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The use and unintended
consequences of pharmaceutical
opioids in Australia?
Michael Farrell
The Difference is Research
The Difference is Research
2
Disclosures
Mundipharma Australia (who market Reformulated OxyContin® and
Targin®) provided travel support for this meeting.
The NOMAD study was funded via an investigator-driven, untied
educational grant from Mundipharma Australia. The funder has no
role in the design, conduct, analysis, interpretation or decision of
what/where to publish.
I have also received untied educational grants for post-marketing
surveillance of new opioid substitution therapy medications by
Reckitt Benckiser, also conducted without any involvement of RB in
the design, conduct, analysis or publication of findings.
The Difference is Research
The Difference is Research
3
Overview
1. Utilisation of pharmaceutical opioids
2. What unintended consequences are causing concern?
3. People with chronic non-cancer pain using opioids
4. Use of Fentanyl by PWID in Australia
1. Utilisation of pharmaceutical opioids
Availability of opioids for pain management (2011-13)
Berterame et al (2016) Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study.
The Lancet.
6
Australia: PBS opioid dispensings
Blanch et al (2014). An overview of the patterns of prescription opioid use, costs and related harms in Australia.
BJ Clinical Pharmacology.
15-fold increase in dispensings
processed, 1992-2012
Issues:
• Opioids costing less than co-
payment threshold
• Authorities
• Private scripts
• Non-PBS listed opioids
• Non-prescribed (OTC) opioids
• Dispensing ≠ consumption
7
The picture in 2013: PBS opioid dispensings
vs. prescription opioid unit sales
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
18,000,000
Strong opioids Other
prescribed
opioids
OTC codeine
Number of PBS prescriptions
dispensed
Number of packs sold
Strong opioids : morphine, oxycodone, buprenorphine patch, methadone tablet, fentanyl, hydromorphone
Other prescribed opioids : prescription codeine, dextropropoxyphene, tramadol, tapentadol
Over-the-counter opioids : codeine products available at pharmacies without a doctor’s prescription
8
What does opioid consumption look like?
• It’s clearly increasing
• Reliance on aggregate PBS statistics will lead to a likely
underestimation of consumption: OTC consumption is
considerable
• Consumption higher in rural and regional areas and areas
with more disadvantage
• Need analyses of person-level data to examine (i)
whether this is a problem, and (ii) how much of this is a
problem
• AND we need direct data on patterns of consumption
(e.g. POINT and NOMAD study)
2. Unintended consequences of opioid use
10
Concerns accompanying opioid use
• Non-adherent use
o Stockpiling
o Doctor shopping
o Tampering
• Diversion
o Diversion to others
o Use of someone else’s medication
• Dependence
• Overdose
Larance et al (2011) Definitions related to the use of pharmaceutical opioids: Extra-medical use,
diversion, non-adherence and aberrant drug behaviours. Drug and Alcohol Review, 30, 236–245.
11
Changing nature of opioid-related deaths
380
182 175
234
278
217
107
195
274 288
0
100
200
300
400
500
600
700
800
900
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
heroin only morphine only methadone & bup
codeine only oxycodone only fentanyl only
several opioids
Source: National Coronial Information System (NCIS); Roxburgh et al (MJA, 2011); Roxburgh et al (2013)
27%
54%
19%
recorded idu history no idu history not known
52%
18%
30%
chronic pain no chronic pain not known
The Difference is Research
Potential risk factors for poorer clinical outcomes:
• Mental health problems
• History of drug and alcohol use problems
• Experience of trauma
• More complex pain problems
• Other illnesses and disabilities
• Other medications
Not everyone is at similar risk for
adverse outcomes
3. People living with chronic non-cancer
pain and using opioids
The Difference is Research
14
• Chronic non-cancer pain (CNCP) is a common complaint
• CNCP has a major impact on quality of life, mental health, health status,
relationships and employment
• There have been considerable increases in prescribing of opioids for CNCP
• Concern about harms related to pharmaceutical opioids
– Will there be greater problems with opioid dependence?
– Will there be considerable diversion of these medications?
– Is long-term use of opioids for chronic pain effective?
Background
The Difference is Research
The Difference is Research
Sample: people living with chronic non-cancer pain, prescribed opioids >=6 weeks
Recruitment across community pharmacies in Australia, with Pharmacy Guild
support:
• Contacted 93% (n=5,332) of all community pharmacies in Australia via fax
and phone
• 33% of pharmacies agreed to be involved in recruitment
Four assessment waves:
• Baseline n = 1,514
• T2 follow up (3 months) 82% follow-up
• T3 follow up (12 months) 83% follow-up
• T4 follow up (24 months) 83% follow-up
Permission to obtain medical records from Medicare for access to Medicare claim
history and prescription history as well as other health records
POINT cohort study design
Campbell et al (2014). Cohort protocol: The Pain and Opioids IN Treatment (POINT) study. BMC Pharmacol & Toxicol.
15
The Difference is Research
The Difference is Research
Pain and treatment experience
Median time experiencing pain 10 years
Median time to opioid prescription after pain
onset
12 months
On some type of opioid continuously (Median) 4 years
More than one pain condition 85%
Median pain conditions in the previous year 3
Back or neck problems (most common
condition)
76%
Median other chronic physical health problems 1
Campbell et al (2015). The Pain and Opioids IN Treatment (POINT) study: Characteristics of a cohort using opioids to
manage chronic non-cancer pain. Pain.
The Difference is Research
The Difference is Research
Current mental disorders
0 10 20 30 40 50
Moderate/severe depression
Moderate/severe Anxiety
Agoraphobia
Panic attacks
Post Traumatic Stress Disorder
Social phobia
Borderline Personality Disorder
Proportion (%)
Campbell et al (2015). The Pain and Opioids IN Treatment (POINT) study: Characteristics of a cohort using opioids to
manage chronic non-cancer pain. Pain.
The Difference is Research
The Difference is Research
Prescription opioid use in the POINT cohort
0
10
20
30
40
50
60
70
Oxycodone Morphine Buprenorphine
Proportion
(%)
• Prescribed opioids for a
median of 4 years
• 20% currently
prescribed ≥2 Schedule
8 opioids
• 63% also taking over-
the-counter opioids
• Median oral morphine
equivalent (OME) mg
per day – 75mg
• 15% taking over 200
OME per day
Campbell et al (2015). Correlates of pharmaceutical opioid use and dependence among people living with chronic pain:
Findings from the Pain and Opioids IN Treatment (POINT) study. Pain Medicine
18
19
Problematic use of pharmaceutical opioids
19
The Difference is Research
The Difference is Research
• One in twelve (8.5%) met lifetime ICD-10 criteria for
pharmaceutical opioid dependence
• One in ten (10.1%) met criteria ICD-10 criteria for harmful
use
• One in five (18.6%) met lifetime criteria for ICD-10
pharmaceutical opioid use disorder
• One in twenty (5%) were dependent in the past year
• Younger, more likely to engage in non-adherent behaviours, history of
benzodiazepine dependence
• All scored intermediate-to-high on Prescribed Opioids Difficulties Scale
Dependence in POINT cohort (ICD-10)
20
Campbell et al (2015). Correlates of pharmaceutical opioid use and dependence among people living with chronic pain:
Findings from the Pain and Opioids IN Treatment (POINT) study. Pain Medicine
The Difference is Research
The Difference is Research
Indicators of problematic use, by dose
0
10
20
30
40
50
60
70
80
< 20mg
OME
21-90mg
OME (ref)
91-199mg
OME
>200mg
OME
Proportion
(%)
% lifetime ICD-10
pharmaceutical opioid
dependence
%lifetime ICD-10 harmful
pharmaceutical opioid use
% at least some non-
adherence, past 3 months
% intermediate-high (>8)
score on the prescribed op
*
**
*
% intermediate-high on
PODS (>8)
Campbell et al (2015). Correlates of pharmaceutical opioid use and dependence among people living with chronic pain:
Findings from the Pain and Opioids IN Treatment (POINT) study. Pain Medicine
21
**
**
***
***
**
**
The Difference is Research
The Difference is Research
23
Trends in Fentanyl injecting and deaths
in Australia
The Difference is Research
24
Opioid Use in Australia
Heroin and Pharmaceutical opioid
injecting
79
66 66 65
69
65
56
58
60
64 63
61
59 60 60
58
56 57
40
50
45
46
41
49 50
47
42 43
39 39
35
35
28
27
27
16
22
26 26
29 28
31 33
31
27
19
16 13
6
8 9
8 7
0
10
20
30
40
50
60
70
80
90
100
%
People
who
inject
drugs
Heroin injected Morphine Injected
Oxycodone Injected Fentanyl Injected
Source: Illicit Drug Reporting
System
The Difference is Research
25
Results: Fentanyl injected on site
2012 to 2017
0
50
100
150
200
250
300
350
400
450
500
Sep-12 Jun-13 Mar-14 Dec-14 Sep-15 Jun-16 Mar-17
Number
of
injections
Fentanyl
The Difference is Research
26
Pharmaceutical opioid deaths (by opioid)
per million population
0
1
2
3
4
5
6
7
8
9
10
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Deaths
per
million
population morphine oxycodone tramadol fentanyl
Source: NCIS; Roxburgh et al, Drug and Alcohol
Dependence 2017
The Difference is Research
The Difference is Research
•Thanks to our participants in all the studies mentioned here
•Collaborators : Louisa Degenhardt, Gabrielle Campbell, Amanda Roxburgh, Natasa Gisev, Suzi Nielsen,
Sarah Larney, Elena Cama, Wayne Hall, Nicholas Lintzeris, Richard Mattick, Raimondo Bruno, Amy
Peacock, Milton Cohen, Robert Ali, Nancy White, Timothy Dobbins, Lucy Burns, Adrian Dunlop, Michael
Farrell, Fiona Shand
•Advisory Committee (POINT): Fiona Blyth, Lesley Brydon, Elizabeth Carrigan, Malcolm Dobbin, Julia
Fleming, Roger Goucke, Simon Holliday, Denis Leahy, Andrea Mant, Jake Najman, Milana Votrubec, Jason
White
•Associate Investigators and Advisory Committee (NOMAD): Lesley Brydon, Gabrielle Campbell, Apo
Demirkol, Malcolm Dobbin, Adrian Dunlop, Angella Duvnjak, Paul Haber, Marianne Jauncey, Robert Kemp,
Richard Mattick, Suzanne Nielsen, Amy Peacock, Nghi Phung, Ann Roche, Nancy White and Hester Wilson
•POINT study team: Gabrielle Campbell (coordinator), Bianca Hoban, Kimberley Smith, Ranira Moodley,
Sarah Freckleton, Rachel Urquhart-Secord, Teleri Moore, Courtney O’Donnell
•NOMAD study team : Ivana Kihas, Toni Hordern, Amy Peacock, Nancy White, Elena Cama, Dominic Oen,
Oluwadamisola and our team of interviewers
•NHMRC project grant: #1022522 (POINT study)
•NHMRC fellowships: Briony Larance, Louisa Degenhardt, Suzanne Nielsen, Richard Mattick
•Mundipharma: Untied educational grant; Billy Henderson
•Pharmacy Guild of Australia
Acknowledgements
28
Thank you!
Louisa Degenhardt
Gabrielle Campbell
Briony Larance
Amanda Roxborough
Research Fellow (NHMRC ECF)
NDARC, UNSW Australia
: (02) 9385 0241
 : (02) 9385 0222
 : Michael.Farrell@unsw.edu.au

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11H00_3_Michael Farrell.pptx

  • 1. The use and unintended consequences of pharmaceutical opioids in Australia? Michael Farrell
  • 2. The Difference is Research The Difference is Research 2 Disclosures Mundipharma Australia (who market Reformulated OxyContin® and Targin®) provided travel support for this meeting. The NOMAD study was funded via an investigator-driven, untied educational grant from Mundipharma Australia. The funder has no role in the design, conduct, analysis, interpretation or decision of what/where to publish. I have also received untied educational grants for post-marketing surveillance of new opioid substitution therapy medications by Reckitt Benckiser, also conducted without any involvement of RB in the design, conduct, analysis or publication of findings.
  • 3. The Difference is Research The Difference is Research 3 Overview 1. Utilisation of pharmaceutical opioids 2. What unintended consequences are causing concern? 3. People with chronic non-cancer pain using opioids 4. Use of Fentanyl by PWID in Australia
  • 4. 1. Utilisation of pharmaceutical opioids
  • 5. Availability of opioids for pain management (2011-13) Berterame et al (2016) Use of and barriers to access to opioid analgesics: a worldwide, regional, and national study. The Lancet.
  • 6. 6 Australia: PBS opioid dispensings Blanch et al (2014). An overview of the patterns of prescription opioid use, costs and related harms in Australia. BJ Clinical Pharmacology. 15-fold increase in dispensings processed, 1992-2012 Issues: • Opioids costing less than co- payment threshold • Authorities • Private scripts • Non-PBS listed opioids • Non-prescribed (OTC) opioids • Dispensing ≠ consumption
  • 7. 7 The picture in 2013: PBS opioid dispensings vs. prescription opioid unit sales 0 2,000,000 4,000,000 6,000,000 8,000,000 10,000,000 12,000,000 14,000,000 16,000,000 18,000,000 Strong opioids Other prescribed opioids OTC codeine Number of PBS prescriptions dispensed Number of packs sold Strong opioids : morphine, oxycodone, buprenorphine patch, methadone tablet, fentanyl, hydromorphone Other prescribed opioids : prescription codeine, dextropropoxyphene, tramadol, tapentadol Over-the-counter opioids : codeine products available at pharmacies without a doctor’s prescription
  • 8. 8 What does opioid consumption look like? • It’s clearly increasing • Reliance on aggregate PBS statistics will lead to a likely underestimation of consumption: OTC consumption is considerable • Consumption higher in rural and regional areas and areas with more disadvantage • Need analyses of person-level data to examine (i) whether this is a problem, and (ii) how much of this is a problem • AND we need direct data on patterns of consumption (e.g. POINT and NOMAD study)
  • 10. 10 Concerns accompanying opioid use • Non-adherent use o Stockpiling o Doctor shopping o Tampering • Diversion o Diversion to others o Use of someone else’s medication • Dependence • Overdose Larance et al (2011) Definitions related to the use of pharmaceutical opioids: Extra-medical use, diversion, non-adherence and aberrant drug behaviours. Drug and Alcohol Review, 30, 236–245.
  • 11. 11 Changing nature of opioid-related deaths 380 182 175 234 278 217 107 195 274 288 0 100 200 300 400 500 600 700 800 900 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 heroin only morphine only methadone & bup codeine only oxycodone only fentanyl only several opioids Source: National Coronial Information System (NCIS); Roxburgh et al (MJA, 2011); Roxburgh et al (2013) 27% 54% 19% recorded idu history no idu history not known 52% 18% 30% chronic pain no chronic pain not known
  • 12. The Difference is Research Potential risk factors for poorer clinical outcomes: • Mental health problems • History of drug and alcohol use problems • Experience of trauma • More complex pain problems • Other illnesses and disabilities • Other medications Not everyone is at similar risk for adverse outcomes
  • 13. 3. People living with chronic non-cancer pain and using opioids
  • 14. The Difference is Research 14 • Chronic non-cancer pain (CNCP) is a common complaint • CNCP has a major impact on quality of life, mental health, health status, relationships and employment • There have been considerable increases in prescribing of opioids for CNCP • Concern about harms related to pharmaceutical opioids – Will there be greater problems with opioid dependence? – Will there be considerable diversion of these medications? – Is long-term use of opioids for chronic pain effective? Background
  • 15. The Difference is Research The Difference is Research Sample: people living with chronic non-cancer pain, prescribed opioids >=6 weeks Recruitment across community pharmacies in Australia, with Pharmacy Guild support: • Contacted 93% (n=5,332) of all community pharmacies in Australia via fax and phone • 33% of pharmacies agreed to be involved in recruitment Four assessment waves: • Baseline n = 1,514 • T2 follow up (3 months) 82% follow-up • T3 follow up (12 months) 83% follow-up • T4 follow up (24 months) 83% follow-up Permission to obtain medical records from Medicare for access to Medicare claim history and prescription history as well as other health records POINT cohort study design Campbell et al (2014). Cohort protocol: The Pain and Opioids IN Treatment (POINT) study. BMC Pharmacol & Toxicol. 15
  • 16. The Difference is Research The Difference is Research Pain and treatment experience Median time experiencing pain 10 years Median time to opioid prescription after pain onset 12 months On some type of opioid continuously (Median) 4 years More than one pain condition 85% Median pain conditions in the previous year 3 Back or neck problems (most common condition) 76% Median other chronic physical health problems 1 Campbell et al (2015). The Pain and Opioids IN Treatment (POINT) study: Characteristics of a cohort using opioids to manage chronic non-cancer pain. Pain.
  • 17. The Difference is Research The Difference is Research Current mental disorders 0 10 20 30 40 50 Moderate/severe depression Moderate/severe Anxiety Agoraphobia Panic attacks Post Traumatic Stress Disorder Social phobia Borderline Personality Disorder Proportion (%) Campbell et al (2015). The Pain and Opioids IN Treatment (POINT) study: Characteristics of a cohort using opioids to manage chronic non-cancer pain. Pain.
  • 18. The Difference is Research The Difference is Research Prescription opioid use in the POINT cohort 0 10 20 30 40 50 60 70 Oxycodone Morphine Buprenorphine Proportion (%) • Prescribed opioids for a median of 4 years • 20% currently prescribed ≥2 Schedule 8 opioids • 63% also taking over- the-counter opioids • Median oral morphine equivalent (OME) mg per day – 75mg • 15% taking over 200 OME per day Campbell et al (2015). Correlates of pharmaceutical opioid use and dependence among people living with chronic pain: Findings from the Pain and Opioids IN Treatment (POINT) study. Pain Medicine 18
  • 19. 19 Problematic use of pharmaceutical opioids 19
  • 20. The Difference is Research The Difference is Research • One in twelve (8.5%) met lifetime ICD-10 criteria for pharmaceutical opioid dependence • One in ten (10.1%) met criteria ICD-10 criteria for harmful use • One in five (18.6%) met lifetime criteria for ICD-10 pharmaceutical opioid use disorder • One in twenty (5%) were dependent in the past year • Younger, more likely to engage in non-adherent behaviours, history of benzodiazepine dependence • All scored intermediate-to-high on Prescribed Opioids Difficulties Scale Dependence in POINT cohort (ICD-10) 20 Campbell et al (2015). Correlates of pharmaceutical opioid use and dependence among people living with chronic pain: Findings from the Pain and Opioids IN Treatment (POINT) study. Pain Medicine
  • 21. The Difference is Research The Difference is Research Indicators of problematic use, by dose 0 10 20 30 40 50 60 70 80 < 20mg OME 21-90mg OME (ref) 91-199mg OME >200mg OME Proportion (%) % lifetime ICD-10 pharmaceutical opioid dependence %lifetime ICD-10 harmful pharmaceutical opioid use % at least some non- adherence, past 3 months % intermediate-high (>8) score on the prescribed op * ** * % intermediate-high on PODS (>8) Campbell et al (2015). Correlates of pharmaceutical opioid use and dependence among people living with chronic pain: Findings from the Pain and Opioids IN Treatment (POINT) study. Pain Medicine 21 ** ** *** *** ** **
  • 22. The Difference is Research The Difference is Research 23 Trends in Fentanyl injecting and deaths in Australia
  • 23. The Difference is Research 24 Opioid Use in Australia Heroin and Pharmaceutical opioid injecting 79 66 66 65 69 65 56 58 60 64 63 61 59 60 60 58 56 57 40 50 45 46 41 49 50 47 42 43 39 39 35 35 28 27 27 16 22 26 26 29 28 31 33 31 27 19 16 13 6 8 9 8 7 0 10 20 30 40 50 60 70 80 90 100 % People who inject drugs Heroin injected Morphine Injected Oxycodone Injected Fentanyl Injected Source: Illicit Drug Reporting System
  • 24. The Difference is Research 25 Results: Fentanyl injected on site 2012 to 2017 0 50 100 150 200 250 300 350 400 450 500 Sep-12 Jun-13 Mar-14 Dec-14 Sep-15 Jun-16 Mar-17 Number of injections Fentanyl
  • 25. The Difference is Research 26 Pharmaceutical opioid deaths (by opioid) per million population 0 1 2 3 4 5 6 7 8 9 10 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Deaths per million population morphine oxycodone tramadol fentanyl Source: NCIS; Roxburgh et al, Drug and Alcohol Dependence 2017
  • 26. The Difference is Research The Difference is Research •Thanks to our participants in all the studies mentioned here •Collaborators : Louisa Degenhardt, Gabrielle Campbell, Amanda Roxburgh, Natasa Gisev, Suzi Nielsen, Sarah Larney, Elena Cama, Wayne Hall, Nicholas Lintzeris, Richard Mattick, Raimondo Bruno, Amy Peacock, Milton Cohen, Robert Ali, Nancy White, Timothy Dobbins, Lucy Burns, Adrian Dunlop, Michael Farrell, Fiona Shand •Advisory Committee (POINT): Fiona Blyth, Lesley Brydon, Elizabeth Carrigan, Malcolm Dobbin, Julia Fleming, Roger Goucke, Simon Holliday, Denis Leahy, Andrea Mant, Jake Najman, Milana Votrubec, Jason White •Associate Investigators and Advisory Committee (NOMAD): Lesley Brydon, Gabrielle Campbell, Apo Demirkol, Malcolm Dobbin, Adrian Dunlop, Angella Duvnjak, Paul Haber, Marianne Jauncey, Robert Kemp, Richard Mattick, Suzanne Nielsen, Amy Peacock, Nghi Phung, Ann Roche, Nancy White and Hester Wilson •POINT study team: Gabrielle Campbell (coordinator), Bianca Hoban, Kimberley Smith, Ranira Moodley, Sarah Freckleton, Rachel Urquhart-Secord, Teleri Moore, Courtney O’Donnell •NOMAD study team : Ivana Kihas, Toni Hordern, Amy Peacock, Nancy White, Elena Cama, Dominic Oen, Oluwadamisola and our team of interviewers •NHMRC project grant: #1022522 (POINT study) •NHMRC fellowships: Briony Larance, Louisa Degenhardt, Suzanne Nielsen, Richard Mattick •Mundipharma: Untied educational grant; Billy Henderson •Pharmacy Guild of Australia Acknowledgements
  • 27. 28 Thank you! Louisa Degenhardt Gabrielle Campbell Briony Larance Amanda Roxborough Research Fellow (NHMRC ECF) NDARC, UNSW Australia : (02) 9385 0241  : (02) 9385 0222  : Michael.Farrell@unsw.edu.au

Hinweis der Redaktion

  1. There have been considerable increases in prescribing of opioids: a 15-fold overall increase in PBS-subsidised opioid dispensings between 1992-2012
  2. Over the period of monitoring…
  3. Efficacy
  4. Twenty-four percent of the cohort met criteria for ‘Addiction’, 18% for DSM-5 use disorder and 19% for ICD-11 dependence. There was moderate concordance between ‘Addiction’ and DSM-IV, and ‘substantial’ concordance between ‘Addiction’ and ICD-11 opioid dependence, with nearly all those meeting criteria for ICD-11 included in ‘Addiction’. Participants meeting criteria for ‘Addiction’ only were older and less likely to have risk factors such as, engagement in non-adherent behaviours, psychological distress and substance use history than those who also met DSM-5 and ICD-11 criteria.   The definition of ‘Addiction’ captures a larger group than other classification systems, and includes people with fewer ‘risk’ behaviours. Despite removal of tolerance and withdrawal for prescribed opioid use for DSM-5, we found that ‘Addiction’ was more closely related to an ICD-11 diagnosis of pharmaceutical opioid dependence.