Will Opioids Kill the AHCA?

As a small group of Senators toil away in secrecy on an effort to recast a sixth of the American economy, one of the sticking points in the legislative negotiation is funding for the opioid crisis.

While substantial cuts in Medicaid seem destined to make it into the bill in one form (a basic cut in funding) or another (a shift to state-level block grants), several Senators from both parties are lobbying to include $45 billion over 10 years for the fight against opioid misuse and abuse, primarily aimed at availability and access to addiction treatment.  Moderate Republicans like Rob Portman of Ohio, Shelley Moore Capito of West Virginia, and Susan Collins of Maine have made this a central issue in work toward a Senate healthcare bill.  A few of their Democratic colleagues, namely Joe Manchin of West Virginia and Bob Casey of Pennsylvania, are arguing for even more funding - the $45 billion over 10 years isn't nearly enough in their view.

Note those states: Ohio, West Virginia, Maine, Pennsylvania.  These Senators are doing what Senators are supposed to do: represent their constituents. Portman has gone so far as to state publicly that he won't be able to vote for a bill that doesn't include this funding.  Keep in mind that to pass the American Healthcare Act (AHCA), Republicans can only afford to lose two of their 52 votes.  If they lose three, the bill won't pass.  

The opioid crisis has created one of the precious few areas of bipartisanship I can recall over the last several election cycles.  We might see legitimate arguments over appropriate funding levels, but the necessity of action is unquestioned and the focus on prevention and treatment is almost universally shared.  (Notably, one person who doesn't appear to share the view that prevention and treatment are superior tactics to criminal justice solutions is former Senator and current Attorney General Jeff Sessions: he'd rather return to a set of failed policies that have done nothing to stem drug-related crime in this country).

Personally, I'm torn.  I want to see substantial funding for prevention and treatment of addiction.  At the same time, if the AHCA dies in the Senate over this issue, it will serve to shine a very bright light on opioid addiction and simultaneously prevent a very bad bill from becoming law.

Michael
On Twitter @PRIUM1



 

The Tobacco Playbook: Opioids Go Global

Remember when the full weight of federal and state governments, along with support from advocacy and public health groups, finally came crashing down on the heads of the tobacco industry?  Do you remember what the tobacco industry did?  They went global.  Today, 75% of the world's smokers live in developing countries. The growth of tobacco use in the developing world hinges on the lack of regulatory controls at each critical step in the value chain: manufacturing, distribution, marketing, retail sales, consumption - it's just easier to get people hooked in the developing world.

A refresher on an oft-quoted statistic: the US is less than 5% of the world's population, but we consume 80% of the world's opioid supply.  As regulatory scrutiny grows around opioid manufacturers, we might expect them to behave as the tobacco industry has over the last quarter century or more.  Imagine if, at some future date, 80% of opioids were consumed outside the US. Would you have the moral courage to resist that investment temptation?

From the great work of the LA Times, we know that's exactly the plan our old friends at Purdue Pharma (makers of Oxycontin) are carrying out.  Through an international subsidiary (with a different name, of course), Purdue is pursuing overseas markets with much the same strategy as they did the US market in the late 1990s (and we can count on a similar result: foul deeds will rise).  They pay medical "experts" to give seminars to doctors that suggest opioids should be used more for pain management, not less.  In one instance cited in the article, Purdue was paying Dr. Joseph Pergolizzi to give such seminars.  Dr. Pergolizzi appears to have some credentialing issues, though.  He claimed an affiliation with Temple University as well as my own alma mater, Georgetown University.  When challenged on those affiliations, he claimed he was having "paperwork issues" at Temple and was "in discussions" with Georgetown.  I was heartened by my alma mater's response: "We are not in discussions with that gentleman."  Good stuff.

Two key questions over the next decade:
1) Will the public health infrastructure in the US, having learned from its experience with Big Tobacco, get out ahead of this potential international opioid crisis and warn developing countries about the dangers they face?
2) Will those developing countries listen?

Michael
On Twitter @PRIUM1

PS: As this will be the last post of 2016 for Evidence Based, I thought I'd take a moment to let you in on a little secret.  This past year was the 400th anniversary of the death of William Shakespeare (that's not a secret... hang with me a second...)  I have a great love of Shakespeare that was instilled in me by the greatest AP Lit teacher on planet Earth, Ross Friedman. He's retired now, but his love of language, culture, art, and great writing lives on in the thousands of students he taught through his career.

And that brings me to the secret of the Evidence Based blog in 2016: To honor The Great Bard (and my great teacher, Mr. Friedman), I have included an allusion to one of Shakespeare's plays or sonnets in every blog post I wrote in 2016 (above: "foul deeds will rise"is from Hamlet, Act I, Scene 2).  If you noticed, well then bonus points for you.  I had fun doing it and learned along the way that Shakespeare had something to say about everything... even healthcare, regulatory policy, and pharma companies.

Happy Holidays!  And thanks for reading!

A New Regulatory Approach to Opioids

The New York Workers' Compensation Board has announced a new avenue for payers to challenge the appropriateness of long-term opioid use.  Published last week, the notice begins:

Opioid addiction is a major public health crisis in the state that deeply affects many of New York’s injured workers. The New York Non-Acute Pain Medical Treatment Guidelines (NAP MTG) adopted by the Chair in 2014 present a comprehensive approach to the management of chronic pain, and include best practice recommendations for the appropriate use of narcotics. 

As the NAP MTG makes clear, long-term opioid use is only recommended in limited circumstances, and must involve constant clinical monitoring and re-evaluation. The NAP MTG also includes best practices for safely weaning injured workers from opioids and other narcotics.

A workers’ compensation hearing can now be scheduled to determine whether continuing opioid usage is necessary or whether weaning from opioids is recommended.

This is an important development, but it's not a panacea.  This new type of hearing is specifically designed to "consider opioid weaning."  If opioid weaning is to be considered, then the payer would be well served to have a suggested weaning plan documented.  While the actual implementation of a tapering schedule may differ from the suggested plan, the prescribing physician should at least be aware of the guidelines associated with the drugs requiring weaning.  As always, the turning of the tide against opioid misuse and abuse requires preparation.  

The potential outcomes are fairly concrete.  According to the Board: 

When the WCLJ rules that the claimant must be weaned from the opioid medication, the insurer will be required to cover the cost of the claimant’s addiction treatment program or weaning protocol, as directed. If the claimant is to be weaned without addiction services, the insurer will remain liable for the claimant’s medications for the duration of the weaning process. If an addiction treatment program has been directed, then after 30 days, the insurer will only be liable for payment of narcotic prescriptions written by an addiction treatment program physician.

We'll be watching closely.

Michael
On Twitter @PRIUM1 

The Broken Disability Safety Net

Much has been said and written on the topic of the recent report from the US Department of Labor regarding the supposed inadequacy of the workers' compensation system.  Critics rightly point out that the report appears to reduce its own credibility by failing to exhibit a sufficient understanding of the system, by assuming that all people claiming to be disabled are actually disabled, and by frightening those who believe that the federal government's involvement in any endeavor dooms all of planet Earth to utter destruction.

To paraphrase Twain, though, reports of the death of the state-based work comp system have been greatly exaggerated.

Nevertheless, those who dismiss this report based solely on its well-deserved criticism are clearly missing the broader picture.  There is a fundamental problem in this country with disability management and the public safety net that supports it.  And when the public safety net is perceived as inadequate, the most politically expedient solutions are to neither generate revenue (i.e., raise taxes) nor to reduce expenses (i.e., cut benefits); rather, the first solution is to look for an exogenous entity to blame and from which, if luck prevails, to extract rent.  In this case, the federal government has found at least one scapegoat: workers' compensation.

And not without cause, mind you.  The relationship between work comp and Social Security Disability Insurance (SSDI) is ill-defined, but we know from an analysis of past and present "off-set payments" (wherein an individual receives payment from both work comp and SSDI) that of those currently receiving SSDI, a little over 12% of them have also received work comp payments.  While those payments are material (on the order of perhaps $10 billion of the total SSDI spend of $145 billion), this analysis fails to address the larger issue: how many SSDI recipients could have filed a work comp claim, but never did?  That's a much bigger number.

One alarming, but nonetheless informative, statistic regarding the SSDI population showed up in the May 2016 edition of Health Affairs.  If you've heard me speak on a blogger panel this summer or fall, you've heard me talk about this.  The graph below shows spending on opioids by the Medicare and Medicaid programs between 1999 and 2012.  The purple line should jump out at you... it represents opioid spending for the Medicare population that is under 65 years of age.

This is effectively the SSDI population (disabled people under 65 receive indemnity payments from SSDI and healthcare coverage from Medicare) and we're spending more than $1 billion of tax dollars per year on their opioids.  This group is about one-fifth the size of the over 65 cohort, yet we're spending more on opioids for them.  On a per person basis, opioid spend for those over 65 is $192 per year.  For the 45-65 cohort covered by Medicare (an approximation for SSDI), it's $683 per year... or nearly 4X more.  Interestingly, the opioid spend covered by private insurers for those aged 45-64 is $274/year and for Medicaid it's $251/year.  

So what the heck is wrong with the Medicare group aged 45-64?  They're disabled, that's what's wrong.  And there's the rub.  If you think it's difficult to track, measure, manage, and mitigate opioid use in work comp, it's comparably impossible today within the SSDI population.

A broken disability safety net is a dangerous political phenomenon - one we should take seriously and treat with the respect it deserves.  

Michael 

On Twitter @PRIUM1

The Guts to Buck the Lobbyists

Ohio has proposed something novel: Let's not pay for expensive naloxone prescriptions and instead invest resources in ensuring the delivery of appropriate medical care and provide help for those struggling with dependence and addiction.

The Ohio BWC's Pharmacy and Therapeutics Committee recently recommended that BWC stop paying for auto-injector pens of naloxone.  While BWC would still cover the less expensive nasal inhalation form of the opioid overdose antidote, the auto-injector pens have become prohibitively expensive (apparently, BWC recently rejected a bill from a single Florida pharmacy for $824,000 worth of naloxone auto-injector pens supplied to 208 injured workers - that's an average of nearly $4,000 per injured worker).

Instead, BWC has put controls in place to ensure that reimbursement for opioid medications is limited to instances in which best practices are being followed.  And they're willing to pay for treatment for opioid dependence for up to 18 months, including two failed attempts at recovery.

So here we have a state significantly curtailing opioid use, providing a cost-effective version of an overdose antidote, and paying for opioid dependence treatment where necessary.  

Before you dismiss Ohio's efforts as impractical in a non-monopolistic state, take a step back and ask yourself whether this isn't a rational, measured, clinically responsible series of measures that will actually promote injured worker health, wellness, and recovery?  If it is, then why isn't it practical in your state?

I think Johnnie Hanna, pharmacy program director at BWC, summed it up: "If they've got the guts to buck the lobbyists... they can get these things done."

It is said that discretion is the better part of valor.  Except, I would suggest, when it's not.  Why aren't you doing these things in your state?

Do you have the guts?

Michael
On Twitter @PRIUM1

The Solution to Every Healthcare Debate: Access vs. Cost

Two things you need to know about Suboxone (or buprenorphine) this morning highlight the essential elements of all past, present, and future healthcare debates.

First, the manufacturer is being sued by the Attorney General of Illinois (and 35 other AGs) for violation of antitrust statutes.  The states allege that Reckitt Benckiser Pharmaceuticals (now known as Indivior, because someone clearly new to marketing thought that would actually be easier to say) has effectively blocked generic competition for Suboxone by scheming to devise a new formulation (the film, an upgrade from the pill) in order to extend the patent protection of its franchise.  Believing, of course, that they are more sinned against than sinning, Indivior took to their web site to issue a statement that they will vigorously defend themselves against the charges.  I'm not sufficiently informed to weigh in on the merits of the suit.  I'll just point out that the company's actions are fairly typical of pharmaceutical companies and that were this a cholesterol medication instead of a potential addiction mitigation drug, I'm not sure we'd see this much attention paid to it by 36 state attorneys general.

Second, current physician capacity for treating opioid use disorder with Suboxone isn't being utilized.  A research letter published last week in the Journal of the American Medical Association shows that despite initial limits on the number of patients a certified physician may treat at any one time of 30 and subsequent limits (after 1 year of prescribing) of 100 patients, these doctors are treating numbers of patients far below those thresholds.  In the 7 states with the highest number of certified physicians, the monthly median patient census per doctor was found to me as follows:

• California: 7
• Florida: 11
• Massachusetts: 22
• Michigan: 7
• New York: 11
• Pennsylvania: 18
• Texas: 10

Increasing the number of certified prescribers and the number of patients they may treat at any one time is a linchpin of the federal government's response to the prescription opioid epidemic.  So it's somewhat concerning that we're so focused on increasing capacity when we're clearly not even close to utilizing the capacity we have.  

Why is this?  Why the law suit?  Why the lack of utilization of existing capacity?  

Like every other debate in healthcare, when you peel back the onion far enough, you find two competing philosophical concepts that dictate nearly every public policy decision that confronts us: COST and ACCESS.  

The law suit is primarily about COST and secondarily about ACCESS (presumably, if a more affordable - read 'lower COST' - generic were to become available, more patients could potentially ACCESS therapy).  

The JAMA study is about ACCESS and it shows that despite our investment in capacity (which COSTS money), we're still not very good at ACCESS itself.  

Follow the money.  Follow the patients.  The solutions to all healthcare issues rest somewhere in the incentives, structure, and balance of the two.  

Michael 

On Twitter @PRIUM1

Market Failure and Medications: The Consequences of Healthcare Economics

I have a friend who happens to be an economist.  He's a really (really) smart guy and I value his views on everything from parenting to high finance.  So when he struck up a conversation about a recent blog post of mine that covered the intersection of drug prices and basic economic principles, I was all ears.  

"You haven't identified the market failure," he said.  

I was caught a little off guard.  I needed a moment to recall the specific definition of "market failure." It's not what most people think.  If the average person hears the term "market failure," they're likely to believe the S&P 500 dropped precipitously that day.  But when an economist uses the term, he means that the supply and demand dynamics of any given market have failed to reach a market clearing price.  The market could be for guns, butter, iPhones, or medications.  Doesn't matter. Buyers are unwilling to buy, sellers are unwilling to sell.  The market isn't working.  It has failed to produce transactions of any kind.     

My friend's point was that the market for naloxone was still functioning.  Buyers were complaining vociferously (in the press, to Congress, to manufacturers, etc.) but naloxone was still being bought and sold.  Howls of protest are one thing, he was saying, but the market still looks like it's working - albeit at a significantly higher market clearing price than a few years ago.  

From a purely economic perspective, he's exactly right.  But this isn't "pure" economics.  This is healthcare economics.  And the difference isn't that we in healthcare don't get it, it's that we have to get it sooner... because the stakes are much higher.  

In my original blog post, I told the story of my son Will and his experience with the supply and demand of chocolate.  I pointed out some of the differences between his experience selling Hershey bars to 1st graders and the pharmaceutical companies raising prices of medications like naloxone.  But there's one difference I did not identify in that original post and it's critical to understanding the current public discourse around naloxone and EpiPens and other medications whose price has risen substantially as of late.  

If Will's market for chocolate fails, then kids neither buy nor sell chocolate.

If the market for EpiPens fails, a kid dies.  

Overly dramatic?  Not in the least.  If access to potentially live saving medications is inhibited by market failure, then preventable death is not only a possible consequence, it's a probable one.  Those of us who work in this space have to anticipate market failures and prevent them from happening. We cannot sit back and wait for the market to fail and then act to correct it.    

Economics is different in healthcare for lots of reasons (government participation in price setting, employer-based health coverage, third party payers, just to name a few), but ultimately, what makes the domain of healthcare economics so unique is that it carries life and death consequences at every turn.  What's past is prologue... and we have to get it right.    

Michael 

On Twitter @PRIUM1

So Why is Naloxone Getting So Expensive?

Last week, I posted a piece on the public health debate around naloxone.  Since then, I've received a stream of new and interesting data to share.  

First, a report showing that naloxone scripts led to fewer ED visits... of the 2,000 patients in this study focused in safety-net clinics around San Francisco, those receiving naloxone along with long-term opioid prescriptions had 47% fewer visits to the emergency department.  That appears to be compelling evidence to suggest co-prescribing naloxone makes sense (though the focus on the safety net clinic population begs the question of how translatable the conclusions might be to other populations).

We also saw the release of a white paper from Fair Health that suggests diagnosis of opioid dependence is skyrocketing.  Fair Health is a non-profit organization dedicated to transparency in health care costs.  They analyzed their database of 20 billion privately insured healthcare claims and found a 3,203% rise in opioid dependence diagnosis between 2007 and 2014.  So maybe we need to focus more on the underlying issue of opioid dependence after all?   

Third, the price of naloxone is rising... this excellent an in-depth piece from Business Insider details the controversy surrounding the price increases.  Out there in social media land, I've seen several comments regarding the price increase that indicate a basic understanding of microeconomics, but that lack the depth necessary to understand what's happening here.  "Demand has gone up," read many of these comments, "so price goes up, right?"

Not necessarily.  A personal story to illustrate the point:     

Some of you have heard me tell one of my favorite “Will stories".  Will is my 10 year old and the kid is a natural entrepreneur.  Back when he was in 1st grade, his school had an activity called Economics Day.  Each of the six 1st grade classrooms in Will's school had to make a simple product and then sell it to their peers in an open “marketplace” (which, in this case, was a series of tables in the school gym).  One class made puppets out of brown paper bags.  Another class made pet rocks.  One class did the classic lemonade stand.  Will’s class made “S’more packs” (two graham crackers, a marshmallow, and a small Hershey’s chocolate bar all in a small plastic sandwich bag).  Each kid had earned “money” to spend through good behavior and acts of service to others over the course of the semester. 

All the first graders gathered in the gym and awaited the signal from one of the teachers.  When she blew her whistle, nearly all of the children would begin freely “shopping” the various tables of merchandise around the gym.  Only a small group of students from each class would remain at their respective “cash registers” to do the actual selling.  William volunteered for this duty first.  While everyone else shopped, Will would be in charge of selling his class’s S'more Packets.  I stood behind him and made sure order was maintained.  Easy duty… or so I thought.

The whistle blows.  Nearly every kid in the gym makes a run for Will’s table.  There’s chocolate there, right?  The kids who don’t run for the chocolate instead go for the lemonade.  The Pet Rock and hand puppet kids are immediately bored.

Suddenly, Will finds himself in the middle of an old fashioned Wall Street trading pit.   He’s surrounded by kids, each holding out $5 of play money and shouting for chocolate.  Initially, Will is collecting money and handing out ‘Smore Packets just as he’s supposed to do. He’s happy his class’s product is popular and he’s clearly grateful for the business.  But as the crowd thickens and the kids grow louder, I begin to notice what Alan Greenspan once called “irrational exuberance.”  The kids are frantic.  Markets are psychological and this one is getting crazy.  Kids are elbowing for position.  They’re screaming Will’s name in an attempt to get his head to swivel in their direction, potentially increasing the probability they’ll be the next to walk away with chocolate.  He’s getting bumped, jostled, and hit.  I’m getting worried about him and I wonder if he’s going to lose it under the pressure.  Should I step in?  Be an adult?  Organize this chaos?  It’s getting out of control…

And at that moment, Will did something both courageous and, to him, completely logical.  Without permission from his teacher, without encouragement from me, without any warning at all…

He raised the price.

“These aren’t $5 anymore,” he yelled over the din, “they’re $10!”  Only a few kids drop out of the crowd.  The rest simply reach into their pockets and pull another $5 of play money out to add to the $5 they’ve already been waving in Will’s face.  He sells a few packets at $10 and realizes he can go higher.  “Now they’re $15!” he yells.  I glance over at his teacher, Ms. Foster, who takes one step toward Will.  I can see she’s a little unsure of what to make of this scene and I have a moment of panic that she’s going to shut down the most perfect example of an efficient market I’ve seen in my life.  Then she pauses, steps back, looks at me, and smiles.  Thank goodness, I think, she gets what’s happening.  This is Economics Day… and these kids are learning economics!

Little did anyone know that the laws of supply and demand would be as intuitive to Will as eating, sleeping, and breathing are to you and me.

By the time I turn my attention back to Will, he’s at $30 and the flow of ‘Smore Packets into the greedy hands of first graders is starting to ebb.  He senses he’s neared the market price, the equilibrium between supply and demand.  This is what economists call it, economists who have studied this phenomenon and only this phenomenon, for longer than Will’s been alive.  To Will, though, there are no fancy terms or theories.  There’s just a point, he says later, that “felt right.”

So how do pharma companies justify jacking up the price of naloxone?  It’s just supply and demand, right?  What’s the big deal? 

Here’s the key difference: Will had a finite supply of chocolate.  Once it was gone, it was gone.  When supply is fixed and demand rises, price increases.  But that’s not true of naloxone.  This stuff is easy to make and has been around for 40 years.  When demand rises (and it certainly has), supply should increase commensurately and price should remain relatively stable over the long term.  That’s how economics works.  Anticipating objections from the "econ major" crowd who will argue we're experiencing a "shift in the demand curve" for naloxone (which is different than a simple increase in demand), I would argue that a commensurate shift in the supply curve is not only possible, but easily achievable given the nature of the underlying molecule.  

"We're not talking about a limited commodity. Naloxone is a medicine that is almost as cheap as sterile sodium chloride — salt water," said Dan Bigg, the executive director of the Chicago Recovery Alliance.

Unless you’re a pharma company.  Then you get to smile and smile... and be a villain.  You get to exploit the average American's lack of understanding of microeconomic theory and suggest that a rise in demand logically leads to an increase in price. 

Supply and demand, right?   

Michael
On Twitter @PRIUM1

Nuance is Necessary in the Naloxone Debate

American Medical Association white paper headline: "Help save lives: Increase access to naloxone"
New York Times headline: "Naloxone Saves Lives, but Is No Cure in Heroin Epidemic"

These headlines aren't inconsistent, but they do hint at the evolving national dialogue around naloxone.  I would say there's a debate brewing around the appropriateness of naloxone access, but the truth is that the debate isn't new - it's been going on for decades.  What makes it feel new to many of us is that the prescription drug and heroin epidemic is pushing our medical and public health professionals to more aggressively pursue any and all possible solutions at our disposal. And with every solution comes a critique.

Let's start with a few basic facts:

• Naloxone was approved by the FDA in 1971.  
• Naloxone is an opioid antagonist, which means (in layman's terms) that the drug kicks opioids off of the receptors in the brain and replaces them, eliminating the "high" and reviving the patient (and also sending them into immediate withdrawal).
• Naloxone works quickly (approximately 2-3 minutes) and its effects last between 30 and 90 minutes depending on the type of opioid that was used; sometimes, more than one administration of naloxone is necessary to reverse an overdose.  
• There is virtually zero potential for abuse of naloxone and virtually zero effect on an individual given naloxone who is not experiencing an overdose.  
• Naloxone comes in various forms: generic via syringe, branded injector pens (EVZIO), nasal spray (Narcan or naloxone w/ atomizer).

Now to the debate, literally an existential one at that (you might say naloxone is the "to be or not to be" drug... that is the question...)   

There are many (Centers for Disease Control, American Medical Association, Substance Abuse and Mental Health Services Administration, American Society of Addiction Medicine) who support widespread access to naloxone.  According to the CDC (and quoted in the AMA's white paper), from 1996 to 2014, the lives of more than 26,000 people were saved by naloxone.    

There are others who express concern that widespread access to naloxone will give addicts a safety net, encouraging risky behavior.  Governor Paul LePage (R) of Maine, never shy and certainly never concerned about causing offense, summed up the argument this way (in light of his veto of naloxone-related legislation): "Naloxone doesn't truly save lives; it merely extends them until the next overdose.  Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction."  

As so often occurs in complicated policy debates, blanket assumptions and blunt statements lead to poor dialogue and lack of action.  So let's explore the nuance by segmenting the population of potential naloxone beneficiaries.  Note that this isn't the only way to segment the population nor is it the most detailed, but it's better than lumping everyone together.

1. First responders: Here, there is little debate.  First responders should be equipped with naloxone. They have a professional duty to save lives and naloxone will help them do that.  They are trained medical professionals and to withhold a vital life-saving antidote in the midst of a prescription drug and heroin epidemic is blatantly irresponsible.  

2. Drug abusers: Whether its prescription drugs or heroin, this is obviously a group at high risk for overdose. What Gov. LePage is missing in his inelegant portrait quoted above is that the person who overdoses will not be the one who administers the naloxone (having naloxone "in the other [hand]" doesn't do one any good if one is unconscious).  He also misses the reality that naloxone administration leads to immediate withdrawal - rather than experiencing "normalcy and security," the addict, while thankfully alive instead of dead, is thrust directly into hell on Earth.  

This segment of the patient population actually highlights two axes along which the debate takes place:  First, should drug abusers have access to naloxone at all?  Second, should we enable non-medically trained people (possibly fellow addicts) to administer the drug? If you believe in LePage's premise, that naloxone "merely extends [lives] until the next overdose," well, then... you are a cold and callous person who doesn't believe in the basic human aspiration toward redemption and recovery.  Might it be a long and hard road?  Yes.  Might there be relapses and multiple overdoses requiring naloxone?  Yes.  If it was your loved suffering from the addiction, would you want to give them every possible chance at recovery?  Yes.  As to whether non-medically trained people should be able to administer it... if I can give my kid an EpiPen injection when he gets stung by a bee, then I can administer naloxone.  No medical degree necessary.  

Thank goodness the Maine Legislature had the good sense to override LePage's veto, allowing Maine to count itself among the 34 states with a standing order for naloxone.   

3. Legitimate prescription drug users: This group is tricky.  These patients are under the care of a doctor, receiving legal prescriptions for opioids, and securing those medications at a pharmacy. I note there could be overlap between this group the group 2 (drug abusers), but this group has the benefit of a doctor overseeing their prescription regimen. The CDC and AMA guidance on naloxone prescribing among primary care doctors is fairly consistent.  A co-prescription for naloxone should be considered if the patient has a history of overdose, a concomitant script for a benzodiazepine, a history of substance use disorder, a mental health condition, or a medical condition that might make the patient susceptible to respiratory distress.  

But wait. Aren't these all the same factors that should cause the doctor to reevaluate the appropriateness of prescribing opioids at all?  Should a doctor manage the risk of overdose by prescribing an overdose antidote?  Or should the doctor be more diligent in exploring non-opioid alternatives first?  

This isn't just theory.  We're seeing it in PRIUM cases.  It's expensive, the cost is rising, and the benefit is unclear.  Surely, there are circumstances in which naloxone will be appropriate for co-prescribing (perhaps immediately post-injury or post-surgery when opioids are indicated for acute pain and the patient has a history of overdose, for example).  But the practice of co-prescribing naloxone for chronic pain patients is troubling.  

When it comes to high dose opioid therapy for chronic pain, we need to demand more from prescribing doctors than a "just in case" antidote.  Chronic pain care requires rigorous exploration of alternatives, difficult conversations with patients, careful management of medications, and a commitment to patient safety.  

Michael 

On Twitter @PRIUM1 

Mental Illness: What Are We Going To Do About It?

My family and I just got back from a trip to our nation's capital (read: I just dragged my three children through a three day, 25 mile hike that will forever be known as The Monument March).  I wanted them to see the White House, the Capitol, the Supreme Court... I wanted them to see our founding documents - The Declaration of Independence, the Constitution, the Bill of Rights... I wanted them to see my alma mater, Georgetown University, and the places I lived and worked during my years in DC.  And we did all of that and more in 95 degree heat with surprisingly few complaints.

There were some surprises on our trip, too, things we had not planned to see.  I happened upon Thomas Jefferson's personal library on display at the Library of Congress.  We encountered a free live jazz concert inside of the Smithsonian Museum of Art and I played checkers with my seven year old daughter while listening to great music and sitting amidst the original portraits of most of the founding fathers.  And at the Smithsonian National Air and Space Museum, we found a full sized Douglas A4 Skyhawk suspended from the ceiling, the plane my father-in-law flew in combat in Vietnam.

And my children encountered homelessness and mental illness for the first time.

Sitting on a bench in Union Station, a woman close by was engaged in a heated argument regarding Social Security, the banking system, and the wisdom of 30 year mortgages.  She was gesticulating wildly and was clearly talking to someone she believed was sitting next to her.  In this age of gadgetry, my kids initially assumed she was talking on a blue tooth head set.  But I knew better.  All of her belongings were in a shopping cart next to her and she clearly hadn't bathed in quite some time.  While we walked from Union Station to the Capitol building, I tried to explain to my kids what they had seen.  At twelve, ten, and seven years old, this was a new experience and they were having trouble processing it.  They began to notice that many of the benches on the US Capitol grounds were occupied by homeless people.  The following conversation with my ten year old ensued:

Will: "How do you become homeless?"
Me [thinking hard about how to explain this to a 10 year old]: "There are a lot of ways people end up homeless... but many people become homeless due to mental illness."
Will: "What's mental illness?"
Me [definitely not a clinician]: "The human brain is a really complex thing... and sometimes, it breaks... it doesn't work right... and the person suffering from mental illness loses touch with reality. They have a really hard time doing normal things like sleeping, working, and talking with others."
Will: "So they're sick?"
Me: "Yes."
Will [thinking this over and jumping right to the heart of the matter]: "What are we going to do about it?"

This incredibly insightful question was put to me by my ten year old in the literal shadow of the US Capitol building.  His timing couldn't have been better.  "A big part of the answer," I told him, "starts right here with the people who were elected to sit in this building."

I'll spare you the detailed policy proposal, but suffice it to say that homelessness and mental illness have become problems we deal with predominantly through the criminal justice system.  Therein, the patient must minister to himself, giving us little to no hope of long term recovery for the mentally ill, including (perhaps especially) those suffering from addiction disorders.  Instead, we need to treat mental illness through the healthcare system, including the appropriate funding (enter Congress) that will entail.

Mental health parity provisions in the Affordable Care Act are a start.  The Comprehensive Addiction Recovery Act is a start.  But to really answer my ten year old's question (what are we going to do about it?), we're going to need broad social, moral, and political commitment to helping those who cannot help themselves.

Michael
On Twitter @PRIUM1

A Tax on Opioids: Who Pays? And Why?

A new bill was introduced last week by US Senator Joe Manchin (D-WV).  The bill calls for a tax on opioids to the tune of 1 cent per milligram.  This tax will fall primarily to the payor community.

Manchin compares this newly proposed tax to current taxes on alcohol and cigarettes.  This analogy is a poor one: the alcohol and cigarette taxes are born by consumers with the express consequence of changing use patterns.  In the case of the opioid tax (as with most economic propositions in a 3rd party payor system), the tax will likely be paid by an entity (the insurer) that is not a party to the originating transaction (the doctor writing a prescription for the patient).  It is therefore doubtful that the proposed tax will have any material impact on utilization.

There are two notable exceptions to this line of logic.  First, cash-based transactions whereby patients pay for the entirety of the opioid prescription will now be more expensive.  At 1 cent per milligram, a standard prescription for Oxycontin 40 mg q12h would lead to a monthly tax of approximately $25. That might not seem like much, but for the patient paying cash, that adds up quickly.  The second possible exception may occur if certain insurers choose to structure plans such that this tax is passed along to the patient in the form of co-pays, deductibles, co-insurance, etc.  This will surely be the case in many health plans and may cause at least certain patients to seek alternative, non-opioid medications from their doctors.

Neither of these potential exceptions will be available to workers' compensation payers.  For work comp payers, the entirety of the tax will be paid by the insurer and neither the doctor nor the patient will have any financial incentive to do anything differently as a result.  A tax, if you will, on all your houses.  

The other interesting consequence of the proposed tax is that it treats a milligram of a brand name drug and a milligram of a generic drug as equivalent for tax purposes despite the fact that the underlying cost of the generic is significantly less than the brand.  This proposed tax will be yet another factor pushing the cost of generics up for payers, a trend that we've already seen unfold over the last 24 months.

If the proposed tax passes, it's expected to raise somewhere in the neighborhood of $1.5 to $2.0 billion.  These dollars will be used to fund outpatient and residential addiction recovery programs, an increase in the number of doctors certified to provide medication-assisted treatment, and other services to support addiction recovery (like housing and employment assistance for those in recovery).

Candidly, lack of access to these programs today is a major barrier to injured worker recovery. If the bill passes, workers compensation payers will bear the brunt of this new tax burden. Perhaps rather than fighting against the tax, we should collectively lobby to ensure that injured workers can easily access any and all of the new programs/centers/providers funded by the new tax?  

Just a thought...

Michael
On Twitter @PRIUM1

When CMS and CDC Conflict: Medicare and Opioids

A few weeks back, the National Alliance of Medicare Set-Aside Professionals (NAMSAP) published a press release calling for a revised approach to MSAs that include opioid medications.  Specifically, NAMSAP stated that it supports the following changes:

1. A hard cap of 90 MED based on the CDC guidelines for no more than one month when the Work Comp MSA includes a surgical projection; and/or,
2. A hard cap of 40 MED for no more than one month, followed by a 10% per week mandatory tapering and weaning plan, as recommended by the CDC, until fully weaned from opioids

I find this attempt at hoisting the federal government with its own petard laudable.  When the federal government's public health agency says one thing, but that same government's healthcare payment policy agency says another, they ought to be called to account for it.  Just about anyone who reads this blog with any regularity is familiar with the crushing clinical and financial burden of opioids in general, but also specifically in regard to MSAs.  Long term use of expensive and potentially addictive medication is driving huge pharmacy allocations and prohibiting settlements.  So good for NAMSAP for putting this issue front and center with more than just a tired complaint, but rather with a specific call to action.  Good stuff.

Only one small problem.  I don't think it has a chance at being implemented. 

There are plenty of smart people in our industry that have forgotten more about MSAs than I will ever know.  But if I were writing the CMS response to NAMSAP, I would probably write: “We recognize that some of the treatment for which we demand allocation is outside of evidence based guidelines.  We support any and all efforts to bring care for these injured workers within those guidelines.  However, we respect the sanctity of the doctor-patient relationship and should a projection include long term use of opioids above the evidence based threshold, CMS will still demand an appropriate allocation for those medications.”  

I think the NAMSAP idea is fantastic - it should start a necessary dialogue around conflicting federal government policies and the clinical and financial risks it creates for patients and payers.  But I believe it has little hope of changing CMS policy, at least in the short term.  Hasn't CMS historically deferred to the treating physician’s approach, even when it makes no sense? 

One might argue that this is different, people are dying of opioid overdoses and the Medicare eligible population is not immune from that phenomenon.

I hope I'm wrong.  

Michael 

Follw me on Twitter @PRIUM1

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

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

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

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