Purdue Pharma is apparently working on an tamper-resistant formulation for stand-alone hydrocodone that may bump Zogenix's new extended release hydrocodone formulation, Zohydro, from the market. Purdue's drug has been through final stage trials and the drug company is now pushing for expedited FDA review. Zogenix is also working on an abuse-deterrent formulation, but that drug won't be ready for FDA review until 2016.
So is this good news? One of the most significant concerns about Zohydro is its lack of abuse-deterrent formulation. Is Purdue going to save the day?
Not from my perspective.
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
On Twitter @PRIUM1
Wednesday, March 12, 2014
Friday, March 7, 2014
Where Physicians MUST Check the PDMP
Oklahoma is inching closer to joining the small number of states that require physicians to check the prescription drug monitoring database in a given state prior to writing certain prescriptions. This isn't a mere reporting requirement; this is a requirement to consult the database and document the results in the medical record prior to writing a script (see section E on page 4 of the bill text).
Oklahoma Senate Bill 1821 has successfully passed through a senate committee and now heads to the full senate. The governor's office issued a press release on this, so I'm assuming the bill has a solid chance of ending up on Governor Fallin's desk.
Should she sign the bill into law, Oklahoma would join Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications. Like in similar legislation elsewhere, SB 1821 creates exemptions for hospice and other end-of-life care situations. Further, the bill prohibits lawsuits against physicians for not checking the database. While a patient couldn't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, prosecution, punishment, etc.
Mandating that pharmacies report prescription drug data into the PDMP is a start. Mandating that physicians sign up as users of the PDMP is a step. But mandating that doctors utilize the PDMP before they write a script and mandating they include evidence of database consultation as part of the patient medical record is the key to successful implementation of a PDMP program.
Otherwise, it's just data sitting in a database.
Michael
On Twitter @PRIUM1
Oklahoma Senate Bill 1821 has successfully passed through a senate committee and now heads to the full senate. The governor's office issued a press release on this, so I'm assuming the bill has a solid chance of ending up on Governor Fallin's desk.
Should she sign the bill into law, Oklahoma would join Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications. Like in similar legislation elsewhere, SB 1821 creates exemptions for hospice and other end-of-life care situations. Further, the bill prohibits lawsuits against physicians for not checking the database. While a patient couldn't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, prosecution, punishment, etc.
Mandating that pharmacies report prescription drug data into the PDMP is a start. Mandating that physicians sign up as users of the PDMP is a step. But mandating that doctors utilize the PDMP before they write a script and mandating they include evidence of database consultation as part of the patient medical record is the key to successful implementation of a PDMP program.
Otherwise, it's just data sitting in a database.
Michael
On Twitter @PRIUM1
Friday, February 28, 2014
Research: Weaning Works Wonders
I hear skepticism all the time about the difficulty of weaning patients off of high doses of opioids in the outpatient environment. Frankly, I hear skepticism about being able to wean them at all, but especially in the outpatient environment. And when the alternative involves inpatient detox (and its associated price tag), the claim handler often feels stuck.
New research suggests that not only is outpatient weaning possible, even in light of extremely high doses of opioids, but that the weaning has a positive clinical effect on the patient in terms of pain scores, depression levels, and activities of daily living.
In an admittedly small sample (16 patients), doctors weaned patients on an average of 945 mg morphine equivalent dosage - or MED (with a range of 300 mg MED to 2,960 MED) down to an average of 275 mg MED (with a range of 0-750 mg MED) over an average of 17.4 weeks.
The patients' average pain scores (measured via the Brief Pain Inventory) dropped from 7.2 to 4.9 and their average depression score (measured via the Patient Health Questionnaire-9) dropped from 13.5 to 9.5. The results were statistically significant.
The next step is clearly to replicate the research on a broader set of patients. That said, this research confirms what we're seeing at PRIUM among the legacy claim work comp population on high doses of opioids.
We can wean these patients. We can do it on an outpatient basis. They will get better as a result. They will cost less as a result.
Michael
On Twitter @PRIUM1
New research suggests that not only is outpatient weaning possible, even in light of extremely high doses of opioids, but that the weaning has a positive clinical effect on the patient in terms of pain scores, depression levels, and activities of daily living.
In an admittedly small sample (16 patients), doctors weaned patients on an average of 945 mg morphine equivalent dosage - or MED (with a range of 300 mg MED to 2,960 MED) down to an average of 275 mg MED (with a range of 0-750 mg MED) over an average of 17.4 weeks.
The patients' average pain scores (measured via the Brief Pain Inventory) dropped from 7.2 to 4.9 and their average depression score (measured via the Patient Health Questionnaire-9) dropped from 13.5 to 9.5. The results were statistically significant.
The next step is clearly to replicate the research on a broader set of patients. That said, this research confirms what we're seeing at PRIUM among the legacy claim work comp population on high doses of opioids.
We can wean these patients. We can do it on an outpatient basis. They will get better as a result. They will cost less as a result.
Michael
On Twitter @PRIUM1
Friday, February 14, 2014
Doctors No Longer Allowed to Take Patients' Blood Pressure
Ok, that's not true. But an analogous and equally dangerous law suit is unfolding in Indiana.
In response to our nation’s prescription opioid epidemic, several states have enacted laws to help stem the tide of opioid misuse and abuse. Notably, Indiana has passed a law requiring that patients prescribed opioids must submit to urine drug testing at the beginning of treatment and at least once a year thereafter. This type of testing is best practice, guidelines driven, and in the best interests of patient safety.
In response to our nation’s prescription opioid epidemic, several states have enacted laws to help stem the tide of opioid misuse and abuse. Notably, Indiana has passed a law requiring that patients prescribed opioids must submit to urine drug testing at the beginning of treatment and at least once a year thereafter. This type of testing is best practice, guidelines driven, and in the best interests of patient safety.
The American
Civil Liberties Union (ACLU) disagrees.
They’ve sued the state on behalf of a chronic pain patient who has been
prescribed opioids for 18 years and doesn’t want to submit to mandatory urine
drug testing. The ACLU claims such
testing is a violation of this man’s 4th amendment rights, which bar
illegal searches and seizures.
This is like a patient with diabetes suing over a doctor’s
assessment of his hemoglobin a1c levels.
Or a patient with high blood pressure suing over a nurse actually
putting a blood pressure cuff on the patient to assess his current BP. Or a patient on warfarin… or a statin… or any
other drug that requires constant clinical monitoring to ensure patient safety
and efficacy of the medication therapy.
Urine drug testing isn’t a “gotcha!” Healthcare providers and patients both
benefit from the information collected from such testing. Important clinical decisions about dosage,
efficacy, and side effects are influenced by urine drug testing results. Though rare, genetic abnormalities involving
the metabolism of opioid medications can be discovered through urine drug
testing.
These drugs are some of the most potent and dangerous
medications ever devised. And they are
miracle drugs for those who legitimately need them to function on a daily basis
or to provide comfort in the waning days of life. But to ensure safe, proper, and efficacious
use of these medications, testing such as that which Indiana mandates is more
than just good public policy – its good medicine.
Thursday, February 13, 2014
When Judges Get in the Way
Louisiana is a troubled state.
With five Circuit Courts of Appeal, a state law may be
interpreted in five different ways. A
new law may be found unconstitutional in one circuit, constitutional in
another, and it may be that no constitutional question in raised in the
others. As a result, when the
legislature makes a change to the law, it has to anticipate not just one unintended
interpretation, but, potentially, five distinct interpretations existing
simultaneously. It also has to
anticipate the possibility that none of those interpretations will allow the
new law to do what it was intended to do.
Again, Louisiana is a troubled state.
This is especially true when it comes to workers’
compensation. The Louisiana State
Legislature has made several attempts to promote responsible treatment of
injured workers, but it seems that each attempt has been undermined by at least
one of the five Circuit Courts of Appeal.
The legislature authorized independent medical examinations
(IMEs), but the Fourth Circuit ruled that an injured employee can’t be
compelled to attend an IME unless the employer already has medical evidence in
its possession showing that an IME is necessary.
The legislature authorized utilization review, but the Third
Circuit ruled that utilization review by itself was an insufficient basis for
denying treatment.
The legislature authorized the Workers’ Compensation
Administration to promulgate treatment guidelines in order to ensure that all
injured workers were treated according to a single standard of care based on
current medical evidence, but as of January 22nd, all but one of the appellate
courts have effectively ruled that Louisiana has two standards of care for
workers’ compensation claims.
On January 22nd, the Second Circuit Court of
Appeals found that the medical treatment guidelines authorized by § 23:1203.1
did not apply to those cases because the date of injury in each case predated
the effective date of the guidelines: July 13, 2011.
Following this ruling, a doctor treating an employee who was
injured on July 13, 2011 will have to comply with an enumerated standard of
care based on current medical research . A doctor treating an employee who was injured
on July 12, 2011 will have no such responsibility.
Louisiana law says that there will be new treatment
guidelines with new effective dates every two years. As Judge Caraway’s dissent points out, the
majority’s interpretation would create different sets of law for each two year
period.
Decisions like these are upsetting -- not just because they
fail to address the problem of irresponsible treatment… not just because they create
a new problem by creating (at least) two very different standards of care… but
because they bind the hands of the only people who can fix that problem.
Wednesday, February 12, 2014
Addiction: Not About "Good Guys" vs. "Bad Guys"
I recently read an appeal
by Dr. Kelly Erola, CMO for Hospice Savannah. She wrote about halting the attack on pain
pills and argued on behalf of legitimate uses for opioids – cancer patients
undergoing chemotherapy, hospice patients, and patients with serious injuries
and acute pain.
She makes an important point. Opioids are an
effective and powerful tool that bring immeasurable relief to individuals
suffering severe pain. Let’s be sure
that those individuals always have a means of getting the care and the drugs
that they need.
What struck me was the contrast she drew between “law-breaking
addicts” and “law-abiding patients.” In
my view, this is a component of our societal struggle with opioids, but misses
the most fundamental and dangerous aspect of the opioid crisis: the group that lies
in the middle – “law-abiding addicts”.
Yes, pill mills are a problem. So is drug diversion. So is the unintended consequence of illicit
drug use. But the group most in danger is,
in fact, the law-abiding patient whose physician is prescribing high doses of
opioids to treat conditions such as non-specific low back pain. Millions of patients are losing out on the
benefits of what contemporary medical evidence tells us is most appropriate for
the treatment of chronic pain: get up, move, exercise, lose weight, sleep
better. Instead, physicians continue to
write prescriptions for powerful pain relievers, leaving us with millions of “law-abiding
addicts”.
Any clinician will rightfully point out that I’m taking
certain liberties with the word “addict” here.
Addiction is a real disease characterized by aberrant, drug-seeking
behaviors – the very behaviors that often lead to illegal activity on the part
of the patient. The point I’m trying to
make is that many of these “addicts” didn’t start out as criminals. And there are millions of patients not
technically addicted, but nonetheless entirely dependent on prescription
opioids on a daily basis. Dr. Erola highlights a single battle in the opioid crisis, but this is where
we’re losing the war.
If the public policy distinction was as black and white as
Dr. Erola suggests, the solutions would be simpler. In reality, the problem of prescription drug
misuse and abuse goes well beyond a simple matter of “good guys vs. bad guys”. Any public health or regulatory discussion around
opioids has to acknowledge that there are lots of “good guys” (i.e., law-abiding
patients) being hurt, too.
Tuesday, January 28, 2014
Closed Formularies Control Drug Utilization
In July of 2012 we took a look at
the early results of the prescription drug formulary in Ohio
and in Texas. Both were showing signs of
favorable results.
Where do we sit 18 months later? In a word, progress.
The Ohio Bureau of Workers Compensation has recently reported a reduction in
prescription drug costs by $22.2 million (16%) since the formulary went into
effect. Included in that curtailment is an 18.1% reduction in narcotic
prescriptions and a 36.4 % reduction in skeletal muscle relaxants for the first
half of 2013 as compared to the first half of 2012. (BWC Annual Report)
Texas has seen even greater
results between its two categories of claims.
For injured workers’ with dates of injury after September 2011, prescription
rates of drugs not recommended by the Texas closed formulary dropped 56% - a
number matched by a cost reduction of over 81%.
Legacy Claims posted similar results with a 23 % reduction in prescriptions
and a 21% reduction in cost. (TDI, Workers’ Compensation Research and
Evaluation Group, 2013.)
While the closed formularies are clearly
having a meaningful impact on prescription drug costs in these states, the
approaches differ quite drastically.
Ohio, a monopolistic work comp state, has implemented a closed formulary
that it developed on its own. Texas is
relying on its well established utilization review process and a third party
set of guidelines (ODG’s N drugs) for its implementation of a closed
formulary. Take-away: there are
different ways of implementing the concept that have been proven to work.
Closed formularies aren’t
implemented over night. If other states
want to start making meaningful impacts to their prescription drug costs at any
point in the near future, decision makers had better have some big plans for
their upcoming legislative sessions.
Monday, January 27, 2014
Fighting Over Fee Schedules
Referencing a new draft bill in Wisconsin seeking to
establish a medical fee schedule for workers’ compensation, Mark M. Grapentine,
a senior vice president of government relations for the Wisconsin Medical
Society, is on the record as saying, “This
will cause a holy war at the capital.”
Might have phrased it differently, but I get his point. He might not even be far off the mark. There are some big stakeholders involved and
one of them (the physicians) wasn’t invited to the table.
A fee schedule seems like a straightforward way to combat
medical inflation and workers’ compensation reimbursement severity, but a
glance at price and utilization numbers out of Wisconsin wouldn’t suggest such
a legislative move is necessary. The
linked article points out, courtesy of the National Council on Compensation
Insurance, Wisconsin ranks in the top third of all states considered with one
of the lowest average costs per medical claim filed between 2010 and 2012. Similarly Wisconsin can boast the fewest work
days lost to disability by total disability claim of any state.
To some extent, we know
what to expect with the implementation of a fee schedule: a negligible
impact on utilization and an inelastic price response. The recent WCRI study on the impact of a fee
schedule adjustment in Illinois serves as an excellent case study. While there was a 30 percent reduction in the
Illinois medical fee schedule enacted in 2011, medical prices on average fell
24 percent. This was accompanied,
however, by more frequent billing of costlier and more complex offices visits.
My guess? This is a
result of income targeting.
An implementation of a fee schedule in Wisconsin might
similarly leave providers to pursue income targeting – increasing the amount of
services provided to maintain the previous income level. Or it might cause providers to exit the business. As always time will tell and hopefully
someone’s keeping track.
The economic recovery, while slow, is still ongoing. As employment numbers rise, so do workers’
compensation claims and expenditures. A
fee schedule is a means of controlling costs, but it may do so at the cost of
quality services and overburdened physicians. And lest we forget, the full impact of the
Affordable Care Act has yet to play itself out as well.
I’d be surprised if Wisconsin legislators were eager to move
on a new fee schedule.
Tuesday, January 14, 2014
The Truth About Lost Prescriptions
If you live in Stillwater, Oklahoma and you lose your prescription drugs, the police will be happy to help you. You just have to take a lie detector test first.
Seriously.
Police in Stillwater have begun keeping a database of any citizen reporting lost prescription drugs. Turns out that local doctors are refusing to replace lost prescriptions without a police report detailing the theft of the original prescription. And some citizens have apparently filed false police reports in order to secure additional prescriptions. Now, if you've already filed one report, police will require a polygraph test before any subsequent police report can be made.
While I'm honestly ambivalent, this policy highlights one of the key factors we often gloss over in the public discussion of prescription drug misuse and abuse: community risk. Often, our dialog, debate, and discourse are focused on individual patient risk and the clinical safety, or lack thereof, of long term opioid use for chronic non-cancer pain. Policies such as Stillwater's place appropriate emphasis on the overall risk to the community of over-prescribing opioids.
The two most common inconsistencies we see from drug test results on our files are a) too much of a particular medication or b) a medication that's supposed to show up that doesn't. Whenever we see "a", we worry about the clinical risk to the patient. Whenever we see "b", we worry about the risk to that patient's community, including their immediate family. Let's face it, those drugs are likely going somewhere. Even if the injured worker isn't engaged in illegal activity (most often, they're not), those medications not consumed by the injured worker can end up in the hands of friends, neighbors, children, or spouses. This puts our communities at risk.
I suspect Stillwater won't be the last place we see this policy enacted.
So... should police require polygraph tests to file a police report for prescription drugs?
Or have they gone a step too far?
Michael
On Twitter @PRIUM1
Seriously.
Police in Stillwater have begun keeping a database of any citizen reporting lost prescription drugs. Turns out that local doctors are refusing to replace lost prescriptions without a police report detailing the theft of the original prescription. And some citizens have apparently filed false police reports in order to secure additional prescriptions. Now, if you've already filed one report, police will require a polygraph test before any subsequent police report can be made.
While I'm honestly ambivalent, this policy highlights one of the key factors we often gloss over in the public discussion of prescription drug misuse and abuse: community risk. Often, our dialog, debate, and discourse are focused on individual patient risk and the clinical safety, or lack thereof, of long term opioid use for chronic non-cancer pain. Policies such as Stillwater's place appropriate emphasis on the overall risk to the community of over-prescribing opioids.
The two most common inconsistencies we see from drug test results on our files are a) too much of a particular medication or b) a medication that's supposed to show up that doesn't. Whenever we see "a", we worry about the clinical risk to the patient. Whenever we see "b", we worry about the risk to that patient's community, including their immediate family. Let's face it, those drugs are likely going somewhere. Even if the injured worker isn't engaged in illegal activity (most often, they're not), those medications not consumed by the injured worker can end up in the hands of friends, neighbors, children, or spouses. This puts our communities at risk.
I suspect Stillwater won't be the last place we see this policy enacted.
So... should police require polygraph tests to file a police report for prescription drugs?
Or have they gone a step too far?
Michael
On Twitter @PRIUM1
Wednesday, January 8, 2014
Closed Formularies: Not All Created Equal
Oklahoma is getting ready to launch a "closed formulary." Among the many reasons Oklahoma is pursuing this regulatory change must be the success enjoyed by its neighbor Texas.
Texas has seen an 80% drop in the cost of "N" drugs for new injuries as of September 1, 2011. For those injuries that occurred prior to September of 2011 (referred to as "legacy claims" in the rules), Texas provided for a two year remediation period (September of 2011 to September of 2013) for payers and providers to communicate with one another regarding the applicability of the closed formulary on a claim by claim basis. This process led to the weaning/discontinuation of "N" drugs on 47% of legacy claims. Impressive.
Unfortunately, Oklahoma's version of the closed formulary has zero chance of replicating these results.
To quote from PRIUM's public comments, submitted to the Oklahoma Workers' Compensation Commission last week:
"The proposed rules identify two groups of claims that will be subject to the closed formulary rules:
1.) Those with a date of injury on or after 11/1/14, and
2.) “Legacy claims” – those with a date of injury on or after 2/1/14, but
before 11/1/14.
It appears that claims with a date of injury prior to 2/1/14 will not be governed by the closed formulary rules. If this is the case, this distinction will effectively create two standards of care for injured workers based on their date of injury.
Other states have countered this problem by applying new laws retroactively with a sufficient transition period for older claims (often referred to as “legacy claims”). While the proposed rules do identify a particular group of claims as “legacy claims” and allow these claims to benefit from a transition period before they are subject to the closed formulary rules, claims with a date of injury prior to 2/1/14 do not fall within the proposed definition of “legacy claims” and are not made subject to the closed formulary rules. Because of this, the inclusion of a transition period for legacy claims fails to remedy the problem of disparate standards of care, as older claims (those with a date of injury prior to 2/1/14) do not become subject to the closed formulary rules at any point, not even after legacy claims have become subject to the closed formulary rules on 11/1/16.
We acknowledge that the Administrative Workers’ Compensation Act limits the authority of the Commission, but we sincerely hope that legislature will either authorize the Workers’ Compensation Court of Existing Claims to adopt the Commission’s closed formulary rules, or that the legislature will authorize the Commission to extend the closed formulary rules to affect claims with a date of injury prior to 2/1/14."
So don't get your hopes up regarding the Oklahoma closed formulary. They have a long way to go, legislatively speaking, before the state can claim to have adequately addressed the problem of prescription drug misuse and abuse within the work comp system.
Michael
On Twitter @PRIUM1
Texas has seen an 80% drop in the cost of "N" drugs for new injuries as of September 1, 2011. For those injuries that occurred prior to September of 2011 (referred to as "legacy claims" in the rules), Texas provided for a two year remediation period (September of 2011 to September of 2013) for payers and providers to communicate with one another regarding the applicability of the closed formulary on a claim by claim basis. This process led to the weaning/discontinuation of "N" drugs on 47% of legacy claims. Impressive.
Unfortunately, Oklahoma's version of the closed formulary has zero chance of replicating these results.
To quote from PRIUM's public comments, submitted to the Oklahoma Workers' Compensation Commission last week:
"The proposed rules identify two groups of claims that will be subject to the closed formulary rules:
1.) Those with a date of injury on or after 11/1/14, and
2.) “Legacy claims” – those with a date of injury on or after 2/1/14, but
before 11/1/14.
It appears that claims with a date of injury prior to 2/1/14 will not be governed by the closed formulary rules. If this is the case, this distinction will effectively create two standards of care for injured workers based on their date of injury.
Other states have countered this problem by applying new laws retroactively with a sufficient transition period for older claims (often referred to as “legacy claims”). While the proposed rules do identify a particular group of claims as “legacy claims” and allow these claims to benefit from a transition period before they are subject to the closed formulary rules, claims with a date of injury prior to 2/1/14 do not fall within the proposed definition of “legacy claims” and are not made subject to the closed formulary rules. Because of this, the inclusion of a transition period for legacy claims fails to remedy the problem of disparate standards of care, as older claims (those with a date of injury prior to 2/1/14) do not become subject to the closed formulary rules at any point, not even after legacy claims have become subject to the closed formulary rules on 11/1/16.
We acknowledge that the Administrative Workers’ Compensation Act limits the authority of the Commission, but we sincerely hope that legislature will either authorize the Workers’ Compensation Court of Existing Claims to adopt the Commission’s closed formulary rules, or that the legislature will authorize the Commission to extend the closed formulary rules to affect claims with a date of injury prior to 2/1/14."
So don't get your hopes up regarding the Oklahoma closed formulary. They have a long way to go, legislatively speaking, before the state can claim to have adequately addressed the problem of prescription drug misuse and abuse within the work comp system.
Michael
On Twitter @PRIUM1
Friday, December 13, 2013
A Critique of the American College of Physicians Position Paper on Prescription Drug Abuse
The American College of Physicians (ACP) just published a
“position paper” on prescription drug abuse.
While one might find fault in the details of such exercises (and I do…
please read on), one should also commend such organizations for attempting
to tackle this very difficult issue. As
the paper states, “the challenge for physicians and public policymakers is how
to deter prescription drug abuse while maintaining patient access to
appropriate treatment.” A challenge,
indeed. In fact, it’s one of the most
significant public health challenges in a generation.
The paper includes several very helpful statements,
including recommendations for:
-
A national prescription drug monitoring program
(PDMP)
-
Consideration by physicians of “the full array
of treatments available for the effective treatment and management of pain.”
-
A comprehensive national policy on prescription
drug abuse
-
The adoption of evidence-based medical treatment
guidelines
On the other hand, several of the other recommendations come
with caveats that are hard to explain given the breadth and depth of the
prescription drug abuse epidemic. For
instance:
The ACP “supports efforts to education physicians… on the
appropriate medical uses of controlled drugs and the dangers of both medical and
nonmedical use of prescription drugs.”
However, the ACP goes on to say that “it does not support additional
legislative mandates or DEA registration prerequisites specifying education
requirements regarding prescribing controlled substances.” Why not?
“The prevention, identification, and treatment of prescription drug
abuse take time, and the significant extra time required to adequately perform
this task is not reimbursed.” I find
that a relatively weak rationale for the avoidance of mandatory education in
light of the largest man-made epidemic in history.
Education isn’t the only area where the economics of
physician practice run afoul of potential best practices. “ACP favors a fair and balanced approach to
permit safe and effective medical treatment utilizing controlled substances and
efforts to reduce prescription drug abuse.
However, educational, documentation, and treatment requirements toward
this goal should not impose excessive burdens on prescribers or
dispensers.” I’m not suggesting that
it’s ok for the provider community to bear excessive administrative burdens,
but the position paper goes on to state that the real issues are potential loss
of DEA licensure, state disciplinary actions, loss of medical license, and
potential criminal sanctions based on failure to comply with documentation and
treatment requirements. We have reviewed
thousands of pages of medical records here at PRIUM and I can vouch for the
fact that most of them are awful. The
documentation related to chronic opioid therapy is critical to the physician
education the ACP says it supports.
Lives are stake. Our view: At a
minimum, make sure documentation is thorough, accurate, and in compliance with
legislative and regulatory standards. Do
it right or face penalties.
The ACP appears to reluctantly support random drug testing when
Medicare, Medicaid, private insurance, or law enforcement authorities identify
patients as being at significant risk of drug abuse. They emphasize that the 3rd party requiring
such testing should pay for that testing (to which I have no objection), but go
on to point out that when a third party mandates drug testing, the patient
should be informed that the testing will occur on a random basis, patient
consent should be obtained, and the procedure should be implemented in a manner
that helps maintain the patient’s dignity.
Finally, the ACP points out that this recommendation only applies to
third party mandated testing rather than a situation in which a physician
includes monitoring as part of an overall treatment plan developed to meet the
evaluated needs of a given patient. Not
one mention of the necessity of random drug monitoring to ensure both patient
and community safety.
The ACP position paper is a start, but rather than balancing
deterrence of prescription drug abuse with access to appropriate treatment, the
ACP appears more focused on balancing deterrence of prescription drug abuse with
physician practice processes and economics.
Thursday, December 5, 2013
California: What's Working, What's Not
I spent some time recently visiting PRIUM's customers in California, a state that might as well be its own country when it comes to workers compensation (and lots of other things). Some specific observations based on my interactions with carriers, self-insured employers, TPAs, and attorneys around the issues of chronic pain management and prescription drug utilization:
The IMR backlog is as frustrating as it is predictable. While the DWC has recently called for a public meeting to gather input on process optimization, the case load continues to mount at Maximus. My own reading of the publicly available IMR decisions has uncovered some disturbing results (like Maximus case number CM13-0000947, the summary of which states that Valium, Duragesic, and Norco are all "medically necessary and appropriate." Read further into the detail of the report, however, and each of these three drugs is actually deemed NOT medically necessary and appropriate. A typo, yes... but a pretty critical one). The results of the medication-related cases that are being acted upon appear favorable amongst PRIUM's customers that have used our peer review, oversight, and utilization review services. Until the process is somehow changed, its incumbent upon payers to have an airtight process to avoid procedural errors and ensure predictable, accurate results that are in the best interest of injured worker health.
Payers are spending way too much on ineffective urine drug monitoring services. I see broad-based intellectual acknowledgement by payers that drug testing should be a part of any chronic opioid therapy regimen. But there remains confusion around implementation, pricing, and what to do with the results. Best practice here is not just to secure a contracted rate with a national drug monitoring vendor, but to develop a process to ensure optimization of the testing process. This means that injured workers are tested at the right time, in the right place, using the best technology and that the results are communicated to the provider and payer as actionable intelligence that informs treatment decisions (not just a diagnostic test that gets thrown in a file). We have a long way to go before this kind of methodical approach is commonplace.
The use of independent medical exams allowed under Labor Code Section 4050 varies widely, but should be used more often. If PRIUM is unable to engage the prescriber in a peer to peer conversation, we ask ourselves, "is there another way to gather information about the injured worker's care? Without having to go directly to UR/IMR and all of its timelines, technicalities, and backlogs?" Several payers in California use these 4050 exams to do just that. What's more, the results of a 4050 exam may be used in the UR/IMR process later and may (under certain circumstances) be admissible in the AME/QME process (if applicable). We're always looking for ways to inject independent, objective, evidence-based views on complex cases and this is another tool available to payers in California - more of whom, in our opinion, should be using 4050 exams.
"Functional Restoration Programs" in California are fast becoming a routine, expensive, and ineffective answer to prescription drug overutilization. Some payers talk about these programs with such disdain and disappointment that it's downright depressing. I asked every customer we met with, "who do you like? where should we send them?" I got a few suggestions, but not many. The few I got are probably familiar to most payers, but in a state with as big an issue as California, there's a dearth of effective alternative treatment centers for injured workers.
By the way, should anyone disagree with that last point and wish to share other treatment programs in California that have great outcomes... I'm more than willing to listen.
Michael
On Twitter @PRIUM1
The IMR backlog is as frustrating as it is predictable. While the DWC has recently called for a public meeting to gather input on process optimization, the case load continues to mount at Maximus. My own reading of the publicly available IMR decisions has uncovered some disturbing results (like Maximus case number CM13-0000947, the summary of which states that Valium, Duragesic, and Norco are all "medically necessary and appropriate." Read further into the detail of the report, however, and each of these three drugs is actually deemed NOT medically necessary and appropriate. A typo, yes... but a pretty critical one). The results of the medication-related cases that are being acted upon appear favorable amongst PRIUM's customers that have used our peer review, oversight, and utilization review services. Until the process is somehow changed, its incumbent upon payers to have an airtight process to avoid procedural errors and ensure predictable, accurate results that are in the best interest of injured worker health.
Payers are spending way too much on ineffective urine drug monitoring services. I see broad-based intellectual acknowledgement by payers that drug testing should be a part of any chronic opioid therapy regimen. But there remains confusion around implementation, pricing, and what to do with the results. Best practice here is not just to secure a contracted rate with a national drug monitoring vendor, but to develop a process to ensure optimization of the testing process. This means that injured workers are tested at the right time, in the right place, using the best technology and that the results are communicated to the provider and payer as actionable intelligence that informs treatment decisions (not just a diagnostic test that gets thrown in a file). We have a long way to go before this kind of methodical approach is commonplace.
The use of independent medical exams allowed under Labor Code Section 4050 varies widely, but should be used more often. If PRIUM is unable to engage the prescriber in a peer to peer conversation, we ask ourselves, "is there another way to gather information about the injured worker's care? Without having to go directly to UR/IMR and all of its timelines, technicalities, and backlogs?" Several payers in California use these 4050 exams to do just that. What's more, the results of a 4050 exam may be used in the UR/IMR process later and may (under certain circumstances) be admissible in the AME/QME process (if applicable). We're always looking for ways to inject independent, objective, evidence-based views on complex cases and this is another tool available to payers in California - more of whom, in our opinion, should be using 4050 exams.
"Functional Restoration Programs" in California are fast becoming a routine, expensive, and ineffective answer to prescription drug overutilization. Some payers talk about these programs with such disdain and disappointment that it's downright depressing. I asked every customer we met with, "who do you like? where should we send them?" I got a few suggestions, but not many. The few I got are probably familiar to most payers, but in a state with as big an issue as California, there's a dearth of effective alternative treatment centers for injured workers.
By the way, should anyone disagree with that last point and wish to share other treatment programs in California that have great outcomes... I'm more than willing to listen.
Michael
On Twitter @PRIUM1
Wednesday, November 13, 2013
Why Do Doctors Keep Prescribing?
The New Yorker published a great piece on the prescription drug epidemic this week. The article is written by Celine Gounder, a physician with personal experience dealing with chronic pain patients.
I found one section of the article particularly helpful in explaining why doctors prescribe these powerful medications even when many of them know it's wrong for the patient:
"The pain-pill epidemic has also forced doctors like me to consider our own role. Doctors have a duty to relieve suffering, and many of us became doctors to help people. But giving that help isn’t straightforward, especially when it comes to chronic pain. Try explaining the downsides of narcotics to a patient while declining to give him the medication he wants. He might accuse you of not understanding because you’re not the one in pain; he might question why you won’t give him what another doctor prescribed; he might give you a bad rating on a doctor-grading Web site. He might even accuse you of malpractice. None of this is rewarding for doctors: we’re frustrated that we can’t cure the pain, and that our patients end up upset with us.
Doctors have a hard time saying no, whether a patient is asking for a narcotic to relieve pain or an antibiotic for the common cold. We are predisposed to say yes, even if we know it isn’t right. Some of us just don’t want to take the extra time during a busy day to explain why that prescription for a narcotic isn’t a good idea. Some of us also use the promise of prescription narcotics to persuade patients to keep their medical appointments, or to take their other medications."
This is the reality in the average physician's office today. These are the cold hard facts of dependence and addiction. And this is why the inappropriate use of prescription pain killers isn't going away any time soon.
This is also why we have to come at these prescribers with more than just medical treatment guidelines that suggest the current drug regimen is inappropriate. Many of these doctors (whether they openly acknowledge it or not) are already aware that the treatment is outside the boundaries of contemporary medical evidence.
So what do we do?
1) Prevent the inappropriate use of these medications in the first place.
2) Where dependence or addiction has arisen, offer the doctor and injured worker alternatives. Cognitive behavioral therapy, functional restoration, referrals to a specialist, comprehensive pain programs, etc.
Is the quality of these various options highly variable? Yes.
Are they potentially expensive? Some more than others, but yes, there's cost associated with these paths.
But as PRIUM's own Nurse Linda likes to say, "If you're going to take away my Hershey Kisses, you have to give me something else."
Michael
On Twitter @PRIUM1
I found one section of the article particularly helpful in explaining why doctors prescribe these powerful medications even when many of them know it's wrong for the patient:
"The pain-pill epidemic has also forced doctors like me to consider our own role. Doctors have a duty to relieve suffering, and many of us became doctors to help people. But giving that help isn’t straightforward, especially when it comes to chronic pain. Try explaining the downsides of narcotics to a patient while declining to give him the medication he wants. He might accuse you of not understanding because you’re not the one in pain; he might question why you won’t give him what another doctor prescribed; he might give you a bad rating on a doctor-grading Web site. He might even accuse you of malpractice. None of this is rewarding for doctors: we’re frustrated that we can’t cure the pain, and that our patients end up upset with us.
Doctors have a hard time saying no, whether a patient is asking for a narcotic to relieve pain or an antibiotic for the common cold. We are predisposed to say yes, even if we know it isn’t right. Some of us just don’t want to take the extra time during a busy day to explain why that prescription for a narcotic isn’t a good idea. Some of us also use the promise of prescription narcotics to persuade patients to keep their medical appointments, or to take their other medications."
This is the reality in the average physician's office today. These are the cold hard facts of dependence and addiction. And this is why the inappropriate use of prescription pain killers isn't going away any time soon.
This is also why we have to come at these prescribers with more than just medical treatment guidelines that suggest the current drug regimen is inappropriate. Many of these doctors (whether they openly acknowledge it or not) are already aware that the treatment is outside the boundaries of contemporary medical evidence.
So what do we do?
1) Prevent the inappropriate use of these medications in the first place.
2) Where dependence or addiction has arisen, offer the doctor and injured worker alternatives. Cognitive behavioral therapy, functional restoration, referrals to a specialist, comprehensive pain programs, etc.
Is the quality of these various options highly variable? Yes.
Are they potentially expensive? Some more than others, but yes, there's cost associated with these paths.
But as PRIUM's own Nurse Linda likes to say, "If you're going to take away my Hershey Kisses, you have to give me something else."
Michael
On Twitter @PRIUM1
Tuesday, November 5, 2013
FDA 2013: A Study in Inconsistency
Let's review the recent activities of the Food and Drug Administration in the area of prescription opioids. If you're scratching your head as you read this, know that you won't be alone:
April 16, 2013:
The FDA announced two related decisions simultaneously. First, they approved updated labeling (i.e., extended the patent for) Purdue Pharma's Oxycontin ER in light of its new abuse-deterrent formulation. Second, the FDA determined that the original formulation of the same drug was pulled from the market in August of 2010 due to concerns about safety. This means that the FDA will not accept or approve any generic forms of the original Oxycontin ER. I wrote about this back in May.
This isn't great news for payers, but it's not the worst possible outcome. Yes, we'll all be paying more for a patent-protected extended release opioid, but I've spoken to many that believe a cheap generic version of this same drug would have created more patient safety issues and more expensive claims over the long term.
My view: Good news.
May 7, 2013:
The FDA approves the generic form of Opana ER, despite the fact that the maker of Opana, Endo Pharmaceuticals, had reformulated the drug with its own abuse-deterrent technology. The FDA claimed the new formulation wasn't more likely to deter abuse than the original formulation. Yes, extended release oxymorphone will be a lot cheaper. But it will also be a lot easier to abuse, it's street price will be attractive for those who might think of diverting medication, and the consequences (both clinical and financial) will be significant.
My view: I'm confused.
But wait, the message gets even more muddled...
September 10, 2013:
The FDA announced label changes to extended release / long acting opioids to indicate that these drugs are appropriate only for "the management of pain severe enough to require around the clock, long-term opioid treatment and for which alternative treatment options are inadequate." The FDA also mandated label changes to include warnings to pregnant women and a requirement for additional post-market studies on drug safety. While these changes are unlikely to impact prescribing behavior in the near term, they at least offered a signal from the government that the FDA understood the issue.
My view: Good news.
October 24, 2013
The FDA formally recommended that the Department of Health and Human Services tell the Drug Enforcement Agency to reclassify products containing hydrocodone to from Schedule III to Schedule II, placing more controls on these drugs. There are pros and cons to this recommendation and I've talked with many pharmacists who have legitimate concerns about patient access. That said, the overwhelming consensus appears to be that patient safety and public safety demand that these drugs be more tightly controlled.
My view: More good news.
October 25, 2013 (the very next day!):
The FDA announced the approval of Zohydro ER, an extended release form of hydrocodone that is likely to come in doses 5-10 times more powerful than existing products containing hydrocodone and which lacks any abuse-deterrent technology. This approval comes over the objection of the FDA's own advisory panel, which voted in December (11-2) against the approval of the drug. Further, the study methods used in the approval process were questionable, at best.
My view: Wait... what?
I'm certain the FDA holds the view that in each of these cases, the agency responded directly and objectively to the data that was presented. But historical experience, public health data, and common sense tell us that the FDA still doesn't get it.
I wonder what 2014 will bring.
Michael
On Twitter @PRIUM1
April 16, 2013:
The FDA announced two related decisions simultaneously. First, they approved updated labeling (i.e., extended the patent for) Purdue Pharma's Oxycontin ER in light of its new abuse-deterrent formulation. Second, the FDA determined that the original formulation of the same drug was pulled from the market in August of 2010 due to concerns about safety. This means that the FDA will not accept or approve any generic forms of the original Oxycontin ER. I wrote about this back in May.
This isn't great news for payers, but it's not the worst possible outcome. Yes, we'll all be paying more for a patent-protected extended release opioid, but I've spoken to many that believe a cheap generic version of this same drug would have created more patient safety issues and more expensive claims over the long term.
My view: Good news.
May 7, 2013:
The FDA approves the generic form of Opana ER, despite the fact that the maker of Opana, Endo Pharmaceuticals, had reformulated the drug with its own abuse-deterrent technology. The FDA claimed the new formulation wasn't more likely to deter abuse than the original formulation. Yes, extended release oxymorphone will be a lot cheaper. But it will also be a lot easier to abuse, it's street price will be attractive for those who might think of diverting medication, and the consequences (both clinical and financial) will be significant.
My view: I'm confused.
But wait, the message gets even more muddled...
September 10, 2013:
The FDA announced label changes to extended release / long acting opioids to indicate that these drugs are appropriate only for "the management of pain severe enough to require around the clock, long-term opioid treatment and for which alternative treatment options are inadequate." The FDA also mandated label changes to include warnings to pregnant women and a requirement for additional post-market studies on drug safety. While these changes are unlikely to impact prescribing behavior in the near term, they at least offered a signal from the government that the FDA understood the issue.
My view: Good news.
October 24, 2013
The FDA formally recommended that the Department of Health and Human Services tell the Drug Enforcement Agency to reclassify products containing hydrocodone to from Schedule III to Schedule II, placing more controls on these drugs. There are pros and cons to this recommendation and I've talked with many pharmacists who have legitimate concerns about patient access. That said, the overwhelming consensus appears to be that patient safety and public safety demand that these drugs be more tightly controlled.
My view: More good news.
October 25, 2013 (the very next day!):
The FDA announced the approval of Zohydro ER, an extended release form of hydrocodone that is likely to come in doses 5-10 times more powerful than existing products containing hydrocodone and which lacks any abuse-deterrent technology. This approval comes over the objection of the FDA's own advisory panel, which voted in December (11-2) against the approval of the drug. Further, the study methods used in the approval process were questionable, at best.
My view: Wait... what?
I'm certain the FDA holds the view that in each of these cases, the agency responded directly and objectively to the data that was presented. But historical experience, public health data, and common sense tell us that the FDA still doesn't get it.
I wonder what 2014 will bring.
Michael
On Twitter @PRIUM1
Monday, November 4, 2013
Close to Home: Tragedies Continue
I came to work Friday to learn that a family friend of two PRIUM employees had passed away from a heroin overdose after a year-long struggle with prescription pain pills. This morning, I found a note in my inbox from one of our physician reviewers about an incredibly sad (and similar) story about a 25-year old New York man who overdosed on heroin after a battle with prescription drugs.
Sitting on my desk is the latest copy of Business Insurance with a front page article about the risks facing physicians who attempt to wean or discontinue prescription drugs. Some doctors feel threatened by some addicts who appear to be willing to inflict physical harm or engage in violence in order to get what they want. The story was light on actual statistics, but the phenomenon is real. We hear about it all the time among the prescribers we engage.
I read last week about Joe Paduda's survey on opioids in work comp. "Here's the key takeaway," he wrote, "most respondents understand the problem and know (generally) what needs to be done, but their organizations aren't doing many of the things they should be." I couldn't possibly agree more with that statement.
Depressing, right?
Time to roll up our sleeves and work harder. We have to do more to educate, to engage, to change this destructive pattern of "treatment."
The note from PRIUM's physician reviewer summed it up: "Please, please, please keep pushing your message. I keep trying to tell my [peer to peer] providers that this is not about the money!"
There's no doubt in my mind our efforts help save payers money. There's no avoiding that, frankly. But we're helping to improve people's lives and, in some cases, save people's lives.
Happy Monday. Let's get to work.
Michael
On Twitter @PRIUM1
Sitting on my desk is the latest copy of Business Insurance with a front page article about the risks facing physicians who attempt to wean or discontinue prescription drugs. Some doctors feel threatened by some addicts who appear to be willing to inflict physical harm or engage in violence in order to get what they want. The story was light on actual statistics, but the phenomenon is real. We hear about it all the time among the prescribers we engage.
I read last week about Joe Paduda's survey on opioids in work comp. "Here's the key takeaway," he wrote, "most respondents understand the problem and know (generally) what needs to be done, but their organizations aren't doing many of the things they should be." I couldn't possibly agree more with that statement.
Depressing, right?
Time to roll up our sleeves and work harder. We have to do more to educate, to engage, to change this destructive pattern of "treatment."
The note from PRIUM's physician reviewer summed it up: "Please, please, please keep pushing your message. I keep trying to tell my [peer to peer] providers that this is not about the money!"
There's no doubt in my mind our efforts help save payers money. There's no avoiding that, frankly. But we're helping to improve people's lives and, in some cases, save people's lives.
Happy Monday. Let's get to work.
Michael
On Twitter @PRIUM1
Tuesday, October 15, 2013
Rx Abuse: Where Does Your State Stand?
The National Safety Council just released its report on state efforts to combat prescription drug abuse. The news is not good. According to the report, only three states (Washington, Kentucky, and Vermont) met the standards outlined in the report.
A few observations:
First, the standards established by the report are a good, solid start for preventing prescription drug abuse. They include assessment of Prescription Drug Monitoring Programs (PDMPs), how states deal with pill mills, whether states have clear prescribing guidelines, and what states are doing to educate prescribers. Let's keep in mind, these are the basic building blocks of prevention, not aspirational, unattainable goals. And yet we have 47 states that can't get their act together.
Second, ask yourself why that is? What's preventing those 47 other states from enacting the legislative and regulatory changes needed to help prevent prescription drug abuse. Ask yourself which groups are standing in the way of necessary change.
Third, ask yourself why workers' comp carriers and self-insured employers can't lead out on this issue at the state level? I know, laughable. Work comp leading the way? In what parallel universe am I living?
Think about it, though.
Work comp experiences this problem in a very unique way. The vast majority of medical issues faced in our industry are fundamentally related to pain. We should be getting better at managing it, right? At a minimum, we should be learning from our mistakes.
We have great guidelines. Some are better than others, but overall, we've spent a lot of time in work comp over the last several years developing the tools we need to assess the medical necessity of medications.
We have a somewhat insulated regulatory bubble that allows us to experiment with new ideas. The Texas Closed Formulary is a great example. Look what happens when you require pre-authorization for a certain set of drugs. Lots of those drugs never get prescribed. How can we translate that idea into the broader fight against drug abuse?
PDMPs are a great concept, but only insofar as prescribers are using them. Outside of Kentucky, New York, Massachusetts, and Tennessee, consulting the PDMP before writing a script is optional. How can work comp payers (and their vendors) influence the voluntary use of PDMPs? We ask about it on every peer review we conduct. If the information is there, why wouldn't you look?
Think about it.
Michael
On Twitter @PRIUM1
A few observations:
First, the standards established by the report are a good, solid start for preventing prescription drug abuse. They include assessment of Prescription Drug Monitoring Programs (PDMPs), how states deal with pill mills, whether states have clear prescribing guidelines, and what states are doing to educate prescribers. Let's keep in mind, these are the basic building blocks of prevention, not aspirational, unattainable goals. And yet we have 47 states that can't get their act together.
Second, ask yourself why that is? What's preventing those 47 other states from enacting the legislative and regulatory changes needed to help prevent prescription drug abuse. Ask yourself which groups are standing in the way of necessary change.
Third, ask yourself why workers' comp carriers and self-insured employers can't lead out on this issue at the state level? I know, laughable. Work comp leading the way? In what parallel universe am I living?
Think about it, though.
Work comp experiences this problem in a very unique way. The vast majority of medical issues faced in our industry are fundamentally related to pain. We should be getting better at managing it, right? At a minimum, we should be learning from our mistakes.
We have great guidelines. Some are better than others, but overall, we've spent a lot of time in work comp over the last several years developing the tools we need to assess the medical necessity of medications.
We have a somewhat insulated regulatory bubble that allows us to experiment with new ideas. The Texas Closed Formulary is a great example. Look what happens when you require pre-authorization for a certain set of drugs. Lots of those drugs never get prescribed. How can we translate that idea into the broader fight against drug abuse?
PDMPs are a great concept, but only insofar as prescribers are using them. Outside of Kentucky, New York, Massachusetts, and Tennessee, consulting the PDMP before writing a script is optional. How can work comp payers (and their vendors) influence the voluntary use of PDMPs? We ask about it on every peer review we conduct. If the information is there, why wouldn't you look?
Think about it.
Michael
On Twitter @PRIUM1
Wednesday, September 11, 2013
FDA Mandates Opioid Label Changes
The FDA yesterday announced that it will require fairly significant changes to the labeling of all extended release and long acting opioid analgesics. First, the good news:
A drug's "label" is the tool the FDA uses to inform the physician community of the approved uses, risks, and safety concerns of all drugs it approves for use. Going forward, the labels for all extended release and long acting (ER/LA) opioid analgesics will include the following changes:
1) "ER/LA opioid analgesics are indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate."
This effectively removes the current indication for ER/LA opioid analgesics for moderate pain and focuses the indication for ER/LA opioids on severe pain only. This may not seem like a big deal (and as you'll read later, it may lead to little change in prescribing behavior), but the FDA has taken a clear stand here - ER/LA opioids are dangerous and should not be used for anything but severe pain.
2) "The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief."
This statement is essentially reflective of the FDA catching up with what we've practically known for some time - these drugs are dangerous at any dose and should only be used to treat patients for whom all other potential treatments have been tried and failed. Now, however, conversations with prescribing physicians who have not tried alternative treatments can be based, at least in part, on a conversation around why they're prescribing ER/LA opioids "off-label". While they have every right to do so, this creates an opportunity to educate the physician community about the new FDA label language.
Finally, the new labeling will also include warnings about the potential for Neonatal Opioid Withdrawal Syndrome (NOWS), one of the saddest consequences of the opioid epidemic. And FDA is also going to require more post-market safety studies focused on addiction and abuse issues.
All great news, right? It's a good sign, but its unlikely to impact prescribing behavior in the short term.
The FDA does not regulate the practice of medicine. While the new label language will slow down pharmaceutical marketing efforts (albeit temporarily), prescribing physicians are still free to use medications as they see fit, even beyond what the FDA label indicates.
So there's still a great deal of work to do. But the FDA has used its authority, however limited, to help us fight the battle against prescription drug misuse and abuse.
Michael
On Twitter @PRIUM1
A drug's "label" is the tool the FDA uses to inform the physician community of the approved uses, risks, and safety concerns of all drugs it approves for use. Going forward, the labels for all extended release and long acting (ER/LA) opioid analgesics will include the following changes:
1) "ER/LA opioid analgesics are indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate."
This effectively removes the current indication for ER/LA opioid analgesics for moderate pain and focuses the indication for ER/LA opioids on severe pain only. This may not seem like a big deal (and as you'll read later, it may lead to little change in prescribing behavior), but the FDA has taken a clear stand here - ER/LA opioids are dangerous and should not be used for anything but severe pain.
2) "The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief."
This statement is essentially reflective of the FDA catching up with what we've practically known for some time - these drugs are dangerous at any dose and should only be used to treat patients for whom all other potential treatments have been tried and failed. Now, however, conversations with prescribing physicians who have not tried alternative treatments can be based, at least in part, on a conversation around why they're prescribing ER/LA opioids "off-label". While they have every right to do so, this creates an opportunity to educate the physician community about the new FDA label language.
Finally, the new labeling will also include warnings about the potential for Neonatal Opioid Withdrawal Syndrome (NOWS), one of the saddest consequences of the opioid epidemic. And FDA is also going to require more post-market safety studies focused on addiction and abuse issues.
All great news, right? It's a good sign, but its unlikely to impact prescribing behavior in the short term.
The FDA does not regulate the practice of medicine. While the new label language will slow down pharmaceutical marketing efforts (albeit temporarily), prescribing physicians are still free to use medications as they see fit, even beyond what the FDA label indicates.
So there's still a great deal of work to do. But the FDA has used its authority, however limited, to help us fight the battle against prescription drug misuse and abuse.
Michael
On Twitter @PRIUM1
Monday, September 9, 2013
Surveys and Guides: Mapping Out Opioids in Work Comp
I just finished reviewing two of the most recent industry pieces on opioids in workers' compensation: first, CompPharma's Tenth Annual Survey on Prescription Drug Management in Workers' Compensation and second, the IAIABC's Policy Guide for Reducing Inappropriate Opioid Use in Treatment of Injured Workers (you have to register to get a copy).
The most significant insight from Joe Paduda's CompPharma survey is that despite the appearance of the industry having drug spend under control, respondents to the survey still see opioids as a "very significant problem, giving it an average of 4.8 [on a scale of 1 to 5]. This remains the highest score for any question in the history of the survey."
My take: While the most of the PBM drug trend reports and industry trade journals seem to celebrate when opioid spend is flat or slightly declining year over year, the payer community is smart enough to realize that a 2-3% drop in opioid spend isn't nearly sufficient to stem the long term clinical and economic impact of inappropriate utilization. Letters to physicians, generic conversion programs, and peer reviews aren't enough. I don't think we'll see that 4.8 score come down until we're seeing opioid utilization dropping by double digits in year over year results.
As the report concludes, "If the industry and individual companies within the insurance and reinsurance industry do not meet this challenge head-on, acknowledge it and develop effective programs to prevent, identify and treat abuse, misuse, addiction and dependency, we will almost
certainly see the bankruptcy of several workers’ comp insurers over the next decade. It remains to be seen if insurers grasp the seriousness of this issue before it is too late."
Regarding the IAIABC Policy Guide, I have been tough on this organization over the last year due to the fact that the Executive Committee shelved the model legislative and regulatory language it had worked on for a year. That said, this new policy guide will serve as an a solid conversation starter in state capitals through the country. Policy recommendations include inter-agency coordination, adoption of treatment guidelines, exploration of pre-authorization and formulary requirements, the necessity of drug tapering, the need for continuing education for physicians, the need for every state to have a functioning prescription drug monitoring program, and a discussion of what a "fast track" dispute resolution process should look like when questions of medical necessity cannot be collegially determined. The guide also includes many helpful references to specific and successful state programs.
The IAIABC Policy Guide isn't perfect. Perhaps out of sheer necessity and obvious resource constraints, the guide glosses over the gritty detail in its examples of certain legislative language and regulatory programs - and as we all know, that's where the success or failure of such things if often determined. That said, the guide is a great overview of the topics that a state workers' compensation program or legislative body needs to consider and it contains enough detail to inform conversations about how best to deal with the crisis of opioid misuse and abuse within the system.
Michael
On Twitter @PRIUM1
The most significant insight from Joe Paduda's CompPharma survey is that despite the appearance of the industry having drug spend under control, respondents to the survey still see opioids as a "very significant problem, giving it an average of 4.8 [on a scale of 1 to 5]. This remains the highest score for any question in the history of the survey."
My take: While the most of the PBM drug trend reports and industry trade journals seem to celebrate when opioid spend is flat or slightly declining year over year, the payer community is smart enough to realize that a 2-3% drop in opioid spend isn't nearly sufficient to stem the long term clinical and economic impact of inappropriate utilization. Letters to physicians, generic conversion programs, and peer reviews aren't enough. I don't think we'll see that 4.8 score come down until we're seeing opioid utilization dropping by double digits in year over year results.
As the report concludes, "If the industry and individual companies within the insurance and reinsurance industry do not meet this challenge head-on, acknowledge it and develop effective programs to prevent, identify and treat abuse, misuse, addiction and dependency, we will almost
certainly see the bankruptcy of several workers’ comp insurers over the next decade. It remains to be seen if insurers grasp the seriousness of this issue before it is too late."
Regarding the IAIABC Policy Guide, I have been tough on this organization over the last year due to the fact that the Executive Committee shelved the model legislative and regulatory language it had worked on for a year. That said, this new policy guide will serve as an a solid conversation starter in state capitals through the country. Policy recommendations include inter-agency coordination, adoption of treatment guidelines, exploration of pre-authorization and formulary requirements, the necessity of drug tapering, the need for continuing education for physicians, the need for every state to have a functioning prescription drug monitoring program, and a discussion of what a "fast track" dispute resolution process should look like when questions of medical necessity cannot be collegially determined. The guide also includes many helpful references to specific and successful state programs.
The IAIABC Policy Guide isn't perfect. Perhaps out of sheer necessity and obvious resource constraints, the guide glosses over the gritty detail in its examples of certain legislative language and regulatory programs - and as we all know, that's where the success or failure of such things if often determined. That said, the guide is a great overview of the topics that a state workers' compensation program or legislative body needs to consider and it contains enough detail to inform conversations about how best to deal with the crisis of opioid misuse and abuse within the system.
Michael
On Twitter @PRIUM1
Thursday, August 29, 2013
Contrasts: Overdose Awareness Day and Doctors Who Still Don't Get It
Overdose Awareness Day is Saturday, August 31. Events are scheduled all over the world to remember those who have fallen victim to drug overdoses and to try to prevent future human tragedy. This is a day that should remind all of us that there are risks associated with opioids that must be dealt with in clinically responsible ways - or such human tragedy will find its way to your company, your claims organization, your desk.
Contrast this forthcoming day or remembrance with a letter PRIUM received today from a treating physician with whom we were attempting to conduct a peer-to-peer conversation.
Many of PRIUM's employees have inserted into the signature block of their emails the following quote of mine from a previous blog post: "We must do everything we can to stop addiction before it starts, provide alternative non-pharmacological therapy whenever we can, and help safely wean those already addicted to medications that are doing more harm than good. This won't be easy, and it won't be cheap, but we have to do it anyway."
Today, I was handed a letter from a treating physician that read, in part: "The goal of the PRIUM review process is to force medication changes by the treating physician, whether or not those changes are in the best interest of the patient or the best judgment of the treating physician. This policy, exemplified by the inflammatory mission statement on PRIUM's correspondence [and he quotes the above statement]."
Other than being a poor excuse to avoid what would have otherwise been a helpful peer to peer conversation, this doctor completely misses the point of my statement. Not to mention that I made those comments at the end of a post about a young man that had overdosed on Adderall - a drug prescribed by his physician despite his physician's awareness of his addiction.
I want to be perfectly clear on this point: the quote does NOT say "we must do everything we can to stop an opioid prescription before it starts..." Rather, it says "we must do everything we can to stop addiction before it starts." PRIUM physicians routinely suggest that opioid medications be continued for patients exhibiting documented functional improvement along with reduction of pain. And we'll continue to do so.
We simply see too many instances in which opioids are being prescribed, dispensed, and potentially consumed without any clinical evidence that the drugs have any positive impact on the patient's quality of life and ability to function.
So... I'll take time to reflect on Overdose Awareness Day about what we're currently doing and all the work that still needs to be done to mitigate the risks of prescription drug misuse and abuse. And I'll hope that doctors like the one that wrote this letter will have the courage to engage, to listen, to learn.
Michael
On Twitter @PRIUM1
Contrast this forthcoming day or remembrance with a letter PRIUM received today from a treating physician with whom we were attempting to conduct a peer-to-peer conversation.
Many of PRIUM's employees have inserted into the signature block of their emails the following quote of mine from a previous blog post: "We must do everything we can to stop addiction before it starts, provide alternative non-pharmacological therapy whenever we can, and help safely wean those already addicted to medications that are doing more harm than good. This won't be easy, and it won't be cheap, but we have to do it anyway."
Today, I was handed a letter from a treating physician that read, in part: "The goal of the PRIUM review process is to force medication changes by the treating physician, whether or not those changes are in the best interest of the patient or the best judgment of the treating physician. This policy, exemplified by the inflammatory mission statement on PRIUM's correspondence [and he quotes the above statement]."
Other than being a poor excuse to avoid what would have otherwise been a helpful peer to peer conversation, this doctor completely misses the point of my statement. Not to mention that I made those comments at the end of a post about a young man that had overdosed on Adderall - a drug prescribed by his physician despite his physician's awareness of his addiction.
I want to be perfectly clear on this point: the quote does NOT say "we must do everything we can to stop an opioid prescription before it starts..." Rather, it says "we must do everything we can to stop addiction before it starts." PRIUM physicians routinely suggest that opioid medications be continued for patients exhibiting documented functional improvement along with reduction of pain. And we'll continue to do so.
We simply see too many instances in which opioids are being prescribed, dispensed, and potentially consumed without any clinical evidence that the drugs have any positive impact on the patient's quality of life and ability to function.
So... I'll take time to reflect on Overdose Awareness Day about what we're currently doing and all the work that still needs to be done to mitigate the risks of prescription drug misuse and abuse. And I'll hope that doctors like the one that wrote this letter will have the courage to engage, to listen, to learn.
Michael
On Twitter @PRIUM1
Tuesday, August 6, 2013
Exciting News from PRIUM and Ameritox
This press release went out this morning. Lots more to come, but our collective fight against prescription drug misuse and abuse got a lot stronger as of this morning...
Ameritox Acquisition of PRIUM Expands Suite of Services
BALTIMORE, Aug. 6, 2013 /PRNewswire/ -- Ameritox, the nation's leader in pain medication monitoring, is proud to announce the acquisition of PRIUM, a leading provider of medical cost management services currently serving the Workers' Compensation market.
"We are extremely excited about the opportunity to bring the unique capabilities of these two great companies together," said Ameritox CEO Scott Walton. "Employers are increasingly aware and concerned about the quality-of-life issues and financial ramifications that the epidemic of prescription drug abuse and misuse is having on their employees, particularly the injured worker. Just as Ameritox pioneered the market for prescription drug monitoring, PRIUM has pioneered a unique set of services on the medical management side of the equation."
Ameritox's mission is to help improve clinical care for patients while at the same time preventing the human tragedy associated with the misuse, abuse and diversion of prescription drugs. Similarly, PRIUM is focused on helping to reduce inappropriate use of prescription medications in the Workers' Compensation market, where more than 20% of claims include a prescription for narcotics such as pain medications.
"The proper use of prescription medication is central to each of our missions," said Michael Gavin, President of PRIUM. "By combining our expertise we can each have a greater impact on quality clinical care. PRIUM is an outstanding fit for Ameritox's expanding business portfolio and we look forward to broadening our services."
Both companies will continue to function as separate entities. Aiding the acquisition, Katten Muchin Rosenman provided legal advice to Ameritox. For PRIUM, SunTrust Robinson Humphrey acted as exclusive financial advisor and Nelson Mullins Riley & Scarborough LLP provided legal counsel.
About PRIUMPRIUM sets the industry standard for workers' compensation medical interventions through its ability to secure higher agreement rates and enforce modified treatment plans. The hallmark of the medical intervention company's success is a collaborative physician engagement process encompassing evidence-based medicine, clinical oversight, and jurisdictional guidelines to ensure optimal financial and clinical outcomes, particularly for patients on chronic opioid therapy. PRIUM eliminates unnecessary treatment through a comprehensive approach that includes complex medical interventions and utilization reviews. Based in Duluth, Ga., PRIUM can be reached at www.prium.net or 888-588-4964. For insight on workers' compensation medical issues, read PRIUM's blog at www.priumevidencebased.com.
About AmeritoxAmeritox is the nation's leader in Pain Medication Monitoring SolutionsSM, offering specialized laboratory testing and reporting services. Ameritox's expertise and innovative science provide physicians with the information and support they need to enhance and optimize the care of chronic pain patients. Monitoring through prescription drug testing can help physicians make more informed clinical decisions while also helping to reduce the possible risk of misuse, abuse or diversion of powerful medications. Ameritox is headquartered in Baltimore, Md. with laboratory facilities in Midland, Texas and Greensboro, N.C.Ameritox can be found online at www.ameritox.com, on Twitter @Ameritox, on Facebook at facebook.com/ameritox, and on YouTube at www.youtube.com/ameritox.
© 2013 Ameritox Ltd. All rights reserved. Ameritox, Ameritox-Medication Monitoring Solutions, Rx Guardian, Rx Guardian INSIGHT and Rx Guardian CD are trademarks of Ameritox. Other trademarks are the property of their owners.
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