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PROJECT DOVEImproving Maternal and Neonatal Health
Through Safer Opioid Prescribing
MODULE 1
Bureau of Justice Assistance,Department of JusticeGrant # PM-BX-Koo4
Partners
Support
1Understanding Opioid Issues in Pregnancy
MODULE
Help patients to understand the implications of opioidsfor chronic pain in pregnancy
Identify ethical and legal considerations related to opioid use disorder and its treatment among pregnant patients
Evaluate pharmacological treatment options for opioid use disorder among pregnant patients
Module 1 provides youwith information and tools to:Learning Objectives
This symbol indicates that the documents referenced are available for download in the Resources section of the online course:
www.brown-cme.com/opioids-pregnancy
Downloadable Resources
Pharmacology of Opioids
Natural—Alkaloids contained in the resin of the opium poppy (e.g., morphine, codeine)
Semi-synthetic—Created from either the natural opiates or morphine esters (e.g., hydromorphone, hydrocodone, oxycodone, buprenorphine)
Synthetic—Fully synthetic (e.g., fentanyl, meperidine, methadone)
Opioids can be categorized as
principal classes of opioid receptors
Opioids that bind to the μ (mu) receptors mediate the reinforcing properties of many drugs.
The receptor is responsible for both the therapeutic (analgesia) and adverse (sedation, respiratory depression, euphoria) effects of opioids.
Opioids bind to specific opioid receptors in the nervous system and other tissues
3 μ (mu)κ (kappa)δ (delta)
Full agonists
interact with receptors
to produce a response
(e.g., morphine,
oxycodone, methadone)
Partial agonists
bind to receptors but
produce only a partial
response, resulting in
a ceiling effect
(e.g., buprenorphine)
Antagonists
bind to receptors but
produce no functional
response and prevent
an agonist from binding
to and activating
the receptor
(e.g., naloxone,
naltrexone)
Affinity Zone
Activity Zone
receptor
Full Agonist
Partial Agonist
Antagonist
receptorreceptor
Opioid agonists and antagonists interact in differing ways with opioid receptors
Physical dependence
The need to keep taking a drug to avoid withdrawal symptoms.
Opioid use disorder
A problematic pattern of opioid use leading to clinically significant impairment or distress.
Opioid use disorder
is distinct from physical
dependence, which is an
expected consequence
of regular opioid use
Neurobiologic path to opioid use disorder
Activation of the mu receptor in the midbrain reward center releases dopamine, encoding a powerful positive association.
The brain’s reward system becomes desensitized to stimulation as tolerance develops. Larger doses are necessary to experience the same effects.
Volkow et al., 2016
Opioid Use DisorderOpioid Use Disorder
Opioid use disorder (DSM-5) is a problematic pattern of opioid use leading to clinically significant impairment or distress as manifested by
At least 2 of the following 11occurrences in a 12-month period
Opioid Use DisorderOpioid Use Disorder
21
43
Taking the opioid in larger amounts and for longer than intended
Wanting to cut down or quit but not being able to do it
Spending a lot of time obtaining opioids
Craving or a strong desire to use opioids
Opioid Use DisorderOpioid Use Disorder
65
87
Repeatedly unable to carry out major obligations at work, school, or home due to opioid use
Continued use despite persistent or recurring social or interpersonal problems caused or made worse by opioid use
Stopping or reducing important social, occupational, or recreational activities due to opioid use
Recurrent use of opioids in physically hazardous situations
Opioid Use DisorderOpioid Use Disorder
109
11
Consistent use of opioids
despite acknowledgment of
persistent or recurrent physical
or psychological difficulties
from using opioids
Tolerance for opioids
This criterion is not considered to be met for those individuals taking opioids solely under appropriate medical supervision.
Withdrawal symptoms when opioids are not taken
This criterion is not considered to be met for those individuals taking opioids solely under appropriate medical supervision.
Opioids During Pregnancy
Chronic opioid use has potential to suppress ovulation, reducing fertility.
Unintended pregnancy is still a key concern. Discussion of contraception is a necessity with women on opioid therapy or using illicit opioids.
Ovulation Suppression
Preconception
Daniell 2008; Vuong et al., 2010
Timing of exposure to substances is relevant
Embryo, weeks 5–10Most susceptible to teratogenesis. Major malformations usually result in miscarriage.Many women do not know they are pregnant and/or do not seek care during this time.
Fetus, weeks 11–40Few major malformations during this time. Generalized growth impairment can occur with substance use.
Fetal Risks
Teratogenic Effects
Broussard et al., 2011; Yazdy et al., 2013
Teratogenic Effects
Limited evidence; retrospective recall studies
For comparison:
Risk of neural tube defects in first trimester exposure to valproate is 1 in 20
Risk of Downs syndrome with advanced maternal age is 60 in 10,000
Several studies have found prescribed opioids in the first trimester are associated with increased risk of congenital heart defects orneural tube defects.
Absolute risk is small: for example, risk of hypoplastic left heart syndrome and neural tube defects is 6 in 10,000.
Higher quality studies are needed to assess individual opioids, duration, and dosage.
Multiple confounding factors limit ability to isolate effects of opioids.
Kocherlakota, 2014 ; Desai et al., 2015; Jones et al., 2010; Kellogg et al., 2011
NAS, a constellation of symptoms associated with opioid withdrawal, will develop in manyneonates exposed to chronic licit and illicit opioids in utero.
Prevalence is low in chronic opioids for pain (2–6%), higher in opioid agonist therapy (methadone, buprenorphine) for opioid use disorder (47–57%) and for illicit opioid use (40–80%).
Presence of additional risk factors (e.g., smoking) contribute to increased risk.
Fetal and Neonatal Risks
Neonatal Abstinence Syndrome
(NAS)
NAS is an expected and treatable condition that follows prenatal exposure to opioid agonists and requires collaboration with the pediatric care team.
NAS is addressed in Module 3
Neonatal Abstinence Syndrome
The transfer of prescription opioids into breast milk is low, 2–4% of the weight-adjusted maternal dose for methadone.
Recommendations of lactation, addiction, public health, and other associations support breastfeeding for most patients on opioid agonist therapy.
Presence in Breast Milk
Infancy and Breastfeeding
Exceptions: Women who are HIV positive, using illicit drugs, or prescribed contraindicated drugs
ACOG, 2012; Bogen et al., 2011; Jansson et al., 2009; Sachs, 2013
Patient Cases
Brief history
▪ Pregnant; estimated 12 weeks gestation
▪ Spinal fusion following car crash, treated with oxycodone 15 mg bid for 6 months
▪ No prior history of substance use disorder; family history of alcohol use disorder
▪ No apparent signs of nonmedical oxycodone use in records
▪ Moderate depression and anxiety treated with sertraline
▪ Other meds: gabapentin, prn acetaminophen
Purpose of visit
▪ Positive home pregnancy test
PATIENT 1
Carol
Age 27
Recently transferred patient from a retired colleague
Treating Carol
Carol’s pregnancy is an opportunity to reassess and make a decision about the continued use of opioid therapy.
The American Pain Society and American Academy of Pain Medicine recommend minimal or no use of opioids during pregnancy unless benefits outweigh risks (e.g., severe pain only responsive to opioids).
Individual decisions should be based on a variety of clinical and patient factors.
biofeedback
counseling (e.g., cognitive behavioral therapy)
physical therapy
regional nerve blocks
spinal manipulation
acupuncture
exercise (e.g., yoga, water exercise)
massage
relaxation techniques
Non-pharmacological
treatments
Chou & Huffman, 2007; Close et al., 2014
Evidence of effectiveness exists for nonpharmacological treatments for many conditions (e.g., low back pain)
What can you offer a pregnant patient with chronic pain?
Acetaminophen
Considered safe throughout pregnancy;should be taken at the lowest doses and shortest duration possible.
Salicylate
Low-dose aspirin generally considered safe throughout pregnancy.
NSAIDs
Considered safe in second trimester. First trimester risk of miscarriage; third trimester risk of premature closure of ductus arteriosus, fetal nephotoxicity, and intraventricular hemorrhage.
Over-the-counter
analgesics
Pritham et al., 2014
Gapabentin
Considered relatively safe during pregnancy.
Tramadol
Not a first-line option in pregnancy and should be avoided in patients with pre-eclampsia and eclampsia or taking SSRIs.
Prescribedanalgesics
Beakley et al., 2015; Carrasco et al., 2015; Hartenstein et al., 2010
Medication for Depression or AnxietyCan provide analgesic benefit.
Neonatal withdrawal can occur with prenatal exposure to gabapentin or tramadol.
Considered an option for severe pain during pregnancy with discussion of the risks.
Ask women of childbearing age about their pregnancy intentions and contraceptive use prior to initiating chronic opioid therapy.
Educate on risks of opioids and smoking. Smoking increases NAS treatment duration and amount of medication.
Opioids
Medications in Pregnancy and Lactation
Resources
National Library of MedicineFree, regularly updatedwww.toxnet.nlm.nih.gov
ReprotoxSubscription. Free to students, residents, fellows www.reprotox.org
Organization of Teratology Information Specialists (OTIS) www.otispregnancy.org
Texas Tech UniversityMedications in Lactationwww.infantrisk.com
The balance of benefits to
harms is relatively close
when treating chronic
pain with opioids.
Clinicians should approach the
initial use of opioids for chronic
pain as a time-limited
therapeutic trial (e.g., 1 month).
The decision to continue opioids should be based on an assessment of the 6 A’s:
Analgesia
Affect (e.g., depression, anxiety)
Activities of daily living
Adjuncts
Adverse effects
Aberrant drug-related behaviors
www.pcss-o.org
Shared Decision-MakingCarol was assessed as low risk with no signs of nonmedical Rx drug use. Her clinician should engage her in a shared decision-making process that includes discussion of:
▪ Current clinical recommendations
▪ Nonpharmacological treatment options
▪ Stability and level of functioning with and without opioids
▪ Personal concerns and preferences
If Carol decides to discontinue opioid therapy, she should be informed about the importance of tapering with medical guidance and frequent follow-up. The second trimester is considered the optimal time to taper.
Treating Carol
Given Carol’s individual history, there is no definitive decision about whether to taper off opioid therapy.
Maintain
FunctioningCarol has previous evidence of improved function, but current functional goals need to be reassessed.
RisksThe dose Carol is taking is relatively low.
Carol is at the end of the first trimester.
Carol is assessed as being at low risk with no signs of nonmedical prescription drug use.
PATIENT 1
Carol
What information might be useful for treating Carol?
Given Carol’s individual history, there is no definitive decision about whether to taper off opioid therapy.
Taper
RecommendationsThe American Pain Society and American Academy of Pain Medicine recommend minimal or no use of opioids during pregnancy unless benefits outweigh risks (e.g., severe pain only responsive to opioids).
AlternativesEvidence on long-term efficacy of opioids for back pain and many other conditions is very limited, and nonpharmacological treatments and nonopioid analgesics may be effective alternatives.
PATIENT 1
Carol
What information might be useful for treating Carol?
Which factors should be considered in decisions about whether to continue opioid therapy for chronic pain? (check all that apply)
Check Your Learning
Clinical recommendations related to pregnancy
Patient stability, function, and apparent nonmedical use
Alternative treatment options, and patient preference
All of the above
A
B
C
D
Check Your Learning
AllTrue
Which factors should be considered in decisions about whether to continue opioid therapy for chronic pain? (check all that apply)
Clinical recommendations related to pregnancy
Patient stability, function, and apparent nonmedical use
Alternative treatment options, and patient preference
All of the above
A
B
C
D
Brief history
PATIENT 2
Sarah
Age 28
New OB/GYN patient
▪ Pregnant; estimated 8 weeks gestation
▪ History of heroin use; on methadone for 2 years; relapse 8 months ago but resumed methadone treatment, 90 mg
▪ HCV+, viral load undetectable
▪ Moderate depression treated with sertraline
▪ Smoking hx: Prior 1ppd; quit at pregnancy test 3 weeks ago; using nicotine gum
▪ Positive home pregnancy test
▪ Would like to discontinue methadone out of concern for the fetus
Purpose of visit
Treating Sarah
Sarah is concerned for the health of her baby.
A robust body of evidence exists, however, for maintaining methadone during pregnancy and discontinuation is not recommended.
This is a good opportunity to discuss:
▪ Reasons for the recommendation that she stay on methadone
▪ Supports she needs to remain abstinent from illicit opioids
▪ Smoking cessation supports
▪ Health actions she can take to improve outcomes (e.g., nutrition, prenatal care)
Methadone
Buprenorphine
and
medications are
available to treat
opioid use disorder
during pregnancy
NOT Recommended
Fetal/neonatal relapse risks growth restriction, abruption, preterm labor, meconium passage, hypoxic-ischemic brain injury
Maternal relapse riskshepatitis C, endocarditis, opioid overdose
Discontinueopioid agonist therapy?
Discontinuing opioid agonist therapy is associated with high illicit opioid relapse rates: 44-57% after detoxing from methadone in pregnancy
Discontinuing raises additional concern: fetal withdrawal stress is difficult to monitor and treat
Burns et al., 2007; Fajemirokun-Odudeyi et al., 2006; Jones et al., 2008; Kaltenbach et al., 1998; Stewart et al., 2013
Prevents erratic maternal opioid levels, which lessens fetal exposure to repeated withdrawal (cycling)
May help patients avoid risky behaviors related to illicit substance use
RECOMMENDEDInitiate/maintainopioid agonist therapy?
Gerstein, 1991; Kaltenbach et al., 1998
Increases participation in prenatal care and services
Reduces maternal drug craving
What should clinicians know about methadone?
An exemption exists if a patient requires hospitalization. In such cases an arrangement must be made before discharge for next day admission to an opioid treatment program
Initiating Treatment
A physician cannot prescribe methadone for opioid use disorder outside of an opioid treatment program
Initiation in pregnancy is often done in a controlled inpatient setting
Protocols exist for inpatient and outpatient initiation with pregnant women (ASAM National Practice Guideline)
Pregnant patients need an adequate methadone dosage that prevents opioid withdrawal and also blocks the euphoric effect of other opioids.
Methadone Dosage
An inadequate maternal methadone dosage may cause fetal stress and increased likelihood for the maternal use of illicit drugs.
The incidence and severity of NASdoes not differ based on the maternal dosage of methadone treatment.
Cleary et al., 2010; Jones et al., 2013 & 2014
The dosage should be adjusted throughout the pregnancy to avoid withdrawal symptoms.
Pharmacokinetic changes such as accelerated metabolism and the increased volume of distribution are likely to require dosage increases, especially in the third trimester.
Dosage Adjustment
Withdrawal symptoms include abdominal cramps, nausea, insomnia, irritability, and anxiety
For many pregnant women, metabolic changes make it difficult to control withdrawal symptoms for 24 hours on a single daily dose; in these cases split dosing (dosing 2 or more times a day) reduces fetal/maternal exposure to withdrawal and may reduce NAS.
Opioid treatment programs need to make special arrangements to provide split dosing.
Split Dosing
McCarthy et al., 2015
What should clinicians know about buprenorphine?
Evidence and current clinical guidelines support the use of buprenorphine as a first-line medication for pregnant patients who are
new to treatment for opioid use disorder
already on buprenorphine before becoming pregnant
Should buprenorphine be prescribed to pregnant patients?
ACOG, 2017 ; Minozzi et al., 2013; WHO, 2014
Buprenorphine is prescribed in office-based settings, and is also available in many opioid treatment programs.
Amount of training required for a waiver to prescribe:
Buprenorphine Prescribers
Physicians 8 hours
24 hoursNurse practitionersPhysicians’ assistants
The Substance Abuse and Mental Health Services Administration provides a number of resources:
A directory of practitioners with buprenorphine waivers who have agreed to be listed:
https://www.samhsa.gov/medication-assisted-treatment/physician-program-data/treatment-physician-locator
Information about trainings to prescribe buprenorphine:
http://pcssmat.org/
An app containing treatment locators, a buprenorphine prescribing guide, and clinical support tools:
http://store.samhsa.gov/apps/MAT
Finding Buprenorphine Treatment
If buprenorphine is selected
As with methadone,
Induction can occur in outpatient or inpatient setting
Patients need an adequate dosage that relieves and prevents withdrawal
Long-term maintenance is needed to attain recovery stability
Formulation
Buprenorphine is available as a single-agent product(buprenorphine alone) or in a combined formulation(buprenorphine + naloxone) with an opioid antagonist to reduce misuse or diversion.
Buprenorphine
Buprenorphine + Naloxone
Recommended during
pregnancy to avoid prenatal exposure to naloxone.
The single-agent product has a
higher potential for injected use and a higher street value.
Formulated to prevent
injected use because naloxone causes severe withdrawal
when injected.
If risk is high or single-agent
buprenorphine is not
available, the combined formulation is not
contraindicated in pregnancy.
Fewer prenatal studies have
been conducted with the combined formulation, though
initial studies show no evidence
that the combined formulation is worse for fetus.
ADVANTAGES
+DISADVANTAGES
-
Buprenorphine Product Comparison
Pregnant women whoare already on prescribed
treatment with . . .
Medication Selection
NeitherBuprenorphineMethadone
Should continue methadone treatment
Should continue buprenorphine
treatment
Selection of buprenorphine or methadone
depends on individual patient
circumstances
BuprenorphineMethadone
Comparing the ADVANTAGES of Methadone and Buprenorphine
More stringent structure for
patients who require more support.
Greater coordination of support
services.
May be prescribed by waivered
clinicians in an office setting.Lower frequency of visits required.
Greater accessibility in areas
without methadone treatment.
Lower severity, duration, and percent requiring treatment for neonatal abstinence syndromeHigher birthweight and gestational age.
Easier induction. Lower risk of overdose and
fewer drug interactions.
No known advantages.
Long-term infant/child outcome
data are available.
No data available.
Accessibility
Neonatal complications
Maternal complications
Long-term outcomes
VS
Methadone MaintenanceThough Sarah’s concern is understandable,withdrawal from methadone is not recommended during pregnancy.
If Sarah decides to discontinue though this is not medically recommended, taper should be slow (ideally over a period of months) and must include increased recovery support.
Methadone DosingThe treatment objective is to maintain an adequate methadone dosage to avoid withdrawal, which might require increases or split dosing. Communication between Sarah, her methadone provider, and her clinician about dosing is important.
What information might be useful for treating Sarah?
PATIENT 2
Sarah
Pregnancy CareSarah and her providers should assess relapse prevention to ensure that she has the social supports she needs and should assess her psychiatric and medical care needs.
Neonatal Care
The clinician should collaborate with the pediatric care team prior to delivery and discuss the plan with Sarah.
The team should provide Sarah with information about NAS and infant comforting techniques and should provide a tour of the neonatal nursery.
PATIENT 2
Sarah
What information might be useful for treating Sarah?
A desire for methadone dose increase in pregnancy may indicate addictive behavior, suggesting that methadone taper might be necessary.
Check Your Learning
True
False
A
B
Pharmacokinetic changes that are common in pregnancy, especially in the third trimester, may necessitate increase in dosage in order to relieve and prevent withdrawal symptoms. Methadone taper in pregnancy is not recommended.
Check Your Learning
A desire for methadone dose increase in pregnancy may indicate addictive behavior, suggesting that methadone taper might be necessary.
False
Check Your Learning
An inadequate maternal methadone dosage may result in opioid withdrawal symptoms and cause fetal stress and increased likelihood for the maternal use of illicit drugs.
True
False
A
B
Check Your Learning
An inadequate maternal methadone dosage may result in opioid withdrawal symptoms and cause fetal stress and increased likelihood for the maternal use of illicit drugs.
True
Split dosing is used to reduce risk of medication diversion.
Check Your Learning
True
False
A
B
Some pregnant women develop rapid metabolism to the extent that it becomes difficult to control withdrawal symptoms for 24 hours on a single daily dose; in these cases, split dosing is optimal. There is no evidence that split dosing affects diversion.
Check Your Learning
FalseSplit dosing is used to reduce risk of medication diversion.
Which medication generally results in less severe neonatal abstinence syndrome?
Check Your Learning
Methadone
Buprenorphine
A
B
Check Your Learning
Methadone
Buprenorphine
A
B
Which medication generally results in less severe neonatal abstinence syndrome?
Brief history
▪ Pregnant; estimated 10 weeks gestation
▪ Eighteen months prior to visit, experienced a tibia/fibula fracture when struck by a car. Multiple subsequent painful conditions in past year (dental pain, injuries/falls).
▪ History of anxiety and past heavy alcohol use.
▪ PDMP shows opioids from multiple providers in the past year, including 3 in past 3 months. Two months prior she was taking up to 200 morphine equivalents daily; her prescriptions have become inconsistent since then.
Purpose of visit
▪ Seeking opioid prescription and prenatal care
Age 34
Existing OB/GYN patient last seen 1 year prior for annual exam
PATIENT 3
Angela
Assessing and monitoring for signs of opioid use disorder is important.
Clinicians who identify substance use disorder during pregnancy must consider ethical and mandatory reporting issues.
Discontinuing service as a patient’s medical provider (i.e., “discharging” the patient) because of opioid use disorder is not considered an ethical option.
Treating Angela
Angela’s clinician will need to:
▪ Review substance use, and prescribed and nonprescribed medications over recent months
▪ Screen Angela for possible opioid use disorder and reassess pain management approach
▪ Discuss motivations related to her pregnancy and in general
▪ Address her service needs related to opioid use disorder and psychosocial stressors. Angela is a likely candidate for medication-assisted treatment
Treating Angela
ScreeningNew patient, new prescription, new pregnancy
MonitoringPatients on opioids for chronic pain, in treatment for or with history of substance use disorder, with concerning behavior
Screening and Monitoring Methods
PDMP
Structured Self-Report Tools
Urine Drug Testing
Communication
Medication Agreement
Pill Counts, Observed Dosing
PDMP
Check the Prescription Drug Monitoring Program (PDMP): ▪ Universally with new prescriptions▪ Regularly with patients with existing prescriptions▪ Routinely when treating patients with history of
or possible substance use disorder
Use nonjudgmental language to explain and ask about any identified issues
Express concern for maternal and fetal safety
Structured Self-Report Tools
Urine Drug Testing
Communication
Medication Agreement
Pill Counts, Observed Dosing
PDMP
Urine Drug Testing
Communication
Medication Agreement
Pill Counts, Observed Dosing
Structured Self-Report Tools
Screen all patients. Single-item screener: “How many times in the past year have you used a recreational drug or a prescription medication for nonmedical reasons?”
Brief validated tools are available for:▪ Substance use (e.g., NIDA Quick-Screen, DAST)
▪ Nonmedical Rx drug use (e.g., COMM)
▪ Pregnancy-focused substance issues (4 P’s Plus)
▪ Mental health issues, trauma, interpersonal violence
PDMP
Communication
Medication Agreement
Pill Counts, Observed Dosing
Structured Self-Report Tools
Urine Drug Testing
Use to monitor patients on prescribed opioids and confirm the absence or presence of any drugs reported verbally.
▪ Obtain informed consent and state who will have access to results▪ Conduct confirmatory GC/MS testing
Be aware that urine drug testing is not recommended for primary screening for illicit drug use in pregnancy due to such concerns as:
▪ False positives and negatives, interpretation challenges, inability to differentiate between intermittent and chronic use
▪ Reporting implications, potential prenatal care avoidance
PDMP
Medication Agreement
Pill Counts, Observed Dosing
Structured Self-Report Tools
Urine Drug Testing
Communication
Assess patients on opioids on the 6 A’s
Use nonjudgmental language to ask about the use of medications, alcohol, and drugs (e.g., “I ask all my patients about things they do that can affect their health...”)
Discuss issues identified through PDMP or other tools
PDMP
Pill Counts, Observed Dosing
Structured Self-Report Tools
Urine Drug Testing
Communication
Medication Agreement
Use to document clinician and patient responsibilities and expectations including:
▪ The goals of therapy
▪ How opioids will be prescribed and should be taken
▪ The type of follow-up and monitoring that will occur
▪ Expectations about the use of alternative therapies
▪ Indications for tapering off opioids
PDMP
Structured Self-Report Tools
Urine Drug Testing
Communication
Medication Agreement
Pill Counts, Observed Dosing
If a patient on opioids for pain or buprenorphine for opioid use disorder needs additional support, use pill counts to determine whether she is taking as prescribed. Be aware that pill counts can be manipulated.
If needed for a patient receiving buprenorphine, the clinician or staff can directly observe medication ingestion.
Monitoring Frequency
CDC’s Guideline for Prescribing Opioids for Chronic Pain, 2016
PDMPRoutinely, ranging fromevery prescription to every 3 months
Structured Self-Report Tools Periodically
Urine Drug TestingGenerally recommended at least annuallyMay be more frequent for pregnant women
CommunicationEvery visit
Pill Counts As needed
The intensity of monitoring should vary depending on the patient’s level of assessed risk.
Should clinicians taper off prescribed opioids in pregnancy if possible opioid use disorder is identified?
Due to high relapse rates,
tapering in response to opioid
use disorder during pregnancy
is generally recommended
only to support the initiation
of opioid agonist treatment.
A retrospective study of medically assisted withdrawal of pregnant women with active opioid use disorder without transition to opioid agonist treatment found that:
Bell et al., 2016
Obstetrical complications were rare
Widely varying NAS rates suggested relapse risk might differ by treatment received:
70% for inpatient detox without intensive outpatient treatment
31% for outpatient detox
17% for inpatient detox with intensive outpatient treatment
Counterpoint
Critical Limitations of the Study
Lack of fetal monitoring and data related to fetal distress
NAS results included only patients who were “fully detoxified”
No disclosure of number of study subjects lost to attrition
Patients followed only until delivery; previous studies have found high relapse rates (> 90%) at 1 year after short-term buprenorphine taper
Weiss et al., 2011
What are the legal and ethical considerations of substance use disorder in pregnancy?
The United States has a long history of imposing harsh legal measures against pregnant women with substance use disorders. Punitive measures can deter women from seeking prenatal care and substance use disorder treatment.
Federal confidentiality regulations (42 CFR Part 2) prohibit the disclosure of information on patients in federally supported substance use disorder treatment programs, with a few exceptions.
Federal
Paltrow and Flavin, 2013
Disclosures are permitted in response to:
▪ A court order
▪ A crime at the treatment facility
▪ Suspected child abuse/neglect
▪ Informed consent for release of information in compliance with HIPPA/42 CFR regulations
Substance use disorder treatment and medical providers should obtain release of information consent in order to communicate information necessary for the coordination of care.
Federal reporting requirements for substance-exposed newborns
The Federal Child Abuse Prevention and Treatment Act (CAPTA), as amended in 2003, requires states to have policies for:
▪ Notifying child protective services of newborns exposed to illicit substances in utero
▪ Establishing a plan of safe care for newborns affected by illegal substance abuse or withdrawal symptoms resulting from prenatal substance exposure
Further amendment of CAPTA under the Comprehensive Addiction and Recovery Act (CARA) of 2016 resulted in additional changes:
▪ Clarified population to infants “born with and affected by substance abuse or withdrawal symptoms resulting from prenatal drug exposure,” specifically removing the term “illegal”
▪ Required plan of safe care to include needs of both infant and family or caregiver
▪ Specified data to be reported by states
▪ Specified increased monitoring and oversight for states to ensure that plans of safe care are implemented and that families have access to services
States vary in clinician reporting requirements
▪ Some states consider prenatal exposure child abuse or neglect
▪ One state allows assault charges against a pregnant woman who uses certain substances
▪ Most states do not provide clear guidance about whether to report NAS due to legitimately prescribed controlled substances or legal substances
▪ Some states require reporting of exposure to or NAS due to opioid agonist treatment (methadone, buprenorphine)
▪ Some states’ policies differ by trimester in which exposure occurred
State reporting requirements
States frequently amend their statutes; check these sources for current information on relevant state laws:
Child Welfare Information Gateway https://www.childwelfare.gov/systemwide/laws_policies/state/index.cfm?event=stateStatutes.processSearch(under Child Abuse and Neglect click Parental Drug Use as Child Abuse)
Guttmacher Institutehttps://www.guttmacher.org/state-policy/explore/substance-use-during-pregnancy
If these resources do not provide sufficient information, check whether your state has posted policies online or contact your state’s child protective services agency.
Rhode Island considers substance abuse during pregnancy to be physical neglect,although providers are not mandated to report before the baby is born
Rhode Island reporting requirements
DCYF will not accept a call until after the baby is born, except if a case is open for another child
After delivery, hospital Pediatrics and Social Work will review the case and determine whether to contact DCYF. Contacting DCYF does not mean that a case will be opened.
▪ DCYF requires a call for a positive urine screen in the second or third trimester
▪ Previously, DCYF did not require a call for NAS due to opioid agonist treatment or opioids used as prescribed. A call is now required; that does not mean that a case will be opened.
The American College of Obstetricians and Gynecologists has stated that maternal drug testing should be performed only with patient’s consent.
Clinicians should discuss with patients:
▪ Confidentiality limits that will result in reporting
▪ How patient information is shared with other providers
Ethics and reporting
ACOG Committee Opinion on Opioid Use and Opioid Use Disorder in Pregnancy, 2017
In a 2001 case, the U.S. Supreme Court ruled that informed consent is required for maternal drug testing.
▪ Nevertheless, in some states maternal testing without consent has continued or is required in some circumstances.
▪ Other states have issued guidelines stating that maternal testing should not be performed without consent.
Informed consent is not required for infant drug testing.
▪ A few states require providers to test neonates if prenatal exposure suspected.
▪ Patients should be informed of potential ramifications of a positive test.
Ferguson v Charleston, SC, 2001
Following birth, relapse alone is not grounds for reporting to child protective services—though reporting is required if the mother’s or caregiver’s substance use seriously impairs parenting ability.
Obstetrician-gynecologists have an ethical responsibility to their pregnant and parenting patients with substance use disorder to discourage the separation of parents from their children solely based on substance use disorder, either suspected or confirmed.
The American College of Obstetricians and GynecologistsJune 2015 committee opinion
Clinician attitudes and beliefs can strengthen or inhibit the therapeutic alliance.
Patients are more likely to respond positively to clinicians who use a nonjudgmental, nurturing approach and communicate honestly and openly.
Angela’s clinician needs to:
▪ Discuss concerns related to prescription opioid use
▪ Consider opioid agonist therapy for opioid use disorder
▪ Address alternative pain treatment options
Angela’s history suggests the clinician should also screen for depression and alcohol use.
Opioid Use Disorder Screening
PATIENT 3
Angela
What information might be useful for treating Angela?
PATIENT 3
Angela
Angela’s clinician needs to:
▪ Discuss her state’s confidentiality limits that will result in reporting to child protective services
▪ Convey how her information will be shared with other providers
▪ Emphasize the care team’s commitment to supporting her success
Confidentiality and Reporting
What information might be useful for treating Angela?
Informed consent of the legal guardian is required for drug testing of a neonate.
Check Your Learning
True
False
A
B
Informed consent is not required for infant drug testing. If testing is performed, whether due to medical necessity or state law, the infant’s mother should be informed of potential ramifications of a positive test result.
Check Your Learning
False
Informed consent of the legal guardian is required for drug testing of a neonate.
When a clinician determines that a pregnant patient has a prescription opioid use disorder, medication should be discontinued immediately.
Check Your Learning
True
False
A
B
False
Abrupt discontinuation will precipitate patient withdrawal as well as fetal stress. A plan for tapering and initiation of opioid agonist treatment, counseling, and other patient supports should be initiated.
Check Your Learning
When a clinician determines that a pregnant patient has a prescription opioid use disorder, medication should be discontinued immediately.
MODULE 1
KEY POINTS
Key Point
For chronic pain patients who do not show signs of prescription opioid use disorder
(such as Carol)
The clinician should engage in a shared decision-making process with the patient to decide whether to continue or taper opioids based on the risks and benefits.
Key Point
For patients using opioid agonist therapyfor opioid use disorder
(such as Sarah)
The clinician should:
▪ Advise the patient of strong evidence of better outcomes for pregnant patients who continue opioid agonist therapy
▪ Use shared decision-making to develop plan
▪ Communicate with the opioid treatment provider to ensure adequate dosage and prevention of withdrawal throughout pregnancy
Key Point
For patients showing signs of opioid use disorder
(such as Angela)
The clinician should use shared decision-making and discuss with the patient:
▪ Opioid use disorder treatment including opioid agonist therapy
▪ Alternative treatment options for pain
▪ Psychosocial stressors and service needs
▪ Mandatory reporting requirements
congratulations!you have completed Module 1