Narrative Does Matter: Self-Guided Opioid Weaning

Perhaps it's obvious.  I write blog posts with regularity, I consume news voraciously, and I've never met a microphone I didn't enjoy speaking into.  But in the event it's not readily apparent, I'm happy to share that the single most important concept in contemporary communications is this: narrative.

"Narrative" is occasionally used as an epithet in political discourse (as in "you're just choosing facts that fit your narrative") and I'm as concerned as anyone else about the balkanization of modern media (which I describe as "choose your own narrative"), but the power of well-told stories to shape, change, or at least influence thinking is undeniable.  We live in a world of competing narratives and while the ability to identify such is critical, the ability to create such can be transformative.

Health Affairs understands this.  Whenever I get a new issue, I typically flip directly to my favorite section: "Narrative Matters."  Here, public health workers on the front lines share stories of what it means when platitudes turn into policy.  It's one thing to talk in the abstract about the CDC's Ebola response... it's quite another to listen to a doctor tell the story of running an Ebola clinic in Liberia.

This month's issue contains another in a long line of compelling stories, though this one hits close to home for those of us fighting to stem the tide of prescription drug misuse and abuse.  The story comes to us from Travis Rieder, a research scholar at the Johns Hopkins Berman Institute of Bioethics.  His journey, despite his role at Hopkins, doesn't have anything to do with his role in public health.  Travis likes to ride motorcycles... and his story begins with a horrific motorcycle accident.

I won't retell the story (you really should read it for yourself), but to summarize: Travis ended up deeply dependent on opioid painkillers.  Knowing he needed to stop taking them, he initiated his own weaning protocol (that was, in retrospect, far too aggressive - even thought it was suggested by one of his doctors).  He lived in agony for days, then weeks.  But he stuck to his plan.  At one point, it got so bad, he contemplated suicide.

Where were his doctors, you ask?  He found the medical profession to be some combination of afraid, inept, reluctant... perhaps all of the above... to assist in the weaning of his opioids.  And this was a motivated patient, asking to be weaned.  A highly educated, white collar academic who was begging for help... and got none.  "How could it be that my doctor's best tapering advice led to that experience?" Travis asks, "And how could it be that not one of my more than ten doctors could help?"  And think: this story found its way to Health Affairs because Travis is a known author in the field of bioethics.  How many non-bioethicists out there are suffering in this same opioid purgatory?

As my colleague Mark Pew has written about extensively, we've arrived at the hard work cleaning up the mess.  He even created a hashtag for it (#cleanupthemess), not because we're trying to score marketing points, but because we needed an organizing principle for the combined and coordinated effort its going to take to accomplish our collective goal.

Travis's story highlights the fact that the clean up may be harder than we imagine.

Michael
On Twitter @PRIUM1

Because What We Really Need Right Now... Is Another Opioid

A twice-daily, extended release, abuse deterrent formulation of oxycodone, to be exact.  And just in time, too.  I was becoming concerned that FDA's recent commitment to take a new approach to the opioid crisis might have actually been genuine.  I guess you can't have too much of a good thing.

The trade name you'll want to look out for is Xtampza ER.  And no, I didn't misspell it.  Wondering how to pronounce it?  Your guess is as good as mine.  The pharma industry appears to be running low on catchy, hip drug names with the letters "x" and "z" that play well in the market.  Someday soon, we're going to see a drug called Xyz ER.  You won't see Xtampza pop up right away - Purdue (makers of Oxycontin) are (predictably) suing Collegium (makers of Xtampza) for patent infringement (because, really, how many extended-release, abuse-deterrent formulations of oxycodone do we need?)  But alas, Collegium appears to have a solid case: you can open up Xtampza capsules and sprinkle the oxycodone on your food without sacrificing its abuse deterrent properties. Science!

First, let's talk mandatory physician education.  While you probably hadn't yet heard of Xtampza, you can be excused for that lack of awareness given that you likely have neither the authority nor the inclination to prescribe it.  But the doctors who can prescribe it are going to learn about it from the sales reps who are pushing it.  We can do better than that.  We need to do better than that.  

And to celebrate the advent of every new abuse-deterrent opioid formulation, I like to remind readers of this blog, both new and returning, that abuse-deterrence is a tool, not a solution.  As I have written before, but share again here:

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication.  But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).  

To me, though, this conversation is a distraction.  While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem.  The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed.  Very little pill crushing.  Very little intravenous injections.  Very little drug dealing.  

The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  

Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.  

Michael
On Twitter @PRIUM1

A Wake Up Call for Employers: One-Third of Opioid Scripts Are Being Abused

Castlight, a health benefits platform provider focused on self-insured employers, published a report last week on the opioid crisis.  The authors were able to take a unique look at the problem through the lens of current data from self-insured employer clients (vs. latent data from public sources).

Lots of interesting data in the report, but here's the headline:

1 out of every 3 opioid prescriptions is being abused.   

I had three reactions, in the following order:

First, I knew that number would seem astronomically large to most people ("Seriously, one-third of all opioid scripts are being abused?  How can that be?")  Fact is there are more sad opioid statistics than most people realize.  It is the disease of not listening.  While it makes for admittedly depressing cocktail party conversation, it is a predictable interchange.  People know there's an issue... they just don't realize how broad and deep it goes.

Second, I personally thought that number seemed low.  While I recognize PRIUM's data is somewhat skewed by our focus on chronic and sub-acute pain (vs. acute pain), our physician consultants conclude that approximately 70% of the the medications we review are not medically necessary based on evidence based guidelines.  I recognize that "lack of medical necessity" and "abuse" are two different phenomenon, but when it comes to opioids specifically, the former tends to lead to the latter. So I thought 1/3 was low.

And that led me to my third reaction: How did Castlight define "abuse"?  They're looking at de-identified diagnosis and prescription data.  I wondered what methodology they used to identify opioid abuse.

Page 12 of the report details their approach:
Excluding cancer diagnoses and hospice care, Castlight defined abuse as meeting both of the following conditions:

1. Receiving greater than a cumulative 90-day supply of opioids; AND
2. Receiving an opioid prescription from four or more providers over the 5 year period between 2011 and 2015.  

Let's acknowledge that this is, at best, a proxy for abuse.  Might there be patients who are defined as "abusers" in the Castlight data who are not, in fact, opioid abusers?  Is it possible that a patient could receive opioid scripts from 4 or more docs over 5 years and not be an abuser?  Of course it's possible.  

But I think the Castlight approach is actually quite conservative.  Using a cut off of 4 prescribers likely leaves out a material number of patients who are abusing opioids but happen to secure their prescriptions regularly from as few as a single provider.  By the way, Castlight doesn't capture work comp data.  So we know (unfortunately) that 1/3 statistic is low.  

A wake up call for self-insured employers?  Hopefully. 

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

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

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

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

We Have to Do Better Than Statistically Significant

Researchers from the Bloomberg School of Public Health at Johns Hopkins have published a paper in the Journal of the American Medical Association looking at the impact of opioid prescribing in Florida after PDMP and pill mill reforms were put in place.  The results are "statistically significant." But statistical significance and public health impact are clearly two different things.

(You can read the abstract and purchase the study here.  You can read a synopsis here.)

The study compared opioid prescribing in Florida and Georgia, an attempt to measure one state's behavior vs. a "control" state that did not implement the reforms that Florida did (at least during the period of study from July 2010 to September 2012).  The results, in a nutshell:

• 1.4% decrease in opioid prescriptions
• 2.5% decrease in opioid volume
• 5.6% decrease in MED per transaction

While we should be celebrating any decrease in opioid use, these statistically significant reductions aren't altogether different than the data we're seeing from our industry's PBM drug trend reports measuring national changes in opioid use.  My reaction to both this study and the PBM drug trend reports is the same: We need to be doing much more to reduce medically unnecessary medications in the treatment of chronic pain.  

Leaving aside some of the shortcomings of this study (the data is from retail pharmacies only) and the frequent confusion among media and industry readers between correlation and causation (something the researchers address, but which is often ignored)... is this really the best we can do?  

It's possible the decreases will accelerate over time.  I'm hopeful that will be the case.  But the detailed results of the study show an interesting phenomena: the reduction in opioid prescriptions written by docs and the reduction in opioid use among patients is very much isolated to high prescribers (80th percentile and above) and high utilizers (80th percentile and above), respectively.  Docs and patients below the 80th percentile actually showed small increases in scripts and use.  

Maybe this shows we're striking the right balance.  Those with legitimate needs still have access while pill mills are being shut down?  Or maybe it shows we still have a lot of work to do... and that PDMPs and pill mill legislation, while absolutely necessary, will be nowhere near sufficient to fix the problem.  

Michael  

On Twitter @PRIUM1

Another New Opioid: Cheeky, This One

Yesterday, I wrote about generics and the distraction of cheap, but still potentially dangerous, medications.  Never fear: there's always an expensive new brand name drug with which to contend.

On December 23, Endo Pharmaceuticals put out a press release announcing that the company has filed a New Drug Application with the FDA for Buprenorphine HCI Buccal Film for the "management of pain severe enough to require daily, round the clock, long-term opioid treatment and for which alternative options were inadequate" (the precise language required on the labeling of any extended release/long acting opioid).  The buccal film will be a strip placed on the inside of the patient's cheek.

According to Endo, this medication is a "partial opioid agonist and a potent analgesic."  Let's break those phrases down so you know what you'll be dealing with if this gets approved.

A partial opioid agonist means that although buprenorphine is an opioid, and thus can produce effects similar to other opioids (more on that next), its effects are less than those of "full agonists" like heroin or methadone.  Many of you will recall buprenorphine as a primary ingredient of Suboxone, a medication indicated for helping patients wean off of other opioids.

But Endo isn't intending this medication to assist in the weaning process.  Rather, Endo is also describing this as a "potent analgesic," with all of the issues associated with other long acting opioids.  The press release does say that the medication demonstrated a "low incidence of typical opioid like side effects."  No mention of the specific side effects or what "low incidence" actually means.

Next, look for the marketing folks to put an inspiring and cool-sounding trade name on this.  For now, we have Exalgo... Nucynta...  Opana... Zohydro... Hysingla... Palladone... This list would be hilarious if it wasn't so tragically true.

Any guesses for this new one?

Michael
On Twitter @PRIUM1

New Opioid Coming Soon: Hysingla ER

Because not only do we need another opioid on the market... but we need a new one from Purdue Pharma.

On the heels of the much debated approval of Zohyrdo ER, the market's first hydrocodone-only painkiller, comes the FDA's approval of Hysingla ER, the market's first hydrocodone-only painkiller with abuse-deterrent technology.  Purdue plans to launch the medication in "early 2015."

Like Zogenix (the makers of Zohydro), Purdue is touting the lack of acetaminophen as an attractive feature of the new medication.  But unlike Zohydro, Hysingla leverages Purdue's RESISTEC technology, which is "expected to deter misuse and abuse via chewing, snorting, and injecting.  However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible." (quoting from the Purdue Pharma press release).  

Now is as good a time as any to restate my position on abuse deterrent technology:

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication.  But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).  

To me, though, this conversation is a distraction.  While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem.  The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed.  Very little pill crushing.  Very little intravenous injections.  Very little drug dealing.  

The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  

Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.  

Michael 
On Twitter @PRIUM1