Safer Opioid Supply Programs (SOS):

A Harm Reduction Informed Guiding Document for Primary Care Teams

Released: October 2019

Last Updated: April 2020

By:

Jessica Hales^[1] NP, Gillian Kolla^[2] PhD, Thomas Man^[3] MD,

Emmet O’Reilly^[4] NP, Nanky Rai3 MD, Andrea Sereda^[5] MD

DISCLAIMER

The following consensus guiding document represents the clinical experience and judgement of the above named clinicians and has not gone through a formal guidelines development and evaluation process. This document has been created using feedback from people who use drugs in our communities. We believe research is urgently needed to better inform our practices in a post heroin era of a poisonous street supply of drugs. Despite a current lack of direct evidence, this document has been created to urgently combat overdose deaths. It is informed by existing research and based out of expert opinion. Safer supply programs are not addiction treatment programs for opioid use disorder, they are programs grounded in harm reduction with the goal of reducing overdose deaths and morbidity related to the use of illicit drugs. Clinicians should exercise sound clinical judgment, taking into account the unique needs of each patient and support clients where possible to obtain access to evidence based first line opioid agonist treatments. This document aims to inform the existing experience and clinical knowledge of clinicians in working with people who use drugs. For those interested in building a community of practice or to let us know how you have used this document, email us at safersupplyON@gmail.com. Please reference it in your work using the following citation: 

Hales, J., Kolla, G., Man, T., O’Reilly, E., Rai, N., Sereda, A. (2019). Safer Opioid Supply Programs (SOS): A Harm Reduction Informed Guiding Document for Primary Care Teams-April 2020 update. Available online: https://bit.ly/3dR3b8m

TABLE OF CONTENTS

Overview        4

Background and Scientific Rationale        4

Guiding Principles        5

Inclusion Criteria/Indications        7

Contraindications        7

Precautions        7

Risk Reduction        8

Initiation and Titration Protocol        8

Assessments        10

Diversion        11

Continuity of Care/Transitions        11

References        12

Appendices        14

Harm Reduction Outcome Data Tool        15

Eligibility Check-List for Safer Opioid Supply Program        16

First Visit RN Safer Supply Program Clinical Template        17

Follow up Visit RN Safer Supply Program Clinical Template        19

First visit MD/NP Safer Supply Program Clinical Template        21

Follow up Visit MD/NP Safer Supply Program Clinical Template        25

Current Opioid Use Tracking Form        28

Diagnosis: Substance Use Disorder Criteria Form        29

Safer Opioid Supply Program (SOS) Agreement and Consent Form        30

How to Use a Safer Supply of Hydromorphone Tablets        32

Draft Letter for Hospitalists/Other Clinicians        36

Draft Letter for Pharmacies        38

Overview

The community-based Safer Opioid Supply program (SOS) is intended to serve as one part of a collective response to the ongoing overdose crisis. It is a harm reduction driven, public health approach to providing a safer, pharmaceutical drug supply to adults who use illicit drugs in Ontario and are at high risk of overdose.

SOS is a low-barrier model intended to reach people who are alienated from other models of health care delivery as a result of structural barriers that prevent those impacted by homelessness, poverty, mental health issues, racism and stigma from accessing needed care. It is administered by a network of primary care clinicians and delivered out of Community Health Centres and primary care clinics.

The goal of the SOS program is to reduce the risk of overdose and overdose deaths by developing a community-based, harm reduction focused safer supply program.

Background and Scientific Rationale

Criminalization of drug use and exposure to illicit opioid supply contaminated by fentanyl, fentanyl analogues, and carfentanil are the major drivers of the current crisis of opioid-overdose deaths in Ontario and Canada1-3. Preliminary data from 2018 found that 4,460 Canadians died (1,471 in Ontario) from opioid-related overdose; from January 2016-December 2018 over 11,500 people died in Canada from opioid overdose3. The expansion of supervised consumption services (SCS) programs - including overdose prevention sites, supervised injection sites and supervised inhalation sites - across Canada in recent years have been responsible for reducing overdose deaths4. Unfortunately, SCS have limited geographical reach, are not available in all communities, and have limited hours of operation; they cannot fully address the drivers of criminalization and contamination in the drug supply. Additional measures are rapidly needed to address the overdose crisis and the contamination of the illicit opioid supply5,6.

SOS aims to reduce overdose by giving participants access to legal, pharmaceutical drugs of known potency and consistency. It is informed by knowledge from Heroin Assisted Treatment programs that have been part of substance use treatment in Europe since the 1970’s7,8. Clinical trials of diacetylmorphine (pharmaceutical heroin) for opioid dependence - including the NAOMI study in Canada - have shown good evidence for the safety, retention in treatment, reduced use of illicit drugs and sustained health and social benefits 8,9. Furthermore, the Study to Assess Long-term Opioid Maintenance effectiveness (SALOME) clinical trial found that hydromorphone was non-inferior when compared to diacetylmorphine10. In the SALOME trial, hydromorphone was found to have a similar profile of adverse events as diacetylmorphine, and was also associated with fewer seizures11. Demonstrated outcomes for both of these studies included: increased and sustained engagement in healthcare, improvements in self-reported mental and physical health, a decline in money spent on drugs and illegal activity, decreased overdose and overall levels of drug use 7-10. Protocols in BC have been developed for injectable opioid agonist treatment (iOAT) programs that are based on the experience delivering these programs in Vancouver12.

Most programs to date have relied on the distribution of medications onsite and on observed dosing for every dose 8,12. This high level of supervision of use and centralized distribution of supply results in programs being  expensive, time consuming to set up, and difficult to scale. In the current emergency situation, these factors present a high barrier to access for people who use drugs. More flexible models are urgently needed as the toxicity of the drug supply increases, and the effects of persistent fentanyl use on tolerance and other health-related factors worsens.

The SOS model is informed by the existing research evidence as well as the clinical experience of our team. It is also based on the lived experience and expertise of people who use drugs within our community and across Canada13. Urgent access to a safer supply is immediately needed. This evidence-informed model will be closely monitored and a range of health and social outcomes for program participants will be assessed. Individual participant responses and program outcomes will be evaluated to help contribute to the generation of knowledge and improvement of care for this critically at risk group.

Guiding Principles

A) People who use drugs are experts: People who use drugs are knowledgeable about the culture of drug use and their own goals and needs. Collaborating with people who use drugs is critical to developing successful programs and strategies to address the overdose crisis. Their expertise should guide the development, implementation and evaluation of safer supply programs.

B) Participant-led and participant-centred care delivery: The program will aim to support people to meet their current goals for drug use in the safest way possible. Our aim is to provide compassionate and equitable health care to people who use drugs.

C) Harm reduction: The program recognizes that drug-related harms stem from several different sources, including from criminalization. It aims to reduce some of the harms associated with drug use by providing a safer drug supply. Clinicians will respect people’s autonomy and choices around drug use and accessing healthcare.

D) Low-barrier care: The program is meant to be as accessible as possible. Clinicians will strive to meet participant needs and ensure access to care through flexibility, problem solving and collaboration.

E) Non-punitive approach: Missed doses or assessments or continued illicit drug use will be addressed through dialogue and support and will not result in discharge from the program.

Program Objectives

Primary:

a) To quickly respond to the ongoing overdose crisis by implementing and evaluating a community-based safer supply model that can be delivered by primary care providers with minimal resources.

b) To reduce the risk of overdose and overdose death by providing adults exposed to the contaminated illicit drug supply with low-barrier access to a safer drug supply.

Secondary:

a) To engage participants who face barriers to accessing traditional models of healthcare, harm reduction and case management services.

b) To reduce harms associated with illegal activities required to access drugs though the street market.

c) To generate evidence of the safety and effectiveness of low barrier prescribing of  hydromorphone 8 mg immediate release tablets for oral or inhalation or intravenous use +/- sustained release oral morphine (SROM) therapy.

Measures of Success

SOS is a harm reduction measure and recognizes that stability is impacted by a variety of factors including health status, prejudice and discrimination and the availability of income and social resources. Complete cessation of street drug use and stabilization are not requirements of the program.

Indicators of success include:

• Decreased use of street drugs
• Decreased money spent on street drugs
• Increased access to primary care
• Decreased anxiety and an increased sense of control
• Improved health status
• Decreased withdrawal symptoms

• Decreased overdose rates  

To monitor outcomes, the Harm Reduction Outcome Tool (see Appendix I) will be completed on enrollment and each month following enrollment. Participation in the program will be reviewed if indicators of success are not observed despite working with a participant to optimize care.

Inclusion Criteria/Indications

• Opioid use disorder (DSM 5 defined opioid use disorder)

• And opioid use consistent with opioid use disorder during the past 12 months

• Self reported regular illicit toxic drug use
• Previous unsuccessful MMT, buprenorphine or SROM only or currently not interested in attempting MMT, buprenorphine, or SROM only
• Urine drug screen positive for opioid(s) (to confirm recent opioid use) and especially heroin, fentanyl analogues, carfentanil or other substances in toxic street supply
• Have the capacity to consent (understand risks and benefits)

Contraindications

• Severe respiratory disease or evidence of severe respiratory disease on physical examination
• Severe liver disease or evidence of severe liver disease on physical / blood work
• GI obstruction or paralytic ileus
• Severe kidney disease, evidence of severe kidney disease on exam / blood work
• Unstable disease: malignancy, severe acute mental health issues leading to an incapacity to consent or high suicide risk
• Medications thought to be incompatible with hydromorphone
• Uncontrolled/unmanaged seizure disorder
• Alcohol use disorder or unpredictable excessive alcohol use based on clinical judgement
• Sedative, anxiolytic or hypnotic substance use disorder

Participants with ongoing medical issues as described above under Contraindications might have less ability to clear opioids and therefore may be at higher risk of overdose. Thus they may require access to an observed model until they are stabilized onto lower barrier take home daily dispense Safer Supply programs.

See program eligibility checklist for intake purposes in Appendix II.

Precautions

• Intoxication by centrally acting sedatives and/or stimulants or any other acute clinical condition that would increase the risk of an adverse event with the use of hydromorphone
• Caution should be exercised for participants with existing injection related infections (septicemia, endocarditis, pneumonia, infective osteomyelitis) and in individuals with coagulation disorders, or history of recent head injury

Risk Reduction

The primary concern identified by the literature addressing the injection of opioids manufactured for oral consumption is the presence of insoluble particles large enough to block blood vessels and potentially increase the risk of developing endocarditis. The following steps have been recognized as effectively addressing this issue: (1) two step filtering process (cotton filter, followed by commercial filter); (2) use of heat to melt any waxy particles; and (3) using a sufficient amount of sterile water to produce the solution.

The risks associated with injecting crushed pills will be mitigated by:

1. Harm Reduction Teaching- Participants will be informed of safe injection techniques and the increased risks associated with injecting controlled release formulations (ie. SROM). Efforts will be made to ensure a sufficient dose of immediate release medication is provided to avoid IV use of SROM. Please see Appendix VIII: How to Use a Safer Supply of Hydromorphone Tablets

2. Wheel Filters- We will work to provide Wheel filters for program participants. http://harmreductionwa.org//wp-content/uploads/2017/06/UN68_Wheel_Filter_Guide_web.pdf & http://www.apothicom.org/sterifilt-general-presentation.htm

Initiation and Titration Protocol 

Option 1: For clients using heroin/fentanyl/fentanyl analogues/carfentanil 

*Due to participant experiences, we advise that all prescriptions for hydromorphone request for brand name tablets only given the ease with which brand name hydromorphone tablets dissolve and with less expedients. Please see Appendix X for a draft letter for pharmacies describing the two arms of the prescription.

**This initial starting dose is conservative in contrast with high potency street supply of opioids. This dose was arrived upon by calculation of MEQ requirements of initial patients and clinical experience. On average, 4 to 6 tabs of dilaudid 8 mg appears to be equivalent to 0.1 grams (or “1 point”) of illicit fentanyl/fentanyl analogues. This does not apply to carfentanil, however given increased risk of overdose with carfentanil we continue to use this starting dose and titrate slowly reduce the client’s reliance on the illicit street supply of opioids.

***Maximum doses of dilaudid 8 mg tablets will be determined based on the potency of the local street drug supply. This maximum daily dose ranges from 16 to 24 tablets at this time. We recognize that in the initiation period we may need to exceed daily maximum doses in order to support participants in discontinuing their dependence on the street supply altogether. We also believe that increasing SROM doses over time can help reduce the amount of D8s required over time.

****We recognize that some individuals on MMT and using toxic street supply will have tolerance rates high enough to require the use of methadone with or without SROM in addition to hydromorphone 8 mg IR tablets. For this reason, participants who are on methadone should be considered on a case by case basis. Risk should be assessed and the SOS MD/NP should consult with the participant’s methadone provider to determine a safe treatment plan. If they are not interested in continuing on MMT, then the participant should be switched to SROM at a 1:4 ratio as described by the BCCSU guidelines on page 51 (https://www.bccsu.ca/wp-content/uploads/2017/02/BC-OUD-Guidelines_FINAL.pdf).

Option 2: For clients using known dose/amount of opioids

• Convert all current opioid use as close as possible to MEQ

• Reduce total MEQ by 25% for incomplete cross tolerance
• Convert new daily MEQ requirement into SROM (daily DOT dosing) and hydromorphone IR 8 mg tablets (MEQ/5 = total HM dose/day, total HM dose/8 = # tabs daily)

Missed hydromorphone doses

If a participant misses 2 or more days of their daily dispense medications, they may have a decreased tolerance for the medications, and they will be required to be reassessed by the prescribing physician or nurse practitioner to restart the program. Consider repeat assessment and restarting at initial doses after prolonged periods (greater than 7 days) of incarceration or hospital admission if participants’ opioid replacement needs are not met. Missed doses from 2 to 7 days require clinical judgement.

For missed SROM doses, follow the BCCSU guidelines on page 52 (https://www.bccsu.ca/wp-content/uploads/2017/02/BC-OUD-Guidelines_FINAL.pdf).  

Assessments

• Participants will be seen by an intake person in order to determine eligibility
• Prior to enrollment into the program and during enrollment, participants can be assessed by harm reduction workers, RNs, health promoters and MD/NPs to track their opioid use using the form available in Appendix V
• Participants can be seen by RNs and NP/MDs or by NP/MDs for the initial intake into the program, see appendix III and IV for clinical templates
• It is recommended that clients are seen daily to 3x/week in the first week of enrollment and initiation into the program
• Clients should then be seen weekly by NPs/MDs until they have achieved SROM and D8 doses that have met their daily requirements and clients have been able to stop their use of street supply of opioids
• Once maintenance doses have been achieved, clients can switch to q2-4week appointments as needed

Diversion

The SOS program is being developed as a harm reduction measure and emergency response to growing overdose deaths. The increased risk of diversion associated with unsupervised doses is recognized. Given the current toxicity of the illicit drug supply and the growing number of overdose deaths, the benefits of delivering a safer drug supply likely outweigh the increased risk of diversion associated with unsupervised doses. In keeping with the assumptions of the program, participants will not be automatically discharged from the pilot if diversion is suspected and/or occurring. Suspected diversion will result in a conversation with the prescribing clinician about participation in the program and the need for adjustments to treatment. The program will mitigate the risk of diversion in the following ways:

a) Harm Reduction Teaching- During enrollment participants will be informed of the risks of diversion by the prescribing clinician and will be notified that suspected diversion will result in a discussion about their enrollment in the program and needed adjustments to care.

b) Urine Drug Screens- UDS will be completed on a weekly to monthly basis. Absence of hydromorphone will result in a discussion around participation and needed adjustments to care. Repeated absences may result in discharge from the program. Point of care urinalysis will be done for the following (with purpose):

i. Heroin metabolites (to assess for changes in illicit opioid use)

ii. Hydromorphone (to assess for usage vs. diversion of program medication)

iii. Fentanyl (to assess for changes in illicit opioid use and program objective, decreased exposure to fentanyl)

iv. Benzodiazepines (to assess poly-substance use)

v. Cocaine (to assess poly-substance use)

vi. Amphetamine (to assess poly-substance use)

vii. Pregnancy (to assess for pregnancy) - IF APPLICABLE

c) Witnessed Doses and Daily Dispense- All SROM doses will be observed at a pharmacy and all hydromorphone doses will be dispensed daily. If a participant has achieved a high level of stability, medication may be dispensed in less frequent intervals. A maximum of one week of medication will be dispensed. Dispensing more than one week of medication may only occur for a limited time in exceptional circumstances (i.e. travel when a guest pharmacy cannot be arranged).

Continuity of Care/Transitions

• The goal of the program is to enroll participants into primary care at the centre so that they can be prescribed safer supply at the same location as they see their family physician/nurse practitioner.
• If the participant has a primary care provider at a different location then the program will notify the family physician/nurse practitioner of the participant's enrollment into the program along with a description of the program. We will also request for the cumulative patient profile (CPP) at baseline (enrollment into program), at 6 months and at 12 months.
• We will notify the participant’s pharmacy and specialists about the program at time of medication start.
• We will notify hospitalists or prescribing clinicians within incarceration facilities if needed to inform them of the participant’s engagement within a safer supply program and request to continue their prescriptions to prevent destabilization.
• We will attempt to connect participants with safer supply prescribers in other communities should they move out of town. Should a safer supply prescriber not be readily available, and the individual is on a stable dosing schedule, participants of the program will be allowed to continue in the program, provided the following requirements are in place:

1. Urine samples for liquid chromatography and mass spectrometry are submitted weekly, showing continued use of prescribed safer supply medications and also for participant education on potential contaminants detected in illicit supply
2. Weekly phone calls appointments or OTN appointments if possible to ensure provider and participant remain connected

• Participants who have moved will be encouraged to seek a medical home where they are able to readily seek primary care.

See Appendix IX for Sample Letters for Hospitalists/Pharmacies etc

References

1. Williams, D. Memo from the Chief Medical Officer of Health of Ontario on Carfentanil in Ontario. Retrieved from: https://drive.google.com/file/d/1WUlsfHD6ouSLubkxiZaHSDblrwQaLiA1/view?usp=sharing

2. Public Health Ontario. Opioid-related morbidity and mortality in Ontario. Public Health Ontario, 2018. Retrieved from: https://www.publichealthontario.ca/-/media/documents/opioid-mortality-surveillance-report.pdf?la=en

3. Special Advisory Committee on the Epidemic of Opioid Overdoses. (2019). National Report: Apparent Opioid related Deaths in Canada (January 2016 to December 2018).Public Health Agency of Canada(pp. 1–22). Ottawa. Retrieved from: https://infobase.phac-aspc.gc.ca/datalab/national-surveillance-opioid-mortality.html

4. Irvine, M. A., Kuo, M., Buxton, J., Balshaw, R., Otterstatter, M., Macdougall, L., et al. Modelling the combined impact of interventions in averting deaths during a synthetic‐opioid overdose epidemic. Addiction, 2019; add.14664–12. http://doi.org/10.1111/add.14664

5. Kolla, G., Dodd, Z., Ko, J., Boyce, N., & Ovens, S. Canada's overdose crisis: authorities are not acting fast enough. Lancet Public Health, 2019; 4(4), e180. http://doi.org/10.1016/S2468-2667(19)30040-4

6. Tyndall, M. An emergency response to the opioid overdose crisis in Canada: a regulated opioid distribution program. Canadian Medical Association Journal, 2018; 190(2), E35–E36. http://doi.org/10.1503/cmaj.171060

7. Strang, J., Groshkova, T., Uchtenhagen, A., Van Den Brink, W., Haasen, C., Schechter, M. T., et al. Heroin on trial: Systematic review and meta-analysis of randomised trials of diamorphine-prescribing as treatment for refractory heroin addiction. The British Journal of Psychiatry, 2015; 207(1), 5–14. http://doi.org/10.1192/bjp.bp.114.149195

8. Ferri, M., Davoli, M., & Perucci, C. A. .Heroin maintenance for chronic heroin dependents. Cochrane Database of Systematic Reviews, 2005; (2), CD003410. http://doi.org/10.1002/14651858.CD003410.pub2

9. Oviedo-Joekes, E., Brissette, S., Marsh, D. C., Lauzon, P., Guh, D., Anis, A., & Schechter, M. T. Diacetylmorphine versus methadone for the treatment of opioid addiction. The New England Journal of Medicine, 2009; 361(8), 777–786. http://doi.org/10.1056/NEJMoa0810635

10. Oviedo-Joekes, E., Guh, D., Brissette, S., Marchand, K., Macdonald, S., Lock, K., et al. Hydromorphone Compared With Diacetylmorphine for Long-term Opioid Dependence. JAMA Psychiatry, 2016; 73(5), 447–9. http://doi.org/10.1001/jamapsychiatry.2016.0109

11. Oviedo-Joekes, E., Palis, H., Guh, D., Marsh, D. C., Macdonald, S., Harrison, S., et al. Adverse Events During Treatment Induction with Injectable Diacetylmorphine and Hydromorphone for Opioid Use Disorder. Journal of Addiction Medicine, 2019; 1–8. http://doi.org/10.1097/ADM.0000000000000505

12. Supervised Injectable Opioid Agonist Treatment Committee. Guidance for Injectable Opioid Agonist Treatment for Opioid Use Disorder. Ministry of Health, British Columbia and British Columbia Centre on Substance Use, 2017; 1–65. Vancouver. Retrieved from: http://www.bccsu.ca/wp-content/uploads/2017/10/BC-iOAT-Guidelines-10.2017.pdf

13. Canadian Association of People who Use Drugs. Safe Supply Concept Document. 2019. http://capud.ca/sites/default/files/2019-03/CAPUD%20safe%20supply%20English%20March%203%202019.pdf 

Additional resources:

Klimas J, Gorfinkel L, Giacomuzzi SM, et al. Slow release oral morphine versus methadone for the treatment of opioid use disorder. BMJ Open 2019;9:e025799. doi:10.1136/ bmjopen-2018-025799

Oviedo-Joekes E, Marchand K, Lock K, MacDonald S, Guy D, & Schechter MT. The SALOME study: recruitment experiences in a clinical trial offering injectable diacetylmorphine and

hydromorphone for opioid dependency. Subst Abuse Treat Prev Policy. 2015;10(3).

doi:10.1186/1747-597X-10-3

Silverman M, et al. Heating Injection Drug Preparation Equipment Used for Opioid Injection May Reduce HIV Transmission Associated With Sharing Equipment. J Acquir Immune Defic Syndr. 2019 Aug 1;81(4):e127-e133.

Appendices

Appendix I

Harm Reduction Outcome Data Tool

1. In the last month, how often have you felt that you were unable to control the important things in your life?

Never | Almost Never | Sometimes | Fairly Often | Very Often

2. In the last month, how often have you felt nervous and stressed?

Never | Almost Never | Sometimes | Fairly Often | Very Often

3. In the last month, how often did you use illicit drugs?

Never | Almost Never | Sometimes | Fairly Often | Very Often

a. Which drugs?

4. In the last month, how much money did you spend on drugs?

5. Have you overdosed in the past month? If so, how many times did this happen?

6. How has receiving this prescription improved things for you? How has it made things worse/more difficult?

Appendix II

Eligibility Check-List for Safer Opioid Supply Program^[6] 

Appendix III

First Visit RN Safer Supply Program Clinical Template

S:

Opioid use history and patterns:

Opioid of choice:

Route of administration: injection, inhalation, oral, patch

First use of substance of choice in life:

Started using regularly (at least once a week):

Days per week using drug of choice (in the past month):

Amount of substance usually consumed per day (in the past month):

Maximum amount consumed on one occasion (in the past month):

Consumption pattern (spaced throughout a day? Morning or evening? If so, how much/how often?):

The usual triggers or desires for consumption (what function does the drug serve?):

Usually consumed alone/with friends/with family/at home/at OPS/SISs?:

Previous experience with methadone, buprenorphine or SROM only?:

• Length of time:
• Max dose of each:

Complications of use:

• Medical: cellulitis, abscesses, endocarditis, sepsis, COPD, liver/renal dx
• Social:
• Family:
• Legal:
• Work:

Longest recent (within the last year) period of abstinence: when? how long? Why?

Withdrawal symptoms:

• Cravings
• Nausea/vomiting/diarrhea
• sweats/chills
• Irritability/anxiety
• Other

Ever need medical attention due to withdrawal symptoms? YES / NO

Any previous OD?s:

If yes, was naloxone used?:

Any previous ER visits or hospitalizations related to substance use (including abscesses/endocarditis/sepsis etc):

Current goals around use:

Other substances: how much, how often, which route (IV/IN/PO/TOP), for how long

Alcohol: None

Tobacco: None

Cannabis: None

Stimulants (Cocaine, amphetamine etc.): None

Benzodiazepines: None

Hallucinogens: None

Other substances: None

PMH:

No known liver dx, no hx of endocarditis or sepsis, no hospitalizations hx, no ER visits re: substance use

No Known HBV/HCV/HIV/STI

Last STI screening done:

Endocrine disorders (diabetes, thyroid disease etc.):

Cardiovascular diseases (hypertension, MI, hypercholesterolemia, atherosclerosis etc.):

Renal diseases: none

Gastrointestinal diseases: none

Liver disease: none

Pulmonary disease (asthma, COPD): none

Musculoskeletal diseases (arthritis, back injury etc):

Cancer: no

CNS (head injury, loss of consciousness or seizure disorder): none

Skin: none

Surgeries: none

Psychiatric history

Current and past diagnoses:

Admissions to mental health institutions (other than medical withdrawal management):

Suicide ideation/attempts:

Meds:

• Herbal or OTC meds?

Allergies:

Current PCP:

Current specialists:

Family history:

Substance use: none

Mental health: none

Illnesses running in family (cancer, cardiovascular disease, diabetes etc.):

Social history:

Housing:

Income:

Occupation: employed / unemployed / self-employed / retired / student

Education level:

Food access & nutrition:

Immigration status:

Social supports/Important relationships:

Children:

O: NAD jaundice ___, diaphoresis ___, general appearance ___, alert___, orientation___

Gait___,

Vitals:

{If concerns raised in PMH, focused physical assessments to be performed}

POC Urine Drug Screen

POS for:

NEG for:

A/P:
- ROI signed for PCPs? - notify PCP if transfering of care or seeing CHC for safer supply consult

- ROI signed for specialist and notification of program enrollment

- Lab work done today: screening labs for CBC, Cr/eGFR, RBG/HbA1c, LFTs + liver enzymes, Hepatitis A/B/C, HIV, syphilis, GC/CHL if required

- Current issues identified today:

Follow up Visit RN Safer Supply Program Clinical Template 

S:

Current safer supply rx:

• Kadian:
• Hydromorphone 8 mg:

Current use pattern - documented on Current Opioid Use Tracking Form, see scanned to chart

Withdrawal symptoms at current dose:

• Cravings
• Nausea/vomiting/diarrhea
• Sweats/chills
• Irritability/anxiety
• Other

Opioid side effects:

• Constipation:
• Drowsiness/sedation:

Other Illicit drugs used since last visit & amount:

«cocaine»

«THC»

«Benzodiazepines»

«Alcohol»

Or NONE

Pt reports «no» concerns regarding current dose.

No acute medical or psychiatric concerns today

No recent high risk exposure activity re HIV/HCV.

Current complications related to use:

Medical:

Work:

Social:

Family:

Legal:

O: NAD. Alert. Oriented.

Vitals:

No signs of cellulitis or abscess

{If concerns raised in PMH, focused physical assessments to be performed}

POC Urine Drug Screen:

A: Safe Supply Program for Opioid Use

P:
- Current issues identified today:

Appendix IV

First visit MD/NP Safer Supply Program Clinical Template

{The following history taking information should not be duplicated if the information has already been obtained by an RN working in your clinic/program. However you may use this opportunity to clarify and further elaborate on subjective information received:}

S:

Opioid use history and patterns:

Opioid of choice:

Route of administration (injection, inhalation, oral, patch):

First use of substance of choice in life:

Started using regularly (at least once a week):

Days per week using drug of choice (in the past month):

Amount of substance usually consumed per day (in the past month):

Maximum amount consumed on one occasion (in the past month):

Consumption pattern (spaced throughout a day? Morning or evening? If so, how much/how often?):

The usual triggers or desires for consumption (what function does the drug serve?):

Usually consumed alone/with friends/family/at home/at OPS/SISs?:

Previous experience with OST:

MMT:

• Highest dose:
• Length of time on highest dose:
• Last dose taken (time, dose):

Bup-naloxone:

• Highest dose:
• Length of time on highest dose:
• Last dose taken (time, dose):

SROM only:

• Highest dose:
• Length of time on highest dose:  
• Last dose taken (time, dose):

Complications of use:

• Medical (cellulitis, abscesses, endocarditis, sepsis, COPD, liver/renal dx):
• Social:
• Family:
• Legal:
• Work:

Longest recent (within the last year) period of abstinence: when? how long? Why?

Withdrawal symptoms:

• Cravings
• Nausea/vomiting/diarrhea
• sweats/chills
• Irritability/anxiety
• Other

Ever need medical attention due to withdrawal symptoms? YES / NO

Any previous OD?s:

If yes, was naloxone used?:

Any previous ER visits or hospitalizations related to substance use:

Current goals around use:

Other substances: how much, how often, which route (IV/IN/PO/TOP), for how long

Alcohol:

Tobacco:

Cannabis:

Stimulants (Cocaine, amphetamine etc.):

Benzodiazepines:

Hallucinogens:

Other substances:

PMH:

No known liver dx, no hx of endocarditis or sepsis, no hospitalizations hx, no ER visits re: substance use

Known HBV/HCV/HIV/STI:

Last STI screening done:

Endocrine disorders (diabetes, thyroid disease etc.):

Cardiovascular diseases (hypertension, MI, hypercholesterolemia, atherosclerosis etc.):

Renal diseases: none

Gastrointestinal diseases: none

Liver disease: none

Pulmonary disease (asthma, COPD): none

Musculoskeletal diseases (arthritis, back injury etc):

Cancer: no

CNS (head injury, loss of consciousness or seizure disorder): none

Skin: none

Surgeries: none

Psychiatric history:

Current and past diagnoses:

Admissions to mental health institutions (other than medical withdrawal management):

Suicide ideation/attempts:

Self-harm:

Abuse or trauma hx (physical, emotional, sexual, verbal, and or neglect)

Meds:

• PREP/HIV prophylaxis?
• Herbal or OTC meds?

Allergies:

Current PCP:

Current specialists:

Family history:

Substance use: none

Mental health: none

Illnesses running in family (cancer, cardiovascular disease, diabetes etc.):

Social history:

Housing:

Income:

Occupation: employed / unemployed / self-employed / retired / student

Education level:

Food access & nutrition:

Immigration status:

Social supports/Important relationships:

Children:

O: NAD jaundice ___, diaphoresis ___, general appearance ___, alert___, orientation___

Gait___,

BP:                  HR:                 SpO2:                 T:  if concerned/appears unwell        Wt:

MSE:

Good eye contact

Speech____

Mood: “_____”

Affect:

TC and TP:

SI____, HI____

insight and judgement:

{If concerns raised in PMH, focused physical assessments to be performed}

CVS: normal S1/S2, no murmurs, no edema

RESP: clear, GAEB

ABD: soft, non-tender, no HSM/mass, liver edge soft, no caput/angiomas

Neuro: no focal signs, normal DTRs

MSK: normal range of motion

Skin: no palmar erythema, track marks?

POC UDS results:

A: This patient meets criteria for «mild» «moderate» «severe» substance use disorder (OUD criteria form completed and scanned to file - See Appendix VI)

Based on current substance use, overdose death risk, incarceration risk and current physical/mental health as well as psychosocial history client meets criteria to enroll into Safer Supply program

P:

1. Offered access to suboxone or kadian only or MMT referral

- client declined, aware if at any time interested in discontinuing IVDU can be transitioned over to first line OSTs at any point during the program

- will continue to revisit

2. If applicable & client consents, ROI signed for (previous) family MD for CPP and to inform MDs involved in clients’ care that they are entering into Safer Supply program

3. For UDS today

4. Lab work: screening labs for CBC, Cr/eGFR, RBG/HbA1c, LFTs + liver enzymes, Hepatitis A/B/C, HIV, syphilis, GC/CHL if required

Other investigations ordered today:

5. Discussed program details and requirements, discussed evidence base that informs current program model showing improvements with iOATs, discussed limited evidence for crush to inject models and that D8 rx off label use for safer supply program

6. Consent form was reviewed and discussed risk of safer supply rx including overdose and death, risk of abscess and infections, DVT, sepsis and endocarditis - client understands risk and agreeable to enroll in program - client consents and has capacity; see consent form signed and scanned to chart (see Appendix VII for consent form)

7. Discussed safer ways of crushing to inject dilaudid, encouraged to use at OPS as much as possible or around others - does this now already, well informed on harm reduction, aware to use pill crusher to prepare powder, a filter, to cook for 10 secs for potentially lowering endocarditis and sepsis risk, aware of sterile needle/equipment use, no sharing of equipment, use of antiseptic protocol for self injections, & answered clients questions; handout on safer injections given to client (see Appendix VIII for handout)

8. Discussed concerns around diversion, discussed risk of tabs getting into the hands of opioid naïve individuals and risk of overdose death if this occurs, client understands risk and agreeable to disclose any diversion, aware will not be negatively impacted by this. Encouraged to invite others into the program if diversion is a concern. If diversion continues, aware will need to consider more observed medication use.

9. Discussed the role of UDSs as part of the program, aware will not be negatively impacted by results, results used instead to understand the degree of contamination of street drug supply and for evaluation purposes of Safer Supply program. Client consents to doing random UDSs.

10. Client initiated on Kadian 50 mg PO DOT and D8s 6-8 tabs today, to be dispensed daily at the following pharmacy:

11. Discussed importance of PO kadian use daily to address concerns around w/d symptoms and risk of crushing/injecting Kadian given ++ expedient which increases risk of endocarditis/sepsis. Client understands and agreeable to use Kadian as PO only at all times. Client agreeable to direct observed dosing of SROM at pharmacy.

12. Client aware to risk of OD/death with concurrent use of benzos/alcohol/stimulants/street supply of opioids with rx

13. Client aware to seek urgent medical attention or go to ER if chest pain, fevers, jaundice, abdo pain, severe joint pain, severe back pain or any concerns

14. F/U «2-3 days» «1 week» «2 weeks» «3-4 weeks»

Discussed case with another MD or NP at ____ without any patient identifiers.

______ NP or MD in agreement with the above plan.

Follow up Visit MD/NP Safer Supply Program Clinical Template 

S:

Current safer supply rx:

• Kadian:
• Hydromorphone 8 mg:

Current use pattern - documented on Current Opioid Use Tracking Form, see scanned to chart OR

Current street use amount, pattern, route:

Inquired today re: ongoing symptoms of opioid intoxication or withdrawal-

No reported withdrawal at current dose

Withdrawal symptoms at current dose:

• Cravings
• Nausea/vomiting/diarrhea
• sweats/chills
• Irritability/anxiety
• Other

No reported sedation or constipation with dose

Opioid side effects:

• Constipation:
• Drowsiness:

Other Illicit drugs used since last visit & amount:

«cocaine»

«THC»

«Benzodiazepines»

«Alcohol»

OR NONE

Pt reports «no» concerns regarding current dose.

No acute medical or psychiatric concerns today

No recent high risk exposure activity re HIV/HCV.

Current complications related to use:

Medical:

Work:

Social:

Family:

Legal:

O: NAD. Alert. Oriented.

BP:                  HR:                 SpO2:         

Gait, General Affect, Coordination and Speech all appear normal.

No signs of cellulitis or abscess

POC Urine Drug Screen:

A: Safe Supply Program for Opioid Use

P:

For full spec UDS with chromatography if any concerns with POC UDS or q2-4 weeks on program

See Rx - dose adjusted to:

Motivational interviewing and supportive counselling done

Reviewed harm reduction protocols including doing smaller shots and importance of using additional toxic street supply with peers/at an OPS/SCS due to higher OST/HDM8 dose, client understands and agreeable

F/U «2-3 days» «1 week» «2 weeks» «3-4 weeks»

Appendix V

Current Opioid Use Tracking Form

Name:                                        DOB:                                         Date:

Appendix VI

Diagnosis: Substance Use Disorder Criteria Form

Patient name:                                      DOB:                         Date of completion:                                        

2-3 symptoms = MILD

4-5 symptoms = MODERATE

6 or more symptoms = SEVERE

Appendix VII

Safer Opioid Supply Program (SOS) Agreement and Consent Form

Date:

The SOS prescriber has reviewed this form in detail with me. I understand the content fully and have been given time to ask questions. The evidence for other treatment options including methadone and suboxone therapy has been reviewed with me.



_________________________       ________________________        ____________________
Participant Name (Print)                Participant Signature                    Date

_________________________       ________________________        ____________________
Prescriber Name (Print)                 Prescriber Signature                    Date

Appendix VIII

How to Use a Safer Supply of Hydromorphone Tablets 

• Your doctor or nurse practitioner will prescribe tablets of hydromorphone (you may know this drug by the brand name Dilaudid). Because this is a medication that is designed to be taken by mouth, there are risks involved if you choose to inject it. We want to help you to use in the safest way possible and avoid these risks.

• Use your medication at an OPS or supervised by someone who has naloxone
  It is much safer to inject this medication at a Supervised Consumption Site or Overdose Prevention Site, where there are trained, friendly staff who can both share tips on injecting safely and also be present in case anything goes wrong. You can also get free clean syringes and other supplies and access referrals to other health and social services. If you are unable to access one of these sites, we strongly recommend that you have a trusted person to supervise your shot. Using alone means that if you overdose, no one will be able to save you, whereas overdose is totally reversible if someone else is there to respond.

• Do not share your medications
  Please do not share the prescribed meds with another person. Hydromorphone in these doses is strong enough to kill a person with no or low tolerance. Ensure that the medication cannot be accessed by children or animals, as if they consume even a small amount of the drug they could die.

• Do not mix your medication with non-prescribed drugs
  Do not mix this drug with benzodiazepines (such as Valium, clonazepam, lorazepam, or any drug whose name ends in “pam”), alcohol, sleeping pills, or other medications that make you drowsy or sedated. This increases the risk of a dangerous overdose.

Here are some steps you can take to inject more safely:

1. Prepare the equipment you will need, making sure to use brand new supplies for each shot. All of these supplies can be accessed for free at any Supervised Consumption Site, Overdose Prevention Site, or Community Health Centre – also, at the very end of this document you will find a list of places in Toronto that carry these supplies.

You will need:

- alcohol swabs

- cookers

-sterile water

- filters

- tourniquets (ties)

- syringes

2. Wash your hands or use an alcohol-based hand sanitizer

3. Use a clean surface to prepare your hit, for example, a clean table, a clean plate, a piece of paper

4. Crush your tablets using a pill crusher or something clean like the bottom of a glass or a spoon

5. Using a new cooker, and the plunger of a new syringe, mix the crushed pill powder with enough sterile water to dissolve it – heat the solution.

6. Use a new cotton filter or a Sterifit filter to draw the liquid up into the syringe

7. Find and prepare a vein (do brief exercise to get the blood flowing, clench and unclench your fist, squeeze a ‘stress’ ball, and/or use a tourniquet above the vein). Alternate veins as much as possible, and if you are using the same vein, use a place that is closer to your heart than the previous injection site. Staying well hydrated can make this process much easier.

8. Insert the needle into the vein at approximately a 30 degree angle with the bevel (hole) in the needle facing up and the needle pointed towards your heart

8. Flag – check that you are in the vein by slowly pulling back on the plunger. If you are in a vein, a small amount of blood should trickle into the syringe

9. Loosen the tourniquet before injecting

10. Inject slowly by pushing the plunger of the syringe

11. Slowly withdraw the needle

12. Use the small cotton pad from the cooker or a clean tissue or cotton ball to apply pressure to the injection site – do not use an alcohol swab after injecting – it increases bleeding and dries out the skin

13. Put the used syringe into a sharps bin and dispose of everything else you used.

14.  Wash your hands again in case there are small amounts of blood on them

15. Bring your sharps bin to a harm reduction program for safe disposal.

While you are starting this program, and at any time during your participation in it, anyone who works here would be more than happy to demonstrate any part of the injection process, assess your injection technique, or give you tips on how to inject with as few risks to your health as possible. We are here to support YOUR goals, needs and interests.

Appendix IX

Draft Letter for Hospitalists/Other Clinicians

DATE:

Dear Healthcare Provider (May personalize if provider known),

(Patient Name) is a patient of mine at (organization). Based on my evaluation and our program's criteria, (Patient name) is eligible for the Safer Opioid Supply Program.

This program provides patients who are at high risk of overdose/overdose deaths with opioid replacement using SROM and hydromorphone 8 mg tablets. This enables the patient to use predictable and safer doses of opioids rather than the poisonous street supply, significantly reducing their risk of death from overdose as well as complications associated with illicit street supply use.

The patient and I have discussed the risks and benefits of this program, as well as alternative options including methadone, buprenorphine, or sustained release oral morphine only. As of this letter's date, the patient's current prescription is as follows:

1. Kadian 100 mg capsules.  1 capsule PO daily. DOT

2. Hydromorphone 8 mg tablets., 2 tabs PO/IV Q4H PRN, Daily dispense __tabs

For ER department:

Please kindly continue to maintain this patient's medications as prescribed or titrate to meet their needs if clinically indicated. Should there be any queries or concerns regarding this patient's prescriptions, please contact me at the clinic listed on this letter or on call number _______. I would be happy to provide support around the management of this patient's opioids.

For hospitalization:

Please kindly continue to maintain this patient's medications as prescribed or titrate to meet their needs if clinically indicated. If desired by the patient, please convert their current dilaudid PO prescription to standing +/- PRN IV hydromorphone while in hospital. Please admit the patient into a private room in the hospital if possible. Given the high dose of opioids, benzodiazepines should be avoided unless deemed to be medically necessary. If benzodiazepines are used while patient is in hospital, please monitor their opioid requirements closely. Use of the Clinical Opiate Withdrawal Scale (COWS) may be beneficial during the course of the patient’s admission to hospital. Should there be any queries or concerns regarding this patient's prescriptions, please contact me at the clinic listed on this letter or on call number _______. I would be happy to provide support around the management of this patient's opioids. Please contact us to ensure coordination at time of discharge as well.

For incarceration:

Please kindly continue to maintain this patient's medications as prescribed or titrate to meet their needs if clinically indicated. If a client is unable to access harm reduction supplies in a correctional setting for their dilaudid prescriptions, please switch them to Kadian only or MMT or suboxone based on patient preference. Should there be any queries or concerns regarding this patient's prescriptions, please contact me at the clinic listed on this letter or on call number _______. I would be happy to provide support around the management of this patient's opioids.

Thank you for continuing to provide care to our mutual patient. I look forward to being in touch.

Sincerely,

Prescriber Name

Clinical Contact Information

On-Call number - if available

Appendix X

Draft Letter for Pharmacies

Dear Pharmacist,

The aforementioned is a patient of mine at (organization). Based on my evaluation and our program's criteria, they are eligible for the Safer Opioid Supply Program.  Based on the patient’s current drug use patterns, this prescription accounts for their opioid tolerance.

This program provides patients who are at high risk of overdose/overdose deaths with opioid replacement using SROM and hydromorphone (Dilaudid) 8 mg tablets. This enables the patient to use predictable and safer doses of opioids rather than the poisonous street supply, significantly reducing their risk of death from overdose as well as medical complications associated with illicit street supply use.

The patient and I have discussed the risks and benefits of this program, as well as alternative options including methadone, buprenorphine, or sustained release oral morphine only.

Based on questions from pharmacists we have received thus far, we wanted to clarify some aspects of the prescription:

Daily observed therapy (DOT) Kadian:

• The daily Kadian is to be observed daily unless script specifies otherwise.
• If a patient presents to the pharmacy intoxicated, the daily observed dose is to be held and the patient’s provider is to be notified.
• If you suspect the patient is not swallowing DOT doses, please inform patient’s provider.
• As the patient’s tolerance decreases, the patient MAY refuse to take their full dose of Kadian at the pharmacy. Please notify us when this occurs. Their refusal to take the full amount of DOT Kadian should not impact their dilaudid prescription.

Daily dispensed Dilaudid:

• The Dilaudid 8mg (brand name only) is to be dispensed daily. Physicians should indicate the amount of tablets to be dispensed daily.
• These do not need to be observed unless otherwise specified.

Missed doses:

• If a participant misses 2 or more consecutive days of their daily dispense medications, they may have decreased tolerance for the medications, and they will be required to be reassessed by the prescribing physician or nurse practitioner to restart the program. Please inform them to come see us in clinic during our drop-in hours on __________ from ___ AM/PM to _____PM.

We will ensure to place start and end dates on all prescriptions. As requested by some pharmacies, we will also include the patient’s follow-up appointment on the prescription so pharmacy staff can remind the patient.

Thank you for working with our team and our clients on this program. At any time during the program we also welcome questions around prescriptions, the program and what we can do to better work with our pharmacist colleagues.

Sincerely,

Prescriber Name

Clinical Contact Information

On-Call number - if available