NEONATAL ABSTINENCE SYNDROME CLINICAL PRACTICE GUIDELINES ... · PDF fileNEONATAL ABSTINENCE...

e488J Popul Ther Clin Pharmacol Vol 19(3):e488-e506; November 23, 2012

© 2012 Canadian Society of Pharmacology and Therapeutics. All rights reserved.

NEONATAL ABSTINENCE SYNDROMECLINICAL PRACTICE GUIDELINES FOR ONTARIO

Kimberly Dow1, Alice Ordean

2, Jodie Murphy-Oikonen

3, Jodie Pereira

4, Gideon Koren

5, Henry Roukema

6,

Peter Selby7, Ruth Turner

8

1Queens University and Kingston General Hospital,

2St Joseph’s Health Centre, Toronto,

3Thunder Bay

Medical Centre,4St. Joseph’s Healthcare, Hamilton,

5The Hospital for Sick Children, Toronto,

6St Joseph’s

Health Centre, London,7Centre for Addiction and Mental Health, Toronto,

8Provincial Council for Maternal

and Child Health, Ontario

ABSTRACT

Ontario’s clinical practice guidelines for neonatal abstinence syndrome (NAS) provide evidence-informedrecommendations that address the needs of substance using pregnant women and newborns at risk ofNAS. NAS is a complex and multifaceted issue that is escalating along with rapidly rising opioid use inOntario. Reducing the incidence and impact of NAS requires immediate action in order to improve thecare of affected women and infants. This includes optimizing and standardizing treatment strategies,assessing and managing social risk, better monitoring of prescribing practices and facilitating theimplementation of better treatment and prevention strategies as they become available. These clinicalpractice guidelines provide the framework to inform and support the development of a coordinatedstrategy to address this important issue and to promote safe and effective care.

Key Words: Opioid, methadone, drug withdrawal, neonate, abstinence syndrome

he impact of drug addiction on a pregnantwoman has profound effects, not only onher health and wellbeing but also on her

newborn baby whose drug withdrawal manifestsitself as neonatal abstinence syndrome (NAS).The growing incidence of NAS across Canada isdirectly impacting scarce resources in the Level IIand III neonatal units due to prolonged length ofhospital stay for specialized care and support ofboth the baby with NAS and the mother.

The Provincial Council for Maternal andChild Health (PCMCH), in its Report on Accessto Care (2010), identified the growing incidenceand challenges associated with managingnewborns experiencing NAS and recommendedthat an expert panel be organized to address theneeds of this population.

NAS is experienced by infants who wereexposed to opioids such as morphine, methadone,codeine, oxycodone and heroin in utero. Thisexposure creates a physical dependence on thosesubstances that often results in withdrawal in theinfant after birth. NAS presents with neurological,gastrointestinal, and respiratory signs including

increased tone, a high pitched cry, poor feeding,sleep-wake abnormalities, poor weight gain,tremors and seizures. Treatment of NAS oftenrequires care in a special care nursery (SCN)setting for a prolonged hospitalization.

Demand for maternal-newborn services,which are already under pressure, is expected toincrease as a result of population growth,increasing maternal age, infertility treatmentsresulting in multiple births and the inherent risksof prematurity. This growing demand placesescalating pressure on the already strainedmaternal and newborn care system. Many LevelIII Obstetrical Units and Neonatal Intensive CareUnits (NICUs) are operating at levels that make itdifficult to respond to surges. Increases in NASadd one more pressure on the system.

Women become dependent on opioids fordifferent reasons. There are women who requireopioids for pain management, women who abusesubstances including opioids, and women whoseek methadone treatment for addiction toprescribed or non-prescribed opioids. Despite thereason for opioid dependency, the majority of

T

Neonatal abstinence syndrome clinical practice guidelines for Ontario

J Popul Ther Clin Pharmacol Vol 19(3):e488-e506; November 23, 2012© 2012 Canadian Society of Pharmacology and Therapeutics. All rights reserved.

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infants exposed in utero are born dependent onopioids. Withdrawal occurs in 55-94% of infantsexposed to opioids in utero and up to 85% ofthose exposed to methadone.1

A high proportion of opioid using mothersalso smoke tobacco, use alcohol, and other drugsincluding cocaine. NAS is not simply a neonatalissue; it is also a marker for life long issues relatedto social and environmental risks that may includeFetal Alcohol Spectrum Disorder, behaviourproblems or developmental delays that mayrequire further assessment and intervention from atreatment team.

Early detection of substance exposure innewborns leads to timely assessment for NAS andsubsequent treatment to reduce symptoms innewborns.2 Substance using women and infantswith NAS benefit from a coordinated circle ofcare that includes both community and hospitalsupports. Services exist to support people withaddictions in the community and should bealigned with hospital-based services. Resourceavailability should not be dependent on the size ofa community and it is essential that accessstrategies address geographic challenges.

The management of substance use and NASis particularly problematic in Northern Ontario.Many First Nations communities have identified astate of emergency regarding abuse of prescriptionnarcotics.3 The vast geographical area of theNorth encompasses multiple remote communities,many of which have a population of less than1000 and rely on a nursing station for health caresupport. These communities have few, if any,local family physicians and rely on distantregional hospitals for their acute healthcare needs.The need to receive healthcare away from homecontributes to isolation, lack of support, andlimited resources. Although methadonemaintenance treatment is considered the standardof care for opioid addiction in pregnancy, many ofthe remote communities lack access to methadoneand therefore, women continue to struggle withopioid addiction throughout pregnancy. Whenmethadone is not available, alternative optionsneed to be explored on an individual basis. Thesemay include other opioids or opioid tapering. Inaddition to the remote communities, regionalfacilities lack resources to support the highprevalence of substance-using women and infantswith NAS.

METHODS

The Neonatal Abstinence Syndrome Work Groupwas convened in May 2010 at the request of theProvincial Council for Maternal and ChildHealth’s (PCMCH) Maternal Newborn AdvisoryCommittee (M-NAC). It was composed of expertsin the clinical care and social support of pregnantwomen, families and infants at risk of NAS whocame together for the purpose of developingrecommendations regarding both harm reductionand the optimal management of NAS, resulting inthese clinical practice guidelines.

This report focuses primarily on NASresulting from opioid dependence and does notaddress the management of NAS resulting fromthe use of selective serotonin reuptake inhibitors(SSRIs), benzodiazepines, barbiturates, ethanol,sedatives and hypnotics. Initial work focused ongathering data in the form of a survey which wassent to Ontario hospitals. The survey resultsindicated that management of NAS varies acrossthe province.

A literature search provided backgroundinformation on the issues. Three themes emergedthat prompted the formation of three subgroupsfocused on:

1. Prenatal and discharge management2. Screening and scoring3. Treatment management includingenvironment.

Data were provided by The Canadian Institutefor Health Information (CIHI) and the OntarioMinistry of Health and Long-term Care(MOHLTC). Clinical experts maderecommendations after careful review of availableliterature based on quality of the evidence andclassification of the recommendations accordingto the Canadian Task Force on Preventive HealthCare definitions.4

Trends and Current StateOntario has the highest rate of narcotic use inCanada5 as well as one of the highest rates ofprescription narcotic use in the world. Between1991 and 2009, the number of prescriptions foroxycodone rose by 900% in Ontario.6 The Collegeof Physicians and Surgeons of Ontario (CPSO)established a methadone maintenance treatment



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MMT) program in 1996 and in 2009, reported thatalmost 26,000 Ontario patients were enrolled inthe program.7 Narcotic abuse-related admissionsto publicly funded treatment and addictionservices in Ontario are on the rise, as evidencedby rates that doubled in Ontario from 2004-2008.8

Concomitant with the increased narcotic use, therewas an increase in the rate of in utero drug

exposure, resulting in an increased incidence ofNAS.

The incidence of NAS in Ontario, as reportedby the Canadian Institute for Health Information(CIHI), has increased from 1.3 cases per 1,000births in 2004, to 4.3 cases per 1,000 births in2010. Ontario surpassed the national average in2009 (Figure 1).

FIG. 1

Canadian data on maternal substance use andNAS9 are limited. Most studies are based onmaternal self-reporting. Concern aboutstigmatization may prevent honest reportingresulting in an underestimation of the prevalenceof substance use and addiction.

Data from the Canadian MaternityExperience Survey10 found that approximately 7%of women had used street drugs in the 3 monthsprior to their pregnancy or before being aware oftheir pregnancy. This proportion was reduced to1% once pregnancy was confirmed. Street drugsincluded use of cocaine, heroin, marijuana andamphetamines. This study excluded women livingon reserves or in institutions and only included

women who were residing with their infants at thetime of the survey (5-14 months postpartum).Therefore, the survey excluded a population ofwomen who are more likely to have significantsubstance use disorders.

In Ontario, the Centre for Addiction andMental Health’s CAMH Monitor11, a longstandingsurvey of adult substance use, demonstrated that23% of women reported using prescription-typeopioid pain relievers in 2009 and 1% of thesewomen used the medication for non-medicalpurposes. The 2010 US National Household DrugSurvey12 reported higher rates of substance useduring pregnancy in a US population. Amongpregnant women aged 15 to 44, 4.4% were



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described as current illicit drug users with rates ashigh as 16.2% among pregnant women aged 15-17 years old. Illicit drug use included marijuana,cocaine, heroin, and others, as well as nonmedicaluse of prescription-type pain relievers and othersedating medications.

In 2009, Ontario established the NarcoticsAdvisory Panel which is comprised of familyphysicians, pain and addiction specialists,pharmacists, representatives from the coroner'soffice, professional regulatory bodies andmembers of law enforcement. Ontario now has aNarcotics Strategy13, which includes a narcotictracking system and also works with medical andpharmacy regulatory colleges to developeducational and training initiatives about painmanagement and appropriate prescribingpractices.

Opioid-dependent pregnant women require acomprehensive, integrated circle of care that linksphysicians, hospitals, public health, communityhealth centres, pharmacies, addiction and mentalhealth agencies, pain and methadone clinics,social services and child protection agencies. Theneeds of the substance using pregnant woman donot end when she gives birth, since she and herinfant will also require long term care andsupport.

There are very few comprehensive substanceuse programs for pregnant women in Canada.Ontario has a small number of residentialaddiction treatment programs that offer services topregnant women, but they are not available inmost communities. A major barrier exists sincecurrent residential programs do not address theunique needs of pregnant women who may haveother children at home. In addition, geographicbarriers may prevent pregnant and parentingwomen from obtaining addiction treatment.

As opioid use is increasing across Ontario,antenatal opioid exposure, both illicit andprescribed, is also increasing, leading to a rise inthe incidence of NAS and associated social risksand therefore a resultant gap in services andavailable resources. A coordinated, streamlinedplan is required to address needs across thecontinuum of care from preconception topostpartum as well as over the long term.

Clinical Practice GuidelinesScreeningRoutine screening of women of childbearing agenormalizes the conversations about the sensitivetopic of substance use. The primary goal ofroutine screening among this population is toencourage a change in substance use prior topregnancy in an effort to promote health andreduce the incidence of NAS. Routine alcohol andsubstance use screening of pregnant women isessential for early intervention aimed at reducingthe effects of alcohol and substance use includingthe risk of premature birth, low birth weight andpoor initiation of prenatal care.14

There is no optimal screening tool forsubstance use. However, given that pregnancyprovides a “window of opportunity” for women toengage in lifestyle changes to improve theoutcomes for newborns15, primary healthcareproviders are encouraged to follow the Society forObstetricians and Gynecologists of Canada(SOGC) Alcohol Use and Pregnancy ConsensusGuidelines (SOGC, 2010) and the Substance Usein Pregnancy Guidelines (SOGC 2011)16 toroutinely screen for alcohol and substance use.Accurate reporting of substance use in pregnancymay mitigate fetal and neonatal effects ofsubstance exposure through improved prenatalcare17 and secure early treatment such as opiatereplacement therapy to promote harm reductionfor both mother and developing fetus.18,19 To assistin accurate disclosure of substance use,communities are encouraged to develop educationstrategies to prevent adverse neonatal outcomesand educate women of childbearing age, as wellas practitioners about the impact of substance usein pregnancy. These campaigns should serve toraise awareness about the adverse health effects ofsubstance use in pregnancy, including the risk ofNAS in substance-exposed newborns.

Methadone Maintenance TherapyMethadone maintenance therapy (MMT) is thecurrent standard of care for the management ofopioid addiction in pregnanc.16 Several researchstudies address the multiple benefits of thistreatment including improved neonataloutcomes20,21,22,23 and the potential for astrengthened maternal-infant relationshipimmediately following the infant’s birth.



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Methadone is the treatment of choice for opioid dependent women in pregnancy. An urgent referralmechanism for pregnant opioid dependent women should be created to initiate Methadone Maintenancereatment (MMT) and for comprehensive care including prenatal care, addiction services, andpsychosocial support. (II-1B)

Contraception counseling is essential to prevent unplanned pregnancy. (III-B)

Collaboration among various health care providers of pregnant substance-using women and theirfamilies is critical to improved outcomes. (III-B)

Buprenorphine should be available and supplied for opioid dependent women during pregnancy. (I-A)

Where available, urgent referrals tomethadone maintenance programs during thecourse of pregnancy are recommended withcareful attention to ensure adequate dosageadjustments in an effort to eliminate withdrawaland cravings for illicit opioids.

Methadone is administered daily under thecare of a physician and pharmacist and, as such,offers consistent opportunities for engagementand intervention for medical and social riskfactors. Within a harm-reduction framework,MMT also facilitates improved access formethadone maintained pregnant women toprenatal care, addiction treatment services, andpsychosocial supports. Comprehensive careconsisting of MMT and obstetrical care forpregnant women has been shown to improvematernal and neonatal outcomes when comparedto continued illicit substance use.

Contraception CounselingMany women experience amenorrhea secondaryto substance use. Also, women on opioid agonisttreatment falsely believe that they cannot getpregnant and therefore do not use contraceptionwhich increases the risk of unplanned

pregnancies. Initiation to methadone orbuprenorphine maintenance treatment can resultin improved fertility and contraception counselingshould be included as part of this treatment orreferral for women’s health counseling should beoffered.24

Alternatives to MMTBuprenorphine is an effective alternativetreatment to methadone for opioid dependenceduring pregnancy. Studies have shown decreasedduration and severity of NAS and decreased needfor treatment resulting in shorter hospital stays ascompared with methadone.25,26 Therefore, accessto buprenorphine maintenance treatment duringpregnancy should be readily available. Currentlybuprenorphine is not available in Canada exceptby special access through Health Canada. Themonoproduct buprenorphine is recommended foruse during pregnancy instead of the readilyavailable combination product with naloxone. It isrecommended that the MOHLTC considerimproving access to buprenorphine for thetreatment of pregnant opioid users as analternative to methadone.

EducationSubstance-using pregnant women are oftenunprepared for the neonatal effects resulting fromin utero exposure to substances such as opioids,including methadone.27 Early preparation for theneonatal effects of substance exposure (NAS) andopportunities for parental involvement in the careof affected newborns create opportunities forsuccess of the family. Given the fears and stigmaassociated with substance use in pregnancy, theprimary goal of early preparation is to build thetherapeutic relationship and engage parents in the

needs and care of their infants. Through educationof women and their partners regarding the infant’shospital experience, including NAS, length ofhospital stay, role of the parent and resourcecontacts, families may be more prepared toeffectively care for infants with NAS. Strategiesfor engagement with families extend from writteneducation, to direct education and support fromthe healthcare team to both encourage andempower parental involvement with affectedinfants. The overall goal is to link with hospitalstaff and initiate a therapeutic relationship as well


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as to build trust and reduce anxiety for the parentsabout newborn care. This also provides anopportunity to assess potential parenting capacityand commence a risk assessment for any potentialchild protection concerns. Even when childprotection concerns are evident, a harm reductionapproach can make a difference in neonataloutcomes. Implementation of a parentalpartnership contract is valuable to enhancecommunication with parents and support their

involvement in the care of their infant. Thiscontract could include plans for feeding and skin-to-skin care, expected visiting commitments andmodes of communication with the team. It isrecognized that not all birth parents are positionedto provide direct care to their infants. Thehealthcare team should endeavor to be inclusiveof extended family and foster parents in the careof infants with NAS.

PTdNacpeicdivakeauitamdneoaso

The substance-using woman and her partner/family should be prepared and educated in advance for theirbaby’s hospital experience and management of NAS. (II-1B)

Every substance using woman should receive written materials explaining NAS, hospital stay expectations,


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role of the parent, and resource contacts, including the healthcare team. (II-1B)

ostnatal Screening and Scoringhe goal of screening is to achieve an accurateiagnosis for the purpose of treatment planningeonatal toxicology testing may be considered on

ll known and suspected cases of NAS28, Theseases include infants of mothers identified byrimary or obstetrical caregivers, mothersngaged in high risk behaviours, mothersdentified by child protection agencies or otherommunity agencies, mothers who disclose illicitrug use in pregnancy, mothers who act in anntoxicated manner on admission or during officeisits, and mothers with a positive history oflcohol and/or drug use/abuse. Screening innown and suspected cases of NAS is a highlyffective way to identify drugs of abuse.29 Resultsre critical to guide treatment, diagnose polydrugse, determine long term follow-up needs, anddentify social risks and referrals. Toxicologyesting should supplement maternal self-reportnd therefore may not be needed in cases ofaternal disclosure of substance use. A medical

irective facilitates early sample collection byurses. It is important that practitioners beducated to understand the need for a physicianrder, the importance of the first sample for urinend meconium, the proper collection method andtorage of samples and the consent requirementsf the specific organization. Practitioners should

be supported to develop a comfort level andconfidence in discussing toxicology testing withwomen and their families. An algorithm for theassessment and care of infants at risk of NAS isprovided in Figure 2.1. Toxicology screening includes the following,

but does not limit additional testing deemednecessary by the physician.30

2. Urine and meconium testing, ideally using thefirst sample passed as later samples may notbe positive.

3. Test urine for: cocaine (and its major metabolitebenzoylegconine), methamphetamine,amphetamine, cannabinoid, benzodiazepinesand opioids. In many centres testing foroxycodone requires a specific order.Confirmatory tests may also not be routine forpositive tests and need to be ordered if required.

4. If the urine is positive, do not repeat sametests on meconium. Test meconium only forfatty acid ethyl esters (FAEE)31 to documentantenatal alcohol use.

5. If urine is negative, consider testingmeconium for all substances listed in 1 b) andalso for FAEE.

6. Hair testing, at the discretion of the physician,after 2 days of life if the opportunity to collectfirst urine and meconium samples has beenmissed. Hair testing may be done up to3months of age, at which time neonatal hairsheds.



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Figure 2: Algorithm for Assessment and Care of Infants at Riskof NAS



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Urine testing detects recent exposure tomaternal drugs. The infant’s first urine sample isbest. A negative result should not be interpreted aslack of exposure because the drugs remain onlyfor a short time in the urine. Knowledge ofwindow periods for detection should beconsidered in proper interpretation of any testresults.

Meconium and neonatal hair tests are highlyeffective in identifying fetal exposure to drugs ofabuse beginning in the second trimester.Meconium testing detects longitudinal drug use.The infant’s first meconium is best. It may becollected and stored for later analysis when aphysician’s order is obtained. The range ofsubstances that meconium is tested for areimportant, not only to guide current treatment butalso long term treatment since not all long termeffects may be known at the time of testing.Infants with NAS are at high risk for in-uteroexposure to alcohol and other drugs of abuse.Objective assessment and identification of infantsat risk for Fetal Alcohol Spectrum Disorder(FASD) is very important for infants with NASbecause women with drug addictions aresubstantially more likely to consume multiplesubstances including alcohol.32 Meconiumanalysis of FAEE is a biomarker for heavymaternal drinking. Positive results put the child athigh risk (40%) for FASD. Positive FAEEindicates the need for neurocognitive follow-up ofthe infant.

Screening may create a conflict betweenmaternal and neonatal interests. Positive testresults for illicit substances necessitate a referralto inpatient social work for further psychosocialassessment of the family. Although positivetoxicology screens are indicative of potential riskto the child, further psychosocial assessment isneeded to determine the level of risk and strengthsin the family. All healthcare professionals have aduty to report potential risk to child protectionservices for further assessment. However,collaborative consultation amongst the teamproviding care to the mother-infant dyad isrecommended to establish the psychosocial careplan for the infant. Positive toxicology results mayindicate risk; however, factors such as MMTexposure in infants must be assessed prior toreferral. MMT in the absence of additional riskfactors does not require child protection

involvement. However, professionals must reportthat a child is or may be in need of protection,even when the information is otherwiseconfidential or privileged. The duty specificallyprevails over any provision of the Personal HealthInformation Protection Act (PHIPA) CFSAs.

Several scoring tools are available forquantifying the severity of neonatal withdrawaland one of these should be used to assesssuspected or known cases of NAS. A modificationof the Finnegan’s Neonatal Abstinence ScoringTool34 is recommended by the AmericanAcademy of Pediatrics and may be found in arecent publication.35 an adaption of another tool36

is provided in Figure 3 as an example andincludes a descriptive guide to assist with its usein the clinical setting.

Scoring should be initiated upon suspicion ofNAS. The purpose of using a scoring tool is toenable a systematic, objective, periodic andthorough evaluation of the infant to support theircare needs and identify the need forpharmacological therapy. The duration of initialscoring should be based on the half life of opioidused. In cases of methadone exposure, the infantshould be monitored with the scoring tool for 120hours since onset of withdrawal may be delayed.In cases of exposure to short-acting opioids,scoring for 48 to 72 hours is recommended.Scoring should be done with each care interaction,typically every 2-4 hrs. Pharmacological treatmentshould be initiated if 3 consecutive scores are ≥ 8 or the average of two scores or two consecutivescores are ≥ 12. Scoring is continued during treatment and weaning. After treatment has beendiscontinued, scoring should continue for anadditional 48-72 hours.

Mother-baby dyad care should be supportedwith rooming-in, if possible, until the infantrequires pharmacological treatment. In somecentres where cardiorespiratory monitoring isavailable on pediatric units, rooming-in may stillbe possible after the commencement ofpharmacological treatment. If an opioid exposedinfant does not withdraw in hospital, they willrequire referral to a knowledgeable care providerfor ongoing monitoring for NAS as an out-patient.The mother and caregivers should be educatedabout observing for signs of withdrawal afterdischarge. All mother-baby nurses will requireinstruction to effectively use the scoring tool so



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that disruption of mother baby dyad care will beminimized. The infant should be awake and calmfor scoring to be done. He/she should be observedundisturbed for approximately 1 minute,undressed to continue observations then redressed,swaddled and observed again for approximately 1minute. The score given should include generalobservations of infant behaviour in the precedingtime period since the last feed or careintervention. In the face of rising scores, scoringshould occur more frequently, and corroborationwith an expert resource person should occur, asrevisions to the plans for care may be necessary.Consideration for workload on the mother babyunit will be required when nurses are caring forinfants with NAS. It is important to identify aresource person with extensive knowledge andexperience to respond to questions and difficultcases on a consultation basis. Participation ofparents, family and other care providers shouldcontinue to be encouraged, even when the baby isin the NICU/SCN. During the weaning process,and when family or facility circumstances permit,all efforts should be made to promote care-by-parent and rooming-in opportunities. Pediatricunits may be utilized, where available, to promotesuch opportunities. If parents wish to dischargetheir infant against medical advice, the childprotection agency should be notified to complete arisk assessment. This action is not unique to theNAS population. However the risk to an infantwith NAS may be considerably greater than inother clinical situation

Non-pharmacological InterventionNon-pharmacological interventions should beutilized prior to the initiation of pharmacologicaltherapy. Practitioners in both the SCN/NICU andthe postpartum unit should be educated in the useof such interventions. In RCTs37,38,39 of healthyinfants, swaddling has been shown to decreasestartle responses, lessen arousals and prolongsleep. In excessively crying infants with cerebralinjury, swaddling significantly decreases theamount of crying compared with massage. It hasalso been shown to decrease the response topainful procedures but does not show anyinfluence on breastfeeding parameters such asnumber and duration of feeds, amount of milkingested or total duration of breastfeeding time.No RCT has specifically looked at swaddling in

the treatment of infants with NAS but it has beensuggested that it may be used as an effectivestrategy to support infants with NAS. Somestudies40,41,42 indicate that the act of breastfeedingby mothers taking methadone is associated withreduced NAS scores, delayed onset of NAS anddecreased need for pharmacologic treatment.Short term safety has been confirmed in the smallnumber of patients studied but long termdevelopmental questions have not beenadequately answered. Staff must be skilled inmeeting the support needs of the breastfeedingmother of an infant with NAS. Pumpingequipment and supplies need to be accessible andaffordable for the mother.

Breastfeeding is not recommended forwomen using illicit drugs until sobriety is reached.These women should pump and discard theirbreast milk to establish and maintain their milksupply. All substances of abuse have beendetected in breast milk and can lead to additionalexposure to these substances and potential forharm. Mothers who choose to continue theirsubstance use or who are unable to stop shouldseek individual advice on the risks and benefits ofbreastfeeding depending on their specificcircumstances.

Care of infants with NAS in NICU/SCNs isbest provided in space that has been adapted ormodified to decrease sensory stimulation includinglimiting visitors, minimizing overhead lighting,decreasing noise, using gentle handling andkangaroo care. There is very little support based onwell designed studies specifically looking at thispopulation. However, given the current state ofknowledge with regards to neonatal physiology andadaptive behaviours, it would seem appropriate tocontinue to promote the implementation of thesesupportive measures. 43,44,45,46

Use of pacifiers, hands-to-mouth, self-clinging and other self-soothing behavioursshould be supported in the management ofneonates with NAS and their beneficialimplications taught to care providers. Specificholding/constraining techniques, properpositioning and use of gentle firm pressure, andgentle vertical rocking can all support theneonates self-regulation. Rocking beds ormechanical swings should be used with cautionas there is evidence that for some neonates thismay result in over-stimulation during the acute


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period of withdrawal and may not beappropriate.47 Frequent, smaller volume,hypercaloric feeds are generally recommended forthose infants who have feeding difficulties due toregulatory control issues and/or poor weight gaindue to excessive caloric expenditure,gastroesphageal reflux and diarrhea. Dieticiansupport is part of the multidisciplinary approachto care of the neonate with NAS. It is paramountto involve the mother and her support person(s) in

all infant care unless there are safety concerns thatmay interfere with the therapeutic relationship.Even when child protection concerns are evident,a harm reduction approach can make a differencein neonatal outcomes. There should be acommitment to continue to educate the mother,her partner and family caregivers so that they areprepared to effectively care for the infant in theunit.

PMoapwomdLIes

pstsmsmUmuUpiAdwt

Non-pharmacological interventions should be utilized prior to pharmacological interventions. (III-B)Swaddling is beneficial to lessen arousals and prolong sleep. (III-B)

Breastfeeding is recommended and safe for methadone-maintained mothers. Breastfeeding is notrecommended for illicit drug-using women until sobriety is reached. (II-2B)

The baby’s environment should be modified to reduce sensory stimulation. Soothing behaviours,


497

positional support and frequent, smaller volume, hypercaloric feeds should be considered. (III-B)

harmacological Treatmentedication should be considered for the treatment

f NAS when supportive measures fail todequately ameliorate withdrawal. Whenharmacologic treatment is necessary the babyith NAS should be admitted to the SCN/NICUr pediatric unit where cardio-respiratoryonitoring is available. Local variations may

ictate the location of the infant for monitoring.evel I centres should consider transfer to a Level

I unit. Parental interaction should continue to bencouraged and observed to assess social risk andafety issues.

Morphine should be considered the first lineharmacologic treatment for NAS whenupportive measures fail to adequately amelioratehe signs of withdrawal. All 17 respondents in theurvey of Ontario hospitals reported usingorphine. Seven/eight of the practice guidelines

ubmitted describe only dosing regimens fororphine. In a survey of 235 neonatal units in theK and Republic of Ireland, 92% reported usingorphine.48 an alternate approach used by one

nit in Ontario that has also been reported in theS36 does not include a weight-based treatmentrotocol. Rather, a fixed dose of morphine isnitiated every 3-4 hours for each range of scores.lthough there is evidence to support symptomosing, generally accepted standards are foreight and symptom management. Other drugs

hat contain morphine include diluted tincture of

opium (DTO) and paregoric. Neither preparationis recommended for use today since both containalcohol and paregoric also contains camphor andbenzoic acid. Methadone is not currentlyrecommended for use in newborns due to its longhalf-life. It is used by some hospitals in the US totreat neonatal opioid withdrawal with length ofstays similar to those for morphine-treated infantsbeing reported49,50 however published experienceis lacking compared with that for morphine.

Morphine is indicated when the average ofthree consecutive scores is greater than or equal to8 on the scoring tool or when the average of twoscores or the scores for two consecutive intervalsis greater than or equal to 12. Dosing guidelinesare presented in Table 1.

Cardio-respiratory monitoring is recommendedfor all infants started on morphine for at least 4 daysand/or until the dose is reduced. Further monitoringshould be at the discretion of the physician. Littlehas been written or investigated with respect tocardio-respiratory monitoring for infants withNAS being weaned on morphine. However, theexpert panel recommends that this is the mostprudent approach.

Using barbiturates alone to treat NAS is notgenerally recommended unless there is a mixedwithdrawal syndrome. The use of morphine incombination with phenobarbital has been reportedin the treatment of infants whose symptoms arenot well-controlled with morphine alone but



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strong evidence of its efficacy is lacking.51 Arecently updated Cochrane Review52 concludesthat where a sedative is used, it should bephenobarbital in preference to diazepam,particularly when there has been polydrug abuse.

Clonidine has been explored as a possibletherapeutic option in combination with morphine.

One small randomized controlled trialdemonstrated that clonidine in addition tostandard opioid therapy reduced the duration ofpharmacotherapy for neonatal abstinence53,54 butevidence is currently insufficient to support itswidespread use.

FIG. 3 Sample Neonatal Abstinence Syndrome Scoring Tool



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FIG. 3 Continued Sample Neonatal Abstinence Syndrome Scoring Tool Guideline



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Non-pharmacological interventions should be utilized prior to pharmacological interventions. (III-B)

Swaddling is beneficial to lessen arousals and prolong sleep. (III-B)

Breastfeeding is recommended and safe for methadone-maintained mothers. Breastfeeding is not

recommended for illicit drug-using women until sobriety is reached. (II-2B)

The baby’s environment should be modified to reduce sensory stimulation. Soothing behaviours,

positional support and frequent, smaller volume, hypercaloric feeds should be considered. (III-B)

Pharmacological TreatmentMedication should be considered for the treatmentof NAS when supportive measures fail toadequately ameliorate withdrawal. Whenpharmacologic treatment is necessary the babywith NAS should be admitted to the SCN/NICUor pediatric unit where cardio-respiratorymonitoring is available. Local variations maydictate the location of the infant for monitoring.Level I centres should consider transfer to a LevelII unit. Parental interaction should continue to beencouraged and observed to assess social risk andsafety issues.

Morphine should be considered the first linepharmacologic treatment for NAS whensupportive measures fail to adequately amelioratethe signs of withdrawal. All 17 respondents in thesurvey of Ontario hospitals reported usingmorphine. Seven/eight of the practice guidelinessubmitted describe only dosing regimens formorphine. In a survey of 235 neonatal units in theUK and Republic of Ireland, 92% reported usingmorphine.48 An alternate approach used by oneunit in Ontario that has also been reported in theUS36 does not include a weight-based treatmentprotocol. Rather, a fixed dose of morphine isinitiated every 3-4 hours for each range of scores.Although there is evidence to support symptomdosing, generally accepted standards are forweight and symptom management. Other drugsthat contain morphine include diluted tincture ofopium (DTO) and paregoric. Neither preparationis recommended for use today since both containalcohol and paregoric also contains camphor andbenzoic acid. Methadone is not currentlyrecommended for use in newborns due to its longhalf-life. It is used by some hospitals in the USAto treat neonatal opioid withdrawal with length of

stays similar to those for morphine-treated infantsbeing reported49,50 however published experienceis lacking compared with that for morphine.

Morphine is indicated when the average ofthree consecutive scores is greater than or equal to8 on the scoring tool or when the average of twoscores or the scores for two consecutive intervalsis greater than or equal to 12. Dosing guidelinesare presented in Table 1.

Cardio-respiratory monitoring isrecommended for all infants started on morphinefor at least 4 days and/or until the dose is reduced.Further monitoring should be at the discretion ofthe physician. Little has been written orinvestigated with respect to cardio-respiratorymonitoring for infants with NAS being weaned onmorphine. However, the expert panel recommendsthat this is the most prudent approach.

Using barbiturates alone to treat NAS is notgenerally recommended unless there is a mixedwithdrawal syndrome. The use of morphine incombination with phenobarbital has been reportedin the treatment of infants whose symptoms arenot well-controlled with morphine alone butstrong evidence of its efficacy is lacking.51 Arecently updated Cochrane Review52 concludesthat where a sedative is used, it should bephenobarbital in preference to diazepam,particularly when there has been polydrug abuse.

Clonidine has been explored as a possibletherapeutic option in combination with morphine.One small randomized controlled trialdemonstrated that clonidine in addition tostandard opioid therapy reduced the duration ofpharmacotherapy for neonatal abstinence53,54 butevidence is currently insufficient to support itswidespread use.



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Medication should be considered for the treatment of NAS when supportive measures fail to adequately ameliorate

withdrawal. (III-B)

When pharmacological treatment is necessary, the baby should be admitted to the SCN/NICU or pediatric unit where

cardiorespiratory monitoring is available. (III-B)

Parental interaction should be encouraged and observed to assess social risk and safety issues.

Morphine should be considered the first line pharmacologic treatment for NAS when supportive measures fail.

Morphine is indicated when the average of three scores is greater than or equal to 8 on the scoring tool or when the

average of two scores or the scores for two consecutive intervals is greater than or equal to 12. (III-B)

Cardiorespiratory monitoring is required for all infants started on morphine and continued for 4 days and/or until the

dose is reduced. Further monitoring should then be at the discretion of the physician. (III-B)

TABLE 1 NAS Pharmacologic Treatment Protocol: Dosing guidelines

Morphine

Morphine is indicated when three consecutive scores are ≥ 8 according to the Modified Finnegan Scoring System or when the average of two scores or the scorefor two consecutive intervals is 12.If the scores remain ≥ 8 for 3 consecutive scores or ≥ 12 on 2 occasions, the morphine dose is increased to the next range i.e. by 0.16 mg/kg/day. If 0.80mg/kg/day fails to control signs of withdrawal, morphine may be increased to 0.96to 1.0 mg/kg/day. Clonidine (see below) should be considered at this point.

WeaningWeaning is initiated when scores are <8 for 24 to 48 hours and ordinarily occurs by10% of the total daily dose with each wean occurring no more frequently thanevery 48 hours to 72 hours. When the total daily dose is <0.2mg/kg/day,consideration may be given to weaning every 24 hours at the discretion of thephysician.

An alternate approach used by some centres is to wean by 0.05mg/kg/day every48 to 96 hours as tolerated.

In both approaches, morphine is discontinued when scores are stable for 48 to 72hours on a dose of 0.05 to 0.1 mg/kg/day.

Dosing guidelines

Score Oral Morphine Dose

8-10 0.32 mg/kg/daydivided q4-6h



17+ 0.80 mg/kg/daydivided q4-6h



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Discharge PlanningAlthough the condition of NAS is confined tothe immediate neonatal period, the needs ofinfants and families extend beyond the confinesof inpatient hospital care to the larger social andcommunity context. Due to the multiple medicaland psychosocial needs of mothers and infantswith NAS, careful discharge planning should beinitiated early in the admission and be inclusiveof both primary health care and psychosocialsupports for families. To avoid gaps in care andmonitoring of affected infants, the primary careprovider of the infant should be identified priorto discharge from the hospital, with a care planestablished for the ongoing assessment ofdevelopmental milestones. It is important thatpractitioners be educated about the importanceof ongoing care and monitoring of both medicaland social risk factors, and expected andsupported to create community partnerships thatcan facilitate transitions through a seamlessreferral process to comprehensive communitysupports. Neonates are at risk forneurodevelopmental impairment55 and thus mustreceive follow-up assessment from primary careproviders on discharge. Psychosocial follow upfor both mother and infant may includeaddiction services, counseling and supportprograms and home visitors to assist in ensuringpositive outcomes for both and to ensure thesafety of the infant. A professional home visitorsuch as a public health nurse specializing inassessing parenting capacity should be part ofthe circle of care at discharge to continue toaddress any risk factors that would compromisethe wellness of the infant and family unit. Thegoal of this type of community involvement is tosupport child development and relapse-prevention and to address risks associated withco-sleeping, SIDS, smoking, and shaken babysyndrome. Of equal importance, the dischargeplan should also ensure that the substanceabusing mother is linked to requiredpsychosocial, medical and addiction servicesthat promote safety and wellness for the infantand family in a community context.

Where the baby is discharged into the careof child welfare, it is essential to develop linksbetween foster parents and local primary careproviders that have expertise and experience inNAS. Teaching foster parents to recognize

withdrawal symptoms in a formerly asymptomaticinfant is vital to ensure that timely medical adviceand intervention is attained.

Given that many pregnancies are unplanned56,education and resources should be provided aboutbirth control, addiction services, MMT, and publichealth on an ongoing basis to promote positivedecision-making. Discharge from the hospitaloffers a unique opportunity to discuss and educatethe mother about planning or preventing futurepregnancies that may present with risk of NAS.

Discharging the infant home on morphineshould only be undertaken if the clinical team isconfident that the social risk is low, the infant isstable and that there is a clear and comprehensiveplan for weaning the infant. A designatedsupervisor is required who will monitor the infantclosely, at a minimum with a weekly visit.Following consultation with the clinical team, thefinal decision to discharge an infant onpharmacologic treatment is at the discretion ofthe physician. When assessing a family fordischarge prior to weaning, the following criteriashould be met: Stable supportive home environment Satisfactory psychosocial assessment

documented No identified risk to planned neonatal follow-

up Identified physician familiar with NAS and

medication weaning for post discharge carewho will follow the infant as often asnecessary but no less frequently than weeklyuntil the medication has been discontinued.

A clearly identified plan for weaning An ability to monitor the appropriateness of

timing of prescription renewals (maximum 7day prescriptions is recommended)

Care provider competence in measuring andadministering the medication should beobserved and documented while in hospital

Care provider education about signs of NASand the need to contact the physician if signsincrease

Care provider education regarding avoidanceof co-sleeping

Post-discharge follow-up with Public Health,CAS, addiction services or identifiedcommunity support worker as required

Pre-discharge case conference to identify anddocument the discharge plan.



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The primary care provider for the infant should be identified prior to discharge. (III-B)

A professional home visitor should be provided to continue to address risk factors and provide support .

(III-B)

Every baby exposed to opioids should have ongoing assessment by a clinical expert in assessing

developmental milestones. (II-3B)

Links between child protection services and the primary health care provider should be developed. (III-B)

The substance abusing mother should be linked to psychosocial, medical, addiction and social services

to ensure safety for the baby at home. (III-B)

Future pregnancies should be planned or prevented through education about risks of future pregnancy

and NAS. (III-B)

Discharging the infant home on morphine should only be undertaken if the clinical team is confident that

the social risk is low, the infant is stable and that there is a clear, comprehensive plan for weaning. (III-B)

CONCLUSION

Although the impetus for the formation of theNAS Work Group was concern regarding thevolume of neonatal beds occupied by infants withNAS across Ontario, the deliberations of the WorkGroup did not result in recommendations thatwould shorten length of stay directly or supportinfants with NAS being weaned at home unlessthe criteria detailed under Discharge Planning aremet. It is the view of the experts in this WorkGroup that standardizing clinical management ofthe substance using woman and the infant at riskfor NAS will result in improved outcomes. Theseimproved outcomes will be the direct result ofearly recognition of symptoms, expeditiousdiagnosis and prompt initiation of treatmentresulting in shortened length of stay. It is alsohoped that improved education of the risks ofopioid use during pregnancy will lead to adecreased incidence of NAS, through reduced useof opioids and/or contraception counseling.

Development of collaborative workingrelationships between hospital and communityclinicians, pain clinics, child protection agencies,

public health and socialservices will enhance thecircle of care and provide a supportive, holisticapproach to prenatal care and addictionmanagement that will not only benefit the womanand her family, but most importantly her unbornbaby. It will also form a long term supportnetwork for these high risk families. Culturalsensitivity is essential in order to engage FirstNations communities in partnership so thatsolutions can be identified to address the uniqueneeds in their communities.

NAS is a complex and multifaceted issue thatis escalating along with rapidly rising opioid usein Ontario. Reducing the incidence and impact ofNAS requires immediate action in order toimprove the care of affected women and infants.This includes optimizing and standardizingtreatment strategies, assessing and managingsocial risk, better monitoring of prescribingpractices and facilitating the implementation ofbetter treatment and prevention strategies as theybecome available. These guidelines provide theframework to inform and support the developmentof a coordinated strategy to address this importantissue.



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AcknowledgementsWe wish to thank the Ministry of Health andLong-Term Care for their enthusiastic support ofthe work of the expert panel. We wish toacknowledge the support and coordinationprovided by the Provincial Council for Maternaland Child Health. In particular, we thank JuneBarrett, former Senior Project Manager, SandraParker, Senior Project Manager and MarilynBooth, Executive Director for their commitmentand assistance with this work.

We accept that the views expressed hereinare those of the authors and do not necessarilyreflect the views of our partners. All errors andomissions are our own.

We wish to thank the following individualsfor their participation on the expert panel and theircontributions to the recommendations: Dr. TaraBaron, Dr. Tony Barozzino, Michelle Gahwiler,Pam Hill, Dr. Alan Hudak, Kim Kalata, WendyMousdale, Franz Noritz, Susan Oley and RitaPalumbo.

Finally, we wish to acknowledge CIHI fortheir help with data analysis.

Corresponding Author: [email protected]

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