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

Drug-Related Deaths (DRDs) soon after release: I Effectiveness on Trial: II Naloxone (heroin antidote) on release to reduce overdose deaths. (sheila.bird@mrc-bsu.cam.ac.uk). HMP Edinburgh. John Pearce, former governor of Edinburgh Prison, 1990. Dr. A. Graham Bird, clinical immunologist.

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

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  1. Drug-Related Deaths (DRDs) soon after release: IEffectiveness on Trial: IINaloxone (heroin antidote) on release to reduce overdose deaths (sheila.bird@mrc-bsu.cam.ac.uk)

  2. HMP Edinburgh

  3. John Pearce, former governor of Edinburgh Prison, 1990 Dr. A. Graham Bird,clinical immunologist.

  4. 1991 WASH Willing[ethical] Anonymous [no deductive disclosure] Saliva & linked self-Q [high volunteer rate] HIV surveillance Linked to self-Qon risks [frank answers]

  5. 1. Seaman,Brettle &Gore: BMJ (1998) Overdose deaths in 2 weeks after HIV injectors’ releases fromHMP Edinburgh [1983-94] 8 times higherthan for comparable other fortnights at liberty (p < 0.01) 7 drug-related deaths, 6 from overdose.

  6. 2. Male index releases from Scottish prisons in July to Dec. 1996-99 [Bird & Hutchinson: Addiction 2003] Eligibility set by [B+H] 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

  7. 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

  8. Drugs-related deaths in fortnight after prison: 19 486 male ex-prisoners, aged 15-35 years, released after 14+days’ incarceration

  9. 1 in 200 adult injectors dead within 2 weeks after prison Judges aware?

  10. Internationally, 6 major studies

  11. 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!

  12. Prison-based interventions • Information leaflet:how to avoid overdose risk after release b) Naloxone on release:heroin antidote

  13. UK’s Advisory Council on the Misuse of Drugs: already on the case in 2000 . . . 2005 Naloxone was added to UK’s exempt list of Prescription Only Medicines for administration by anyone in an emergency to save life

  14. 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

  15. 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 . . .

  16. Prison-based, with-consent* RCT for 56,000 pre-release adult IDUs

  17. If CE threshold is £20K($40K) per life year gained, & Naloxoneprevents 42drug deaths in 1st+2nd fortnight per 28,000 IDU releases  Per injector-inmate, UK’s NHS can afford to pay: {42 * £20K}/28,000 = £30 for pre-release Naloxone UK-affordable cost of Naloxone

  18. N-ALIVE designed to fit with UK prison routines . . .Induction: drug awareness +N-ALIVE DVD1-1 consent: each randomized prisoner has an assignedN-ALIVE pack.Assigned N-ALIVE packs held inPharmacy or Prisoner’s valuables.Prisoner escort  release from court . . .Date of release is critical.*N-ALIVE DVD copy for prisoner’s family ** Re-randomization of recidivists . . . ?

  19. 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)

  20. Informed consent by prisoners • Treatments = Naloxoneor control pack at release [information leaflet & prepaid reply card] • Confidential database linkage to deaths register [and NFO A&E 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)

  21. N-ALIVE Recidivist self-Q RCT flag against prisoner numberso thaton 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.

  22. Pilot N-ALIVE . . . & kicking via Medical Research Council’s 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 E&W (Dave Marteau, Martin Lee) Prisoners in both services

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