Tighter Opioid Label Restrictions?

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MindOverMatter

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I came across an interesting article the other day, and wanted to pass it along to you guys to see how you feel about this issue.

http://www.medscape.com/viewarticle/768214

Tighter Opioid Label Restrictions, Physicians Tell FDA

July 26, 2012 — A coalition of 37 physicians that includes pain management and addiction experts petitioned the US Food and Drug Administration (FDA) yesterday to tighten label restrictions for opioid analgesics as a way to combat the epidemic of addiction and fatal overdoses associated with these drugs.

Under the proposed label changes, opioids would no longer be indicated for moderate noncancer pain. The petition notes that moderate to severe pain is the FDA-approved indication for nearly all instant-release opioids as well as extended-release versions when 24/7 pain relief is needed for a long stretch of time. Such "overly broad indications" imply that the FDA has established that long-term use of opioids is safe and effective, the petition states. "An increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses."

In addition, the maximum daily dose would be the equivalent of 100 mg of morphine, and the maximum duration for continuous daily use would be 90 days under the proposed label changes. Both limits would apply to noncancer pain.

One of the petitioners, Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing, told Medscape Medical News that the label changes would not prevent physicians from prescribing opioids at doses and durations that they deem appropriate for patients on a case-by-case basis. However, the changes would limit claims that drug companies can make about their products.

"Right now, drug companies are promoting long-term opioids as proven safe and effective for chronic pain," he said. "They'll promote [them] for lower back pain, fibromyalgia, osteoarthritis, whatever they want…because the current label is like a blank check."

"By prohibiting the aggressive marketing, we can reduce the overprescribing," said Dr. Kolodny. Physicians who understand that opioids are not necessarily safe and effective long term may resort to other treatments such as behavior modification, physical therapy, and weight loss, he added.

Other physicians signing the petition include

Roger Chou, MD, Associate Professor of Medicine, Oregon Health & Science University
Edward Covington, MD, Director, Neurological Center for Pain, Cleveland Clinic
Stuart Gitlow, MD, MPH, Acting President, American Society of Addiction Medicine
Elinore McCance-Katz, MD, PhD, Professor, Department of Psychiatry, University of California–San Francisco
Nirav Shah, MD, MPH, Commissioner, New York State Department of Health
Sidney Wolfe, MD, Director, Health Research Group at Public Citizen
Label Change Called Necessary for Effective REMS

The petition to revise the label of opioid analgesics comes on the heels of a new FDA initiative to help turn the tide of the prescription painkiller epidemic, which is causing more fatal overdoses than cocaine and heroin combined, according to the US Centers for Disease Control and Prevention. Earlier this month, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids prescribed for moderate to severe chronic pain. More than 20 opioid manufacturers must make available to prescribers continuing education programs on the proper use of these drugs. This education will be funded through grants from manufacturers to continuing medical education providers, who will develop the training based on a blueprint for content provided by the FDA and will deliver the training.

Dr. Kolodny told Medscape Medical News that the REMS for opioids "isn't going to help and could potentially make things worse."

Without the label change sought by his coalition, he said, the REMS curriculum would still leave doctors "with the false impression that long-term opioid therapy was proven safe and effective."

One company that would be affected by the envisioned label change is Purdue Pharma, the maker of controlled-release oxycodone (OxyContin), which is indicated for moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period. When asked to comment on the petition to the FDA, Purdue Pharma issued a statement saying, "[The] FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate.

"We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges," the company added.

Ensure Opioid Availability for Legitimate Need, Cautions Pain Expert

One pain expert interviewed by Medscape Medical News sounded a cautionary note about the petition submitted to the FDA about revising opioid labels.

"I share the concern of this group," said Charles Argoff, MD, a professor in the neurology department at Albany Medical College and director of the Comprehensive Pain Program at Albany Medical Center in New York. "However, we need to establish prospectively whether this approach accomplishes what this petition suggests it would. This group has yet to prove that the recommendations in the petition are appropriate recommendations."

Any changes to opioid labeling must be anchored "in the highest-quality medical evidence," said Dr. Argoff, a member of the editorial advisory board for Medscape Neurology. Otherwise, patients could suffer harm.

"We have a prescription drug abuse crisis...that we must combat," he said. "But [the petition] does not address the millions and millions of people who have been appropriately prescribed this medication, who have been appropriately monitored, and who have lived a more functional life as a consequence. We need to ensure the availability of these drugs for patients who can benefit from them and establish concrete approaches to limiting the abuses and misuses."

Dr. Argoff has spoken out in the past on the problem of "allowing physicians with insufficient training to prescribe medications that can kill people." He reiterated that concern in his remarks on the opioid-labeling petition.

"To demonize the drug is ignoring the responsibility of the prescriber," he said.
 

Ducttape

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i am for some stricter control, and for the use of high doses of opioid therapy to be prescribed by someone who has the knowledge and education about the risks and benefits of high dose opioid therapy, and who can monitor those patients appropriately.

similarly to how a patient needs to see a rheumatologist for Enbrel or Humira, see an oncologist for methotrexate, etc.
 

PMR 4 MSK

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I like the idea of guidelines rather than laws. Educate people rather than restrict them.
 

Ducttape

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I like the idea of guidelines rather than laws. Educate people rather than restrict them.

at what point do "guidelines" turn into law? how often do we see ACLS protocol being used in legal matters to define quality of care, irregardless of what the AHA recommends?

and in this particular arena, one that is monitored specifically by a federal agency, laws might be more apropos than guidelines.
 

Aether2000

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I agree...this group is attempting to manage the issues of substance abuse and opioid related deaths by defining 100mg a day morphine equivalent as a maximum dose. This will be latched onto by insurance companies, legislatures, and trial courts nationwide. The problem is the studies on which it is based are non-closed retrospective data. Suicides cannot be ruled out. The amount the person was taking at the time of death is completely unknown nor from what sources. The VA study has the most glaring weakness ....I contacted the author and was told one of the causes of death not investigated was how many were obtaining opioid narcotics from non-VA sources, but based on the deaths from opioids from those taking zero from the VA, it appears it is substantial (due to VA data on prescriptions being exempted from being entered in state PMPs). We also don't know how the drug was administered at the time of death (snorting? huffing?) nor the cofactors that include benzodiazepines that drastically increase death rates. So all in all, the 100mg number is simply a fabricated number, not based on any solid data.
The entire exercise is designed to reduce death and substance abuse by using a "harm reduction" model of simply cutting off higher doses of the medication. This is contrary to the concept of appropriate opioid monitoring by the prescribing physician. Both methods would reduce accidental death but the former will also potentially increase suicide deaths in chronic pain patients. It is a very thorny issue.
 

Ducttape

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your last point seems to be a far reach, and i have never seen data that a ceiling leads to increases in suicide rate.

let me get this straight... putting a max limit on opioid use may, possibly, cause more chronic pain patients to consider suicide, and that would lead to more chronic pain patients to commit suicide...

that would mean making two unsupported assumptions in conjunction.

now i am not in favor of a legalized max, but i am in favor of having physicians who prescribe a higher dose than is "typical" should be appropriately trained and use due diligence with regards to use. given what we see nowadays with pill mills, i cannot see that happening...
 

Aether2000

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Well, duh, yeah it does have that potential. The patients receiving 300mg equivalent a day are decreased to (as in Washington State) 120mg a day, have massive withdrawal and commit suicide due to the intractable exacerbation of pain that occurs due to these limits. It has occurred on several occasions and is being noted in newspaper articles. There are no studies of people killing themselves because of reduction in dose and it is unlikely any ethics committee would approve a prospective study.
 

Ducttape

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Well, duh, yeah it does have that potential. The patients receiving 300mg equivalent a day are decreased to (as in Washington State) 120mg a day, have massive withdrawal and commit suicide due to the intractable exacerbation of pain that occurs due to these limits. It has occurred on several occasions and is being noted in newspaper articles. There are no studies of people killing themselves because of reduction in dose and it is unlikely any ethics committee would approve a prospective study.


im sorry, most of your posts are reasoned and thought out... of course there is always potential - but then so does the fact that it is rainy half the time in Washington.

does that by default mean we as a society need to offer heroin to every addicted patient so that they dont withdraw and contemplate suicide? and by default, that means that no patient can be tapered off of his or her high dose opioids because of the potential risk of suicide.

and can we no longer recommend cessation of unhealthy habits - ie. smoking, driving without a helmet, eating bonbons in bed - because of the "potential" risk for suicidal ideation?
 

PMR 4 MSK

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at what point do "guidelines" turn into law? how often do we see ACLS protocol being used in legal matters to define quality of care, irregardless of what the AHA recommends?

and in this particular arena, one that is monitored specifically by a federal agency, laws might be more apropos than guidelines.

If guidelines are published and accepted, then they should be adhered to in most situations. If a particular patient situation falls outside the norm, it should be documented why the guidelines don't apply. You can always be sued, but need to have a defense.

When it gets to the courts, it who the judge or jury believes.
 

Aether2000

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It is the irresponsible behavior of physicians in Washington and Florida that are directly responsible for the suicides. If patients were indeed tapered, then there would be no issue. But the imposition of draconian rules causes a large number of physicians prescribing opioids to give patients a 30 day supply and tell them they have to find another physician to prescribe them since the current physician will no longer be responsible for prescribing due to the imposition of the state laws. The patients become increasingly desperate when they discover through scores of telephone calls and contacting the local medical society that no one they can identify is prescribing them any longer except for pain clinics. The patients call the pain clinics- oops....they only do injections and spinal cord stimulation now and have actually given up the management of pain. The patient nears the end of their supply of medicine and calls the prescribing physician back to help....won't do it. Won't prescribe a tapering dose, won't prescribe an alternative to reduce symptoms of withdrawal, won't help in any way. The patient, in the midst of withdrawal on a medication they had received at a stable dose for several years, now decides to end it all. And they do. This is not simply hypothetical: it has been documented in the press and in patient forums. So if responsible physician behavior had been used with tapering the patient gradually or if the physician had tried to find another physician to prescribe or if the patient were given alternative medications such as clonidine/klonopin or tizanidine or if the sheep had not all panicked and stopped prescribing suddenly, then I agree, there would not be an issue. But physicians when threatened by prescribing laws do suddenly alter their behavior and in doing so may have unintended consequences.
 

Ducttape

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but that scenario does not necessitate stopping the meds, and does not mean that these physicians should continue to prescribe these medications. The example you are citing point at the process, not the goal, of reduced therapy, and the process should be adjusted appropriately.

To come to the conclusion that there should not be a limitation on the max dose because of inappropriate tapering (and thus, inappropriate prescribing) from these examples is nonsequitor.


in fact, if any of these doctors in Washington reviewed recommendations from their state agencies... i did a very quick 5 second search and while i did not find anything related to these suicides, i found this...

http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf

On page 14-15, i believe, is a bullet point about tapering by 10% per week. and there is an additional Appendix H.
 

Aether2000

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The process of adoption is causing suicides indeed, through lack of appropriate process being spelled out for the freaked out family docs. But on the other hand, there is a tacit assumption by many pain physicians that there is no rationale for high dose opioids because of the risk of death, therefore the doses must be limited. The real driving force in Washington had nothing to do with saving lives of Medicaid patients (the state would actually be better financially off if they all killed themselves) but due to fiscal policies to reduce expenditures. Florida had an out of control prescribing, not by family docs, but by drug dealers with MD after their name, that did not even create a pretense of practicing medicine. But do we know for sure that limiting the dosage of opioids will have the desired effect of saving lives or will it cause people to now turn to OTC meds and NSAIDS that will kill their liver and kidneys and cause gastric bleeds. Others turn to methadone clinics to obtain pain medications, others to suboxone, and some to the street. This behavior does not mean they were not using the meds legitimately when prescribed, nor does it necessarily mean they are drug addicts: they may have legitimate pain control needs that are managed by higher than normal dosages.
If we really want to stop deaths from drugs then this would require we will make all classes of drugs controlled substances, such as Advil, and limit prescribing through state laws. But if the goal is to cost shift from the state to the patient, then dose limitations do make sense. However we must be prepared for unintended consequences when legislatures dabble in the practice of medicine.
 

PMR 4 MSK

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If we really want to stop deaths from drugs then this would require we will make all classes of drugs controlled substances, such as Advil, and limit prescribing through state laws. But if the goal is to cost shift from the state to the patient, then dose limitations do make sense. However we must be prepared for unintended consequences when legislatures dabble in the practice of medicine.

Even prescribed NSAIDs kill people. Scheduling them will not prevent that.
 

Aether2000

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True, and neither will limiting daily dose to 100mg morphine will prevent death. Therefore limitation of amount of a medication prescribed is really nonsensical. Where physicians have failed is in their assiduousness in monitoring of patients and holding their feet to the fire with respect to the medication control and usage. We are soon entering an interim session in our legislature that will hopefully adopt the latter approach rather than the former. Only 40% of MDs in our state with DEA licenses have enrolled in the PMP, yet 90% prescribe opioids. That means more than half the physicians prescribing opioids never even bother to check a PMP system that takes 23 seconds to access a years worth of data from 4 different states.
 

Ducttape

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personally, i think it is more than tacit assumption of increased risk of death at higher doses that drives me to limit high dose of opioids - it includes the increased risk of diversion and nonfatal side effects. i suspect, as do many, that high dose opioid therapy is truly a futile attempt to overcome tolerance.

again, to make the assumption that not being able to use high dose of opioids will result in these chronic pain patients overdosing on other medications and drugs is not justification in and of itself for continuing encouraging use of high dose opioids. that, too is nonsequitor.

im not sure what concerns you more, the fact that legislatures want to get involved in medical decision making or justifying high dose opioid therapy.

From the first issue - legislatures and nondoctors already have a large influence on medical decision making, whether it is from licensure or what CMS or insurances will pay for procedurewise.

From the second issue - the evidence is, at very best, moderate for chronic opioid therapy. there is no evidence i have ever seen that suggests any benefit for high dose opioid therapy for chronic nonmalignant pain syndromes...
 

Aether2000

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Guess it depends on what "high dose" means. Most physicians prescribing opioids for chronic pain would not consider 100mg morphine a day to be "high dose". There are a large number of short term studies demonstrating the benefits of higher dose opioids in chronic pain and 6 longer term studies of a year or more. Most are not randomized controlled trials. There are 3 studies demonstrating harm with higher dose opioids using retrospective analysis of assumed daily amounts being taken (the assumption is that the amount consumed per day was the amount prescribed per day by one prescriber) and comparing death rates on that basis. Of course this approach has many holes in it. So we have a moderate amount of low level evidence demonstrating benefit and a few poorly constructed studies showing harm. Yet, there is no doubt deaths are increasing due to opioid increased availability. However when one further analyzes the data, many of the deaths and the majority in more than one state coroner registry shows the majority of those overdosing and dying did not have a prescription for the medications that were taken. So it is not simply the amount of medication being prescribed- it is what happens to the medication once in the hands of the pain patient. They may give it away, trade it, or sell it. So the general approach at harm reduction comes down to one of two methods: limit the amounts being prescribed (either via legislation to control amounts or by developing medical board rules for appropriate prescribing) or to make patients more responsible for their use of the drug (via mandatory action being taken after drug tests, pill counts, PMP, aberrant behavior, family reports, friend reports, police reports, etc).

The mindless method is to adopt some random number for all of society....this is the Washington State and physicians for responsible prescribing organization approach. There is no clinical evidence harm will NOT occur due to this approach via increased suicides, and since one cannot construct an ethical study to prospectively determine this, it will be years before the data mounts to show this harm in the medical literature. This is exactly the same reason cardiologists continue Plavix for years after placing cardiac stents. There is no evidence at all to support use beyond one year and the only good evidence is for 6 month use, yet cardiologists are unwilling to risk the lives of their patients by stopping Plavix without having a study to show harm will NOT occur. However in pain patients taking chronic opioids, the state is mandating that we engage in a giant uncontrolled experiment by simply limiting the amount of the drug prescribed not knowing at all the outcome except that it will place more $$$ in the coffers of the state.

If there were studies showing limited harm, limited increase in pain or dysfunction, and limited peripheral adverse effects with a numerical limit on opioids, AND it had the desired effect of reduction of death, there would be little argument that this would be the best approach. However it simply has not been studied.

The incursion of control by a government at this micromanaged level is NOT par for the course and portends the government's ability to dictate medical care on ANY level. Supposing Washington State devised a rule that a person may have only one epidural injection of any kind per year (not that they will pay for only one per year, but that the person is limited by law to have only one per year). The doctors would protest that such infrequency would not cover the pain for a year and that the patients would suffer. The state's response: tough. We are engaging in harm reduction since increased frequency leads to increase in body weight, hypertension, diabetes, osteoporosis, psychiatric disorders, etc. Oh and by the way, we are saving the taxpayers money. This is the parallel that could occur in interventional pain medicine.

No one wants patients to be harmed by our interventions whether medical or via needle injections or neuroablation or neuromodulation. However if we adopt the attitude that it is acceptable for the state to place arbitrary limits not on payment but on the numbers that may be employed per year or time period, we do our patients a disservice. There is a better way that does not develop a new modus operandi of unprecidentedly heavy handed approaches by the state.
 

Ducttape

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So it is not simply the amount of medication being prescribed- it is what happens to the medication once in the hands of the pain patient. They may give it away, trade it, or sell it. So the general approach at harm reduction comes down to one of two methods: limit the amounts being prescribed (either via legislation to control amounts or by developing medical board rules for appropriate prescribing) or to make patients more responsible for their use of the drug (via mandatory action being taken after drug tests, pill counts, PMP, aberrant behavior, family reports, friend reports, police reports, etc).

The mindless method is to adopt some random number for all of society....this is the Washington State and physicians for responsible prescribing organization approach. There is no clinical evidence harm will NOT occur due to this approach via increased suicides, and since one cannot construct an ethical study to prospectively determine this, it will be years before the data mounts to show this harm in the medical literature. This is exactly the same reason cardiologists continue Plavix for years after placing cardiac stents. There is no evidence at all to support use beyond one year and the only good evidence is for 6 month use, yet cardiologists are unwilling to risk the lives of their patients by stopping Plavix without having a study to show harm will NOT occur. However in pain patients taking chronic opioids, the state is mandating that we engage in a giant uncontrolled experiment by simply limiting the amount of the drug prescribed not knowing at all the outcome except that it will place more $$$ in the coffers of the state.

If there were studies showing limited harm, limited increase in pain or dysfunction, and limited peripheral adverse effects with a numerical limit on opioids, AND it had the desired effect of reduction of death, there would be little argument that this would be the best approach. However it simply has not been studied.

The incursion of control by a government at this micromanaged level is NOT par for the course and portends the government's ability to dictate medical care on ANY level. Supposing Washington State devised a rule that a person may have only one epidural injection of any kind per year (not that they will pay for only one per year, but that the person is limited by law to have only one per year). The doctors would protest that such infrequency would not cover the pain for a year and that the patients would suffer. The state's response: tough. We are engaging in harm reduction since increased frequency leads to increase in body weight, hypertension, diabetes, osteoporosis, psychiatric disorders, etc. Oh and by the way, we are saving the taxpayers money. This is the parallel that could occur in interventional pain medicine.

No one wants patients to be harmed by our interventions whether medical or via needle injections or neuroablation or neuromodulation. However if we adopt the attitude that it is acceptable for the state to place arbitrary limits not on payment but on the numbers that may be employed per year or time period, we do our patients a disservice. There is a better way that does not develop a new modus operandi of unprecidentedly heavy handed approaches by the state.

in a recent retrospective study in a throwaway journal, albeit a very poor methodology, i believe something like 91% of patients who unintentionally OD'd on prescription meds had an opioid prescription written and took opioid meds within the last year. (anesthesiologynews.com)

that would go against what was found in that one state coroner registry.

and while i am not for government intrusion, first, it is already here. in the state i am at, for WC, there are already state "guidelines" that are almost never deviated from, that limit the number of procedures, etc. CMS already limits who may have what procedures done. I have read a lot about Noridian and treatment for facet arthropathy, as i am sure you are. While these are not "legal" requirements, they are financial constraints with the exact same effect of limiting procedures, etc.

finally, the philosophical debate again is whether to do something, because we are seeing evidence that there seems to be much greater use of prescription medications for non-medicinal purposes, and there seems to be an increase in prescription overdoses, and although that data might be faulty, its very hard to dismiss what appear to be trends towards greater misuse and complications from opioid medications.

The alternative from a PR standpoint is almost never accepted - "We will continue to study and watch". And this is not how the CDC views itself - and with good reason, as most of what they get noticed for are outbreaks of disease that do require emergent intervention (i.e. Ebola, bird flu, pandemics, etc.)

i for one feel that high dose opioids are being inappropriately prescribed by physicians who are unfamiliar with the ramifications of such therapy. Physicians who use these high doses need education, not only on how to prescribe, but how to screen and monitor and, ultimately, stop their use if necessary. It would be preferable for this to be done by the industry itself (i.e. physicians and their organizations), but noone is stepping up, and we as a group are "studying and watching" instead of "doing", so we ultimately have let the government come in and take over.
 

PMR 4 MSK

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I would suspect that the greatest number of inappropriate opioid rx's come from well-meaning but inadequately educated or empowered primary care docs. Most docs with real pain management training do not do things like 3 LAOs + 2 SAOs, or vicodinsomaxanax QID. They do not treat undiagnosed pain for months or years with opioids.

If this postulate is true, then what we need is more education and empowerment to PCPs to have a higher threshold for treating pain aggressively, to teach them what responsible and rational opioid prescribing is, and, importantly, how to tell a patient "No, I will not give you a prescription for Vicodin!"

I've talked with many PCPs who do not realize how co-dependent they have become - pts want pain pills, doc wants E&M fees, doc gives pills so pt keeps coming back and pt doesn't get mad.

At the same time, Docs running what we would recognize as "pill mills" need to have their "feet held to the fire" along with a better system for identification of these clinics, closing loopholes in places like FL, yet somehow protecting the rights of patients and doctors to access to legitimate opioid use.

That last part seems almost insurmountable.
 
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