The document discusses the Vancouver experience with opioid dependence and the development of supervised injection sites, specifically focusing on the salome clinical trial that tests hydromorphone versus diacetylmorphine for chronic opioid addiction treatment. It outlines eligibility criteria for participants and the recruitment process, along with a legal case involving the compassionate access of diacetylmorphine. Additionally, it touches upon the operational guidance for Fair Price Pharma's inhalable diacetylmorphine program amidst a challenging regulatory environment.

1. Improving the Quality of Life of People with
Opioid Dependence.
The Vancouver Experience
Kurt Lock
Research Coordinator of the NAOMI and SALOME Heroin Assisted Treatment Trials

2. I am employed at the British Columbia Center for Disease Control.
While most of the time my personal thoughts of how to advocate for
expanding harm reduction does align with the BCCDC, in this
presentation I am in no way am I speaking for the BCCDC. I am
speaking from my own background in a large part based on my
experience working at INSITE, NAOMI, SALOME and the advocacy
that went alongside that.

3. Show a picture of DTES
VA N C O U V E R

4. BACKGROUND

5. After years of hard fought and thoughtful
activism, the first supervised injection site
[INSITE] in North America was opened in
Vancouver in 2003.
At the time INSITE was the flagship for pushing
the boundaries of harm reduction in Canada.
INSITE OPENS

6. THE NAOMI STUDY

7. Compassionate
Access denied by
Health Canada

8. SALOME is a follow-up study to the NAOMI clinical trial that took place from March 2005 through July 2008. SALOME
will test whether hydromorphone (Dilaudid®), a licensed medication, is as good as diacetylmorphine, the active
ingredient of heroin, at benefiting people suffering from chronic opioid addiction who are not benefiting sufficiently
from other treatments. This study will also test if those effectively treated with these two injectable medications can be
successfully switched and retained to the oral formulations of the medications.
R E C R U I T M E N T
For more information about SALOME please visit the website:
http://www.providencehealthcare.org/SALOME/
When: Monday December 19, 2011 between 9am and 4pm
How:
People who meet the criteria and are interested in joining the first group of partici-
pants should call SALOME or visit a recruitment table on, and not before, Monday
December 19 between 9am and 4pm.
- Call SALOME at 604 682 7515 or 604 682 7518
SALOME is set to begin receiving applications from people interested in participat-
ing in the clinical trial. Those who meet the following criteria MAY be eligible for
SALOME:
- Visit a recruitment table at the Lifeskills Center located at 412 E. Cor-
dova street between 10 am and 2 pm. Dec. 19 only
- Visit a recruitment table at Pigeon Park Savings located at 92 East
Hastings street between 11 am and 2 pm. Dec. 19 only
Because of clinic capacity we cannot enroll more than 20 participants a month. Ap-
plicants who meet the pre-screening criteria will be assigned a number that will be
entered into a draw to determine the order the applications will be processed to enter
the study.
People interested in SALOME who miss the first day of recruitment can still apply
through the SALOME phone line on weekdays between 9am and 4pm. After Decem-
ber 19th applications will be processed in the order they are received.
* Regular use of opioids for five years
* Injecting opioids in the last year
* Two attempts at treatment including opioid substitution (eg. methadone)
* Must be a legal adult
* Struggling with drug related problems
Dear Service Providers:
THE SALOME STUDY

9. SALOME rationale
 Health Canada denied compassionate access for DAM in May 2008:
 “In the course of reviewing your request, we determined that there are other options (i.e., marketed
drugs) that we would consider alternative to diamorphine at this time”.
 NAOMI provided HDM to a small group (to test for street heroin markers in urine):
 blinding was not broken;
 almost identical treatment effect compared to diacetylmorphine (however, study not powered to test this
hypothesis).
 Hydromorphone:
 Licensed drug in North America;
 Similar pharmacodynamic profile of that of morphine, similar pharmacology of that of DAM

10. Total Street Acquired Opioid Use

11. Mean daily dose prescribed and received of DAM
equivalent by arm

12. Summary
 The observed treatment effect of injectable DAM
was consistent with prior clinical trials:
 use of street heroin at six months around 3 to 5 days in
the prior 30 days.
 Treatment retention was as high (above 80%) and
virtually identical between groups
 In the total 88,451 injections, the most common
related serious adverse events were opioid
overdoses (n=14) and seizures (n=11), all
successfully treated on site without
hospitalization.

14. IN THE SUPREME COURT OF BRITISH COLUMBIA
Citation: Providence Health Care Society v. Canada
(Attorney General),
2014 BCSC 936
Date: 20140529
Docket: S-138411
Registry: Vancouver
Between:
Providence Health Care Society and Deborah Bartosch, Charles English,
Douglas Lidstrom, Larry Love and David Murray on their own behalf and on
behalf of all persons with severe opioid addiction who have previously not
responded to other available treatments and on whose behalf a SAP request
for diacetylmorphine is made by a medical practitioner
Plaintiffs
And
Attorney General of Canada
Defendant
And
Vancouver Coastal Health Authority
Intervenor
Before: The Honourable Chief Justice Hinkson
Reasons for Judgment
Counsel for the Plaintiffs, Providence Health
Care Society, Bartosch, English, Lidstrom,
Love and Murray:
J.J. Arvay, Q.C., A.M. Latimer,
A. Juva
Counsel for Defendant: L. Lachance, K. Reimer, S. Smiley
Counsel for Intervenor: S. Tucker
Counsel for Interested party,
British Columbia:
L. Greathead, K. Evans
Place and Date of Trial: Vancouver, B.C.
March 25, 26, and 27, 2014
Place and Date of Judgment: Vancouver, B.C.
May 29, 2014
SNAP: Telling Our Stories, Heroin‐
Assisted Treatment and Advocacy
SALOME/NAOMI ASSOCIATION of PATIENTS (SNAP) and
Compassionate Access approved by
Health Canada, but denied by the
Federal Government. The
Government loses in court and
participants allowed to keep
receiving diacetylmorphine

15. Very little action from Government
since SALOME

16. Price (excluding VAT) in Luxembourg: EUR 15
EMCDDA
INSIGHTS
New heroin-as
s
is
ted treatm
ent
Recent evidence and current
practices of supervised
injectable heroin treatment
in Europe and beyond
1
1 11
About the EMCDDA
The European Monitoring Centre for Drugs and Drug Addiction
(EMCDDA) is one of the European Union’s decentralised agencies.
Established in 1993 and based in Lisbon, it is the central source
of comprehensive information on drugs and drug addiction in Europe.
The EMCDDA collects, analyses and disseminates factual, objective,
reliable and comparable information on drugs and drug addiction.
In doing so, it provides its audiences with an evidence-based picture
of the drug phenomenon at European level.
The EMCDDA’s Insights are volumes conveying the findings of study
and research on topical issues in the drugs field.
E
MC
DD
A
INS
IG
HT
S
Ne
w
he
roin-as
s
is
ted
treatm
ent:
R
ece
nt
e
vide
nce
and
current
practice
s
of
s
upervis
ed
injectable
he
roin
treatm
ent
in
E
urope
and
be
yond
ISSN
16
0
6
-16
8
3
TD-XD-11-011-EN
-C
Heroin maintenance for chronic heroin-dependent individuals
(Review)
Ferri M, Davoli M, Perucci CA
Thisisareprint of aCochranereview, prepared and maintained byTheCochraneCollaboration andpublished in TheCochraneLibrary
2012, Issue5
http://www.thecochranelibrary.com
Heroin maintenance for chronic heroin-dependent individuals(Review)
Copyright © 2012 The Cochrane Collaboration. Published by J
ohn W iley & Sons, Ltd.

17. Fentanyl appears – high rate of death

18. Fentanyl appears – high rate of death

19. Fentanyl appears – high rate of death

24. Federal government supports, province does not.

26. Access to Prescribed Safer Supply
in British Columbia: Policy
Direction
July 15, 2021
Ministry of Mental Health and Addictions
Ministry of Health

28. www.fairpricepharma.ca
I am reaching out to you, Ministers of Health, regulators of health professions and
organizations representing health care practitioners, to ask you to do all you can to help
provide people who use drugs with a full spectrum of options for accessing medication,
depending on their individual circumstances, that will help them avoid the increased risks
from the toxic drug supply. This includes your support for programs that provide greater
access to a safer, pharmaceutical-grade alternative to the toxic street supply.
The Honourable Patty Hajdu, Minister of Health of Canada
August 2020
Steps for a Sponsor to get Started
The following are steps for a sponsor to get started:
Contact FPP if you have not already done so at: info@fairpricepharma.ca
Identify clients who will benefit from a safe supply of inhalable DAM
Identify prescribers who can prescribe the medication to these clients
Identify a secure room or safe where the product can be stored
Obtain funds for an initial round of dispensing
Operations
The following steps will occur on a regular basis for operations:
1. The Sponsor will forward prescriptions to FPP
2. The Prescriptions will identify:
a. The patient
b. The prescriber
c. Customary instructions on use
d. Instructions on where to deliver medication
3. FPP will produce and package the medication as per instructions
4. FPP will deliver medication as per delivery instructions
5. Because of the extended shelf-life of the sachets, this cycle does not have to be repeated daily
and can be done on a weekly basis for example
6. FPP will invoice the Sponsor monthly for the medication provided as per costs below
Costs (2021-22)
Diacetylmorphine Base for INHALATION (3:1 ratio with caffeine)
DAM Base Caffeine Price Dispensing Fee
75 mg 25 mg $5.25 $0
100 mg 33 mg $7.00 $0
150 mg 50 mg $10.50 $0
200 mg 67 mg $14.00 $0
Financing Models
The Ministry of Health and the Regional Health Authorities are not funding this proven treatment at the
present time. Other sources of funding that are being considered by Sponsors are:
Federal SUAP grants
Donor funds
User Pay Cost Recovery Models (several community groups of PWUD have expressed a
willingness to pay in the absence of government support)
www.fairpricepharma.ca
Fair Price Pharma Inhalation Diacetylmorphine Operational Guide
The purpose of this document is to provide operational guidance to medical practices, clinics, co-ops,
OPS, NGO, SIS, etc. who wish to provide Fair Price Pharma (FPP) inhalable diacetylmorphine (DAM) to
their clients.
The Parties
1. Sponsor = your medical practice, clinic, co-op, OPS, NGO, SIS, or similar agency wishing to
provide DAM to your clients
2. Client = a client of the Sponsor who will benefit from a safe supply of DAM
3. FPP = Fair Price Pharma
4. Prescriber1 = a physician or nurse practitioner who will prescribe the use of DAM for clients who
will benefit from it
The Product
The initial product from FPP is inhalable DAM base, provided in sachets.
sachets contain powder diacetylmorphine base in a 3:1 mixture with caffeine2
four doses of DAM are available: 75mg, 100mg, 150mg and 200mg
sachets can be stored at room temperature for up to 6 months
unlike street heroin, diacetylmorphine base only requires regular lighters for heating
FPP plans to also supply injectable DAM as well as immediate release and sustained release oral
diacetylmorphine hydrochloride capsules after inhalable DAM distribution is in place.
1 In the absence of a Section 56 Exemption for a Cooperative or Compassion Club model, or a broader-based public health
prescription model, individual prescriptions will be required
2 This formulation has been demonstrated to be highly effective in studies in the Netherlands
3 https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-
practices/guidance-documents/policy-manufacturing-compounding-drug-products.html#a51; FPP will comply with all aspects
of Health Canada POL-0051.
The Legal and Regulatory Situation
Compounding, as defined by Health Canada Policy POL-00513, is
an activity that health professionals undertake to provide a
customized therapeutic solution to improve patient care without
duplicating an approved drug product. When there is no supply of
a commercially available product and the healthcare professional
has determined a medical need for this product, the product may
be compounded during the period of no supply. There is no
inhalable DAM product commercially available in Canada at
present. While FPP is developing one, this will not be ready for at
least 18 months. Compounding of inhalable DAM does not
require a Health Canada commercial license, a Drug Identification
Number (DIN) or a Section 56 exemption.

29. Explain Heroin in Canada now
Thank you