Education & Advocacy Track: A Consensus Roadmap to Curb Deaths from Rx Drug Misuse and Abuse in the U.S.

1. Education and Advocacy Track:
A Consensus Roadmap to Curb
Deaths from Rx Drug Misuse and
Abuse in the U.S.
Presenters:
• Shannon Frattaroli, PhD, MPH, Associate Professor of Health Policy and
Management, Johns Hopkins Bloomberg School of Public Health, and
Associate Director for Outreach, Center for Injury Research and Policy
• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House
Foundation, Inc., and Director of Physicians for Responsible Opioid
Prescribing
• Alexander Chan, MPA, MCM, Associate Director of National Strategy,
Clinton Health Matters Initiative
• Alex Cahana, MD, Professor in Pain Medicine and Bioethics,
University of Washington
Moderator: Nancy Hale, President and CEO, Operation UNITE

2. Disclosures
Shannon Frattaroli, PhD, MPH; Andrew Kolodny, MD;
Alexander Chan, MPA, MCM; Alex Cahana, MD; and
Nancy Hale have disclosed no relevant, real, or
apparent personal or professional financial
relationships with proprietary entities that produce
healthcare goods and services.

3. Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
– Carla Saunders – Speaker’s bureau: Abbott Nutrition

4. Learning Objectives
1. Research the Clinton Foundation’s national,
cross-disciplinary team charged with
identifying Rx drug abuse strategies.
2. Outline the team’s recommendations for
strategies to reverse alarming trends in
opioid related injuries and deaths.

5. A Consensus Roadmap to Curb Deaths
from Prescription Drug Misuse and
Abuse in the United States
Context of Our Initiative
Community-based Prevention Strategies
Shannon Frattaroli, PhD, MPH
The Johns Hopkins Bloomberg School of Public Health
Center for Injury Research and Policy

6. Disclosure
• Shannon Frattaroli, PhD, MPH, has disclosed
no relevant, real, or apparent personal or
professional financial relationships with
proprietary entities that produce healthcare
goods and services.

7. Consensus Roadmap Background
• Johns Hopkins Bloomberg School of Public Health
and the Clinton Health Matters Initiative
• Identifying Experts
• Town Hall
• Expert Meeting
• Post-Meeting Commitments

9. Consensus Roadmap Working Groups
• Engineering strategies: Rx drugs and
packaging
• Prescribing guidelines
• Prescription drug monitoring programs
• Naloxone distribution
• Community-based prevention strategies
• Addiction treatment
• PBMs and Pharmacies

10. Working Groups’ Charge
• Draft a Report
– Statement of the Problem
– Synthesis of Available Evidence
– Recommendations for Action
– Communications Recommendations

11. Plan for the Consensus Roadmap
• Annual Event
• Report Release
• Engagement with New Stakeholders
• Dissemination Strategy
• Next Steps

12. Community-based Prevention Strategies
• Statement of the Problem
– There is no organized community approach to
primary prevention of OPR misuse and abuse

13. Community-based Prevention Strategies
• Synthesis of Available Evidence
– OPRs: Activity vs. Evidence
• Harm reduction
• Prevention
– Lessons from Other Topics
• Antibiotic use and children
• Alcohol
• Other substances

14. Community-based Prevention Strategies
• Recommendations for Action: Focus on
Specific Populations
– School Children
– College Students
– Substance Users
– Acute Pain Patients
– Chronic Pain Patients
– General Public

15. Community-based Prevention Strategies
• Communications Recommendations
– Funders and the need for evaluations of
community-based interventions
– Varied stakeholders and the need for storage and
disposal interventions
– Policymakers (legislative and executive) at the
state and local levels and opportunities for
leadership on this issue

16. Contact Information
Shannon Frattaroli
sfratta1@jhu.edu

17. Responding to North America’s
Opioid Addiction Epidemic
Andrew Kolodny, M.D.
Chief Medical Officer, Phoenix House Foundation Inc.
Executive Director, Physicians for Responsible Opioid Prescribing
Senior Scientist, Heller School for Social Policy and Management, Brandeis University
Research Professor, Global Institute of Public Health, New York University

18. Disclosures
• Andrew Kolodny, MD, has disclosed no relevant, real, or
apparent personal or professional financial relationships with
proprietary entities that produce healthcare goods and
services.

19. How the opioid lobby frames the the Rx problem
Source: Slide presented by Lynn R. Webster MD at FDA meeting on
hydrocodone upscheduling, January 25th, 2013.

20. Pain Patients “Drug Abusers”
63% admitted to using opioids for
purposes other than pain1
35% met DSM V criteria for
addiction2
1. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample Receiving
Daily Opioid Therapy. J Pain 2007;8:573-582.
2. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients:
comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194.
This is a false dichotomy
92% of opioid OD decedents
were prescribed opioids for
chronic pain.
3. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description of
Decedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.

21. 21
Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. Annu
Rev Public Health. 2015: 36:559-574
Non-medical use (abuse) of painkillers declining since 2002

22. 22
Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. Annu Rev Public
Health. 2015: 36:559-574
Non-medical Opioid Users Opioid Overdose Decedents

23. 23
Death rates from overdoses of heroin or prescription opioid pain relievers (OPRs), by
age group
SOURCE: CDC. Increases in Heroin Overdose Deaths — 28 States, 2010 to 2012
MMWR. 2014, 63:849-854

24. 24
Heroin admissions, Age & Race: 2001- 2011

25. 0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
20,000
22,000
24,000
26,000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Painkillers Heroin Total Opioid
Year
Opioid Related Overdose Deaths
United States, 1999-2013
Source: CDC National Center for Health Statistics

26. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
26

27. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
27

28. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
28

29. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
29

30. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
30

31. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
31

32. Controlling the epidemic:
A Three-pronged Approach
• Prevent new cases of opioid addiction
• Treatment for people who are already addicted
• Supply control- Efforts to reduce over-prescribing
and black-market availability
32

34. Opioid Addiction Treatment
• Psychosocial Approaches
– 12 Step
– Residential
– Cognitive Behavioral Therapy
• Pharmacological Approaches
– Buprenorphine
– Methadone
– Naltrexone

35. Buprenorphine Experience in France
• Introduced in the mid 90s
• 80% decline in OD deaths in 6 years*
• Associated with diversion and injection use
*Emmanuelli J, Desenclos JC. Harm reduction interventions,
behaviours and associated health outcomes in France, 1996–2003.
Addiction 2005;100:1690–1700.

36. Full Opioid Agonists

37. Buprenorphine- A Partial Agonist

38. Retention in Treatment
Kakko, Lancet 2003
Treatment duration (days)
Remainingintreatment(nr)
0
5
10
15
20
0 50 100 150 200 250 300 350
Detoxification
Maintenance

39. Buprenorphine RCT
A Tragic Appendix: Mortality
Kakko, Lancet 2003
Placebo BPN
Dead 4/20 (20%) 0/20 (0%)

40. Barriers to Buprenorphine
• Ideological
• Federally imposed patient caps
• Federally imposed ban on NP and PA
prescribing
• Addiction stigma limiting integration in
primary care
• Inertia

41. Summary
• The U.S. is in the midst of a severe epidemic of
opioid addiction
• To bring the epidemic to an end:
– We must prevent new cases of opioid addiction
– We must ensure access to treatment for people
already addicted

42. A Consensus Roadmap to Curb
Deaths from Prescription Drug Misuse
and Abuse in the United States
Scaling Access to Naloxone in
Communities of Need

43. Alex Chan has no disclosed relevant, real or apparent personal or
professional financial relationships with proprietary entities that produce
health care goods and services.
Disclosures

44. The Clinton Foundation helps transform lives and
communities from what they are today to what they can
be by creating partnerships of great purpose to deliver
sustainable solutions and empower people to live better
lives.
Clinton Foundation Purpose & Approach

45. Clinton Health Matters Initiative
What We Do
• Build strategic partnerships that will
help facilitate the development and
scaling of health promoting
solutions.
• Work across sectors to develop and
implement coordinated, systemic
approaches to creating healthier
communities.
• Leverage technology and digital
innovation to help advance health
and wellness at the national and
community levels by disseminating
evidence-based individual, systems,
and investment strategies.

46. Prescription Drug Abuse & Misuse
Goal: The Clinton Foundation seeks to cut
prescription drug abuse deaths in half – saving
approximately 10,000 lives – through strategic
partnerships that raise consumer and public
awareness, advance business practice change, and
mobilize communities.
The
Campus
Program
Johns
Hopkins
Partnership
Scaling
Access to
Naloxone

47. Why Naloxone?
1. In the US in 2010, opioid analgesics, such as
oxycodone, hydrocodone, and methadone, were
involved in about 3 of every 4 pharmaceutical
overdose deaths (CDC, 2013).
2. Most prescription opioid deaths occur outside of
medical settings (Paulozzi , 2012).
3. The number of community-based overdose education
and naloxone distribution (OEND) programs has been
on the rise; at least 188 community-based programs
were in existence in the US in 2010 (Wheeler,
Davidson, Jones, & Irwin, 2012).
4. Data from a 2010 survey found that 48 OEND
programs in the US had trained and provided
naloxone to over 50,000 individuals between 1996
and 2010, and reported over 10,000 opioid overdose
reversals

48. Starting Points
•April 2014
•25 Cross-sectorial
•Identified barriers and
Naloxone
Working
Group
•May 2014
•25 Representatives across
and sectors
•Identified common agenda
established 7 key priorities
Johns
Hopkins
Working
Group
Naloxone
Purchasing
Agreement
s

49. Barriers to Usage
• Lack of awareness of naloxone across
a complex healthcare delivery system
• CMS: Engaging CMS in the
conversation
• Role of business
• Stigma: as it applies to 1) individuals;
2) community (cultural acceptance);
3) people/ organizations (i.e. law
enforcement) that are promoting
naloxone access
• Training: Need for professional
training; not well defined currently
• Laws: Numerous laws need to be
addressed that prevent access
• Lack of Data:
• Need for better data to support
different prevention and
organizational
recommendations
• Need for better data about cost-
effectiveness of Naloxone
• Need for data about co-
prescribing
• Politics: the different ideologies
that are likely to clash
• Lack of unified message
• Money: Someone needs to pay for
this; thinking about how other
groups might be able to pay
• Affordability
• Accessibility of naloxone in the
physical space
• Confidentiality: Issue of
confidentiality and the lack of
sharing information
• Coverage
• Criteria for Use of naloxone
• Communication to patients +
individuals

50. Barriers to Usage: Training
• Integrating Naloxone education into
a variety of education programs;
certifications; and surveys
• Lack of accessible CME content
through different mediums for a
variety of groups
• How to develop content that
people want to learn
• No clear framework on how to get
doctors to “buy-in”
• Making Naloxone access a norm ( i.e.
seatbelt : following a road safety
norm)
• Messaging ( i.e. how to position this
as a universal precaution)
• How to translate this technical
space into something that is
engaging
• Putting message into
untraditional + “edgy” forms
• Org taking Leadership role: Who is
taking the leadership role? What is
their responsibility?
• Education: Educating patients on
how to educate caregivers
• Lack of awareness in
understanding overdose
• CME: Time, interest and incentive
to schedule this into your CME
• Training: Time, interest and
incentive to create broader
training; Integrating training into
the collective bargaining process
• Antiquated training system
• Lack a standard of delivery
• Workforce: No workforce for
disseminating this information
• Government providing advice and
guidance and developing medical
boards
• Lack of understanding of medical
legal standard of care
• Figure out ways to work with state
and national boards

51. Barriers to Usage: Community Access
• Developing syringe exchange
framework
• Catalyzing parent involvement
• Risk of overdose is more privatized
• Barriers around the law: what is legal?
• Issues of stigma and community
perception
• Issue of warm hand-off to treatment
• Funding for the community &
coverage
• Lack of integration in the healthcare
system ( i.e. education, advocacy) ;
how do you make it apart of the
whole solution?
• Education between prescription and
using Naloxone
• Developing a pharmacy care model;
what’s pharmacy’s role?
• Stuck in a prescription model
• Mode of delivery; how to make it
more accessible
• Shelf life of Naloxone ( awareness)
• Complexity of system
• Availability and accessibility

52. What’s Working
• Reversal success is self-perpetuating
• Re-define community groups :
success with law enforcement and
first responders
• All EMTs (local and rural) will be
trained
• Naloxone distribution with education
+ awareness campaigns through a
variety of channels - expanding the
definition of gate-keepers to include
places such as local schools
• Leadership investment changes what
the outcomes are
• Needle exchange programs
• Collaborative practice agreements
• Professional association expectation
• Needing better models on education
(Rhode Island model is very
promising)
• Building on the REMS Framework
• Developing new aspects to
Prescription Drug Monitoring
Programs - incorporate pharmacy
benefit managers as well as insurance
companies as well
• Create evidence-base and more
• Getting attention of doctors on how
it is effecting their patient
population
• Developing guidelines on who to
prescribe Naloxone to
• Creating new terminology
• Improving supply chain
• Improving the standard of care
• Making it user-friendly
• Empowering parents (i.e. moms) to
be heroes and working with
families
• Emphasis on prevention
(addressing over prescribing),
education and awareness
• Building strong community
partnerships (i.e. law enforcement)
• Exercise caution when labeling
things as “safe”
• Making it widely available through
simplicity and accessibility ( i.e.
community centers)
- Finding ways to meet people
where they are

53. What Does Success Look Like?
1. Provide a predictably affordable supply of Naloxone
to community groups, creating a window of
opportunity for the naloxone distribution field to
scale over the next four years.
2. Expand digestible and engaging continuing medical
education on naloxone targeting doctors, nurses,
dentists, pharmacists and others.
3. Accelerate efficient and rigorous implementation of
community-based distribution and access efforts.

54. Negotiated Agreement Experience
• 2002: CHAI negotiates
discounts for antiretroviral
medicine in Sub-Saharan
Africa
• 2004: AHG brokers
beverage industry
agreement.
• 2006: CHAI and UNITAID
expand coverage to
pediatric ARV in developing
countries
• Ongoing: AHG supports
employers who adopt the
Healthier Generation
Benefit.

55. Purchasing Agreements & Partnerships
1. Negotiate agreements with manufacturers of all forms
of naloxone, including inhalants, injectables, and
other forms under development.
2. Determine appropriate pricing mechanism that allows
public safety agencies and community based
organizations to purchase naloxone at a discount
close to federal pricing.
3. Develop purchasing platforms and mechanisms to
assist qualified organizations to participate in the
discount pricing program.

56. Initial Target Audiences
1. Campus Program Colleges
• 80 Schools
• 23 States
2. Public Safety Agencies &
Community Based Organizations
• Houston, TX
• Jacksonville, FL
• Little Rock, AR
• Coachella Valley, CA
• Adams County, MS

57. Timeline

58. A Consensus Roadmap to Curb Deaths
from Prescription Drug Misuse and
Abuse in the United States
Legislative and Policy Remedy
The story of WA state

59. Disclosures
• Alex Cahana, MD, has no disclosed relevant,
real or apparent personal or professional
financial relationships with proprietary
entities that produce health care goods and
services.

60. Approved learning objectives:
• At the end of the session attendees will be
able to describe essential elements within
policies that positively impact care for patients
who are candidates for opioid therapy
• Describe recommendations to improve state
policies

61. Reference:
Franklin G, et al, Am J Public Health, 2015

62. AMDG Guidelines
• In response to opioid related deaths in WA
• April 2006 AMDG (Medicaid; worker’s comp;
DoCorr; DoH; Public employees) convened
• w/ UW, private practitioners; 5 x 3h meetings
• Consensus Guidelines
• 120mg/d MED yellow flag
• April 2007 educational pilot

63. www.agencymeddirectors.wa.gov

67. Voluntary educational efforts
• 35 Category I CME presentations to primary care
• 2 hour free category I online test
• WSMA endorsement
• AHRQ endorsement
• In 2009, web based survey:
• 45% were familiar and applied guidelines
• 54% who treat pain patient have concerns
• 86% believe 120mg MED is reasonable or too
high

68. Results from Workers compensation:

69. ESHB 2876 (2010)
• Repeal WAC 246-919-830 from December
1999
• “no disciplinary action will be taken against a
practitioner based solely on the quantity or
frequency of opioids prescribed”

70. ESHB 2876 mandated:
• Use of Opioid dosing criteria (AMDG)
• Guidance on when to seek pain consultation
(TeleHealth)
• Guidance on tracking adherent use of opioids
(PDMP)
• Guidance on tracking clinical progress focusing
on pain interference, mood and function

71. Rules: 2011

72. Other legal remedies:
• ESHB 2127: requiring ED opioid guidelines
• ESHB 1370: Take back medicine programs
• ESHB 5516: Samaritan law
• ESHB 1671: Increased access to Naloxone
• ESHB 1403: Paying for TeleMedicine

73. Health Impact

74. Recommendations:

75. http://www.cdc.gov/phlp/publications/topic/prescription.html

76. Pain & Policy Study group, 2014
www.painpolicy.wisc.edu

78. Education and Advocacy Track:
A Consensus Roadmap to Curb
Deaths from Rx Drug Misuse and
Abuse in the U.S.
Presenters:
• Shannon Frattaroli, PhD, MPH, Associate Professor of Health Policy and
Management, Johns Hopkins Bloomberg School of Public Health, and
Associate Director for Outreach, Center for Injury Research and Policy
• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House
Foundation, Inc., and Director of Physicians for Responsible Opioid
Prescribing
• Alexander Chan, MPA, MCM, Associate Director of National Strategy,
Clinton Health Matters Initiative
• Alex Cahana, MD, Professor in Pain Medicine and Bioethics,
University of Washington
Moderator: Nancy Hale, President and CEO, Operation UNITE