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The Importance of Following
Forensic Principles
in Newborn Drug Testing
October 6th, 2015
Irene Shu, PhD, DABCC (CC, TC)
A...
Objectives
o Federal/State child welfare policies
o Forensic toxicology principles
o Pre-analytical factors: Specimen type...
Federal/State Policies of Child Welfare
Lester BM et al., Harm Reduct J, 2004, 1, 5.
Federal/State Policies of Child Welfare
Lester BM et al., Harm Reduct J, 2004, 1, 5.
Federal/State Policies of Child Welfare
Lester BM et al., Harm Reduct J, 2004, 1, 5.
Federal/State Policies of Child Welfare
o 80s-90s: legislative proposals addressing women
drug use during pregnancy
• Incr...
Federal/State Policies of Child Welfare
o 2003 Keeping Children and Families Safe Act
• Eligibility requirement of child w...
Federal/State Policies of Child Welfare
o 2003 Keeping Children and Families Safe Act
o State laws have different policies...
Federal/State Policies of Child Welfare
National Conference of State Legislatures, Children’s Policy Initiative, Sept 2004.
(IA, KY, MN, ND)
IL
Guttmacher Institute, State Policies in Brief: Substance abuse during pregnancy,
June 2015.
(TN) (MN, SD, WI)
IL
Guttmacher Institute, State Policies in Brief: Substance abuse during pregnancy,
June 2015.
IL
(IA, KS, MI, OK)
Guttmacher Institute, State Policies in Brief: Substance abuse during pregnancy,
June 2015.
Federal/St...
Objectives
o Federal/State child welfare policies
o Forensic toxicology principles
o Pre-analytical factors: Specimen type...
Forensic Toxicology Principles
o Chain of Custody: collector-receipt-testing-storage-
disposal
Collector’s signature
Acces...
Forensic Toxicology Principles
o Chain of Custody: collector-receipt-testing-storage-
disposal
Forensic Toxicology Principles
o Initial testing:
• Presence/Absence of a group of drugs
• Immunoassays
• Instrumental scr...
Forensic Toxicology Principles
o Data Certification:
• Quality control acceptance criteria; dual review process
• Confirma...
Objectives
o Federal/State child welfare policies
o Forensic toxicology principles
o Pre-analytical factors: Specimen type...
Pre-analytical factors: Specimen types
o Urine
o Hair
o Meconium
o Umbilical Cord
Pre-analytical factors: Specimen types
o Detection window:
0 20 40 60 80 100 120
Urine
Hair
Meconium/
Umbilical cord
Days
...
Pre-analytical factors: Specimen types
o Sample Collection
Quantity
Urine
May not be
sufficient
Hair
May not be
sufficient...
Pre-analytical factors: Specimen types
o Sample Collection
Quantity Availability
Urine
May not be
sufficient
Not
published...
Pre-analytical factors: Specimen types
o Sample Collection
Quantity Availability Timing
Urine
May not be
sufficient
Not
pu...
Pre-analytical factors: Specimen types
o Sample Collection
Quantity Availability Timing
CoC
Integrity
Urine
May not be
suf...
Pre-analytical factors: Specimen types
o Test Methods
Specimen
Type Test method concerns
Urine
• Workplace drug screen/tes...
Objectives
o Federal/State child welfare policies
o Forensic toxicology principles
o Pre-analytical factors: Specimen type...
(AMP)
(THC)
(COC)
(OPI)
(PCP)
(MTD)
(BARB)
(BZP)
(PPX)
(OXY)
(MEP)
(TRAM)
(BUP)
Survey July-Dec 2014
Panel Meconium UCord
...
o Umbilical cord test methods
• Screening: ELISA
(homogenization treatment)
• Confirmation:
 GC-MS: THC, PCP
 LC-MS/MS: ...
Survey July-Dec 2014
Positive rate
in Meconium
Positive rate
in Umbilical Cord
Positive rate
in Meconium
Positive rate
in Umbilical Cord
Survey July-Dec 2014
Positive rate
in Meconium
Positive rate
in Umbilical Cord
Survey July-Dec 2014
Survey July-Dec 2014: THC
5 5o THCA in umbilical cord
• GC-MS
• HFIP/PFPA
o THCA in meconium
• GC-MS
• MTBSTFA
(1,315/8,16...
Positive rate
in Meconium
Positive rate
in Umbilical Cord
Survey July-Dec 2014
Maternal Opiate/Opioid Use and NAS
o Incidence (per 1000 births) in the U.S.
Maternal Opiate Use
2000-2009
Patrick SW et a...
Maternal Opiate/Opioid Use and NAS
o Neonatal Abstinence Syndrome (NAS)
• Premature birth, lower birth weight
• High-pitch...
Maternal Opiate/Opioid Use and NAS
Patrick SW et al. J Perinatol, 2015, in press.
Division SE Central
New
England
NE Centr...
o OPI in umbilical cord
• LC-MS/MS: LLOQ 0.2 ng/g
• Confirmed analytes:
 Hydrocodone/Hydromorphone
 Codeine/Morphine
Sur...
Survey July-Dec 2014: Opiates
o OPI in meconium
• GC-MS: LLOQ 40 ng/g
o OPI in umbilical cord
• LC-MS/MS: LLOQ 0.2 ng/g
5 5
Survey July-Dec 2014: Opiates
o OPI in meconium
• GC-MS: LLOQ 40 ng/g
o OPI in umbilical cord
• LC-MS/MS: LLOQ 0.2 ng/g
 ...
Heroin Exposure
6-MAM
(6-monoacetylmorphine)
Morphine
Heroin
(diacetylmorphine)
Absence of 6-MAM
does not justify
abstinence of
heroin use because
of its short half-life
Heroin Exposure
Morphine
Heroin
...
Heroin Exposure
Morely et al. J Anal Tox, 2007, 31, 105.
Meconin
Metabolite of Noscapine
Noscapine
Contaminant of Heroin
o Add meconin to the opiates umbilical cord assay
• Oct 2012-Sept 2013 (1 year): 1,773 morphine ≥0.5ng/g
Heroin Exposure
0...
o Add meconin to the opiates umbilical cord assay
• Oct 2012-Sept 2013 (1 year): 1,773 morphine ≥0.5ng/g
Heroin Exposure
0...
o Add meconin to the opiates umbilical cord assay
• Oct 2012-Sept 2013 (1 year): 1,773 morphine ≥0.5ng/g
• July-Dec 2014 (...
o Add meconin to the opiates umbilical cord assay
• July-Dec 2014 (6 months): 1,061 morphine ≥0.5ng/g
Survey July-Dec 2014...
o BUP in umbilical cord
• LC-MS/MS: LLOQ 0.1 ng/g
• Confirmed analytes:
 Buprenorphine
 Norbuprenorphine
Survey July-Dec...
o BUP in umbilical cord
• LC-MS/MS: LLOQ 0.1 ng/g
Survey July-Dec 2014: Buprenorphine
o BUP in meconium
• LC-MS/MS: LLOQ 8...
o OXY in umbilical cord
• LC-MS/MS: LLOQ 0.2 ng/g
• Confirmed analytes:
 Oxycodone
 Oxymorphone
Survey July-Dec 2014: Ox...
o OXY in umbilical cord
• LC-MS/MS: LLOQ 0.2 ng/g
Survey July-Dec 2014: Oxycodone
o OXY in meconium
• GC-MS: LLOQ 40 ng/g
...
o MTD in umbilical cord
• LC-MS/MS: LLOQ 0.8 ng/g
• Confirmed analytes:
 Methadone/EDDP
Survey July-Dec 2014: Methadone
o...
Survey July-Dec 2014: multiple drugs
o OPI/BUP/OXY/MTD positive samples:
Meconium Umbilical Cord
OPI/BUP/OXY/MTD+ 1,047 (1...
Survey July-Dec 2014: multiple drugs
o OPI/BUP/OXY/MTD positive samples:
Meconium Umbilical Cord
OPI/BUP/OXY/MTD+ 1,047 (1...
o BZP in umbilical cord
• LC-MS/MS: LLOQ 0.8 ng/g
• Confirmed analytes:
 Oxazepam (33, 0.2%)
 Temazepam (43, 0.3%)
 Dia...
o Perform neonatal drug testing following forensic
toxicology principles
o Pre-analytical and analytical factors should be...
Thank you for your attention!
Irene Shu, PhD, DABCC (CC, TC)
Assistant Laboratory Director
irene.shu@usdtl.com
Phone: 847-...
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The Importance of Following Forensic Principles in Newborn Drug Testing

This webinar described why newborn drug testing should be performed following the principles of forensic toxicology and present toxicology survey results from a 6-month period from USDTL laboratory.

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The Importance of Following Forensic Principles in Newborn Drug Testing

  1. 1. The Importance of Following Forensic Principles in Newborn Drug Testing October 6th, 2015 Irene Shu, PhD, DABCC (CC, TC) Assistant Laboratory Director United States Drug Testing Laboratories, Inc.
  2. 2. Objectives o Federal/State child welfare policies o Forensic toxicology principles o Pre-analytical factors: Specimen types o Analytical factors: Survey July-December 2014 • Prevalence of drug types • Analytical concerns
  3. 3. Federal/State Policies of Child Welfare Lester BM et al., Harm Reduct J, 2004, 1, 5.
  4. 4. Federal/State Policies of Child Welfare Lester BM et al., Harm Reduct J, 2004, 1, 5.
  5. 5. Federal/State Policies of Child Welfare Lester BM et al., Harm Reduct J, 2004, 1, 5.
  6. 6. Federal/State Policies of Child Welfare o 80s-90s: legislative proposals addressing women drug use during pregnancy • Increase services and treatment to pregnant women/children • Provide preventative and educational programs • Research the extent of the problem • Criminal penalties for drug using pregnant women Governmental Responses to Pregnant Women Who Use Alcohol or Other Drugs, 2000; Women’s Law Project and National Advocates for Pregnant Women
  7. 7. Federal/State Policies of Child Welfare o 2003 Keeping Children and Families Safe Act • Eligibility requirement of child welfare funding from Child Abuse Prevention and Treatment Act. • Healthcare providers: Notify CPS when recognizing newborns “affected by illegal substance abuse or withdrawal symptoms resulting from prenatal drug exposure.” • Child Protective Services (CPS): develop a “plan of safe care” for such infants National Conference of State Legislatures, Children’s Policy Initiative, Sept 2004.
  8. 8. Federal/State Policies of Child Welfare o 2003 Keeping Children and Families Safe Act o State laws have different policies: • Notifying CPS is only mandatory in some States • Prenatal drug exposure: child abuse and neglect National Conference of State Legislatures, Children’s Policy Initiative, Sept 2004.
  9. 9. Federal/State Policies of Child Welfare National Conference of State Legislatures, Children’s Policy Initiative, Sept 2004.
  10. 10. (IA, KY, MN, ND) IL Guttmacher Institute, State Policies in Brief: Substance abuse during pregnancy, June 2015.
  11. 11. (TN) (MN, SD, WI) IL Guttmacher Institute, State Policies in Brief: Substance abuse during pregnancy, June 2015.
  12. 12. IL (IA, KS, MI, OK) Guttmacher Institute, State Policies in Brief: Substance abuse during pregnancy, June 2015. Federal/State Policies of Child Welfare
  13. 13. Objectives o Federal/State child welfare policies o Forensic toxicology principles o Pre-analytical factors: Specimen types o Analytical factors: Survey July-December 2014 • Prevalence of drug types • Analytical concerns
  14. 14. Forensic Toxicology Principles o Chain of Custody: collector-receipt-testing-storage- disposal Collector’s signature Accessioner’s signatureContainer Seal All meconium collection events
  15. 15. Forensic Toxicology Principles o Chain of Custody: collector-receipt-testing-storage- disposal
  16. 16. Forensic Toxicology Principles o Initial testing: • Presence/Absence of a group of drugs • Immunoassays • Instrumental screening techniques • Blind QC o Confirmatory testing (2nd aliquot): • Identity and quantity (concentration) of a specific drug • Different scientific principle than initial testing • Chromatography separation/mass spectrometry detection
  17. 17. Forensic Toxicology Principles o Data Certification: • Quality control acceptance criteria; dual review process • Confirmatory results are reviewed with initial testing results
  18. 18. Objectives o Federal/State child welfare policies o Forensic toxicology principles o Pre-analytical factors: Specimen types o Analytical factors: Survey July-December 2014 • Prevalence of drug types • Analytical concerns
  19. 19. Pre-analytical factors: Specimen types o Urine o Hair o Meconium o Umbilical Cord
  20. 20. Pre-analytical factors: Specimen types o Detection window: 0 20 40 60 80 100 120 Urine Hair Meconium/ Umbilical cord Days 3 months *Since 2nd Trimester Detection window
  21. 21. Pre-analytical factors: Specimen types o Sample Collection Quantity Urine May not be sufficient Hair May not be sufficient Meconium May not be sufficient Umbilical Cord Sufficient
  22. 22. Pre-analytical factors: Specimen types o Sample Collection Quantity Availability Urine May not be sufficient Not published Hair May not be sufficient Not published Meconium May not be sufficient 80% Umbilical Cord Sufficient 100%
  23. 23. Pre-analytical factors: Specimen types o Sample Collection Quantity Availability Timing Urine May not be sufficient Not published Within 3 days Hair May not be sufficient Not published Not critical (environment) Meconium May not be sufficient 80% Within 2 days Umbilical Cord Sufficient 100% Not critical (at birth)
  24. 24. Pre-analytical factors: Specimen types o Sample Collection Quantity Availability Timing CoC Integrity Urine May not be sufficient Not published Within 3 days Intact Hair May not be sufficient Not published Not critical (environment) Intact Meconium May not be sufficient 80% Within 2 days May be broken Umbilical Cord Sufficient 100% Not critical (at birth) Intact
  25. 25. Pre-analytical factors: Specimen types o Test Methods Specimen Type Test method concerns Urine • Workplace drug screen/test cut-off is too high for neonatal toxicology test Hair • Drug extraction from hair may be overnight process • High sensitivity technique Meconium • Newborn-specific metabolite may need to be included for confirmation (ex. meta-hydroxy-benzoylecgonine) Umbilical Cord • Homogenization in sample preparation • High sensitivity technique
  26. 26. Objectives o Federal/State child welfare policies o Forensic toxicology principles o Pre-analytical factors: Specimen types o Analytical factors: Survey July-December 2014 • Prevalence of drug types • Analytical concerns
  27. 27. (AMP) (THC) (COC) (OPI) (PCP) (MTD) (BARB) (BZP) (PPX) (OXY) (MEP) (TRAM) (BUP) Survey July-Dec 2014 Panel Meconium UCord 5 2,741 2,749 7 1,095 1,002 9 896 1,240 12 1,406 3,589 13 2,031 8,405 Total 8,169 16,985
  28. 28. o Umbilical cord test methods • Screening: ELISA (homogenization treatment) • Confirmation:  GC-MS: THC, PCP  LC-MS/MS: AMP, COC, OPI, MTD, BABR, BZP, PPX, OXY, MEP, TRAM, BUP Survey July-Dec 2014 o Meconium test methods • Screening: CEDIA/EMIT (SPE treatment) • Confirmation:  GC-MS: AMP, COC, OPI, THC, PCP, MTD, BARB, BZP, PPX, OXY, MEP, TRAM  LC-MS/MS: BUP
  29. 29. Survey July-Dec 2014 Positive rate in Meconium Positive rate in Umbilical Cord
  30. 30. Positive rate in Meconium Positive rate in Umbilical Cord Survey July-Dec 2014
  31. 31. Positive rate in Meconium Positive rate in Umbilical Cord Survey July-Dec 2014
  32. 32. Survey July-Dec 2014: THC 5 5o THCA in umbilical cord • GC-MS • HFIP/PFPA o THCA in meconium • GC-MS • MTBSTFA (1,315/8,169) (2,581/16,985)
  33. 33. Positive rate in Meconium Positive rate in Umbilical Cord Survey July-Dec 2014
  34. 34. Maternal Opiate/Opioid Use and NAS o Incidence (per 1000 births) in the U.S. Maternal Opiate Use 2000-2009 Patrick SW et al. JAMA, 2012, 307, 1934. Patrick SW et al. J Perinatol, 2015, in press. Neonatal Abstinence Syndrome (NAS) 2000-2012
  35. 35. Maternal Opiate/Opioid Use and NAS o Neonatal Abstinence Syndrome (NAS) • Premature birth, lower birth weight • High-pitched cry, tremors, stiff limbs, GI problems, feeding intolerance, seizures, respiratory distress • Time of onset is drug type dependent  Alcohol 3-12hrs  Heroin within 24hrs; opioids 1-7 days  Sedatives 1-3 days  Barbiturates 4-7 days (1-14 days) • Treatment: morphine as 1st line; phenobarbital for polysubstance exposure; breast milk feed; minimal sensory stimulation • Total hospital charges $0.7  $1.5B 2009-2012 Patrick SW et al. JAMA, 2012, 307, 1934. Patrick SW et al. J Perinatol, 2015, in press.
  36. 36. Maternal Opiate/Opioid Use and NAS Patrick SW et al. J Perinatol, 2015, in press. Division SE Central New England NE Central South Atlantic Middle Atlantic Mountain NW Central Pacific SW Central NAS Rate 16.2 13.7 6.8 – 6.9 5.1 2.6 – 3.4
  37. 37. o OPI in umbilical cord • LC-MS/MS: LLOQ 0.2 ng/g • Confirmed analytes:  Hydrocodone/Hydromorphone  Codeine/Morphine Survey July-Dec 2014: Opiates o OPI in meconium • GC-MS: LLOQ 40 ng/g • Confirmed analytes:  Hydrocodone/Hydromorphone  Codeine/Morphine (719/8,169) (2,071/16,985) 411 (5.0%) 100 (1.2%) 208 (2.5%) HYC/HYM+ 308 COD/MOR+ 511 (6.2%) 994 (5.8%) 168 (1.0%) 909 (5.3%) HYC/HYM+ 1077 COD/MOR+ 1162 (6.8%) 5 5
  38. 38. Survey July-Dec 2014: Opiates o OPI in meconium • GC-MS: LLOQ 40 ng/g o OPI in umbilical cord • LC-MS/MS: LLOQ 0.2 ng/g 5 5
  39. 39. Survey July-Dec 2014: Opiates o OPI in meconium • GC-MS: LLOQ 40 ng/g o OPI in umbilical cord • LC-MS/MS: LLOQ 0.2 ng/g  6-MAM+Meconin in MOR/COD+ cases for heroin exposure 5 5
  40. 40. Heroin Exposure 6-MAM (6-monoacetylmorphine) Morphine Heroin (diacetylmorphine)
  41. 41. Absence of 6-MAM does not justify abstinence of heroin use because of its short half-life Heroin Exposure Morphine Heroin (diacetylmorphine)
  42. 42. Heroin Exposure Morely et al. J Anal Tox, 2007, 31, 105. Meconin Metabolite of Noscapine Noscapine Contaminant of Heroin
  43. 43. o Add meconin to the opiates umbilical cord assay • Oct 2012-Sept 2013 (1 year): 1,773 morphine ≥0.5ng/g Heroin Exposure 0 20 40 60 80 100 120 140 86 (4.9%) 6-MAM and/or Meconin ≥ 0.2ng/g (LOQ) Jones JT, et al. Ther Drug Monit, 2015, 37, 45. 2012-2013 2014
  44. 44. o Add meconin to the opiates umbilical cord assay • Oct 2012-Sept 2013 (1 year): 1,773 morphine ≥0.5ng/g Heroin Exposure 0 20 40 60 80 100 120 140 86 (4.9%) 6-MAM and/or Meconin ≥ 0.2ng/g (LOQ) +11 (0.6%) Meconin Only ≥ 0.2 ng/g Jones JT, et al. Ther Drug Monit, 2015, 37, 45. 2012-2013 2014
  45. 45. o Add meconin to the opiates umbilical cord assay • Oct 2012-Sept 2013 (1 year): 1,773 morphine ≥0.5ng/g • July-Dec 2014 (6 months): 1,061 morphine ≥0.5ng/g Heroin Exposure 0 20 40 60 80 100 120 140 2012-2013 2014 118 (11.1%) 6-MAM and/or Meconin ≥ 0.2ng/g (LOQ) +15 (1.4%) Meconin Only ≥ 0.2 ng/g 86 (4.9%) 6-MAM and/or Meconin ≥ 0.2ng/g (LOQ) +11 (0.6%) Meconin Only ≥ 0.2 ng/g
  46. 46. o Add meconin to the opiates umbilical cord assay • July-Dec 2014 (6 months): 1,061 morphine ≥0.5ng/g Survey July-Dec 2014: Opiates
  47. 47. o BUP in umbilical cord • LC-MS/MS: LLOQ 0.1 ng/g • Confirmed analytes:  Buprenorphine  Norbuprenorphine Survey July-Dec 2014: Buprenorphine o BUP in meconium • LC-MS/MS: LLOQ 8.0 ng/g • Confirmed analytes:  Buprenorphine  Norbuprenorphine (134/2,031) (956/8,405) BUP+ 644 (7.7%) NorBUP+ 938 (11.2%)BUP+ 127 (6.2%) NorBUP+ 132 (6.5%) 125 626 13 13 312 (3.7%)
  48. 48. o BUP in umbilical cord • LC-MS/MS: LLOQ 0.1 ng/g Survey July-Dec 2014: Buprenorphine o BUP in meconium • LC-MS/MS: LLOQ 8.0 ng/g (134/2,031) (956/8,405) 13 13
  49. 49. o OXY in umbilical cord • LC-MS/MS: LLOQ 0.2 ng/g • Confirmed analytes:  Oxycodone  Oxymorphone Survey July-Dec 2014: Oxycodone o OXY in meconium • GC-MS: LLOQ 40 ng/g • Confirmed analytes:  Oxycodone (64/3,437) (551/11,994) 64 (1.9%) OXC+ OXC+ 517 (4.3%) 205 (1.7%) OXM+ 239 12 12
  50. 50. o OXY in umbilical cord • LC-MS/MS: LLOQ 0.2 ng/g Survey July-Dec 2014: Oxycodone o OXY in meconium • GC-MS: LLOQ 40 ng/g (551/11,994) (64/3,437) 12 12
  51. 51. o MTD in umbilical cord • LC-MS/MS: LLOQ 0.8 ng/g • Confirmed analytes:  Methadone/EDDP Survey July-Dec 2014: Methadone o MTD in meconium • GC-MS: LLOQ 40 ng/g • Confirmed analytes:  Methadone/EDDP (254/5,428) (529/14,236) Methadone+ 248 (4.6%) EDDP+ 253 (4.7%) 247 Methadone+ 529 (3.7%) EDDP+ 516 (3.6%) 516 7 7
  52. 52. Survey July-Dec 2014: multiple drugs o OPI/BUP/OXY/MTD positive samples: Meconium Umbilical Cord OPI/BUP/OXY/MTD+ 1,047 (12.8%) 3,661 (21.6%)
  53. 53. Survey July-Dec 2014: multiple drugs o OPI/BUP/OXY/MTD positive samples: Meconium Umbilical Cord OPI/BUP/OXY/MTD+ 1,047 (12.8%) 3,661 (21.6%) AMP/COC/THC+ 235 (22.4%) 783 (21.4%)
  54. 54. o BZP in umbilical cord • LC-MS/MS: LLOQ 0.8 ng/g • Confirmed analytes:  Oxazepam (33, 0.2%)  Temazepam (43, 0.3%)  Diazepam (145, 1.1%)  Nordiazepam (226, 1.7%)  Alprazolam (139, 1.1%)  Midazolam (75, 0.6%) Survey July-Dec 2014: Benzodiazepines o BZP in meconium • GC-MS: LLOQ 40 ng/g • Confirmed analytes:  Oxazepam (0.1%) (414/13,234) (5/4,333) 9 9
  55. 55. o Perform neonatal drug testing following forensic toxicology principles o Pre-analytical and analytical factors should be considered for result interpretation o Umbilical cord tissue collects drugs/metabolites at much lower concentrations than meconium o Meconium and umbilical cord provide similar positivity rates and prevalence of each drug type • THC > OPI > BUP > MTD > OXY > BZP > AMP/COC Summary
  56. 56. Thank you for your attention! Irene Shu, PhD, DABCC (CC, TC) Assistant Laboratory Director irene.shu@usdtl.com Phone: 847-493-8953 Fax:847-375-0775

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