial, will further the plan drastically.  Without data, it is hard to figure out the exact problem and viable solutions. Having specialized OBGYNs would provide a much easier way to establish accurate statistics without invasion of privacy from the patients.  Having a support group for women going through the same thing as described in the report is of immense value. It is remarkable that these groups continue even after the children are born, and it is likely an essential reason to help prevent these women from falling into the same situation in the future. Formulating a plan to make these groups more organized and readily available to those in need is indispensable. Having a specialized OBGYN would provide an environment that would stimulate the creation of these groups. Having women all dealing with the same issue in one place makes the creation of these groups extremely easy, and with their success already proven it should be contribution towards finding a solution. These women can become mentors for others.  They should use their experience to educate others not just that are in the same situation but before they get there. It is essential that these women who have experienced the pain of carrying a baby while using opioids and having a baby suffering from NAS use their experience to discourage others from enduring the same suffering. In general, the solution will be found in education of children, women and health care professionals. Bringing about awareness of the problem and its frequency as well as specifics as to what infants exposed to opioids experience will be a strong starting point. Specializing medical professionals to address the growing issue will be the ultimate force that can produce change in the future outcome. Support from peers and those who have grown through the same experience will empower women to stop the trend. Finally, continued education and support after childbirth will be essential to avoiding recurrence.  As was said, women are often on treatment plans that use opioids and are advised to continue said treatments. But whether they obtain opioids medically or recreationally, their access to the drugs cannot and will not be prevented as it is unethical to force someone to not treat him/herself for the good of a fetus, nor will the illegal drug trade stop functioning. The most practical solution to prevent fetal exposure to harmful drugs, such as opioids, and the limit the costs and burdens of treatment is to provide women with effective birth control. Preventing often unwanted pregnancies will dramatically reduce the strain on the government to provide or assist the mothers who experience prenatal complications due to their opioid usage as well as the strain to provide and treat damaged infants who, might possibly, suffer from disabilities due to their prenatal exposure throughout their lives. During a SOAR event in Somerset, KY; I learned the troubling statistics given by a representative of Pikeville Medical Center who presented that 30% of the babies being born in their facility were diagnosed with Neonatal Abstinence Syndrome.  A representative from Louisville suggested that the statistics are more like 50% in Louisville of babies being born with Neonatal Abstinence Syndrome. This troubling data has given me the recognition that Neonatal Abstinence Syndrome is an epidemic and really needs to be acted on.I have provided some resources below that I do not claim to be my own, but data that I have researched to find.The American College of Obstetrics and Gynecologistshttp://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Health-Care-for-Underserved-Women/Opioid-Abuse-Dependence-and-Addiction-in-PregnancyAn excerpt from this article:Long-Term Infant OutcomeRecent data on long-term outcomes of infants with in utero opioid exposure are limited. For the most part, earlier studies have not found significant differences in cognitive development between children up to 5 years of age exposed to methadone in utero and control groups matched for age, race, and socioeconomic status, although scores were often lower in both groups compared with population data . Preventive interventions that focus on enriching the early experiences of such children and improving the quality of the home environment are likely to be beneficial.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2989871/ This is an excerpt from the article:For opioid-dependent pregnant and postpartum women in treatment, methadone maintenance is the treatment of choice in the United States. In contrast to other substances, concentrations of methadone in human milk and the effects on the infant have been studied, and the concentrations of methadone found in human milk are low; therefore women stable on methadone maintenance should be permitted to breastfeed if desired, and irrespective of maternal methadone dose. There are no apparent short-term or long-term effects of methadone in human milk on neurodevelopment. However, infants chronically exposed to opiates in utero typically experience neonatal abstinence syndrome (NAS), a constellation of signs and symptoms that includes neurologic excitability (tremors, irritability, increased wakefulness, high-pitched crying, increased muscle tone, hyperactive reflexes, seizures, frequent yawning and sneezing), gastrointestinal dysfunction (poor feeding, uncoordinated and constant sucking, vomiting, diarrhea, dehydration, poor weight gain), and autonomic signs (increased sweating, nasal stuffiness, fever, mottling of skin). Withdrawal signs and symptoms typically present within 48-72 hours of birth following in utero opioid exposure, but these can manifest up to 4 weeks later in some infants. Infants with significant NAS symptoms can have difficulties with breastfeeding mechanics, which can impact their ability to breastfeed. Despite this, there is increasing evidence to support that methadone-exposed infants may benefit from breastfeeding and/or breast milk; infants who are breastfed are less likely to have severe NAShttp://pediatrics.aappublications.org/content/129/3/e827.fullThis is an excerpt from this article:Maternal substance abuse is not a categorical contraindication to breastfeeding. Adequately nourished narcotic-dependent mothers can be encouraged to breastfeed if they are enrolled in a supervised methadone maintenance program and have negative screening for HIV and illicit drugs. Street drugs such as PCP (phencyclidine), cocaine, and cannabis can be detected in human milk, and their use by breastfeeding mothers is of concern, particularly with regard to the infants long-term neurobehavioral development and thus are contraindicated. Alcohol is not a galactogogue; it may blunt prolactin response to suckling and negatively affects infant motor development. Thus, ingestion of alcoholic beverages should be minimized and limited to an occasional intake but no more than 0.5 g alcohol per kg body weight, which for a 60 kg mother is approximately 2 oz liquor, 8 oz wine, or 2 beers. Nursing should take place 2 hours or longer after the alcohol intake to minimize its concentration in the ingested milk.101 Maternal smoking is not an absolute contraindication to breastfeeding but should be strongly discouraged, because it is associated with an increased incidence in infant respiratory allergy and SIDS. Smoking should not occur in the presence of the infant so as to minimize the negative effect of secondary passive smoke inhalation. Smoking is also a risk factor for low milk supply and poor weight gain.The research appears to suggest that withdrawal during pregnancy may be harmful to the infant in utero and breastfeeding may be of benefit to ease withdrawal.   I think this is a great bill that NEEDS to be passed! So many children are being exposed to drugs at such a young age and there are not enough consequences for this crime. The law needs to crack down on these awful people that are ruining childrens lives. I support this bill 100% 