Economic Insecurity and Chronic Pain

Earlier this year, the estimable industry consultant Peter Rousmaniere published a report entitled The Uncompensated Worker: Financial Impact of Work Comp on Households.  In the report, Peter summarizes the realistic impact that workers compensation has on families: "The scenarios [explored in the report] show that a brief work disability often results in a sharp cut in take-home pay, after the deductibles are applied. An extended disability lasting for months can cause many injured workers to struggle to meet their household expenses, forcing these employees to dig into their savings and risk losing their financial cushion."

And in an article last week published on Insurance Business America, Mark Walls, Vice President of Communications and Strategic Analysis at Safety National, noted the economic anachronism that is our current work comp system.  "Today, there are lots of skilled craftspeople who earn more than that [an indemnity cap of $1,100/week].  For anyone who earns a good living, going on workers comp can be a devastating blow, when it should not be."

While the world certainly affords no law to make an injured worker rich, our current system doesn't even appear to allow some injured workers to avoid poverty.  These two pieces came to mind when I saw this headline recently in the Harvard Business Review: The Link Between Income Inequality and Physical Pain.  Researchers from UVA and Columbia hypothesized that there might be a link between fiscal pain and physical pain.

First, they looked at the consumption patters of over-the-counter painkillers among 33,000 US households.  Compared to households in which at least one head of household was employed, those in which both were unemployed exhibited 20% higher spend on OTC painkillers.  Next, researchers asked people how much physical pain they were currently experiencing, but did so after informing the respondent of the unemployment rate in his or her state.  Employment status again proved to be a predictor of physical pain levels and, interestingly, simply living in a state with a high unemployment rate appears to lead to higher reports of physical pain.  They also did a fun experiment involving undergraduates and buckets of ice water, but you can read the article see how that went.

The researchers sum up their findings across studies as follows: "When people encounter economic insecurity, they typically feel a lost of control.  A sense of control is one of the foundational elements of well-being.  When people lose their sense of control, their body goes a bit haywire and responds to stimuli differently - displaying a weakened resilience and a lower pain threshold."

So here's an existential question for you this Monday morning: Might the very system we've devised to address pain resulting from workplace injury actually induce pain instead?  

Michael
On Twitter @PRIUM1

President Obama at the National Rx Drug and Heroin Abuse Summit

Imagine getting the chance to hear the President speak in person.
Now imagine he comes to your home town to offer some thoughts on a given topic.
Finally, imagine the topic of his remarks is the very center of your professional life and something you eat, sleep, and breathe every day.

That was my day today.

As my legendary 12th grade English teacher Ross Friedman would say: today was a 9.9 on the groovy scale (note: there are no 10s... so this was clearly a really great day).

President Obama came to Atlanta today to talk about prescription drug and heroin abuse.  Rather than give a speech from a prepared text, he sat on a panel moderated by CNN's Dr. Sanjay Gupta along with two recovering addicts and an emergency room doctor who also serves as Baltimore City's Health Commissioner, Dr. Leana Wen (who, by the way, proved to be an incredible advocate for changing the way we view chronic pain and addiction... she issued a standing order in Baltimore so that any citizen in the city can secure a Naloxone prescription - an overdose antidote - under her name.  Just walk into any pharmacy in Baltimore and pick it up.  Beat that with a stick).

This format enabled President Obama to speak extemporaneously and candidly on a range of topics under the umbrella of prescription drug and heroin abuse.  He talked about the Affordable Care Act, mental and behavioral health, criminal justice reform, patient and physician education, addiction prevention, treatment, and recovery.  While I'm not supposed to betray my personal politics on the blog (at least according to my PR advisers), most people who know me know that I'm a fan of the president.  Despite my admitted admiration for Obama, I expected today to be filled with presidential sounding platitudes like "we need more addiction treatment in this country" and other relatively obvious and safe statements.  And he said most of the things I expected him to say along those lines.

But he said more than that.  My impression is that President Obama understands both the policy nuance and personal tragedy of this issue at a level I honestly didn't expect.  This is a guy fighting multiple battles against an array of terrorist organizations, he's steeped in a Supreme Court nomination fight, he's trying to figure out how and where to weigh in on the circus that has become the 2016 presidential election, and he's dealing with a hundred other issues on a daily basis.  But he came to Atlanta today to talk about prescription drug and heroin abuse.  And amidst all of the other issues on his desk, it's evident that he gets this.  And it shows.

When asked by Sanjay Gupta what brought him to Atlanta this afternoon, President Obama offered this: "When I show up, the cameras usually do, too."  He wasn't being arrogant.  He was suggesting that his mere presence, regardless of what he said, helps bring needed attention to this critical issue.  He was saying that he consciously chose to use the power of his office to shine a light on prescription drug and heroin abuse.  And he's right - there certainly were a lot of cameras there today.

He said "we need to think about this [drug abuse issue] as a public health problem, not a criminal justice problem."  Many of us close to this issue agree with that statement, but when the President of the United States says it out loud, it reshapes the broader public dialogue and helps further the aims of those of us who have been thinking that way for years.  Such a public statement will help reshuffle the priorities of agencies like the FBI, DEA, ATF, CDC, and NIH.

He said he was "shocked to learn how little education medical residents receive in pain management."  And as a result, 60 medical schools announced today their intention to significantly enhance pain management training in medical school residency programs.  The bully pulpit is real.

Finally, he said "we medicate... self-medicate... a lot of problems in this country."  I was floored when he said that.  We know that's true, he knows that's true, but for the president to say it out loud is to acknowledge the fundamental need for cultural change necessary to truly stem the tide of prescription drug and heroin abuse.  Perhaps the most deeply rooted of all the root cause issues behind prescription drug abuse is the notion that Americans expect to be pain free, stress free, anxiety free.  Opioids aren't ragingly popular simply because they help manage pain.  Opioids also have psychoactive attributes that make the slings and arrows of our difficult and complicated lives seem easier to handle.  And President Obama said it.  And that matters.

Today was a great day for me, personally and professionally.  I think today might also turn out to be a great day in the broader fight against prescription drug misuse and abuse.  And that's a great day for all of us.

Michael
On Twitter @PRIUM1

The Patient Should Not Be Punished for the Sins of the Prescriber

Dr. Mitchell Katz of the Los Angeles County Health Department wrote an editorial that was published in last week's issue of the Journal of the American Medical Association (JAMA has made this set of editorials on opioid prescribing available free of charge).  The title caught my eye - Opioid Prescribing for Chronic Pain, Not for the Faint of Heart.  Indeed.

His intent is to offer a realistic appraisal of the new CDC opioid guidelines.  The tone of the editorial is best described as "great guidelines... but here's how the world really works."  While the pharmaceutical industry appears to have sheathed their swords for lack of argument, the physician community now has to figure out what to do with these new guidelines (if anything at all). Dr. Katz is supportive of the guidelines, but offers his view of their application through a lens of honest practicality.

A few key excerpts (emphasis added):

Even when seeing a patient who has not already begun taking opioids, we physicians have few alternatives for patients who have already tried nonsteroidal anti-inflammatory medications and acetaminophen without relief. Of the pharmacologic and nonpharmacologic options, none is likely to provide rapid pain relief, and none is very effective. Moreover, many of us work in resource-poor systems where arranging for someone to receive physical therapy or cognitive behavioral therapy—two useful therapies—is more difficult than weaning someone from long-term opioid use. To all patients, I give my well-rehearsed speech on why I believe opioids cause more harm than good for chronic pain, but ultimately I will prescribe them for a patient in pain for whom I see no other realistic option.

Embedded in this paragraph are two brutal facts that we must confront: 1) access to non-pharmacological modalities is not easy and cannot be assumed; 2) sometimes, even good doctors are faced with a choice between the lesser of two evils.  I would add that work comp payers should focus on alleviating issue #1 (by approving alternative modalities, going the extra mile to find practitioners, placing alternative non-pharm modalities in-network, etc.) in an attempt to relieve prescribers of burden #2.

Another cogent point from Dr. Katz:

One thing I am certain of: we need to engage patients in an honest and open way rather than quickly writing or refusing to write opioid prescriptions. Given that many patients may be defensive about using opioids, I always speak of my fears. I do not say “You are going through the pills too quickly.” Rather, I say “I am worried that at the doses of medication you are taking, the medicine will harm you.”

Language matters.  This is a subtle but critical point in the fight against opioid misuse and abuse: patient engagement isn't as complicated as we sometimes make it out to be.  Clinicians that are willing to have difficult conversations and who are willing to be honest and transparent with their patients will have more success treating pain than clinicians who find themselves, in Dr. Katz's words, "quickly writing or refusing to write opioid prescriptions."  

Finally, in the context of the complicated matter of opioids and benzodiazepines (you'll have to read his editorial for his full view on the matter), Dr. Katz offers this piece of advice: The patient should not be punished for the sins of the prescriber.  

That should serve as a guiding principle to all of us engaged in this fight.  Above all else, we need to focus on the health, safety, and functionality of injured workers.

Michael
On Twitter @PRIUM1

What the New CDC Opioid Guidelines Will Mean to Work Comp

Not much, I fear.  Allow me to explain...

What the CDC has done here is critically important to addressing the public health crisis that is opioid misuse and abuse.  While the CDC's process came under scrutiny (from, among others, me), the resulting guidelines are evidence-based, well-written, and carry the imprimatur of the preeminent public health agency in this country.  That's groundbreaking.  But I'm not sure we're going to see a significant impact in workers' compensation for three reasons.

Before we dive in, here's a link to the guidelines.
Here's a link to Dr. Tom Frieden's (CDC Director) letter regarding the guidelines in NEJM.
And here's perhaps the most practically valuable thing the CDC published earlier this week - a checklist for primary care physicians who prescribe opioids (this is excellent).

Reason #1 we're unlikely to see a significant impact in work comp: It takes a long time for new medical evidence to penetrate actual physician practice.  The guidelines have received a lot of press coverage over the last few days, but busy primary care physicians may not be immediately responsive to new medical evidence even if they see it on the front page of the local newspaper. First, not all physicians have the same faith in an agency of the federal government that I possess.  In fact, for some, the notion that the federal government published these guidelines may be the primary source of skepticism.  Second, there will armies of pharma reps to gently, diplomatically, but firmly push back, find holes, work arounds, etc. to increase the likelihood that current prescribing practices remain intact.  Third, there are obviously no enforcement mechanisms in connection with these guidelines.  A primary care doc who chooses not to follow them will face no immediate consequences (though, we should be clear, the long term consequences to the patients of such a doctor could be catastrophic).

Reason #2: Our primary cost drivers in work comp are long term, chronic pain cases.  The new guidelines offer precious little guidance for these types of cases.  Most of the guidelines focus on opioid initiation and to the extent chronic opioid therapy is addressed, the guidelines suggest avoiding it.  Well... what if we have an injured worker who has been on opioids for that past 10 years?  Whose dose has escalated regularly and dangerously over that period?  The guidelines suggest those opioids should be weaned.  Right.  Telling a primary care doc to simply wean a patient off of opioids in the midst of a long term, complicated, polypharmacy drug regimen is perhaps expecting too much.  I would have liked to have seen more detailed guidance on how to deal with such complex patients.  So why didn't the CDC go there?  Because it's really complicated, that's why.

Reason #3: Primary care docs, by and large, didn't create most of our pain management issues in work comp.  Granted, I'm dealing with a very skewed subset of cases here at PRIUM.  I recognize we suffer from adverse selection, so this might not be accurate for the entirety of the work comp universe.  But what we see is that surgeons and pain management specialists tend to initiate complex pain management drug regimens (after the profitable procedural work is done) and then, in perhaps the most unkindest cut of all, the patient is discharged back to the primary care doc... who is now overwhelmed by a monster of a drug regimen that he did not create.  Yes, primary care docs write almost 10 times more opioid scripts per year (28 million) than pain management and interventional pain management doctors combined (3 million), but will these new guidelines - aimed at primary care docs - help them much if they're not the ones making the initial prescribing decision?

I'm thrilled the CDC published these guidelines.  I think they represent useful, cogent, and practical thinking.  And I hope I'm wrong that we won't see a material impact in work comp.

Michael
On Twitter @PRIUM1 (just click the link to follow!)

States Take On Painkillers

Despite efforts at the federal level (CDC guidelines - such as they are, the Obama administration committing $1 billion to fight drug abuse, etc.), the real public policy movement on prescription drug and heroin abuse is happening at the state level.  And it's happening fast.

This morning, Massachusetts Governor Charlie Baker signed into law new restrictions on opioid prescriptions in his state.  Perhaps most notably, new opioid prescriptions are not to exceed a 7 day supply.  This is groundbreaking legislation and could lead to similar bills throughout the country. Yes, there are carve outs for cancer patients and chronic pain patients, but these are reasonable caveats necessary to maintain access to care.  Whether or not opioids are medically necessary for most chronic pain patients (they're not) is a separate discussion.  This law will help prevent dependence and addiction in new patients.  We still have a lot of work to do with the existing chronic pain population.  One more tidbit - there's no exception for work comp.  I've scoured the 42 pages of the bill and injured workers will be subject to the same protocol as everyone else.  

From today's New York Times, a recap of state-level efforts to curb painkiller and heroin abuse (highlighting the above mentioned efforts in Massachusetts).  Did you know that there are 375 proposals moving through state legislatures nationwide regarding prescription painkillers, pain clinics, and other aspects of treatment?  That's a dizzying pace of regulation.  The fault, our governors have decided, will not fall to the underlings of the federal bureaucracy - they're going to do something about this.  Now.  Governor Pete Shumlin of Vermont, who devoted the entirety of his 2014 State of the State speech to this topic, summed it up best: "The states are going to lead on this because Big Pharma has too much power."  I'd add that state medical associations have a lot of power, too, but they've come to the table across the country.  In Massachusetts, the president of the state's medical society put in plainly: "Usually we are opposed to carving anything in stone that has to do with medical practice.  But we are willing to go forward with this limitation [the 7 day supply restriction] because we recognize this is a unique public health crisis."  

The Times also has a piece today covering direct-to-consumer (DTC) advertising for pharmaceutical products, a practice that the American Medical Association has advocated be banned.  The research suggests that there may be benefits to DTC advertising.  Yes, utilization of advertised drugs goes up.  But so does utilization of competitive drugs in the same class. The article seems to think this is good news - conditions historically stigmatized (like depression) are being treated more frequently because DTC advertising is prompting doctor-patient conversations that might not have taken place otherwise.  I acknowledge this is a good thing, but can we not come up with a better way to remove stigma and treat mental health conditions than spending hundreds of millions of dollars on TV ads?  Finally, there appears to be an uptick in patient medication compliance as a result of DTC advertising (you see the ad, you're reminded to take the pill that's already been prescribed to you).  That's great, but again... can we not come up with better approaches to patient medication compliance?  I still think the risks and costs of DTC advertising outweigh the benefits.

Lots going on.  I sense progress.

Michael
On Twitter @PRIUM1

Nurse by Day, Officer by Night: One of Our Industry's Greats

We've recently heard a lot about getting back to basics in work comp, celebrating the things we do right, fixing the things we do wrong, advocating for injured workers, and rewarding individuals who make great contributions.  I think this is a great idea.  And I'd like to make a contribution to this industry-wide conversation...

...by utterly embarrassing a trusted colleague (who, after she reads this, may never speak to me again).  

We like to think of ourselves here at PRIUM as "fighting the good fight" against the scourge of opioid misuse and abuse, the fundamental public health problem of chronic pain management, and the potentially overwhelming clinical and financial consequences of complex work comp claims. Most of us come to work each day prepared for battle - passionate about what we do, but also acutely aware of past battles won and lost.  Good days find us celebrating wins: better health, safety, and functionality for injured workers.  Bad days find us coping with the death of an injured worker whose medication regimen wasn't changed quickly enough.  Sometimes we just don't have enough time.

But after good days and bad days, all of us go home, detach, unplug, do something else to help us prepare for the next day's battles.

All of us, that is, except for one.

Linda Breads is PRIUM's Director of Medication Oversight Services.  She's a nurse by training and experience and she leads a group of dedicated professionals here at PRIUM in following up, coordinating, and creating accountability on necessary medication changes for injured workers.  She's extraordinarily good at what she does here at PRIUM.  But that's just the start of her day...

When Linda leaves work, she doesn't detach.  She serves our local community as a standby paramedic at local youth sports events.  I took my kids to a high school football game last year and had the pleasure of running into Linda, ready and waiting on the sideline in case an injured player needed medical attention.

But perhaps her greatest contribution to our community is the role she plays in helping keeping all of us safe.  Since 2005, Linda has served as a Citizens Auxiliary Police Service (CAPS) Officer with the Alpharetta, GA police department.  And she's done more than just volunteer.  Linda has three times been awarded CAPS "Officer of the Quarter"; in 2009, she was awarded CAPS "Officer of the Year"; and in 2014, she was awarded "Police Safety Volunteer of the Year." (None of which, by the way, she's ever mentioned to me.  I had to send spies to find out about all of this).

In the course of her work as a CAPS officer, Linda routinely confronts the brutal reality of prescription drug and heroin abuse.  She lives it here at PRIUM... and she lives it in her role as community volunteer.  Up close and personal, for the entire live-long day.  Two weeks ago, I wrote about the heroin epidemic here in my local community.  As I wrote that post, it occurred to me that while I might research, write, and talk about the issue, Linda leaves a full day of hard work here at PRIUM and goes out into our community to actually do something about it.  

And I think that's awesome.  Linda spends her free time trying to do exactly what she does during her professional time: make the world a little bit safer.  

Linda would have been a superb professional police officer.  But I'm personally glad she became a nurse.  I'm proud that she works here at PRIUM.  I'm even prouder that she works so hard and is so dedicated and passionate about her job.  But most of all, I'm proud she lives in my community.  The world is made up of communities just like ours, just like yours.  And the world would be a safer place with more people like Linda in it.

Michael
On Twitter @PRIUM1

Physician Education is Key to Chronic Pain Management

Two themes to which I find myself frequently returning:

1. Primary care doctors are overwhelmed by and ill-equipped to deal with chronic non-cancer pain patients and related long-term opioid therapy; and
2. Mandatory physician education would make a significant difference in the fight against opioid misuse and abuse. 

A paper just published from the University of Missouri puts some data around both of these themes and offers an encouraging path forward on physician training (online link not yet available).

Hariharan Regunath, MD, and some colleagues in the Department of Medicine at the University of Missouri conducted a survey asking 45 internal medicine residents about outpatient chronic non-cancer pain management with opioids.  Some unsettling, but not altogether surprising, results:

• 77.8% reported lack of training in this area
• 86.7% reported lack of consistent documentation from other providers
• 62.2% had at least 1 patient about whom they had concerns for misuse or addiction
• On the bright side, 86.7% believed that focused education could make a difference

So the researchers decided to try some focused education!  After reviewing the results of the initial survey, Dr. Regunath and his team put together a series of educational modules specifically targeting the areas of identified knowledge deficits among the surveyed residents.  

The results were fantastic:

(on a scale of agree to neutral to disagree, % that "agreed" is reported in the table below)

The authors note that despite these compelling results (albeit among a small sample), progress is slow.  "Even at this time, medical education in chronic pain management is still not a mandatory Accrediting Council of Graduate Medical Education (ACGME) component..."  This attitude among the medical education establishment - what's done cannot be undone... or revised, or updated, or improved, even in the midst of a public health crisis - is utterly ridiculous.  

I guess if we can't get mandatory education in place for currently practicing doctors, we might at least start with medical schools and residency programs?  The doctors of the future deserve it.  And so do their patients.   

Michael 

On Twitter @PRIUM1

Heroin is in Your Community - You Just Don't Know It

The local NBC affiliate here in the Atlanta area, 11-Alive, has just produced an in-depth story about heroin use and overdose deaths.  It's an outstanding series of videos and if you don't have much time on your hands, at least spend 7 minutes watching the first one in the series (after which you'll probably end up watching all of them).  Those of us that follow this public health crisis closely are no longer surprised by these stories, but to have such solid reporting that is so focused on my own community offered me an opportunity to talk about this with others for whom the story might be relatively new.  

Here's what surprises people:

First, this problem is concentrated in the wealthy suburbs of our major cities, not poorer areas with which drugs and related crimes have historically been linked.  The local reporters here in Atlanta discovered a triangle that connects Marietta to the west, Alpharetta to the north, and Johns Creek to the east.  Inside this triangle, you'll find some of the wealthiest ZIP codes in the state (and among the wealthiest ZIP codes in the country, for that matter).  And these reporters also found a heroin overdose death rate inside of this triangle that has skyrocketed nearly 4,000% just since 2010.  

Second, and correlated with the first point, people so closely (and incorrectly) link drugs and crime and poverty that they are completely missing the fact that heroin dealers are making home deliveries all over the north metro Atlanta suburbs.  This is how simple it is now: you text your dealer, you leave $20 under the door mat, the dealer takes the $20 and leaves the heroin.  Done.  No shady street corners, no dark alleys, no dangerous meet ups, no abandoned houses.  It's as easy as ordering a pizza.

Third, it's about as cheap as ordering a pizza, too.  That $20 isn't a made up number - that's what it costs to get secure a supply of heroin that will keep you high for up to several days.  

Fourth, this problem usually doesn't start with other illicit drugs or alcohol (though it certainly can). Heroin addiction most often begins with prescription painkillers.  And while much of the painkiller abuse in high schools is non-prescribed, recreational use, there is a substantial portion of teenage heroin addicts that started out with a legitimate prescription for opioids from a well-intentioned doctor.  Parents I've spoken to routinely miss this critical link.  Otherwise upstanding kids can get addicted to opioids (particularly after a wisdom teeth extraction or a sports injury - see this Sports Illustrated article for a more in-depth view of opioid use among high school athletes).  And when they get hooked and can no longer access painkillers (when doctors cease prescribing them and/or they can't find or afford non-prescribed pills), they're turning to heroin.  

I don't often tell people they're wrong - it's impolite and usually counterproductive.  But... if you don't think this is happening in your community, you're wrong.  If you don't think this is going on in your kid's high school, you're wrong.  If you don't think this could potentially impact you and your family directly, you're wrong.  

Strong reasons ought to make for strong actions.  Tell your friends, share the link above with your neighbors, make sure teachers and counselors and pastors are aware.  Above all else, be vigilant.  

Michael

On Twitter @PRIUM1

As the Pendulum Swings, Governors Weigh In

June 13, 2001: In the first case of its kind, an Alameda, California jury awards the Bergman family $1.5 million for under-treatment of pain during a hospital stay.  The case facts are dense and the clinical arguments are nuanced (according to this law review article, the best summation of the case and its implications I could find), but the trial represented a referendum on pain treatment in this country and despite the treating provider's prescriptions for Demerol and Vicodin, the jury found he had not done enough to manage the patient's intractable pain.

October 30, 2015: In the first case of its kind, a California doctor is convicted of murder in the deaths of three patients who were prescribed "crazy, outrageous amounts" of painkillers.  Dr. Lisa Tseng earned $5 million in one three-year period as she built her practice around prescribing huge amounts of opioids with little record keeping and total disregard for patient safety.  "You can't hide behind a white lab coat and commit crimes," said the district attorney.

In the intervening 14 years between the Bergman case the the Tseng case, a lot has happened.  To be clear, I'm not comparing the two cases.  Nor am I suggesting that either is wholly representative of current approaches to pain management generally or opioid use specifically.  Rather, I see these two cases as sentinels - two opposing, symbolic, and instructive cases that exhibit how far the pendulum of pain management is capable of swinging.

This weekend, the National Governor's Association gathered in Washington, D.C.  To the surprise of some, the sessions have been dominated by bipartisan concerns over prescription drug abuse.  The group of governors decided over the weekend to explore creating new guidelines on painkiller prescriptions that could include restrictions on the number of prescriptions that can be written and "locking in" a doctor and pharmacy so patients can only secure painkillers at a single location.

This is a good sign.  Perhaps the governors can find the right place for the pendulum to come to rest, a balance between public health crisis and pain management access.  Governor Shumlin of Vermont, who devoted his entire State of the State address to this issue in 2014, summed it up best: "You have the most conservative Republican governors and the most liberal Democratic governors agreeing" on the urgent need to get something done.  In this winter of political discontent, when is the last time we could say that about any public policy issue?

But they face significant challenges:

First, guideline overload.  CDC, ODG, ACOEM, State of (fill in the blank), FDA labeling, NIH, and a dozen other reputable organizations all have guidelines around opioid prescribing.  If the governors add another set of guidelines, we risk alienating the very primary care physicians we're trying to reach and educate.

Second, unintended consequences.  This list is admittedly tough:

• Limiting the number of pills in circulation may prove to be correlated with an increase in heroin use; 
• Laws aims at bad docs can make good docs less willing to treat pain patients; 
• One state's successful efforts to combat prescription drug misuse and abuse can shift such activity to neighboring states.  

Despite all of these obstacles, this is obviously a fight worth fighting.  And with such bipartisan support, maybe our governors can actually lead the way toward solutions that make sense.  

Michael 

On Twitter @PRIUM1

More Than Kin and Less Than Kind: Opioids, Moms, and Newborns

In the midst of the opioid epidemic, we've encountered several important questions of medical ethics. For instance, the growing availability of Narcan for the reversal of potential overdoses and its associated widespread political support begs a question: does a ubiquitous antidote to overdose encourage risky behavior among addicts?  Public health data suggests this isn't the case, but it's still an important ethical question that deserves discussion.  Or another: Does an opioid treatment agreement (sometimes referred to - inappropriately, according to many ethicists - as an opioid 'contract') create sufficient friction in the doctor-patient relationship that such documents could do more harm than good?  The relatively sparse data on the topic suggests this isn't the case either, but again, it's a question worth exploring.

Here's a particularly thorny ethical question: How do we deal with pregnant women who are dependent on or addicted to drugs?  I carefully chose the phrase "deal with" as opposed to "treat" because whether and how we "treat" these women is among the fundamental questions we need to answer as a society.  Do we "treat" them like criminals?  Or do we "treat" them like patients?   What role should doctors and nurses play in involving state agencies like child protection services?  Should they be legally required to report expectant mothers that are misusing, abusing, or simply 'taking as prescribed' medications like opioids?  And if child protection services become involved, might these agencies remove the child from the care of the mother?  Or should they be legally prohibited from doing so, thus removing a potential ethical barrier to mandatory reporting?  

If you care about these questions and want to get closer to answers that might make sense, then this series of pieces from Reuters is required reading for you.  Leaving aside for the moment that Duff Wilson and John Shiffman deserve a Pulitzer for this work, it's the first in-depth analysis I've seen that combines public health data, public policy critique, heart-wrenching anecdote, and journalistic discipline.  Read the stories, study the graphics, watch the videos.  

We need new legislation in this area.  And we need to be enforcing legislation that already exists (like the Keeping Children and Families Safe Act of 2003, which most states and hospitals are either ignoring or they're adhering to state legislation which directly conflicts with the federal law).  

As I've written in the past, newborns suffering from Neonatal Abstinence Syndrome (NAS) are perhaps the saddest cost of the opioid epidemic.  But it's now clear the risk to these babies extends beyond the neonatal intensive care unit and into their homes, where accidental and preventable deaths are occurring at an alarming rate.  To think that a newborn can painfully but successfully deal with the effects of mom's drug use and yet still risk death at the hands of the very mother who gave them life, whose responsibility it is to care for the child, who would, under any normal circumstances, likely sacrifice her own life for the life of the child - this is tragedy, writ... small.  Even the smallest among us. 

These moms need help, not handcuffs.  They need assistance, not punishment.  They need psychological and emotional support, not the psychological and emotional destruction of having a child taken away.  

We can do better.  We have to do better.

Michael 

On Twitter @PRIUM1

 

A New Approach to Opioids From FDA?

After we were all inundated with direct-to-consumer advertising from the pharma industry on Sunday evening, I thought I'd share some potentially good news from federal regulators (the same regulators that would do us all a favor by banning DTC advertising from pharma).  The emphasis here is on the word "potentially."

Last week, three physician leaders at the Food and Drug Administration (FDA) published an article in the New England Journal of Medicine that suggests a new approach to how FDA should deal with opioids as a medication class.  The article concisely lays out new steps, clear priorities, and a commitment to better handling issues around pain management.  While the paper is characterized as part of a larger initiative on the part of the Department of Health and Human Services (HHS), those who follow FDA activities closely know that this is also a response to significant criticism over the last several years regarding FDAs unpredictable and haphazard responses to new drug applications in the opioid class.  FDA mandated necessary and positive label changes to all extended release / long acting opioids... and also approved Zohydro and generic Opana ER... Clearly, the agency has suffered from a lack of a clear and comprehensive strategy.

While it's been forever and a day, FDA finally appears to be crafting one.  The key quote: "... the United States much deal aggressively with opioid misuse and addiction, and at the same time,... it must protect the well-being of people experiencing the devastating effects of acute or chronic pain.  It is a difficult balancing act, but we believe that the continuing escalation of the negative consequences of opioid use compels us to comprehensively review our portfolio of activities, reassess our strategy, and take aggressive actions when there is good reason to believe that doing so will make a positive difference."

FDA will now reexamine the role of pharmaceuticals in pain management, encourage the development of non-opioid alternatives, focus on abuse-deterrent formulations of new drugs, support the development of evidence-based guidelines for opioid use, and ensure that the approach to pediatric pain management is the right one.

But to me, the most important commitment FDA appears to make in this announcement is a willingness to "balance individual needs for pain control with the risk of addiction, as well as the broader public health consequences of opioid abuse and misuse."  

This the first time, to my knowledge, that FDA has acknowledged public health concerns as part of its mandate related to pain management medications.  Should FDA develop a rational, repeatable, replicable approach to balancing the safety and efficacy to an individual patient with the safety and efficacy to the broader public, this will represent a major step forward in the fight against opioid misuse and abuse.

This is promising.  But now the hard work begins.  FDA actually has to implement this.

Michael
On Twitter @PRIUM1

The Flu, My Inbox, and Opioids

I found myself felled by the flu last week.  I'm glad to be back on my feet and figured it would make my life easier if I caught up on my inbox and blogged about what I found there at the same time... Here's what popped in there while I couldn't stand to stare at a screen:

Vicodin scripts plummeted due to the rescheduling of hydrocodone from SIII to SII.  There were over 26 million fewer scripts (a 22% drop) and over 1 billion fewer tablets (a 16% drop) as a result of the change.  That's a dramatic shift.  But did those scripts disappear?  Or were they replaced by other opioids?  Yeah, that's what I think, too.

US Senator Ed Markey (D-MA) is holding up confirmation of a new FDA Commissioner over some of the practices that appear to have caused the last FDA Commissioner to resign.  Markey wants a reformed approach to opioid approvals and for FDA to rescind its approval of oxycodone for pediatric populations.  These are tough tactics.  Whether or not you agree with him, here's a Senator using the power of his office to shine a light on a major issue and trying to create change in an agency that desperately needs it.

Any high school in the US that wants Narcan on hand in case of a drug overdose can now have it free of charge (thanks to the the drug's manufacturer and the Clinton Foundation).  I'm not supportive of a Narcan script along with every opioid script, but having this drug on hand in high schools as standard operating procedure is good public policy.  Why would a high school turn this down?  Any principal that does so risks being hoist by his own petard... and on the front page of his local paper trying to explain why the poor kid died when he might have been saved.

The US Preventative Services Task Force has recommended that all adults >18 be screened for depression.  Some of you are thinking, "whoa... that's gonna be expensive!"  And you're right, it will be.  But you know what the only thing more expensive than diagnosed depression is?  Undiagnosed, untreated depression.  So let's start getting used to this being a good idea.  Quote to take away on this one is from Dr. Keith Humphreys, a professor of psychiatry at Stanford: "The reality of American healthcare is that mental health has to be done in primary care."

So I guess I didn't miss much.

Michael
On Twitter @PRIUM1

Drug Abuse and the 2016 Presidential Election

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

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:

1. 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. 
2. 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

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  

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%).

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

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:

1. Public education
2. Affordable/available healthcare
3. Reducing crime
4. Attracting and retaining businesses and jobs
5. Protecting the environment
6. Reducing drug abuse
7. 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

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:

• 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

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

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:

"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? 

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."

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.

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