Following White House Proclamation, MotherToBaby Offers One-Stop for Latest Information about Opioid Effects on Developing Babies

BRENTWOOD, TN –A series of new opioid-specific fact sheets, blogs and a recent webinar are just some of the pregnancy and breastfeeding-related resources unveiled by MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists (OTIS), in response to the alarming toll opioid addiction is taking on communities from coast to coast. The new resources come as the U.S. recognizes National Recovery Month and the White House proclaims September 16 – 22, 2018 Prescription Opioid and Heroin Epidemic Awareness Week.

MotherToBaby is recommended by many agencies, including the Centers for Disease Control and Prevention (CDC), for evidence-based information about exposures, like opioids, during pregnancy and breastfeeding. It has 15 affiliates across the country that provide this service to all 50 states as well as the US territories.

The new MotherToBaby resources surrounding opioids can be found at www.MotherToBaby.org/opioids and include resources to help healthcare providers, addiction specialists, and women struggling with addiction to prescription and illicit drugs:
• Evidence-based fact sheets on a variety of opioids such as oxycodone, hydrocodone, fentanyl, morphine, buprenorphine, heroin, hydromorphone, methadone, codeine and tramadol.
• A webinar for health care providers on Opioid Abuse in Pregnancy and Breastfeeding, conducted by OTIS, the National Society of Genetic Counselors, the Society of Maternal-Fetal Medicine and the Teratology Society.
• Opioid-specific blogs authored by teratogen information specialists, experts in assessing birth defects risks from exposures during pregnancy and breastfeeding.
• Ways for women and health care providers to receive free and confidential personalized risk assessments through MotherToBaby’s toll-free helpline (866) 626-6847, text line (855) 999-3525 (standard messaging rates may apply), live chat and email-an-expert services.
• Additional resources for addiction support.

“It’s reached the level where it’s almost on a daily basis that I take care of pregnant and breastfeeding women struggling with opioid dependency,” said Sarah Obican, MD, Maternal-Fetal Medicine Subspecialist at the University of South Florida and director of the new MotherToBaby Florida affiliate set to open in November. Florida is just one of the states where health officials and providers are seeing the opioid epidemic unfold first-hand. Rates of Neonatal Abstinence Syndrome (NAS) among Florida’s infants have increased over the past four years, according to the Florida Birth Defects Registry which tracks the number of infants diagnosed with NAS.

“While there’s no evidence at this time of an increased risk for birth defects, babies with NAS born to opioid-addicted mothers may be at an increased risk for adverse neurobehavioral effects,” explained Dr. Obican. “They are simply not getting the best possible start to life that they deserve, but we can change that by supporting mom and getting her the resources she needs.”

More about MotherToBaby, a service of OTIS.
OTIS is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of: obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. MotherToBaby is a suggested resource by many federal agencies including the CDC and the Food and Drug Administration’s (FDA) Office of Women’s Health. MotherToBaby has been able to embark on new outreach efforts to reach underserved populations and launch new communication technologies, such as the MotherToBaby app (available for free download on iOS and Android markets), through a cooperative agreement with the U.S. Health Resources and Services Administration, as well as through the generous donations made by the public. To learn more about MotherToBaby, the ways to contact its network of experts, or how to support its services, please visit www.MotherToBaby.org.

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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org. Interviews in Spanish are also available.

IN CASE YOU MISSED IT: Webinar Regarding Rising Opioid Abuse Trends in Developing Babies

BRENTWOOD, TN –“On an almost daily basis I take care of women struggling with opioid addiction or dependency in pregnancy and the post-partum period.” Sarah Obican, MD, Maternal-Fetal Medicine Subspecialist at the University of South Florida, knows she’s not alone as the opioid epidemic rages on in America. “I actively screen patients in early pregnancy and see them on our antepartum units.” It’s a crisis she and other birth defects experts from the Organization of Teratology Information Specialists (OTIS) are trying to curb by offering the latest data surrounding opioid exposure in pregnancy and lactation during a free webinar held on January 24, 2018.

For those who missed the live webinar, a recording of it can be accessed for free at the following link (you’ll have to fill out a registration form before the recording will play): https://attendee.gotowebinar.com/register/6698504499390044674

“The Opioid Epidemic: Its Impact on Pregnancy and Breastfeeding” webinar was a joint collaboration with the National Society of Genetic Counselors (NSGC) and, in addition to OTIS, included presenters representing the Teratology Society and the Society of Maternal-Fetal Medicine. The webinar covers an overview of the association of opioid use in late pregnancy and the risk of Neonatal Abstinence Syndrome (NAS), the risk for malformations and adverse neurobehavioral effects in fetuses exposed to opioids in-utero, as well as the effects of opioid exposure on the breastfed infant. CEUs are available, but only for members of the Prenatal SIG through the NSGC.

More about OTIS

The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of: obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC). To be connected with a MotherToBaby expert, please call (866) 626-6847, text questions to (855) 999-3525 (standard messaging rates might apply, check with your carrier) or visit www.MotherToBaby.org.

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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org.

Katherine L. Wisner, MD, MS, a long time OTIS member and perinatal psychiatrist, recently co-authored an op-ed in support of a new Illinois law set to take effect this summer that will address the legal liability women have when they commit criminal acts while suffering from severe postpartum mental illness. The op-ed was published in The Hill and can be read here.

The new law, a first of its kind, will highlight postpartum mental illness as a factor for judges to consider when determining an appropriate punishment for a crime. It will also allow women who were convicted of a felony, but did not have evidence of postpartum mental illness presented at their trial or sentencing, apply to reduce their sentence post-conviction. Because mood disorders, particularly depression, are common complications of childbearing, this law will focus on treatment rather than punishment for women convicted of a crime while suffering from the devastating effects of postpartum mental illness.

OTIS Offers Relief for Pharma Companies under Pressure to Update Labels with Pregnancy and Lactation Info

BRENTWOOD, TN –“It’s the first service of its kind to aid pharmaceutical companies in this way,” described Stephen Braddock, MD, a St. Louis-based pediatrician and dysmorphologist in reference to a new endeavor offered by birth defects experts at the Organization of Teratology Information Specialists (OTIS). The unique offering aims to support the implementation of the FDA Pregnancy and Lactation Labeling Rule (PLLR) pharmaceutical companies now must adhere to, creating an urgent need for fetal and lactation risk summaries on thousands of medications.

The PLLR implementation requires the revision of product labeling for all drugs approved after June 2001. “Thousands of prescription medications fall under the PLLR timeline over the next five years, an overwhelming task for many companies,” added Dr. Braddock, who also serves as the OTIS president. OTIS, Inc. is a wholly owned Benefit Corporation established by the non-profit OTIS. “OTIS experts can step in to provide current reviews of existing data and comprehensive risk summaries pharmaceutical companies are under pressure to produce.”

Thorough literature reviews, synthesis and translation of the data are all part of the
OTIS communication process already, according to Melissa Tassinari, PhD, a retired Sr. Clinical Advisor for the US Food and Drug Administration and founding PLLR project leader. “OTIS has been communicating pregnancy and lactation risk exposure through its MotherToBaby helpline service for more than 30 years,” explained Dr. Tassinari. “Pharmaceutical companies can now take advantage of that established expertise to save an enormous amount of time.”

Christina Chambers, PhD, MPH, an epidemiologist and OTIS, Inc. board ad hoc advisor said the process for assistance will begin with a quote, which pharmaceutical companies can request via MotherToBaby.org/OTISInc or by emailing contactus@otispregnancy.org. The rest of the literature review process will be carried out painlessly, timely and accurately. “To develop OTIS, Inc. we were supported by an advisory board comprised of the world’s leading experts in the area of prenatal risk exposure with extensive backgrounds in academia, research, government and industry to ensure that the highest quality product possible will be delivered,” she said.

The full OTIS, Inc. Board includes:

• Stephen R. Braddock, MD, OTIS President
• Melissa S. Tassinari, PhD, retired Sr. Clinical Advisor, US Food and Drug Administration
• Sarah G. Obican, MD, University of South Florida Morsani College of Medicine
• Katherine L. Wisner, MD, MS, Northwestern University Feinberg School of Medicine
• Christina D. Chambers, PhD, MPH, OTIS President-Elect, Ex-Officio Member

OTIS, Inc. Advisory Board members include:

• Philip O. Anderson, Pharm D, Author of LactMed® database
• Gerald G. Briggs, B Pharm, FCCP, Co-Author of Drugs in Pregnancy and Lactation
• Cheryl S. Broussard, PhD, Centers for Disease Control and Prevention, NCBDDD
• Alicia B. Forinash, Pharm D, FCCP, BCPS, BCACP, Co-Author of Drugs in Pregnancy and Lactation
• Jan M. Friedman, MD, PhD, TERIS Principal Investigator
• Janine E. Polifka, PhD, TERIS Project Director
• Anthony R. Scialli, MD, Reprotox® Director

To read more about the product service offered by OTIS, Inc., please see its digital prospectus here.

More about OTIS

The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of: obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC).
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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org.