Lawmakers Dictate to Doctors: New Legislative Approaches to Opioids

Amidst all the talk of 7-day initial opioid script limits in New York, Massachusetts, and New Hampshire (with New Jersey, Connecticut and others likely not far behind), we appear to have missed a piece of legislation that, in my view, represents the single most stringent legal construct for opioid prescribing in the country.   Before we get to Maine's new law, a quick aside on the new approach sweeping the northeastern US: These new limits are extremely helpful, but not the panacea some are making them out to be.  A 7-day limit for new scripts (in most states, for acute pain only) will absolutely help limit black market diversion and over-utilization generally... but we'll also see more office visits (on day 8!) and not enough progress on long term chronic pain cases.  A necessary step, no doubt, but insufficient to address the entirety of the problem.  

Back to Maine: Guess what they did back in April that no one noticed?  They put a statutory cap on morphine equivalent dosage per day.  The state legislature passed it, the governor signed it, it goes into effect on January 1, 2017... and not a lot of people are talking about it.

The cap is 100 mg MED per day.  Specifically, a licensed practitioner in Maine "may not prescribe... to a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day."  But what if a patient is already on more than 100 mg MED per day?  Doctors cannot prescribe to such individuals opioid pain medication in excess of 300 mg MED per day between January 1, 2017 and July 1, 2017.  But starting July 1, 2017, even those individuals need to be weaned down to at or below 100 mg MED per day.

Enforcement mechanisms?  They thought of that, too.  "An individual who violates this section commits a civil violation for which a fine of $250 per violation, not to exceed $5,000 per calendar year, may be adjudged. The Department of Health and Human Services is responsible for the enforcement of this section."    

The bill also includes several other requirements including mandatory PDMP checks, mandatory electronic prescribing, and mandatory education for prescribers (3 hours of CE) to be renewed every 2 years.  There are exceptions, of course, but the exceptions are logical and do not undermine the intent and broad application of the bill (active treatment for cancer, hospice care, inpatient settings, etc. are all exempt - as they well should be).

What does all of this mean?

Some will see this as a huge step forward in fighting the most significant public health crisis of a generation.  Some will see this as a vast government overreach into the practice of medicine.

It's both, really,  And it's what we get when the clinical community fails to educate and police itself. "Our remedies oft in ourselves do lie..."  And when they don't, we get new laws.  Look for this approach in a state legislature near you...

Michael
On Twitter @PRIUM1

The Bio-psycho-social Model: Challenges in Application

Hardly a day, a conference, a meeting, or a case goes by without a serious discussion about the need for a 'biopsychosocial' approach to injury resolution.  In fact, I've recently heard griping in some circles that the discussion has run its course.  "We get it... can we talk about something else now?"

Sigh.  We don't get it.  And we still have a lot of work to do.  I offer the following observation as proof of such...

A study hit my desk this past week from the Journal of Occupational and Evironmental Medicine and I'd like to ask for your forbearance as I share the abstract:

"The cost and prevalence of chronic work-related musculoskeletal pain disability in industrialized countries are extremely high.  Although unrecognized psychiatric disorders have been found to interfere with the successful rehabilitation of these disability patients, few data are currently available regarding the psychiatric characteristics of patients claiming work-related injuries that result in chronic disability.  To investigate this issue, a consecutive group of patients with work-related chronic musculoskeletal pain disability (n = 1595), who started a prescribed course of tertiary rehabilitation, were evaluated.  Psychiatric disorders were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders.  Results revealed that overall prevalences of psychiatric disorders were significantly elevated in these patients compared with base rates in the general population.  A majority (64%) of patients were diagnosed with at least one current disorder, compared with only 15% of the general population. However, prevalences of psychiatric disorders were elevated in patients only after the work-related disability.  Such findings suggest that clinicians treating these patients must be aware of the high prevalence of psychiatric disorders and be prepared to use mental health professionals to assist in identifying and stabilizing these patients.  Failure to follow a biopsychosocial approach to treatment will likely contribute to prolonged pain disability in a substantial number of patients."  

Great study, right?  Isn't that the right message?  And we couldn't ask for a more specific sample set: Work related!  Musculoskeletal pain!  Disability!

Here's the kicker: this study was published in 2002 (J Occup Environ Med, 2002; 44:459-468).

I thought that had to be a typo.  It's not.  Sadly, even in these modern times in which information flows freely and ubiquitously, contemporary healthcare and insurance models still take close to two decades to translate research into clinical practice.  Some see this phenomenon as madness without method.  My own view is that the disconnect is driven not by laziness, lack of awareness, or lack of desire to apply new clinical knowledge.  Rather, the time lag between the establishment of evidence and its clinical application is created by the very hard work of leaping from intellectual recognition to actual clinician behavior change.  We sometimes fall victim to the assumption that chronic pain patients are the only constituency in need of behavior modification.  In fact, all stakeholders must adapt to evolving notions of clinical best practices; adjusters, nurses, claims leadership, doctors, attorneys, service providers, therapists, pharmacists, injured workers, actuaries, underwriters, brokers... all must adapt to both the clinical and economic realities of (what should be contemporary) chronic pain management.

I hear near unanimous intellectual recognition of the need to apply a biopsychosocial model to chronic pain care.  We must now do the hard work of applying this new knowledge.  For knowledge itself is insufficient to solve the problem.  One can know something to be factually true and yet fail to apply that knowledge.  Ever know it's raining... and still forget your umbrella?  Knowledge, when applied, is wisdom.  

And we have work to do.

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

ProPublica: Drug Seeking Irony

Say the name "ProPublica" in a work comp meeting these days and watch what happens.  It's like a pinata at a little kid's birthday party... everyone takes a swing, only a precious few actually connect (but when they do connect, we all get candy... or something like that).  Metaphors and Mondays don't always mix.

By way of brief background, ProPublica is an independent, non-profit news organization that focuses on investigative journalism.  "Journalism in the public interest" is their tagline.  Regardless of how you feel about the organization, they've done good work in the past and the pieces they publish deserve at least a glance, regardless of where you think the organization sits on the political spectrum.

Over the last year or so, ProPublica's Michael Grabell and NPR's Howard Berkes have teamed up for a memorable series of articles on the work comp industry.  I chose the word "memorable" carefully - the aim of this post isn't to offer my view of the work.  Topics ranged from the state politics surrounding system change to how much one's arm would be worth if one lost it in a work-related accident, from the wisdom of opt-out initiatives to the appropriateness of benefit levels.  These articles were the source of much conversation and the target of a great deal of criticism, much of it obviously emanating from our industry.
 
Another of ProPublica's efforts that made news over the last couple of years was the publication online of a trove of Medicare Part D data in the form of a searchable database.  Journalists have used this data to identify trends in prescribing patterns that might be newsworthy.  Public health officials have used the data to develop and support both policy initiatives as well as fundamental research. Doctors and health systems have used the data to measure how they stack up against other groups.

And guess who else uses the data?  That's right!  Opioid seekers aiming to identify doctors most likely to prescribe pills. 

First of all, this isn't ProPublica's fault.  Secondly, they rushed to both publish their own story on this phenomenon and add additional warnings to their site regarding the dangers of opioid misuse and abuse.  So this is obviously a simple case of unintended consequences.  And frankly, the benefits of having the prescription data made public still outweigh the risks of inappropriate use.  The database is neither good nor bad; it's use makes it so.  

But it does beg the question: How many of those "drug seekers" on the ProPublica web site are injured workers?  And how many of them went to the site initially to satiate their appetite for complaining about the work comp system... and ended up learning where they might be able to get more opioids?

Michael
On Twitter @PRIUM1



  

Remember, Effective [Pain] Relief Just Takes Two

I hope you're sitting down.  Turns our Purdue Pharma may have engaged in inappropriate marketing for OxyContin.  Shocking, I know.  But read on... it's worse than you think.

Most of the news coverage around the plethora of lawsuits in which Purdue is engaged focuses on whether or not Purdue leadership and sales personnel misrepresented the abuse and/or addiction potential of OxyContin.  While this is a critical issue that continues to be litigated, my sense is that this particular line of attack has faded into a sort of white noise amidst the overall opioid crisis.

From the LA Times late last week, though, comes a new thing of darkness, a perhaps more clinically dangerous question about Oxycontin.  First, a few quick background facts:

• OxyContin is a brand name for oxycodone which, according to CWCI's latest (excellent) research, is the 3rd most often prescribed opioid in the California work comp system and the fastest growing opioid from 2005 to 2014.  And OxyContin itself is clearly the opioid on which more money is spent in work comp than any other (according to NCCI, 7.4% of 'total paid' across all drugs, all classes in work comp).    
• Purdue created a huge competitive advantage over other long acting opioids by submitting (and receiving approval for) an application focused on OxyContin providing pain relief via just twice a day dosing (q12h).  
• This led to Oxycontin sales reaching a high of over $3 billion in 2010 and total franchise revenue of over $30 billion.

While past allegations of inappropriate marketing led to a $635 million fine paid by senior Purdue executives back in 2007, the issue of appropriate dosing was never a central theme in the public health debate about OxyContin.

Until now.

Turns out a material percentage of patients don't actually get 12 hours worth of relief from an Oxycontin script.  Through access to previously undisclosed records, the LA Times has uncovered the following:

• Purdue has known about the problem for decades.  Even before OxyContin went on the market, clinical trials showed many patients weren't getting 12 hours of relief. 
• The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin's market dominance hinges on its 12-hour duration.
• When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to "refocus" physicians on 12-hour dosing. Anything shorter "needs to be nipped in the bud.  NOW!!" one manager wrote to her staff. 

Here's where things get dangerous. Purdue reps routinely encountered doctors who were dosing at shorter intervals, typically every 8 hours.  This creates two fundamental issues:

First, when the Oxycontin doesn't relieve the pain for the expected 12 hours and instead only offers relief for 8 hours, this creates a 4 hour gap during which pain comes roaring back... and makes the craving for the next dose all that much more powerful.  If this sounds like a recipe for addiction, it is. Dr. David Egilman, a Brown University professor, described this phenomenon to the FDA and summed it up as follows: "In other words, the Q12 dosing schedule is an addiction producing machine." 

Second, Purdue trained the reps to recommend that prescribing doctors (and this is the part that makes me viscerally angry)... up the dose.  That's right.  OxyContin 20 mg every 12 hours not working?  Try 40 mg every 12 hours.  Or 80 mg every 12 hours.  Safe MED levels?  Overdose potential?  Not a care in the world from Purdue about such matters of life and death.  Just make sure to hang on to the 12-hour dosing competitive advantage.

Take a look at your files.  How many claims do you have with OxyContin?  Lots, right?  So let's ask two critical questions... 1) Was the dose artificially increased over the years because some Purdue rep was telling the doctor to maintain the 12-hour schedule?  2) Or do you have lots of injured workers on 8-hour cycles of OxyContin that fall outside of Purdue's recommended dosing... thus providing further evidence that their 12-hour pain relief claim is fictitious?

Either way, I hope you're as fed up as I am.

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

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

President Obama at the National Rx Drug and Heroin Abuse Summit

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

That was my day today.

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

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

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

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

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

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

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

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

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

Michael
On Twitter @PRIUM1

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

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

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

A few key excerpts (emphasis added):

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

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

Another cogent point from Dr. Katz:

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

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

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

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

Michael
On Twitter @PRIUM1

What the New CDC Opioid Guidelines Will Mean to Work Comp

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

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

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

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

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

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

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

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

States Take On Painkillers

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

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

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

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

Lots going on.  I sense progress.

Michael
On Twitter @PRIUM1

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

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

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

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

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

All of us, that is, except for one.

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

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

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

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

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

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

Michael
On Twitter @PRIUM1

Physician Education is Key to Chronic Pain Management

Two themes to which I find myself frequently returning:

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

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

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

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

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

The results were fantastic:

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

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

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

Michael 

On Twitter @PRIUM1

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

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

Here's what surprises people:

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

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

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

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

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

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

Michael

On Twitter @PRIUM1

As the Pendulum Swings, Governors Weigh In

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

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

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

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

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

But they face significant challenges:

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

Second, unintended consequences.  This list is admittedly tough:

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

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

Michael 

On Twitter @PRIUM1

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

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

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

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

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

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

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

We can do better.  We have to do better.

Michael 

On Twitter @PRIUM1

 

A New Approach to Opioids From FDA?

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

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

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

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

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

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

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

Michael
On Twitter @PRIUM1

The Flu, My Inbox, and Opioids

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

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

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

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

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

So I guess I didn't miss much.

Michael
On Twitter @PRIUM1