Transcript Plenary Panel Binswanger 2015

Ingrid Binswanger, MD, MPH, MS
Senior Investigator, Kaiser Permanente Colorado
Associate Professor, Division of General Internal Medicine,
University of Colorado School of of Medicine
Research Team
 Jason M. Glanz, PhD
 Steve Koester, PhD
 Edward M. Gardner, MD
 Shane Mueller, MSW
 Komal J Narwaney, PhD
 Kristin Breslin, MPH
Disclosures
 The following personal financial relationships with commercial
interests relevant to this presentation existed during the past 12
months:
– None to disclose
Outline: Naloxone in Primary Care
 Rationale
 Perceptions:
– How do primary care staff perceive naloxone and it role in their
practice?
– How do patients perceive it?
 Evidence gaps:
– Who should it be prescribed to? Three approaches
– How should it be provided to patients?
– What are the benefits and harms?
Naloxone
 An efficacious, FDA approved short-acting opioid antagonist
 Traditionally administered by first responders & other medical
personnel to reverse opioid induced respiratory depression
 No abuse potential
 Can precipitate withdrawal and return of pain
 Additional doses and/or monitoring may be required for long acting
opioids
 Not traditionally prescribed in outpatient settings
Community-based Naloxone
 Increasingly distributed to people who use heroin and other opioids
for “take-home” or “bystander” use
 Community-based programs provide overdose education and
naloxone
– >150,000 people trained and dispensed naloxone,1996-2014
– >26,000 reversals reported
 Cost effective for people who use heroin
 Associated with improved community level overdose outcomes
Wheeler et al., MMWR 2015; Walley et al., BMJ 2013; Coffin et al., Ann Int Med, 2013
Reverse Translation: Community  Clinic
 Patients on chronic pharmaceutical opioids for pain could also benefit
from medication safety/overdose education and naloxone prescription
 Primary care and HIV clinics in large health systems offer opportunity
to reach many at risk
 However, little is known about provider and patient attitudes towards
this emerging practice
Mueller et al., Subst Abus 2015
Objectives for Qualitative Investigations
 Assess knowledge, attitudes and beliefs about overdose prevention
and naloxone prescription among primary care and HIV medical staff
and patients taking high-dose opioids for pain
 Determine the barriers and facilitators to overdose risk assessment,
counseling and naloxone prescription
Binswanger et al., JGIM 2015
Methods: Study Design
 10 one hour qualitative focus groups with medical staff at clinic sites
over lunch in three diverse Colorado health systems, 2013-14
 22 individual interviews with randomly selected patients who received
3+ high dose (≥100 milligrams morphine average daily dose) opioid
prescriptions in last 6 months, 2014-15
 Patient interviews conducted by an Anthropologist and doctoral
student
 Focus group and interview guides based on the Theory of Planned
Behavior and the Health Belief Model
Focus Group Guide: Selected Constructs
Constructs
Knowledge
Susceptibility
Benefits
Barriers
Facilitators
Sample question
What do you know about naloxone?
Who do you think is at risk of overdose?
What benefits and risks do you see in prescribing
naloxone to your patients?
Have there been any barriers to counseling patients
in your practice about overdose or prescribing them
naloxone?
How could these barriers be addressed?
What would help you provide effective counseling to
your patients?
Results: Themes Emerged in 5 Constructs
Each construct will be presented from the perspective of the medical staff followed by the patients
1. Knowledge Gaps
2. Target Groups/Perceived Risks of Overdose
3. Benefits of Overdose Education & Naloxone
4. Barriers
5. Facilitators
1. Provider Knowledge
 Little knowledge about naloxone for bystander use
 Direct knowledge of naloxone was limited to “in hospital” use or
medical school training
 Confusion with addiction treatment medications: Suboxone™
(buprenorphine/naloxone), naltrexone
 Concerns about adverse effects in their patient populations
 As a consequence, little prescribing even when available
1. Provider Knowledge
“I probably just don’t have quite as much knowledge
about the outpatient safety of it to feel comfortable
prescribing it right now.”
— Name, Title (20pt Arial Narrow)
1. Patient Knowledge
 Patients reported few prior discussions about overdose risk with the
providers who prescribed them opioids
 For some, engagement in past opioid risk behaviors was linked to
lack of knowledge and experience
 Some had prior knowledge about naloxone use for heroin
 Patients generally had no knowledge about naloxone use for
prescribed opioids
1. Patient Knowledge
“There’s not too much education about it
[overdose]… When I first started taking it [the opioid
medication], no one told me about OD or anything
about that, you know what I mean? Because I was
taking it not [as] prescribed… I was just like when I
felt pain I would just take like five or six of them or
whatever. Then at the end, I’d run out.”
— Name, Title (20pt Arial Narrow)
1. Patient Knowledge
“Well, I think that what puts people at risk for any
problematic medication situations is lack of
education.”
— Name, Title (20pt Arial Narrow)
1. Patient Knowledge
Respondent: “I think they [doctors] assume we’re
stupid… I think they make the assumption that we’re
not going to get it even if we’re told it, you know, the
truth…the side effects, whatever…”
Respondent 2 (caregiver): “And [they assume] that
someone else already told you, that a nurse told
you.”
2. Target Groups
Medical staff identified wide spectrum of patients who could be
prescribed naloxone, including patients with:
– High-dose opioid prescriptions
– Concomitant mental health problems
– Impulsivity
– Poorly controlled pain
– Early refill requests
– Household members at risk
2. Target Groups
“I think the patients on the maximum dose [200 mg] are a
good place to start, but I think that’s not… those aren’t the
only people at risk for overdose and in fact those are
probably the most tolerant of all our patients…
I had a patient whose daughter accidentally overdosed on
her meds…so, I’m wondering, shouldn’t we be offering it
more broadly…?”
2. Patient Perceived Risk
 Patients perceived themselves at negligible risk for overdose
 Yet, they endorsed having multiple known risk factors, engaging in
risk behavior, and prior safety events and overdoses not disclosed to
primary care providers
 Felt safe if took medication “as prescribed” and “for pain”
 Perceived others as at higher risk than themselves
 Risk tied to “abuse” of the medication
2. Patient Perceived Risk
Interviewer: “Do you think it would be helpful to have
a drug like naloxone around, or for your doctor to
prescribe it to you?”
Respondent: “I’ve never overdosed in my life… I’m
54 years old and I don’t think I’m going to start now.”
— Name, Title (20pt Arial Narrow)
2. Patient Perceived Risk
Interviewer: “Do you think it would be helpful to have
it [naloxone] for yourself?”
Respondent: “No.”
Interviewer: “You don’t think naloxone would be
helpful for you to have around?”
Respondent: “No”
Interviewer: “Why is that?”
Respondent: “Because I don’t need it.”
2. Patient Perceived Risk
(Same respondent)
Respondent: “Well, at one point I was taking a good
chunk of morphine during the day and…well, to be
honest with you, I burnt all kinds of holes in the
carpet from smoking cigarettes and I’d go like this…
[nodding]”
Interviewer: “Nodding off or…yeah.”
Respondent: “You know, and that was when I was
taking too much.”
2. Patient Perceived Risk
Interviewer: “Has your doctor ever asked you about
anything like [alcohol use]? Like have you ever drank
with your medications?”
Respondent: “I said yeah, I have a few beers. I don’t
drink every day, but yeah, I have a few beers. ‘Do you
drink?’ Yeah, I have a few beers…that’s what I told them,
you know, and then it was just a mess, you know.
Drinking with your medications, drinking with this,
drinking with that, you know, you’re an alcoholic, you
need this, you need Alcohol Anonymous, you need…I’m
like no. So, [now] I tell them I don’t [drink].”
2. Patient Perceived Risk
“I know that people have died. People die… Yeah, it’s
serious, but I think also that either they had mixed their pills,
you know, and got confused or some people really just right
out abuse them and was trying to get a high or something
and abused them or were seriously trying to kill themselves
and did it.
That’s the way I see that, but I think if you take them as
prescribed, you’re OK.”
3. Benefits Identified by Patients and Providers
 Indirect: understanding the overdose potential of opioids, enhancing
medication safety behavior
 Direct: preventing death from accidental overdose
3. Benefits Identified by Providers
“Actually I think even prescribing it to a patient [on
high doses]… just that conversation that alerts their
minds, would just perhaps make them think about
that possibility [overdose]. It might be just enough to
scare them just a little.”
— Name, Title (20pt Arial Narrow)
3. Benefits Identified by Patients
“I wish that some of the people that I’ve known that
I’ve really care about that I lost had this medication.
Gosh. This would have been helpful. It really would,
but that’s good that, you know, they’re doing
something about it now. I think that’s really good.”
— Name, Title (20pt Arial Narrow)
4. Provider Barriers
 Giving mixed messages about opioids to patients/families
 Giving permission for riskier use, encouraging more use
 Being viewed negatively for targeting patients for overdose education
or naloxone, offending patients because it implies distrust
 Uncomfortable reflection on own opioid prescribing practices
4. Provider Barriers
“…the naloxone might give them permission to play
with their dose, and you know, try and get high. That
type of thing at higher doses, but I think that since
we’ve got such tight control over when they get their
refills and that type of thing, that that would be
somewhat of a mitigation.”
— Name, Title (20pt Arial Narrow)
4. Provider Barriers
“It seems kind of intuitive, like glucagon for insulin...
But it just feels a little uncomfortable. You know, it
just feels a little uncomfortable where glucagon just
doesn’t…
It seems like it may have merit. On some level it also
makes me feel likes it’s sort of putting our head in
the sand just a little bit, you know. If you feel like, my
God, this patient is going to kill themselves. Maybe
the solution is to not have them on opioids.”
4. Patient Barriers
 Need to be perceived as a non-abusing patient and have pain
legitimized – be on the right side of the line between pain and abuse
 Prior negative experiences with open disclosure of risk behaviors:
feeling “punished”
 Poor communication from providers
 Distrust in providers around opioid prescribing, particularly recently
 Anger about urine screening
 Fear of negative consequences from providers if naloxone is used on
them: losing access to pain medications after an overdose event
4. Patient Barriers
“I was totally honest before and I got screwed… If I agreed to
have this [naloxone] in my house and God forbid something
happened and I had to use it or someone had to give it to me or
whatever, I don’t think I’d come back and tell [my doctor] that I
had to use it. Just because of the way that everything’s been
treated… I think that the doctors… need to be a little more
forthcoming about what they are doing and they need to let a
patient know that there will be no consequences, you know,
because I can just hear them now, you know. ‘You OD’d. We
told you this was going to happen. You had to use this
whatever that drug is and then all the repercussions coming
from it.’ I can just hear it all now and I wouldn’t be very
forthcoming with it.”
4. Patient Barriers
Interviewer: “And what gets in the way of trust and
communication with your doctor?”
Respondent: “A fear that he’s going to take my
medicine away and I’m going to be in pain…I’m not
going to be high. With me it’s I’m going to be in pain.
There’s a lot of people, it’s ‘I’m not going to be
getting high any more.’”
5. Provider Facilitators
 Guidelines that could be applied in a standard fashion about
who to prescribe to and how
 Guidance on opioid management after an overdose
5. Provider Facilitators
“So I would want there to be guidelines in place…
institutionally sanctioned as to how to risk stratify
patients and what the appropriate prescribing
guidelines would be.”
— Name, Title (20pt Arial Narrow)
5. Patient Facilitators
 Pain legitimization
 Framing naloxone as being a “worst case scenario” option
 Explicitly not linked to concerns about opioid misuse
 Training and education about overdose as valuable as
receipt of the medication itself
 Open communication about management after an event
5. Patient Facilitators
“If I had not heard what your description [of
naloxone] was, I would probably almost be offended
or something. I might be like you think I’m abusing
them [my medications].”
— Name, Title (20pt Arial Narrow)
5. Patient Facilitators
“I think the training would be as important as
making the drug available.”
— Name, Title (20pt Arial Narrow)
Provider Focus Groups: Conclusions
While they understood potential benefits of naloxone in primary care,
they need evidence on:
– Who to prescribe it to
– Whether it affects patient satisfaction
– How it affects risk behavior, positively or negatively
– What is potential for adverse effects in broad populations
– How to follow-up on naloxone use/overdose events
Patients: Conclusions
 Mixed about naloxone acceptance in primary care
 To accept, needed:
– Provider disclosure of the overdose risks of opioids
– Transparency about adverse effects of naloxone
– Personal perception of own risk
– Distance from misuse or abuse
– Pain legitimized
– Clear communication about consequences of disclosures of risk
behavior and/or naloxone use
Outline: Naloxone in Primary Care
 Rationale
 Perceptions:
– How do primary care staff perceive naloxone and it role in their
practice?
– How do patients perceive it?
 Evidence gaps:
– Who should it be prescribed to in primary care? 3 approaches
– How should it be provided to patients?
– What are the benefits and harms?
Implications for the Field: Who?
Three approaches to patient selection:
– Self-selection: patient or family member requests based on selfassessment of risk
– Risk-based: provider assesses individual risk and prescribes
based on criteria
– Universal: all patients prescribed an opioid, independent of risk
characteristics
For health systems, each approach has different implications for policies
and procedures, staffing, supply, and cost
Thank you
 Denver Health Pain Workgroup and Opioid Safety Workgroup
 Kaiser Permanente Colorado Pain Governance Council and the
Naloxone Workgroup
 Colorado Consortium for Prescription Drug Abuse Prevention
 Harm Reduction Action Center
 Sarah Duffy, NIDA
 Funding from NIDA R34DA035952
[email protected]