Transcript A1 Pregnancy and MAT - Kentucky Association of Sexual Assault

MAT AND PREGNANCY
Deborah Acker RN, CFN
Nurse Service Administrator
Division of Protection and Permanency
Department for Community Based Services
Cabinet for Health and Family Services
OBJECTIVES
• Discuss the medications available to treat opioid addiction
• Understand the pros and cons associated with each
medication
• Understand the risks and benefits of utilizing these
medications during pregnancy
Definitions
MAT – Medication Assisted Treatment
MMT – Methadone Maintenance Program
SAMHSA – Substance Abuse and Mental Health Services
Administration
FDA – U.S. Food and Drug Administration
Half life – how long it takes for half of the drug to be
eliminated from the bloodstream
42 CFR – federal law that governs confidentiality in
substance abuse field
Definitions cont.
Schedule II drug – drugs with a high potential for abuse,
but less abuse potential than Schedule I
drugs. Examples: Percocet, Oxycontin, Adderall,
Fentanyl, Methadone
Schedule III drug – drugs with a moderate to low potential
for physical and psychological dependence.
Examples: Vicodin, Tylenol 3, Suboxone, Tussionex
NAS – Neonatal Abstinence Syndrome
MOTHER study - Maternal Opioid Treatment: Human
Experimental Research
Medication Assisted Treatment
SAMHSA defines MAT as:
“The use of medications, in combination with counseling and
behavioral therapies, to provide a whole-patient approach to
the treatment of substance use disorders. Research shows
that when treating substance-use disorders, a combination of
medication and behavioral therapies is most successful.”
MEDICATION ASSISTED
TREATMENT OPTIONS
• Methadone
• Buprenorphine- Suboxone and Subutex
• Naltrexone- ReVia and Depade
Benefits of MAT in Pregnancy in a Clinical Setting
• Assist women in remaining free of illicit drugs, by preventing opiate
withdrawal and cravings.
• Assist in eliminating criminal activity and other high risk behaviors that
may be harmful.
• Increase probability of access to prenatal care.
• Allow for substance abuse education and therapy in a structured
setting.
Benefits of MAT in Pregnancy in a Clinical Setting
• Breastfeeding is possible and often preferable for most women on
MAT (minimal amount of methadone found in breast milk).
• Decrease risk to fetus of infection of HIV, Hepatitis and Sexually
Transmitted Diseases.
• Decrease the possibility of fetal death by stabilizing the intrauterine
environment from fluctuations associated with abstinence syndrome.
Methadone
Methadone – a drug or a medication?
Methadone is both.
Methadone is a medication that if used illicitly may
be thought of as a drug of abuse.
Methadone is a medication that if used correctly is
a pain reliever and a part of drug addiction
detoxification and maintenance programs.
Methadone
• Dolophine hydrochloride, Methadose
• Schedule II narcotic
• Long acting opioid analgesic (6-12 hours)
Methadone
• Long half-life (12-59 hours)- taken once daily or
may be “split-dosed”
• Administered orally- 5 and 10 mg tablets, 40 mg
disket and liquid
• 40 mg tablets (disket) only available to treat
opioid addiction (as of January 2008)
Stabilization
• Methadone is metabolized in the liver
• It is then stored in the liver and bloodstream ……..
• Unlike Heroin or other opiates, Methadone is time-released
into the brain for up to a period of (2) days from one dose.
• Methadone enables the person to remain stable or functional
without the use of illicit drugs.
Methadone benefits
• Right dose should not cause euphoric or tranquilizing
effects.
• Reduces/blocks effects of other opioids.
• Tolerance is slow to develop.
• Relieves cravings.
• Allows the individual to feel “normal”.
Methadone benefits
• Improved employment and family relationships.
• Decrease in criminal activities.
• Decrease in high risk behaviors such as IVDU = decrease
in HIV and Hep C.
• Improved health and health care.
Methadone limitations
• Can only be dispensed/administered through an OTP.
• Private can be expensive.
• Heavily regulated, lots of rules, can be time consuming.
• Heavily stigmatized
Methadone limitations
• Abuse liability and diversion.
• Increased risk when combined with other drugs.
• Associated health complications.
• Detoxification can be difficult.
Potential Methadone draw-backs
• NAS
• Not always available
• Stigma
• Daily visits (difficult with rural populations)
• Treatment services often quite variable so outcomes can
be quite variable
Methadone Maintenance - During Pregnancy
• Since the late 1970’s methadone has been accepted to
treat opioid addiction during pregnancy
(Kaltenback et al. 1998; Kandall et al. 1999)
• In 1998 the National Institutes of Health consensus panel
recommended MMT as the standard of care for pregnant
women with opioid addiction.
(National Institutes of Health Consensus Development Panel 1998)
• Methadone is currently the only opioid medication
approved by the FDA for MAT for opioid addiction in
pregnant patients.
Methadone Maintenance - During Pregnancy
• As the pregnancy progresses the woman may
experience withdrawal symptoms and require an
increase in her methadone dose due to greater plasma
volume and increased renal blood flow.
• Often “Split Dosing” will better stabilize the woman and
avoid withdrawal without having to continue to increase
the amount of methadone needed.
• Medically supervised withdrawal is not recommended
for pregnant women.
Methadone Dosing during Pregnancy
• Often methadone dose needs
adjustment upwards
• Greater plasma volume
• Increased renal blood flow
Pond et al., 1985; Swift et al., 1989; Jarvis et al., 1999; Wolff
et al., 2004)
Breastfeeding on Methadone
• Mothers maintained on methadone can breast-feed if they are not HIV
positive, are not abusing substances, and do not have a disease or
infection in which breast-feeding is contraindicated (Kaltenback et al.
1993).
• American Academy of Pediatrics and the World Health
Organization’s Working Group on Human Lactation approves
breastfeeding among women on methadone.
• Studies have found minimal transmission of methadone in breast milk
regardless of maternal dose (Geraghty et al. 1997; Wojnar-Horton et
al. 1997)
Buprenorphine
Another Option - Buprenorphine
• Development of Subutex®/Suboxone®
• Suboxone (buprenorphine/naloxone)
• Suboxone contains four parts buprenorphine and one part naloxone.
• Naloxone was added to in an effort to dissuade patients from injecting the tablets.
• Subutex (buprenorphine)
• Subutex contains only buprenorphine.
• U.S. FDA approved Subutex® and Suboxone® sublingual strips for opioid addiction
treatment on October 8, 2002.
• Product launched in U.S. in March 2003
• Interim rule changes to federal regulation (42 CFR Part 8) on May 22, 2003
enabled Opioid Treatment Programs (specialist clinics) to offer buprenorphine.
Buprenorphine
• Long half-life (24-60 hours)
• Administered as sublingual tablet* or film
 Subutex- 2 mg or 8 mg buprenorphine
 Suboxone- 2 mg buprenorphine + .5 mg naloxone
8 mg buprenorphine + 2 mg naloxone
Subutex
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Initially used as an analgesic (but not in sublingual form)
Has been used in France for over a decade for opioid addiction
Use buprenorphine without naloxone in pregnancy
Schedule III pain medication (Buprenex)
Approved in 2002 for outpatient treatment of opiate addiction
Partial opiate agonist (sublingual tablet)
Only approved M.D.’s can prescribe Subutex/Suboxone.
Most have no affiliation with, or background
in treating addiction.
Administered as sublingual film
• Subutex- 2 mg or 8 mg buprenorphine
Suboxone
• Naloxone added as means to decrease misuse.
• Poor bioavailability sublingually, but if dissolved and injected, will
precipitate withdrawal.
• Reduced abuse potential.
• Film meant to provide added means to combat diversion.
 Administered as sublingual film
• Suboxone- 2 mg buprenorphine + .5 mg naloxone
8 mg buprenorphine + 2 mg naloxone
Buprenorphine benefits
• Virtually no euphoric or tranquilizing effects unless opiate naive.
• Blocks effects of other opiates.
• Relieves cravings to use other opiates.
• Allows “normal function”.
• Lower abuse liability and diversion potential than Methadone.
• Increased anonymity and less intrusive, vs. attending a MAT clinic
daily.
Buprenorphine benefits
• Increased treatment options/access to treatment.
• Decrease in high-risk behaviors.
• Good “step down” option for those tapering from Methadone.
• Provides option for those that cannot tolerate methadone.
• Is currently covered by Medicaid.
Buprenorphine limitations
• Can be expensive when self pay.
• Currently still no generic for Suboxone.
• Should not take if opiates still in system.
• Counseling may not be available or affordable in the same
area as doctor.
Buprenorphine limitations
• Not enough certified doctors or doctors willing to treat.
• No regulations for office based opiate treatment, only
“practice guidelines”.
• Potential for overdose of other opiates due to ceiling effect.
• Abuse and diversion potential still exists.
Buprenorphine breastfeeding
• Does get into breast milk
• Poor oral bioavailability
• No reports of NAS when women acutely stop taking
buprenorphine while breastfeeding
MAT and Pregnancy
Substance Abuse lifestyle
Concern for mother - fetus - and - neonate
• High rates of smoking, other drug use, depression,
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anxiety, PTSD among mothers
High rates of dysfunctional families, abusive partners
Lack of social supports
Often financially struggling
Poor coping and parenting skills
Legal problems
Unemployment, lack of job skills
What happens to Mom happens to baby…
MAT and pregnancy standards
• Federal standards
• Prenatal care
• Gender-specific services
• Additional state standards
• Medically able to participate
• Collaborate with OB-GYN
• Post-partum care
• Nutrition, parenting, and weekly drug test
MAT and pregnancy
• “Cold turkey” detox may trigger miscarriage, pre-term labor.
• Methadone has most research and is still preferred.
• Subutex has shown very positive results – MOTHER Study.
• Several reports of using Suboxone with positive results.
• Well metabolized and well tolerated.
MAT and pregnancy
• Individualized approach, informed choice
• Decreases/ceases cycles of intoxication and
withdrawal
• Decrease in high risk behaviors
• Opportunity to address other factors-mental health,
social supports, basic needs
Potential medical complications for the pregnant
opioid using females and the fetus
• HIV, Hepatitis C, STDs, seizures
• Gestational diabetes, preeclampsia and eclampsia
• Spontaneous abortion
• Intrauterine Growth Retardation
• Placental abruption
• Premature rupture of membranes and labor
• Placental insufficiency
• Postpartum hemorrhage
Methadone and pregnancy
• Methadone has been used to treat pregnant opiate
addicts for nearly 40 years.
• While relatively safe, not completely without risk.
• Minimizing risk includes:
• comprehensive assessment
• education with family and patient regarding risks/benefits
• providing medical supervision to decrease/eliminate illicit drugs of
abuse.
Potential Risks
• Neonatal Methadone Abstinence Syndrome. Similar to that of heroin,
often longer lasting
• In-utero exposure to methadone may lead to low birth weight. (Many
patients also smoke—uncertain which causes the low weight)
• Onset of withdraw can be delayed for several hours to two weeks.
• The maternal dose vs. NAS severity is the subject of some debate.
• Seizures can be seen in a minority of babies. Although some MDs
attribute this to the use of benzodiazepines during pregnancy.
Potential Neonatal complications
• Premature birth
• Low birth weight and small for gestational age
• Microcephaly
• Meconium aspiration syndrome
• Neonatal abstinence syndrome
• SIDS
• HIV infection
Post Delivery Issues
• Neonatal Abstinence (Finnegan Scale)
• “Look what you’ve done to your baby” attitude by hospital staff
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and family members
Pain management issues
Dose adjustment/regulation
Confidentiality in the hospital: Drs. and nurses must not discuss
methadone in the presence of anyone other than the patient
Support Network: often limited - needs to attend 12-step
meetings, church, self-help groups, etc.
Increased risk of relapse
Post-Partum depression
Now what? - work on parenting issues, relationship with baby’s
father, family of origin, friendships, life issues…
NEONATAL ABSTINENCE SYNDROME
NAS is defined as:
Neonatal abstinence syndrome (NAS) is a group of
problems that occur in a newborn who was exposed
to addictive illegal or prescription drugs while in the
mother’s womb. Babies of mothers who drink during
pregnancy may have a similar condition.
NAS Predictability
• Can happen with any opioid (heroin, oxycontin,
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methadone, etc.)
Not clearly related to methadone dose in mother
May occur less often with buprenorphine
Contribution of genetics, other drugs
Smoking and vagal tone have been associated with NAS
Neonatal Abstinence Syndrome (NAS)
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CNS excitability such as hyperactivity, irritability, sleep
disturbance
Autonomic Nervous System such as fever, sweating,
nasal stuffiness
Gastrointestinal dysfunction such as uncoordinated
sucking/swallowing, vomiting, loose stools
Respiratory Distress such as increased respiratory
rate, bluish color around the mouth, nasal flaring
NAS Treatment
• Pharmacotherapies used to reduce withdrawal symptoms
include:
• Phenobarbital
• Morphine
• Methadone
• Non-pharmacologic supportive care
• Decrease sensory inputs
• Stabilize environment
• Help parents have realistic expectations (babies are not addicted)
Remember…
• Opiate addiction is a disease, an epidemic.
• There is no cure, but we do have options and we
need to take advantage of all of them.
• Treatment is not “one size fits all.”
• Just as addiction is lifelong, so is the recovery
process.
• Chances of maintained recovery significantly
increase when combined with counseling,
drug tests, medication call backs, etc.
Remember…
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No “perfect” medication that is one size fits all.
Medication is a tool, not a “cure”.
MAT may be appropriate for pregnant women
but must be closely monitored and have
informed consent.
MAT is a legal, valid, and widely researched
evidence-based treatment for addiction.
Individuals receiving MAT are in recovery!
Then what?
Infant/child development
• Difficult to determine the effects of methadone vs. other drugs of
abuse/genetic problems, etc.
• Head circumference normalizes by preschool (Lifshitz, 1985)
• Neurological development assessed by Bayley Scales of Infant
Development within normal limits (Patso, 1989)
• Poorer performance in fine and gross motor coordination,
attention, language vs. controls (for review see: Chapt. 20 of
Strain and Stitzer, The Treatment of Opioid Dependence, 2006
and Helmbrecht 2008)
Factors influencing long-term outcomes of
methadone exposed children
• Effects of poverty
• Effects of other drugs of abuse (including nicotine and
alcohol)
• Effects of environments (supports, opportunities)
• Caregiver capacity
• Infant, child, young adult resilience
OPOID ADDICTION PROGRAM’S
TREATMENT PROTOCOL
• Pregnant woman contacts the clinic.
• She is assessed for appropriateness on the phone and
then comes in for a face to face assessment.
• Once deemed appropriate, “patient” is then admitted to
hospital for prenatal assessment and induction to
methadone.
• She will stay in the hospital for 5-7 days and is typically
discharged on 30 to 40mg of methadone.
• Upon discharge from hospital, patient will come to MAT
clinic and have a psychiatric assessment by the physician.
OPIOD ADDICTION PROGRAM’S
TREATMENT PROTOCOL
• Patient will then go for up to 30 days of residential substance
abuse treatment—she will get her methadone dose there.
• Upon completion of residential substance abuse treatment,
patient will begin daily dosing in the clinic, meet with her
therapist once a week, and submit to random drug testing.
• Referral to other services (group counseling, self-help,
parenting classes, vocational rehab, etc.) may be required
as is prenatal care.
• It is recommended, when appropriate, the patient continue
residential long-term treatment.
Vincent Dole:
“Some people became overly converted. They felt,
without reading our reports carefully, that all they had to
do was give methadone and then there was no more
problem with the addict…I urged physicians should see
that the problem was one of rehabilitating people with a
very complicated problem and that they ought to tailor
their programs to the kinds of problems they were
dealing with. . .The stupidity of thinking that just giving
methadone will solve a complicated social problem
seems to me beyond comprehension (Courtwright, 1989,
p 338)”
Remember…
• The substance abusing lifestyle brings concerns for
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mother, fetus and neonate.
Although there are risks, Medication Assisted Treatment
(MAT) provides benefits to the opiate addicted pregnant
woman.
Methadone maintenance is still the treatment of choice
and standard of care in the US.
Buprenorphine (Subutex) treatment is possible, evidence
still lacking.
Detoxification is contraindicated unless done in hospital
with monitoring.
And one more thing:
She’s in RECOVERY!