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Treatment: Caring for Specific Populations - Dr. Sarah Melton and E. Kyle Cook

Treatment: Caring for Specific Populations - Dr. Sarah Melton and E. Kyle Cook

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  • 1. Caring  for  Specific  Popula2ons   Sarah  T.  Melton,  PharmD,BCPP,BCACP,CGP,FASCP   E.  Kyle  Cook,  APN,  NNP-­‐BC  
  • 2. Disclosure  Statements   •  Sarah  T.  Melton  has  no  financial  rela5onships   with  proprietary  en55es  that  produce  health   care  goods  and  services.   •  E.  Kyle  Cook  has  disclosed  no  relevant,  real  or   apparent  personal  or  professional  financial   rela5onships.  
  • 3. Learning  Objec5ves   1.  Describe  the  role  of  each  member  of  the  interprofessional   team  (e.g.,  physician,  nursing,  clinical  pharmacist,  addic5on   counselor,  and  peer  recovery)  in  providing  outpa5ent   medica5on-­‐assisted  care  for  the  pregnant  woman  with   opioid  dependence  in  Appalachia.       2.  Assess  whether  the  pregnant  pa5ent  is  mee5ng  desired   outcomes  in  an  outpa5ent  opioid  treatment  facility.   3.  Discuss  how  the  interprofessional  team  communicates   treatment  plans  with  outside  providers  (e.g.,  obstetricians,   neonatologist,  primary  care)  during  the  pregnancy  to   ensure  best  possible  outcomes  for  the  mother  and  baby.   4.  Design  a  comprehensive  outpa5ent  program  to  meet  the   referral  and  popula5on  needs  of  indigent,  pregnant  women   with  opioid  dependence  in  rural  Appalachia.    
  • 4. Caring  for  Pregnant  Women  Addicted  to   Opioids  in  Rural  Appalachia:     An  Interprofessional  Collabora<on    Wednesday,  April  23,  2014,  1:30  pm  –  2:45  p.m.   .   Sarah  T.  Melton,  PharmD,BCPP,BCACP,CGP,FASCP  
  • 5. Learning  Objec5ves   1.  Describe  the  role  of  each  member  of  the  interprofessional  team   (e.g.,  physician,  nursing,  clinical  pharmacist,  addic5on  counselor,   and  peer  recovery)  in  providing  outpa5ent  medica5on-­‐assisted  care   for  the  pregnant  woman  with  opioid  dependence  in  Appalachia.       2.  Assess  whether  the  pregnant  pa5ent  is  mee5ng  desired  outcomes   in  an  outpa5ent  opioid  treatment  facility.   3.  Discuss  how  the  interprofessional  team  communicates  treatment   plans  with  outside  providers  (e.g.,  obstetricians,  neonatologist,   primary  care)  during  the  pregnancy  to  ensure  best  possible   outcomes  for  the  mother  and  baby.   4.  Design  a  comprehensive  outpa5ent  program  to  meet  the  referral   and  popula5on  needs  of  indigent,  pregnant  women  with  opioid   dependence  in  rural  Appalachia.    
  • 6. •  Mission   To  merge  cu@ng  edge  medical  care  and  an  authenCc   recovery  community  to  heal  lives  broken  by  addicCon   •  Loca5on   •  Southwest  Virginia   •  Russell  County,  VA     •  3rd  highest  overdose  death  rate  in  the  Commonwealth   •  Only  provider  for  pregnant  women  with  opioid  addic5on    in   a  4-­‐county  region  
  • 7. Treatment  Team   •  Samuel  Melton,  MD,  FAAFP,  ABAM   •  Margaret  Gregorczyk,  MD   •  Hope  Fennewald,  LPC,  CSAC   •  Sarah  Melton,  PharmD,  BCPP   •  Angie  Muncy,  Peer  Recovery  Coach   •  Steve  Ray,  Peer  Recovery  Coach   •  Dwight  Sullins,  Peer  Recovery  Coach  
  • 8. Pregnancy  Referrals   •  Local  Community  Service  Boards   •  Department  of  Social  Services   •  Court,  proba5on  system   •  Obstetricians   •  Self-­‐referral  
  • 9. Program   •  Mo2va2onal   Enhancement  Therapy   •  Communica2on  with   obstetrician  and   pediatrician  before  &   a@er  delivery   •  One-­‐on-­‐one  mee2ng  with   physician  and  cer2fied   substance  abuse   counselor   •  Comprehensive  drug-­‐of-­‐ abuse  history   •  Treatment  agreement   (signed  by  pa2ent  and   provider)  
  • 10. Program   •  Educa5on  and  baseline  laboratory  studies   •  Induc5on  onto  buprenorphine   •  Group  therapy  with  other  pregnant  women   •  Stabiliza5on  and  maintenance  of  therapy   •  Prepara5on  for  delivery,  pain  management,   breaseeding,  contracep5on  
  • 11. Program   •  Insurance  accepted  like  all  medical  condi5ons   •  Witnessed  urine  drug  screening,  breath  alcohol  each  visit   •  Pill/film  counts  (each  visit  and  at  random)   •  Program  is  zoned  based  on  stability  and  support  level   •  Zone  0:  3  5mes/week  visits  at  start  of  program   •  Zone  4:  Poten5al  of  monthly  visits  when  pa5ent  is   working,  volunteering,  or  ac5vely  engaged  as  a   caretaker  of  children   •  Mandatory  support  sessions  between  visits  (NA,  AA,   Celebrate  Recovery)   •  Monthly  individual  counseling  visits  with  the  addic5on   counselor  required   •  Assessment  for  mood  or  anxiety  disorders  as  well  as  other   medical  condi5ons.  
  • 12. Program   •  Medica5ons  not  allowed  in  the  program   •  Benzodiazepines   •  Gabapen5n   •  Pregabalin   •  Carisoprodol  and  other  muscle  relaxants   •  Seda5ve-­‐hypno5cs   •  Other  controlled  substances  
  • 13. Monitoring   •  Pa5ents  earn  a  discharge  warning  for  viola5ng  any   treatment  requirement     •  Posi5ve  urine  drug  screens  for  substances  other  than   buprenorphine     •  Incorrect  pill  count     •  Nonadherence  with  appointments  for  group,  counseling,  or   support  group  mee5ngs   •  Not  showing  for  random  urine  drug  screen  or  pill  count     •  Rude  or  disrup5ve  behavior  at  either  office  or  pharmacy     •  Evidence  of  aberrant  behavior   •  Prescrip5on  Monitoring  Program  results   •  Early  refills   •  Lost  prescrip5ons   •  Doctor  shopping  
  • 14. Outcomes  –  In  Progress   July  2012  -­‐  present   •  41  pregnant  females   •  Average  age:  25  years   •  70%  first  pregnancy   •  75%  enter  very  early  in  pregnancy,  others  in  2nd  or  3rd   trimester   •  Average  dose  of  buprenorphine  =  11  mg  daily   •  85%  also  use  tobacco     •  Number  of  neonates  with  Neonatal  Abs5nence  Syndrome   (NAS)  requiring  extended  stay  in  hospital:    16   •  Length  of  stay  ranged  from  3  days  to  3  weeks;  most  had   stays  less  than  1  week     •  Dose  of  buprenorphine  does  NOT  correlate  with  NAS    
  • 15. Outcomes  –  In  Progress   July  2012  -­‐  present   •  Most  neonates  had  minimal  NAS,  those  with   most  severe  NAS  came  into  program  late  into   pregnancy  or  con5nued  to  test  posi5ve  for  illicit   substances   •  6  pa5ents  remained  in  program  ajer  delivery     •  Program  “too  strict”   •  Transporta5on  difficulty   •  Family  not  suppor5ve   •  Return  to  using  illicit  substances   •  3  pa5ents  discharged  during  pregnancy   •  4    discon5nued  treatment  on  their  own    
  • 16. Recurrent  Issues   •  Physical,  sexual,  and  emo5onal  abuse   •  Exposure  to  violence   •  HIV  and  Hepa55s-­‐C  at-­‐risk  behaviors   •  Concomitant  drug  use   •  Co-­‐occurring  psychological  issues   •  Lack  of  family  support   •  Insecurity  about  paren5ng  skills   •  Legal  issues   •  Lack  of  educa5on,  training  for  employment   •  Nutri5on  
  • 17. Take  Home  Messages  from  Our  Team   •  More  pregnant  women  are  addicted  than  we   realize   •  All  pregnant  women  should  be  screened  for   substance  abuse  with  appropriate  screening   instruments   •  Urine  drug  screens  during  pregnancy  are   helpful  to  iden5fy  substance  abuse  and  help   prevent  or  limit  NAS    
  • 18. Take  Home  Messages  from  Our  Team   •  Buprenorphine  is  not  a  perfect  answer  as  babies   are  ojen  born  dependent,  but  bener  than  illicit   use  of  substances  and  alcohol   •  Pregnant  women  with  addic5on  need  to  be   treated  with  care  and  kindness  –  s5gma  prevents   many  from  seeking  appropriate  treatment   •  Pregnancy  can  be  a  powerful  mo5vator  for   pa5ents  to  work  on  recovery   •  Teachable  5me   •  Benefit  from  lots  of  support  with  weekly  visits      
  • 19. Take  Home  Messages  from  Our  Team   •  There  are  some  mothers  who  have  already   hurt  their  babies  with  alcohol  and  drugs   before  they  come  into  treatment,  and  some   mothers  simply  will  not  or  cannot  accept  help   for  their  addic5on   •  Pregnant  women  must  be  held  accountable   like  other  pa5ents  with  regard  to  support   sessions,  counseling,  relapses,  etc.    
  • 20. Take  Home  Messages  from  Our  Team   •  It  is  impera5ve  to  maintain  close  contact  with   the  obstetricians,  especially  at  the  5me  of   delivery   •  Post-­‐delivery  and  post  C-­‐sec5on  pain  can  be   managed  with  extra  buprenorphine  rather  than   switching  to  the  usual  opioids,  which  may   increase  relapse  rates   •  Keeping  mothers  in  treatment  ajer  delivery  is   challenging  
  • 21. Take  Home  Messages  from  Our  Team   •  Consider  advoca5ng  for  pregnant  mothers  to   remain  in  treatment  6  months  ajer  delivery   to  avoid  involvement  of  Child  Protec5ve   Services   •  This  allows  12  months  of  therapy  AND  lets   recovery  be  part  of  their  recovery  from   pregnancy  so  they  can  see  that  they  can  stay   abs5nent  when  not  pregnant  
  • 22. Resources  for  Prac5ce   hnp://store.samhsa.gov/product/TIP-­‐51-­‐Substance-­‐Abuse-­‐Treatment-­‐Addressing-­‐ the-­‐Specific-­‐Needs-­‐of-­‐Women/SMA13-­‐4426   hnp://www.who.int/ substance_abuse/ac5vi5es/ pregnancy_substance_use/en/  
  • 23. NEONATAL  ABSTINENCE  SYNDROME    TREATMENT  CHOICES     AND     CHALLENGES   E.  Kyle  Cook,  APN,  NNP-­‐BC  
  • 24. Opioids are not the only type of drugs that cause withdrawal symptoms.       Other substances can cause withdrawal symptoms in a baby and cause neonatal drug withdrawal syndrome (ICD-9 code 779.5) (ex: Caffeine, tobacco) Most  are  exposed  to  mul2ple  classifica2ons  of  drugs  which   can  cause  withdrawal  symptoms  if  the  baby  is  dependent   and  the  source  of  the  drug  is  interrupted  at  birth     Withdrawal vs NAS
  • 25. Morphine  would  be  both  an   opiate  and  an  opioid     Methadone  would  be  an   opioid  but  not  an  opiate     So  all  opiates  are  opioids,  but   not  all  opioids  are  opiates..    
  • 26. Neonatal Abstinence Syndrome (NAS)   •  Constellation of withdrawal symptoms   •  CNS   •  Inconsolability, high-pitched crying, skin excoriation, hyperactive reflexes, tremors, seizures   •  GI   •  Poor feeding, excessive sucking, feeding intolerance, loose or watery stools   •  Autonomic/metabolic   •  Sweating, nasal stuffiness, sneezing, fever, tachypnea, mottling"
  • 27. Agonist  Treatments  for  Opiate-­‐Dependent   Pregnant  Women   • Methadone,  buprenorphine,  (BPH)  slow  release   morphine     • Cochrane  review  of  271  pregnant  women  from  4   trials  analyzed   • High  drop  out  rate  (30-­‐40%),  with  methadone   beZer  than  other  treatments   • No  differences  in  side  effects  in  mothers,  less   frequent  with  BPH  in  infants     • No  overall  difference  in  the  incidence  of  NAS,  but   BPH  may  be  beZer   • Maternal  dose  not  associated  with  NAS  
  • 28. Neonatal  Abs2nence  Syndrome   • Gene2c  factors  may  be  important   • Single  nucleo2de  polymorphisms   (SNPs):  Single  base  pair  changes   that  can  alter  protein’s  func2on   • SNPs  influence  opioid  dosing,   metabolism,  and  addic2on  in   adults   • No  prior  studies  of  gene2c  links  to   NAS  
  • 29. What  is  Epigene2cs?   •  Changes  in  DNA   (methyla2on,  histone   modifica2on)  affec2ng   func2on  without  a  change   in  the  sequence   •  Environmental  triggers   •  Can  lead  to  gene  silencing     •  Can  be  passed  on  through   genera2ons  
  • 30. Epigene2cs  of  Addic2on   •  Chronic  opioid  exposure  can   lead  to  methyla2on  at  CpG   sites  within  the  OPRM1  gene     •  Increase  in  OPRM1  promoter   methyla2on  -­‐  decreased   mRNA  content  and  reduced   levels  of  the  mu  opioid   receptor   •  Methyla2on  =  Gene  silencing   •  Changes  can  be  passed  on  to   the  next  genera2on      
  • 31. Adult  Opioid  Dependence   • SNPs  present  in  40-­‐50%  of  the  popula2on  have  been   studied  in  adults   • Mu  Opioid  Receptor  (OPRM1)  =  Site  of  Ac<on   •  118A>G  SNP   • Mul2-­‐Drug  Resistance  Gene  (ABCB1)  =  Transporter   •  1236C>T  SNP;  3435C>T  SNP;  2677G/T/A  SNP   • Catechol-­‐O-­‐methyltransferase  (COMT)  =  Modulator   •  158A>G  SNP    
  • 32. JAMA.  2013;309(17):1821-­‐1827  
  • 33. Candidate  Genes  for  NAS   • Mu  Opioid  Receptor  (OPRM1)  =  Site  of   Ac<on    118A>G  SNP   • (switch  that  turns  on  and  of  opiate  receptor  on  and  off)   • Catechol-­‐O-­‐methyltransferase  (COMT)  =  Modulator   • 158A>G  SNP    
  • 34. Future  Direc2ons   • NIH  Grant  –  “Improving  Outcomes  in  Neonatal   Abs2nence  Syndrome”   • Randomize  188  infants  to  receive  morphine  or   methadone  (best  prac2ce)     • Evaluate  long-­‐term  neurodevelopmental   outcomes  of  infants  treated  for  NAS   • Establish  other  gene2c  factors  -­‐  Addic<on  Array   (1350  SNPs),  epigene2cs  
  • 35.  What  we  think  we  know,     may  not  be  so   Epigene5cs  may  play  greater  role  in  severity  and   dura5on  of  withdrawal  more  than  drug,  dose,  and   dura5on  of  intrauterine    
  • 36. Intrauterine Drug Exposure   The presence or absence of ! NAS ! does not ! indicate the severity ! of ! intrauterine drug exposure or abuse.  
  • 37. NAS  SCORING  TOOLS   Finnegan  Neonatal   Abs5nence  Scoring  System   Lipsitz  Neonatal  Drug-­‐ Withdrawal  Scoring  System   Ostrea  Tool   Neonatal  Withdrawal   Inventory   Neonatal  Narco5c   Withdrawal  Index  
  • 38. FINNEGAN    
  • 39. Treatment  of  NAS   • Significant  variability  in  treatment  (weight,  score)  with  no   large,  randomized  trials   • Morphine  is  the  most  common  and  methadone  the  2nd   most  commonly  used  drug   • Sublingual  buprenorphine  also  being  studied   • Morphine  has  a  shorter  half  life  (dosed  every  4  h);   methadone  dosed  every  8  -­‐  12  h   • Clonidine,  phenobarbital  -­‐  second  line  drugs   • Some  pediatricians  are  discharging  babies  on  methadone,   phenobarb;  weaning  as  an  outpa2ent  
  • 40. Treatment  of  NAS  
  • 41. Morphine  vs  Methadone   Which  drugs  should  be  used  in  NAS:   • Results  from  a  small  clinical  trial   • Results  in  older  children,  adults   • Lectures  or  ar2cles  from  “experts”     • We  should  not  translate  borderline  evidence   into  standard  of  care   • We  need  large  randomized,  controlled  clinical   trials  to  help  us  decide  
  • 42. Morphine  in  Newborn  Infants   • 898  preterm  infants  received  either  morphine  or  placebo   for  pain  control   • Morphine  group  with  higher  rates  of  death,  severe  IVH,   PVL,  hypotension,  worsened  respiratory  outcome,  delayed   feeds   • At  7  years  old,  smaller  HC  and  weight,  more  social   problems,  less  task  oriented,  weaker  short  term  memory   • May  develop  seizures  or  increased  brain  apoptosis  (animal   models)  –  Smart  Tots  ini2a2ve  at  FDA  
  • 43. Norman  et  al,  Clin  Invest,  2013   BP   SaO2   EEG  
  • 44. Weight  Based  Dosing  Regimen   • Star5ng  dose  and  escala5on  occurs  if  the  infant  con5nues   to  have  NAS  scores  ≥  8  for  2  consecu5ve  scores,  or  1  score   ≥ 12   • Dosing  related  to  BW  and  Finnegan  score   • Wean  10%  of  the  total  dose  every  24  -­‐  48  hours    Level    NAS  Score    Star5ng  Dose  -­‐  0.4mg/mL          1            8-­‐10              0.3  mg/kg/day  ÷  q4h          2            11-­‐13            0.5  mg/kg/day  ÷  q4h          3            14-­‐16            0.7  mg/kg/day  ÷  q4h          4            17+              0.9  mg/kg/day  ÷  q4h  
  • 45. ETCH Treatment Plan Holistic multidisciplinary approach – Non-Pharmacological •  Environment •  Diet •  Cuddlers – Pharmacological •  Oral Morphine Sulfate – Symptom-based vs weight-based dosing •  Non-narcotic – Acetaminophen – Simethicone
  • 46. ETCH   TREATMENT   ALGORITHM  
  • 47. ETCH Haslam Neonatal Intensive Care Unit   •  152 beds / Level III NICU – 60 beds" •  30-50 % of our NICU admissions 
 primarily for NAS treatment" •  135 admissions for 2011" •  283 admissions for 2012" •  258 admissions for 2013" •  Highest daily census: 37 in September, 2012   Average Daily Census for NAS babies 1st Quarter (JAN-MAR) 2nd Quarter (APR-JUN) 2011 8 13 2012 29 24 2013 28 26
  • 48. Typical course of treatment 90 % of NAS babies –  Wean in 27 days –  No adjunctive meds –  LOS 30 days –  50% LOS 21 days 10 % of NAS babies –  Require adjunctive meds •  Phenobarbital (27%) •  Phenobarbital +Clonidine (7%) –  LOS 65 days •  (longest LOS = 155 days)
  • 49. Physical Challenges •  Environment •  Work load •  Pharmacy •  Daily NAS rounds •  Repackaging of doses / stocking Omnicell vending machines •  Social Work •  Increased DCS workload •  Family Support •  Staff Support •  Volunteer Services •  Phone, Door, Cuddling •  Rehabilitation Services •  Speech therapy •  Physical/occupational therapy •  Security
  • 50. Emotional Challenges Attitudes / Perceptions •  Preventable nature of condition •  Personal prejudices Feelings •  Confusion / fear –  HIPPA concerns –  Ethical Issues Family / Caregiver Issues •  Personal addiction of parents •  Mental health issues •  Literacy problems •  Comprehension/ retention issues Fatigue/exhaustion/burnout Educational deficit regarding the science of addiction
  • 51. Long  Term  Follow-­‐up  of  Infants  with  NAS   • Opioid  exposed  children  more  likely  to  have  ADHD,   disrup2ve  behavior,  psych  referrals   • Polydrug  (including  opiates)  exposed  children  have   smaller  brains,  thinner  cortex,  reduced  cogni2ve  ability   and  more  behavior  problems   • Many  studies  are  small  -­‐  precludes  adjustment  for  use   of  mul2ple  drugs  during  pregnancy   • No  studies  of  long  term  effects  of  prenatal  exposure  to   buprenorphine  or  prescrip2on  opioids  
  • 52. LONG-TERM EFFECTS • BRAIN DEVELOPMENT • SIDS • SLEEP • NUERODEVELOPMENTAL DELAYS • BEHAVIOR REGULATION • SENSORY PROCESSING • COGNITIVE/LEARNING DELAYS • PSYCHOSOCIAL IMPLICATIONS
  • 53. Conclusions   •  NAS  is  a  complex  disorder  with  many  factors   contribu2ng  to  incidence,  severity   •  Significant  uncertainty  -­‐  who  to  treat,  when  to  treat,   how  to  treat,  how  to  wean,  and  the  op2mal  agent(s)   to  use   •  Concerns  of  safety  and  efficacy  of  NAS  treatments  –   primum  non  nocere   •  SNPs  in  the  OPRM1  and  COMT  genes  associated  with   reduced  treatment  and  LOS   •  Epigene2c  factors  appear  to  be  important  
  • 54. NAS is 100% preventable • The impact of NAS does not end in the NICU. • Long-term benefits to both the healthcare system and society are significant. • Prenatal care in the otherwise healthy woman is widely accepted to be beneficial to mothers and babies. • We must do all we can to promote prenatal care and substance abuse treatment/counseling in this high-risk population. • Incentives to seek help may allow more opportunities for the woman to receive successful treatment with lifelong benefits.
  • 55. hat  we   what  
  • 56. Contact: E. Kyle Cook, APN, NNP-BC EKCook@etch.com Questions?
  • 57. Hudak  ML,  Tan  RC,  The  Comminee  on  Drugs  and  the  Comminee  on  Fetus  and  Newborn.    Neonatal  Drug  Withdrawal.  Pediatrics.   2012;129;e540.   Osborn  DA,  Jeffery  HE,  Cole  MJ.  Seda5ves  for  opiate  withdrawal  in  newborn  infants.  Cochrane  Database  of  SystemaCc  Reviews  2010,   Issue  10.  Art.  No.:  CD002053.   Osborn  DA,  Jeffery  HE,  Cole  MJ.  Opiate  treatment  for  opiate  withdrawal  in  newborn  infants.  Cochrane  Database  of   SystemaCc  Reviews  2010,  Issue  10.  Art.  No.:  CD002059.