# Presentation: 056441

## Welcome

## Training CurriculumBased on TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs

- Module 12: TIP Chapter 13

## Course Goals

- The goals of this training are to...
- Familiarize you with the content of TIP 43; and
- Increase your awareness of issues related to medication-assisted treatment of opioid addiction.

## Module 12:  MAT for Opioid Addiction During Pregnancy

- During this module, you will become familiar with:
- Common medical and obstetrical complications for pregnant patients in MAT;
- Strategies for methadone dosage and maintenance in pregnant patients;
- Issues of postpartum treatment in pregnant patients;
- Use of buprenorphine in pregnant patients;
- Importance of integrated, comprehensive services for pregnant patients; and
- Nutritional issues for pregnant patients in MAT.

## Methadone Maintenanceas Standard of Care

- Methadone has been accepted since the late 1970s to treat opioid addiction during pregnancy.
- In 1998, a NIH consensus panel recommended methadone maintenance as standard of care for pregnant women with opioid addiction.
- Methadone is currently the only opioid medication approved by the FDA for MAT in opioid addicted pregnant patients.

## Methadone Maintenanceas Standard of Care

- Effective medical maintenance treatment with methadone has the same benefits for pregnant patients as for patients in general.
- Methadone reduces fluctuations in maternal serum opioid levels and protects fetus from repeated withdrawal episodes.

## Diagnosing Opioid Addictionin Pregnant Patients

- Many women confuse amenorrhea with infertility.
- Methadone normalizes endocrine function; possible to become unintentionally pregnant early in MAT.
- Opioid addicted women may not acknowledge pregnancy readily, or may misinterpret early pregnancy signs for withdrawal symptoms.
- Pregnant women may sometimes increase their use of illicit opioids to alleviate these symptoms.
- Increased use of illicit opioids doesn’t alleviate perceived withdrawal symptoms; instead, it exposes the fetus to increased opioid serum levels.

## Diagnosing Opioid Addictionin Pregnant Patients

- Diagnosing opioid and other addictions in pregnant women should incorporate information from:
- Medical and substance use histories;
- Physical examinations;
- Drug test reports;
- Observed signs or symptoms of withdrawal;
- Evidence of diseases associated with drug use;
- Poor attendance for prenatal care; and
- Unexplained fetal growth abnormalities.

## Diagnosing Opioid Addictionin Pregnant Patients

- Using an opioid antagonist to diagnose addiction in pregnant women is _absolutely contraindicated_.
- Inducing even mild withdrawal can cause adverse fetal effects.

## Common Medical Complications

- Pregnant women who abuse substances have a greater-than-normal risk of medical complications.
- Monitor regularly for signs of anemia, poor nutrition, increased blood pressure, hyperglycemia, sexually transmitted diseases (STDs), hepatitis, preeclampsia, other complications of pregnancy, or premature labor.
- Prescribed medications other than methadone should be monitored for compliance with usage directions and for adverse effects.

## Common Medical Complications

- Chronic substance use in pregnancy can cause medical complications; including infections.
- Infections can be profoundly harmful to both women and their fetuses if unrecognized and untreated during gestation.
- Hepatitis B and C, bacterial endocarditis, septicemia, tetanus, cellulitis, and STDs are especially frequent.

## Exhibit 13-1:Common Medical Complications

|  |  |  |  |
| --- | --- | --- | --- |
|  |  |  |  |

- Anemia

- Bacteremia/ septicemia

- Cardiac
- disease, esp.
- endocarditis

- Depression
- and other
- mental
- disorders

- Cellulitis

- Edema

- Gestational
- diabetes

- Hepatitis (acute and chronic)

## Exhibit 13-1:Common Medical Complications

|  |  |  |  |
| --- | --- | --- | --- |
|  |  |  |  |

- Exhibit 13-1:Common Medical Complications

- STDs

- Tetanus

- Tuberculosis

- Urinary
- tract
- infections

- Hypertension/
- tachycardia

- Phlebitis

- Pneumonia

- Poor dental
- hygiene

## Common Medical Complications:  Hepatitis B

- Rate of perinatal transmission of HBV ranges from 70-90+ percent; especially if mother has active infection in the third trimester or within 5 weeks postpartum.
- If new mother’s antigen is positive for hepatitis B, neonate should receive both hepatitis B vaccine and hepatitis B immune globulin.
- Rate of perinatal transmission of HCV is lower than that of HBV.

## Common Medical Complications:  Hepatitis C

- Pregnant injection drug users are at high risk for (HCV) and should be screened for anti-HCV antibody.
- Perform HCV RNA testing if anti-HCV antibody test is positive.
- Infants whose mothers have hepatitis C should receive HCV RNA testing along with antibody testing for HCV.
- HCV can be transmitted vertically from mother to fetus.
- Breast-feeding and vaginal delivery do not appear to increase the risk of neonatal HCV infection significantly.
- Available treatments to prevent vertical transmission are limited due to risk of fetal toxicity.

## Common Medical Complications:  HIV/AIDS

- Pregnant women who are opioid addicted and HIV positive present a unique treatment problem.
- In early 1990s, perinatal HIV transmission was 16-25%.
- After the implementation of new guidelines, transmission rates dropped to 5-6%.

## Common Medical Complications:  HIV/AIDS

- Recent rates below 2% when antenatal antiretroviral drugs or AZT combined with
- 	cesarean section.
- AZT prophylaxis reduces risk of perinatal HIV infection, but monotherapy often is inadequate to treat mother’s HIV.
- Combination antiretroviral therapy is now standard of care.

## Common Medical Complications:  HIV/AIDS

- Pregnancy has no effect on HIV progression.
- No increases in birth defects or fetal malformation related to HIV infection.
- Women who are opioid addicted and HIV infected should receive additional counseling and support during postpartum period.
- Breast-feeding by HIV-infected women has been associated with an increased risk of HIV transmission and should be discouraged.

## Common Obstetrical Complications

- Obstetrical complications in pregnant women who are opioid addicted are the same as those seen at increased rates in all women who lack prenatal care.
- When obstetrical complications are confirmed, standard treatments, including use of medications to arrest preterm labor, can be initiated safely.

## Exhibit 13-3:Common Obstetrical Complications

|  |  |  |  |
| --- | --- | --- | --- |
|  |  |  |  |

- Abruptio
- placentae

- Chorio-amnionitis

- Intrauterine
- death

- Intrauterine
- growth
- retardation

- Intrauterine
- passage of
- meconium

- Low Apgar
- scores

- Placental
- insufficiency

- Postpartum hemorrhage

## Exhibit 13-3:Common Obstetrical Complications

|  |  |  |  |
| --- | --- | --- | --- |
|  |  |  |  |

- Pre-
- eclampsia

- Premature
- labor/ delivery

- Premature
- rupture of
- membranes

- Septic
- thrombo-phlebitis

- Spontaneous
- abortion

## Methadone Treatment

- Pharmacology of methadone in pregnant women has been evaluated thoroughly.
- As pregnancy progresses, the same methadone dosage produces lower blood methadone levels, due to increased fluid volume, a larger tissue reservoir for methadone, and altered opioid metabolism in both the placenta and fetus.

## Methadone Treatment

- Women often experience symptoms of withdrawal in later stages of pregnancy.
- Dosage increases are required to maintain blood levels of methadone and avoid withdrawal symptoms.
- Daily dose can be increased and administered singly or split into twice-daily doses.

## Methadone Treatment

- Treatment providers have based dosing on the need to reduce neonatal abstinence syndrome (NAS).
- This low-dose approach has been contradicted by recent studies.
- Higher dosages have been associated with increased weight gain, decreased illegal drug use, improved compliance with prenatal care.
- Reduced methadone dosages may result in continued substance use and increase risks to both expectant mothers and their fetuses.

## Methadone Treatment:Induction and Stabilization

- Women who received methadone before pregnancy should be maintained initially at prepregnancy dosage.
- Pregnant women who were not maintained on methadone should be inducted either in an outpatient setting or admitted to a hospital.

## Methadone Treatment:Induction and Stabilization

- For induction in an outpatient setting, give initial methadone doses of 10 to 20 mg per day, based on a patient’s opioid use history.
- Patient returns at the end of the day for followup evaluation, and initial dose may be followed by regular adjustments of 5 to 10 mg based on therapeutic response.

## Methadone Treatment:Induction and Stabilization

- Twice daily observation should continue until patient is stabilized.
- If evidence of intoxication or withdrawal emerges, adjust patient’s dosage immediately.
- Most patients are stabilized within 48 to 72 hours.
- In outpatient settings, fetal monitors are usually unavailable; crucial that patients record fetal movement at set intervals.

## Methadone Treatment:Split Dosing

- Split-dosing methadone regimens are accepted widely for pregnant patients, but little empirical investigation has been done regarding its effects on fetuses or maternal plasma levels.

## Methadone Treatment:Managing Polysubstance Use 

- Many pregnant women continue to use substances.
- Essential to monitor patients for use of licit and illicit drugs and alcohol to manage perinatal care.
- Polysubstance use is a special concern during pregnancy because of adverse effects and the serious maternal and fetal health risks from continued substance use and lack of adequate prenatal care.

## Management of Acute OpioidOverdose in Pregnancy

- Opioid overdose in pregnancy threatens pregnant women and their fetuses.
- Naloxone should be given to pregnant patients only as a last resort.
- Administer naloxone intravenously (0.01 mg/kg of body weight) after an airway is established.
- Additional naloxone doses may be given every 5 minutes after patient regains consciousness.

## Management of Acute OpioidOverdose in Pregnancy

- Naloxone’s duration of action is 30 minutes to 2 hours, depending on dose and type of substance used.
- Continue administering naloxone at intervals until effects of illicit opioids markedly diminish; this may take 2-3 days.
- Special care needed to avoid acute opioid withdrawal, which can harm fetus.
- Titrate naloxone dose against withdrawal symptoms and use short-acting opioid to reverse acute withdrawal symptoms.

## Managing WithdrawalFrom Methadone

- Medically supervised withdrawal (MSW) not recommended for pregnant women.
- Conduct thorough assessment, because procedure frequently results in relapse. Appropriate MSW patients:
- Live where methadone maintenance is unavailable;
- Have been stable in MAT and request MSW before delivery;
- Refuse to be maintained on methadone; and
- Plan to undergo MSW through structured treatment program.

## Managing WithdrawalFrom Methadone

- Withdraw from methadone only under supervision by physician experienced in perinatal addiction treatment.
- Patient should receive fetal monitoring.
- MSW usually is conducted in second trimester; danger of miscarriage may increase in first trimester and danger of premature delivery or fetal death may increase in third trimester.

## Managing WithdrawalFrom Methadone

- If MSW undertaken, methadone should be decreased by 1.0 to 2.5 mg per day (inpatient) and by 2.5 to 10.0 mg per week (outpatient).
- Fetal movement should be monitored twice daily in outpatient MSW, and stress tests should be performed at least twice weekly.
- MSW should be discontinued if it causes fetal stress or threatens to cause preterm labor.

## Postpartum Treatmentof Mothers in MAT

- Current treatment practices include continuing methadone after delivery at dosages similar to those before pregnancy.
- For women who began methadone maintenance during pregnancy, continue treatment at approximately half the dosage received in the third trimester.
- No empirical data to support these approaches; any decrease should be based on signs of overmedication, withdrawal symptoms, or patient blood plasma levels.

## Breast-Feeding

- Mothers maintained on methadone can breast-feed if they are not HIV positive, not abusing substances, and do not have a disease or infection in which breast-feeding is contraindicated.
- Hepatitis C no longer considered a contraindication for breast-feeding.
- Studies have found minimal transmission of methadone in breast milk regardless of maternal dose.

## Effects on Neonatal Outcome:  NAS

- Infants prenatally exposed to opioids have high incidence of neonatal abstinence syndrome (NAS).
- NAS characterized by hyperactivity of central and autonomic nervous systems; reflected in changes in gastrointestinal tract and respiratory system.
- NAS babies often suck frantically on fists or thumbs but may have extreme difficulty feeding.
- Withdrawal symptoms begin minutes or hours after birth to 2 weeks later; most appear within 72 hours.
- Preterm infants have milder symptoms, delayed onset.

## Effects on Neonatal Outcome:  NAS

- Many factors influence NAS onset, including:
- Types of substances used by mothers;
- Timing and dosage of methadone before delivery;
- Characteristics of labor;
- Type and amount of anesthesia or analgesic during labor;
- Infant maturity and nutrition;
- Metabolic rate of the infant’s liver; and
- Presence of intrinsic disease in infants.

## Effects on Neonatal Outcome:  NAS

- NAS may be mild and transient, delayed in onset or incremental in severity, or biphasic in its course; including acute neonatal withdrawal signs followed by improvement and then onset of subacute withdrawal.
- Other conditions may mimic NAS.
- To rule out such conditions, infants suspected of having NAS should have complete blood cell count with differential, electrolyte and calcium levels, comprehensive neurological consultation, and head ultrasound if indicated.

## Effects on Neonatal Outcome:  NAS

- Abstinence scoring system should be used to monitor opioid-exposed newborns to assess onset, progression, and diminution of symptoms.
- The Neonatal Abstinence Score is used widely to estimate NAS severity and determine whether pharmacotherapy is needed.
- Infants should be scored every 4 hours.
- Control achieved when Neonatal Abstinence Score is less than 8, infants exhibit rhythmic feeding and sleep cycles, and have optimal weight gains.

## Effects on Neonatal Outcome:  NAS

- If pharmacological management is indicated, treat with neonatal opioid solution in 6-8 divided doses, timed with feeding schedule.
- Dosage should be increased as needed until control achieved or maximum dosage is reached.
- If Neonatal Abstinence Scores remain high but daily doses approach the maximum, infant’s symptoms should be reassessed and concurrent pharmacotherapy with Phenobarbital considered.
- When control is achieved, dosage should be continued for 72 hours before pharmacological weaning begins.

## Maternal Methadone Dosageand Extent of NAS

- The relationship between maternal methadone dosage and NAS has been difficult to establish.

## Perinatal Outcomes

- Early research on intrauterine growth of infants is inconsistent.
- Some studies found reduced fetal mortality and greater birth weights for infants of women maintained on methadone whereas others found no differences.
- Researchers investigating neurobehavioral characteristics in newborns undergoing opioid withdrawal consistently found differences in behavior between these infants and infants born to women not opioid addicted.
- These infants frequently difficult to nurture, causing poor mother–infant bonding.

## Developmental Sequelae

- Research on developmental sequelae associated with in utero methadone exposure found that infants through 2-year-olds function well within normal developmental range.

## Use of BuprenorphineDuring Pregnancy

- Buprenorphine use not approved in U.S., but may be used in pregnant patients under certain circumstances.
- Consensus panel recommends buprenorphine be used only when physician believes potential benefits justify risks.
- Such patients may continue on buprenorphine with careful monitoring.

## Use of BuprenorphineDuring Pregnancy

- Potential candidates for buprenorphine include:
- Women who are opioid addicted but cannot tolerate methadone;
- Those for whom program compliance has been difficult; or
- Those who are adamant about avoiding methadone.

## Use of BuprenorphineDuring Pregnancy

- In such circumstances, patient's medical record should clearly document that she:
- Has refused methadone maintenance treatment or such services are unavailable;
- Has been informed of risks of using buprenorphine, which has not been thoroughly studied in pregnancy; and
- Understands these risks.

## Use of BuprenorphineDuring Pregnancy

- When treating pregnant patients, providers should use buprenorphine monotherapy tablets (Subutex®).
- Patients already maintained on buprenorphine-naloxone combination tablets, who become pregnant, can be transferred directly to buprenorphine monotherapy tablets.

## Buprenorphine Effects on NAS

- A study reviewed 21 reports of buprenorphine use during pregnancy; most from Europe.
- NAS was reported in 62 percent of ~309 infants exposed to buprenorphine
- 48 percent of those required treatment, 40 percent were confounded by other drug use.
- Infants born to women receiving methadone, or comprehensive prenatal care plus buprenorphine, had improved birth outcomes.

## Buprenorphine Effects on NAS

- Buprenorphine-associated NAS generally appears within 12-48 hours, peaks at 72-96 hours, and lasts 120-168 hours
- Some reports indicated buprenorphine-related NAS lasting 6-10 weeks.
- Buprenorphine-associated NAS less intense than that associated with methadone.

## Breast-FeedingDuring Buprenorphine Treatment

- Research indicates that only small amounts of buprenorphine pass into breast milk.
- These data are inconsistent with product labeling, which advises against breast-feeding.
- Based on research data, particularly findings that buprenorphine is likely to be poorly absorbed by infants orally, it is recommended that women maintained on buprenorphine be encouraged to breast-feed.

## Importance of Integrated, Comprehensive Services

- Comprehensive treatment services address physiological and psychological effects of substance use and psychosocial factors.
- Services should eliminate substance use, develop personal resources, improve family and interpersonal relationships, eliminate socially destructive behavior, and help new parents cope.
- Integrated services should be woman centered and directly address traumatic events.

## Psychosocial Barriers

- Women addicted to opioids typically face financial, social, and psychological difficulties that affect options and treatment progress.
- Histories of negative experiences with legal system or children’s protective services, and guilt and shame, coupled with low self-esteem and self-efficacy, produce difficult behaviors.
- Care should be provided in gender-specific, nonpunitive, nonjudgmental, nurturing manner, with attention to patient’s fears and cultural beliefs.

## Contingency ManagementTreatment Strategies

- Contingency management strategies effective in treating a range of substance use disorders.
- Voucher-based reinforcement therapy effective in increasing abstinence, strengthening behaviors.
- Evidence indicates that positive-contingency rewards can improve pregnancy outcomes.
- Many pregnant women who receive MAT discontinue treatment prematurely.
- For pregnant women maintained on methadone, escalating reinforcement procedures decreased substance use, increased outpatient attendance.

## Nutrition Assessment, Counseling, and Assistance

- People with substance use disorders often are poorly nourished.
- Other lifestyle factors associated with substance use play a significant role, including poverty, poor eating and exercise habits, lack of concern about nutrition and health, and diets restricted by physiological conditions.

## Nutrition Assessment, Counseling, and Assistance

- Pregnant patients in MAT should receive:
- An assessment of nutritional status, eating habits, and weight;
- Education on appropriate diet and weight;
- Counseling;
- Supplemental nutrients when nutritional needs cannot be met by diet changes; and
- Information and referral to food assistance programs.

## Nutritional Education for Pregnant Patients in MAT

- Encourage wholesome, well-balanced diets consistent with ethnic or cultural backgrounds,financial situations.
- American Dietetic Association refers inquirers to registered dietitians in the area (800-366-1655 or www.eatright.org).
- “Pregnancy and Nutrition” is a pamphlet from National Women’s Health Information Center (www.4women.gov/faq/preg-nutr.htm).
- U.S. Department of Agriculture’s survey forms (www.barc.usda.gov/bhnre/foodsurvey).

## Food Program Assistance for Pregnant Patients in MAT

- Pregnant women in MAT who are nutritionally at risk or financially needy may be eligible for supplemental food assistance.
- School-age children also may qualify for breakfast, lunch, and summer food programs.
- OTP counselors should be familiar with services and requirements of each type of program, make appropriate referrals.
- Browse these websites for further information:
- www.fns.usda.gov/wic; or www.nal.usda.gov/wicworks.

## Jeopardy Review!

** **

## Jeopardy Review!

**1.1  This medication has been accepted since the late 1970s to treat opioid addiction during pregnancy. ****(Page 211)**

## Jeopardy Review!

**1.2 What is methadone?**

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**2.1 Using this type of drug to diagnose addiction in pregnant women is *****absolutely contraindicated*****. ****(Page 212)**

## Jeopardy Review!

**2.2 What is an opioid antagonist?**

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**3.1 Hepatitis B and C, septicemia, tetanus, cellulitis and this infection are especially frequent in pregnant women. ****(Page 212)**

## Jeopardy Review!

**3.2 What is bacterial endocarditis?**

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**4.1 If a new mother is antigen positive for this infection, her newborn should receive both vaccine and immune globulin. ****(Page 213)**

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**4.2 What is hepatitis B?**

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**5.1 The rates of perinatal transmission of this virus are lower than that of hepatitis B. ****(Page 213)**

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**5.2 What is hepatitis C?**

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**6.1 Recent studies find perinatal transmission rates for this virus below 2% when antenatal drugs are combined with****C-section. ****(Page 214)**

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**6.2 What is HIV?**

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**7.1 HIV-infected women engaging in this activity has been associated with increased risk of HIV transmission to their babies and should be discouraged. ****(Page 215)**

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**7.2 What is breast-feeding?**

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**8.1 Obstetrical complications in pregnant women who are opioid addicted are the same as those seen in all women who lack this type of care. ****(Page 215)**

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**8.2 What is prenatal care?**

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**9.1 Pregnant women often require dosage increases to maintain blood levels of this drug to avoid withdrawal symptoms. ****(Page 216)**

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**9.2 What is methadone?**

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**10.1 Postpartum, women who received methadone before pregnancy should be maintained initially at this therapeutic level. ****(Page 216)**

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**10.2 What is their prepregnancy dosage?**

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**11.1 In outpatient settings, this equipment is usually unavailable, so it is crucial that patients record fetal movement at set intervals. ****(Page 217)**

## Jeopardy Review!

**11.2 What are fetal monitors?**

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**12.1 It is essential that patients be monitored for use of these substances to appropriately manage the perinatal care of both mothers and infants.****(Page 217)**

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**12.2 What are drugs and alcohol?**

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**13.1 Opioid overdose in pregnancy threatens pregnant women and their fetuses. This medication should be given to pregnant patients only as a last resort. ****(Page 217)**

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**13.2 What is naloxone?**

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**14.1 Although medically-supervised withdrawal is not recommended for pregnant women, it can be attempted in this trimester. ****(Page 218)**

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**14.2 What is the second trimester?**

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**15.1 This type of movement should be monitored twice daily throughout medically supervised withdrawal. ****(Page 218)**

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**15.2 What is fetal movement?**

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**16.1 This virus is no longer considered a contraindication for breast-feeding. ****(Page 218)**

## Jeopardy Review!

**16.2 What is****hepatitis C?**

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**17.1 Studies have found minimal transmission of this medication in breast milk regardless of maternal dose.****(Page 218)**

## Jeopardy Review!

**17.2 What is methadone?**

## Jeopardy Review!

**18.1 Infants prenatally exposed to opioids have a high incidence of neonatal abstinence syndrome, characterized by hyperactivity of these systems. ****(Page 218)**

## Jeopardy Review!

**18.2 What are the central and autonomic nervous systems?**

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**19.1 This instrument is widely used to estimate NAS severity and determine whether pharmacotherapy is needed. ****(Page 219)**

## Jeopardy Review!

**19.2 What is the Neonatal Abstinence Score?**

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**20.1 This medication has not been approved for use in pregnant women in the U.S., although it may be used under certain circumstances. ****(Page 220)**

## Jeopardy Review!

**20.2 What is buprenorphine?**

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**21.1 Many women receiving compre-hensive prenatal care plus buprenorphine experienced this type of outcome. ****(Page 221)**

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**21.2 What is an improved birth outcome?**

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**22.1 Buprenorphine-associated NAS was found to be less intense than that associated with this medication. ****(Page 221)**

## Jeopardy Review!

**22.2 What is methadone?**

## Jeopardy Review!

**23.1 Because buprenorphine is likely to be poorly absorbed by infants orally, women taking buprenorphine are encouraged to engage in this activity with their babies. ****(Page 222)**

## Jeopardy Review!

**23.2 What is breast-feeding?**

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**24.1 Comprehensive treatment services are needed for women, including individual, group, and this type of therapy. ****(Page 222)**

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**24.2 What is family therapy?**

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**25.1 Evidence indicates that these types of rewards for abstinence or treatment attendance can improve pregnancy outcomes. ****(Page 223)**

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**25.2 What are positive-contingency rewards?**

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**26.1 Pregnant patients in MAT should receive information and referral to these types of programs. ****(Page 224)**

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**26.2 What are food assistance programs?**

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**27.1 This U.S. department has created a survey to ascertain respondents’ knowledge of nutrition. ****(Page 224)**

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**27.2 What is the U.S. Department of Agriculture?**

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**28.1 Pregnant women in MAT who are nutritionally at risk or financially needy may be eligible for this type of assistance. ****(Page 224)**

## Jeopardy Review!

**28.2 What is supplemental food assistance?**

## Training CurriculumBased on TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs

- Module 12: TIP Chapter 13