Drug-Related Deaths (DRDs) soon after release: I Effectiveness on Trial: II Naloxone (heroin antidote) on release to reduce overdose deaths

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Drug-Related Deaths (DRDs) soon after release
IEffectiveness on Trial II Naloxone (heroin
antidote) on release to reduce overdose deaths

• (sheila.bird_at_mrc-bsu.cam.ac.uk)

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HMP Edinburgh
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John Pearce, former governor of Edinburgh Prison,
1990

• Dr. A. Graham Bird, clinical immunologist.

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1991 WASH

• Willing ethical
• Anonymous
• no deductive disclosure
• Saliva linked self-Q high volunteer rate
• HIV surveillance
• Linked to self-Q on risks frank answers

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1. Seaman, Brettle Gore BMJ (1998)

• Overdose deaths in 2 weeks after HIV injectors
  releases from HMP Edinburgh 1983-94
• 8 times higher than for comparable other
  fortnights at liberty (p lt 0.01)
• 7 drug-related deaths, 6 from overdose.

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2. Male index releases from Scottish prisons in
July to Dec. 1996-99 Bird Hutchinson
Addiction 2003

• Eligibility set by BH
• Applied by Scottish Prison Service SPS
• male
• born in 1960 aged 15-35 years on release
• served 14 days in prison
• 1st release in July-December
• calendar years 1996 to 1999

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Design assumptions

• 20,000 eligible releases
• 2. At least 40 adult 20 young offender male
  index releases injectors (IDUs)
• 3. Drugs-Related Deaths (DRDs) mainly IDUs
• In 1990s one DRD per 3000 recently released
  IDU-days (not 1 per 1000, as Seaman)
• 5. Relative Risk 1st fortnight DRDs 4

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Drugs-related deaths in fortnight after prison
19 486 male ex-prisoners, aged 15-35 years,
released after 14days incarceration
DEATHS 1st 2 weeks subsequent 5 fortnights RELATIVE RISK(95 CI)
Drugs-related 34 23 (11 in 2nd fortnight 12 in next 8 wks) 7 (3 to 16)
Other causes 3 18 0.8 (0.2 to 2.4)
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1 in 200 adult injectors dead within 2 weeks
after prison

• Judges
• aware?

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Internationally, 6 major studies
Merrall et al., 2010 Addiction Studies DRDs pys at risk DRD rate per 1 000 pys DRDs pys at risk DRD rate per 1 000 pys DRDs pys at risk DRD rate per 1 000 pys 1st fortnight Relative Risk (95 CI)
Merrall et al., 2010 Addiction Studies 1st fortnight 2nd fortnight next 8 weeks 1st fortnight Relative Risk (95 CI)
UK (EW Scotland) 92 2 588 36 20 2 547 8 42 10 795 4 7.5 (5.7 to 9.9)
Australia (NSW Western) 187 7 759 24 64 7 416 9 144 27 334 5 4.0 (3.4 to 4.8)
USA (Washington State New Mexico prisons) 27 1 466 18 8 462 17 5 1 426 4 3 462 6 10 5 409 2 10 1 845 5 8.4 (5.0 to 14.2) 3.1 (1.3 to 7.1)
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Why prisoners outside implications?

• Need
• Research Efficiency
• concentration of adult heroin injectors ( 40)
• ii) at very high risk
• iii) well-defined period soon after release
• iv) Third to half injectors in prison in past
  year
• v) proof-of-principle for other settings
• 1 in 8 Scottish DRDs occurs in 4 weeks after
  release!

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Prison-based interventions

• Information leaflet how to avoid overdose risk
  after release
• b) Naloxone on release heroin antidote

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UKs Advisory Council on the Misuse of Drugs
already on the case in 2000 . . .

• 2005
• Naloxone was added to UKs exempt list of
• Prescription Only Medicines
• for administration by anyone
• in an emergency to save life

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N-ALIVE randomise 56,000 eligible prisoners in
50 UK prisons in 5 years

• Good luck, Prof Bird . . .
• Three musketeers (2008) John Strang, Max Parmar
  Sheila Bird

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Design assumptions N-ALIVE

• Eligibility 18-44 years, history of heroin
  injection,
• 7 days incarceration.
• 1. At 80 of overdoses, some-one else is present
• 2. 75 chance ex-prisoner carries Naloxone in 1st
  4 weeks post-release 50 chance in next 8 weeks
• 3. 50 chance that Naloxone is administered by
  present other.
• Effectiveness in 1st 4 weeks 30
• Effectiveness in weeks 5 to 12 20
• 21st C One overdose death in 1st 4 weeks per 200
  ever-IDUs randomised to control group.
• 5. Contamination . . .

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Prison-based, with-consent RCT for 56,000
pre-release adult IDUs
Expected drugs deaths 1st 4 weeks after release Next 8 weeks after release
Controls 28,000 IDUs 140 35
Naloxone 28,000 IDUs 98 28
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UK-affordable cost of Naloxone

• If CE threshold is 20K (40K) per life year
  gained,
• Naloxone prevents
• 42 drug deaths in 1st2nd fortnight per 28,000
  IDU releases ?

• Per injector-inmate, UKs NHS can afford to pay
• 42 20K /28,000 30
• for pre-release Naloxone

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N-ALIVE designed to fit with UK prison routines .
. .Induction drug awareness N-ALIVE DVD 1-1
consent each randomized prisoner has an assigned
N-ALIVE pack.Assigned N-ALIVE packs held in
Pharmacy or Prisoners valuables.Prisoner
escort ? release from court . . .Date of release
is critical.N-ALIVE DVD copy for prisoners
family Re-randomization of recidivists . . .
?
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N-ALIVE cleaves to prison routines

• Prisoner-induction includes drugs awareness
  session N-ALIVE DVD added.
• (educates peers/family re N-ALIVE Naloxone)
• N-ALIVE addiction workers informed consent,
  randomisation, liaison with pharmacy Clinical
  Trials Unit re release dates.
• (half-time is research activity)
• N-ALIVE pack handled by pharmacy escort staff
  as a medicine that accompanies prisoner to court,
  on transfers.
• (issued only on release)

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Informed consent by prisoners

• Treatments Naloxone or control pack at release
  information leaflet prepaid reply card
• Confidential database linkage to deaths register
• and NFO AE admissions in N-ALIVE PILOT RCT
• Random assignment blinded until release
• Follow-up of recidivists via brief self-Q (unique
  )
• Single phone contact in 1st or 2nd fortnight
  after release (for HALF only of randomised
  participants in PILOT RCT only . . . Because
  phone-contact contaminates N-ALIVE intervention)

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N-ALIVE Recidivist self-Q

• RCT flag against prisoner number so that on
  re-incarceration applies to 60 of IDUs
• IDU attends prison health to answer
• no-names, selotape-seal, self-Q re
• overdose(s) witnessed fatal/non,
• overdose(s) experienced alone/accompanied
• naloxone use/disposal/acquisition/where kept
• heroin use.

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Pilot N-ALIVE . . . kicking via

• Medical Research Councils Clinical Trials Unit
  welcomes international collaborations
• Scottish Prison Service
• (Karen Norrie, Andrew Fraser Ruth Parker,
  Stephen Heller-Murphy governors, security HC)
• Health Department/Prison Service in EW
• (Dave Marteau, Martin Lee)
• Prisoners in both services