Treating and Managing Opioid Use Disorder in Pregnancy Mishka Terplan, MD, MPH Diana Coffa, MD

Agenda Overview of the CCC Substance Use Warmline Overview of the “Clinical Guidance for Treating Pregnant and Parenting Women with Opioid Use Disorder and their Infants” Case study of OUD treatment in pregnancy

Substance Use Warmline: Free clinical consultation on managing substance use in primary care 6 am – 5 pm PST, Monday – Friday 1.855.300.3595 or submit cases online at nccc.ucsf.edu The Clinician Consultation Center is pleased to offer confidential telephone consultation focusing on substance use evaluation and management for primary care clinicians nationally. With special expertise in pharmacotherapy options for opioid use, our addiction medicine- certified physicians, clinical pharmacists, and nurses provide advice based on Federal treatment guidelines, up-to-date evidence, and clinical best practices. Learn more at http://nccc.ucsf.edu/clinician-consultation/substance-use-management/ This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U1OHA30039-01-00 (AIDS Education and Training Centers National Clinician Consultation Center) in partnership with the HRSA Bureau of Primary Health Care (BPHC) awarded to the University of California, San Francisco.

Substance Use Warmline Peer-to-Peer Consultation and Decision Support (855) 300-3595 or submit cases online at nccc.ucsf.edu Our consultants can help: Support primary care providers in managing complex patients with addiction, chronic pain, and behavioral health issues Improve the safety of medication regimens to help decrease risk of harm, including overdose Enhance the treatment, care and support for people living with or at risk for HIV and viral hepatitis Discuss useful care and communication strategies for clinicians regarding substance use, addiction and chronic pain Develop comprehensive treatment plans for special circumstances including pregnancy

The Opioid Crisis in Pregnant and Postpartum Women Opioid use in pregnant women more than doubled between 1998 and 2011 In 2016, the number of women of childbearing age (15‒44 years) who reported past-month use of opioids (including heroin or pain reliever misuse) 1,090,000 in 2016 1.49% increase from 2015 Primary prevention: Use non-pharmacologic therapies and non-opioid medications Reference??

Women of reproductive age who use opioids More than 35% of women of reproductive age with Medicaid and more than 25% of women of reproductive age with private insurance filled a prescription for an opioid Data from the CDC shows that many women between the ages of 15-44 years fill prescriptions for opioids. During 2008–2012, more than one third of Medicaid-enrolled and more than one fourth of privately insured reproductive-aged women (15–44 years) filled a prescription for an opioid from an outpatient pharmacy each year. MMWR. Opioid Prescription Claims among Women of Reproductive Age - United States, 2008-2012. Jan 23, 2015. 64(02); 37-41

Unintended pregnancy Up to 45% of pregnancies are unintended in the United States Almost 86% of pregnancies are unintended among women who use opioids Increased access to contraception is important to reduce neonatal abstinence syndrome (NAS) Heil SH, Jones HE, Arria A, et al. Unintended Pregnancy in Opioid-abusing Women. Journal of Substance Abuse Treatment. 2011;40(2):199-202. Terplan, M, Hand D. J., Hutchinson, M et al. Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review. Preventive Medicine. 80. 23-31

Barriers to OUD treatment in women Legal consequences in seeking treatment High rates of depression, PTSD, anxiety, bipolar and other mental health disorders High rates of family instability High rates of domestic violence Childcare responsibilities Legal consequences in seeking treatment High rates of depression, PTSD, anxiety, bipolar and other mental health disorders High rates of family instability High rates of domestic violence Childcare responsibilities

Neonatal Abstinence Syndrome (NAS) Signs of withdrawal that may occur in a newborn exposed to opioids in utero Up to 50-80% of opioid-exposed infants develop NAS Between 2009-2012, infants diagnosed with NAS increased from 3.4 to 5.8 per 1000 hospital births More than 20,000 infants with NAS in 2012 What is Neonatal Abstinence Syndrome? Signs of opioid withdrawal that may occur in a newborn exposed to opioids in utero Up to 50-80% of opioid-exposed infants develop NAS Between 2009-2012, infants diagnosed with NAS increased from 3.4 to 5.8 per 1000 hospital births More than 20,000 infants were diagnosed with NAS in 2012

SAMHSA Guidelines Available as a PDF https://store.samhsa.gov/product/SMA18-5054 One of many resources used by the CCC to provide consultation Will form the foundation for our discussion today A short statement on how the guidance was developed?

Fact Sheets Mention how fact sheets were developed Evidence based recommendations based on the literature and an expert panel

How to use the fact sheets Each fact sheet consists of The clinical scenario Clinical action steps Supporting evidence and clinical considerations Web resources

Factsheet #1 In the guidance, there are summaries of each fact sheet for your reference too.

Factsheet #1 Prenatal screenings and assessment - Healthcare professionals should ask all pregnant women about their use of alcohol and other substances (i.e., past, present, prescribed, licit, and illicit use) as early as possible in the pregnancy and at every follow- up visit* - Interviews and Instruments- different tools are available (page 19) - Toxicology screens- conduct a baseline test *WHO, Guidelines for the Identification and Management of Substance Use and Substance Use Disorders in Pregnancy, 2014 Screenings - Healthcare professionals should ask all pregnant women about their use of alcohol and other substances (i.e., past, present, prescribed, licit, and illicit use) as early as possible in the pregnancy and at every follow-up visit (WHO, Guidelines for the Identification and Management of Substance Use and Substance Use Disorders in Pregnancy, 2014) Interviews and Instruments—different tools are available which are provided in the manual - Toxicology screens- should be performed as a baseline State-based Prescription Drug Monitoring Program (PDMP) Social, medical, and legal consequences- varies per state

State-based Prescription Drug Monitoring Program (PDMP) Collects data from pharmacies on prescriptions of controlled substances - Can determine if the patient is going to multiple providers to get prescriptions - Can detect use of unreported medications Healthcare professionals should consult their states PDMP for prescription drug use history State’s have different rules on who can access data

Social, Medical and Legal Consequences Pregnant women with OUD receive no, or very little, prenatal care Important to coordinate care between providers Pregnancy is a time of great potential for positive changes – women may be more motivated Women with OUD are at higher risk for HIV/AIDS and viral hepatitis Resource: ASAM Public Policy Statement on Women, Alcohol and Other Drugs, and Pregnancy SAMHSA’s

Factsheet #2

Factsheet #2 Initiating pharmacotherapy for OUD Medication Assisted Treatment (MAT) Methadone or buprenorphine and behavioral interventions Patient education – Explain the risk of NAS No known risk of increased birth defects with pharmacotherapy for OUD Treatment plans need to be individualized Healthcare professionals should educate women about potential legal, social and medical consequences of each treatment option

Resources Substance Abuse Mental Health Services Administration (SAMHSA) Behavioral Health Treatment Services Locator https://findtreatment.samhsa.gov/ Opioid Treatment Program Directory https://dpt2.samhsa.gov/treatment/directory.aspx American Society of Addiction Medicine National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use https://www.asam.org/resources/guidelines-and-consensus-documents/npg SAMHSA has nationwide directories of health care professionals who help people with substance use disorders Pregnant women and new mothers can get treatment at behavioral health treatment centers or opioid treatment programs. Locations can be found in these two web-based resources The American Society of Addiction Medicine National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use

Counseling about NAS risk and prevention Other substances contribute to NAS Encourage quitting tobacco use Encourage avoidance of benzodiazepines Encourage breastfeeding after delivery If not possible, encourage skin-to-skin, rooming in Advise about standards of care in your setting Length of monitoring for NAS? Rooming in? Mother in nursery? Dose of MAT does not predict NAS

Factsheet #4 Managing pharmacotherapy over the course of pregnancy Need for periodic adjustments of pharmacotherapy for OUD Pharmacotherapy dose does not affect NAS Counseling can encourage women to continue treatment and prevent return to substance use Role of peer support specialists A Collaborative Approach to the Treatment of Pregnant women with Opioid Use Disorders (SAMHSA) A pregnant woman will likely need periodic adjustments to the dose of her pharmacotherapy in response to the physiological changes of pregnancy. Metabolism rates increase as the pregnancy progresses Typically doses need adjusting upwards, especially in the third trimester Adjustments in medication should be individualized. Pharmacotherapy doses does not affect the risk of NAS Counseling can encourage and motivate women to continue treatment, enhance coping skills and prevent the risk of return to substance use The women’s care should be coordinated by a team of health care professionals, including physicians, substance use disorder specialists, nurses , case managers and peer recovery coaches A resource available is SAMHSA’s A Collaborative Approach to the Treatment of Pregnant women with Opioid Use Disorders which provides information on treating pregnant women with OUD, summarizes guidelines, and presents a framework for organizing community efforts

Factsheet #3 Changing Pharmacotherapy During Pregnancy Medically assisted withdrawal is not recommended What about changing from buprenorphine to methadone and vice versa? Maintaining stability is key Any change in medication represents a period of vulnerability to return to substance use

Factsheet #5 Addressing co-morbid behavioral health disorders Comorbid behavioral health disorders are common and may require medications Depression and other psychiatric conditions are common among women with OUD Follow SAMHSA’s Screening, Brief Intervention, and Referral to Treatment (SBIRT) Understand possible drug interactions with other medications Comorbid behavioral health disorders are common and may require medications A women with comorbid behavioral health disorders may need to continue other psychiatric medications Depression and other psychiatric conditions are common among women with OUD. Many women with OUD have a history of sexual assault, trauma or domestic violence Follow SAMHSA’s Screening, Brief intervention, and referral to treatment (SBIRT) to screen for depression, anxiety, and tobacco and alcohol use Understand possible drug interactions with other medications

Factsheets #6 and #7 Factsheet #6 Factsheet #7 Addressing polysubstance use during pregnancy Factsheet #7 Planning prior to labor and delivery There are factsheets #6 and #7 which we will not go into today with additional information

Factsheet #8 Peripartum pain relief Pregnant women with OUD need to be assured that they will receive adequate pain relief during labor and postpartum Options include epidural and short acting opioids During labor and delivery, she should be maintained on her current dose of opioid agonist therapy for OUD Pregnant women with OUD need to be assured that they will receive adequate pain relief during labor and postpartum Options include epidural and short acting opioids During labor and delivery, she should be maintained on her current dose of opioid agonist therapy for OUD Her existing opioid agonist dose should not be expected to provide adequate pain relief during or after delivery

Factsheet 11: Breastfeeding Considerations for infants at risk for NAS Women who are stable on MAT should be advised to breastfeed Levels of buprenorphine and methadone are very low in breast milk Healthcare professionals should discuss benefits of breast feeding Any breastfeeding can decrease infants need for pharmacotherapy treatment for NAS Women who are stable on MAT should be advised to breastfeed Levels of buprenorphine and methadone are very low in breast milk Healthcare professionals should discuss benefits of breast feeding Any breastfeeding can decrease infants need for pharmacotherapy treatment for NAS and the length of therapy and hospitalization. May be due to the contact between mother and infant during breastfeeding

Substance Use Warmline: Free clinical consultation on managing substance use in primary care 6 am – 5 pm PST, Monday – Friday 1.855.300.3595 or submit cases online at nccc.ucsf.edu The Clinician Consultation Center is pleased to offer confidential telephone consultation focusing on substance use evaluation and management for primary care clinicians nationally. With special expertise in pharmacotherapy options for opioid use, our addiction medicine- certified physicians, clinical pharmacists, and nurses provide advice based on Federal treatment guidelines, up-to-date evidence, and clinical best practices. Learn more at http://nccc.ucsf.edu/clinician-consultation/substance-use-management/ This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U1OHA30039-01-00 (AIDS Education and Training Centers National Clinician Consultation Center) in partnership with the HRSA Bureau of Primary Health Care (BPHC) awarded to the University of California, San Francisco.