Monday, February 29, 2016

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




Monday, February 22, 2016

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

Monday, February 15, 2016

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



 

Tuesday, February 9, 2016

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

Monday, February 1, 2016

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







Monday, January 18, 2016

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

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:
  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


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%).


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:
  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

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:

  • 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

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:
"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

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?

  1. People are dying.  That much is statistically evident.  
  2. These deaths appear to be correlated with chronic pain, drug use, mental illness, and addiction. 
  3. 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.  
  4. 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

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

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:

  • 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?  

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

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

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:

  1. A Canadian study suggests that veterinarians still receive 5X the number of hours of pain management training than physicians.  
  2. The American Medical Association (AMA) task force on opioid prescribing has been weak thus far in its recommendations.  
  3. 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