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Dr Mary Rowlands Consultant Psychiatrist in Substance Misuse, ENDAS

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1 Dr Mary Rowlands Consultant Psychiatrist in Substance Misuse, ENDAS
SOLOMON’S JUDGEMENT Alcohol/Illicit drug use, misuse and dependent use Pharmacological interventions in pregnant substance misusers Dr Mary Rowlands Consultant Psychiatrist in Substance Misuse, ENDAS

2 LECTURE OVERVIEW Introduction –evidence limitations
Classification of misuse & dependence Gender & stigmatisation Effects of selectively clinically important drugs Evidence base of prescribing in pregnancy Interactive learning- Clinical multiagency practice & care pathways

3 Evidence-based practice is mostly extrapolated from non-pregnant studies
Evidence base for effects of illicit drugs on pregnancy (database search Medline, PsychLit) Evidence base for pharmacology interventions in pregnancy now established (BAP 2004) Pharmacological studies: Secretion of non-prescribed/prescribed drugs in breast milk Clinician weighs these limitations, social care needs and complex clinical presentation of pregnant drug misuser in the assessment of risk to foetus to guide multi-agency management Solomon had no evidence but used “clinical”judgement and chose the real motheras the woman whon acted in the best interest of her child

4 Differences between ICD-10 & DSM-4
ICD-10 classification of Harmful use (physical, psychological harms causing damage to health) Nature of harm identifiable and specified criticism is it is limited to health Continuous use for >1 month Time similar to DSM-4 in intermittent use of >12 months DSM(IV) abuse emphasises social complications including impairment of adult functional roles, recurring in physically hazardous situations , legal, interpersonal; never met criteria for dependence

5 Dependence definitions are more specific and similar
Control loss (compulsion), tolerance, withdrawal, (neuroadaptation) secondary symptoms of salience & persistence ICD-10 difference-reinstatement after abstinence DSM-4 difference is social,occupational, or recreational activities given up or reduced DSM5(2010) will emphasise that difference between abuse and dependence is the addicted state i.e. it is a behavioural difference in terms of pathological “disease” definition

6 Legality, availability & potency of abused substances changed in 20th Century
Cultural assimilation of “alien drugs “ is poor Legal until 1920 Contrasts with lifting of wartime alcohol restrictions

7 Unchanging social disapproval of
female substance misuse denigrates women Modern social pressures are hypocritical expecting women to match men in amounts abused e.g. binge pattern

8 Greater stigmatisation and adverse childcare outcomes compared to male drug misusers
Greater physical complications from substance misuse compared with males for same quantity of substance because there are gender differences in body mass, and fat to water distribution for water soluble drugs e.g.alcohol More common for substance dependent women to be in physically and emotionally abusive relationships

9 Mary Hepburn: Empowering women to make informed reproductive health choices
Prevalence of drug misuse has increased in both genders 2:1in terms of recent drug related deaths but M:F drug specialist service users is 3:1 improved was 4:1

10 Common themes in pregnant drug misusers
Ambivalence-fear of maternal role Versus motivation to change++ Low self esteem, extreme guilt Associated deprivation,domestic violence Reduced fertility but not infertile

11 Common themes in pregnant drug misusers
Irregular / absent periods No contraception Unplanned pregnancy common, further turmoil Risky chaotic lifestyle, Salience of drug seeking Poor multiagency attendance, avoids Social Service and antenatal

12 Alcohol-our favourite drug
Use <1 to 1 alcohol unit daily in pregnant (RCOG) Non-pregnant Hazardous use:>2-5 units daily (RCPsych) Harmful use: >5 units daily likely physical damage, especially binges Foetal alcohol syndrome May have modified syndrome Dose related effect including repeated binges & individual susceptibility

13 Foetal Alcohol Syndrome
Underweight,small in body length at birth poor growth and development failure to thrive Irritable or fractitious, tremulous, Poor sucking response Heart defects- about 30% Kidney problems-structural physiological Hyperactivity Delayed development-psychomotor & language

14 KEY Facial features-short upturned nose, indistinct upper lip & eye-lid narrowing
(receding chin)

15 Modified versus severe FAS

16 Stimulants- Physical signs of intoxication
Tachycardia Hypertension Sweating Pyrexia Dilated pupils But not always because: Chronic users develop tolerance

17 Stimulant Withdrawal “Crash”- depression, lethargy, hunger
Later- Craving, anxiety, irritability, depression, suicidal ideation Extinction- Specific cue related cravings

18 Amphetamine effect on foetus Low dose no evidence.
Harmful use: Higher dose, increased frequency Decreased head circumference Length and birth weight Growth restriction Increased rates of abruption Severe (Dependence): intracranial lesions- cysts haemorrhage, infarction

19 Cocaine most severe stimulant effects
Meta-analysis of studies showed similar effects to polydrug misuse whether or not they misused cocaine. Polydrug misuse was the norm in one Australian study.

20 Cocaine in USA pregnant, dependent users research associated with severe socio-economic deprivation
Confounding variable because infant mortality rates in these areas approached third world statistics Increased risk of abnormal pregnancy outcomes including increased rate of SIDS Cocaine vasoconstriction Increased abruption

21 Benzodiazepine effects on foetus
Diazepam-No proven association: head & digit abnormalities isolated reports contaminated by polydrug & alcohol misuse Chlordiazepoxide-non reproducible study showed increased teratogenicity in 0-42 days old foetus In high doses,?empirical definition>60mg/day/>3/12 Flat, flaccid baby at delivery after recent use Late pregnancy- increased neonatal hypothermia, hypotonia, respiratory depression Neonatal withdrawal symptoms: -poor feeding in full term, lower APGAR scores -respiratory depression in premature babies

22 Hallucinogenic drug effects on foetus
Plastic effects, unpredictable bad trips so less reinforcing and addict has more control Maternal health education that although unimportant clinically in adult, too little is known of the effect on the foetus Ecstacy also has stimulant effects (MDMA-methylene,dioxy, methamphetamine) Isolated reports of neurotoxic effects in adults related to frequent use commonly used in moderate doses No research on effect on foetus, mothers may seek health education on effect in the first trimester

23 Cannabis effects on foetus -most commonly used illicit drug
No consistent morphological abnormalities Some loose association with reduced birth weight & height. Subtle neurobehavioural abnormalities with heavy drug use described but not evidenced

24 Heroin dependence effects on foetus
No increased morphological abnormalities Reduced birth weight & height. Premature births Increased(2.5 x general population)peri-natal death rates Increased maternal death rates

25 Management of SU problems
Assess in therapeutic relationship History, MSE, physical, urines, bloods Other investigations as indicated Psycho-social investigations PPS formulation of problems Determine priorities Harm reduction


27 Management Physical Substitute pharmacology:-
Titration & stabilisation, &/or detoxification Psychological Motivational Interviewing; CBT; Relapse prevention; Support Social NA; Rehabilitate; Relate; Lifestyle changes; Safe environment

28 Clinical Management is still pragmatic !!!
Methadone Reduction in the middle trimester not a graded evidence base but expert consensus High rate of miscarriage in this group but rate 1 in 5 for all pregnancies so informed consent to start methadone in first trimester Drug misusers less often reach full term, but it may be more related to state of nutrition/placental function Increased blood volume in third trimester may require an increase in Methadone so all methadone reductions should stop theoretically at weeks if client informed maybe later

29 Methadone in pregnancy
Higher dose titration – Higher birth weights, Achieves more antenatal care Higher NAS I-P titration 10 to 20 mls, 4 hourly using modified Maudsley guidelines and opiate withdrawal scales Heroin withdrawal begins at 24 hrs+ for neonate Methadone withdrawal begins at 2-7 days Sub-acute withdrawal may persist for 4-6 months since slower metabolism in neonates (Bell GL) Acute withdrawal monitoring in first month increased risk of SIDS, failure to thrive,fits,infection

30 Methadone Assess/Treatment
Quantity, frequency and route of use duration of opiate (heroin or methadone) use Stage of pregnancy Past AND CURRENT treatment response MMT Plus Comprehensive multi-agency antenatal care Contingency planning for lapses in a chronic relapsing condition, even if a trial of abstinence in highly motivated Regular core group reviews Essential contingency plans

31 Methadone in pregnancy increases duration, reduces complications & improves birth weight
Reduces illicit drugs Reduces blood borne virus risk to mother and baby Increases antenatal engagement Reduces foetal distress by ?steady blood opiate levels <20ml reduces NAS but does not reduce illicit drug use, or infant death rate

32 Buprenorphine [Subutex] in pregnancy
Same rationale as Methadone Competative agonist Agonist-Antagonist -less intense opiate side-effects Blocks opiate based pain relief in labour NAS less severe but less established evidence Continue with pre-pregnant stabilised patient with informed consent but initiation complicated by need for early withdrawal Previous Buprenorphine stabilization needs to be considered

33 Opiates-Postpartum Neonatal Withdrawal Syndrome (NAS)
Narcan should not be given, Increases rate of perinatal mortality by precipitating severe withdrawal Jittery babies, poor feeding High pitched cry,vulnerable to fits. Rx Neonatal Paediatrician, Obstetrician,or SCBU May need oromorph

34 Opiates- Postpartum follow-up
Methadone exposed foetus showed no difference in developmental progress compared with socially matched peers, in S London (Burns 1996)

35 Opiates-Postpartum follow-up
The health and development of a group of children aged 3-7 years born to and reared by mothers who abused opiates when pregnant and who remained on methadone maintenance was compared to a group of age and socially matched control children. There was no difference between the two groups in terms of health and development although smaller head circumference measurements than the controls.

36 Opiates-Postpartum follow-up
More than half of the index children had been on the child protection register during infancy; all but one were off the register at the time of the study Results suggest that drug-abusing women who are on methadone maintenance and attending a drug dependency unit may rear and care for their children as well as parents from a similar social background who are not drug abusers.

37 Breast feeding Low breast milk drug level (DOH) All mothers encouraged
3% of maternal plasma level in one study But 1-2 hours after any opiate medication advised Baby immunity improved Weaning off gradually helps manage but insufficient milk drug level to avoid NAS Except Risk of vertical transmission HIV Also in Hepatitis B / C

38 Breast feeding contraindication if
Pregnant drug misuser is chaotic, or inconsistent use Not engaged or stabilised on methadone High dose Methadone >80mls stabilised does not exclude Cocaine (also passes into breast milk) Heavy amphetamine use increases neonate jitters, irritability Benzodiazepines sedate

39 Ia: Evidence from meta-analysis of randomized controlled trials
BAP Recommendations Categories of evidence for causal relationships and treatment Ia: Evidence from meta-analysis of randomized controlled trials Ib: Evidence from at least one randomized controlled trial IIa: Evidence from at least one controlled study without randomization IIb:Evidence from at least one other type of quasi-experimental study

40 BAP Recommendations III: Evidence from non-experimental descriptive studies, such as comparative studies, correlation studies and case-control studies IV: Evidence from expert committee reports or opinions and/or clinical experience of respected authorities

41 BAP Recommendations Proposed categories of evidence for observational relationships
I: Evidence from large representative population samples II: Evidence from small, well-designed, but not necessarily representative samples III: Evidence from non-representative surveys, case reports IV: Evidence from expert committee reports or opinions and/or clinical experience of respected authorities

42 BAP Recommendations Strength of recommendation
A: Directly based on category I evidence B: Directly based on category II evidence or extrapolated recommendation from category I evidence C: Directly based on category III evidence or extrapolated recommendation from category I or II evidence D: Directly based on category IV evidence or extrapolated recommendation from category I, II or III evidence S:Standard of Care based on expert practical or ethical consensus

43 BAP Recommendations Nicotine & pregnancy
Psychosocial interventions should be offered since they are effective(A) Risk:benefit ratio should be considered for offering nicotine replacement therapy © Reduces low birth-weight & pre-term babies Bupropion(amfebutamone) should be avoided no published evidence

44 BAP Recommendations Alcohol & pregnancy
Women should be advised not to drink alcohol or at most,one drink per day(S) Adequate screening should be routine(S) Psychosocial interventions should be offered & be the mainstay of treatment(B) Patients with symptomatic withdrawal should be offered medical cover for their detoxification ideally, as an in-patient(D) Medication to sustain abstinence should be avoided(D)

45 BAP Recommendations Alcohol & pregnancy
Key uncertainties Risks of alcohol withdrawal versus benzodiazepine prescribed versus continued alcohol consumption to the foetus and whether any trimester carries more risk than at other times? Risk of acamprosate, naltrexone or disulfiram in pregnancy?

46 BAP Recommendations Opioids and pregnancy
Methadone maintenance results in improved maternal & foetal health & should be offered to opioid dependent pregnant women (B) Less data are available for buprenorphine maintenance but it appears similar benefits are seen for mothers & foetus as for methadone(B) Detoxification should be avoided in the first trimester, is preferred in the second & used with caution in the third.

47 BAP Recommendations Opioids and pregnancy
Methadone is the best known substitute pharmacotherapy in pregnancy & will usually be the first choice; however, recent experience with buprenorphine is encouraging. Clinicians may therefore consider continuing buprenorphine in patients doing well on established treatment. Potential problems with opioid analgesia during labour must be anticipated

48 BAP Recommendations Opioids and pregnancy
Key uncertainties Does Methadone or buprenorphine have advantages over the other in terms of maternal or foetal /neonatal outcomes?

49 BAP Recommendations Stimulants and pregnancy
Limited evidence to make any recommendations except say ‘stop’ Substitution therapy is not recommended despite no studies(S) What to offer?

50 Lecture Summary Use and misuse is quantitatively imprecise in terms of foetal drug plasma levels achieved, addictive behaviour/patterns can guide clinically The mainstay of treatment for use, misuse is education and brief interventions. Awareness of the potential risk of teratogenicity poor health in mother leading to poorer neonate outcomes, Advice aimed at the harm reduction that the mother can achieve and working to a hierarchy of health enhancing goals

51 Lecture Summary Highest adverse foetal effect of high dose misuse
and dependence especially stimulants and alcohol. In the majority of cases pharmacological alcohol detoxification is not required. Inpatient management is recommended. BAP recommendations for high dose Methadone maintenance to improve outcomes for mother and baby, but evidence base for buprenorphine is increasing, but dose effect is unknown.

52 REFERENCES: Evidenced based guidelines for the pharmacological management of substance misuse, addiction and comorbidity: recommendations from British Association for Psychopharmacology, Journal of Psychopharmacology(2004) Management of drug misuse in pregnancy Ed Day & Sanju George Advances in Psychiatric Treatment, Journal of Continuing Professional Development, The Royal College of Psychiatrists,Vol 11,Issue 4, July 2005, ,

53 REFERENCES:- Methadone Neonatal Withdrawal
Bell GL,Lau K Pediatr Clin North Amer,1995 Apr;42(2): Drug Misuse in Pregnancy Breastfeeding Project (2003) Breastfeeding and Drug Misuse: An Information Guide for Mothers: University of Plymouth.

54 REFERENCE:- The health and development of children whose mothers are on methadone maintenance. Claire Burns , Margaret O'Driscoll , Gem WasonChild Abuse Review Volume 5, Issue 2, Pages (May 1996) Solomon had no evidence but used “clinical” judgement that the mother that acted in the best interest of her child was the true parent

55 Case Study Late presenter isolated with partner
Stabilisation as in-patient revealed minimisaton of use Informed maternal decision to breast-feed Complicated attitude from partner-previous partner died blamed drug services, he had care of 7 year-old daughter of this relationship Medical history of this child of congenitalheart disease hidden Social services assessed as safe to return home with other child at core meeting

56 Further pre-discharge meeting mother determined to breast-feed although duration of stabilisation was short-full risk info given Neonatal paediatrician found no spcific signs of withdrawal—did not access maternal notes(system now changed) Mother went home and apparently cooperative with community mid-wives Not informing them nursing baby in bed Over a weekend unilaterally rapidly reduced Methadone dose-pharmacist unaware recently delivered-used heroin, baby rolled off bed died of hypothermia

57 Lessons from local perinatal death of continued Maternal Heroin Use whilst prescribed Methadone Post-natally Risk to baby increased if no evidence of clean urines and/or unstable drug use even though the addiction treatment service philosophy and evidence base is harm reduction but heroin use must be reduced enough to allow a suitable environment for safe &sustainable child care routines and requires urgent review which may need to be intensive & on-going e.g. be aware of protracted neonatal methadone withdrawal, twice weekly drug urinalysis during early post-natal period > 14 days, supplemented by further health & social care worker monitoring

58 If there is evidence of continued drug use then drug using carer in the household increases risk of harm to the child post natally Risk management is required of the potential for mother to fall asleep at night whilst feeding baby, due to heroin use on top of methadone, but what should be the child protection consequences of “dirty urines”, in practice social services reluctant to implement child removal if mother is “cooperating”with drug & obstetric services and prescribed Methadone

59 Should mother & baby be admitted to increase dose of methadone for safe monitoring, what about the risk assessment and management if other children require child care Previous parenting may not be relevant since past drug misuse may have been more stable & less severe than current drug misuse

60 If parents are rejecting of services antenatally and present later in pregnancy more child protection is needed if parental preference is for breast feeding, both in terms of access to the home &/or trying to control the script by altering medication without involvement of keyworker or prescriber, this behaviour increases risk & communication from pharmacist essential

61 Proposed Care Pathway developed locally
Rapid assessment including health education for harmful use and access into treatment ideally no later than early in middle trimester Prompt Specialist S/m Cons and liaison nurse involvement, and Cons O&G S/m Specialist 5ml/week reduction or stabilise by 32 week ideally then involve neonatal paediatrician to plan neonatal management at & post-delivery, into puerperium

62 Proposed Care Pathway contd
Locally developing multiagency guidelines with social services with 4 weekly core group meetings For the future aspirations to more shared care with GPSi and antenatal services but multiagency pathways must first work in practice in specialist services before altering the model of service

63 Management of primary dependent stimulant users is a greater issue for amphetamine rather than cocaine in SW England. Polydrug use is the norm. Systematic development of pilot intensive community based psychosocial programmes is required to improve evidence of enhanced foetal outcomes BAP recommendations underscore the experimental evidence base as well as the expert consensus for treatment of pregnant drug misusers which does exist & should be incorporated in routine joint working between obstetric, social & substance misuse services

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