**Transcript of Cyberseminar**

**Spotlight on Pain Management**

**Overdose Among VA Patients Receiving Opioid Therapy for Pain: Risk Factors and Prevention**

**Presenter: Amy Bohnert, PhD, MHS**

**October 2, 2012**

**Overdose Among VA Patients Receiving Opioid Therapy for Pain: Risk Factors and Prevention**

**October 2, 2012**

Dr. Bob Kerns:Good morning, everybody. This is Bob Kerns, I’m National Program Director for Pain Management and Director of our Health Services Research Center here at VA Connecticut, the PRIME Center. And it is my pleasure to welcome you this morning to this webinar series, this Cyber Seminar Series called “Spotlight on Pain Management,” which is an explicit partnership with the Center for Information Dissemination and Educational Resources. And I want to thank Heidi and her team at CIDER for their support for this initiative.

Today it is my great pleasure to introduce Dr. Amy Bohnert, who will be our speaker today. Dr. Bohnert is an investigator at the Ann Arbor VA Health Services Research and Development Center and an Assistant Professor at the University of Michigan Department of Psychiatry. Her work focuses on substance abuse and pain-related health services research and she is the recipient of an HSR&D Career Development Award focusing on Unintentional Overdoses Among Veterans Receiving Opioids for Pain. The title of her talk today is “Overdose Among VA Patients Receiving Opioid Therapy for Pain: Risk Factors and Prevention.” And with that, I welcome Dr. Bohnert.

Dr. Amy Bohnert: Thank you, Dr. Kerns, for that introduction. So I will be speaking today on the topic of “Overdoses Among Veterans Receiving Opiates for Pain,” and while overdoses are a relatively rare adverse outcome of opiate therapy, I hope that the research I will present has implications for reducing adverse outcomes of pain care more broadly.

First, I would like to acknowledge support from the VA in the form of an HSR&D Career Development Award as well as support from Mental Health Operations towards the collection of data that I will be presenting. And I have no conflicts of interest relevant to the topic of this presentation.

As I mentioned, overdoses are a relatively rare outcome compared to less serious adverse effects of opiates, but the overdoses resulting from pain treatments have received substantial attention in the popular press. For example, this is a heading from an article that came out just this weekend, “Overdoses among OIF/OEF veterans.” The data on trends in opiate overdoses, which I will present in more detail in a moment, has sparked a fairly significant debate including among pain care providers about the use of opiates for pain care. 

The opinions on this topic are fairly divided, with some advocating for a sharp reduction in their use, others arguing that the evidence of the role of pain care in overdoses is overstated. And others are concerned that the suffering of those with pain have been lost in the debate.

In this webinar, I will not be able to resolve all of these issues, but I will present data that describes factors that are related to overdose risk among patients receiving opiate therapy, with a particular focus on research I conducted from data collected in the VA. I will also describe some recent research that highlights a particular clinical study that had the opportunity of interviewing with patients at risk for overdose; and will end by describing by a number of strategies for reducing overdose risk among pain patients.

First, I want to quickly acknowledge that the whole story, so to speak, of opiate overdoses, is not limited to adverse outcomes with pain treatment. Data from the National Household Survey on Drug Use and Health have demonstrated that non-medical use, meaning use that is not consistent with medical care, is one of the more common forms of substance misuse in the U.S. 

I have also depicted the circles here to demonstrate both the pain treatment use of opiates and the non-medical use as overlapping to represent the fact that there is some proportion of patients who are receiving their opiates for pain who engage in behaviors that are consistent with misuse or abuse, while others who misuse are obtaining them from non-medical sources.

With that said, I will first focus on epidemiologic research about opiate overdoses. First, I will go over data on trends in overdose and then I will describe research on risk factors, specifically among pain patients.

This figure reports data from the CDC’s National Death Index, which is online through 2010 and is a couple years behind because it is based on collecting and processing data reports from state medical examiners. The rate of fatal overdoses has increased, and this increase has been largely seen among deaths classified as unintentional, which you can see in the pink line here. And actually the 2010 data was just put up recently and you can see that the rate increased further from 2009.

To give it some context, here is the count of fatal unintentional overdoses per year along with the count of fatal motor vehicle traffic accidents and also unintentional falls. You can see that traffic-related deaths, the pink line, fell in the U.S., while the rate of unintentional overdose deaths, the blue line, increased such that there were actually more unintentional poisoning deaths in the U.S. in 2010 than traffic accident deaths. This is for the first time and this certainly represents some successes and improvements in traffic safety; but it also highlights how unintentional overdoses have become the major public health burden in terms of unintentional injury in the U.S.

Heidi:Amy, we did get a request if you could speak up just a little bit, that would be great.

Dr. Amy Bohnert:Sure.

Heidi:Thank you.

Dr. Amy Bohnert:I am sorry. Thank you for letting me know. This slide also reports CDC data and you can see that this is nonfatal overdoses and these have also gone up in the 2001-2010 period, and again, mostly due to unintentional.

The publicly available data does not allow a breakdown by substances involved in the overdoses. But the CDC has released some data such as that which is in this figure that has shown that much of the increase has been accounted for by prescription drugs and opiate medications specifically.

In contrast, there are 12,000 or so prescription opioid-related deaths in a year in recent years. There are about 2,000 heroin-related deaths and 6,000 cocaine-related deaths each year.

Leonard Pelosi at the CDC and others have highlighted how this trend has been parallel to the increases in the use of these medications. So you can see the blue line in this figure represents that increase.

This problem is particularly relevant to the VA. Research we conducted examining overdose rates in 2005 found that the rate among VA patients was about twice as high as the rate in general population after counting for age and sex distribution. By that I mean the overall standardized mortality ratio that is in the red box at the bottom there was about two, representing a two-fold higher rate.

Next I am going to cover some risk factors for overdose specifically among patients treated with opiates for pain. 

There has not been a whole lot of research in this area, but perhaps the most well-researched factor has been opiate dose. Different studies have operationalized dose in different ways including the prescribed daily dose or the amount filled over a period of time divided by number of days. But the results have been pretty similar across studies.

This data comes from a study that I conducted with colleagues examining opiate overdoses among VA patients treated for pain. The different lines in this figure represent the adjusted regression results for models with different patient groups defined by their diagnoses. You can see that across all these groups there is a dose response association such that the larger the daily dose, the greater the probability of overdose.

In relative terms, the hazard ratios are six or seven that were found for those patients receiving a hundred or more morphine-equivalent milligrams are some of the highest – largest effect sizes that we will see among the risk factors that we are going to look at in this field of study.

This figure takes the data that I used in a prior study just – sorry, in a prior slide that was just for those patients with chronic pain and then it compares it to the same relationship among chronic pain patients in an HMO which was in Group Health Cooperative. And you can see that despite some differences in the way both the outcomes were measured and the prescriptions were measured, the results are strikingly similar. So there is some consistency across studies.

In our VA study, we also examined opiate schedule. And in the adjusted analyses, which I will not show, we found that schedule seemed to be explained by total dose, the association of opiate schedule with overdose, that is. But you can see here in this section within the red box on this figure that in the unadjusted analyses, we found that those patients who were prescribed both an opiate to be taken on a regular schedule and also an opiate to be taken as needed, which is a strategy for break-through pain, had higher rates of overdose than those prescribed just one type or another. So the point estimates there on the far right, you can see, are higher than the ones for the same group in the point estimates on the left side of that box.

Another potential risk factor which has been of interest but for which there is not much high-quality research is opiate type. One case control study came out this year that did examine the prevalence of use of specific opiates among individuals who died of drug overdoses compared to controls. And there were a number of significant differences. 

However, I am hesitant to put too much weight on these results because there was no adjustment for the many factors that determined what opiate a patient received that may also be related to their risk of overdose.

In contrast, a study by Krebs and colleagues focused on all-cause mortality but did adjust for selection effects and found lower mortality among patients prescribed methadone than those prescribed long-acting morphine.

So those are some medication factors, and there has also been some interest in research examining patient factors and most basically demographic factors.

In a study that examined dose and overdose risk among VA patients that I have been talking about, we included a couple demographic factors that are available in medical records. Unlike in the general population, male sex was not related to overdose in this sample, probably because it was restricted treated to patients treated with opiates. But age was strongly associated with overdose rate decreasing as age increases. We also found that patients who died of overdoses were more likely to be white and less likely to be black than other patients.

Another type of patient characteristic of interest was the patient’s medical condition. This work has mostly focused on pain diagnosis type, mental health conditions, and substance use disorders.

This slide reports more data from our VA study, and there were some significant differences by pain diagnosis. And also having an acute pain diagnosis among patients with chronic pain was associated with overdose risk in the adjusted analyses, not just in these unadjusted analyses.

I particularly want to highlight, though, the findings in regard to mental health conditions, which is in the red box. And again, this is looking at unintentional overdoses, not suicide, which was surprising in that substance use disorders – sorry– it is actually not surprising that substance use disorders were associated with overdose risk, with forty percent of overdose decedents having had a documented substance use disorder compared to ten percent of other patients.

But the fact here that 66 percent of the opiate overdose decedents had had another psychiatric disorder was perhaps more of a surprise compared to 33 percent in the overall sample of pain patients.

A final patient factor I want to talk about is behavioral characteristics. The primary behavior that has been the focus of overdose research is what is commonly called “doctor shopping.” By that I mean going to multiple doctors to request opiates. A very recent study used a case-control design to look at this comparing those who died of drug-related causes to other prescribed opiates – others who, sorry, were prescribed opiates.

This study found that both doctor shopping and what the authors called “pharmacy shopping,” meaning filling prescriptions at multiple pharmacies, were associated with drug-related deaths. Doctor shopping, though, is probably a useful indicator of a fairly severe misuse problem related to prescription drugs. And though doctor shopping and the prescribed dose in some ways are proxies for the same underlying factor, which is difficult to measure, which is essentially the amount of opiate medications a patient actually takes or possesses.

Unfortunately, there has been little research examining other behavioral factors that could be helpful towards identifying patients who are at risk and particularly ones that might be easier to observe.

To summarize, there has been research on medication factors in relation to overdose risk as well as some research on patient factors. But I think what has really been missing in the research so far is other aspects of care other than the medication itself, such as provider characteristics, clinic setting, and health system characteristics.

I want to add an additional word of caution that all of this research comes from observational data. So it is important to be careful in assuming that these associations are causal. Instead, I would say that these factors such as dose and diagnoses are useful indicators of overdose risk that can be used to identify those patients likely to be at higher risk and that they may or may not be causes of overdoses directly.

However, it would be highly unfeasible to conduct a randomized controlled study that would be large enough that it would be possible to, for example, compare the rate of overdose for patients randomized to different doses of opiates.

Next I am going to describe some in-progress work.

We have just covered some data that can help identify patients at risk of overdose, but that does not help us much if we do not know where to find them. So for this analysis, we looked at just seeing patients who died of a prescription opiate overdose and looked at what types of clinics they visited in the period prior to their death.

This was a retrospective study and essentially included just the cases from the prior study I described, but also included individuals who died of an overdose of opiates that they obtained from somewhere other than the VA, which was about 44 percent of all cases.

Here is the descriptive data. This slide is a little bit busy, but I am going to highlight some parts of it. About 92 percent of the patients who died of an opiate overdose had been seen in VA ... *[no audio............].*

Heidi:Amy, if you are still there, we lost your audio. It looks like your phone went gray. I do not know if you can hear me. My apologies to the audience. Amy, once again, if you can hear me, we lost your audio. Please try calling back in. I am not sure what happened there. I apologize to our audience. Hopefully we will have her back in just a moment. Oh, we are getting a couple of comments here to please place with the audio on. We lost the audio for our presenter. It looks Amy just called back in. Amy, can you hear me?

Dr. Amy Bohnert:Yes. Sorry about that. I do not know what happened. Suddenly my phone was beeping.

Heidi:That ... I ... I wish I had an explanation. I tried to work through CITRIX on some of this stuff, but at least we caught it fairly quickly and we will turn it back over to you again. Thank you.

Dr. Amy Bohnert:Sounds good. Thank you very much and I apologize for that. So here is the descriptive data on treatment utilization for patients who died of an opiate overdose in the period prior to their death. I am going to highlight that about 92 percent had been seen in the VA in the year prior to their death and over half had been seen in the 30 days prior to their death. These numbers, sorry, I am going to cough for a second [cough]—these numbers are roughly similar to utilization among patients who died of suicide which were reported by Elgin and colleagues in the American Journal of Public Health paper. But not surprisingly, many of the cases who received care had been seen in primary care.

But what we thought was more interesting was that actually mental health clinics were more common than specialty substance abuse clinics or pain clinics to have recently treated patients prior to their overdose death.

So I think the key implication here is that primary care and mental health clinics are likely the best condition in terms of setting for interventions that would see the greatest reduce in overdose mortality overall in the VA.

For the last part of this webinar, I am going to focus on prevention strategies with an eye towards the strengths of the evidence base for each. 

To go back to this slide, I started with around opiate use. There are different prevention strategies for overdose among those prescribed and among those not prescribed opiates. For this talk, I am going to focus on those with pain treatment. The naloxone distribution is a strategy which may apply to both and I will describe that more in a moment.

First is patient selection. The DoD/VA guidelines for opiate therapy include – indicate a number of groups of patients for whom opiate therapy is not appropriate. The rationale for avoiding use with patients who have an untreated substance use disorder and patients taking medications with known interactions are both particularly aimed at reducing overdose risk.

Next is prescription drug monitoring programs, which are state-run registries controlled substance prescribing with the goal that prescribers or pharmacists will use these to identify patients who are doctor-shopping or if they fill phony prescriptions. I will not say too much about this because I know the VA policy regarding the use of these systems has been in flux over the past few years. But the one evaluation to date of these programs did not find that they had an impact on overdose rates, and that is the paper by Paulozzi and colleagues that came out last year.

However, this study did not examine the degree to which the data that is available is used by providers; and barriers to implementation and inconsistent implementation are likely important to whether or not these programs have an impact. Since obviously the evidence that many people who died of an overdose had doctor-shopped would suggest that an effective program would likely help reduce overdose rates.

I described before that opiate dose is one of the best studied and strongest indicators of overdose risk, and I certainly think that there is – it is appropriate to interpret these findings carefully, given that this is observational data. And I also want to point out that there has not been any study of whether or not a dose limit would have an impact on overdose risk.

But dose limits have been implemented in some settings, so hopefully we will have more data on that in the future. And in light of our findings on dose and overdose risk for veterans, the TBM and Medsafe did recommend doses over 100 morphine equivalent milligrams per day only be used after careful consideration of risks and benefits and with increased patient education on risks and monitoring for adverse effects. The details for this are laid out in an issue of the Medication Safety in Seconds publication last year of which I included the cover page.

I also do not want to go too much about patient and caregiver education because it is not an expertise of mine at this point. But I do want to say that there has not been a comprehensive study of the impact of this type of intervention to my knowledge. I also want to point you both towards Erin Krebs’ webinar from earlier this year as part of the Pain Spotlight Series that did a wonderful job of describing the complexity of using opiate contracts as a patient education tool.

Increased monitoring is another aspect of pain care that may impact overdose risk. However, this also has not been studied in a comprehensive way. But I thought I would note that there are a number of monitoring activities recommended in the DoD/VA Opiate Therapy Guidelines that relate directly to reducing risk of overdose. And this includes assessing for adherence and misuse at every visit. They suggest particularly the SOAPP screening tool to assess for misuse, random urine drug screens, evaluating for adverse effects, and considering ongoing evaluation of potential drug-drug interactions.

Finally, I would like to talk for a couple minutes about naloxone distribution. Naloxone is an opiate antagonist and is used clinically in settings like the emergency department to treat opiate overdoses. There has been some research on programs that train individuals to provide first aid and administer naloxone when witnessing an overdose, but these programs have been initially aimed at reducing heroin overdoses and most often were part of needle exchange services. The studies to date have provided some positive support for this approach, but there has not been a randomized controlled trial that I know of. But I know there is one just starting in the Seattle area.

Given how many more overdoses that are due to prescription opiates than heroin in the U.S., there has been some interest in extending this type of intervention to medical settings. An example is the Project Lazarus in North Carolina, which has the component on training the family members of patients treated with high doses of opiates to administer naloxone and particularly using a nasal spray form. This project has helped to establish the feasibility of patient accessibility of this type of program, but it is certainly still a novel approach and has not been studied in terms of outcomes at this time.

It is also important to note that there are some barriers to this type of approach, which I am not going to describe in detail, but it may prove to be a useful tool. However, overdoses that occur while the victim is alone or with others who are not the caregiver, who is trained to provide the naloxone, cannot possibly be prevented from this approach logically.

With that, I thank you for attending this webinar and am happy to take any questions.

Heidi:We do have several questions that have been submitted so far. And for our audience, we do have plenty of time for questions. So please use this opportunity. You can submit questions using your Q&A pane on your GoToWebinar dashboard located on the right-hand side of your monitor. Just click on that orange arrow to open up or close that dashboard, and the Q&A screen is located near the bottom of that. Okay. Let us go back in here. Okay. First question: How can we supplement the vague points of the 2010 VA/DoD Opiate Guidelines, specifically getting supporting clarification for: 1) contraindications for opiates; 2) use of the universal precautions; 3) ceilings of opiates with lower ceiling for riskier veterans.

Dr. Amy Bohnert:That is a great question. Is Dr. Kerns still on the line?

Dr. Bob Kerns:Yes, I am here.

Dr. Amy Bohnert:Do you – I hate to jump in on how to use the guidelines seeing that I am not a care provider myself. Do you have any thoughts on that?

Dr. Bob Kerns:I think it is a great question and I think it is all worth noting that research being done by people like Amy and others on this topic is happening rapidly and we are very interested and appreciative of the research in a way that can help inform further policy guidance. The questions, however, are not easy when we try nationally to approach an issue. 

For example, some dose limits for at-risk patients, there are always exceptions to the rule. And the evidence, although it may start to appear like it is clear, rarely is as clear as one would hope that it would be in terms of being able to establish policy. So I think the bottom line is that what is happening right now is that the discussions are continuing, the research is continuing, and we may actually move in the direction of us publishing more explicit guidance that will complement or supplement the VA/DoD Clinical Practice Guideline recommendations over the next months and years. And the mechanisms for being able to do that, I think, are several. But probably we will expect that this will be forthcoming.

So at the present time I would say, probably at facilities – there are facilities that are making some local decisions about safety practices, for example the practice of using templates for opioid prescribing, only allowing or somehow monitoring opioid prescribing in the context of using things like urine drug monitoring or opioid pain care agreements. Some may actually even be starting to utilize some kinds of dose limits for certain kinds of practitioners or teams of subject matter experts that can be brought to bear on examining cases or patients in which opioids are being prescribed above some threshold. And we are interested in looking at that approach of trying to foster innovation as the VA is so good at doing and trying to track those innovations and identify what we might call strong or best practices that might be also useful in informing some national policy guide. 

But in the meantime I think our office is really trying to promote these kinds of educational exchange, information exchange, the best of what our health services and other researchers—the information that they can bring to bear to help people continue to think about this at the local level. And I certainly want to let you know that we are involved, or I am involved anyway, in multiple groups nationally that are thinking about these data and where to move VA in terms of policy and practice guidance as well.

Dr. Amy Bohnert:Great. I would add that one of the things that the person who asked the question mentioned was the issue of drug-drug interactions, and I thought that the guidelines do have some nice specific ones laid out. But it is limited to ones for which there is good evidence base. I know there are a lot that have not been studied and that is something that we are hoping to do next. So if anybody has specific ones they have been wondering about or are interested in, please feel free to email me. I will incorporate that in what we do.

Heidi:Great. Thank you. 

Dr. Bob Kerns:I really do want to emphasize what I have already emphasized. I just say we are really trying, I think, to continue to make sure that our policies and our guidance to the field really is as strongly informed by the evidence, maybe supplemented with expert opinion where necessary, but as strongly supported by the evidence as possible. And I think most of you can know that VA investigators like Dr. Bohnert and others that have presented on this spotlight on pain management series in some ways are among the leading authorities in this area. But there continue to be very important gaps in our knowledge. We do not want to jump the gun, so to speak, and rush to impose what might be viewed as restrictions on, for example, access to opioid therapy and risk unintentional harms in terms of either encouraging providers to think about opioids as a treatment option for their veterans. And certainly we do not want to want to unnecessarily or prematurely or ultimately at all disadvantage veterans with chronic pain from access to what continues to be viewed as an important therapeutic option by kind of a backlash related to these data about harms. 

And so this is again why there may be an interest in pursuing limits on opioid prescribing. But I would say right now the data that can inform those decisions are really overall quite limited. And again, it may be what Dr. Bohnert was just emphasizing: go back to the source document, which is the VA/DoD Clinical Practice Guidelines. Its full implementation across VA really has not been actualized or realized yet. So for those – there are a couple hundred people on the call that work in facilities. I am guessing that many of you work in facilities that really have not thoroughly digested those guidelines and looked to implement the recommendations of the guidelines at a facility level, let alone at an individual practice level. And we should be doing that first before we move into territory where there is less of it. So thank you. Good question.

Heidi:Great. Thank you for the response. Next question that we received: Based on increase in opiate deaths at greater than 50-milligram morphine equivalent daily and lack of evidence of opiate changing chronic pain in lower back pain, should we use ceiling of 50 mg rather than 100 or 200 mg as red-flagged dosages?

Dr. Amy Bohnert:That is a great question. I appreciate that someone could look at the data closely to catch that, that the increase in risk actually starts fairly early on in the dose quantity and actually while it is very large at the higher end, there is actually an association there even at the 50 mg level.

I think in light of what Dr. Kerns just said, I think that there is a lot of hesitancy to impose dose limitations based on this observational data for good reason. But I think it would be interesting to consider potentially a small study that could look at what impact that might have. I agree with Dr. Kerns’ concern that given the limitations of the data, it is difficult to impose something that could potentially, for some patients, really limit their access to these medications in a way that could impact their functioning.

Heidi:Okay. Great. Thank you. The next question that we received: What is more correct for talking about those that abuse opioids: substance misuse, substance use disorders, or prescription opioid misuse, or prescription overdose disorder?

Dr. Amy Bohnert:Sorry. Beginning with specifically about people who were [overlapping voice] but not necessarily ....

Heidi:What is more correct for talking about those that abuse opioids?

Dr. Amy Bohnert:So I did not actually include this in the slides, but actually my preferred term would probably be “extra-medical use” when you are talking about people who are getting them for pain. So – and the reason why I like that term is that it essentially implies that they are using it in ways that are above and beyond their medical purpose. I know among the other people who research these kinds of topics, outside the clinical setting a lot of people like and prefer the term “non-medical use” even when referring to people who are misusing them, to use the more common term among  pain patients.

So I think that is a complicated question. I think misuse is often more easily understood. But as I said, my personal preference is actually “extra-medical use.”

Heidi:Right. Thank you. The next question: Is there a lab test that will quantify the use of controlled substances rather than just have negative or positive results?

Dr. Amy Bohnert:Dr. Kerns, do you know the answer to that?

Dr. Bob Kerns:I am sorry. What was the question?

Heidi:Is there a lab test that will quantify the use of controlled substances rather than just a negative or positive result?

Dr. Bob Kerns:So I have learned a little bit about this. The answer is that there are a range of strategies for assessing the use of for example, even opiates, how much opiate is in one’s system. And/or the degree or presence of other substances. And there are advances in technology all the time on the blood front, hair front, as well as urine.

It is my understanding that there is not one single standard laboratory test right now across VA. And that seems to me to suggest that there is some varying level of sensitivity that is being employed in terms of urine drug tests and laboratory tests. We are working a little bit with our colleagues in pathology and laboratory medicine to explore whether there should be some national standard.

It may be possible even at your local facility to request more ultrasensitive tests if that is your interest, but right now I think the bottom line is there is no national standard and this is another area of all things are local. So I would encourage you to work with your laboratory medicine colleagues to better understand what they are using, and to promote education of your staff at your facility in the test that is being employed. Maybe in that context explore whether there are more sensitive tests, for example, that might be employed either on a routine basis or on a selective patient basis.

Heidi:Great, thank you very much. The next question that we received: Are you familiar with any prospective studies in the emergency department around opioid misuse? I am interested in how ED physicians can begin to stem the tide of opioid prescribing.

Dr. Amy Bohnert:That is – I hate to keep saying they are great questions, but that is a really intriguing question as well as being a good question. I am not aware of any prospective study. My colleague here actually at the Ann Arbor VA has a proposal under review at NIDA specifically to collect prospective data looking at prescription opiate use among ED patients and to follow them over time. So if we get lucky we will actually be able to have that data fairly soon. 

I also know that there has been – there are some studies looking specifically at interventions in the ED. So the RCT of naloxone distribution that I mentioned is actually an ED-based study. So they will be recruiting participants from the Emergency Department who have heroin use or who have prescription opioid use and doing some brief psychoeducation around overdose risk reduction and also distributing naloxone. 

And then here in Ann Arbor, we just got a CDC-funded study to do a similar intervention but without the naloxone distribution, so really focusing heavily on the psychoeducation and some motivational interviewing-type work around reducing one’s own overdose risk that will also be based in the Emergency Department. So I guess my response to that is stay tuned and hopefully there will be some both data on what happens with patients who are misusing opiates who are in the – who are identified through the ED and also what can be done about it.

Heidi:Great, thank you. The next question that we received: What were stats for recent contact with the VA based on consults sent for SATP but not acted upon by the veteran?

Dr. Amy Bohnert:I – yeah. We did not look at that, so I do not know offhand. That is a great question. How much were those patients who, if I understand, who were sent – either sent for consult but did not go, it sounds like, and that would be particularly interesting in light of how little substance use treatment there was that we found. What is it potentially that the people who were unwilling to go are more likely to overdose? That is a great question that will – we should look at in the future.

Heidi:Great. Thank you.

Dr. Bob Kerns:I would like to mention—I think there are some examples of – at the local level of efforts to build kind of an intermediate capacity within primary care mental health integration teams who can better partner with their primary care provider or PACT colleagues in trying to engage – in the service of engaging patients in accepting substance use disorder treatment. I think the work of building our – more extended capacity of our primary care providers and PACT teams to actually help patients understand their risks and the – especially early identification of what seems to be an emerging substance use disorder and to act constructively really to prevent harms before things get out of control, I guess, are also things that we want to be trying to encourage.

So I think as we start to understand the emergence of frank substance use disorder problems, early efforts to detect early what we call aberrant medication-related behaviors and to communicate concern to patients may be an important strategy as we move forward. Having said that, of course, the issue of how to engage or what to do with the patient who has been identified as having a frank substance use disorder who is not accepting referral for that treatment, I think we need to continue to struggle with how we can still work, I guess, to do what we can to protect that veteran from potential harms even in the absence of their engagement in substance use disorder treatment. 

And all of this is again an effort that I think can best be worked on by a collaboration between clinicians in the trenches, so to speak, and the health services research community who can think about innovations in this area and an investigation of these innovations so that we can learn as we are trying out new models of care and strategies for addressing these important challenges.

Heidi:Great. Thank you. The next question that we received: As providers are becoming more conservative about prescribing, I wonder if doctor shopping will become less of a reliable indicator of misuse or abuse, since patients who truly are simply seeking relief and believe opioids are the answer will try other doctors to find someone willing to prescribe. For example, well intentioned relief seeking versus doctor shopping.

Dr. Amy Bohnert:I think that is certainly a valid concern that actually that could if – once the prescription drug buying programs actually became – become more fully implemented, their utility may be decreased if, in a sense, doctor shopping becomes more common. Or what we observe and call doctor shopping in that for some people it may not be motivated by misuse and that’s really an interesting idea.

Heidi:Great. Thank you. The next question: Many programs in the community are giving training and Narcan to their patients/significant others and others. Why is the VA taking so long to do this?

Dr. Amy Bohnert:So I know that I do not want to speak out of turn. But I know that the – it is under consideration. And I think we here at SMITREC where we do some evaluation work related to this and have done some work on figuring out how many potential lives could be saved per year relative to the amount of implementation that would be required. So I know it is underway. But it has been complicated to get our hands around the number of people who – what groups to target, where in terms of giving out the Narcan and also working through the assumptions of that then the overdose would have to occur in front of that caregiver, if you try and bring the caregiver in versus send it home with the patient and have the caregiver watch a video. So I think it is complicated. But I appreciate the frustration that in many community settings things have already been implemented. I think it would also be great if hopefully from the project Lazarus there will be more data coming in the future that will help make the case for that extra effort of going through that intervention being worthwhile.

Heidi:Great. Thank you. We received a followup comments from the question on the 2010 Guidelines stating that 2010 Guidelines are a start but are not specific enough to help non-expert PCP to deal with their angry vet patients and their supervision asking why they did not give the veteran more opiates.

Dr. Amy Bohnert:That is a great comment and useful feedback. I do not have the response. Dr. Kerns, do you do?

Dr. Bob Kerns:Well, I appreciate what you are saying. And again, I think that there are widely recognized challenges about this. When our Primary Care Pain Task Forces worked on the competencies that we expect primary care providers to have related to pain management in the primary care setting, communication and learning how to communicate effectively with veterans always emerges as one of the big domains along with assessment and management of pain. And I can say in our VISN there has been VISN 1—I say our VISN. That is where I am located here at VA Connecticut.

There has been a considerable emphasis on training of primary care providers in communication with veterans with pain. This really on the positive side is trying to encourage communication that promotes pain self-management and issues related to engaging with behavioral health specialists and substance use disorder specialists, complementary and alternative approaches to care ... as opposed to necessarily kind of zooming in on communication or managing the threatening patient. But in that context of that kind of positive framing of the communication challenges, issues about trying to de-escalate the veteran who is frankly threatening always come up.

 I know that a lot has been learned from these efforts, at least in our VISN, and there have been efforts to disseminate this kind of education and training, frank training, around communication in other VISNs and other formats, even our national face-to-face meetings. 

But I do not know who or where the person is speaking from. I do want to reflect certainly an understanding of the challenges of this situation. It is probably far more common that we wish it was. Maybe I would suggest the person post this—this is maybe a good question for posting on the VA Pain Listserv, for example. You may get some – somebody that is willing to talk to you about what kind of resources have been brought to bear at our – at their facilities that could be helpful maybe for you as an individual provider, or for your facility more generally.

Because I think there has been some effort out there to address this challenge in particular and we in VA, I think, should take full advantage of our communication infrastructure to try to foster sharing of those practices.

Heidi:Great. Thank you. The next question that we received: Do you think that PDMPs can be used in combination with patient medical history, especially mental health history, to reduce opioid misuse?

Dr. Amy Bohnert:Well, as a personal opinion, I think that it is a useful tool for getting more information. I think what would be particularly useful would be knowing just when there is a disconnect between what the patient is saying that they are taking or have been prescribed and what their PDMP record indicates. And so I think while the evidence has not been there to show efficacy – sorry, effectiveness, actually, because it was an observational evaluation, I think certainly that there is a – that it is probably a useful tool.

And it is a – like I said, the [inaudible] to implementation improving – could it improve its utility? It would be hard to think that it has no value given the data that it is giving you as a provider that you do not otherwise have on a patient.

Heidi:Okay, great. Thank you. The next question: Is opioid-induced hypogonadism a risk factor for overdose, intentional or otherwise?

Dr. Amy Bohnert:I do not know that that has ever been looked at, so I appreciate the person asking that, because I will look at that in future work. Thank you.

Heidi:Thank you. The next question: What is the state of the evidence as to why PCP in VA give non-guideline-based opiates?

Dr. Amy Bohnert:I am sorry. Could you repeat that?

Heidi:What is the state of the evidence as to why PCP in VA give non-guideline-based opiates?

Dr. Amy Bohnert:I do not know the answer to that. Dr. Kerns, do you have a response?

Dr. Bob Kerns:I am not sure I even understand the question. Would you say it again, Heidi? Sorry.

Heidi:What is the state of the evidence as to why PCP in VA give non-guideline-based opiates?

Dr. Bob Kerns:So there seem to be a couple of assumptions there that primary care providers are providing opiates outside of published guidelines, I think, or even maybe indications for opiates. And I think that may or may not be the case, I am not sure. I think VA does what it can to promote the development of evidence-based guidelines and to disseminate those and to promote their uptake across institutions. And specific institutions may do their own tracking and monitoring and in the context of quality improvement efforts or within setting efforts to further ensure that those guidelines are being implemented and practiced. And I would say there are probably always exceptions to the rule.

So I think broadly speaking, no one is interested in tying the hands of our primary care providers to limit their ability to use their own judgment or to collaborate with patients in practicing care that may actually be outside specific evidence-based or practice guidelines. Beyond saying that, I am really not sure that I know what this person – the person asking the question is really looking for.

I would just say we do our best to develop and disseminate and promote uptake and encourage local facilities or VISNs  to put in place efforts to promote quality of care and in that context promote the use of guidelines in their efforts. Beyond that, I am not sure what else I can say.

Heidi:Okay. Thank you. The next question: Would you please comment on the availability of opiate replacement therapy in VA around the country.

Dr. Amy Bohnert:Let’s see. I personally have not looked too much into it, so I do not have a good sense of opiate availability. I know, Dr. Kerns, that is somewhat outside of the topics you are kind of most keyed into policy-wise, but do you have anything to add?

Dr. Bob Kerns:So, I am not sure if this is exactly what they are referring to, but there are again some efforts certainly at some local facility levels to develop – to build the capacity of primary care providers to utilize, for example buphrenorphine, suboxone in those settings. And there are also efforts to promote opioid substitution treatment programs for people with frank opioid use disorders in particularly psychiatry or substance use disorder, especially substance use disorder treatment settings.

I really cannot speak to the specifics of how – what that capacity really is and certainly at the facility level I am sure there is considerable variability. I think both of those strategies are growing. 

There is an effort to build that capacity in VA. If that is a weakness at your facility, I would encourage you to follow up with your primary care provider leadership, for example, or – and/or your mental health service line or care line leadership to discuss this as an apparent challenge for you at your facility. Maybe I am misunderstanding the question, but I think that is what they are asking.

Heidi:Thank you. The next question that we have here: What is the status of state prescription drug monitoring in VA settings?

Dr. Bob Kerns:So, I probably can answer that. We have been communicating to the field pretty regularly about the fact that right now there has been guidance that allows VA providers to query state prescription monitoring program databases in the states that have them, with veteran consent. I think everyone knows that there is – that there was legislation that was passed and that VA is working on developing the regulations that ultimately will extend that capacity both in terms of VA contributing data to the databases and to allow – to develop more specific guidance that will allow VA providers to query the databases. But right now all I can say is that that is continuing in development, so that the current state of the art, so to speak, is really the guidance that was disseminated much earlier this year. There has been no change or update to that guidance. I would suggest if you have specific questions about that, I would point you in the direction of your facility clinical leadership or your regional counsel, who would have up-to-date information about that guidance.

Heidi:Great. Thank you. And we are just about at the top of the hour here. We do still have over 30 pending questions that have been submitted. Amy, I know I spoke with you beforehand and I wanted to check to see if you are able to stay on the call and do some more of these questions or if you prefer to handle these offline. I am not sure how long it will take to get through these questions.

Dr. Bob Kerns:Let me also mention that I actually cannot stay on. I have another meeting that I need to go to, and some of – it seems like a considerable number of these questions really are best kind of headed my direction.

Heidi:Okay.

Dr. Bob Kerns:So, Amy, I mean if there is some way for you to stay on but field those questions that maybe are directly related to your work, I do not know how Heidi would isolate those, but I would appreciate it if you would be willing to do that. Or it may better be handled offline. So I will leave that up to the two of you. But I do need to get off the call today. So before I do, I really want to thank Dr. Bohnert and of course CIDER again for their support of this.

I hear loud and clear that there is quite a bit of interest in this topic, broadly speaking. And I want you to know that we will continue to make sure that at least every few months there is somebody that’s kind of broadly addressing what I will call the opioid issue and – opioid prescribing issues on these calls. It is clearly important that we provide a forum for scientists such as Amy to get their work out and for the field to be doing what they can to keep up-to-date on the science. So know that we will be trying to play our part in doing this.

And again, thank you, Amy, for a great presentation and discussion today.

Dr. Amy Bohnert:Thank you very much and thanks for helping with handling questions that were policy-related. I greatly appreciate it.

Heidi:Amy, do you want to continue on with some questions and if it is something that is ... yeah, can you not hear me?

Dr. Amy Bohnert:I can hear you fine, yeah.

Heidi:Okay, good. I have my second phone, I can hear myself on there so good. Amy, do you want to continue taking questions and if it is outside of your scope just let me know and I will put a note in here and I can forward it over to Bob after the call is finished, or how would you prefer to handle it?

Dr. Amy Bohnert:That sounds like a good plan.

Heidi:Okay. Sounds good. The next question that we received: What funding streams might be available for non-VA research? Would NIDA be a good source?

Dr. Amy Bohnert:That is a—it is like I keep saying this. I want to reinforce future fantastic questions. That is an excellent question and I – because I agree that there is not necessarily an obvious NIH institute for a lot of you to choose. 

Obviously, the ones that touch on abuse are appropriate for NIDA and I have been surprised, pleasantly surprised, that they are interested in funding things that are not even wholly focused on the abuse issues related to opiates. I think they do see the broader issues on this topic related to their body of work and their responsibility, I would say.

I also mentioned that we have an overdose-focused project that was funded by the CDC and I know the CDC also has a lot of interest in the overdose issue specifically through their injury center, given the data that has become such a huge part of their domain of public health concerns. But I also know the CDC considers prescription drug use – misuse in general as part of their injury portfolio.

So yes, I would say NIDA as well as the CDC would be primary places that I am aware of.

Heidi:Great, thank you. The next question we have here:What is the position of the VA nationally on the sharing of registries and checking on veterans of getting opioids from private sector?

Dr. Amy Bohnert:I think Bob mentioned that just a couple of minutes ago. But just to reinforce it, I think the current expectation is that, that the – I imagine that means essentially the prescription drug monitoring program that includes data that come from non-VA providers and including ones that are in private practice, for those states that have those programs, and checking those are allowed with patient consent currently. And I think they are still working on broadening that.

Heidi:Great, thank you. The next question:  Our UDS screens do not indicate drug levels for opiates, which makes misuse extremely difficult to address? Would best practice require our VA site to give drug levels?

Dr. Amy Bohnert:Let’s see. That may be better fielded by Dr. Kerns. I agree that that is a complex  scene. It sounds like he is – from what he was saying earlier about the question having to do with urine drug screens that it may not – even if it were best practice, it may not be available everywhere at this point. I think certainly it is important to also consider other ways of getting information on misuse outside of just the urine drug screens, such as the SOAPP, which was adjusted by the Guidelines, obviously can be difficult to get honest answers to questions about misuse when asking a patient who may be worried that you are going to stop prescribing if they answer honestly and indicate that they are misusing. So I hope that we can do more research also in how to better implement some of those screening tools that are available.

Heidi:Great. Thank you. The next question that we received:  Can you repeat the slide about contraindications for opiate treatment?

Dr. Amy Bohnert:Let’s see. I think I just had a slide mentioning that that was one of the things in the DoD/VA Guideline. I think it is the fourth bullet point down there that they suggest not using opiates with patients who are on a handful of specific medications. I think the guidelines specifically mention interactions that are with specific opiates generally as opposed to all opiates. So I think in reality if you look at the DoD/VA Guidelines, it is less saying that the patient should not get any opiate, but that certain combinations should be avoided.

As I mentioned, this is something that I am very much hoping to do more work on to actually increase the evidence base in the future. And I am very interested to know if people have any thoughts of specific combinations that they are worried about, or specific types of drugs that they interact with opiates as a whole class that we potentially may not be thinking of.

Heidi:Thank you. The next question:  What are the advantages and disadvantages to routine drug screens versus random screens?

Dr. Amy Bohnert:That is not something that – I think that might be a good Dr. Kerns question. But even better, I think Erin Krebs talked about – touched on some of those issues in her webinar earlier this year that was just part of the Pain Spotlight Series, and I bet she would have even more knowledge on that issue. So if the person who put that question in is still on the call, they may want to email Erin Krebs. K-R-E-B-S.

Heidi:Great. Thank you. The next question:  Would you repeat the slide for patient selection risk factors?

Dr. Amy Bohnert:So we are on that slide currently, so I can – that probably resolves that question. 

Heidi:Okay. My computer is actually a little frozen right now. I have got someone else who is coming on in just a second to help us finish up with the question.

Dr. Amy Bohnert:Okay.

Heidi:I do not know what happened here. I can read what I have got on the screen and I cannot do anything more. So I have got Molly Kessner, who is getting on. She should be here any second. While we are waiting for her, I just want to let our attendees know we really appreciate them. I have got 154 of you who are still hanging on with us. We really appreciate you sticking with us. We still have about 25 pending questions. We are going to try to get through as many as we can. Molly, did I hear you join us?

Molly:You did. Thank you, Heidi. 

Heidi:Fantastic. Are you able to see the questions?

Molly:I am.

Heidi:Okay. I see. I just finished with Karen Brown’s question that came in at 11:26.

Molly:Great. Thank you so much.

Heidi:Thank you.

Molly:All right, ladies and gentlemen, hold one second, please, while I find my place in here. Okay. The next question we have: I am surprised to see that approximately 25 percent of OD patients had no VA encounter in the past year. How were these patients identified as VHA patients?

Dr. Amy Bohnert:I can back up to that. Here it is. So the – let’s see. It was about 92 percent, so only eight percent had no treatment in the past year. That might have been the past 30 days that the caller had noticed that it – which was about half. But to go back one slide. How we defined VA patients was anyone who had used the VA in the last two years prior to death. So the individuals who were in this eight percent who had not used in the year prior were individuals who had used in the year prior to that year leading up to their death.

Molly:Excellent. Thank you for that response. The next question:  Can you give us an overview of any structured opioid monitoring programs within the VA that are being used to assess for doctor shopping/diversion?

Dr. Amy Bohnert**:**I do not know how many programs have been focused specifically on doctor shopping. And probably the main reason for that has been the fact that there has been some back and forth on the guidance in terms of using prescription drug monitoring programs, which are really the key tools for assessing doctor shopping. So I am not sure about programs specifically for those concerns, the doctor shopping and the diversion.

Obviously, the urine drug screens when there is a negative screen when – for something that someone is prescribed is one way of also measuring diversion. But I am not sure of any comprehensive studies of the impact of that and that would provide more guidance on and interpreting and managing that.

I do know that a couple months back there was a presentation as part of the series on the POD system that was a computerized way of monitoring and managing prescription opiate treatment more broadly that has been piloted in the VA. I think if you Google VA and PODS, it will probably come up that has – there are some publications with nice details on what those programs look like.

Molly:Thank you for that response. Before we move on to the next question, I just want to make a brief announcement. I do see that a number of our attendees have the hand-raising function clicked, and what you need to do is please submit your question in writing using the question function located on your dashboard. If you are having difficulties, please email cyberseminar@va.gov and you could submit your question that way. Thank you. The next question we have:  Any information on how often benzodiazepines present in these accidental overdoses?

Dr. Amy Bohnert:That is something that we have data on and we hope to look at next when we think – when we look more at interactions. Obviously that will both be looking at what people are prescribed and also what they overdose on. I can say off the top of my head because I was looking at it yesterday, that about 10 percent of all unintentional overdoses among VA patients involve benzodiazepines. But that includes both ones that – probably a small number that are due to benzodiazepines alone as well as ones that are in combination with other medications. I am sorry that that is not an exact answer. And that is something that I hope that we can report more data on here soon.

Molly:Thank you for that reply. The next question has some comments and has some questions involved:  Is it a fair assumption that most chronic pain medication prescriptions are prescribed by primary care providers? If so, with respect to reducing adverse outcomes and doing so during a primary care visit, was there any look at doing a functional assessment? We can end there. There are a couple more questions, but we can stop there.

Dr. Amy Bohnert:I believe the person who asked the question is correct that in terms of by volume most – the vast majority of opiates in the VA are prescribed by primary care doctors. We have not done anything here looking at providing a functional assessment in that setting as a way of looking at this. I know actually Will Becker, who works with Dr. Kerns at the – there at the West Haven VA is – has actually a CDA to look more at assessment practices in primary care in relation to improving the safety of opiate prescribing.

Molly:Thank you for that reply. The followup questions – or I am sorry, the remaining questions were: Was any tool identified that may be useful? Was there any look at Athena-opioid therapy to see if a clinical decision in making informatics tools might be useful, especially in reducing mortality?

Dr. Amy Bohnert:That – yeah. Those are useful questions for me understanding where the person asking the questions is coming from a little bit more. We have not looked at Athena at all here in a systematic way particularly related to adverse effects. I know that the group there in Palo Alto that designed Athena recently got funding from the—I may butcher the name—but the National Center of Inquiry for Patient Safety from the VA to do more of an evaluation on that program. Because I know that there has not – I think there has not been a comprehensive evaluation to date, which is why they propose to do that and will hopefully be able to provide more data on the utility of that program.

Molly:Thank you for that reply. The next question we have:  What is the VA policy about prescribing naloxone to patients for use by their partners to prevent overdose? Is any VA training patients and their partners to use naloxone?

Dr. Amy Bohnert:I would say that there – I do not think there currently is a policy one way or the other. Or to my knowledge there has not been specific guidance on that. I know that the VA is considering implementing that and with that specific approach of educating the caregiver. So I think actually Project Lazarus has some education materials available if people are interested in seeing what that looks like. And I know that naloxone is already on formulary because it is used in the ED, but I do not think it is at this point intended to be prescribed to patients to take home.

Molly:Thank – pardon me. Thank you for that reply. The next question we have:  In regards in patient to opioid overdose and the use of patient-controlled analgesia, what are the recommendation prevention strategies? Quality of evidence specifically related to STCO2 monitoring?

Dr. Amy Bohnert:That probably should be a Dr. Kerns question. So I cannot – I do not know if Heidi mentioned that Dr. Kerns had to go off the call, but for some questions we are hoping to forward them to him afterwards.

Molly:We can absolutely take care of that. Thank you.

Dr. Amy Bohnert:Thank you.

Molly:Mm hm. Are there any studies showing a decrease in opioid-related overdoses or any other benefits to not using immediately release opioids for chronic opioid therapy? For example, using only extended release opioids for chronic opioid therapy.

Dr. Amy Bohnert:That has not been studied and that is something that along with the interactions, the drug-drug interactions, that is part of a proposal that we currently have in and it is something I am hoping to do in the coming year or so. So I think it is an actually an important issue and a great question and I am hoping at some point to have an answer.

Molly:Thank you for that reply. The next question we have: one moment, please. Okay, here we are. Are there—pardon me. Was there any examination of whether primary care providers were aware of the VA/DoD Guidelines and whether they follow them?

Dr. Amy Bohnert:I am not personally aware off the top of my head of any research that looked at that comprehensively. So I have been – and there was similar question earlier that Dr. Kerns responded to and it sounded like he was also not aware of any work that looked at that, that has at least been published at this point.

Molly:Okay. Thank you for that reply. Next question. Pardon me. There are quite a few in here. Okay. Is the use of alternative therapies being used anywhere, for example chiropractic, massage, yoga, TM for pain management instead of narcotics?

Dr. Amy Bohnert:I am sure it is being used somewhere and I know that there have been some studies of that. But whether it is being used in the VA I am not sure. I would not – I think that is probably something that at this point is not tracked very well.

Molly:I apologize. Thank you for that reply. Next question:  Do you think that because the VA does not contribute to the PDMP programs influence its utility?

Dr. Amy Bohnert:I suppose for VA providers directly – probably – hopefully it wouldn’t influence utility because you have access to that – or providers have access to that data within the VA system. I think potentially for providers who are treating veterans who are non-VA providers, yes, it probably decreases the utility of that data to them in treating that veteran if that veteran is also getting care at the VA. And, as Bob mentioned, there are efforts underway, too, and there has been policy that this will happen, that the VA will be sharing their data with PDMP for states that have them.

Molly:Thank you very much. Next question we have:  Do you use SOAPP or something similar to help identify opioid risk for veterans?

Dr. Amy Bohnert:What I personally used in research, and this has not been in the VA so much but in other settings including an earlier questioner mentioned ED studies and we have some studies in the Emergency Department that include both people using opiates for – who did not get them from a doctor and those who did; but we have used the COMM, which is the – it is a similar measure. It stands for Current Opiate Misuse Measure. And there are typically six items. We wanted to use a briefer screener because the actual full one for both the COMM and for the SOAPP are quite long. We have six items at least in terms of face validity were appropriate to a variety of settings because some of them are on things that are less directly related to opiate misuse.

And those six specific items can be found in a paper. The first author is Amanda Price, so it is Price, Bohnert and Elgin. And that specific study was done in an addiction setting, but it lists those six items that we use specifically when we wanted a shorter screener.

Molly:Excellent. Thank you. We do have – we are getting through our questions list quite quickly, so thank you to those of you who stuck around, and of course to our presenter, Amy, thank you. Our UDS screens do not indicate drug levels for opiates, which makes misuse extremely difficult to address. Would best practice require our VA site to give drug levels?

Dr. Amy Bohnert:I think that one we did a couple back. It sounds word-for-word the same, so I think it probably got repeated.

Molly:Okay. Thank you. Next question:  Can you please repeat the slide about contraindications for opiate treatment?

Dr. Amy Bohnert:I think that one was also previously ...

Molly:Okay.

Dr. Amy Bohnert:... included. But here it is again just in case.

Molly:Thank you. I am playing catch-up just a little bit here. Do you promote physicians in your VISN to get the certification to prescribe—I am sorry; I am going to butcher this word—buprenorphine ...

Dr. Amy Bohnert:Buprenorphine. Yes.

Molly:Thank you. ... for treatment of opioid dependence?

Dr. Amy Bohnert:I think that question was probably intended for Bob; but judging from what he said earlier when talking about the buprenorphine issue. I think while I am not sure for sure what his role is in recommending or not recommending it specifically within his VISN, I think certainly the hope is that if more providers go through the process to get that certification, it certainly increases the access to buprenorphine for patients, which I think is clearly a good thing.

Molly:Thank you for that. Is there any evidence regarding undertreatment of pain as a risk for suicide using prescription opioids?

Dr. Amy Bohnert:I do not think that that has been established. And obviously there is the – I think probably the rationale behind the – this question is that there is a complicated balance between the risk of undertreating pain and that undertreatment contributing to someone’s – a poor psychological state and some suicidality versus the other end of someone who may already have some suicidal thoughts and then prescribing an opiate that gives them a means of committing suicide. And you can see actually since the guidelines are still up the second point there, that it is contraindicated for patients with acute suicidality. 

I do know on the SOAPP – so I do not know too much about whether there has been any study looking at undertreatment of pain specifically. I do know that there is a paper coming out by my colleague Mark Ilgen looking at a number of pain diagnoses among VA patients as they relate to suicide risk. And there were a number of specific—not all, but a number of specific and I cannot remember off the top of my head which they were—but there are pain conditions that relate to risk of suicide. And it is possible that one of the mechanisms underlying that association is the degree to which some pain may be undertreated and that the impact that pain has on someone’s mental health.

Molly:Thank you for that reply. How patient-centered do you think pain management therapies are right now? Or do you feel that approaches are more paternalistic given the need to mediate risk?

Dr. Amy Bohnert:I think that is probably a Bob question. But I think the person asking the question is definitely on to something in terms of thinking about the balance of wanting to have policies that are helpful and provide helpful guidance but also not wanting to have such clear structure and rules around who can get prescribed what and in what quantity that we lose track of patient preference and other considerations like that. But I think maybe we should also forward that one on to Bob.

Molly:Thank you very much. With regard to outcomes—sorry. What concerns do you have about integrating naloxone into VA?

Dr. Amy Bohnert:I personally – I am not sure I have a strong personal opinion on this one way or the other. I guess I am somewhat of an agnostic when it comes to naloxone. I know some providers I have talked to have been concerned about the idea that giving a patient naloxone to take home may send a concerning message in terms of the provider indicating that they think that they are over-prescribing to the patient and giving them too much.

And is that patient then going to take less of their medication and potentially undertreat their pain on their own? Are there possibly some liability issues in that message of saying essentially here are a lot of opiates and then here is some naloxone in case you overdose. I think those are some issues that at least in implementation still need to be worked through.

The other concern I have is that it could – as I kind of touched on in the slides, the – many overdoses and actually overdose deaths occur when the person who overdoses is by themselves. And the premise of naloxone assumes that for it to have any good, there has to be someone there when the person overdoses who knows how to use it. And I think if we focus so much on that solution as the only solution, we may pay less attention to other ways to reduce overdose risk that could potentially have more of an impact broadly because they would also address reducing overdoses that could occur while someone is alone.

Molly:Thank you for that reply. We do have about half a dozen pending questions. Are you available to stay on, Dr. Bohnert?

Dr. Amy Bohnert:Sure.

Molly:Great. Thank you so much for your time. We do have a couple comments. I am going to run through those real quick. The reality is the practitioner’s license is on the line. They have the right to prescribe or not prescribe any medication. Patient safety should be the primary endpoint. 

Another comment: Under consideration is good. But to an upset mother of a veteran who died of an overdose, it does not seem to be a good answer. This is what we are dealing with on the front lines. So we appreciate you providing your comments from the field. Thank you. 

With regard to a previous question about naloxone—sorry if I keep mispronouncing it—I believe somebody was searching for a title of a paper, and the title was “Role of Naloxone in Opioid Overdose Fatality Prevention.” And it discusses a lot of the issues with getting this intervention more widely distributed.

Next question:  Is there someone I can contact regarding the proposed study to NIDA regarding the prospective study in the ED?

Dr. Amy Bohnert:I – let’s see. The – I am a little confused. I think there were a couple different studies I mentioned there. There is a study that was proposed to NIDA that was to do prospective data collection on – among patients using opiates who are recruited from the Emergency Department. The PI on that proposal is Mark Ilgen, I-L-G-E-N, who is also a VA-HSR&D investigator here at Ann Arbor.

The other study I may have mentioned that is also Emergency Department based is – the PI on that is Caleb Banta-Green, two words, Banta and Green. He is at – he is in Seattle. He is not a VA researcher and that is a – also a NIDA-funded study.

So I am not sure which, but those are the PIs who would have the most information on those proposals and potentially also could find other information on – I remember there was an earlier question about who was interested in funding that kind of research. They may have more guidance on that as well.

Molly:Thank you. As we are down to the last few questions, please do let me know again if I am repeating any of them. Does the drug Nucynta follow in the opioid therapy for pain? If so, how much alcohol does one have to consume that is on opioid therapy to be at risk for overdose?

Dr. Amy Bohnert:That is probably a Dr. Kerns question.

Molly:Okay. Thank you. There is another comment about the naloxone distribution. With regards to recent questions, there was a recent FDA meeting with regard to the naloxone distributions. So thank you for that.

And please again let me know if I repeated this one. In regards to inpatient opioid overdose and the use of patient-controlled analgesia, what are the recommendation prevention strategies quality of evidence specifically related to ETCO2?

Dr. Amy Bohnert:And this is specifically about inpatient patients?

Molly:Inpatient-controlled analgesia.

Dr. Amy Bohnert:I – let’s see. I – most of the work has focused on patients who were outpatients, particularly the overdose work the VA stuff we have done off of the paper by Dunn and colleagues at Group Health Cooperative. And that is in part because I think they are certainly separate issues in terms of the level of monitoring around what the patient is taking. And so unfortunately I do not think there has been much research to guide inpatient practices that I am aware of. We could forward that to Dr. Kerns and see if he has anything to add.

Molly:Thank you for that reply. What role do you think qualitative data/research could play in informing new VA Guidelines and Best Practices for pain management/opioid therapy?

Dr. Amy Bohnert:I think that certainly qualitative data collection in general always provides a definitely unique and complimentary perspective to what the quantitative data can give us. And I think that is important as well. I – but I would say that I do think that as some of the questions earlier highlighted, there are a lot of issues that we still need some more quantitative data to be able to provide clear guidance on things like drug-drug interaction, for example, that it would be difficult to deal with through qualitative data. But it sounds like from the questions that there is a lot of questions about that are not resolved currently in the guidelines. I do think that the qualitative work, particularly qualitative focus groups with providers, could really help with some recommendations around some of the issues that – particularly the first question was about – around managing on how to implement some of these recommendations in the real life clinical context and with the balance of what the patient is asking for and what the recommendations are.

Molly:Thank you very much. Next question:  What is the medical literature evidence for efficacy especially in improvement of function of opioids over 100 mEq a day and longer than three months in the treatment of chronic nonmalignant pain? 

Dr. Amy Bohnert:I am not sure that there is a study that has even looked at that, let alone has positive findings. So my answer, I suppose, is that I do not think there is any evidence. And that is an important consideration. But to be fair, I think there are a lot of medications that we use for long periods of time and most of the trials that the FDA requires in order to get approval for their use are short-term. So I am not sure that this is an issue specific to opiates so much as how medication testing in general is done. But there are unique concerns with opiates because of the adverse effects that maybe they are special in terms of the degree to which long-term data is needed.

Molly:Thank you. Next question:  What types of monitors has the speaker seen implemented in her facility to monitor opioid prescription practices?

Dr. Amy Bohnert:I actually am full-time in research and am not a clinician. So I have not directly observed monitors in my facility. So I cannot provide anything out of personal experience. But Dr. Kerns may be able to field that and talk a little bit more about actually the variety of monitors across the facility that have been implemented.

Molly:Thank you. We are down to our last few questions. How much dialog is there between veteran and providers about psychological aspects of pain management? For instance, working with mental health and substance abuse providers and helping veterans consider and develop other means of managing pain.

Dr. Amy Bohnert:That is a really core issue that I would be very interested to know the answer on, too. Again, I am not a provider, so I do not want to make any general statements on what – on whether providers are talking to their patients about those issues and how much they are. I know that there is a national rollout of making cognitive behavioral therapy for pain more available across VAs, and I think perhaps having more access to that will hopefully open up the possibilities of conversations more because providers will have a non-pharmacological treatment option to refer patients to. And particularly those patients who have mental health or substance use concerns that complicate their treatment.

Molly:Thank you for that reply. What are the advantages and disadvantages to routine drug screen versus random drug screens?

Dr. Amy Bohnert:I think that one came up earlier and Dr. Kerns responded to it.

Molly:Okay, great. This one looks like it was a followup because it begins with the word “or.” But I will throw it out there. Or ...

Dr. Amy Bohnert:Okay. I am ready.

Molly:Or if primary care providers had VA-provided chronic pain care education.

Dr. Amy Bohnert:So – okay, so the idea being – and we are not sure what that’s in relation to, but that it sounds like the questioner is throwing out that it would be great for the VA, perhaps, to have their own training around chronic pain care. I think that is a great point and a great idea. And I would refer to an article by Will Becker, who is a colleague of Dr. Kerns, that highlighted the fact that a lot of the trainings that are being created now in response to the [inaudible] for long-acting  opioids are being funded by the drug companies. And obviously there would be an advantage to the VA providing more guidance on that that coming from the – obviously, the VA’s interest is in improving the – reducing pain and improving functioning and reducing the risk of adverse effects for veterans as opposed to being a profit-oriented motive. So that is a great point.

Molly:Thank you. Is there any evidence that looked at the undertreatment of pain – oh, I am sorry. We did get to that one. And this is a question, also a followup because it begins with the word “and.” But – is there a national directive or something similar—I am sorry—there is no frame of reference here. So.

Dr. Amy Bohnert:That is the whole question?

Molly:Yeah.

Dr. Amy Bohnert:Yeah. I probably cannot answer that. But if the person is still on the line, I am happy to – if they want to send me an email I am happy to talk about the question more, whatever it is.

Molly:Great. We also had several people write in saying, thank you so much, this was a very informative talk. We do appreciate you bringing your expertise to the field. And that is our final pending question. Thank you so much for staying on as long as you have. And as you mentioned, we will be forwarding a lot of these questions on to Bob and we will get back to the audience with those answers. And as – I would like to give Amy the opportunity to make any concluding comments before we wrap it up.

Dr. Amy Bohnert:I do not think I have anything in conclusion. Thanks to everybody who called in. I am sorry that I was not able to better answer questions around practice or around policy, particularly after Dr. Kerns was off the line. And I am always interested to hear anybody’s thoughts on what are things that they feel are important that we are not looking at enough in research and that our research could help if we did it—could help inform your practice. So please feel free to contact me about anything.

Molly:Thank you so much. And just a reminder to all of our attendees—please do join us the first Tuesday of every month at 11 a.m. Eastern for our regularly scheduled Spotlight on Pain Management Cyber Seminars. You can go to the HSR&D web page and find our Cyber Seminar catalog in order to sign up for future sessions.

And with that I also do want to mention that as you leave today’s session, you will be prompted to fill out a quick survey, and we do appreciate you taking the time to answer those few questions. It does help us improve our program to help satisfy your needs.

So thank you for everybody joining us and for your patience during today’s presentation. And this does conclude today’s Cyber seminar. Have a wonderful day.

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