The Opioid Epidemic s Impact on the Most Vulnerable GINA CONNELLY MD TMC OBSTETRICS MEDICAL DIRECTOR; OBSTETRICS SERVICES; TUCSON MEDICAL CENTER

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1 The Opioid Epidemic s Impact on the Most Vulnerable GINA CONNELLY MD TMC OBSTETRICS MEDICAL DIRECTOR; OBSTETRICS SERVICES; TUCSON MEDICAL CENTER

2 Illicit Drug Use in Pregnancy Opioid use during pregnancy has escalated, in parallel with the opioid epidemic in the general population. Pregnant women who use opioids are at increased risk for pregnancyassociated complications and death. Their infants are at risk for Neonatal Abstinence Syndrome 5.4% of pregnant women admit to using one or more illicit drug By age group 15-17: 14.6% 18-25: 8.6% 26-44: 3.2% More women drink alcohol (9.4%) and smoke (15.4%) than all other drugs combined. 90% of women addicted to opioids smoke cigarettes

3 700 Maternal Newborn Substance Dependent Patients Number of Patients Patients Visits Data by Year

4 Illicit Drug Use and Pregnancy A drug s effects on the fetus depend on many things: How much? How often? Fetal response? When during pregnancy was it used? First trimester The early stage of pregnancy is the time when main body parts of the fetus form. Second, Third trimester Interfere with the growth of the fetus Increase preterm birth Increase in fetal death Other confounding factors Other Medical Conditions Social Psychological

5 Lack of Prenatal Care 86% of pregnant opioid using women report pregnancy was unintended Establish late care Missed opportunities for screening, diagnosis, and treatment of pregnancy and medical problems that can improve outcomes for mother and baby Ashamed to seek care Legal ramifications Users may not even realize that they are pregnant Misinterpret early signs of pregnancy as opioid withdrawal Nausea, vomiting, abdominal cramping Pregnant women are typically highly motivated to modify their behavior in order to help their unborn child. In a national survey from the United States, the mean rate of pregnancyrelated abstinence among users of illicit drugs was 57 percent.

6 Opioid Associated Maternal Complications Infections Needle sharing Hepatitis B, C and HIV Bacteremia/Sepsis Cellulitis Endocarditis Sexually transmitted infections HIV, Syphilis, Gonorrhea, Chlamydia

7 Opioid Related Pregnancy Complications 6-fold increase in obstetrical complications Intra-amniotic infection Abruption Fetal passage of meconium 21-46% versus12-13% Premature labor 28% versus 12% Preeclampsia Postpartum hemorrhage Victims of violence

8 Opioid Associated Pregnancy Complications: Fetal Recent study that opioids users had increased risk of congenital heart defects Observational and poor study, no direct evidence Decreased birthweight 2490g versus 3176g Fetal growth restriction Placental Insufficiency Fetal death Stillbirth Miscarriage Neonatal abstinence syndrome (NAS) Drug withdrawal syndrome that opioid-exposed neonates may experience shortly after birth Meconium passage Flucuations in drug level causes placental changes that decrease nutrients to fetus 20% versus 4%

9 AZ: NAS and Other Drug Exposure

10 Neonatal Abstinence Syndrome (NAS): Symptoms Tremors Yawning, stuffy nose, sneezing Irritability(excessive crying) Vomiting Sleep problems Diarrhea High-Pitched cry Dehydration Tight muscle tone Sweating Hyperactive reflexes Fever or Unstable Temperature Seizures Poor feeding and suck

11 Other Drugs with Associated with Neonatal Withdrawal Syndromes SSRI-Poor Neonatal Adaption Syndrome 10-30% chance of symptoms if taken in the last trimester of pregnancy Hesitant breathing at birth Jitteriness Seizures Exaggerated startle reflex Weak cry Increased motor activity Poor self regulation Higher arousal Poor muscle tone Hypoglycemia Jaundice Non-narcotic withdrawal Alcohol, Barbiturates, Benzodiazepines, Hydroxyzine Marijuana No withdrawal but may have long term developmental effects Cocaine Symptoms at birth are of the drug toxicity, withdrawal may come later, usually shorter

12 Withdrawal Scoring Finnegan Neonatal Abstinence Scoring An objective numerical scoring system that permits standardized care if inter-rater reliability is verified Divided into three assessment groupings When an infant scores a certain amount then medication is often initiated As scores stabilize, then the treatment doses are decreased

13 Which infants develop NAS that requires treatment? VARIABLE! If methadone alone: Genetic basis Longer the treatment and the higher the dose may correlate with severity but not predictable If methadone + SSRI or benzodiazepines, Prolong the withdrawal period Early data suggest buprenorphine withdrawal is shorter Heroin withdrawal is shorter than methadone, but the health consequences during pregnancy are worse

14 Long-Term Outcomes Specific long term effects of isolated drugs are difficult to determine due to comorbid substance exposure and also environmental and medical risk factors A variety of results of NAS studies: minimal to no effect greater than the underlying drug use effect during toddlerhood that then resolves persistent effect Motor effects (more tense, less active, and poor coordination) may recover or are more closely correlated to sociodemographic factors (SES status, nutrition-birthweight, head circumference at birth) Behavioral effects include less social responsivity, short attention span, and poor social engagement

15 Beyond the Nursery Infant Discharge Planning All newborns should have a medical home (PCP) determined prior to discharge to allow flow of information on risk status, referrals, and follow up Care-givers with a substance abuse disorder are more likely to perceive care of a child as stressful and miss well child visits Early intervention services can positively impact drug exposed newborns at risk for developmental delay Home nurse visitation programs may reduce encounters for ingestions, injuries, and maltreatment; also can pick up behavioral problems in the children or parental stress

16 Detoxification in Pregnancy Associated with poor neonatal outcomes. Early preterm birth or fetal demise The major reason not to attempt detoxification is that it is generally unsuccessful, Relapse rates of 50% or more. If attempted, it is best to wait until the end of the first trimester Limited data suggest that miscarriage rates may be higher in the first trimester. Robust evidence has demonstrated that maintenance therapy during pregnancy can improve outcomes Opioid use during pregnancy can put infants at risk of Neonatal Abstinence Syndrome Including MAT, prescription opioid use for pain, or non-medical opioid use However, NAS is both expected and treatable, and evidence has shown that it does not lead to long-term complications ACOG continues to recommend use of Medication Assisted Therapy (MAT) as the standard of care during pregnancy for women with opioid use disorders.

17 Opioid Substitution Therapy in Pregnancy Agent Barriers to treatment 1 g heroin Lack of health insurance 80 mg methadone Incarceration 8 mg buprenorphine Advantages Mental Illness Transportation Oral administration Childcare needs Known dose and purity Safe and steady availability Improved maternal/fetal/neonatal outcomes Guilt about the effect of drugs on the fetus Fear of legal consequences Loss of custody of children Opportunity to enter obstetrical care

18 Benefits of Methadone Maintenance Goal of harm reduction, rather than elimination through abstinence. Have been demonstrated in the pregnant population. The average dose needed to achieve clinical stability is between 80 and 120 mg daily. A dose lower than 60 mg is believed to be insufficient to prevent drug-seeking behavior. Due to the physiology of pregnancy, split daily dosing is sometimes recommended Earlier and more-compliant prenatal care Improved nutrition and weight gain Fewer children in the foster system Improved enrollment in substance abuse treatment and recovery programs Remain opiate dependent, but generally become more functional The goal of treatment is to provide sufficient dosing to prevent drug cravings, eliminate illicit use, and keep additional opiates from creating euphoria.

19 Buprenorphine (Subutex) Gaining recognition as a treatment for opioid addiction during pregnancy. Favored over buprenorphine/naloxone (Suboxone) Lack of safety data regarding the combination product May produce maternal and subsequently fetal hormonal changes. Less autonomic withdrawal associated with buprenorphine Buprenorphine demonstrates favorable qualities similar to methadone Decreasing drug cravings with daily dosing Additional benefit of being prescribed by specifically certified physicians as opposed to federally funded clinics. This benefits patient autonomy and opiate maintenance. Controversial as there are many social and mental health benefits that are less available in this model.

20 Comparison of Methadone/Buprenorphine Jones et al, NEJM 2010;363(24):2320 Continued treatment to end of pregnancy NAS Methadone 82% Buprenorphine 67% Buprenorphine needed less morphine: Shorter hospital stay: 10d versus 17.5d Shorter treatment for NAS: 4.1 versus 9.9d The 2010 MOTHER (Maternal Opioid Treatment: Human Experimental Research) Addiction 2012 Nov;107 Suppl 1:1-4 Buprenorphine was associated with Significantly lower doses of morphine for treatment of NAS Shorter duration of treatment Shorter hospital stay than methadone.

21 CASE PRESENTATION A.A. is a 23yo G3P2 at 28 weeks of pregnancy Presents to the Emergency Room Friday evening at 11pm requesting to detox from her heroin addiction Unplanned pregnancy No prenatal care Past medical history includes anxiety and depression for which she stopped her medications when she found out she was pregnant Other children in foster care with a family member

22 PAPN: Polysubstance Abuse in Pregnancy and Newborn Coordinate community resources in Tucson, Arizona Community wide effort to improve patient care in women with polysubstance abuse in pregnancy with focus on opioid addiction Social Services Community Treatment Programs Physicians Pharmacists Successes Community wide drug screening tool Develop protocols for safe transition to methadone/subutex in off hours. Increase communication and entry into community treatment programs and prenatal care Establish neonatal abstinence program

23 PAPN Universal Screening Tool Multiple societies and agencies consider screening for substance abuse a part of complete obstetric care and recommend asking all pregnant women about their use of alcohol and illicit drugs Universal screening In past 12 months, have you used the following? Please include onetime use. Alcohol (beer, wine, liquor) Tobacco (Patch, Vape) Cannabis (marijuana, pot, grass, hash, spice, etc) * Cocaine (coke, crack, etc.) * Prescription stimulants (Ritalin, Concerta, Dexedrine, Adderall, Diet Pills, etc) Yes No Last Used Frequency Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Substance users come from all economic strata, ages and races Methamphetamine (Speed, Crystal Meth, Ice, etc) * Amount used: Never Once or Twice Daily Weekly Monthly Amount used: Ideally, screening is performed at the initial prenatal visit Inhalants (Nitrous oxide, glue, gas, paint thinner, etc) Sedatives or Sleeping pills (Valium, Serepax, Ativan, Xanax, Librium, Rohypnol, GHB, etc) Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Amount used: All Hospitals involved in development Hallucinogens (LSD, Acid, Mushrooms, PCP, Special K, Ecstasy, Molly, Bath Salts, etc) * Street Opioids (Heroin, Opium, etc * Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Amount used: Prescription Opioids (Fentanyl, Oxycodone, [OxyContin, Percocet], Hydrocodone [Vicodin], Methadone, Buprenorphine, etc) * Other Specify Script? Never Once or Twice Daily Weekly Monthly Amount used: Never Once or Twice Daily Weekly Monthly Amount used:

24 Risk Factors for Drug Testing Substance Abuse Indications for testing Positive screening tool Previous positive drug test History of illicit drug use Monitoring compliance with methadone/subutex Pregnancy complications associated with drug use Frequent requests for prescription drugs of abuse Noncompliance with prenatal care

25 Universal Drug Laboratory Testing Generally still not recommended because of the limitations of these tests There is no consensus regarding when drug tests should be used in pregnant women or the best method for analyzing biological samples (urine, blood, hair, saliva) Urine drug testing is the most common Positive tests for illicit drugs can have legal and economic implications. Women should be informed of the potential ramifications of a positive test result and should give informed consent prior to testing Must have a plan to treat Random testing is unethical unless patient: Unconscious Obvious signs of intoxication and testingto provide approprtiate medical interventions Know State requirements for testing and reporting drug test results.

26 ACOG Toolkit on STATE LEGISLATION Pregnant women & drug abuse, dependence and addiction If considering mandatory urine testing, Legislation should specify: Testing is permitted only with the patient s consent and to confirm suspected or reported drug use. Patient consent also applies to testing by hospitals when pregnant women are admitted for labor and delivery. In the Medicaid program, a pregnant woman s eligibility for Medicaid should not be contingent on submitting to a mandatory urine drug test. Similarly, reimbursement for prenatal, labor and delivery care should not be contingent on performance of urine drug testing.

27 Methadone Induction Team Sport Patient agrees to long term treatment program and MAT therapy Physician and Pharmacy team initiate therapy under standardized guidelines Social worker to identify outpatient program Outpatient program facilitates timely admission to care Obstetrical care is instituted All within a limited timeline

28 NASA Neonatal Abstinence Syndrome Annex Separate area of the NICU so sights and sounds can be better regulated according to infant state Parents know they are all in the same situation so less shame is felt A group of nurses who self identified with personal interest in this population Aromatherapy-lavender and peppermint oil Neonatal massage, integration with pediatric therapies Standardized protocol for medical and nutritional management

29 Preventing Pregnancy Risk Associated with Opioids Types of Long Acting Reversible Contraception

30 Postpartum LARC The immediate postpartum period is a particularly favorable time for IUD or implant insertion. 45% of women who planned on an IUD postpartum failed to return for insertion Women who have recently given birth are often highly motivated to use contraception, they are known not to be pregnant, and the hospital setting offers convenience for both the patient and the health care provider. Postpartum LARC is now reimbursed by AHCCCS Not reimbursed by all commercial plans In addition, women are at risk of an unintended pregnancy in the period immediately after delivery. In a study in which women were instructed to abstain from sexual intercourse until 6 weeks postpartum, 45% of participants reported unprotected sex before that time.

31 Parting thoughts.. Opioid abuse in pregnancy is a significant problem affecting 2 patients mother and newborn Developing standardized screening, more cases in pregnancy will be identified and possible intervention started Establishing coordinated referral to treatment and prenatal care can improve outcomes Coordinating community resources will empower us to more efficiently treat the problem Mental health support Emphasis on contraception and planned pregnancy

32 References 1. Gossop M, Green L, Phillips G, Bradley B. Lapse, relapse and survival among opiate addicts after treatment. A prospective follow-up study. Br J Psychiatry. 1989;154: Dashe JS, Jackson GL, Olscher DA, et al. Opioid detoxification in pregnancy. Obstet Gynecol. 1998;92(5): Rementeriá JL, Nunag NN. Narcotic withdrawal in pregnancy: stillbirth incidence with a case report. Am J Obstet Gynecol. 1973;116(8): Zuspan FP, Gumpel JA, Mejia-Zelaya A, et al. Fetal stress from methadone withdrawal. Am J Obstet Gynecol. 1975;122(1): Luty J, Nikolaou V, Bearn J. Is opiate detoxification unsafe in pregnancy? J Subst Abuse Treat. 2003;24(4): Jones HE, O Grady KE, Malfi D, Tuten M. Methadone maintenance vs. methadone taper during pregnancy: maternal and neonatal outcomes. Am J Addict. 2008;17(5): Burns L, Mattick RP, Lim K, Wallace C. Methadone in pregnancy: treatment retention and neonatal outcomes. Addiction. 207;102(2): McCarthy JJ, Leamon MH, Parr MS, Anania B. High-dose methadone maintenance in pregnancy: maternal and neonatal outcomes. Am J Obstet Gynecol. 2005;193 (3 Pt 1): Arunogiri S et al. Managing opioid dependence in pregnancy: a general practice perspective. Aust Fam Physician Oct; 42(10): Baldacchino A. Neurobehavioral consequences of chronic intrauterine opioid exposure in infants and preschool children: a systematic review and meta-analysis. BMC Psychiatry Apr 8; 14: Desai RJ. Increase in prescription opioid use during pregnancy among Medicaid-enrolled women. Obstet Gynecol May; 123(5): Foder A et al. Behavioral effects of perinatal opioid exposure. Life Sci May 28; 104(1-2):1-8. Fullerton CA et al. Medication-assisted treatment with methadone: assessing the evidence. Psychiatr Serv Feb 1; 65(2): Prasad, M. When opiate abuse complicates pregnancy. Contemporary Ob/Gyn. 2014, Feb 1.

33 References 15. Fischer G. Treatment of opioid dependence in pregnant women. Addiction 2000; 95: ACOG Committee on Health Care for Underserved Women, American Society of Addiction Medicine. ACOG Committee Opinion No. 524: Opioid abuse, dependence, and addiction in pregnancy. Obstet Gynecol 2012; 119: Johnson RE, Jones HE, Fischer G. Use of buprenorphine in pregnancy: patient management and effects on the neonate. Drug Alcohol Depend 2003; 70:S Jones HE, Johnson RE, Jasinski DR, et al. Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome. Drug Alcohol Depend 2005; 79: Kakko J, Heilig M, Sarman I. Buprenorphine and methadone treatment of opiate dependence during pregnancy: comparison of fetal growth and neonatal outcomes in two consecutive case series. Drug Alcohol Depend 2008; 96: Jones HE, Kaltenbach K, Heil SH, et al. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med 2010; 363:2320.