Drug Effects on the Fetus

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Transcript Drug Effects on the Fetus

Neonatal
Abstinence
Syndrome
Erin L. Keels RN MS NNP-BC
NAS Taskforce Chair
NNP Program Manager
Nationwide Children’s Hospital
Columbus, Ohio
………………..……………………………………………………………………………………………………………………………………..
Disclosures
• No conflicts of interest
• Off label use of medications for treatment
of NAS
………………..……………………………………………………………………………………………………………………………………..
Objectives
• Describe the contributing factors and
symptoms of patients with NAS.
• Outline the treatment methods available
for patients with NAS.
• List stressors of staff caring for patients
and families with NAS.
………………..……………………………………………………………………………………………………………………………………..
Substance Use in Pregnancy
• 2011 National Survey on Drug Use and Health http://www.samhsa.gov/
– Illicit drug use among pregnant teens= 16.2%
– Illicit drug use among pregnant women (18-25 yrs)= 7.4%
• Pregnant women under-report drug use by 25%
• High correlation between substance use/abuse and mental
health issues
• Approx 55-99% of women in substance abuse treatment have
experienced trauma (sexual abuse, domestic violence, etc) (TIP
51, Addressing Specific Needs of Women, 2009)
………………..……………………………………………………………………………………………………………………………………..
Maternal Treatment
• Pregnancy can be motivating factor
• Risks of treatment outweigh risk of non-treatment
or withdrawal during pregnancy
• Benefits of maternal treatment:
•Decreased risk of relapse
•Improved prenatal care
•Higher likelihood of abstinence from concomitant drug use
•Improved fetal well being; improved birth weight and
gestational age
………………..……………………………………………………………………………………………………………………………………..
Maternal Treatment
• Methadone vs. Buprenorphine
▪MOTHER Study- infants of buprenorphine treated
mothers:
▪ Required less morphine to treat NAS (89%)
▪ Spent 43% less time in the hospital
▪ Spent 58% less time in the hospital being
medicated for NAS
………………..……………………………………………………………………………………………………………………………………..
Maternal Drug Testing
• ACOG and AAP: All women should be screened for
alcohol, tobacco and drug use at least occasionally
• Motivational interviewing (ex. SBIRT)
–
–
–
–
Include complete history
Consistent questions
Nonjudgemental
May occur over time
• Urine Drug Testing Benefits
– Confirms presence of a drug
– Determines the use of multiple drugs
– Determines if a newborn is at risk for withdrawal
………………..……………………………………………………………………………………………………………………………………..
– Used for Legal and CPS documentation
Maternal Drug Testing Limitations:
• Negative results do not rule out substance use
• A positive test does not tell how much/how often a drug is used
• Alcohol (most widely abused substance, greatest impact on
fetus) is the hardest to detect due to its short half-life.
• A woman who knows she will be tested may delay access to
prenatal care
• False positive results can be devastating for a drug-free client
• UNIVERSAL drug testing is not recommended
• Establish a consistent protocol and use it every time a woman
meets criteria
………………..……………………………………………………………………………………………………………………………………..
Drug Effects on the Fetus
• Direct:
– Teratogenic to embryo
– Subtle effects after organogenesis:
• Abnormal growth, maturation
• Altered neurotransmitters, synapses, brain organization
• Indirect:
• Mimic naturally occurring neurotransmitters
• Altered delivery of nutrition related to placental
insufficiency due to mother’s health, wellness and saftey
………………..……………………………………………………………………………………………………………………………………..
Drug Effects on Fetus and Newborn
Opioids:
Readily cross placenta, decrease brain growth and development
Neonatal Abstinence Syndrome (NAS) irritability of GI,
CNS, ANS:
irritability, tremors, seizures, poor sleep
high pitched crying
diarrhea, overeating, emesis
hypertonic, poor suck
restlessness
sweating
………………..……………………………………………………………………………………………………………………………………..
Drug Effects on Fetus and Newborn
Opioids
Poor fetal growth
Prematurity and/or low birth weight
Neurobehavioral abnormalities
Urogenital abnormalities
Cerebral vascular anomalies, accidents
Necrotizing Enterocolitis in term newborns
STD- Hep B and/or C; HIV
Prolonged QTc with methadone
………………..……………………………………………………………………………………………………………………………………..
Drug Effects on Fetus and Newborn
Cocaine:
Placental abruption
Prematurity
Respiratory distress, TTNB
Low birth weight
Microcephaly, neural tube defects
Vascular accidents
Defects: limb, heart, genitourinary, seizures, cerebral
bleeding
Long term: poor growth, delayed neurobehavioral
milestones
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Drug Effects on Fetus and Newborn
Heroine:
Low birth weight
SSRI:
Readily crosses placenta
CNS irritability
Feeding problems
Sleep disturbances
Amphetamine:
Readily crosses placenta and blood-brain barrier
Poor fetal growth
………………..……………………………………………………………………………………………………………………………………..
Cardiac anomalies
Drug Effects on Fetus and Newborn
Alcohol
Significant concentrations in fetal and maternal
compartments
Congenital anomalies
FAS: abnormal facies
poor tone and suck
restlessness
excessive cry
poor sleep, poor growth
neurodevelopmental delay
………………..……………………………………………………………………………………………………………………………………..
hearing and visual disturbances,
Drug Effects on Fetus and Newborn
Nicotine:
Concentrations higher in fetal compartment than
maternal serum levels
Preterm labor, PROM, previa, abruption
Poor growth, esp head
Tremors
Eye and ear malformations
Heart and brain abnormalities
Risk of SIDS
Childhood asthma
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ADHD
Drug Effects on Fetus and Newborn
Marijuana:
THC easily crosses placenta; 11-nor-9carboxyTCH does not
Remains in body up to 30 days, increases fetal and neonatal exposure
Infant neurobehavioral effects:
– Decreased self-quieting ability
– increased fine tremors and startles, hand to mouth activity
– sleep pattern changes
Longer term:
– Disturbed nocturnal sleep
– Behavior problems:
• inattention, impulsivity and hyperactivity,
• delinquency and externalizing problems
………………..……………………………………………………………………………………………………………………………………..
• self-reported depressive and anxiety symptoms
Long Term Neurodevelopmental
Outcomes
• Negligible difference between opioid exposed infants and nonopioid exposed infants at age 2, 3 and 5 (school age)
• Documented adverse neurodevelopmental outcomes from
nicotine, alcohol, possibly THC exposure
• Possible epigenetic changes?
• Direct impact on outcomes- environment and social factors
………………..……………………………………………………………………………………………………………………………………..
Incidence of NAS
• 2000-2009:
– Rate of NAS per 1000 hospital births increased from 1.2 to
3.39
– Rate of antepartum maternal opiate user per 1000 hospital
births increased from 1.19 to 5.63
– Hospital charges per patient related to NAS increased from
$39,400 to $53,400
– 77.6% attributed to Medicaid
– LOS 16 days (Patrick et al., 2012)
………………..……………………………………………………………………………………………………………………………………..
Neonatal Drug Withdrawal
• 20-90% of drug exposed infants will exhibit withdrawal
symptoms, depending on:
– Type of drug/s- singular or multiple, half life; concomitant
SSRI and tobacco use
– Maternal: weight, drug dosage and timing
– Infant weight, gestation
– Infant’s intrinsic metabolism
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Neonatal Drug Withdrawal
• Drug toxicity- symptoms resolve as drug clears
• Drug withdrawal- symptoms worsen as drug
clears
• NAS= opioid withdrawal
• Neonatal Drug Withdrawal= everything else
• Onset: 24 hours to days
• Duration: 16 days to months, self limiting
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Neonatal Observation
• Minimum 2-3 days for any maternal history of
drug use
• 5-7 days if mom on multiple and/or long
acting drugs
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NAS Assessment Tools
• Finnegan Neonatal Abstinence Scoring Tool
• Neonatal Withdrawal Inventory (NWI)
• The Neonatal Narcotic Withdrawal Index
• The Neonatal Drug Withdrawal Scoring System (Lipsitz)
• Ostrea Tool
• ………………..……………………………………………………………………………………………………………………………………..
Neonatal Drug Withdrawal Scoring System (NDWSS)
NAS Assessment
• 2005 study: 81% centers surveyed use assessment
tool, 52% have guidelines
• Allows for “common language”, decrease variability
• Based on opiate withdrawal
– One tool for all substance withdrawal?
• Confounding factors
– Term vs preterm vs beyond neonatal period
– Staff training and competency maintenance
– Subjectivity
•………………..……………………………………………………………………………………………………………………………………..
Parent involvement
NAS Withdrawal Scales
Scale
Finnegan
Neonatal Withdrawal
Inventory
(NWI)
When
1975
1986 mod
Term neonates
up 28 DOL
1988
Scored
items
Withdrawal
assessed
31 items
Scale 1-5
Opiates
Comments
Comprehensive
Complex
Originally
developed as
clinical research
tool
N
DOL
Neonatal Narcotic
Withdrawal
Index
(NNWI)
1981
Lipsitz
Ostrea
1975
1976
41 neonates
35-40 GA
196 neonates
37 GA
7 items
Scale 0-4
Opiate (methadone,
heroine)
24 hours old, 50 FT
methadone exposed vs
40 FT non-exposed
7 items + “other”
Scale 0-2
Opiate (Methadone 4065 mg/day, +/- heroine)
11 items
Scored 0-3
“narcotic addicted
mothers”
Tx at score of 8
Established inter-rater
reliability, sensitivity,
specificity
Tx for 2 scores 5+ in 24
hrs
Established reliability,
inter-rater reliability
Highly subjective
(yes/no,
normal/abnormal)
Compared healthy
term and near term
to NAS
6 items
Rank order
Opiate
(methadone > or <
20 mg/day;
heroine)
No guidelines for
therapy
Not
comprehensive
80 term neonates
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Neonatal Drug Testing
Urine
Meconium
●Detects recent use of nicotine,
opiates, cocaine, amphetamine, TCH
●High rate of false negatives
●Bagged specimen can be difficult to
obtain
●Parent, staff stress related to trying
to collect sample
●Turnaround time
●Relatively inexpensive
●Detects more long-term use of
nicotine, alcohol, opiate, cocaine,
amphetamine, THC
●? Effect of urine, transitional stoll on
sample
●Can be difficult to collect
●May pass in utero/during birth.
●May not be timely -obstruction,
short stay, delayed stooling
●Parent, staff stress related to trying
to collect sample
●Turnaround time
………………..……………………………………………………………………………………………………………………………………..
Neonatal Drug Testing
Hair
Umbilical Cord
●Highly reliable
●Detects long term exposure to
nicotine, alcohol, cocaine,
amphetamine
●Valid
●Specimen collection difficult for
newborns
●Highly reliable and
valid
●Expanded panel of
drugs
●Chain of custody
●Turnaround time
●Expense
●Ease of collection
●Storage
………………..……………………………………………………………………………………………………………………………………..
NAS Nonpharmacologic care
Dyad care when possible
Decrease in LOS and NICU admissions
Decrease stimuli
Cluster care
Quiet environment
Containment- then transition to back to sleep
Pacifier
?kangaroo care
Slow, smooth rhythmic rocking/swaying
Small,
frequent feeds
………………..……………………………………………………………………………………………………………………………………..
Skin care
Breastfeeding
Benefits:
–
–
–
–
Attachment
Nutritional benefits
Other health benefits
Financial benefits,
convenience
– Decreased NAS severity
– Could improve mom’s
abstinence or treatment
adherence
Risks:
-Medical
Drug transfer
Type of drug/s
Maternal infections
- Legal
State Law
Organizational Policies
………………..……………………………………………………………………………………………………………………………………..
Breastfeeding
• AAP Recommendation:
– “No clear reason to discourage breastfeeding
in mothers who adhere to methadone or
buprenorphine maintenance treatment”
• What is your Hospital’s policy?
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Pharmacologic Treatment
• Used to relieve symptoms not controlled with nonpharm (seizures, weight loss)
• Prolongs hospital stay and exposure to drugs
• No evidence for improved long term outcomes with
drug therapy
•………………..……………………………………………………………………………………………………………………………………..
No evidence for short or long duration drug therapy
Pharmacologic Management
Paragoric
toxic ingredients: camphor (a CNS stimulant), benzoic acid (acidosis, CNS
depression, seizures and death in premature infants) high concentration of
alcohol (~45%)
Tincture of Opium
25 fold concentration of morphine solution- increases possibility of
medication errors
contains alcohol
Morphine
short half life; allows for quicker weans
given Q3 hours with feeds- interrupts ad lib/breastfeeding
Methadone
………………..……………………………………………………………………………………………………………………………………..
longer half life; given frequently- easier with ad lib/breastfeeding
Pharmacologic management
Buprenorphine- study shows promise
Phenobarbital-treatment of seizures, sedation
Clonidine- used to help decrease ANS output (tachycardia,
hypertension, diaphoresis, diarrhea); effective as primary or
adjunct treatment
Benzodiazepine-impaired excretion, late onset
seizures
………………..……………………………………………………………………………………………………………………………………..
NCH Medical Treatment (2012)
Protocol should be initiated if an infant has 2 consecutive scores > 8 or 1 score > 12 within a
24 hour period (just as was done previously with the methadone taper).
Concentration of Enteral Morphine to be used for ALL doses: 0.2 mg/ml
Starting Dose:
Enteral: 0.05 mg/kg/dose po q3h
IV: 0.02mg/kg/dose (IV morphine and enteral morphine doses are not equivalent)
Titration:
Enteral: Increase by 0.025-0.04 mg/kg every 3 hrs until controlled (NAS <8)
IV: increase by 0.01 mg/kg every 3 hrs until controlled (NAS <8)
*Rescue Dose*: If infant has 1 score of > 12. double the previous dose given (enteral or IV) x
1 and then adjust accordingly:
- If NAS score now < 12: make the scheduled maintenance dose (MD) the same as the
rescue dose that was just administered. The first higher MD should be given at the next
scheduled care/feed.
- If NAS score still > 12: increase next dose by 50%. Continue to do so until score is < 12.
………………..……………………………………………………………………………………………………………………………………..
Once <12. then follow guideline listed above
NCH Medical Treatment (2012)
Wean: Once stabilized on a dose for 72-96 hours, use this dose as the starting point of the
wean (please note this dose on infant’s card). Begin weaning the dose by 10% (of the original
dose when the first wean was started) every 24-48 hours. Drug may be discontinued when a
single dose is < 0.02 mg/kg/dose. Please see below for example.
*Ad lib infants*: Given the shorter duration of action of enteral morphine, it is best suited to
be dosed on a q3hr schedule. Infants should be allowed to ad lib feed volumes but kept on a
q3hr schedule.
*Backslide*: If infant’s NAS scores become consistently elevated (ex: 2 consecutive >8) during
the weaning process, assure that nonpharmacological measures are optimized (ie: swaddling,
holding, decreased stimuli, etc) before going back to pervious dose at which patient was
stable. If infant’s scores continue to be elevated (even after physical exam to ensure nothing
else is wrong/bothering the infant), either weight adjust medication and/or continue to back
up in a stepwise fashion until patient’s scores are <8. Once stabilized on a new dose for
minimum 48 hrs. resume 10% wean but consider weaning at longer intervals.
Discharge:
Observe in-house x 48-72 hours off of medication before discharge.
………………..……………………………………………………………………………………………………………………………………..
NCH Medical Treatment (2012)
• Phenobarbital
• Adjunct therapy: Opioid ‘CNS’ issues not controlled by
morphine/methadone
– Tone, irritability, sleeplessness
– Added at 14 days of therapy empirically if still unable to wean
morphine
• Clonidine
• Increased autonomic s/sx of opioid withdrawal not controlled with
morphine/methadone
– MOA: a2 receptor agonist
• Negative feedback  prevents further sympathomimeitc release
– Side effects:
• Hypotension, bradycardia
………………..……………………………………………………………………………………………………………………………………..
• Reflex tachycardia/HTN can occur if stopped abruptly
Discharge Management
• Safe Home Environment:
– States, counties vary re: CPS referral
– Work through Social Worker
• Family Education
– ? Ongoing scoring
– Nutrition
– Well baby parenting
• Follow Up
– Developmental screening
………………..……………………………………………………………………………………………………………………………………..
– ? Risk for Hep, HIV
The Nationwide Children’s Hospital
Experience
Nationwide Children’s Hospital
(NCH) is a large, free-standing
academic pediatric facility in
Columbus, Ohio with 450
licensed beds.
Neonatal Services (NS)
8 Intensive care nurseries
191 Neonatal beds
2300+ admissions/year
22% < 1500 g birth weight
………………..……………………………………………………………………………………………………………………………………..
Length of Stay Issues
Background:
In 2009 at NCH
– 7.6% of all NICU/NSCU admits
– Average Length of Stay (ALOS) 35.5 days on the main
campus, 78 days in an off-campus unit
Significance:
Long LOS negatively impacts psychosocial situation
Created backlog of NICU/NSCU beds
Majority Medicaid Managed Care-capitated
Caregiver stress
………………..……………………………………………………………………………………………………………………………………..
Staff Concerns
• Poor communication and inconsistency of plans of
care
• Poor competency with assessment and
documentation of symptoms
• Stress related to neonatal care
• Stressful family dynamics and interactions
•………………..……………………………………………………………………………………………………………………………………..
Discharge planning
………………..……………………………………………………………………………………………………………………………………..
Nursing Assessment and Documentation
Finnegan Training Courses ( March- April 2010)
Two half day NAS Workshops
Train the trainer format
Implement standardized training of new staff
with commercially produced program
Ongoing competency for all staff
………………..……………………………………………………………………………………………………………………………………..
Workshop Intra-rater Reliability
Pre- workshop
Post-workshop
Paired T for Post-Workshop – Pre-Workshop
N
Mean
St Dev
SE Mean
Post-Workshop
82
13.8
1.6
0.1
Pre-Workshop
82
12.1
2.6
0.2
95% CI for mean difference: (1.0, 2.3);
T-Test of mean difference = 0 (vs not = 0): T-Value = 5.1 P-Value = 0.000
Conclusion:
………………..……………………………………………………………………………………………………………………………………..
The
Post-Workshop NAS Scores appear to be significantly different than the Pre-Workshop NAS Scores.
Pharmacologic Management
Initially used Methadone
Changed to Oral Morphine
Continue to refine based on outcomes
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NAS Taskforce
“Clearing house” of information, resources, and potentially better
practices
Monthly interdisciplinary collaborative meetings:
Developed practice guidelines
Enhanced antenatal professional communication,
collaboration
Outreach education and support for providers in the Region.
MOD Grant: improved maternal Methadone treatment retention
rate by 25%
………………..……………………………………………………………………………………………………………………………………..
Collaboration Outside of NICU
MIU/WBN education and training
Maternal Providers
Follow up Clinic
Perinatal Region Education and Support
State Level
………………..……………………………………………………………………………………………………………………………………..
Outcomes:
Main Campus
………………..……………………………………………………………………………………………………………………………………..
Balance Measure:
30 day Readmission Rate
• 28 Readmissions 2010-2012 (N= 440)
– NAS symptoms (2)
– CNS symptoms unrelated to NAS Hx (3)
– Feeding issues unrelated to NAS Hx (4)
– BPD exacerbation (1)
– Infections (13)
– Surgical problems (5)
………………..……………………………………………………………………………………………………………………………………..
Savings to Date
• $ 2.8 Million on Main Campus
………………..……………………………………………………………………………………………………………………………………..
Next Steps: Staff Support
Nurses struggle with issues of beneficence and
nonmaleficence, frustration, burnout and dissatisfaction when
caring for this population of patients and families.
Do our Nurses struggle with this as well??
2013 NAS Taskforce Goal:
1. Determine NCH staff level of comfort in caring for the
NAS patients and families
2. Determine if additional education, training and resources
are needed to help staff care for and cope with NAS patients
………………..……………………………………………………………………………………………………………………………………..
and families
Nursing Staff Survey
• Qualitative and quantitative data
• Sent to all nursing staff of Neonatal
Services (LPN, RN, APN) via email.
• N= 580
• Returns= 167
• Response rate= 28%
………………..……………………………………………………………………………………………………………………………………..
Survey Results
N= 167
Yrs Neonatal Nursing
Type of Nurse
0-5 years= 50 (30%)
6-10 years= 37 (22%)
11-20 years= 29 (17%)
Over 20 years= 48 (28%)
Unknown= 3 (2%)
RNs= 130 (78%)
LPNs= 5 (3%)
APNs= 30 (18%)
MD=1 (0.6%)
Unknown=1 (0.6%)
………………..……………………………………………………………………………………………………………………………………..
On a scale of 1-5, rate your comfort
caring for babies with NAS
Overall average= 4.2
Years of experience
0-5 yrs= 4.2
6-10 yrs= 4.1
11-20 yrs= 4.3
Over 20 yrs= 4.3
Type of Nurse
APN= 4.56
LPN= 4.2
RN= 4.2
………………..……………………………………………………………………………………………………………………………………..
On a scale of 1-5 rate your comfort
interacting with families of NAS patients
Overall average= 3.8
Years of experience
0-5 yrs= 4
6-10 yrs= 3.6
11-20 yrs= 3.8
Over 20 yrs= 3.9
Type of Nurse
APN= 4.0
LPN= 3.8
RN= 3.9
………………..……………………………………………………………………………………………………………………………………..
What are some of the biggest challenges that
you experience caring for babies with NAS
………………..……………………………………………………………………………………………………………………………………..
What are some of the biggest challenges that
you experience caring for babies with NAS
4. Workload
– Not enough time to console
– Too many babies to care for
5. “Ethics”
– Patience for self and of others
– “Prejudiced nurses”
………………..……………………………………………………………………………………………………………………………………..
2013 NAS Taskforce Action Plan
• 1 Staff Education:
– NAS quarterly taskforce meetings
– VON iNICQ Webinar series
– Annual NCH conference- NAS
Postconference
– Ohio Opiate Summit
– Podcasts by Neonatologist and Addiction
Specialist
– Ethics lectures
………………..……………………………………………………………………………………………………………………………………..
Action Plan
• 2. Staff Resources
– Develop website or sharepoint for
• Guidelines, references, articles
• Meeting minutes
• iNICQ proceedings
– Bedside resource packet
– EPIC EMR with best practice alerts
– Unit based NAS committees with Superusers
………………..……………………………………………………………………………………………………………………………………..
Action Plan
• 3. Staff Training
– FNAST ongoing competency training
– Inter-rater reliability testing
• 4. Re-survey
………………..……………………………………………………………………………………………………………………………………..
Summary
• Incidence of Neonatal Drug Withdrawal, including NAS, is
increased
• NAS has profound impact on baby, family and healthcare
system
• Each unit should have an NAS protocol:
– Screening and testing of mom and baby
– Assessment/scoring
– Treatment- non pharm and pharm
– Discharge management and Follow Up
• LOS can shortened by decreasing variability in treatment
• Staff can feel challenged /stressed when caring for NAS
patients and families
………………..……………………………………………………………………………………………………………………………………..
• Much research is needed!
Questions?
• [email protected]
………………..……………………………………………………………………………………………………………………………………..
References
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