Communicating aberrant drug related behavior

[Aether2000]

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J Opioid Manag. 2009 Mar-Apr;5(2):97-105.

Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients
with chronic pain.

Wallace M, Moulin DE, Rauck RL, Khanna S, Tudor IC, Skowronski R, Thipphawong J.

San Diego Medical Center, University of California, La Jolla, California, USA.

OBJECTIVE: To assess the safety and efficacy of long-term repeated dosing of OROS
hydromorphone in chronic pain patients.
DESIGN: This multicenter, open-label extension trial enrolled patients from three
short-term OROS hydromorphone trials.
SETTING: Fifty-six centers in the United States and Canada.
PATIENTS: Adults with chronic cancer pain or chronic nonmalignant pain who were
receiving stable doses of OROS hydromorphone (> or = 8 mg/day). Three hundred and
eighty-eight patients were enrolled, 106 patients completed at least 12 months of
therapy.
INTERVENTIONS: OROS hydromorphone (individualized doses) was administered once
daily.
MAIN OUTCOME MEASURES: Safety and efficacy (Brief Pain Inventory and patient and
investigator global evaluations) were assessed at monthly visits.
RESULTS: The median duration of extended OROS hydromorphone therapy was 274 days.
The median daily dose of study medication was 32.0 mg at extension-study
baseline, 40.0 mg at month 3, and 48.0 mg at months 6, 9, and 12, respectively.
The most frequently reported adverse events were nausea (n = 93, 24.0 percent)
and constipation (n = 75, 19.3 percent). The analgesic effects of OROS
hydromorphone, assessed using the Brief Pain Inventory, were maintained
throughout the extension. At 12 months, 72.4 percent of patients and 75.9 percent
of investigators rated overall treatment as good, very good, or excellent.
CONCLUSIONS: Once-daily OROS hydromorphone is an osmotically driven,
controlled-release preparation that may be particularly well suited to long-term
use, because it provides consistent plasma concentrations and sustained
around-the-clock analgesia. In this study, the benefits of OROS hydromorphone
attained in short-term studies were maintained in the long-term when daily
administration was continued.

 

[Aether2000]

Pain Med. 2008 Oct;9(7):786-94. Epub 2008 Jun 18.

Experience of methadone therapy in 100 consecutive chronic pain patients in a
multidisciplinary pain center.

Peng P, Tumber P, Stafford M, Gourlay D, Wong P, Galonski M, Evans D, Gordon A.

Wasser Pain Management Center, Mount Sinai Hospital, Toronto, Ontario, Canada.
[email protected]

OBJECTIVE: The objective of the study was to describe the experience of methadone
use in 100 consecutive chronic pain patients managed in a single
multidisciplinary center.
DESIGN: A chart review of chronic pain patients on methadone therapy initiated at
the Wasser Pain Management Center from January 2001 to June 2004. SETTING,
PATIENTS, AND INTERVENTION: Outpatients receiving methadone for chronic pain
management in a tertiary multidisciplinary pain center.
OUTCOME MEASURE: Effects on pain relief and function, conversion ratio from other
opioids, side effects, and disposition were reviewed.
RESULTS: Charts of 100 methadone patients (age 45 +/- 11 years old; M/F: 3/7;
duration of pain 129 +/- 110 months) managed by five physicians and one nurse
were reviewed. The main reason for the initiation of methadone therapy was opioid
rotation (72%). The average oral morphine equivalent dose was 77 mg/day before
methadone therapy, and the methadone dose after initial stabilization was 42 mg
with no consistent conversion ratio observed. The mean duration of methadone
therapy was 11 months. Most of the patients (91%) were taking concomitant
adjuvant analgesics or psychotropic agents, mostly antidepressants and
anticonvulsants. The average Numeric Verbal Rating Score before and after
methadone treatment was 7.2 +/- 1.7 and 5.2 +/- 2.5 (P < 0.0001). Thirty-five
patients discontinued their methadone treatment mainly because of side effects,
ineffectiveness, or both.
CONCLUSION: From our experience, methadone is an effective alternative to
conventional opioids for chronic pain management when used by experienced
clinicians in a setting that allows for close monitoring and careful dose
initiation and adjustment.

 

[emd123]

The procedures need to be limited to fellowship trained anes,PMR,neuro, and psych docs.

Agree with all except this. If a non-anesth/non-pmr/non-neuro/non-psych physician overcomes the overwhelming odds of getting an ACGME fellowship by demonstrating great interest, dedication and self study in pursuing a Pain Medicine career, and successfully completes an ACGME fellowship and gets ABMS pain sub-boarded, that person deserves every bit of a "seat at the table" so to speak whether you like it or not. You can't have the ACGME encouraging, allowing and training non-anesth/neuro/pmr/psych physicians and then bar them from practicing. The numbers are few, but need to be recognized. Do you want punish the docs who did an accredited fellowship? How about focusing on non-physicians, non-fellowship trained, non-boarded, and non-accredited fellowship graduates, not trying to ban the people who are following the rules. Yes, the rules have changed, but these are the rules.

I practiced as an attending for many years prior to fellowship and treated literally thousands of chronic pain patients, prior to fellowship (ACGME accredited). This should not be recognized?

 

[101N]

agree with all except this. If a non-anesth/non-pmr/non-neuro/non-psych physician overcomes the overwhelming odds of getting an acgme fellowship by demonstrating great interest, dedication and self study in pursuing a pain medicine career, and successfully completes an acgme fellowship and gets abms pain sub-boarded, that person deserves every bit of a "seat at the table" so to speak whether you like it or not. You can't have the acgme encouraging, allowing and training non-anesth/neuro/pmr/psych physicians and then bar them from practicing. The numbers are few, but need to be recognized. Do you want punish the docs who did an accredited fellowship? How about focusing on non-physicians, non-fellowship trained, non-boarded, and non-accredited fellowship graduates, not trying to ban the people who are following the rules. Yes, the rules have changed, but these are the rules.

I practiced as an attending for many years prior to fellowship and treated literally thousands of chronic pain patients, prior to fellowship (acgme accredited). This should not be recognized?

1+

 

[Aether2000]

The above studies are all a year with the exception of methadone, that averaged 11 months. There are other studies of opioids that extend much longer but their primary outcome measures were not targeted to pain level reduction.
I agree that opioids are problematic, but given several outcome studies showing 12 month relief or more in chronic non-malignant pain patients using several different agents, it is difficult to argue that interventional therapies could compete with medical management using generic MS, methadone, etc. There are more studies being released soon using long term opioid treatment and more granular outcome measures.... This is what we are up against...

 

[mille125]

...

 

[mille125]

Agree with all except this. If a non-anesth/non-pmr/non-neuro/non-psych physician overcomes the overwhelming odds of getting an ACGME fellowship by demonstrating great interest, dedication and self study in pursuing a Pain Medicine career, and successfully completes an ACGME fellowship and gets ABMS pain sub-boarded, that person deserves every bit of a "seat at the table" so to speak whether you like it or not. You can't have the ACGME encouraging, allowing and training non-anesth/neuro/pmr/psych physicians and then bar them from practicing. The numbers are few, but need to be recognized. Do you want punish the docs who did an accredited fellowship? How about focusing on non-physicians, non-fellowship trained, non-boarded, and non-accredited fellowship graduates, not trying to ban the people who are following the rules. Yes, the rules have changed, but these are the rules.

I practiced as an attending for many years prior to fellowship and treated literally thousands of chronic pain patients, prior to fellowship (ACGME accredited). This should not be recognized?

I totally agree with you on the non pmr/anes/neuro/psych fellowship trained docs....my apologies as this is an omission on my part.....I should have said all fellowship trained docs....


Concerned the grandfathering point (which is essentially what you are asking), my question is that if you are willing to devote your life to helping chronic pain patients, why wont you just go back and do the 1 year fellowship? You will find it more difficult to practice in the future without a fellowship whether my proposition goes through or not. I feel that moving forward fellowship should be required. This is my opinion. Others will agree with you. I just dont see what is stopping you from getting a fellowship....

 

[mille125]

Agree with all except this. If a non-anesth/non-pmr/non-neuro/non-psych physician overcomes the overwhelming odds of getting an ACGME fellowship by demonstrating great interest, dedication and self study in pursuing a Pain Medicine career, and successfully completes an ACGME fellowship and gets ABMS pain sub-boarded, that person deserves every bit of a "seat at the table" so to speak whether you like it or not. You can't have the ACGME encouraging, allowing and training non-anesth/neuro/pmr/psych physicians and then bar them from practicing. The numbers are few, but need to be recognized. Do you want punish the docs who did an accredited fellowship? How about focusing on non-physicians, non-fellowship trained, non-boarded, and non-accredited fellowship graduates, not trying to ban the people who are following the rules. Yes, the rules have changed, but these are the rules.

I practiced as an attending for many years prior to fellowship and treated literally thousands of chronic pain patients, prior to fellowship (ACGME accredited). This should not be recognized?

Not to generalized as I am an anesthesiologist myself. Some of my non- fellowship trained brethren are the leading perpetrators of at least the series of three......

 

[Tenesma]

algos - thank you for posting those.... it's interesting data - did you look at the inclusion criteria?

 

[hyperalgesia]

Thanks for posting Algos.

It's sad but my argument for procedures>opioids has nothing to do with pain control and everything to do with overall consequences of unleashing narcotics. I don't think procedures in general can compete with pharmaceutical endorphin anologues for "pain relief"... It is a fool's errand.

What I would gleefully pursue is a demonstration of the "more harm" case of narcotics>procedures over the long term. And to me "long term" is 10 years, not 1 year. Discarding "pain relief" for a second, in my experience, procedures have been essentially harmless. OTOH I have had several patients (that I know about) who diverted opioids and God knows where they ended up and what they did. The pills not the patients. If ONLY looking at the patients as the studies do, one could argue that both pain and financial well being are both improved with opioids.

 

[emd123]

I totally agree with you on the non pmr/anes/neuro/psych fellowship trained docs....my apologies as this is an omission on my part.....I should have said all fellowship trained docs....


Concerned the grandfathering point (which is essentially what you are asking), my question is that if you are willing to devote your life to helping chronic pain patients, why wont you just go back and do the 1 year fellowship? You will find it more difficult to practice in the future without a fellowship whether my proposition goes through or not. I feel that moving forward fellowship should be required. This is my opinion. Others will agree with you. I just dont see what is stopping you from getting a fellowship....

I am doing an ACGME fellowship. That's my whole point. I don't want to go through the whole accredited fellowship after years of practice and then have someone tell me I can't practice pain medicine when there's plenty of people that did little or no training and just practice on untouched.

 

[Aether2000]

True, the inclusion criteria cherry pick in the opioid studies, but these studies do unfortunately show continuous relief, not the roller coaster relief that is provided by interventional techniques. I have many many more that are 6 months in duration but these provide longer term relief than do most interventional procedures. The lack of long term (10 year) opioid outcome studies is really no different than the lack of long term (10 year) outcome studies from interventional procedures. We really have no idea what harm we may be causing patients long term with epidural steroid injections.....hasn't been studied. So our challenge is that we must produce some quality studies demonstrating at least cost effectiveness to provide better health with interventional techniques than opioids.

 

[mille125]

I am doing an ACGME fellowship. That's my whole point. I don't want to go through the whole accredited fellowship after years of practice and then have someone tell me I can't practice pain medicine when there's plenty of people that did little or no training and just practice on untouched.

again my initial comments were not directed at you....anyone no matter what their initial background who completes a fellowship will practice unfettered.....

 

[101N]

Those numbers are a little off (it could be your sample size). With thousands screened I have found in my practice the following:

65-70% show full compliance
4% did not have meds that I prescribed (automatic discharge)
11% had meds that I did not prescribe (automatic discharge and very dangerous)


25% illegals is consistent with my findings with the vast majority as THC. Many did have THC again or did not return (automatic wean of opioids).

Most did not argue with results and actually admitted THC usage. A few of the cocaines and others did argue.


I think if my findings were like PMR's, I would likely not write opioids either....

Limiting the definition of aberrancy to inconsistent UTS findings is what Portnoy, Passik, & Joranson have argued for years and it's gotten the nation into a prescription drug epidemic. I've long held that these guys liberal opioid policies have more to to do with their industry ties than with patients or society's best interests. Look at their disclosures and you'll see that they've been in the pocket of big Pharma for years.

The quote below is from the NYTs article about Hurwitz.

“Half of pain patients would have to stop taking their medicine if the rule went out that every so-called red-flag behavior meant you couldn’t prescribe,” Dr. Portenoy says. He and researchers like Dr. Steven D. Passik, a psychologist at the Memorial Sloan-Kettering Cancer Center, have found that about half of pain patients exhibit at least a couple of the warning signs, and that even veteran physicians cannot agree on which signs are the most important to look for."

That's a tacit endorsement of ignoring aberrant behavior. I think we need to do precisely the opposite and codify aberrancy in all it's manifestations, agree upon it, document it, and then either wean or discharge when we observe it. If I'm called to do a peer review and I see the following aberrant behaviors documented in the chart:

claiming allergies to everything but dilaudid and oxy, requests for early refills,
frequent clinic calls, missed appointments, loud, disruptive, argumentative
behavior in clinic, bizzarre behaviors in clinic such as sobbing, lying on the floor, the overwhelming smell of patchouli oil, insisting on wearing sunglasses during the visit, frequent incarceration, DUI's, warning calls from pharmacies, police, families, etc.

but the physician/extender keeps prescribing in spite of this, I won't be sympathetic. Aberrancy extends beyond the UTS findings.

 

[emd123]

again my initial comments were not directed at you....anyone no matter what their initial background who completes a fellowship will practice unfettered.....

Thank you.

 

[Jcm800]

agree completely. I dont think these guys are prescribing opiates to "stamp out pain" their disclosures are unbelievable. they need a second page for the disclosure...

Limiting the definition of aberrancy to inconsistent UTS findings is what Portnoy, Passik, & Joranson have argued for years and it's gotten the nation into a prescription drug epidemic. I've long held that these guys liberal opioid policies have more to to do with their industry ties than with patients or society's best interests. Look at their disclosures and you'll see that they've been in the pocket of big Pharma for years.

The quote below is from the NYTs article about Hurwitz.

“Half of pain patients would have to stop taking their medicine if the rule went out that every so-called red-flag behavior meant you couldn’t prescribe,” Dr. Portenoy says. He and researchers like Dr. Steven D. Passik, a psychologist at the Memorial Sloan-Kettering Cancer Center, have found that about half of pain patients exhibit at least a couple of the warning signs, and that even veteran physicians cannot agree on which signs are the most important to look for."

That's a tacit endorsement of ignoring aberrant behavior. I think we need to do precisely the opposite and codify aberrancy in all it's manifestations, agree upon it, document it, and then either wean or discharge when we observe it. If I'm called to do a peer review and I see the following aberrant behaviors documented in the chart:

claiming allergies to everything but dilaudid and oxy, requests for early refills,
frequent clinic calls, missed appointments, loud, disruptive, argumentative
behavior in clinic, bizzarre behaviors in clinic such as sobbing, lying on the floor, the overwhelming smell of patchouli oil, insisting on wearing sunglasses during the visit, frequent incarceration, DUI's, warning calls from pharmacies, police, families, etc.

but the physician/extender keeps prescribing in spite of this, I won't be sympathetic. Aberrancy extends beyond the UTS findings.

 

[jsaul]

I interviewed in 6 practices across the country- NYC, LA, Chicago, Atlanta, Houston, San Fran

And in every practice that I interviewed in- they all prescribed opioids. In fact at one place they laughed at me when I ask "do you prescribe opioids?"

I am friends with other pain docs who currently are in a ATL, Dallas, Austin, Denver, chicago, LA, and they all precribe opioids.

Opioids are prescribed reasonably by the great majority of pain docs. Especially in large cities and large practices.

Are opioids for everyone? no. Do I prescribe? yes. I don't prescribe soma or xanax.

 

[ghost dog]

I interviewed in 6 practices across the country- NYC, LA, Chicago, Atlanta, Houston, San Fran

And in every practice that I interviewed in- they all prescribed opioids. In fact at one place they laughed at me when I ask "do you prescribe opioids?"

I am friends with other pain docs who currently are in a ATL, Dallas, Austin, Denver, chicago, LA, and they all precribe opioids.

Opioids are prescribed reasonably by the great majority of pain docs. Especially in large cities and large practices.

Are opioids for everyone? no. Do I prescribe? yes. I don't prescribe soma or xanax.

I agree. I don't understand scripting benzos on a chronic basis; over the short term for an acute stressor (1-2 weeks and stop), OK.

Long term- no benefit, and lots of drawbacks (i.e. addictive, synergistic sedative / resp depressant effect with opioids, fall risk, etc.) Inevitably, these patients always complain of poor sleep - so WHY are they still taking them 5 years later?

 

[PMR 4 MSK]

The above studies are all a year with the exception of methadone, that averaged 11 months. There are other studies of opioids that extend much longer but their primary outcome measures were not targeted to pain level reduction.
I agree that opioids are problematic, but given several outcome studies showing 12 month relief or more in chronic non-malignant pain patients using several different agents, it is difficult to argue that interventional therapies could compete with medical management using generic MS, methadone, etc. There are more studies being released soon using long term opioid treatment and more granular outcome measures.... This is what we are up against...

1 year or more of continuous relief in patients who were most likely screened from a more general population - "cherry picked" as you say. Only one of the studies appears to have looked at abberant behaviors.

I agree 100% opioids help pain.
I agree 100% they can be taken long term with little-to-no physical AEs.
Most elderly people won't abuse their pills.
Most pain patients don't want opioids.

These studies mostly avoid the big questions, however:
How much of a problem is opioid tolerence?
What % of patients in a general population show abuse?
What % of patients are abusing other medications and illegal drugs?
What % of patients are selling their pills?
Is there anything a doctor can do in a patient who shows abuse or addiction to help the patient?
How do I avoid getting sued by the survivors in the family of an idiot who thought it was ok to take a month's worth of pills in 1 week?

There are some studies that look at prevelance of these problems, but none that really look at the incidence over time.

When I have a 30 yo male in my office claiming that nothing has helped him, but "Man, doc, them Norcos sure did the trick fer me," I am not quesitoning if opioids will improve his pain from a 9/10 to a 5/10. I don't really care, as that is a ridiculous endpoint. I want to know if Billy Bob is going to get a job, or be able to wash is clothes, or hell, maybe even make it to the dentist. I want to see if they make him productive.

My anecdotal experience is that the majority of young people on opioids are using them to make Jerry Springer a more pleasurable viewing experience. Or to supplement their income. Or to barter for marijuana. Who knows? We will probably nerver know as these aren't things you can study.

Is there a study utilizing an objective measure of function in chronic pain patients? One that does not rely on the patients giving subjective assessments of their own function, like "Yeah, I used to only be able to get my socks on, but now I can get my shoes on too!"

Or maybe a study on why chronic pain patients can afford to consume 4000 calories a day along with 2 packs of cigarettes, but can't come up with the $2 co-pay Medicaid requires them to pay a specialist. Or how a chronic pain patient never has a working phone when we need to call them for an important medical issue, but they can call us when they run out of pills 6 days early?

 

[hyperalgesia]

Just to return to the original post for a minute...

What we did in my previous clinic (now I just make recs, leaving the UDS to the PCP) is this:

I would get the urine AFTER interviewing the patient. I would tell him he can have the script for the meds if he provides the urine. He takes the script and walks out the door. When the UDS comes up with cocaine, MJ, barbs, benzos with trace amounts of urine, I note it in the chart. And now, here's the good part, the NURSE contacts the patient to inform him of the results and very diplomatically states that we are not able to provide any more narcotics for him. We are happy to continue to see him but we are prohibited from giving any more narcs. Maybe this is a chicken $h!t way to do it, but having the nurse call really cut down on the uncomfortable confrontations in the office. Now when the pt came back he already new what the deal was, no surprises. Most of them never returned. Of course the disadvantage is we gave a last refill to a substance abuser, but it was a worthy trade-off to me.

 

[painstop]

I'm sensing a lot of burned out pain docs...at least the ones prescribing opiates (me included). I'm just waiting for the day when science can make opiates provide analgesia without activating the reward centers in our brain (a dopamine antagonist mixed into every oral opiate or something else a genius pharmacologist can figure out). Imagine how nice it would be if prescribing opiates was like prescribing migraine or cholesterol medication...a man can dream. The other path things can go (if half the country becomes addicts) is that insurance/CMS will start limiting the amount of opiates prescribed (like Washington with morphine equivalent doses) except for certain conditions by certain "pain" docs...sounds far fetched but it could happen.

 

[PMR 4 MSK]

Just to return to the original post for a minute...

What we did in my previous clinic (now I just make recs, leaving the UDS to the PCP) is this:

I would get the urine AFTER interviewing the patient. I would tell him he can have the script for the meds if he provides the urine. He takes the script and walks out the door. When the UDS comes up with cocaine, MJ, barbs, benzos with trace amounts of urine, I note it in the chart. And now, here's the good part, the NURSE contacts the patient to inform him of the results and very diplomatically states that we are not able to provide any more narcotics for him. We are happy to continue to see him but we are prohibited from giving any more narcs. Maybe this is a chicken $h!t way to do it, but having the nurse call really cut down on the uncomfortable confrontations in the office. Now when the pt came back he already new what the deal was, no surprises. Most of them never returned. Of course the disadvantage is we gave a last refill to a substance abuser, but it was a worthy trade-off to me.

Yeah, it is a chicken-$hit way to do it, but it probably works. It never bothered me to do it face-to-face. The lies, the excuses, the "yeah, but"s all made it worth it...