Wednesday, September 10, 2014

Medical Marijuana is NOT the Answer to the Opioid Problem

At least not yet.  But the conclusion being drawn by many a reporter in our industry would have you believe otherwise.  "Fewer Opioid Related Deaths in States with Medical Marijuana" read one headline.

A study published in the Journal of the American Medical Association at the end of August is causing a lot of confusion in our space.  The abstract of the study (which is, unfortunately, all that most reporters seem to have read) states the following: "States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate... compared with states without medical cannabis laws."  One has to crack the cover and actually read the study to understand this conclusion results from a multi-variate linear regression model that compares behavior of individual states that have medical cannabis laws to what the behavior might have been in that state without such laws.  I have absolutely no issue with the the methodology or the related conclusion.  I'm a data geek and I love a good linear regression model as much as the next guy.

But on page 3 of the study, you quickly learn that the actual observed historical data tells the opposite story. States with medical cannabis laws exhibit a consistently higher opioid overdose mortality rate vs. states without such laws.  Marcus Bachhuber, the lead author of the study, points out that its hard to compare states to each other and much more statistically relevant and reliable to compare states to themselves (what does California look like vs. what we would expect California to look like without a medical marijuana law?)  This is a perfectly valid academic exercise, but not one from which we should be drawing policy conclusions.  Dr. Bachhuber himself writes in the study, "In summary, although we found a lower mean annual rate of opioid analgesic mortality in states with medical cannabis laws [again, according to the linear regression model, not the observed historical data], a direct causal link cannot be established."

Kudos to Ben Miller at WorkCompCentral, who actually read the entire study and presented a balanced view of the issue in his article yesterday.  I was interviewed for and quoted in the article and stated the case much like I'm stating it here. I was impressed that Ben was willing to dig beyond abstract and take his story in a direction he may not have originally intended.  We need more reporters like him in our industry.

Bottom line: Medical marijuana laws cannot be said to lead to a reduction in opioid overdose deaths.  

Michael

Friday, September 5, 2014

What's Actually Happening at the Pharmacy?

A lot, it turns out.  The local retail pharmacy represents another front, and a complicated one at that, in the battle against prescription drug misuse and abuse.  And you need to be aware of what some injured workers are facing when they take their prescriptions to the pharmacy.

Pharmacists are asking doctors questions about medical necessity... and doctors don't like that.  "They [pharmacists] call us sometimes and if (a prescription) is medically necessary," says Dr. Rafael Miguel, an anesthesiologist in Tampa.  "Well, if I write a prescription and it's got my DEA number and my signature on it, what do you think, I'm joking around?"

No, no one thinks this is a joke.  But pharmacists, insurance adjusters, case managers, other physicians, public health workers, and many others think you might be lacking key clinical knowledge regarding the appropriateness of certain prescriptions (yes, even doctors can be under-educated).  We don't think it's funny, we think it's tragic.

Then again, are pharmacists the right ones to be asking this question?  I have neither the clinical knowledge nor the courage to weigh in on that, but it's a question with which the healthcare industry is currently wrestling.  There is new tension in the traditionally high functioning relationship between doctors, pharmacists, and patients and pain killers are at the center of that tension.

For pharmacists and doctors reading this, nothing new here.  But for insurance industry personnel, it's important for you to get up to speed on the details of what's happening in the midst of an ordinary pharmacy visit.  We're revisiting some fundamental questions about the roles and responsibilities of various clinical constituencies.  I'm confident the pendulum (currently swinging at different rates in different directions in different places) will eventually come to rest where it should.

In the meantime, be on the look out for injured workers caught in the crossfire.

Michael

Wednesday, August 27, 2014

The Rescheduling of Hydrocodone: Don't Get Too Excited

The Drug Enforcement Agency has published its final rule on HCPs - hydrocodone containing products - which will be rescheduled (from schedule III to schedule II) beginning on October 6.

The two areas that appear to be of greatest concern in the market regarding this move are:
1) The impact on pharmacies which will now be required to handle, store, and dispense these drugs with greater restrictions going forward, undoubtedly increasing costs for pharmacy operations; and
2) The impact on patient access.  Will patients in pain still be able to get these drugs?

On the first issue, we should all acknowledge the reality of retail pharmacy operations.  This will cause changes and those changes will lead to increased costs.  While I would argue the clinical and public health benefits of the rescheduling of HCPs outweigh those costs, I'm not running a retail pharmacy.  My hope is that these costs trend down over time as pharmacy operators adapt to the new routines required.

To the second issue regarding patient access, let's keep in mind that a rescheduling of a drug may not necessarily impact prescribing patterns.  Yes, schedule II drugs cannot be written for more than a 30 day supply and each prescription requires an office visit.  This will inconvenience some patients in chronic pain.  That said, there are "work arounds".  At the Georgia Workers' Compensation Education Conference here in Atlanta yesterday, I moderated a panel regarding medication usage for the treatment of chronic pain.  A suggestion was made that some doctors may just write two 30 days scripts with a "do not fill before" date on the second script.  Voila! 60 day supply.

Most troubling, though, is the sentiment I've heard from several workers' compensation professionals that goes something like "if a patient really wants the drug - and they will still want HCPs - they'll jump through whatever hoops necessary to get it."  On the one hand, I get it.  It's not as if cynicism in our industry doesn't have obvious and ubiquitous roots.  On the other hand, we cannot allow patient directed care to dictate appropriate treatment pathways for injured workers.  The rescheduling of HCPs should signal to physicians that the drugs are potentially more dangerous than we originally thought.  Doctors, not patients, should therefore be engaged in differential decision making.  If patients are going to be involved in that decision at all (and they certainly should be), the discussion should surround the significant risks and limited long term benefits of opioid use - not figuring out what hoops they have to jump through to continue getting it.    

Bottom line: The rescheduling of HCPs is more symbolic than anything else.  After 15 years of debate and discussion, the DEA, FDA, and clinical community have finally decided that virtually all opioid analgesics should be scheduled the same way (on schedule II, indicating high potential for abuse).

But don't expect to see a huge drop in HCP scripts in work comp.  Our expectations of what's possible are far too low for that to happen.   

Michael

Thursday, August 7, 2014

A Defense of New Opioid Guidelines

[Another guest post from Dr. Pamella Thomas, PRIUM's Medical Director.  Recently, another physician challenged both the science behind ACOEM's 50 mg MED threshold as well as its applicability to chronic pain cases. This was the response from Dr. Thomas.]

Dr. ----

Hope all is well.

I am a bit surprised that you would challenge the 50 mg morphine equivalent dose (MED) threshold supported in the updated ACOEM guidelines.  We are in a CDC-declared opioid epidemic.  People are dying needlessly.  It is difficult to dissent against ACOEM’s 50 MED threshold when the reported death rate is 3 to 5 times greater in patients prescribed 50 mg MEDs and above than in patients prescribed 49 mg MEDs and below.  For context the current CDC VitalSign report shows that, nationally, 46 opioid overdose deaths occur each day.

Furthermore the ACOEM guidelines are – contrary to your suggestion – both applicable to and directed toward chronic cases.  As the most recently updated standards for the practice of occupational medicine, ACOEM further reveals our developing understanding of opioid best-practices.  There is simply no credible evidence to support long term opioid use for chronic non-cancer pain.  Conversely a Cochrane review demonstrated that back pain patients taking opioids for more than a week, when compared with a similar cohort taking opioids for a week or less, were twice as likely not to return to work within a year.  A related review contradicted the practice of escalating doses.  High doses of opioids were shown to be no more effective than lower doses of opioids, supporting the intuitive notion that once opioid receptors are saturated, increasing the dose does not yield additionally beneficial results.  If you have not yet read the two studies used to confirm the new ACOEM morphine equivalent dose (MED) level, you should.

Another concerning issue that pain management physicians among others are not taking into account?  Up to 30% of patients can’t properly metabolize approximately 25% of drugs currently used clinically due to inherent pharmacogenetic deficiencies (Wang et al., 2009).  Drugs in this grouping include codeine, tramadol, oxycodone, hydrocodone and many synthetic and semisynthetic opioids which are not adequately metabolized by other CYP450 isoenzymes.  As result many patients are building up levels of the parent drug causing cascading effects such as hyperalgesia, which in turn often causes the treating physician to further increase dosage.  Dose escalation is often pursued instead of weaning without documenting either improved function or reduced pain.

Following a psychosocial evaluation, most patients feel better once weaning starts in conjunction with pain management and mind-body therapies (e.g. cognitive behavioral therapy, motivational interviewing, etc.).  However, only about 4-7% of patients are ever evaluated for these potential treatment options despite prolonged treatment and a history of attenuated improvement.  Similarly medically indicated evaluations for dependence and addiction or interventions for smoking cessation are often left unaddressed.

My feeling is that a number of clinicians still practice based on an outdated biomedical model instead of utilizing a growing body of evidence supporting a psychosocial model of pain and its correlation to impairment and disability.  It is ignored that psychologically and/or socially distressed people seek medical treatment for psychosocial conditions.  Due to this lack of recognition, many psychosocial conditions are being managed through inappropriate modalities and passed off as anatomically  diagnosed biomedical pain.  These inappropriate modalities (e.g. opioids, surgery, and interventional treatment) share complicit complications and side effects that further exacerbate long term disability and failed syndromes.

Consider that in October 2010, the CDC published a report indicating that over 60% of US children had suffered some form of traumatic abuse prior to the age of 18.  These same children grow up and enter the work force.  Some of them eventually file claims because of unresolved, unaddressed issues amplified by a work related injury, leaving the worker feeling victimized by a supervisor, a poor work environment, or low wages.  Injecting opioid treatment into this psychosocial complexity without addressing the underlying issues leads to long term disability and frequent social isolation due to unsympathetic family, friends, and coworkers.

I hope that this will help clarify why the decision was made that, when people are dying daily, we cannot apologize for taking action to ensure patient safety.  While we realize guidelines take time to be updated (MTUS is being rewritten currently), an epidemic exists at this moment which can be controlled by removing the cause.

We do not want to be downstream catching bodies but upstream saving lives.
Thank you for your understanding.


Dr. Thomas

Thursday, July 31, 2014

PDMPs: At Least Someone in Missouri is Paying Attention

Missouri is the last state in the union without an approved Prescription Drug Monitoring Program.  While that's inexcusable and embarrassing, it also has real consequences for the state.  Past legislative attempts to create a database have met with resistance from Dr. Robert Schaaf, a family practice physician and Missouri state senator.  The St. Louis Post Dispatch published an op-ed on the topic yesterday, which reads, in part:
"Sen. Schaaf, a family practice physician, said his opposition to the database is about freedom. The drug database would infringe on patients’ personal liberty, he says.
Of course, his opposition makes life easier for greedy doctors and unscrupulous pill-pushers, and more dangerous for drug addicts.
Dr. Schaaf is not opposed to all databases or impinging on the freedom of poor people. He voted in favor of legislation in 2011 that required the state Department of Social Services to set up a database to screen some welfare recipients for drug use.He also voted last session for a bill that would have required the state Division of Workers’ Compensation to develop and maintain a database allowing employers access to workers’ compensation records. 
So much for freedom, eh, Dr. Schaaf?"
Ouch.  
I've spoken to Senator Schaff directly on this topic and asked him to explain the inconsistency of his positions.  I'm not sure he understands the importance of the issue at hand.  
You can find a front page article from the NY Times on this here.
The St. Louis Post Dispatch op ed is here
My past critique of Sen. Schaaf is here and here
Hopefully this national media attention will get things moving in Missouri... and convince Sen. Schaaf to change his position.  
Michael 

Wednesday, July 30, 2014

H.R. 4709 Offers Little Help in the Fight Against Prescription Drug Abuse

If you want to bill that purports to mitigate prescription drug misuse and abuse, but actually has no hope of doing so - well, look no further than the 113th Congress.  Turns out they can be counted on for something.

Rep. Tom Marino (R-PA) is sponsoring H.R. 4709 which passed the House yesterday and now heads to the Senate.  The bill's purpose is to "improve enforcement efforts related to prescription drug diversion and abuse..."  It does so by amending the Controlled Substances Act (CSA) to more clearly define that certain drugs may represent an "imminent danger" to the public (though it doesn't name those medications, it just makes it possible to designate such medications) and to make it easier for the DEA to leverage the CSA to suspend certain medications that pose a substantial public health risk (though, of course, pharma companies are given the opportunity for remediation with the Attorney General before a drug is actually suspended).  The bill also calls for the Department of Health and Human Services to report back to Congress on law enforcement activities related to patient medication access and, in so doing, consult with every possible constituency and stakeholder on the planet (including tribal law enforcement agencies).

I wonder if anyone in Congress will ever have the courage to do what's actually needed.  Namely:

  • Take on the American Medical Association around the issue of mandatory physician education for pain management and opioid prescribing.  The AMA consistently argues such a measure would infringe upon the practice of medicine.  That ship has sailed.  The good doctors want this education and seek it out anyway.  Doctors who either aren't aware of the need for education or are willfully ignorant of best practices in opioid prescribing should be required to engage in such education before prescribing opioids.  
  • Provide more federal funding for state level Prescription Drug Monitoring Programs (PDMPs) and additional funding for a fully integrated, national PDMP database.  We're seeing regional efforts along these lines that are promising (see Ohio and Kentucky collaborating on PMIX), but more needs to be done in the areas of standardization, integration, data sharing, access, etc.  The federal dollars currently flowing to these initiatives are minuscule given the severity of the problem.  The Harold Rogers Prescription Drug Monitoring Program and the National All Schedules Prescription Electronic Reporting Act are both under-funded and under-utilized.  California legislators fought tooth and nail over $3 million to fund its CURES database and it's still woefully under-funded and under-utilized. The federal government's FY2015 HHS budget contains $10 million through the Substance Abuse and Mental Health Services to "help state substance abuse authorities develop comprehensive prevention approaches through collaboration with state partners and integration of health information exchange systems with strategic plans."  A) I don't know what that means; B) It's not enough.  
  • Leverage data and surveillance from the Medicare and Medicaid programs to identify and deal with high prescribers of opioid medications.  To be fair, the federal government is already working toward this.  See page 73 of the HHS budget overview.    
  • Take on the pharma companies through better Congressional oversight of the FDA approval process.  FDA is and should be an independent agency, but serious doubts have been cast regarding the agency's independence and consistency regarding approval of opioid analgesic formulations.  
More needs to be done.  More can be done.  HR 4709 has little chance of moving the needle.  

Michael 

Monday, July 28, 2014

Abuse Deterrent Opioids: Technology vs. Medical Necessity

Last week, the FDA approved Targiniq ER, an extended release / long acting opioid with abuse deterrent properties.  In this case, the Purdue Pharma medication contains naloxone, which blocks the euphoric effects of the oxycodone when the pill is crushed and snorted (or crushed, dissolved, and injected).

I've posted thoughts along these lines before, but I'd like to remind everyone that abuse deterrent opioids are an excellent solution to a limited set of misuse and abuse issues posed by prescription analgesics.

I wish to be perfectly clear on this point: 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