In last week's State of the Union address, President Obama mentioned prescription drug abuse as an issue where he saw opportunity for bipartisan compromise. Notably, he mentioned this in the first three minutes of the speech. And not coincidentally, he mentioned it in the same breath as another, related issue that will be a necessary component of prescription drug abuse mitigation: criminal justice reform.
Governor Chris Christie has made prescription drug abuse a centerpiece of his stump speech. He regularly shares a personal experience of losing a close friend from law school to an overdose. Just last week, Christie made headlines by shutting down a New Jersey prison in order to convert it to a drug addiction treatment facility. "The victims of addiction deserve treatment..." he said.
In last night's Democratic primary debate, Secretary Clinton and Senator Sanders both touched on the subject. After noting that she hears of horrible stories wherever she goes on the campaign trail and after advocating for first responders to carry and be authorized to use Narcan, she closed her comments along the same lines as Governor Christie: "We have to move away from treating the use of drugs as a crime and instead, move it to where it belongs, as a health issue. And we need to divert more people from the criminal justice system into drug courts, into treatment, and recovery." Senator Sanders added, after placing at least some of the blame at the feet of the pharmaceutical companies, that "we need a revolution in this country in terms of mental health treatment."
This is clearly going to be a 2016 presidential campaign issue. Beyond the mere fact that crises often make for strange bedfellows (Clinton and Christie offering nearly interchangeable quotes?!?!), why are we hearing more about prescription drug abuse from candidates now than ever before?
First, New Hampshire. Everyone knows the Granite State figures prominently as the first primary - on February 9 - in both parties' nomination process (Iowa - on February 1 - is a caucus, not a primary). What many may fail to recognize is that New Hampshire's citizens have been hit especially hard by the opioid/heroin epidemic over the last several years. A quarter of New Hampshire voters believe prescription drug and heroin abuse is the single most important issue of the 2016 election, marking the first time in eight years a plurality of voters have ranked any issue more important than jobs and the economy. If you're going to win the New Hampshire primary - from either party - you better be prepared to address prescription drug misuse and abuse.
Second, it's not an exaggeration to say that we're losing a material portion of entire generation of Americans to this epidemic. First, we saw the findings of a recent study from the National Academy of Sciences indicating that the death rate among white, middle-aged Americans has grown over the last two decades while the death rate among almost all other groups has declined. Now, the New York Times has analyzed nearly 60 million death certificates collected by the CDC and found that the death rate among young, white adults has risen to levels not seen since the AIDS epidemic of the late 1980s and early 1990s. This generation will be the first since the Vietnam War to experience higher death rates in early adulthood than the generation that preceded it. The figures indicate that the 2014 death rate from prescription drug and heroin overdose among 25 to 34 year olds was five times its level in 1999.
We have presidential candidates talking about this issue because it is the preeminent public health issue of our time. If there's any comfort for us at all, it's that both parties appear to be taking it seriously. If there's to be a concern, it's that whoever wins will need to make difficult decisions and real progress. We're losing a generation of Americans.
Michael
On Twitter @PRIUM1
Michael Gavin, President of PRIUM, focuses on healthcare issues facing risk managers in the workers' compensation space and beyond. He places particular emphasis on the over-utilization of prescription drugs in the treatment of injured workers.
Monday, January 18, 2016
Tuesday, January 12, 2016
Primary Care Physicians Aren't Prepared for Substance Abuse Issues
In the course of consuming news, studies, and other information related to prescription drug misuse and abuse, I sometimes come across seemingly unrelated data sets that paint a picture of broad, systemic issues. Often, connecting these dots can illuminate a potential path forward, focus our efforts, and create progress toward solutions. This week's example:
Data Set #1
First, the CDC's latest data on drug poisoning deaths is disheartening. After leveling off and even slightly declining in 2010-2013, the opioid death rate jumped considerably in 2014. Meanwhile, heroin overdose deaths have continued a depressingly steady climb that goes back nearly two decades, but has clearly accelerated within the last 5 years. Certainly, we have seen better days.
Data Set #2
Health Affairs published an interesting piece in its December 2015 issue comparing primary care systems across 10 countries. Primary care doctors were surveyed regarding general capabilities and attitudes. While the survey was wide ranging, one of the categories stood out to me: the % of primary care doctors who report their practice is well prepared to manage the care of patients with complex needs. Two key data points:
- Patients with substance-use related issues:
- US primary care docs: 16% are well prepared. This ranked near the bottom of the 10 country survey. The UK was at the top of the list with 41% of primary care physicians reporting that they're well prepared to deal with substance-use related issues.
- Patients with severe mental health problems:
- US primary care docs: 16% are well prepared. This ranked second to last (just behind Sweden at 14%) among the ten countries. The UK also topped this category with 43% of primary care docs reporting they feel well prepared to deal with severe mental illness.
To sum up...
We have an escalating death rate from opioid and heroin overdose deaths in this country, driven in large part by substance-use related issues and mental illness. And we have a primary care system not equipped to deal with the complexity of these patients.
Help may be on the way in form of increased and mandated reimbursement for substance abuse and mental/behavioral health treatment via the Affordable Care Act. But I'm struck by the fact that the vast majority of opioid prescribing occurs at the primary care level, not in the specialist's office. If we're to make any progress, we need to focus education, resources, and tools within the primary care community so that a-heck-of-a-lot more than 16% of primary care physicians feel they're well prepared to help this complex group of patients.
Michael
On Twitter @PRIUM1
Labels:
addiction,
addiction treatment,
Affordable Care Act,
clinical practice,
education,
healthcare system,
heroin,
mandatory education,
mental illness,
opioid,
opioids,
public health,
public policy
Monday, January 4, 2016
When Opioids Almost Kill You, Chances Are You'll Get More Opioids
I really wanted the first post of 2016 to be positive, uplifting, inspiring... but a study I read over the break was so unnerving, I had to go and ruin "return to work" day, already a day that lives in infamy, with even more depressing news.
Researchers at Boston Medical Center used a national database of prescription information to assess the likelihood of continued opioid prescriptions after a non-fatal overdose. They looked at prescription information from 3,000 patients who experienced a non-fatal overdose between 2000 and 2012. These patients were all prescribed opioids for chronic, non-cancer pain.
Think about this: These 3,000 patients have already overdosed on prescription opioids. They are lucky to be alive. Surely, their healthcare providers will find another way, another mechanism, another approach to managing their pain. The risk here isn't illness or infection or a change in blood pressure... it's death.
The bad news:
- Over 90% of these patients continued to receive opioids after their non-fatal overdose event
- 50% of these continued to receive the prescriptions from the same doctor
- 7% of the original group experienced a second overdose
- Two years after the first overdose, those with continuing opioid prescriptions were twice as likely to experience a second overdose event compared to those who were no longer receiving opioids.
Why is this is happening?
First, our fragmented healthcare system doesn't make it easy for prescribing physicians to discover the clinical events experienced by their patients outside of their immediate purview. And patients may not want to disclose an overdose event for fear of having their medications discontinued. I get that. And it makes we wonder whether PDMPs should also include the ability for inpatient settings to report both fatal and non-fatal overdose events to the database so doctors can see this information whether its reported by the patient or not. Linking electronic health records to PDMP systems would be a good start down this path.
The second phenomenon driving these sorry statistics is that doctors are not comfortable weaning opioid (and other) medications. No one, least of all me, would ever suggest immediate cessation of opioid therapy in light of a non-fatal overdose. That's clinically irresponsible and potentially dangerous for the patient. But the necessary steps forward are complicated: If the patient is on multiple medications that require weaning, which should we weaned first? What titration steps should be used? Is medication-assisted-therapy (MAT) an option? Should I refer the patient or try to handle this myself? These are hard questions and the primary care community, by far the most frequent prescribers of opioids, is currently ill-equipped to handle them.
Welcome to 2016. Once more unto the breach, dear friends.
Michael
On Twitter @PRIUM1
Tuesday, December 15, 2015
It's Actually NOT 10% of Doctors Driving the Opioid Epidemic
A brief research letter in the Journal of the American Medical Association published just yesterday highlights a fascinating phenomenon in opioid prescribing and does so against the backdrop of workers' compensation data from the California Workers' Compensation Institute (CWCI).
Recall that CWCI data indicates that 10% of prescribers are responsible for nearly 80% of the opioid prescriptions in the California work comp system (and 88% of opioid costs!). That's an astounding statistic and one that has led many observers and decision-makers to conclude that the solution to mitigating the opioid epidemic is to change the behavior of a small subset of prescribers that were driving the utilization of potentially dangerous medications. I've heard this from a multitude of sources: "It's a relatively small group of the prescribers who are really responsible for this problem. How do we change their prescribing behavior?"
The authors of this recent research letter decided to test whether the same ratio was exhibited in a much broader data set: all Medicare claims. Granted, this is a data set not representative of the work comp injured worker population, but it's still an interesting question: Do we see that 10% of prescribers to Medicare patients drive 80% (or more) of the opioid prescriptions? The answer would lend itself to opioid misuse and abuse mitigation strategies that go far beyond work comp and speak to the national effort to curb addiction and overdose deaths. What are we aiming for? 10% of prescribers? Or a broader group?
The answer: the top 10% of Medicare prescribers account for only 56.7% of all opioid claims. Not only is this far below the CWCI data point of 80%, but it's also significantly less than the percentage of overall prescriptions (opioids and non-opioids) written by the top 10% of overall Medicare prescribers (63%).
Recall that CWCI data indicates that 10% of prescribers are responsible for nearly 80% of the opioid prescriptions in the California work comp system (and 88% of opioid costs!). That's an astounding statistic and one that has led many observers and decision-makers to conclude that the solution to mitigating the opioid epidemic is to change the behavior of a small subset of prescribers that were driving the utilization of potentially dangerous medications. I've heard this from a multitude of sources: "It's a relatively small group of the prescribers who are really responsible for this problem. How do we change their prescribing behavior?"
The authors of this recent research letter decided to test whether the same ratio was exhibited in a much broader data set: all Medicare claims. Granted, this is a data set not representative of the work comp injured worker population, but it's still an interesting question: Do we see that 10% of prescribers to Medicare patients drive 80% (or more) of the opioid prescriptions? The answer would lend itself to opioid misuse and abuse mitigation strategies that go far beyond work comp and speak to the national effort to curb addiction and overdose deaths. What are we aiming for? 10% of prescribers? Or a broader group?
The answer: the top 10% of Medicare prescribers account for only 56.7% of all opioid claims. Not only is this far below the CWCI data point of 80%, but it's also significantly less than the percentage of overall prescriptions (opioids and non-opioids) written by the top 10% of overall Medicare prescribers (63%).
Does this mean the CWCI data is less accurate or less valuable to us? Absolutely not. On the contrary, the CWCI data should help focus our work comp specific strategies for opioid misuse and abuse. But for those of us concerned with the broader, national (and, increasingly, international) issue of opioid misuse and abuse, this JAMA research letter suggests that a broader, more comprehensive set of strategies that span a wider swath of prescribers will be necessary.
Perhaps of even greater consequence is the specialty make-up of the prescribers. The number of opioid claims in the Medicare data set are overwhelmingly from general practitioners (note that this chart is on a log scale... look at the actual numbers... family practice and internal medicine doctors are responsible for about 28 million opioid claims vs. a little over 3 million for pain management and interventional pain management combined).
Two conclusions:
1) We need broad-based strategies to confront the opioid epidemic, though in work comp our efforts may be focused on a smaller subset of prescribers.
2) These broad efforts need to focus on education for general practitioners. Chronic pain is fundamentally an issue of primary care and we would be wise to treat it as such.
Michael
On Twitter @PRIUM1
Monday, December 7, 2015
A Sad Addition to our Shared Experiences
Think of the number of truly consequential experiences that Americans have in common. Not the "mom and apple pie" stuff, but experiences that really impact our lives in deep and meaningful ways. How many of us know someone affected by cancer? How many of us are products of our public education system? How many of us have lost a loved one?
Thanks to the results of the recent Kaiser Health Tracking Poll, we can now add another shared experience among Americans: more than half of us (56%) know someone connected to prescription drug misuse or abuse. 45% of us know someone who has taken a prescription drug not prescribed to them. 39% of us know someone who has been addicted to prescription drugs. 16% of us know someone who has died from an overdose of prescription painkillers. (56% of those polled answered "yes" to at least one of these questions).
Interestingly, the poll reveals a demographic and socioeconomic trend around those who answered "yes" to at least one of the questions (know someone who took a drug not prescribed, know someone who has been addicted, or know someone who has died of an overdose). The top 8 groups, by percentage of those polled answering "yes" at least once:
- 63% of whites
- 63% of those making more than $90k per year
- 62% of those aged 18-29
- 61% of those aged 30-49
- 61% of those having "some" college education
- 59% of those with a college degree
- 59% with residency in a suburban area
- 59% of males
That paints a picture of the prescription drug misuse and abuse epidemic.
And yet, when asked to prioritize public policy goals, reducing drug abuse comes in 6th:
- Public education
- Affordable/available healthcare
- Reducing crime
- Attracting and retaining businesses and jobs
- Protecting the environment
- Reducing drug abuse
- Reforming the criminal justice system
In studying this list... I wonder if we can't make a significant impact on #6 by tackling #2, #3, and #7. What if we thought differently about mental healthcare? What if we thought differently about addiction? What if we didn't treat addicts like criminals? It's possible - and the regulatory and private enterprise infrastructure to make that happen is actually developing all around us.
There is hope.
Michael
On Twitter @PRIUM1
Tuesday, December 1, 2015
The Opioid Crisis: A Playbook Arrives
The Bloomberg School of Public Health at Johns Hopkins has published a paper entitled "The Prescription Opioid Epidemic: An Evidence Based Approach." Click here for a copy. Read it. Study it. Commit its recommendations to memory. This is an important document in the fight against prescription drug misuse and abuse.
What makes it important is its comprehensiveness. The team at Hopkins attacks the issue at every step in the drug distribution value chain: prescribing guidelines, prescription drug monitoring databases (PDMPs), pharmacy benefit managers (PBMs) and pharmacies, overdose and addiction, and community based prevention strategies.
The document is the summation of work performed by seven sub-committees that discussed, debated, and deliberated the options for addressing opioid misuse and abuse. The committees were made up of experts in the field and the passion, commitment, and resolve of these individuals is apparent in the resulting recommendations.
Perhaps most impressive, the paper appears to leave politics aside (as any good public health institution should) and advocates for specific tactics that have long faced strident opposition from well-funded groups. Specifically, the paper calls for mandatory prescriber education and mandatory prescriber use of PDMPs... the American Medical Association has pushed back on the former and while they've recommended the latter, many state level medical associations have balked at mandatory PDMP use.
The paper should also be commended for suggesting innovative (though controversial) ideas, such as:
What makes it important is its comprehensiveness. The team at Hopkins attacks the issue at every step in the drug distribution value chain: prescribing guidelines, prescription drug monitoring databases (PDMPs), pharmacy benefit managers (PBMs) and pharmacies, overdose and addiction, and community based prevention strategies.
The document is the summation of work performed by seven sub-committees that discussed, debated, and deliberated the options for addressing opioid misuse and abuse. The committees were made up of experts in the field and the passion, commitment, and resolve of these individuals is apparent in the resulting recommendations.
Perhaps most impressive, the paper appears to leave politics aside (as any good public health institution should) and advocates for specific tactics that have long faced strident opposition from well-funded groups. Specifically, the paper calls for mandatory prescriber education and mandatory prescriber use of PDMPs... the American Medical Association has pushed back on the former and while they've recommended the latter, many state level medical associations have balked at mandatory PDMP use.
The paper should also be commended for suggesting innovative (though controversial) ideas, such as:
- Authorize third party payers to access PDMP data with proper protections
- Require oversight of pain treatment (through mandatory tracking of pain, mood, and functionality at each patient office visit)
- Empower licensing boards and law enforcement to investigate high risk prescribers
- Require that federal support for prescription drug misuse, abuse, and overdose interventions include outcome data
Work like this gives me hope.
Michael
On Twitter @PRIUM1
Tuesday, November 17, 2015
Why Aren't We Linking PDMPs and EHRs?
The development of prescription drug monitoring programs (PDMPs) nationwide is a necessary, albeit insufficient by itself, step in our fight against prescription drug misuse and abuse. I've long advocated not just for mandatory reporting to PDMPs (which requires doctors and pharmacies to contribute data to the database) but also of mandatory use of the PDMP (by prescribing physicians prior to writing prescriptions for potentially dangerous medications).
Many physicians (and their associated lobbying groups) have pushed back on the notion of mandatory use of PDMPs based on three categories of objections:
First: "I don't get paid for this..." Fair enough. One could argue that a surgeon isn't explicitly paid to wash her hands prior to surgery and does so anyway because it's in the best interests of patient safety... though the reality is that our fee-for-service RVU-based system actually does pay the surgeon for that activity. So I get this argument.
Second: "The data isn't reliable... it's either not timely or not accurate..." This is certainly an issue, though one that will resolve itself over time with proper funding and enforcement of reporting requirements.
Third: "The database access is inefficient, the technology isn't robust..." Also an issue, but one that I think will resolve itself over time as critical mass develops around the need to exchange this data.
But what if we could fix all three issues in a single stroke of technological innovation?
Ohio is doing just that. Governor (and Republican presidential candidate) John Kasich is spending the necessary dollars (a whopping $1.5 million) to integrate Ohio's PDMP with the electronic health records systems of doctors, hospitals, and pharmacies.
This is genius.
"The message to Ohioans, despite the fact that will still see a tsunami of drugs, is that we're not going to give up in this state until we win more and more battles, maybe ultimately the war," Kasich said at a news conference.
Why isn't every governor in the country working on this?
Michael
On Twitter @PRIUM1
Many physicians (and their associated lobbying groups) have pushed back on the notion of mandatory use of PDMPs based on three categories of objections:
First: "I don't get paid for this..." Fair enough. One could argue that a surgeon isn't explicitly paid to wash her hands prior to surgery and does so anyway because it's in the best interests of patient safety... though the reality is that our fee-for-service RVU-based system actually does pay the surgeon for that activity. So I get this argument.
Second: "The data isn't reliable... it's either not timely or not accurate..." This is certainly an issue, though one that will resolve itself over time with proper funding and enforcement of reporting requirements.
Third: "The database access is inefficient, the technology isn't robust..." Also an issue, but one that I think will resolve itself over time as critical mass develops around the need to exchange this data.
But what if we could fix all three issues in a single stroke of technological innovation?
Ohio is doing just that. Governor (and Republican presidential candidate) John Kasich is spending the necessary dollars (a whopping $1.5 million) to integrate Ohio's PDMP with the electronic health records systems of doctors, hospitals, and pharmacies.
This is genius.
"The message to Ohioans, despite the fact that will still see a tsunami of drugs, is that we're not going to give up in this state until we win more and more battles, maybe ultimately the war," Kasich said at a news conference.
Why isn't every governor in the country working on this?
Michael
On Twitter @PRIUM1
Monday, November 9, 2015
The Case for Physician Education in Light of Rising Death Rates
Two recent and related op-ed pieces in the NY Times lay out the logic I articulated in my last blog post on addiction and mental health. The two pieces, taken together, offer a glimpse of the crushing reality of contemporary social and cultural circumstances for some population groups in this country as well as at least one clear imperative for how we might begin to fix it. I don't have the bully pulpit of the Times editorial page (I wish), so I'm happy to defer to a Nobel prize winning economist and a professor from Cornell's medical school, respectively, to lay out this critical message to a much broader audience.
Paul Krugman (he's the Nobel prize winner) puts the recent research on rising death rates of white middle-aged Americans into political and economic context. While he is a unapologetic liberal, his ultimate conclusion is that our politics didn't necessarily cause this despair, at least not in any direct sense. Rather, the issues are more existential in nature. One of the study's authors, Angus Deaton, offers a hypothesis: this group, he says, has "lost the narrative of their lives." Krugman puts it in his own words this way: "we're looking at people who were raised to believe in the American Dream and are coping badly with its failure to come true." And one of the most significant and negative coping mechanisms employed by this group? Prescription painkillers.
Richard Friedman (he's the professor from Cornell medical school) builds a case for mandatory physician education for pain management and does so by building on the same Deaton-Case research from which Krugman's piece is derived. He writes:
But one thing we must certainly do is ensure that the medical professionals charged with the health and well-being of their patients are, in fact, helping and not hurting our progress.
Michael
On Twitter @PRIUM1
Paul Krugman (he's the Nobel prize winner) puts the recent research on rising death rates of white middle-aged Americans into political and economic context. While he is a unapologetic liberal, his ultimate conclusion is that our politics didn't necessarily cause this despair, at least not in any direct sense. Rather, the issues are more existential in nature. One of the study's authors, Angus Deaton, offers a hypothesis: this group, he says, has "lost the narrative of their lives." Krugman puts it in his own words this way: "we're looking at people who were raised to believe in the American Dream and are coping badly with its failure to come true." And one of the most significant and negative coping mechanisms employed by this group? Prescription painkillers.
Richard Friedman (he's the professor from Cornell medical school) builds a case for mandatory physician education for pain management and does so by building on the same Deaton-Case research from which Krugman's piece is derived. He writes:
"All medical professional organizations should back mandated education about safe opioid treatment as a prerequisite for licensure and prescribing. At present, the American Academy of Family Physicians opposes such a measure because it could limit patient access to pain treatment with opioids, which I think is misguided. Don’t we want family doctors, who are significant prescribers of opioids, to learn about their limitations and dangers?
The more I read and write about chronic pain issues, the clearer it becomes to me that when we focus on root case issues, we increase the probability of making a dent in the problem. This can be hard and depressing work, though. Tracing chronic pain and drug abuse to root causes remains elusive - the answers are tied to social, cultural, economic, and historical forces we're just beginning to understand and unravel.It is physicians who, in large part, unleashed the current opioid epidemic with their promiscuous use of these drugs; we have a large responsibility to end it."
But one thing we must certainly do is ensure that the medical professionals charged with the health and well-being of their patients are, in fact, helping and not hurting our progress.
Michael
On Twitter @PRIUM1
Wednesday, November 4, 2015
Mental Health and Addiction: What if We Had What We Really Need?
Consider several seemingly unrelated articles that all ended up in my stack of "articles to read" just in the last three days:
First, a report from the Proceedings of the National Academy of Sciences that found that the death rate among white, middle-aged Americans has grown since the 1990s, while death rates among the same age cohort within other ethnicities and countries has continued to decline. From the report: "Rising midlife mortality rates among non-Hispanics were paralleled by increases in midlife morbidity. Self-reported declines in health, mental health, and ability to conduct activities of daily living, and increases in chronic pain and inability to work, as well as clinically measured deteriorations in liver function, all point to growing distress in this population." The researchers speculated that relatively easy access to opioid pain killers may be linked to the rise in incidence of mental illness. While I think they have the cause and effect backward, there's little doubt in my mind that the two are related.
Second, a report from WESH in Orlando on a US government study that estimates there are 4 million baby boomers struggling with addiction. "Baby boomers," the group of Americans born within the 19 year period following WWII, are now in their 50s and 60s and they're suffering from drug and alcohol addiction at a rate that rehabilitation and recovery services cannot accommodate. "It's hard to imagine grandma with a heroin problem," says Dr. Heather Luing, medical director at Recovery Village, "but that's the reality we sometimes see."
Third, there was a lot of international coverage of a controversial paper from the United Nations Office on Drugs and Crime (UNODC) that suggested UN-member countries should consider "decriminalizing drug possession for personal consumption." The paper was retracted by UNODC leadership with an explanation that it was written by a mid-level policy person simply expressing a viewpoint and was never sanctioned or adopted as a formal UNODC position. This public policy approach, however, has been tested, perhaps most notably in Portugal. Despite warnings of potentially dire consequences, Portugal decriminalized the simple possession of all drugs back in 2001. Since that time, Portugal has seen overall drug use fall, it has the second lowest overdose death rate in all of Europe, and HIV infections among drug users are dramatically lower, The resources formerly focused on arresting and prosecuting simple drug possession were instead poured into mental and behavioral health, education, and job training/placement programs. And if you think such a program wouldn't be possible in the US, check out what Worcester, MA is doing.
What are the common themes here?
So if the demand is there, why don't we have the mental/behavioral health resources we need? Because we've never devoted the reimbursement dollars necessary, either public or private, to ensure such programs were economically viable. But now, with the Affordable Care Act's parity provisions, we have legislatively mandated reimbursement policies around mental health coverage offered by private insurers. The resources haven't yet caught up to the demand, but billions of dollars of private equity investment is being poured into the sector. Hopefully, it's just a matter of time before the number of trained professionals and the facilities and technologies they need to practice are in place.
And that leads us to an interesting thought experiment: What if we did have the mental and behavioral health infrastructure we so desperately need? Could we fundamentally change how we approach drug abuse in our society?
Michael
On Twitter @PRIUM1
First, a report from the Proceedings of the National Academy of Sciences that found that the death rate among white, middle-aged Americans has grown since the 1990s, while death rates among the same age cohort within other ethnicities and countries has continued to decline. From the report: "Rising midlife mortality rates among non-Hispanics were paralleled by increases in midlife morbidity. Self-reported declines in health, mental health, and ability to conduct activities of daily living, and increases in chronic pain and inability to work, as well as clinically measured deteriorations in liver function, all point to growing distress in this population." The researchers speculated that relatively easy access to opioid pain killers may be linked to the rise in incidence of mental illness. While I think they have the cause and effect backward, there's little doubt in my mind that the two are related.
Second, a report from WESH in Orlando on a US government study that estimates there are 4 million baby boomers struggling with addiction. "Baby boomers," the group of Americans born within the 19 year period following WWII, are now in their 50s and 60s and they're suffering from drug and alcohol addiction at a rate that rehabilitation and recovery services cannot accommodate. "It's hard to imagine grandma with a heroin problem," says Dr. Heather Luing, medical director at Recovery Village, "but that's the reality we sometimes see."
Third, there was a lot of international coverage of a controversial paper from the United Nations Office on Drugs and Crime (UNODC) that suggested UN-member countries should consider "decriminalizing drug possession for personal consumption." The paper was retracted by UNODC leadership with an explanation that it was written by a mid-level policy person simply expressing a viewpoint and was never sanctioned or adopted as a formal UNODC position. This public policy approach, however, has been tested, perhaps most notably in Portugal. Despite warnings of potentially dire consequences, Portugal decriminalized the simple possession of all drugs back in 2001. Since that time, Portugal has seen overall drug use fall, it has the second lowest overdose death rate in all of Europe, and HIV infections among drug users are dramatically lower, The resources formerly focused on arresting and prosecuting simple drug possession were instead poured into mental and behavioral health, education, and job training/placement programs. And if you think such a program wouldn't be possible in the US, check out what Worcester, MA is doing.
What are the common themes here?
- People are dying. That much is statistically evident.
- These deaths appear to be correlated with chronic pain, drug use, mental illness, and addiction.
- Efforts over the last three decades to deal with the issue from a criminal justice standpoint appear to be at least ineffective and at most counterproductive.
- The current supply of mental and behavioral health resources in the US is nowhere near sufficient to meet demand.
So if the demand is there, why don't we have the mental/behavioral health resources we need? Because we've never devoted the reimbursement dollars necessary, either public or private, to ensure such programs were economically viable. But now, with the Affordable Care Act's parity provisions, we have legislatively mandated reimbursement policies around mental health coverage offered by private insurers. The resources haven't yet caught up to the demand, but billions of dollars of private equity investment is being poured into the sector. Hopefully, it's just a matter of time before the number of trained professionals and the facilities and technologies they need to practice are in place.
And that leads us to an interesting thought experiment: What if we did have the mental and behavioral health infrastructure we so desperately need? Could we fundamentally change how we approach drug abuse in our society?
Michael
On Twitter @PRIUM1
Tuesday, October 27, 2015
Low Back Pain: What's the Best Medication Approach?
Wouldn't it be great if there was a study that compared patient outcomes among several groups based on a single, common diagnosis but several potential medication regimens? How might such a study be designed?
Perhaps you could identify 300 patients, all of whom presented in the emergency department of a hospital with acute low back pain. We might assess their level of disability utilizing a widely used health status measure like, say, the Roland Morris Disability Questionnaire (RMDQ). We might divide the patients into three groups based on their medication regimen:
1. Naproxen + placebo
2. Naproxen + cyclobenzaprine
3. Naproxen + oxycodone/acetaminophen
We'd make sure the initial RMDQ scores were roughly similar across all three groups. We'd also make sure all three groups were similar demographically and that each patient received education on management of low back pain prior to discharge from the hospital. Then we'd call the patients at the 1 week mark and the 3 month mark to re-assess their level of disability. That would tell us which of the three various medication regimens provides for the best patient outcomes.
Such a study would be helpful, right?
Well, researchers at Montefiore Medical Center and Albert Einstein College of Medicine conducted just such a study and the results are compelling.
It appears that "take two Aleve and get some rest" may, in fact, be the best (and certainly the safest) course of action when it comes to preventing acute LBP from becoming chronic LBP.
Michael
On Twitter @PRIUM1
Perhaps you could identify 300 patients, all of whom presented in the emergency department of a hospital with acute low back pain. We might assess their level of disability utilizing a widely used health status measure like, say, the Roland Morris Disability Questionnaire (RMDQ). We might divide the patients into three groups based on their medication regimen:
1. Naproxen + placebo
2. Naproxen + cyclobenzaprine
3. Naproxen + oxycodone/acetaminophen
We'd make sure the initial RMDQ scores were roughly similar across all three groups. We'd also make sure all three groups were similar demographically and that each patient received education on management of low back pain prior to discharge from the hospital. Then we'd call the patients at the 1 week mark and the 3 month mark to re-assess their level of disability. That would tell us which of the three various medication regimens provides for the best patient outcomes.
Such a study would be helpful, right?
Well, researchers at Montefiore Medical Center and Albert Einstein College of Medicine conducted just such a study and the results are compelling.
It appears that "take two Aleve and get some rest" may, in fact, be the best (and certainly the safest) course of action when it comes to preventing acute LBP from becoming chronic LBP.
Michael
On Twitter @PRIUM1
Tuesday, October 20, 2015
What Happens When Regulators Don't Trust Clinicians?
USA Today published an interesting point/counterpoint this week on the question of whether doctors should be forced to check a prescription drug monitoring database prior to writing a prescription for an opioid. The advocates for such an approach (me included) argue that fundamental public health concerns trump the arguments against mandatory checks, primarily that this new step in the process of clinical delivery presents privacy and convenience hurdles.
But if one examines the true concerns of clinicians that have pushed back against mandatory PDMP checks, one would find a deeper, more meaningful, more consequential issue: when it comes to prescription drug misuse and abuse, government regulators are exhibiting ever higher levels of distrust of the medical community.
Perhaps nowhere else has this been laid more plain than in Massachusetts. Governor Charlie Baker, a former physician group and health plan CEO, has proposed an aggressive set of measures to stem the opioid epidemic in his state. I'm not using the term "aggressive" lightly here...
Among several other potentially controversial provisions, the proposed bill would limit new prescriptions for opioids to 72 hours (with very limited exceptions for emergency situations). A patient in Massachusetts might go to the doctor, complain of low back pain, and receive a script for pain management. But the max a doctor would be able to write is a 3-day script. After that, the patient would need to come back to the doctor for an additional script if the continuation of the medication is deemed necessary.
As expected, the reaction of Massachusetts doctors appears to range from supportive to skeptical to deeply concerned.
I haven't decided whether or not this is a good idea. I'll be researching the approach and discussing it with others for a while before I come to any conclusions.
What strikes me is that regulatory bodies ranging from state work comp agencies (think "closed formularies") to state legislators (think "mandatory PDMP checks") to state governors (think "Charlie Baker's plan") are essentially saying: Enough of this. It's gone on too long and too many people are dying. The clinical community has had their chance. It's time for us to step in and shut this down.
Will there be unintended consequences? Yes. Will it result in the mitigation of prescription drug misuse and abuse for which we all hope? TBD.
Might the clinical community awake and recognize the necessity for them to self-correct this problem to avoid further unwelcome intrusion into clinical practice from the regulatory community?
I hope so.
Michael
On Twitter @PRIUM1
But if one examines the true concerns of clinicians that have pushed back against mandatory PDMP checks, one would find a deeper, more meaningful, more consequential issue: when it comes to prescription drug misuse and abuse, government regulators are exhibiting ever higher levels of distrust of the medical community.
Perhaps nowhere else has this been laid more plain than in Massachusetts. Governor Charlie Baker, a former physician group and health plan CEO, has proposed an aggressive set of measures to stem the opioid epidemic in his state. I'm not using the term "aggressive" lightly here...
Among several other potentially controversial provisions, the proposed bill would limit new prescriptions for opioids to 72 hours (with very limited exceptions for emergency situations). A patient in Massachusetts might go to the doctor, complain of low back pain, and receive a script for pain management. But the max a doctor would be able to write is a 3-day script. After that, the patient would need to come back to the doctor for an additional script if the continuation of the medication is deemed necessary.
As expected, the reaction of Massachusetts doctors appears to range from supportive to skeptical to deeply concerned.
I haven't decided whether or not this is a good idea. I'll be researching the approach and discussing it with others for a while before I come to any conclusions.
What strikes me is that regulatory bodies ranging from state work comp agencies (think "closed formularies") to state legislators (think "mandatory PDMP checks") to state governors (think "Charlie Baker's plan") are essentially saying: Enough of this. It's gone on too long and too many people are dying. The clinical community has had their chance. It's time for us to step in and shut this down.
Will there be unintended consequences? Yes. Will it result in the mitigation of prescription drug misuse and abuse for which we all hope? TBD.
Might the clinical community awake and recognize the necessity for them to self-correct this problem to avoid further unwelcome intrusion into clinical practice from the regulatory community?
I hope so.
Michael
On Twitter @PRIUM1
Wednesday, October 7, 2015
A Prescription for Preventing Overdose Deaths
I've been openly critical of the American Medical Association's approach to the opioid epidemic. I've labeled it "necessary, but insufficient" - meaning that the initial recommendation of the AMA's Opioid Abuse Task Force was to encourage physicians to register and use their state's prescription drug monitoring program (PDMP).
Politically safe. Glaringly obvious.
In response to that blog post, several physicians reached out to me to express their frustration with the AMA. One of PRIUM's physician consultants pointed out that AMA membership now represents a mere 15% of practicing physicians in the US. I checked that stat and she's right. AMA membership has been steadily declining since the 1950s, when nearly 75% of physicians belonged to the group. I'm beginning to understand why (though I'll admit the AMA's support for the Affordable Care Act and the rise of specialty physician associations has certainly contributed).
I did award points for the AMA's willingness to join the discussion and offer solutions. I expressed hope that this was just the start and that we would see further, more aggressive measures among the future recommendations that the task force promised it would be making.
This week, the AMA Task Force has offered the next step: "With the United States in the midst of an opioid misuse, overdose, and death epidemic [emphasis added], the AMA Task Force to Reduce Opioid Abuse strongly encourages widespread access to naloxone as well as broad Good Samaritan protections to those who aid someone experiencing an overdose."
Politically safe. Glaringly obvious.
We should all be advocating for increased access to naloxone, though I've focused my advocacy on providing the overdose antidote to first responders and care givers in high risk populations. The concept of co-prescribing and physician standing orders (every script for an opioid comes with a script for naloxone) troubles me. The AMA statement encourages doctors to ask the following questions when considering co-prescribing naloxone:
Politically safe. Glaringly obvious.
In response to that blog post, several physicians reached out to me to express their frustration with the AMA. One of PRIUM's physician consultants pointed out that AMA membership now represents a mere 15% of practicing physicians in the US. I checked that stat and she's right. AMA membership has been steadily declining since the 1950s, when nearly 75% of physicians belonged to the group. I'm beginning to understand why (though I'll admit the AMA's support for the Affordable Care Act and the rise of specialty physician associations has certainly contributed).
I did award points for the AMA's willingness to join the discussion and offer solutions. I expressed hope that this was just the start and that we would see further, more aggressive measures among the future recommendations that the task force promised it would be making.
This week, the AMA Task Force has offered the next step: "With the United States in the midst of an opioid misuse, overdose, and death epidemic [emphasis added], the AMA Task Force to Reduce Opioid Abuse strongly encourages widespread access to naloxone as well as broad Good Samaritan protections to those who aid someone experiencing an overdose."
Politically safe. Glaringly obvious.
We should all be advocating for increased access to naloxone, though I've focused my advocacy on providing the overdose antidote to first responders and care givers in high risk populations. The concept of co-prescribing and physician standing orders (every script for an opioid comes with a script for naloxone) troubles me. The AMA statement encourages doctors to ask the following questions when considering co-prescribing naloxone:
- Is my patient on a high opioid dose?
- Is my patient also on a benzodiazepine?
- Does my patient have a history of substance use disorder?
- Is there an underlying mental health condition?
- Does the patient have a co-morbid respiratory disease?
- Might my patient be in a position to help someone who is at risk of overdose?
With the exception of that last question, this should represent the list of questions doctors ask themselves to determine whether they should continue to prescribe opioids at all (vs. considering whether to prescribe another drug to counteract the potentially disastrous side effects of the current medication regimen that is so obviously dangerous, the risk of overdose appears imminent).
This latest set of necessary, helpful, but totally insufficient recommendations from the AMA helped me to recognize what I think is the fundamental issue with their approach: These recommendations are focused on how to deal with risks after the drugs are prescribed and dispensed.
So here's my challenge to the AMA: What can we do before the drugs are dispensed?
(Here's a hint: mandatory education would be a big help).
Michael
On Twitter @PRIUM1
Tuesday, October 6, 2015
The Opposite of Addiction is Not Sobriety
At the close of the blogger panel in Dana Point last week, Mark Walls asked each of the panelists what we thought needed to change in workers' compensation. There's a lot of potential material there, I know. And my co-panelists - David DePaolo, Bob Wilson, and Tom Robinson - all offered great suggestions that included more meaningful engagement with injured workers and simplifying the system with the aim of focusing on what matters most.
I took the "personal soap box" approach to answering the question. Here's what I said (actually, here's what I meant to say):
I think that we, in workers' compensation, will spend the next 10 years paying for the sins of the last 10 years. While we may have a (slightly) better handle on medication management for new injuries today, we spent the last 10 years paying for too many drugs to be given to too many patients. And, as a result, for the next 10 years, we're going to be looking straight into the abyss of addiction.
We better learn how to deal with it because ignoring it is neither a clinical nor an economic option for payers. Payers didn't write the prescriptions, but they did pay for them. Resulting cases of dependence and addiction are natural extensions of medication treatment that long ago ceased to have any chance of resolving the underlying injury, but has instead led to a life (if you can call it that) completely consumed by the need for more drugs.
I don't have a silver bullet solution to offer here. This is going to be hard and it's probably going to be expensive. But if we do it right, as an industry, we can create models for how other systems (group health, municipalities, even countries) approach the issue.
Here's a place to start:
http://www.ted.com/talks/johann_hari_everything_you_think_you_know_about_addiction_is_wrong
My colleague, Scott Yasko, sent out a TED talk on addiction that I found fascinating. Leave the political questions aside for a moment (the speaker, Johann Hari, offers some interesting thoughts on decriminalization, but don't get distracted by that...) and focus instead on the underlying psychosocial argument he's making. (I should also acknowledge that Hari has a checkered past as a journalist, but his thoughts here are well-researched and profound... and presumably his own). If you stick with it until the end, you'll hear him conclude:
"The opposite of addiction is not sobriety. The opposite of addiction is connection."
Does that make you think differently about how we might approach the issue of addiction in workers' compensation?
Michael
On Twitter @PRIUM1
I took the "personal soap box" approach to answering the question. Here's what I said (actually, here's what I meant to say):
I think that we, in workers' compensation, will spend the next 10 years paying for the sins of the last 10 years. While we may have a (slightly) better handle on medication management for new injuries today, we spent the last 10 years paying for too many drugs to be given to too many patients. And, as a result, for the next 10 years, we're going to be looking straight into the abyss of addiction.
We better learn how to deal with it because ignoring it is neither a clinical nor an economic option for payers. Payers didn't write the prescriptions, but they did pay for them. Resulting cases of dependence and addiction are natural extensions of medication treatment that long ago ceased to have any chance of resolving the underlying injury, but has instead led to a life (if you can call it that) completely consumed by the need for more drugs.
I don't have a silver bullet solution to offer here. This is going to be hard and it's probably going to be expensive. But if we do it right, as an industry, we can create models for how other systems (group health, municipalities, even countries) approach the issue.
Here's a place to start:
http://www.ted.com/talks/johann_hari_everything_you_think_you_know_about_addiction_is_wrong
My colleague, Scott Yasko, sent out a TED talk on addiction that I found fascinating. Leave the political questions aside for a moment (the speaker, Johann Hari, offers some interesting thoughts on decriminalization, but don't get distracted by that...) and focus instead on the underlying psychosocial argument he's making. (I should also acknowledge that Hari has a checkered past as a journalist, but his thoughts here are well-researched and profound... and presumably his own). If you stick with it until the end, you'll hear him conclude:
"The opposite of addiction is not sobriety. The opposite of addiction is connection."
Does that make you think differently about how we might approach the issue of addiction in workers' compensation?
Michael
On Twitter @PRIUM1
Tuesday, September 29, 2015
Safety is Just As Important After the Injury as Before the Injury
The National Safety Council is holding their annual Congress this week here in Atlanta. Tuesday is the only day this week I'm actually in Atlanta, so I thought I'd check it out.
For those of you that have attended the NWCDC in Vegas each year, the expo hall at the National Safety Council Congress is every bit as impressive. Lots of people, lots of educational sessions, lots of booths, lots of pitches. The exhibitors here in Atlanta this week represent an interesting contrast to the typical booths we see at our work comp conferences. Whereas a lot of the booths at our conferences are focused on the life of the worker after the injury, the National Safety Council appears to primarily attract companies and organizations focused on preventing the injury in the first place. There are lots of apparel companies... fire retardant clothing, dozens of different shoe/boot companies, more companies selling gloves than I could have ever imagined... as well as safety equipment... ropes, ladders, harnesses, etc. to keep workers safe.
But I couldn't help but notice what wasn't represented on the exhibit floor. The conclusion I drew from the menagerie of booths was that safety concerns apparently cease once an injury occurs. Employers and insurers are assuming, incorrectly, that once a worker is injured and enters the medical system for treatment, that injured worker's safety is assured.
That's simply not the case. And we know better.
In fact, our collective concern about injured worker safety needs to be just as focused, just as important, just as urgent as it was before the injury occurred.
The National Safety Council is leading the way on this. Dr. Don Teater and Tess Benham at the National Safety Council are working to leverage the brand and clout of their non-profit organization to help tackle the safety issues related to prescription drug misuse and abuse. They're doing research, engaging employers, writing white papers, giving speeches, and working hard to bring attention to this issue.
I challenge you to check out the NSC's work on this topic (see the link in the previous paragraph) and to see if there's a way you can help advance the good work they're doing. The NSC has been around a long time (100 years!) and they've worked on some of the biggest safety issues we've confronted as a society. You know how your claims frequency is trending down, year after year, for the last 50 years? Well, the NSC has played at least some small part in that through their work on driver safety, worker safety, fire safety, and other key areas.
Now they're tackling prescription drug misuse and abuse. That's a wake up call for all us. This is serious.
Michael
On Twitter @PRIUM1
For those of you that have attended the NWCDC in Vegas each year, the expo hall at the National Safety Council Congress is every bit as impressive. Lots of people, lots of educational sessions, lots of booths, lots of pitches. The exhibitors here in Atlanta this week represent an interesting contrast to the typical booths we see at our work comp conferences. Whereas a lot of the booths at our conferences are focused on the life of the worker after the injury, the National Safety Council appears to primarily attract companies and organizations focused on preventing the injury in the first place. There are lots of apparel companies... fire retardant clothing, dozens of different shoe/boot companies, more companies selling gloves than I could have ever imagined... as well as safety equipment... ropes, ladders, harnesses, etc. to keep workers safe.
But I couldn't help but notice what wasn't represented on the exhibit floor. The conclusion I drew from the menagerie of booths was that safety concerns apparently cease once an injury occurs. Employers and insurers are assuming, incorrectly, that once a worker is injured and enters the medical system for treatment, that injured worker's safety is assured.
That's simply not the case. And we know better.
The National Safety Council is leading the way on this. Dr. Don Teater and Tess Benham at the National Safety Council are working to leverage the brand and clout of their non-profit organization to help tackle the safety issues related to prescription drug misuse and abuse. They're doing research, engaging employers, writing white papers, giving speeches, and working hard to bring attention to this issue.
I challenge you to check out the NSC's work on this topic (see the link in the previous paragraph) and to see if there's a way you can help advance the good work they're doing. The NSC has been around a long time (100 years!) and they've worked on some of the biggest safety issues we've confronted as a society. You know how your claims frequency is trending down, year after year, for the last 50 years? Well, the NSC has played at least some small part in that through their work on driver safety, worker safety, fire safety, and other key areas.
Now they're tackling prescription drug misuse and abuse. That's a wake up call for all us. This is serious.
Michael
On Twitter @PRIUM1
Thursday, September 24, 2015
Mandatory Education for Prescribers
Massachusetts Governor Charlie Baker and the deans of state's four medical schools are teaming up to educate medical school students about misuse and abuse of opioids. Boston University, Tufts University, Harvard University, and the University of Mass. will collaborate to develop a curriculum around pain management that balances the need for pain relief with the risks of opioid addiction. As far as I can tell, this effort is the first of its kind in the nation.
A week before this announcement from Mass., Dr. Douglas Grant, registrar of the college of Physicians and Surgeons of Nova Scotia, told a Canadian audience of doctors that physicians should be subject to mandatory continuing medical education in the appropriate prescribing of opioids.
"With respect to opioids, there's been in my view a general loss of awareness, a growing casual attitude about the risks of these medications," he said. He also noted there's been a shift in expectations among patients to be not only treated for pain, but to be pain-free. "That's created a positive feedback loop which I think has led to the present rates of high prescribing," said Grant, observing that Canada now exhibits the second highest per capita usage of prescription opioids in the world.
Yeah, we're still #1 here in the U.S.
Some observations in light of these recommendations:
If we're going to make real and rapid progress in the fight against prescription drug misuse and abuse, the AMA needs to get behind mandatory prescriber education. Now.
Michael
On Twitter @PRIUM1
A week before this announcement from Mass., Dr. Douglas Grant, registrar of the college of Physicians and Surgeons of Nova Scotia, told a Canadian audience of doctors that physicians should be subject to mandatory continuing medical education in the appropriate prescribing of opioids.
"With respect to opioids, there's been in my view a general loss of awareness, a growing casual attitude about the risks of these medications," he said. He also noted there's been a shift in expectations among patients to be not only treated for pain, but to be pain-free. "That's created a positive feedback loop which I think has led to the present rates of high prescribing," said Grant, observing that Canada now exhibits the second highest per capita usage of prescription opioids in the world.
Yeah, we're still #1 here in the U.S.
Some observations in light of these recommendations:
- A Canadian study suggests that veterinarians still receive 5X the number of hours of pain management training than physicians.
- The American Medical Association (AMA) task force on opioid prescribing has been weak thus far in its recommendations.
- The voluntary educational programs available today are valuable, but they're only capturing the good docs that have a sincere desire to do this right and make the time to learn best practices.
If we're going to make real and rapid progress in the fight against prescription drug misuse and abuse, the AMA needs to get behind mandatory prescriber education. Now.
Michael
On Twitter @PRIUM1
Wednesday, September 16, 2015
CDC Opioid Guidelines: Poor Process for Public Participation
The CDC held a public comment webinar on a set of 12 proposed opioid prescribing guidelines. I bet you'd like to know what those 12 recommendations are, right? I wish I could tell you. Here's how the webinar went:
The recommendations were not (and will not be) published. Therefore, they cannot be circulated to anyone not able to join the webinar. I tried to take good notes, but I didn't catch the recommendations with precision (and it's clear CDC is aiming for precision in its language). Because I can't share them exactly as written, I'm not going to paraphrase from my notes.
But the webinar was recorded, right? Yes, it was. But "for archive purposes only." The webinar recording will not be made available to the public.
No one could ask questions. We were reminded several times that the webinar presenters couldn't answer questions. We could only make comments. To which there were, of course, no responses.
About 30 minutes in, there were technical difficulties and we had to start over.
Ugh.
If this is how the Centers for Disease Control and Prevention is going to handle the process of addressing the largest man-made epidemic in history, we're in trouble. No dialogue, no exchange of ideas, no questions. This webinar was about "checking a box" so CDC could say they solicited public comment - this was NOT about actually getting valuable feedback.
A few observations I did make on the recommendations:
The recommendations were not (and will not be) published. Therefore, they cannot be circulated to anyone not able to join the webinar. I tried to take good notes, but I didn't catch the recommendations with precision (and it's clear CDC is aiming for precision in its language). Because I can't share them exactly as written, I'm not going to paraphrase from my notes.
But the webinar was recorded, right? Yes, it was. But "for archive purposes only." The webinar recording will not be made available to the public.
No one could ask questions. We were reminded several times that the webinar presenters couldn't answer questions. We could only make comments. To which there were, of course, no responses.
About 30 minutes in, there were technical difficulties and we had to start over.
Ugh.
If this is how the Centers for Disease Control and Prevention is going to handle the process of addressing the largest man-made epidemic in history, we're in trouble. No dialogue, no exchange of ideas, no questions. This webinar was about "checking a box" so CDC could say they solicited public comment - this was NOT about actually getting valuable feedback.
A few observations I did make on the recommendations:
- It's not clear whether these recommendations are useful for those patients already on chronic opioid therapy.
- There's no explicit discussion about informed consent or pain management agreements.
- CDC is suggesting "additional precautions" should be taken above 50 mg MED and dosages above 90 mg MED should be avoided. What are those "additional precautions"? They don't say.
- CDC appears to be suggesting naloxone should be considered for any long term opioid patient. This is going to be expensive.
- There's no discussion of weaning or tapering opioid (or polypharmacy) regimens.
- These guidelines are pointed in the right direction, but CDC's attempt at specificity has actually led to ambiguity. Nearly every recommendation leaves several, critical open questions.
- This process is moving fast: CDC plans to submit these recommendations to HHS in early November and will be published in January.
Here's my one comment:
Dear CDC:
Make these recommendations publicly available, in written form, so doctors, patients, and other stakeholders can study them and offer you informed comment.
Michael
On Twitter @PRIUM1
Monday, September 14, 2015
The Rule of Law: Laws Require Rules
Remember these two from when you were a kid?
So it looks like California is putting the concept of a drug formulary into law (thanks, in no small part, to PRIUM's own Mark Pew and host of others that stayed close to the process, educated the stakeholders, answered a multitude of questions, and made the case clear that formularies are in the best interest of injured worker safety). Assembly Bill 1124 passed through the California state legislature late on Friday night and will likely be signed by the governor sometime in the next few weeks.
Then what?
Then the hard work starts. Where the charming childhood educational video ends, the real work of governing and public policy begins. Most (though admittedly not all) laws are conceptual in nature. AB 1124 is a good example. The law instructs "the Administrative Director of the Department of Workers' Compensation to create an evidence-based drug formulary, with the maximum transparency possible, for use in the workers' compensation system..." There are some other instructions and caveats in the bill, but this sums it up.
Perhaps you're wondering about that phrase "with the maximum transparency possible." That language is a reminder to the DWC that the real work of creating regulatory infrastructure around the drug formulary needs to be an open, transparent process so that stakeholders throughout the system not only understand what's going to happen, but also have an opportunity to influence the ultimate outcome.
Some key questions that the rule-making process needs to address:
Watching the video brings back fond memories... and highlights some pretty significant gaps in the process, as well.
So it looks like California is putting the concept of a drug formulary into law (thanks, in no small part, to PRIUM's own Mark Pew and host of others that stayed close to the process, educated the stakeholders, answered a multitude of questions, and made the case clear that formularies are in the best interest of injured worker safety). Assembly Bill 1124 passed through the California state legislature late on Friday night and will likely be signed by the governor sometime in the next few weeks.
Then what?
Then the hard work starts. Where the charming childhood educational video ends, the real work of governing and public policy begins. Most (though admittedly not all) laws are conceptual in nature. AB 1124 is a good example. The law instructs "the Administrative Director of the Department of Workers' Compensation to create an evidence-based drug formulary, with the maximum transparency possible, for use in the workers' compensation system..." There are some other instructions and caveats in the bill, but this sums it up.
Perhaps you're wondering about that phrase "with the maximum transparency possible." That language is a reminder to the DWC that the real work of creating regulatory infrastructure around the drug formulary needs to be an open, transparent process so that stakeholders throughout the system not only understand what's going to happen, but also have an opportunity to influence the ultimate outcome.
Some key questions that the rule-making process needs to address:
- What guidelines will we use? In other words, what will be the "source" for determining inclusion / exclusion for specific drugs?
- How will the formulary leverage (or not) the existing utilization review and dispute resolution processes in California?
- How will we deal with the concepts of dependence and addiction for long term, but medically inappropriate, opioid use?
- How will the formulary balance the concepts of "authorization" and "access"?
- How will we measure the success or failure of the formulary?
California needs a formulary. The DWC now has a legislative mandate to create one. Now we have to decide what it will look like and how it will work.
Michael
On Twitter @PRIUM1
Wednesday, September 9, 2015
Effective Chronic Pain Treatment: An Overview
[Part 2 of 2 from PRIUM's Medical Director, Dr. Pamella Thomas]
Divergent Treatments for Chronic Pain
Assessment
Choosing between Coordinated Interdisciplinary Care and a Functional
Restoration Program
Evidence for Coordinated Care
Conclusions
Divergent Treatments for Chronic Pain
As I described in the previous post, chronic pain initially
begins, appropriately, as acute pain – a biological event in response to
noxious stimuli. However, as time
progresses, social, psychological, and cultural factors impede and complicate
recovery. These psychosocial factors
become complicit in exacerbating the pain and disrupting pain management.
Unless underlying triggers are recognized and addressed
early on, the treating clinician is left to treat the symptomology of the
patients’ pain, often with repeated surgeries and ever escalating doses of
narcotic analgesics. Such treatments may
not be addressing the real pain generators.
More often than we’d like, surgeries are treating MRI results. As many as 30% of these diagnostic screenings
are potentially inaccurate. MRIs may return false positives that hint at
physiological incongruences that are only potentially associated with the
patient’s pain pathology. Often the
patient’s medical file tells a treatment story of narcotic analgesics in large
doses for multiple years. The present
reality is that the patient is now both physically and emotionally dependent on
these medications.
The question then is what to do with injured workers with
complicating psychosocial factors which can range from adverse childhood events
(ACE) to more recent post-traumatic stress disorder (PTSD). Selected treatments should account for a
patient’s psychosocial and behavioral complications. As an industry we are faced with a myriad of
options and limited guidance as to how best to choose between them. However, the focus should be on providing
carefully selected interdisciplinary care and referring the injured worker for
modalities that can simultaneously address a patient’s pain while building
endurance and addressing the psychosocial drivers of chronic pain.
Assessment
The probable starting point is to identify the goal of
treatment and the disposition of the patient.
It may not be possible to return the injured worker to a pre-injury
state, but treatment should be geared towards restoring the patient to maximum
medical improvement. The goal of this treatment should be to facilitate the
worker’s return to some form of employment - even if that is at a restricted
duty level.
For patients with
longstanding chronic pain Motivational Interviewing (MI) is commonly a good
starting point to assess the patient. It
is a patient-centered treatment modality meant to engage the patient and assess
ambivalence and anxiety. This also
provides a screening opportunity.
You may find that understanding an injured worker’s chronic
back pain, ongoing for 10 or more years, may be attributed to nothing more than
age progression degenerative changes. The spine begins to lose its water
content in the early 30’s which increases the risk of bulges, herniations, and
even annular tears. These degenerative
changes impact almost everyone, even without symptoms. Studies show disc degeneration in about 37%
of all asymptomatic 20 years-olds, 80% of asymptomatic 50 year-olds, and 96% of
all asymptomatic 80 year-olds.
Or you may also find as part of an initial screening of the
patient, a history of a more traumatic event.
Significant diagnoses such as PTSD can occur in instances such as rape,
traumatic brain injury, gun point robbery, severe motor vehicle accidents,
veterans returning from combat, or employees witnessing a shooting incident or
murder. These individuals need to be
referred to a specialist who can provide the necessary interventions
recommended by the American Psychological Association issued in their “A” list
included in the published 2008 guidelines.
Frequently you will find the injured worker’s status can be
improved through referral to multiple modalities addressing pain, function, and
comorbid conditions as well as addressing smoking and weight issues.
Choosing between Coordinated Interdisciplinary Care and a Functional
Restoration Program
Without engagement, a patient chronically treated with
narcotic analgesics, now likely dependent, will be resistant to change and
unlikely to achieve any progress of either their pain or function. It is
critical however that the delivery of care be improved. Common options
include referring the patient to a Functional Restoration Program (FRP) or by
coordinating analogous care by referring to multiple modalities in an
integrated system, inclusive of motivational counseling such as cognitive
behavioral therapy (CBT).
Functional Restoration Programs
A FRP is a rehabilitation program aimed at increasing
physical functioning, improving pain-coping skills, and returning the patient
to a productive lifestyle at home and at work.
These treatment programs will be inclusive of multiple provider types,
commonly including physical therapists, addictionologists, psychiatrists and/or
psychologists, orthopedists and others.
These programs excel at providing coordinated care through treatment
teams that jointly assess and construct treatment plans weaving multiple
modalities together.
However, FRP programs cost anywhere from about $40,000 on
the low-side to upwards of $90,000 on the higher end. Unfortunately, due to their size and volume,
a number of these programs do not have peer reviewed, published, prospective,
randomized controlled studies to support their published claims of
outcomes. While there are fantastic
programs available, they come at significant cost and with refutable evidence
of their program's ability to produce improved functionality, pain control,
medication management, or return to work.
When considering the incredible cost of these programs, it
is important to also account for patients who are poor candidates for such a
program. Patients who are retired, or
who will never return to work in any function, would not be good candidates for
referral. Additionally patients with
comorbidities that would prevent full participation in all the modalities of an
FRP (e.g., suicidal ideations, unstable heart conditions, uncontrolled
hypertension, asthmatics, exertional dyspnea etc.) would not be good
candidates. Other poor candidates
include patients who have previously failed CARF accredited programs, have
unrealistic expectations of treatment such as immediate cure, or patients who
are depressed or not motivated to fully participate. Those who are already dependent on narcotics
with existing neurobiological changes may not recover as expected.
There is no advantage for the payer, physician, patient or
anyone else to refer a patient for therapy that will not provide efficacy for
that individual patient.
Cognitive Behavioral Therapy
Depending on diagnosis, CBT when used in
conjunction with other treatment modalities (such as needed physician consults
by orthopedist, psychiatrist, psychologists etc.) biofeedback, physical therapy
(PT), aqua PT, or other PT modalities such as Alexander or McKenzie’s protocol
which may help to centralize or relocate the pain, can restore patients to
function in a shorter time than putting them through all the sessions of the
FRP. It can often be even more
beneficial as FRP programs often require the patients be housed near the campus
which silos the patient away from their family and support systems.
Utilizing this integrated coordinated
outpatient delivery of care, the patient can also be taught protocols to be
done at home after they are mastered in the facility ,allowing the injured
worker better continuity of care.
Including a dietitian can also help the patient by reconstructing their
diet around anti-inflammatory foods, limiting sugars, fats, sodium intake and
introducing more plant-based fibrous foods into their diets. This has the added advantage of addressing
other elevated medical risk-associated with raised BMI levels.
All of this can be provided for the
patient while keeping them at or close to home at a much lower cost to the
payer.
Evidence for Coordinated Care
When coordinate care delivery programs are utilized in a
hospital facility, various specialty providers have weekly group strategy
meetings focused on each patient's needs.
The team sets treatment goals for each patient and each team member then
coordinates their intervention to achieve the team goal.
Other team members like an addiction specialists,
nutritionists and a vocational rehabilitation provider, can also be brought in
as needed, to help address patient detox, weaning, medication management, and
return to work. This often includes the
assistance of a psychotherapist with associated lifestyle goals such as weight
reduction and return to work with necessary modifications. In this setting a PM&R specialist
sometimes act as the team coordinator.
In 2007 G. Roche et al., published a comparison of an FRP
intervention and an active individual therapy (AIT) intervention post five-week
study period(1). The included a study
groups included the FRP program utilized
fort 25 hrs/wk, versus active individual physical therapy group utilizing 3
hrs/wk for patients with chronic low back pain.
The objective of this randomized controlled trial was to compare short
term outcomes of each intervention.
The study was conducted within two Rehab Centers and private
ambulatory PT facilities. There were a number of outcome measures including
flexibility and endurance, daily activities, reports of work ability,
resumption of sports and leisure activities. The results showed all outcome measures improved except the
endurance in the active individual PT group. There was inter- group difference
in pain intensity or Dallas Pain Score, daily activities or work and leisure
activity scores. However, better results were observed in FRP for the other
outcome measures.
Low cost ambulatory AIT is effective. The main advantage of
FRP is improved endurance. They speculated that this may be linked to better
self-reported work ability and more frequent resumption of sports and leisure
activities. Personally, I would think
being at a facility 25 hours per week as opposed to 3 hours would lend itself
to more availability of other aerobic sport and leisure activities to build
endurance, this can be done just as well in a community gym etc.
Conclusions
Treatment of chronic pain starts with careful assessment of
the patient. This in turn relies
strongly on an engaged treating physician and solid patient-physician
relationship. When coordinating the
delivery of interventional care it is critical that the right care be selected
to achieve the greatest impact for the patient with the least wasted
expense. Not all care is equally
effective, and not all patients of similar diagnoses will be similarly impacted
by identical care. Leading with a
motivational assessment is a good place to start when choosing between care
delivery models. While integrated and
collaborative care delivery as is provided in hospital settings and intended to
be provided by FRPs is the gold standard when it comes to chronic pain
interventions, finding such a program close to a patient's home, with the
necessary modalities, with objective outcomes, and at an acceptable cost is
often an impossible task. In many cases
these hindrances to care outweigh the benefits that may be obtained. Analogous, low cost care can be provided
through carefully integrated and coordination for each injured worker with
multiple modalities.
Dr. Thomas
1. Roche G,
Ponthieux A, Parot-Shinkel E, et al. Comparison of a functional restoration
program with active individual physical therapy for patients with chronic low
back pain: a randomized controlled trial. Arch Phys Med Rehabil.
2007;88(10):1229-1235. doi:10.1016/j.apmr.2007.07.014.
Tuesday, September 8, 2015
California's Formulary: An Update from the Field
[Mark Pew, Senior Vice President of PRIUM, has been following, working, talking, meeting, eating, sleeping, and breathing California formulary for months - actually, years. Mark's latest update below.]
The language has been approved (published late on Sep 4) for a bill to establish a Work Comp drug formulary in California - I will let you read it for yourself rather than restating it's contents here. AB 1124 should have its third reading on Sep 8, a vote on either Sep 9 or Sep 10, and with enough AYE votes Governor Brown will sign it into law shortly thereafter. I certainly don’t want to jinx it by unequivocally stating that a drug formulary will be implemented in California by July 1, 2017, but that possibility is as promising as it has ever been.
But … It hasn’t been easy. And I and others at PRIUM have had a front row seat to the entire process:
- In November 2009, we started following the development of the Texas drug formulary, staying engaged through the 9/1/11 and 9/1/13 implementations.
- On November 8, 2012 at the National Work Comp & Disability Conference in Las Vegas, I presented an overview of the Texas drug formulary and opined that California was a logical candidate to consider something similar.
- In December 2013, I had my first meeting with California’s Department of Workers’ Compensation (DWC) to present the concept of a drug formulary.
- In January 2014, I had my first meeting with leaders in the Assembly, Senate and Labor to discuss the concept of a drug formulary.
- In October 2014, the first major milestone in California’s discussion of a drug formulary came after the California Work Comp Institute (CWCI) published a whitepaper “Are Formularies a Viable Solution to Controlling Prescription Drug Utilization and Cost in California WC” with a tentative answer of “yes”.
- On March 5, 2015, the second major milestone occurred when Assemblyman Henry Perea (D-Fresno) introduced AB 1124 to direct the DWC’s Administrative Director to adopt a formulary (read about it in thisWorkCompCentral article that requires subscription.
Since that date, the process of filling in the details has been a consuming priority for me and many others involved in Work Comp in California. There have been many formal and informal meetings involving almost every stakeholder and constituent. There was a public hearing in the Assembly and then in the Senate, both interesting in their content and participants, from praise to guarded optimism to limited opposition. An advisory committee has been working directly with Assemblyman Perea’s office in July and August to develop the content of the bill. It has been an adventure in spirited dialogue and compromise in a decidedly non-antagonistic environment (though one not totally devoid of disagreement). The committee was comprised of representatives from every possible corner of Work Comp in California, and while the final version of the bill does not reflect all of the suggestions, the dialogue has been extremely helpful in establishing what will need to be addressed in the rule-making process. In collaboration with the DWC, the focus has been on crafting a bill to become law that mandates action but provides flexibility.
The third major milestone? July 23, 2015 at the CCWC conference in Anaheim where David Lanier (Secretary of the Labor and Workforce Development Agency) stated “Based on the work to date and the urgent need I have instructed Christine [Baker, Director of the Division of Industrial Relations] to move forward with creating a formulary as expeditiously as possible". This strategic statement sent an unmistakable message that a formulary was going to happen. Period. I still recall seeing people in the audience turning their heads and whispering to each other “did I just hear that right?” while I was writing notes to myself with exclamation marks.
And it got done (well, almost done). Think about it – from March 5, 2015 until now, all constituents in the California Work Comp system have basically agreed that a drug formulary is needed. In California! In less than six months! Amazing!
Of course, there is much work still to be done. And likely the hardest work to be done. Deciding on the concept of a drug formulary and some general parameters is one thing – crafting the actual rules and process to initiate intended consequences and mitigate unintended consequences are yet another. My July 2015 article on Claims Management magazine, "A Formulary for Success", will provide some insights into guiding principles that should be taken into account.
The first step to that is September 8, 2015 from 10:00am till Noon when a public hearing will be held to establish the goals of the DWC and listen to feedback from all interested parties. This meeting will just be the start of a long journey, and I will continue to be a technical adviser as the rules are developed. Unfortunately, I will not be able to attend as I had previously committed to speak at a North Bay Work Comp Association event in Santa Rosa, but if you’re interested go to the Elihu Harris State Office Building (Room 2, Second Floor, 1515 Clay Street, Oakland, CA 94612) on Tuesday.
The stated goals of the DWC are:
- Improve appropriate care through the dispensing of evidenced-based medicine
- Expedite pharmaceutical treatment for ill and injured workers
- Reduce delays, including reducing the need for elevated utilization review and independent medical review
- Improve efficient delivery of medical benefits and reduce administrative costs
Those are the lofty goals that have driven this entire process since the beginning, and one reason why consensus through compromise has been achieved so quickly.
The common theme I’ve heard throughout this process has been to ensure injured workers receive appropriate treatment with a renewed focus to limit the damage prescription drugs with very dangerous and even life-threatening effects can wreak. Part of that is to ensure those who have become reliant / dependent upon / addicted to dangerous polypharmacy regimens are not suddenly thrust into withdrawal but allowed to thoughtfully and carefully be tapered to a more appropriate drug regimen while being equipped with more robust coping skills to deal with the pain that remains.
In other words, whether it’s Labor or applicant attorneys or defense attorneys or physician groups or carriers or self-insured employers or legislators or PBM's or any other interested party, the focus has been squarely on combating the epidemic of over/misuse of prescription drugs and creating a path to less dangerous and more efficacious pain management for those that need it. And who can argue with that? Apparently, nobody.
Because there have been so many people integral to this process, I won’t even try to name them all. So, instead, I will just say “Kudos Cali”!
Mark
On Twitter @RxProfessor
Subscribe to:
Posts (Atom)