National Ethics Teleconference

**Ethical Considerations in Opioid Therapy for Chronic Pain Management**

**November 30, 2005**

# INTRODUCTION

**Dr. Berkowitz:**

Good day everyone. This is Ken Berkowitz. I am the Chief of the Ethics
Consultation Service at the VHA National Center for Ethics in Health
Care and a physician at the VA NY Harbor Healthcare System. I am very
pleased to welcome you all to today\'s National Ethics Teleconference.
By sponsoring this series of calls, the Center provides an opportunity
for regular education and open discussion of ethical concerns relevant
to VHA. Each call features an educational presentation on an interesting
ethics topic followed by an open, moderated discussion of that topic.
After the discussion, we reserve the last few minutes of each call for
our \'from the field section\'. This will be your opportunity to speak
up and let us know what is on your mind regarding ethics related topics
other than the focus of today\'s call.

# PRESENTATION

**Dr. Berkowitz**:

Today's presentation will focus on the topic of *Ethical Considerations
in Opioid Therapy for Chronic Pain Management*. This will include a
discussion of ethics concerns relating to opioid therapy for chronic
pain management as well as policies and guidelines relating to opioid
therapy for chronic pain management.

Joining me on today's call is Robert D. Kerns, PhD, National Program
Director for Pain Management for VA. Dr. Kerns is also Chief of
Psychology at the VA Connecticut Healthcare System and Professor of
Psychiatry, Neurology and Psychology at Yale University. Thank you, Dr.
Kerns for being on the call today.

Dr. Kerns, can you begin today by discussing some of the ethical
obligations in assessing and managing chronic pain?

**Dr. Kerns:**

Sure Ken. As outlined in many accreditation standards, professional
licensure, VA policy and in the ethics literature, health care
professionals have the responsibility to assess pain and provide the
most effective relief attainable for patients. In fact, even Congress
has weighed in on this subject by declaring this the Decade of Pain
Control and Research. It's important to note that not only do we have
the ethical duty to treat all patients including those with chronic
pain, with compassion and dignity, but we must also consider how a
patient's unrelieved pain can compromise their ability to exercise
autonomy in that unrelieved pain could interfere with a patient's
ability to understand and weigh risks and benefits or make choices and
decisions about their care. Some have specifically raised concerns about
whether persons' motivation to obtain relief from unrelenting pain may
create a vulnerability to coercion or undue influence in treatment
decision-making. We will come back to this point later in our discussion
today.

**Dr. Berkowitz:**

To help assure that all of our patients get the pain care they need, VA
has in place a national pain management strategy designed to promote
appropriate pain care for veterans. Will you briefly describe this
initiative?

**Dr. Kerns:**

Yes, Ken. In November 1998, the former Under Secretary for Health, Dr.
Kenneth Kizer, announced the VHA National Pain Management Strategy
designed to provide an integrative approach to pain management across
the VHA. In May 2003, VHA Directive 2003-021 on Pain Management was
published, and this document continues to provide guidance for providers
and administrators. The Directive highlights several key goals or
objectives. Central to the Strategy is the call for routine screening
for the presence and intensity of pain, comprehensive pain assessment,
and timely implementation of a multidimensional and multidisciplinary
approach to pain care for all veterans receiving care in VHA facilities.
The Directive also emphasizes the importance of education for providers
and also for patients and their families. Finally, the Strategy
emphasizes the importance of continuing research in the area of pain and
pain management.

**Dr. Berkowitz:**

The VHA's Pain Management Strategy also established a multidisciplinary
national Pain Management Coordinating Committee. You are currently chair
of this group in your role as National Program Director for Pain
Management, please tell us about that.

**Dr. Kerns:**

The Coordinating Committee has overall responsibility for advising me in
the development and dissemination of VHA policies and standards
regarding pain management. Working groups chaired by members of the
Committee focus on several key aspects of the Pain Management Strategy
including development of educational resources, performance monitoring
and improvement activities, development of resources for assessment and
outcome measurement, guideline development, policies regarding use of
pharmaceuticals and pain-relevant research.

VISN Pain Points of Contact are in place to facilitate implementation of
the Strategy, and most VHA facilities have established local pain
management committees who share in this responsibility at the facility
level. Increasingly, facilities have developed a range of educational
and clinical programs to support their efforts to meet the pain care
needs of veterans. These resources often include the development of
multidisciplinary teams that include experts from the disciplines of
medicine, rehabilitation, psychology, pharmacy, nursing, and others. I
am pleased to acknowledge the extraordinary efforts of providers in the
field and to note that available evidence from the External Peer Review
Program (EPRP) and other data sources suggests that major strides have
been made across the VHA in meeting several of the key goals of the
Strategy.

**Dr. Berkowitz:**

That's terrific to know, Dr. Kerns. Let me now turn to the more specific
topic of today's teleconference. One of the most challenging problems
facing providers in today's health care system is the management of
chronic pain. What are some things that health care practitioners should
consider when assessing a patient with chronic pain for opioid therapy?

**Dr. Kerns:\
**

The key to optimal management of chronic pain is a comprehensive
assessment of the "person" with persistent pain, rather than pain, per
se. This assessment needs to take into account not only the site,
duration, intensity and quality, and impact of pain, but also a broad
range of possible contributors to the person's experience of pain,
disability, and emotional distress. These factors, of course, include
what can be known about the underlying disease or structural pathology
that is presumed to be contributing to pain, but also any number of
psychosocial factors, including psychiatric and substance abuse,
comorbidities, and other behavioral factors.

Informed by this comprehensive pain assessment, the provider is
encouraged to collaborate with the patient in the development of a
multimodal and often multidisciplinary approach. This approach commonly
involves both pharmacological and non-pharmacological interventions such
as physical therapy, psychological interventions, and even complementary
and alternative approaches. It is in this context that the use of opioid
analgesics are sometimes considered. Opioids are usually considered when
alternative interventions have been of limited benefit.

**Dr. Berkowitz:**

One of the important efforts of the VHA Pain Management Strategy has
been collaboration with the Department of Defense (DoD) in the
development of practice guidelines for promoting optimal pain
management. One of these guidelines is the Chronic Opioid Therapy
Guideline. This guideline was informed by empirical evidence and expert
opinion and can serve as an important resource for providers who are
considering the use of opioids for the management of chronic pain. Dr.
Kerns, please tell us a little more about the Chronic Opioid Therapy
Guideline.

**Dr. Kerns:**

Many of the key elements of this clinical practice guideline were raised
in our discussion earlier but the 12 key elements in the practice
guideline include the following:

1)  use of opioid therapy when other pain therapies are inadequate;

2)  determine goal of therapy with patients and caregivers;

3)  understand that opioid therapy for chronic pain has an average
    decrease in pain score of 30%, with a similar incidence of
    significant adverse effects;

4)  assure safety - do no harm. Optimize therapy through trial and
    titration based on assessment;

5)  obtain comprehensive assessment of the patient before initiating
    therapy;

6)  regularly assess adverse effects, adherence to treatment plan,
    efficacy, and satisfaction;

7)  develop an opioid therapy agreement with the patient to define
    responsibilities and expectations of both the patient and the
    provider;

8)  educate patients about therapy, adverse effects, and withdrawal;

9)  apply multimodal adjunctive therapy as indicated by the patient and
    the disease process;

10) accurately document all prescriptions, agreements and assessments;

11) refer and/or consult with pain clinic or substance use specialties
    when needed; and

12) discontinue opioid therapy when it is not indicated.

**Dr. Berkowitz:**

How then do health care professionals treat chronic pain in patients who
have a current diagnosis or a history of addiction or substance abuse or
who are recovering from known addiction or substance abuse?

**Dr. Kerns:**

These are terrifically important and complex questions. First, it is
important to acknowledge that the use of opioids in the management of
chronic, non-cancer pain remains controversial in the field of pain
management. On the one hand, although there is good evidence to support
the efficacy of opioids in the management of acute and cancer pain, the
evidence is not as compelling in the case of chronic non-cancer pain.
Nevertheless, many experts in the field encourage the use of chronic
opioid therapy when clinically indicated and when appropriate safeguards
are in place.

These types of situations do present clinically challenging situations,
but what is clear is that ethically, patients with current addiction or
abuse are entitled to the most effective pain management attainable.
Simply put, a patient should not be denied opioid therapy for chronic
pain if it is clinically appropriate and if the safety of the patient
can be assured.

The Chronic Opioid Therapy Guideline includes references to several
tools that can aid the provider and patient in reaching decisions about
whether or not to consider the use of opioids and how to best monitor
its use. One tool that was just mentioned is the use of an Opioid
Agreement that may serve an important role in the education of the
patient about his or her responsibilities when opioids are being
prescribed. We'll talk more about treatment agreements later but first
I'd like to consider some of the barriers to the effective treatment of
chronic pain.

**Dr. Berkowitz:**

In fact, Dr. Kerns, despite the clear ethical obligations to assess and
manage chronic pain that we've discussed, and our policies and
guidelines that reinforce our professional standards and obligations,
there are many barriers to this type of treatment. Can you please help
us think about some of the barriers at the system, provider and
patient/family level?

**Dr. Kerns:**

Well Ken, despite the significant improvements in pain management
occurring in recent years, many patients still encounter barriers to
receiving effective treatment, especially when treatment for chronic
pain includes indications for the use of opioid analgesics. One of the
most commonly cited barriers in opioid therapy for chronic pain
management is what many refer to as "opiophobia". "Opiophobia" can be
described as health care professionals' reluctance to prescribe opioids
for fear that patients will become addicted and/or divert or misuse
medications. In today's climate where there is a focus and concern on
the use of controlled substances and substance abuse, it is
understandable that many health care professionals are concerned about
liability issues and the use of controlled substances for pain
management. Patients and health care administrators often share similar
concerns. What is important to remember, however, is that there must be
a balance between assessing a patient and determining a plan of care
that minimizes risk for the patient and the provider. The guidelines
that have been developed emphasize basing decisions about chronic opioid
therapy on a comprehensive assessment that takes into account the
potential benefit of chronic opioid therapy as well as the risks
associated with this treatment choice. The use of additional tools for
promoting adherence and optimizing benefit has been proposed.

As I've already mentioned, there continues to be controversy about the
efficacy of chronic opioid therapy for chronic pain. Provider knowledge,
in addition to attitudes, is also known to be an important barrier.
Healthcare system barriers include extra administrative burdens
associated with prescribing (i.e., refills every 30 days, extra
paperwork in some instances). Patient barriers also include fears of
addiction (their own and their families) and adverse side effects.

**Dr. Berkowitz:**

These are important points you raise Dr. Kerns. While we need to
acknowledge the reality of the current climate as it relates to opioid
therapy for chronic pain management, ethically, health care
professionals should not let fear prevent them from providing clinically
appropriate treatment for a patient. Health care professionals have the
ethical duty to treat all patients with compassion and dignity and
treating patients with chronic pain is certainly no exception.

Dr. Kerns, can you tell us then how does a health care professional
balance the use of opioid therapy for chronic pain management with the
associated risks to the patient and sometimes to the provider?

**Dr. Kerns**:

Well, there are many factors to consider. As mentioned before, we can
all acknowledge the concerns related to using controlled substances in
chronic pain management but what we must do is to create a balance and
not contribute to the fear given that reality. We all understand that
the Drug Enforcement Agency (DEA) must monitor how controlled substances
are used in medical treatment. Likewise, the increase in inappropriate
uses of controlled substances is also of concern to both DEA and health
care professionals.

**Dr. Berkowitz:**

One common approach that some people find helpful to use in opioid
therapy for chronic pain management is a formal pain management
agreement. In fact, it's one of the suggestions in the guideline.
Although pain management agreements can serve many purposes both as a
communication tool as part of informed consent, or as a framework for
management and treatment, pain management agreements also provide ground
for some of the most common ethical missteps in chronic pain management.
Some of pain management agreements that we've seen don't really seem
like agreements at all, but rather are written more like contracts and
presented sometimes to a patient without choice or appropriate
education. In this sense, they can seem stigmatizing and coercive and
might in fact be a barrier to sound treatment.

**Dr. Kerns:**

Yes, that is correct. A pain management agreement should do several
things. It should establish realistic expectations, set attainable goals
for therapy, set out both the patient's and the health care
professional's roles and provide a description of how medication will be
prescribed and dispensed. A pain management agreement should also
include the terms and conditions for receiving opioid therapy for
chronic pain as well as the consequences for not adhering to the agreed
upon conditions. Each pain management agreement should consider the
patient's specific circumstances and their educational needs. In other
words, each pain management agreement should be the result of shared
medical decision making between the provider and the patient.

Of course, additional challenges to the therapeutic relationship between
prescribers and patients arise when the patient fails to adhere to the
opioid agreement. Sometimes the failed agreement provides an opportunity
for constructive discussion of the treatment plan and ways to improve
it. Most often, in this context, the provider and patient must
collaborate in the development of an alternative treatment plan,
sometimes one that does not involve the continued use of opioids.
Sometimes the failed agreement provides information about apparent
substance abuse and leads the patient's acceptance of a referral for
appropriate treatment. Commonly, however, additional parameters are put
into place that accommodates for the continued use of an opioid as one
component of a multimodal pain care plan. Additional safeguards may
include more frequent monitoring of pain and adherence to the treatment
plan, switching to a long-acting or extended release opioid that may be
less addictive or subject to abuse, and/or the initiation of adjunctive
non-pharmacological interventions such as cognitive-behavior therapy
that targets adherence and development of more adaptive pain coping
skills. The important point to remember is that non-adherence to the
agreement does not relieve our responsibility to continue to try to
assess and treat the pain as well as possible.

**Dr. Berkowitz:**

I think it's important to re-emphasize that pain management agreements
for opioid therapy should respect a patient's autonomy and dignity. We
must be careful to assure that the agreement is not framed in such a way
that would stigmatize a patient or be perceived as manipulation or
punishment for unvalued behavior. Also, they cannot be coercive. They
should preserve and reinforce, rather than replace the patient's role in
shared decision making about their care plan.

Nevertheless, although patients' rights to optimal pain management is
one key factor in determining the use of opioids, providers have equally
important obligations to prevent abuse and an obligation to minimize the
likelihood of diversion of these controlled substances. Dr. Kerns, can
you please address these provider obligations.

**Dr. Kerns:**

Providers do need to take these responsibilities seriously. They have
the professional responsibility to provide for the patient's safety and
a public health responsibility to minimize the diversion of controlled
substances. In addition to the opioid agreement, the provider might find
it useful, as suggested in the practice guideline, to employ random
urine tox screens to monitor the patient's appropriate use of the
medication and in some instances identify patients who may be diverting
the medication.

**Dr. Berkowitz:**

Dependence, tolerance and addiction are also problems and sometimes
these terms are confusing. I think that understanding these concepts can
help people make more appropriate decisions regarding opioid therapy,
can you please walk us through some of this terminology?

**Dr. Kerns:**

To make clinically and ethically appropriate decisions about opioid
therapy, it helps to understand the differences between the several
important terms - tolerance, dependence, substance abuse, addiction and
pseudoaddiction.

In using opioids for chronic pain management, the term, *tolerance*,
which is the neuroadaption of the effects of opioids, and *physical
dependence,* come to mind. It is important to remember that neither term
implies addiction. *Substance abuse*, however, is the use of any
substance for non-therapeutic purposes or of medications for a purpose
other than it is intended. *Addiction* is the pattern of behavior that
includes impaired control of drug use, craving, compulsive use, and
continued use despite adverse physical, psychological, and social
consequences while *pseudoaddition* is an iatrogenic condition that
results when undertreatment of pain leads patients to behave in ways
that seem to suggest addiction.

Health care professionals should pay careful attention to the
differences in these terms and when assessing a patient with chronic
pain to determine if an appropriate plan of care should include opioid
therapy. Clinicians always need to remember the role of comprehensive
assessment and the need to tailor the plan for each individual patient.

# 

# MODERATED DISCUSSION

**Dr. Berkowitz**:

Thank you Dr. Kerns for discussing the topic of Ethical Considerations
in Opioid Therapy for Chronic Pain. We've covered a lot of ground. We
started by recognizing and reviewing the ethical imperative to assess,
and where possible to minimize through proper treatment, any patient's
pain. We reviewed relevant VHA and professional policies and guidelines
for accomplishing this, with emphasis on the 12 key elements in the
VHA/DoD clinical practice guideline for chronic opioid therapy. Next, we
considered some common barriers to effective chronic pain management and
reviewed some of the more confusing terminology in this area. But, we
anticipated that there would be a lot of discussion about today's topic,
so we left plenty of time for discussion. But before I turn the lines
over to our audience for questions and comments, I wanted to reiterate
the 12 key elements of the VHA/DoD chronic opioid therapy clinical
practice guideline because I think they not only reinforce good health
care practice but also they are foundationally related to some of the
ethical obligations we've been talking about. So the guideline, again,
reasserts the following:

1)  use opioid therapy when other pain therapies are inadequate;

2)  determine goal of therapy with patients and caregivers;

3)  recognize that opioid therapy for chronic pain has an average
    decrease in pain score of 30%, with a similar incidence of
    significant adverse effects;

4)  assure safety - do no harm. Optimize therapy through trial and
    titration based on assessment;

5)  in fact, you should obtain a comprehensive assessment of the patient
    before initiating therapy;

6)  you should regularly assess adverse effects, adherence to treatment
    plan, efficacy, and satisfaction;

7)  develop an opioid therapy agreement with the patient to define
    responsibilities and expectations of both the patient and the
    provider;

8)  educate patients about therapy, adverse effects, and withdrawal;

9)  apply multimodal adjunctive therapy as indicated by the patient and
    the disease process;

10) it is the provider's responsibility to accurately document all
    prescriptions, agreements and assessments;

11) refer and/or consult with pain clinic or substance use specialty
    when needed; and

12) discontinue opioid therapy when it is not indicated.

Of course all of this information is available on the Web and we'll
include links to the Pain Program and the practice guidelines in the
follow-up e-mail to this call.

Now we'd like to hear if our audience has any responses, comments or
questions.

**DISCUSSION:**

#  Eric Sessions, Brooklyn VAMC:

This has been a very good conversation. I've really enjoyed this. One
thing that I'd like to point out is that about the random urine drug
screens. Everyone needs to be aware of that when you are doing this, the
limitations or the scope of the urine drug screen that is used in your
own laboratories. One thing that I've found is that I was using it to
see if a patient was actually on a very high dose of Fentanyl patches
just to spot check because you can see the patches on him and you see
the evidence of previous patches and the patient came out negative for
opioids. It turns out that our lab urine test will not come positive for
either Fentanyl or for oxycodone use. So you just need to be aware of
that. Make sure you contact your laboratory because those have to be
actually checked by blood tests and they of course were positive.

**Dr. Kerns:**

I'm really appreciative of you emphasizing that point. In fact, this was
a point of discussion over the last few days and even today on the VA
Pain Listserv. If you're not a member of that listserv, you might want
to find out about it. The point that you're making is really very
important. I think many providers don't appreciate the limitations of
the urine tox screen and probably need to consult with their pharmacy
and laboratory about those limitations:

**Dr. Berkowitz:**

Again I think that's a great point. We've had several consultations
recently from patients who have brought up very valid objections about
whether or not their urine toxicology test results are in fact accurate.
I think that this is very important to realize that if you get a result
that is surprising you, not always to immediately jump to conclusions
and blame the patient but to really think about what it means and how
you got the result.

#  Eric Sessions, Brooklyn VAMC:

Absolutely.

**Dr. Kerns:**

I'm wondering if there are other people on the call from laboratory
medicine or pharmacy or other pain management experts that have
experience with this who want to add to this discussion.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

We've been using urine drug testing for over a year now and we've
identified it as a very valuable and effective tool in pain management.
It is important to become familiar with the lab testing, to develop a
relationship with your local toxicologists and develop a procedure in
terms of how you will respond to lab results. We do find that the
positive testing is very helpful but negative testing is not as helpful
because of possible false negatives. In testing, we come up with about
30% to 40% of patients testing positive either with non-prescribed or
illicit substances in our clinic. Positive marijuana is a big issue.
About 25% of patients show positive for marijuana and that's been sort
of a debate as to how to assess patients as to are they using or abusing
and whether to discontinue opioid therapy in those patients. It is a
very valuable tool in our clinic.

**Dr. Kerns:**

This points to the other issue. This first issue was more about when the
screen comes back negative for the opioid and the obvious risk is
jumping to conclusions about diversion. The other issue is about
positive evidence of other illicit substances and my own view, and I
think Dr. Berkowitz may want to comment as well, and you've just
emphasized it Dr. Lee, is that this isn't, probably in most cases, black
or white either. Ultimately the toxicology screen I would view as a tool
as you described it, and certainly not one that is black and white or
should be used as the definitive nail in the coffin so to speak to an
opioid therapy plan. Ultimately, it really comes back to the point I'm
trying to emphasis today which is these are complex and challenging
issues that ultimately can be resolved by a practice that focuses on the
person and everything that you can know about that person and
collaborative discussions between patient and provider and potentially
other family and caregivers as well.

**Dr. Berkowitz:**

I think that Dr. Lee's point is well taken. And I'll ask the audience
sort of how to respond to the question. What do you do if you know that
25% of your chronic opioid therapy patients come back with a positive
urine tox screen for marijuana? What does that mean, what should you do
about it and how does that affect the overall circumstances of the case?

**Dr. Jeffery Fudin, Albany VAMC:**

I'm a PharmD here in Albany. Since the question was asked for input with
regards to the urine tox screens, I thought that maybe I would try to
help people compartmentalize what they mean and how they should or
should not be used. Basically, there are several categories of opioids.
This may help make it easier for people to understand this. The opioids
that are included in the urine screens pretty much include all of them
except for Fentanyl and the diphenylheptanes. If you split these out by
chemistry, it's very easy to figure this out. The diphenylheptanes
include methadone and propoxyphene and they are not included in the
urine tox screens. Fentanyl is not included in the urine tox screens and
interestingly that shady area that was already mentioned, and I agree
with, is oxycodone. Oxycodone falls into a chemical category called
phenanthrenes and that includes oxycodone, hydrocodone, morphine,
codeine, herorin, and several others. All of those, theoretically, are
included in the urine tox screens. The problem is, the urine tox screens
that the VA does, and most other people do, have a cut of 2000 nanograms
per ml for the measurable amount. So that means that if somebody was
taking let's say 20 mg a day of oxycodone and their urine screen
actually measures 1800 nanograms per ml, the lab is going to report that
as negative because it is below the cutoff. So one of the things that is
very, very important to do is that if you have a patient on oxycodone
and the urine comes back negative, you need to call the lab and ask them
what the quantitative value was because although it's not reported, they
do have that data. So if you call them up, you may say well its 1446,
you should feel a little bit better knowing that there is something in
the urine. Generally speaking, and this is very general, if a patient is
on 40 mg a day or more of oxycodone on a regular basis generally
speaking, their urine will be positive for oxycodone. If however, they
are on a lower dose or about that dose or a PRN dose, it's a very, very
good change it's going to come back negative. And you can really make
the same arguments for hydrocodone because they are both synthetic
dehydroxylated phenanthrenes. If anyone on this call is interested in
getting a copy of all the opioids on a single chart and how they split
out and where they fall on urine screens, I'll be happy to provide it.

**Dr. Berkowitz:**

Dr. Lee, if you can email that to me, we'll include information on this
in the follow-up to this call.

But I think the take home point really is if you're going to be
prescribing these tests and using it as part of your treatment plan I
think that both you and the patients really need to know what they are
good for and what they are not good for and the purpose of it.

I would like to come back to Dr. Lee's and Dr. Kern's point about what
do you do if you have evidence of other illicit substances and I'll use
Dr. Kern's specific example, if you know that 25% or 30% of his patients
concurrently come up positive for marijuana.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

We have developed a urine drug testing guideline recommendation for VISN
20 and I can also email that to the moderator to send out. On that
guideline, we have decided how we would approach specific findings on
urine testing. For example, we have a procedure for patients who come up
with illicit drugs -- methamphetamines, cocaine and a different
procedure perhaps for patients who come up with marijuana.

#  Eric Sessions, Brooklyn VAMC:

There is one point I was going to make which is that I don't have that
experience a lot with my drug screens but culturally in certain
circumstances marijuana is almost not even considered an illicit drug in
some sort of settings. I want to throw it out there, how this should
effect our treatment if this is truly an abused drug or if this just
something that is not viewed on as that. I don't how what to make of
that.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

The way that we've sort of approach this is to comprehensively assess
the patient in terms of their substance use and function. If the patient
appears to be managing their opioid medications well, they have no
evidence clinically of an active substance use disorder it appears that
the marijuana is more of an episodic use of marijuana, we will allow the
patients to remain on chronic opioid therapy and monitor them closely.

#  Eric Sessions, Brooklyn VAMC:

I agree with that.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

If at any time it appears that the marijuana itself is a problem and
contributing to a patient's decline or functional problems, then we will
ask that the patient abstain. If the patient is unable to abstain, we
will require addictions treatment and evaluation.

**Dr. Berkowitz:**

One thing that always strikes me and if someone can provide a little
perspective on how patients who use opioids are selected for this degree
of scrutinization. Is there ethical justification for that? For
instance, is it different for a patient who is on a chronic
benzodiazepine and why don't those patients have an agreement or
scrutinization for other substances?

**Dr. Timothy Lee, VA Puget Sound Pain Clinic**

We basically see that if a patient is on a controlled substance, then
they need to be evaluated more carefully. The question is would you do
this if a patient is on an anti-inflammatory medication. I personally
think that marijuana can be a very dangerous substance for some
patients. Even if they are not on a controlled substance, I would still
question the patient about their marijuana use and explore whether the
marijuana was causing any potential problems for that patient.

**Dr. Robert Litwack, Richmond VAMC:**

I'm concerned about this collaborative development of agreement because
I think that in terms of marijuana use and other issues, potential side
effects such as death, that the physician really has to step in and
sometimes bypass this collaborative agreement. And I think this is where
a lot of the controversy comes in from our patient reps and our
administrators and goes along with this culture of we no longer have
patients they are customers. My perspective is that at a basic level it
is not collaborative. We have to enforce certain guidelines as we see
them.

**Shirley Toth, Portland VAMC:**

Ken I think the National Center for Ethics actually sent out a call for
topics and for those of us in VISN 20, and I appreciate Dr. Lee's
comments, the states of Alaska, Oregon and Washington all have medical
marijuana laws and one of the dilemmas that we're facing. We do have a
narcotic agreement at Portland. A couple of issues that continue to face
our providers are those that relate to a person who has a medical
marijuana card that's been approved by the state and they are also on
narcotics and that comes up on a urine drug screen. So I think that this
topic probably will need to be or can generate additional communication
and conversation so I appreciate Dr. Lee brining that up.

**Dr. Berkowitz:**

Thank you, Shirley. I would like to come back to Dr. Litwack's comment.
I can appreciate, Dr. Litwack, that you're feeling that there are
certain things that aren't really collaborative and there are limits to
a patient's autonomy in general in providing health care. But I think
what we were trying to get as was that each case is individual. I think
that a 'cookie cutter' contract approach is less ethically defensible
than to say, okay, here we have some new information that came as a
result of some screen or some assessment and now it is an opportunity
for reconsidering the plan and are there such safety concerns raised
that the patient is really no longer a candidate for opioids and to tell
them that. But to give it to them with a justification and not just
saying everyone who has 'x' can't get these medicines but really let
them know why and let them know what will be required and let them know
if you're going to alter the plan in a way, what other treatment options
they still have. So it's never our way or the highway and it's always to
me an opportunity for continuing evolution of the plan in light of the
patient's specific circumstances. Does that help?

**Dr. Robert Litwack, Richmond VAMC:**

Not exactly. No it doesn't. I think the issue here is that we have
limited time to consult and console and have these discussions with
these patients. We get many consultations but in real life practice, we
just don't have that luxury and those finances. I guess we find, I hate
to admit it, that we do have certain 'cookie cutter' guidelines as you
described them that we put down in our contract. I guess we're not
supposed to use that word.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

That's illegal because that's a legal definition of contract.

**Dr. Robert Litwack, Richmond VAMC:**

Okay so we don't want contracts.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

Agreements.

**Dr. Robert Litwack, Richmond VAMC:**

Okay I'll change my verbiage here. So we do, in fact, say marijuana, no
you're out. You miss so many clinic appointments, no you're out. And
this is just a matter of survival. It terms of the ethical
consideration, we also have to consider that we have many, many patients
to treat and limited resources.

**Dr. Kerns:**

So the challenge is when you have to make a decision that somebody came
back with a urine toxicology screen that was positive for marijuana and
opioids aren't required, what do you do? When you have a moral and
ethical imperative to still provide for optimal pain management.

**Dr. Robert Litwack, Richmond VAMC:**

I agree. It doesn't mean my way or the highway or get out of here. If
the patient is violent, we have to call the police and those situations
do happen on occasion. But no we certainly discuss with the patient
other alternatives for pain management but discontinue the narcotic.

**Dr. Kerns:**

I was imagining that that would be answer. The issue then becomes if the
issue that led you to that black and white policy was one of time
management or time constraints. I'm not sure that that issue gets solved
by the black and white policy either. Because ultimately you're left
with having to discuss and negotiate an alternative plan as well.

**Dr. Berkowitz:**

Dr. Litwack, I'm a provider in the system and I do a lot of clinical
activity so I know how this is going to sound but I think that we just
can't as providers allow that to rule the way we provide care. If we
need more resources whether they be time or whatever, we need to say
look we can't give the appropriate care to our patients without more
time and we need to negotiate to find a way to either be more efficient
or to get it. Because I find that some people are going to have a
difficult time saying that we would like to do it another way but we
don't have the time so instead we're going to have a practice that is
less ethically desirable.

**Dr. Kerns:**

I think people are struggling with this issue and the issue about time
management or efficiency or effectiveness of a plan and different
facilities are struggling with this and coming up with alternative
solutions including the idea of a small or limited number of providers
who are responsible for providing chronic opioid therapy, the idea of
external peer review groups to help provide consultation to providers
when they are making these decisions, and so forth. There are other best
practices out there that might be considered as alternatives to the
challenges that individual providers experience in the primary care
setting. I'm not endorsing any of those but I'm just aware of different
facilities struggling with this and coming up with different
alternatives.

**Dr. Berkowitz:**

One other thing that I'd like to mention is that we did a recent call on
the possibility of group medical appointments as a way to gain a lot of
efficiency and develop this sort of increased time when patients need
it. I'm not sure if they are necessarily appropriate for patients on
opioid therapy but something that I think is worth thinking about if
you're feeling time as a constrained resource.

**Tony Mariano, Seattle VAMC:**

I am a psychologist and I chair our review board that monitors
prescriptions. One of the things that I want to just toss out is really
the ethical obligation we have to provide comprehensive and effective
treatment and I think too often this gets translated into the obligation
to provide opioids when in fact, and I think Dr. Kerns has done a good
job of emphasizing a more comprehensive approach, for many patients with
active problems, the ethical obligation is to withhold these kind of
medications.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

I agree with that. I think it's important not to put out the message and
this is why I actually have an issue with this term "opiophobia". I know
that it's defined as a reluctance to prescribe opioids out of fear out
of addiction or misuse of medications but I think given the fact that
substance use and addiction is quite prevalent in the chronic pain
population, having some fear around prescribing opioids can be healthy
and providers shouldn't be pressured or forced into believing that they
need to prescribe opioids. And the issue of resources, we know that when
we're prescribing opioid therapy, it is important to monitor these
patients and assess them and reassess them. Then the safe thing may be
to not provide opioid therapy as part of the treatment plan or refer the
patient of course.

**Dr. Kerns:**

I really appreciate your acknowledgement of both sides of the coin. It
was my point to try and emphasize, one this isn't a panacea to base a
multimodal, multidisciplinary, multidimentional treatment plan that's
informed by a comprehensive assessment really is in the forefront of our
decision making. And even with all of that, and the specific issue of
opioid therapy and acknowledging what you just said, Tony, I do think
that the term "opiophobia" does come into play and may be an
inappropriate one for some providers who really aren't seeing the gray
and are responding to their patients based on fear. I see a lot of
conferences that seem to sell that fear by having a high significant
proportion of conference presenters being somebody from the DEA or
somebody advising them against all the restrictions about opioid therapy
and so forth. I think the state of the art now is that it's not a black
and white issue and the issue isn't resolved and we need to be having
these kinds of discussions that we're having today. I appreciate your
comments.

**Dr. Berkowitz:**

Thank you, Dr. Kerns and everyone who commented.

# FROM THE FIELD

**Dr. Berkowitz:\
**

Now I want to turn to our "From the Field" segment, where we take
comments from our listeners on ethics topics not related to today's call
or we can continue our discussion on the *Ethical Considerations in
Opioid Therapy for Chronic Pain Management*. Please remember, no
specific consultation requests in this open format, but I invite you now
to make your comments on other ethics-related topics, or to continue our
discussion on ethical concerns about chronic pain management.

**Kathy Rinehart, Iowa City VAMC:**

I have a question regarding the urine drug screens. How many sites
collect the sample under observation, in other words, go in with the
patient? That gets to be kind of a sticky situation but yet they go to
the laboratory on a different floor and we've had samples that have been
turned into water and apple juice has been tried. You never know if it
might be a friend's or a girlfriend's sample so I'm wondering if there
are any ethical concerns there or if most sites collect under
observations.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

We've had a lot of experience with this and we do not observe urine
collections and it's mostly because it does require increased staff to
do this we. We do not consider urine drug testing to have any legal
power. It's basically a clinical tool. I think that testing is taken
into consideration or context as part of the patient's whole scenario
and basically we would see if a patient is going to try and cheat the
system. It becomes evident after a period of time.

**Marian Baxter, Richmond VAMC:**

We don't mean to be cynical but we're having fun with this. We don't
observe urine collections here in Richmond either but let's say
hypothetically the patient dies and family is going to sue the hospital.
Does the urine screen then become part of the legal chart?

**Dr. Timothy Lee, VA Puget Sound Pain Clinic**

I think as long as it's not done under the legal requirements, then it
can't be used under the court of law.

**Dr. Berkowitz:**

But at the same time then you're saying though that it can be sort of
useful in the clinical course to make real clinical decisions.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic**

And again it's one tool that you need to take into account all the
factors in the patient's clinical history.

**Dr. Berkowitz:**

One thing I will add is that we're aware of several cases where the
responsibility for the sample after it comes from the patient for having
a clear chain of custody and accurately labeling the specimen that is
coming from the patient, that sort of inadequate chain of custody has
resulted in several complaints at different facilities where patients
say I've been told to just take my sample and just put it on a table
with other samples in a container that wasn't labeled. If you are going
to do this I do think that whether you observe it our not, I think you
really need to pay attention to your chain of custody because it really
makes for a lot of invalid results and problems around in our own
facilities that we know of.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

Yes, I agree with that.

**Rodney Eiger, Chicago, IL:**

I was wondering if anyone had any opinions about the use of methadone
and the treatment of chronic pain, the sorts of settings in which that
should be done and any thoughts about the relative efficacy of methadone
compared with other analgesics that are commonly used to treat chronic
pain.

**Dr. Timothy Lee, VA Puget Sound Pain Clinic:**

Methadone is the primary medication that we prescribe for chronic
non-cancer pain. We've been using it for about 20 years in our clinic.
It is a very effective and safe medication when it is prescribed and
taken properly. A big problem is that the doses tend to be started too
high and escalated too quickly. We find that if you transition patients
carefully from previous opioid therapy to low levels of methadone with
appropriate education and expectations and it's used in a comprehensive
self-care rehabilitation context, methadone is very safe and effective.

**Dr. Kerns:**

I wanted to say that rather than jumping into more clinical issues about
pain management and moving away from the ethics issues, I can also
inform people via Dr. Berkowitz, about other resources associated with
our National Pain Initiative including our VA Pain listserv, monthly
conference calls where maybe some of these clinical issues would be
better addressed.

**Dr. Berkowitz:**

I think that's a good point Dr. Kerns and we will get you that
information.

**CONCLUSION**

**Dr. Berkowitz:**

Well, as usual, we did not expect to conclude this discussion in the
time allotted, and unfortunately we are out of time for today\'s
discussion. We will post on our Web site a very detailed summary of each
National Ethics Teleconference. So please visit our Web site to review
today\'s discussion. We will be sending a follow up email for this call
that will include the links to the appropriate web addresses for the
call summary and the CME credits.

We would like to thank everyone who has worked hard on the development,
planning, and implementation of this call. It is never a trivial task
and I appreciate everyone\'s efforts, especially, Dr. Robert Kerns,
Nichelle Cherry, and other members of the Ethics Center and EES staff
who support these calls.

-   Let me remind you that this is our last call for 2005. Our next NET
    call will be on Wednesday, January 26, 2006 at 1:00 pm ET. Please
    look to the Web site at vaww.va.gov/vhaethics and your Outlook
    e-mail for details and announcements about the 2006 schedule of NET
    calls

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    Center, the other resources we mentioned today, the summary of this
    call and the instructions for obtaining CME credits.

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-   Please let us know if you or someone you know should be receiving
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-   Again, our e-mail address is: vhaethics@va.gov.

Thank you and have a great day!

References

IN fOCUS: Ethical Considerations in Opioid Therapy for Chronic Pain,
April 2005\
<http://vaww1.va.gov/vhaethics/download/InFocus/InFocus_April05.pdf>

VHA Directive 2003-021, Pain Management, May 2, 2003.

Key Points: VA/DOD Clinical Practice Guideline for the Management of
Opioid Therapy for Chronic Pain,
<http://www.oqp.med.va.gov/cpg/cot/G/OT_key.pdf>

Fudin J., Levasseur, DJ, Passik SD, et al. Chronic pain management with
opioids in patients with past or current substance abuse problems.
Journal of Pharmacy Practice 2003; 16(4):291-308.

VA Pain Management Website: <http://www1.va.gov/pain_management/>

[Additional Resources\
]{.underline}*(inclusion of these resources does not indicate
endorsement by the National Center for Ethics in Health Care)*

[\
Opioid Chemistry:]{.underline}
[[http://www.paindr.com/04%20chemistry%20revised%20-%20clean.pdf]{.underline}](http://www.paindr.com/04 chemistry revised - clean.pdf),
Provided by Jeffrey Fudin, R.Ph., B.S., Pharm.D., DAAPM

Clinical Pharmacy Specialist, VAMC-Albany, Adjunct Associate Professor
of Pharmacy Practice, Albany College of Pharmacy

[Opioid Predictability Chart]{.underline}:
[[http://www.paindr.com/06-2005%20Opioid%20Metabolite%20Chart.pdf]{.underline}](http://www.paindr.com/06-2005 Opioid Metabolite Chart.pdf),
Provided by Jeffrey Fudin, R.Ph., B.S., Pharm.D., DAAPM Clinical
Pharmacy Specialist, VAMC-Albany, Adjunct Associate Professor of
Pharmacy Practice, Albany College of Pharmacy

[VISN 20 -- Urine Drug Testing Guideline, Chronic Non-Malignant Pain
Management](http://www.va.gov/vhaethics/download/Transcripts/VISN20PainGuideline.doc),
(Guideline in progress), Provided by Timothy J. Lee, MD, Medical
Director, Pain Clinic, VA Puget Sound