Line In The Sand

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emd123

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I know some will say this question is unanswerable but I'm going to ask it anyways:

For chronic non-cancer pain, what is your max opiate dose you just don't go over, no matter what the circumstances, assuming no side effects and no aberrant behavior?

I know it varies from patient to patient, doc to doc and that some believe there's no ceiling other than side effects/aberrant behaviors, but realistically, we all have a "line in the sand" somewhere.

So, at what point do your say, "If opiates have failed to control your pain up to this point, no further increases would be expected to do any different"?

A) What's your "line in the sand" (in po Morphine equivalents)? and,

B) Assuming the patient does not want a pump, at what point do you say, "You're at "X" dose of opiate, you're still in pain, therefore, OPIATES JUST AREN'T GOING TO HELP YOU, we must taper and discontinue"?

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I know some will say this question is unanswerable but I'm going to ask it anyways:

For chronic non-cancer pain, what is your max opiate dose you just don't go over, no matter what the circumstances, assuming no side effects and no aberrant behavior?

I know it varies from patient to patient, doc to doc and that some believe there's no ceiling other than side effects/aberrant behaviors, but realistically, we all have a "line in the sand" somewhere.

So, at what point do your say, "If opiates have failed to control your pain up to this point, no further increases would be expected to do any different"?

A) What's your "line in the sand" (in po Morphine equivalents)? and,

B) Assuming the patient does not want a pump, at what point do you say, "You're at "X" dose of opiate, you're still in pain, therefore, OPIATES JUST AREN'T GOING TO HELP YOU, we must taper and discontinue"?

Well, great question, I have no line (but wish I could draw the line at 1 vicodin/week).

However, there is some data that efficacy doesn't improve over 60mg morphine equivalents/day. Also, very good surveillance data that shows mortality for those using 50mg morphine equiv (as opposed to those under this) is 2x, and over 200mg it is 3x. Compared to a cohort matched non-opioid user, it's about 9x the mortality.

So anyone over 60mg/day has a triple the risk of dying with no added benefit.

Food for thought.
 
http://www.annals.org/content/152/2/I-42.long

Very good question. More than one author has shown that the risk of serious adverse events - overdose - increases dramatically at 100mg MSO4 qD. This is where the WA state guidelines come from.

"no ceiling', "pain is whatever the patien says it is" and pseudo addiction are concepts of CA pain mgt. They do not apply to non-malignant pain.
 
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15mg morphine TID. It would be zero but sometimes I feel compelled to say we did an opioid trial. I just can't see the logic in chasing after tolerance.
 
Well, great question, I have no line (but wish I could draw the line at 1 vicodin/week).

However, there is some data that efficacy doesn't improve over 60mg morphine equivalents/day. Also, very good surveillance data that shows mortality for those using 50mg morphine equiv (as opposed to those under this) is 2x, and over 200mg it is 3x. Compared to a cohort matched non-opioid user, it's about 9x the mortality.

So anyone over 60mg/day has a triple the risk of dying with no added benefit.

Food for thought.
what study is this in? Got a reference? Would like to have the ammo to use it :smuggrin:
 
8 Tramadol a day. How many equivalents is that?
 
I agree with 60-100 MS.
Methadone 10 tid
OxyContin 40 bid, or maybe tid if they spontaneously tell me it wears off at 8-10 hours
Ms contin 30-45 bid-tid
Fent 50

For true real factual badness, ie obvious CRPS with physical changes I might go a bit higher with excellent analgesia and increase in function and no CNS side effects and no aberrancy.

In practice, most pts come to me on outside high dose opioids and generally get better and lower opioids with a multidisciplinary approach and appropriate neuropathic meds.
 
For chronic non-cancer pain, what is your max opiate dose you just don't go over, no matter what the circumstances, assuming no side effects and no aberrant behavior?

Does such a creature exist?

The bigger question is what to do with those patients who hit your limit and still complain of significant pain. In the prudent doc's mind, this is a failure of opioids to control the patient's pain. In the mind of most patients and most Portnoyans, you just keep bumping up the dose, titrating to either subjective pain relief or side effects.

IME, 75%+ of those who fail opioids and I attempt to wean them become oppositional and argumentative or just leave the practice for the guy "down the street" who will give them what they want. Then, sooner or later, someone sends them back.

E.g 3 years ago, I saw a lady on Fentanyl patch 150/hr + Percocet 2 TID. 9/10 pain. Dx polyOA +/- seronegative RA. I recommended weaning off opioids. She got down to 2 Percocet a day with same dose of fentanyl and 12-15 phone calls later she left my practice.

A few months ago, a new PCP refers her back to me, now on OxyContin 80 mg TID + those same 6 Percs a day. I sent him a letter advising him of my previous experience with the pt, and to wean her off the opioids, how to do it, and when she was opioid-free, I could see her again.

I'm guessing I lost a referring source. But if he puts patients on those high doses, I don't want them from him.
 
The highest I go routinely is 60mg tid MSContin or equivalent plus upto 3 BT doses per day of any short acting opiates.

So max dose in 95% of my patients is 270mg MS equivalents.

Most are on less, but I'm willing to go that high if needed.
 
The highest I go routinely is 60mg tid MSContin or equivalent plus upto 3 BT doses per day of any short acting opiates.

So max dose in 95% of my patients is 270mg MS equivalents.

Most are on less, but I'm willing to go that high if needed.

Just to play devils advocate...

So you are willing tolerate a 27fold risk of overdose in your high utilizer opioid patients. But you wont inject a particulate steroid transforaminally because it's too risky regardless of the level.

That's not a balanced approach to mitigating risk.

(FWIW, my prescribing patterns are probably pretty much like your own. And like you I have a lot of surveillance for the few
high dose folks - elderly - I manage.)

Ann Intern Med. 2010 Jan 19;152(2):85-92.
Opioid prescriptions for chronic pain and overdose: a cohort study.
Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M.
Source
Group Health Research Institute, Seattle, Washington 98101, USA.
Abstract
BACKGROUND:
Long-term opioid therapy for chronic noncancer pain is becoming increasingly common in community practice. Concomitant with this change in practice, rates of fatal opioid overdose have increased. The extent to which overdose risks are elevated among patients receiving medically prescribed long-term opioid therapy is unknown.
OBJECTIVE:
To estimate rates of opioid overdose and their association with an average prescribed daily opioid dose among patients receiving medically prescribed, long-term opioid therapy.
DESIGN:
Cox proportional hazards models were used to estimate overdose risk as a function of average daily opioid dose (morphine equivalents) received at the time of overdose.
SETTING:
HMO.
PATIENTS:
9940 persons who received 3 or more opioid prescriptions within 90 days for chronic noncancer pain between 1997 and 2005.
MEASUREMENTS:
Average daily opioid dose over the previous 90 days from automated pharmacy data. Primary outcomes--nonfatal and fatal overdoses--were identified through diagnostic codes from inpatient and outpatient care and death certificates and were confirmed by medical record review.
RESULTS:
51 opioid-related overdoses were identified, including 6 deaths. Compared with patients receiving 1 to 20 mg/d of opioids (0.2% annual overdose rate), patients receiving 50 to 99 mg/d had a 3.7-fold increase in overdose risk (95% CI, 1.5 to 9.5) and a 0.7% annual overdose rate. Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk (CI, 4.0 to 19.7) and a 1.8% annual overdose rate.
LIMITATIONS:
Increased overdose risk among patients receiving higher dose regimens may be due to confounding by patient differences and by use of opioids in ways not intended by prescribing physicians. The small number of overdoses in the study cohort is also a limitation.
CONCLUSION:
Patients receiving higher doses of prescribed opioids are at increased risk for overdose, which underscores the need for close supervision of these patients.
PRIMARY FUNDING SOURCE:
National Institute of Drug Abuse.
 
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Just to play devils advocate...

So you are willing tolerate a 27fold risk of overdose in your high utilizer opioid patients. But you wont inject a particulate steroid transforaminally because it's too risky regardless of the level.

That's not a balanced approach to mitigating risk.

(FWIW, my prescribing patterns are probably pretty much like your own. And like you I have a lot of surveillance for the few
high dose folks - elderly - I manage.)

Ann Intern Med. 2010 Jan 19;152(2):85-92.
Opioid prescriptions for chronic pain and overdose: a cohort study.
Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M.
Source
Group Health Research Institute, Seattle, Washington 98101, USA.
Abstract
BACKGROUND:
Long-term opioid therapy for chronic noncancer pain is becoming increasingly common in community practice. Concomitant with this change in practice, rates of fatal opioid overdose have increased. The extent to which overdose risks are elevated among patients receiving medically prescribed long-term opioid therapy is unknown.
OBJECTIVE:
To estimate rates of opioid overdose and their association with an average prescribed daily opioid dose among patients receiving medically prescribed, long-term opioid therapy.
DESIGN:
Cox proportional hazards models were used to estimate overdose risk as a function of average daily opioid dose (morphine equivalents) received at the time of overdose.
SETTING:
HMO.
PATIENTS:
9940 persons who received 3 or more opioid prescriptions within 90 days for chronic noncancer pain between 1997 and 2005.
MEASUREMENTS:
Average daily opioid dose over the previous 90 days from automated pharmacy data. Primary outcomes--nonfatal and fatal overdoses--were identified through diagnostic codes from inpatient and outpatient care and death certificates and were confirmed by medical record review.
RESULTS:
51 opioid-related overdoses were identified, including 6 deaths. Compared with patients receiving 1 to 20 mg/d of opioids (0.2% annual overdose rate), patients receiving 50 to 99 mg/d had a 3.7-fold increase in overdose risk (95% CI, 1.5 to 9.5) and a 0.7% annual overdose rate. Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk (CI, 4.0 to 19.7) and a 1.8% annual overdose rate.
LIMITATIONS:
Increased overdose risk among patients receiving higher dose regimens may be due to confounding by patient differences and by use of opioids in ways not intended by prescribing physicians. The small number of overdoses in the study cohort is also a limitation.
CONCLUSION:
Patients receiving higher doses of prescribed opioids are at increased risk for overdose, which underscores the need for close supervision of these patients.
PRIMARY FUNDING SOURCE:
National Institute of Drug Abuse.

I can deal with the Rx risk better than the quad risk.
Also, the study is not representative of my practice. I am a Pain Physician with adequate and appropriate training, not a PCP. I've preselected my patients to die less from overdose. :D I hope.
 
what study is this in? Got a reference? Would like to have the ammo to use it :smuggrin:

sure. Attached.
View attachment opioid drug related mortality.pdf

Also, here is a reference from JAMA. I won't attach that since I hate that POS journal - I have no idea why they have such a high impact factor.

Bohnert ASB, et al. “Association Between Opioid Prescribing Patterns and Opioid Overdose-Related Deaths,” Journal of American Medical Association (Apr. 2011): Vol. 305, No. 13, pp. 1315-1321
 
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1 tylenol #3 q month

I know some will say this question is unanswerable but I'm going to ask it anyways:

For chronic non-cancer pain, what is your max opiate dose you just don't go over, no matter what the circumstances, assuming no side effects and no aberrant behavior?

I know it varies from patient to patient, doc to doc and that some believe there's no ceiling other than side effects/aberrant behaviors, but realistically, we all have a "line in the sand" somewhere.

So, at what point do your say, "If opiates have failed to control your pain up to this point, no further increases would be expected to do any different"?

A) What's your "line in the sand" (in po Morphine equivalents)? and,

B) Assuming the patient does not want a pump, at what point do you say, "You're at "X" dose of opiate, you're still in pain, therefore, OPIATES JUST AREN'T GOING TO HELP YOU, we must taper and discontinue"?
 
So, what's your line in the sand for the other 5%? That's really the question...

2 t#3 q month for the other 95%...

i can say it till im blue in the face...just say no.
 
So, what's your line in the sand for the other 5%? That's really the question...

I have one patient on 200mcg fentanyl q2d, 30mg oxycodone #120.

To demonstrate functional status I make her send me postcards.
Last year I got Patagonia for a fishing trip and Fimmvorouhais, Iceland.

Wealthy semi-retired community volunteer who takes massive doses of opiates to maintain a busy travel schedule with her friends. 73 y/o female with no signs of addiction or diversion. Fused C-spine, T-spine, L-spine, several wrist surgeries, several leg surgeries.

I have no one on anything higher than this.
 
2 t#3 q month for the other 95%...

i can say it till im blue in the face...just say no.

So, do you have a non-narcotic or intervention-only practice, or are you just being sarcastic?
 
Does such a creature exist?

The bigger question is what to do with those patients who hit your limit and still complain of significant pain. In the prudent doc's mind, this is a failure of opioids to control the patient's pain. In the mind of most patients and most Portnoyans, you just keep bumping up the dose, titrating to either subjective pain relief or side effects.

IME, 75%+ of those who fail opioids and I attempt to wean them become oppositional and argumentative or just leave the practice for the guy "down the street" who will give them what they want. Then, sooner or later, someone sends them back.

E.g 3 years ago, I saw a lady on Fentanyl patch 150/hr + Percocet 2 TID. 9/10 pain. Dx polyOA +/- seronegative RA. I recommended weaning off opioids. She got down to 2 Percocet a day with same dose of fentanyl and 12-15 phone calls later she left my practice.

A few months ago, a new PCP refers her back to me, now on OxyContin 80 mg TID + those same 6 Percs a day. I sent him a letter advising him of my previous experience with the pt, and to wean her off the opioids, how to do it, and when she was opioid-free, I could see her again.

I'm guessing I lost a referring source. But if he puts patients on those high doses, I don't want them from him.

being a relatively new pain doc that took over an established practice where opioids were a mainstay of therapy, i have been in a similar situation often.

surprisingly, most of the doctors who would refer those patients to me on high dose opioids have for the most part been very accepting of my telling them that high dose opioids have not been shown to provide improvement in long term functioning or quality of life (or at best inconclusive - see http://summaries.cochrane.org/CD006605/opioids-for-long-term-treatment-of-noncancer-pain).

The primary care physicians i have talked to have all stated something to the effect that they appreciated my providing them feedback that confirms their impression, and it makes them more comfortable weaning patients...
 
If that study is true my practice should be seeing several OD deaths per year, which it certainly is not. I have had 2 OD deaths in my practice, both due to polypharmacy in patients who obtained drugs from multiple sources and autopsy showed several drugs not prescribed by me.

This is why you need to read more than the abstract:

"Patients whose deaths were related to opioids were similar to controls with respect to demographic characteristics and comorbidities but were more likely to have received antidepressants, benzodiazepines, methadone, psychotropic
drugs, or other sedating medications prior to death
. They were also more likely to have a history of alcoholism and to have obtained opioids from multiple physicians and pharmacies." (emphasis mine)

Know your patients and do proper surveillance. I have considered going to a ceiling dose, but I want make the limit the dose where clinical returns diminish significantly. How do we establish that?
 
being a relatively new pain doc that took over an established practice where opioids were a mainstay of therapy, i have been in a similar situation often.

surprisingly, most of the doctors who would refer those patients to me on high dose opioids have for the most part been very accepting of my telling them that high dose opioids have not been shown to provide improvement in long term functioning or quality of life (or at best inconclusive - see http://summaries.cochrane.org/CD006605/opioids-for-long-term-treatment-of-noncancer-pain).

The primary care physicians i have talked to have all stated something to the effect that they appreciated my providing them feedback that confirms their impression, and it makes them more comfortable weaning patients...

"The findings of this systematic review suggest that proper management of a type of strong painkiller (opioids) in well-selected patients with no history of substance addiction or abuse can lead to long-term pain relief for some patients with a very small (though not zero) risk of developing addiction, abuse, or other serious side effects. However, the evidence supporting these conclusions is weak, and longer-term studies are needed to identify the patients who are most likely to benefit from treatment. "

This sounds more positive than negative. Change a few words around and you have the Cochrane review of invasive pain management.
 
It reminds me of the studies that show no benefit in tight glucose control for diabetes.

http://www.medscape.com/viewarticle/747569

Does that mean Internists shouldn't prescribe insulin, because one dose doesn't make people better forever? No. Nor should we stop employing interventional therapies in certain patients, or stop prescribing opiate trials in certain patients. We all know the certain patients respond well to certain interventions, others respond well to a reasonable opiate trial, others to adjuvants/PT/etc. Huge portions of medical dogma is based on tradition and the best advice from past leaders in their fields, and NOT evidence. Yes, we should strive to produce evidence for what we do and don't do, and good evidence should override opinion, but in the absence of evidence we have to really on our best medical, and yes, ethical judgement. Yes, that leaves a lot of room for the unscrupulous to commit various inappropriate acts. The key is proper patient selection, setting limits, and doing what's best for each patient individually. It's not always easy.
 
So, do you have a non-narcotic or intervention-only practice, or are you just being sarcastic?

I have a minimal narcotic practice and I am being sarcastic.
 
Internists should prescribe insulin as there IS evidence for glucose control in general. There is, however, NO evidence for use of opioids for management of chronic non cancer pain. NONE. doesn't exist.

THe "thought leaders" and "experts" in our field were bought by the pharmaceutical companies a long time ago.

You're right there are many things that are traditions in medicine that are probably not effective. So instead of just continuing to make the same mistakes in the name of good intentions, maybe we should just stop - and first, do no harm.

It reminds me of the studies that show no benefit in tight glucose control for diabetes.

http://www.medscape.com/viewarticle/747569

Does that mean Internists shouldn't prescribe insulin, because one dose doesn't make people better forever? No. Nor should we stop employing interventional therapies in certain patients, or stop prescribing opiate trials in certain patients. We all know the certain patients respond well to certain interventions, others respond well to a reasonable opiate trial, others to adjuvants/PT/etc. Huge portions of medical dogma is based on tradition and the best advice from past leaders in their fields, and NOT evidence. Yes, we should strive to produce evidence for what we do and don't do, and good evidence should override opinion, but in the absence of evidence we have to really on our best medical, and yes, ethical judgement. Yes, that leaves a lot of room for the unscrupulous to commit various inappropriate acts. The key is proper patient selection, setting limits, and doing what's best for each patient individually. It's not always easy.
 
Some observations based on a strategy I learned in fellowship along with a good friend who was my co fellow. This applies more toward real pathology and normalish non-drug seeking non-diverting patients.

This OxyContin 20 bid is great but I need something stronger. Sure, let's go to 40, but in 2-3 months you'll have the same pain but more constipation and sedation.

3 months later, I have more pain, I need more to function. And im constipated. Sure, let's go 80 bid, but in three months your pain will be unchanged, you'll be really constipated and sleepy.

3 months later, you know what doc, my pain is the same, I can't think clearly, and I can't poop. Help me get off this stuff and let's try something else.

Sure, it takes some time, but certain patients need to be shown that it isn't a great long term strategy before buying into other modalities. The drug seekers and diverters will have burned bridges or had improper pill count or UDS by then.
 
There are now several long term studies of 6 months or more of opioid prescribing that demonstrate safety and efficacy of opioids for the treatment of chronic non-malignant pain. There are a couple of studies that viewed every overdose or exacerbated side effect of opioids as due to the opioid, and were unable to parse the effect of opioids from the combined effects of opioids plus other medications. There are several studies showing substance abuse rates ranging from 20-40% and addiction rates between 0.2% and 5%. There is a huge financial disincentive for interventional pain physicians to do procedures instead of having a medication prescribing practice, typically 10:1 ratio of income per time. These facts make opioid prescribing a thorny issue, and explain some of the controversy in both whether to prescribe or not, and to the appropriate amount, which remain undefined in spite of the overdose studies.
 
There are now several long term studies of 6 months or more of opioid prescribing that demonstrate safety and efficacy of opioids for the treatment of chronic non-malignant pain. There are a couple of studies that viewed every overdose or exacerbated side effect of opioids as due to the opioid, and were unable to parse the effect of opioids from the combined effects of opioids plus other medications. There are several studies showing substance abuse rates ranging from 20-40% and addiction rates between 0.2% and 5%. There is a huge financial disincentive for interventional pain physicians to do procedures instead of having a medication prescribing practice, typically 10:1 ratio of income per time. These facts make opioid prescribing a thorny issue, and explain some of the controversy in both whether to prescribe or not, and to the appropriate amount, which remain undefined in spite of the overdose studies.


i continuously look up this subject online.

there are efficacy studies for reduction of pain, but the evidence that demonstrate improvement for quality of life long term (i.e. over 6 months) is not there.

for example, the Cochrane review that last looked at this in 2010 noted "Findings regarding quality of life and functional status were inconclusive due to insufficient quantity of evidence" (for oral) and "inconclusive" (for intrathecal and transdermal). imo, that roughly translates to no evidence for improvement in qol or functionality...
 
Internists should prescribe insulin as there IS evidence for glucose control in general. There is, however, NO evidence for use of opioids for management of chronic non cancer pain. NONE. doesn't exist.

THe "thought leaders" and "experts" in our field were bought by the pharmaceutical companies a long time ago.

You're right there are many things that are traditions in medicine that are probably not effective. So instead of just continuing to make the same mistakes in the name of good intentions, maybe we should just stop - and first, do no harm.

I was saying that we should use sound clinical and ethical judgement when data is lacking, not follow dogma that doesnt make sound clinical and ethical sense.

So are you saying you never prescribe opiates for chronic non-cancer pain or that you are very strict about patient selection and try to keep doses as low as possible?
 
"The findings of this systematic review suggest that proper management of a type of strong painkiller (opioids) in well-selected patients with no history of substance addiction or abuse can lead to long-term pain relief for some patients with a very small (though not zero) risk of developing addiction, abuse, or other serious side effects. However, the evidence supporting these conclusions is weak, and longer-term studies are needed to identify the patients who are most likely to benefit from treatment. "

This sounds more positive than negative. Change a few words around and you have the Cochrane review of invasive pain management.


which is why i emphasize behavioral medicine/pain psychology/mindfulness therapy, physical therapy/tai chi/yoga, and tell patients to focus on functionality and qol rather than pain. i use interventions as a temporary bridge to get them to that place, but patients dont typically develop dependence to interventions...
 
Are there studies of interventional procedures showing long term QOL improvements?

No. Moreover, are there any studies of interventional - pain - procedures showing improved physical function, increased return to work, diminished use of opioids? No.
 
No. Moreover, are there any studies of interventional - pain - procedures showing improved physical function, increased return to work, diminished use of opioids? No.

Except for ablative procedures, nothing we do is expected to last long. If I get 3 months out of a steroid injection, I'm happy.

That's the problem with the current state of pain medicine. Studies look at 3 months+ and insurance companies expect more return on their investment.
 
I sound nihilistic but I'm not. IMO, pain mgt is a lot like the rehab of serious injuries, success is often measured in nanometers.

I think we need to be very honest about evidence, outcomes, and over-utilization, in order to establish some much needed credibility.
 
There are now several long term studies of 6 months or more of opioid prescribing that demonstrate safety and efficacy of opioids for the treatment of chronic non-malignant pain. There are a couple of studies that viewed every overdose or exacerbated side effect of opioids as due to the opioid, and were unable to parse the effect of opioids from the combined effects of opioids plus other medications. There are several studies showing substance abuse rates ranging from 20-40% and addiction rates between 0.2% and 5%. There is a huge financial disincentive for interventional pain physicians to do procedures instead of having a medication prescribing practice, typically 10:1 ratio of income per time. These facts make opioid prescribing a thorny issue, and explain some of the controversy in both whether to prescribe or not, and to the appropriate amount, which remain undefined in spite of the overdose studies.

Can you provide the references? Thanks.
 
No. Moreover, are there any studies of interventional - pain - procedures showing improved physical function, increased return to work, diminished use of opioids? No.

Wrong.

SCS for CRPS type 1, 5 year data.

It works.
 
Wrong.

SCS for CRPS type 1, 5 year data.

It works.

Give me the article and I will have a look. I am a believe in SCS in the non-work comp realm. But, my experience is that it is a palliative endeavor, not rehabilitative. By that I mean that doesn't improve return to work, functional status (SF-36, or ODI), and meta-analyses have shown - last year's NANS - that it doesn't diminish opioid use.
 
LONG TERM 1 year or more OPIOID OUTCOMES NON-Malig Pain (last study is mixed noncancer+cancer)


Int J Clin Pract. 2010 May;64(6):763-74. Epub 2010 Mar 29. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. 1 year study

Pain Pract. 2010 Sep-Oct;10(5):416-27. doi: 10.1111/j.1533-2500.2010.00397. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain 1 year study

Arthritis Rheum. 2005 Jan;52(1):312-21. Opioid use by patients in an orthopedics spine clinic. 3 year study

J Pain Symptom Manage. 2010 Nov;40(5):747-60. Epub 2010 Jul 1.
Long-term safety and tolerability of fentanyl buccal tablet for the treatment of
breakthrough pain in opioid-tolerant patients with chronic pain: an 18-month
study.

J Pain Symptom Manage. 2010 Nov;40(5):734-46.Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and
sequestered naltrexone, in patients with chronic, moderate to severe pain. 1 year study

Pain Med. 2005 May-Jun;6(3):262-5.Retrospective analysis of Kadian (morphine sulfate sustained-release capsules) in patients with chronic, nonmalignant pain. 1 year study

J Opioid Manag. 2009 Mar-Apr;5(2):97-105. Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain. Mixed cancer and non-cancer 56 sites 1 year study
 
Not to shoot arrows.. but, unless im reading these studies wrong...

1. Not a double blinded study. Interestingly, the baseline BPI is looks the same as the "results". Oxycodone/naloxone is, as far as i am aware, not available yet. 22% of patients dropped out, which seems kind of high.

2. Comparing tapentadol to Oxycodone. I admit, i use a lot of tapentadol. the treatment related adverse events rate was 90% with oxycodone with a 36.8% discontinuation rate. i dont necessarily think that that is an implication that this medication is safe/beneficial.

3. Retrospective study, so thats an issue. Did show what they call statistical significance in reduction of pain (i didnt specifically parse out the stats, not my strength) but unclear how that was determined. 58% had "mild opioid side effects". Dosages of equivalent roughly 22 mg morphine - 78 mg morphine a day. They state that numbers show that tolerance doesnt occur, but then they note that 17 out of 58 long term opioid patients required at least 10 mg morphine dose increase. Also, they "completed study" in 50/58 long term opioid patients but only 45/72 nonopioid patients.

4. Study on adding buccal fentanyl to opioid tolerant patient. Doesnt address issue if opioids should be used in the first place. 18% had serious opioid adverse events... Average pain ratings remained apparently "constant" but the study said there was improvement in functional status.

5. Use of morphine/naltrexone. Not a blinded study from what i can tell, 81% had adverse events, only 160 out of 465 completed study tho. There was improvement in mean scores of pain from baseline for the % of people that did go past the first week (30% of those who dropped out apparently did so in month 1). 7% severe adverse reactions.

7. This study is again about patients who are already committed to long term opioid therapy to the tune of 8mg hydromorphone a day. 388 enrolled, only 106 completed 12 months of therapy.

in summary, i dont see any significant evidence on these studies that long term opioid therapy is "better" than non-opioid therapy for chronic nonmalignant pain syndromes, and each of these studies seem to have flaws. Additionally, these studies all in one form or other state that the adverse side effects seen are "typical" for those seen in any opioid... most studies are quoting in the area of 80% adverse effects. Also, seems taht the dropout rate is fairly high on some of these studies.

besides the Cochrane review, do you know of any study that compares chronic opioid therapy vs. non-opioid therapy for endpoints such as functionality and quality of life?
 
Pain medicine has yet to define what would be considered a measurable outcome in the use of opioids for chronic pain. VAS/NRS is worthless. There is no, as of yet, validated functional scale for chronic pain. Return to work is all-or-none. Everything else is too subjective.

When we can agree on a way to measure success in pain medicine, and can get a true longitudinal, multi-center (not just academic) study of chronic opioid use that doesn't exclude the undesirables from the start, we may find the truth.

Either pain medicine does these studies, or dies from lack of payments.
 
Pain medicine has yet to define what would be considered a measurable outcome in the use of opioids for chronic pain. VAS/NRS is worthless. There is no, as of yet, validated functional scale for chronic pain. Return to work is all-or-none. Everything else is too subjective.

When we can agree on a way to measure success in pain medicine, and can get a true longitudinal, multi-center (not just academic) study of chronic opioid use that doesn't exclude the undesirables from the start, we may find the truth.

Either pain medicine does these studies, or dies from lack of payments.

Generally speaking I agree. However, pain isn't going to go away nor will pain patients. If you take axial spine pain as an example, in spite of all its deficiencies, 'pain management' is probably less harmful, less costly, and about as effective as surgical fusion.
 
There is not a study ever conducted that doesn't have some methodological flaw that will be used to destroy the value of the study. Cochrane is NOT standard of care: they are elitist that believe only in the value of double blind randomized controlled trials and anything less will be met with derision, stating the science does not support whatever Cochane has chosen to evaluate. Therefore, one must take Cochrane for what it is worth: only assigning value to the highest level studies while discounting all others. Evidence based medicine is far from this approach, and clinical practice is even further. The studies I quoted would not meet the criteria of Cochrane, but they do rise to the level of evidence based medicine that assure the use of opioids are effective in the treatment of chronic non-malignant pain. Only a fool would attempt to construct a double blind placebo controlled study with opioids in this population, therefore Cochrane will always and forever deem opioids to be not indicated. The realities of clinical practice are that studies conducted showing opioids having a significant impact in pain long term are far more valuable than the impossible criteria laid out by Cochrane designed for the purist, that doesn't practice in the real world. It also is important to understand some doctors will never ever prescribe opioids long term for chronic non-malignant pain, which is fine, but that there are published literature references demonstrating efficacy as listed above.
 
There is not a study ever conducted that doesn't have some methodological flaw that will be used to destroy the value of the study. Cochrane is NOT standard of care: they are elitist that believe only in the value of double blind randomized controlled trials and anything less will be met with derision, stating the science does not support whatever Cochane has chosen to evaluate. Therefore, one must take Cochrane for what it is worth: only assigning value to the highest level studies while discounting all others. Evidence based medicine is far from this approach, and clinical practice is even further. The studies I quoted would not meet the criteria of Cochrane, but they do rise to the level of evidence based medicine that assure the use of opioids are effective in the treatment of chronic non-malignant pain. Only a fool would attempt to construct a double blind placebo controlled study with opioids in this population, therefore Cochrane will always and forever deem opioids to be not indicated. The realities of clinical practice are that studies conducted showing opioids having a significant impact in pain long term are far more valuable than the impossible criteria laid out by Cochrane designed for the purist, that doesn't practice in the real world. It also is important to understand some doctors will never ever prescribe opioids long term for chronic non-malignant pain, which is fine, but that there are published literature references demonstrating efficacy as listed above.

So, Algos, the original question was: what is your line in the sand in Morphine equivalents?
 
I measure function based on role in family, occupation, and society.

If you take 10mg Lortab a week and cannot get out of bed- it's worthless.
If you are 90 yrs old and take MSContin 30mg bid and Norco 10mg tid and can bake the world's greatest pound cakes and show up for emergency hip injections to get through the next 8 hrs of prepping food for your church function or to ride in the wagon train parade- This is what I dictate. My best patients can cook. And a few are professional chefs. Life is good around the holidays when I need to measure functional improvements.
 
My line in the sand depends on the patient and their functionality. The fully employed (a significant part of my practice) receive as low a dose as possible but enough to keep them fully employed, missing as few days of work as possible, no problems due to disorientation or sedation. The elderly generally have lower doses, and my lowest doses with most stringent requirements are for those 35 and younger. Sleep apnea, prior history of substance abuse or overdose or overuse, and insistance of opioids in lieu of medically indicated procedures/physical therapy/alternatives are all met with strict limitations on opioids with no chance of dose change ever. Also, if patients claim an opioid is not working, I will double it. If there is still no improvement in pain, I cheerfully inform them I am required by law to stop prescribing the opioid since I must have a legitimate medical purpose for prescribing, and no relief at all is not a legitimate medical purpose. As for dose equivalencies in my practice, they are all over the map depending on the patients, but my lowest dose prescribed in equivalents of morphine per day is around 5mg and my highest is around 1200mg. The vast majority are below 120mg a day.
 
My line in the sand depends on the patient and their functionality. The fully employed (a significant part of my practice) receive as low a dose as possible but enough to keep them fully employed, missing as few days of work as possible, no problems due to disorientation or sedation. The elderly generally have lower doses, and my lowest doses with most stringent requirements are for those 35 and younger. Sleep apnea, prior history of substance abuse or overdose or overuse, and insistance of opioids in lieu of medically indicated procedures/physical therapy/alternatives are all met with strict limitations on opioids with no chance of dose change ever. Also, if patients claim an opioid is not working, I will double it. If there is still no improvement in pain, I cheerfully inform them I am required by law to stop prescribing the opioid since I must have a legitimate medical purpose for prescribing, and no relief at all is not a legitimate medical purpose. As for dose equivalencies in my practice, they are all over the map depending on the patients, but my lowest dose prescribed in equivalents of morphine per day is around 5mg and my highest is around 1200mg. The vast majority are below 120mg a day.

We need benchmarking by ICD-9. Ameritox, Millenium, & yada, yada, yada need to report on the geographic variation in opioid dosing - MS04 Equivalents - by ICD-9 dx, age, sex, BMI, and payor mix. That, would be an eye opener.
 
The studies I quoted would not meet the criteria of Cochrane, but they do rise to the level of evidence based medicine that assure the use of opioids are effective in the treatment of chronic non-malignant pain. Only a fool would attempt to construct a double blind placebo controlled study with opioids in this population, therefore Cochrane will always and forever deem opioids to be not indicated. The realities of clinical practice are that studies conducted showing opioids having a significant impact in pain long term are far more valuable than the impossible criteria laid out by Cochrane designed for the purist, that doesn't practice in the real world.

Ironically, in reviewing some of the Cochrane reviews, i came to the opposite conclusion - that Cochrane reviews and academia seem to espouse the "weak evidence" for chronic opioid use in nonmalignant pain syndromes.

After all, reading position papers put out by some of the pain organizations (and geriatric societies) seem to suggest that everyone should be given opioid medications.

im not trying to be a contrarian (sic). i use the same criteria that you use, probably a bit stricter, and i let disease condition influence my decision to start opioids (i.e. almost never for fibro, more willing for post-amp pain).
 
Measuring function is, for me, one of the hardest things in chronic pain. E.g. -

Pt at first visit, I ask him "What is the pain preventing you from doing?"
Pt - "Everything."
"You cannot do anything?"
"No."
"Can you walk?"
"Some"
"How far?"
"It depends"
"On what?"
"How much I hurt"
"Can you get up to go to the bathroom?"
"Sometimes"
"What do you do if you can't?"
"Can't what?"
"Go to the bathroom."
"I don't go."
"How do you get to the bathroom then?"
"I don't"
"You urinate where you are sitting, like on the couch?"
"No."
"So what do you do?"
"I just suffer and make my way to the bathroom."
"So you can walk to the bathroom if you need to."
"Sometimes."
"Did you walk into this building today?"
"Yeah, but it hurt"


"Do you work?"
"I can't"
"Do you want to work?"
"Yeah, but I can't"
"What could we do that would get you back to work?"
"Get rid of my pain."
"If we could not get rid of your pain, but could improve it, could you work?"
"Depends."
"On what?"
"How much I hurt."

No matter what you do, the focus always comes back to "I hurt." "I can't." Etc.

Pts actively refuse to allow you to measure either their level of function or allow you to determine what reasonable goals are for them. They just want to not "hurt."
 
Measuring function is, for me, one of the hardest things in chronic pain. E.g. -

Pt at first visit, I ask him "What is the pain preventing you from doing?"
Pt - "Everything."
"You cannot do anything?"
"No."
"Can you walk?"
"Some"
"How far?"
"It depends"
"On what?"
"How much I hurt"
"Can you get up to go to the bathroom?"
"Sometimes"
"What do you do if you can't?"
"Can't what?"
"Go to the bathroom."
"I don't go."
"How do you get to the bathroom then?"
"I don't"
"You urinate where you are sitting, like on the couch?"
"No."
"So what do you do?"
"I just suffer and make my way to the bathroom."
"So you can walk to the bathroom if you need to."
"Sometimes."
"Did you walk into this building today?"
"Yeah, but it hurt"


"Do you work?"
"I can't"
"Do you want to work?"
"Yeah, but I can't"
"What could we do that would get you back to work?"
"Get rid of my pain."
"If we could not get rid of your pain, but could improve it, could you work?"
"Depends."
"On what?"
"How much I hurt."

No matter what you do, the focus always comes back to "I hurt." "I can't." Etc.

Pts actively refuse to allow you to measure either their level of function or allow you to determine what reasonable goals are for them. They just want to not "hurt."

our profession in a nutshell
 
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