Monday, November 24, 2014

New Opioid Coming Soon: Hysingla ER

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

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

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

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

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

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

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

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


Friday, November 7, 2014

Dangerous Databases? Security Risks and Public Health Benefits

Prop 46 was defeated in California on Tuesday by a 2-1 margin.  The proposition, among other things, required drug testing among doctors and lifted the caps for medical malpractice damages.  Prop 46 also would have required physicians to check the CURES database before prescribing or dispensing any schedule II-IV medication.

Predictably, the bill was unpopular among California physicians.  Disappointingly, the Prop 46 attack ads apparently devolved into scare tactics and silliness.  According to a WorkCompCentral article this morning, California voters heard things like the following, probably in the form of a voice over that made it sound dark and evil and conspiratorial:

"The vulnerable, government-run database is subject to being hacked, compromising the security of every Californian's personal prescription drug history" and "your personal prescription drug history could be made available for anyone to see."

Political ads are anathema to sound, rational policy debate.

Yes, there are risks associated with the existence of any public database (or private data, for that matter: see Home Depot, Target, etc.)  But no, those risks do not outweigh the obvious public health benefits of mandated PDMP use by prescribing physicians.

As I've written before, mandating that pharmacies report prescription drug data into the PDMP is a start.  Mandating that physicians register as users is a next step.  But mandating that doctors check the database before writing prescriptions that could be potentially dangerous to a patient or a community is the key to a successful PDMP program.  

Otherwise, it's just data sitting in a database.  

Apparently, plans are in the works to bring back this particular component of Prop 46 in front of the legislature.  Hopefully, this time around, the scare tactics will be drowned out by the voices of reason.


Tuesday, November 4, 2014

Opioid-Related Emergency Room Visits Driving Costs

With all the focus on opioid overdose deaths, it's easy to forget that the actual death rate from opioid overdoses is surprisingly low.  In fact, the most common destination for most opioid overdoses isn't the grave - it's the emergency department, followed by an expensive hospital stay.

A new study published this week in the Journal of the American Medical Association estimates that there were over 92,000 ED visits related drug overdoses in 2010.  Of these visits to the emergency department:

  • 68% involved prescription opioids (vs. 16% for heroin)
  • 55% were admitted to the hospital where the average stay was 3.8 days, costing an estimated $1.4 billion in hospital care;
  • 53% were women;
  • 40% were in the South;
  • Only 1.4% of overdose-related ED visits resulted in death, suggesting our healthcare system's growing sophistication in dealing with this crisis.  
Overall, inpatient and ED costs for overdoses resulted in $2.4 billion in healthcare expenditures in 2010.  

I wonder how many claims organizations examine this specific metric as a proxy for injured worker safety: ED visits and/or costs that are medication related.  

In other words, how much of that $2.4 billion did you pay for?  


Monday, October 27, 2014

NNT in Pain Management: You've Been Right All Along

The National Safety Council's Dr. Don Teater, MD has penned a white paper that contains powerful data and interesting insights regarding the use of opioids for chronic non-cancer pain.  And it turns out, you've been right all along...

First, a pause for acronym education.  Just when you were getting a handle on MEDs... let me introduce you to NNT (number needed to treat).  This is a common measure in clinical studies that answers the question: how many people need to be treated with a given intervention for 1 person to receive a defined effect.  A lower NNT means the intervention is more effective (1 is the ideal... if you treat 1 person and that person achieves the defined effect, an NNT = 1 means you've got a really effective treatment).  A higher NNT means the intervention is less effective.

For instance, how many people need to be treated with Oxycodone 15 mg for 1 person to receive 50% pain relief?  Turns out the answer to that question is 4.6.

How many people need to be treated with a combination of ibuprofen 200 mg + acetaminophen 500 mg for 1 person to receive 50% pain relief?  Drum roll, please........ 1.6.

He also shares similar data from couple of other studies.

Why do providers turn to opioids so frequently in light of data such as this?  Why does this inherent belief exist that suggests opioids are more powerful analgesics?  Dr. Teater sites several reasons, but the two that caught my eye:

  1. Opioids exhibit powerful psychotherapeutic effects not found with ibuprofen and acetaminophen.  If a patient's back hurts, tylenol and advil will work fine.  If a patient's back hurts and they're depressed, opioids are more likely to be perceived by the patient as effective.  This sounds obvious to most of us, but separating the clinical effects of opioids into "analgesic" vs. "psychotherapeutic" has significant implications for the use of these medications.  
  2. The pharma companies have spent several billion dollars over two decades getting doctors comfortable with opioids.  Where there's money to be made... there's usually a rep standing by to help a doctor make a decision that may not be fully informed.  

Bottom line: You've been right all along.  For most patients, ibuprofen and acetaminophen are safer and more effective than opioids.  


Thursday, October 23, 2014

Guidelines That Matter, Part 2

Michigan is in the midst of developing opioid guidelines that matter (and yes, some guidelines matter more than others).  Guidelines that matter are specific, based on clinical evidence, and are tied to reimbursement.  Any guidelines that don't meet those criteria are mere suggestions that only help ensure the safety of injured workers in the most extreme circumstances (e.g., when a judge finally says to a doctor and patient, "that's enough with the opioids..." - and we all know how hard and expensive it is to get to that point).  Guidelines that matter exist within a regulatory structure and dispute resolution process that allows for mitigation of patient safety concerns without consistent involvement of judges.  Medical professionals should be able to work out these differences based on rational discussion and evidence based guidelines.

Michigan has taken a huge leap toward such an approach with the proposed draft of rules developed by the Health Services Committee of the state's Workers' Compensation Agency.  Paul Kauffman from Accident Fund chaired the committee and several other devoted members worked along with him for over a year on these draft guidelines.  

Voices of dissent have cropped up, predictably from plaintiff's attorneys that fear this is simply a mechanism to take away needed medications from injured workers.  I don't think that's the case here.  Candidly, Michigan is a state where it's far too hard to ensure injured worker safety and far too easy for injured workers to remain on dangerous levels of opioids for too long.  These guidelines clearly aren't aimed at people who genuinely need pain management therapy.  Rather, these guidelines are aimed at ensuring the safe and effective use of these medications.

In an effort to provide some transparency to the discussion, here's the exact proposed language.  In it, you'll find a list of best practices all doctors should follow.  You'll also find that doctors can be reimbursed for checking the state's prescription drug monitoring database.

Rule 1008a. (1) In order to receive reimbursement for opioid treatment beyond 90
days, the physician seeking reimbursement shall submit a written report to the payer
not later than 90 days after the initial opioid prescription fill for chronic pain and every
90 days thereafter. The written report shall include all of the following:
 (a) A review and analysis of the relevant prior medical history, including any
consultations that have been obtained, and a review of data received from an automated
prescription drug monitoring program in the treating jurisdiction, such as the
Michigan Automated Prescription System (MAPS), for identification of past history of
narcotic use and any concurrent prescriptions.
 (b) A summary of conservative care rendered to the worker that focused on increased
function and return to work.
 (c) A statement on why prior or alternative conservative measures were ineffective or
 (d) A statement that the attending physician has considered the results obtained from
appropriate industry accepted screening tools to detect factors that may significantly
increase the risk of abuse or adverse outcomes including a history of alcohol or other
substance abuse.
 (e) A treatment plan which includes all of the following:
 (i) Overall treatment goals and functional progress.
 (ii) Periodic urine drug screens.
 (iii) A conscientious effort to reduce pain through the use of non-opioid medications,
alternative non-pharmaceutical strategies, or both.
 (iv) Consideration of weaning the injured worker from opioid use.
 (f) An opioid treatment agreement that has been signed by the worker and the
attending physician. This agreement shall be reviewed, updated, and renewed every 6
months. The opioid treatment agreement shall outline the risks and benefits of opioid
use, the conditions under which opioids will be prescribed, and the responsibilities of
the prescribing physician and the worker.
 (2) The provider may bill the additional services required for compliance with these
rules utilizing CPT procedure code 99215 for the initial 90 day report and all
subsequent follow-up reports at 90-day intervals.
 (3) Providers may bill $25.00 utilizing code MPS01 for accessing MAPS or other
automated prescription drug monitoring program in the treating jurisdiction.
R 418.101008b Denial of reimbursement for prescribing and dispensing opioid
medications used to treat chronic, non-cancer pain.
 Rule 1008b. Reimbursement for prescribing and dispensing opioid medications may
be denied, pursuant to the act. Denial of reimbursement shall occur only after a
reasonable period of time is provided for the weaning of the injured worker from the
opioid medications, and alternative means of pain management have been offered.

Judge for yourself.


Tuesday, October 21, 2014

Chronic Pain Malpractice Claims Are Rising

I've been in more than a few meetings with payers discussing the problems with opioids when someone wonders aloud, "Why aren't some of these patients suing their doctors?"

Turns out, they are doing just that... in increasing numbers.

A study of malpractice claims over the last 30 years presented at the 2014 Annual Meeting of the American Society of Anesthesiologists concludes that the number of claims related to chronic pain management is increasing far out of proportion to the growth in the number of pain management practitioners.  Further, the analysis shows the prescription medications are playing a significant role.

As a proportion of anesthesia malpractice claims, those claims related to pain management rose from 3% in 1980 to 18% in 2012.  Medication management claims increased from 2% to 17% of anesthesiology malpractice claims.

Perhaps more alarming: in the 1980s, death was the cited reason for a claim 6% of the time and severe injury for another 6% (the rest of the claims related to temporary and/or minor injuries).  After 2000, death was cited in 19% of claims and severe injury in 28%.  That's nearly half of all chronic pain malpractice claims.

Not only are chronic pain malpractice claims becoming more frequent, but the resulting injuries are becoming much more severe.

What to do?

I'm not a lawyer, but it strikes me that payers should probably be having conversations about provider network strategy and sticky things like subrogation, right?  Where does work comp leave off and med mal pick up?  When a payer has done all they can legally do to provide safe care for an injured worker and the doctor continues to prescribe absurd levels of opioids... what are the options when that injured worker doesn't wake up one morning?


Monday, October 20, 2014

A Name You Should Know: Jack Conway

David Armstrong has written a piece on that should be required reading.  Not only does it recap the overarching legal strategies currently being pursued by various municipalities against manufacturers of painkillers, but it dives keep into Kentucky's battle - by far the longest and potentially most successful suit thus far.

Recall that in 2007, Purdue Pharma paid a $634 million fine in connection with inappropriate marketing of Oxycontin.  Of that fine, $160 million was specifically earmarked to reimburse the federal government and state governments for damages suffered by the Medicaid program.  Kentucky's share of that fine was to be $500,000.

Kentucky said "no thanks" and filed its own lawsuit.

Seven years later, we're as close as we've ever been to a trial and it's more likely than not that we'll see this trial play out at "ground zero" (Pike County prosecutor Rick Bartley's phrase, not mine) of the opioid epidemic.  For Purdue, whose chief financial officer is on record as saying that this could be a billion dollar case and would have a "crippling effect on Purdue's operations and jeopardize Purdue's long-term viability," this is nothing less than a "save the company" moment.

On the opposite side of the courtroom will be Kentucky Attorney General Jack Conway, a rising political star in the state.  He lost the 2010 US Senate Race to Rand Paul, but remains an up and comer in the Democratic party in Kentucky.  This is one of those cases in which an Attorney General can set himself up for future political wins.  And beyond that, I think he genuinely wants to do the right thing here.  And the right thing, according to Mr. Conway, is to hold Purdue accountable.  I met Mr. Conway and got to talk with him for a few minutes at last year's National Prescription Drug Abuse Summit in Atlanta.  He's the real deal.  He cares about the issue of prescription drug misuse and abuse.

The most interesting take-away from the article: Purdue hired an outside consultant to assess the likelihood of getting a fair trial in Kentucky.  The findings?

  • 40% of Pike County residents knew someone who had run into criminal trouble because of an Oxycontin addiction;
  • 33% knew someone who overdosed to was otherwise seriously hurt by the drug;
  • 29% knew someone who had died;
  • 90% agreed that Oxycontin had a "devastating effect" on the community.  
I'm not a legal expert.  I don't know if Purdue can get a fair trial in Pike County or not.  But either way, it sounds to me like there's going to be a fight - and a very public and very ugly fight at that.