Communicating aberrant drug related behavior

[nwbgn]

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Just wondering how others are handling patients with abnormal tox screens:

1) Do you call the patient and let them know the result, or do you wait until their next follow up appointment to discuss and make further recommendations / discharge the patient?

2) Do you contact the patient's other providers to warn them of the abnormal tox? Do you contact PCP, referring doc, etc?

3) Do you treat the situation differently based on use of medications not prescribed, absence of meds on tox differently from presence of illicit substances?

I ask because I do not yet have a standardized way of handling these situations.

 

[Aether2000]

Usually have the patient come back and discuss....
1. If illicits found (other than marijuana)or non-prescribed by us methadone or buprenorphine, then immediately stop all prescribing of controlled substances and offer to refer to drug rehab or suboxone clinic. The reason we stop prescribing if methadone or buprenorphine is found is because patients can visit methadone clinics or suboxone clinics or drug rehab centers and this will not show up in prescription databases.
2. If marijuana found x 1....warning and continue prescribing as long as there are no other aberrancies at the time
3. If other non-prescribed by our office opioids found, then must have a script or have received these in a hospital/ASC recently (we check). If not and it is a schedule II, then stop all opioids. If it is a schedule III will either wean or give one warning if the patient states it was from an old script and document this warning.
4. If our opioids are NOT found and the patient should have opioids (we write a 30 day supply and write max _ per day on every prescriptions), then we bring the patient back every 1-2 weeks for scripting then gradually move to one month, but no later follow up visits.

 

[nwbgn]

Thanks for your thorough reply Algos. Do you also notify the patient's other providers (PMD, referring doc, etc)? Do you send your last progress note that reflects the issue or directly contact the providers?

I do recognize the importance of this, particularly, behaviors such as illicit drug abuse, etc. However, I can't imagine that we would be able to know all of the patient's providers or spend the time contacting all of them.

 

[Aether2000]

Yes, we notify the referring and treating docs. Unfortunately, there is no other database that could be universally accessed by new physicians that would unwittingly treat these individuals. For instance: patient seeing us and double dipping at the VA pain clinic...getting their Schedule II prescriptions filled in the VA pharmacy. No entry is made in the patient prescription databank for the state by the VA. If the patient is getting the same meds from both locations, it would be impossible to discover the subterfuge via UDS and any future docs may be oblivious that the VA was treating the patient also. Methadone and suboxone clinics also pose serious problems, effectively increasing the rate of substance abuse and drug addiction due to their non-reporting of drugs to the prescription databanks.

 

[mille125]

My approach is similar to algos and I do share information with the referring doctor. Many times the patient will go back to the PCP and say "I did not like Dr. X". They need to know the truth.

Also positive marijuana patients will need to be negative at the next test and all subsequent tests.

 

[101N]

Good thread.

IMO a large part of the current prescription drug abuse epidemic is direct result of physicians - and physician extenders - not documenting and responding to aberrant behavior. I read notes from local pain practices - FNPs and PA f/u's mostly - which list frequent calls to the clinic, unendorsed dose escalations, threatening and cajoling for dose escalations, etc. But then in the assessment and plan the same providers make no mention of aberrant behavior?

Here is my list. Please feel free to add to it.

Aberrant Behaviors:
1. Forging or altering prescriptions
2. Stealing, borrowing, trading, buying, or selling drugs
3. Injecting or snorting oral drugs
4. Injecting or snorting fentanyl or suboxone patches
5. Doctor shopping/ER visits for opioids
6. Current abuse of alcohol or illicit drugs
7. Falls, accidents, or other sedation related sequelli
8. Stolen or lost prescriptions
9. Resisting changes to medications in spite of adverse affects
10. Aggressively complaining about the need for more drugs
11. Drug hoarding
12. Unsanctioned drug escalations
13. Obtaining prescriptions from multiple providers and/or the ER.
14. DUI’s
15. Frequent calls to the office with requests for more medications or early refills
16. Requesting specific drugs
17. Multiple reported opioid and NSAID sensitivities or allergies
18. Clinical ambushes with hovering, agressive, family members/spouses arguing for dose escalations

 

[ctts]

Great advice here on this thread.

I would add that for positive marijuana, I might wait to check their urine in 2 months as it can hang around in the system for a long time especially in obese chronic users.

I have a few questions as well - sorry if I'm getting a little off topic...

Any thoughts on interpreting a urine drug screen that is negative for opiates when you are expecting it to be positive by attributing it to "individual metabolism" or "sub threshold levels of drug"?

Thoughts on saliva testing versus urine testing?

Finally, in regard to Algos' point #3, whey wean for schedule III only and not schedule II?

 

[specepic]

Great advice here on this thread.

I would add that for positive marijuana, I might wait to check their urine in 2 months as it can hang around in the system for a long time especially in obese chronic users.

I have a few questions as well - sorry if I'm getting a little off topic...

Any thoughts on interpreting a urine drug screen that is negative for opiates when you are expecting it to be positive by attributing it to "individual metabolism" or "sub threshold levels of drug"?

Thoughts on saliva testing versus urine testing?

Finally, in regard to Algos' point #3, whey wean for schedule III only and not schedule II?

don't forget that typical UDS has a low senstivity for most opioids. I learned this lesson after fellowship b/c we did little chronic narcs in fellowship. Now I ask for confirm and/or specific test, i.e. "in addition to UDS send out for oxycodone confirm", lab still usually screws it up but at least I'm trying to do right by my pts and policies.

 

[101N]

If the patient is getting the same meds from both locations, it would be impossible to discover the subterfuge via UDS and any future docs may be oblivious that the VA was treating the patient also.

I think this will show a 'sudden' Rt shift on the standard curve provided in Ameritox & Millenium reports.

 

[mille125]

Great advice here on this thread.

I would add that for positive marijuana, I might wait to check their urine in 2 months as it can hang around in the system for a long time especially in obese chronic users.
I have a few questions as well - sorry if I'm getting a little off topic...

Any thoughts on interpreting a urine drug screen that is negative for opiates when you are expecting it to be positive by attributing it to "individual metabolism" or "sub threshold levels of drug"?

Thoughts on saliva testing versus urine testing?

Finally, in regard to Algos' point #3, whey wean for schedule III only and not schedule II?

I wait at least three months and then check again..by surprise...

 

[PMR 4 MSK]

From data collected from my own patients a few years ago: I tested mainly for suspicious behaviors - those with moderate or high risk. These were not iniital patient visit UDS,only from F/U. About 150 tests collated.

13% showed full compliance - what I wrote for was in their system, nothing I did not write for was in their system, no illegals.

Around 50% did not have the meds I prescribed in their system.
40% had meds I did not prescribe in their system.

25% had illegals in their system. Much of it (15% of the total) was MJ.
Of those who tested positive for MJ,on f/u screening over the next 6 months, more than 70% of them tested positive again.

95% of the "unexpected" results were met with disbelief and BS. Excuses, denials, anger, etc. "I have no idea how that cocaine got in there!" "What? I didn't take oxycodone!" "Doc, your test is wrong!" 5% or so admitted their wrong doing, only after confronted with the results.

I gave people second chances, even third chances. Almost every single one blew it. Subsequent testing would again be inconsistent with prescribing. They would be caught going to other docs for pills. They would lose prescriptions, etc.

This convinced me opioids are not for the masses. It simply is not worth it to spend so much time being a policeman and arguing with probable addicts. Excuses you cannot disprove but you don't believe. Promises to adhere to the previous promise to adhere to the opioid agreement. All lipservice.

Better screening before prescribing may improve these numbers somewhat. There is always room for improvement.

 

[Tenesma]

when I used to rx narcotics (a long time ago) - i was surprised with the % of normal, functioning, upstanding community members, who would test positive for cocaine... yikes!

 

[nwbgn]

I believe I will be sending my progress note discussing the aberrant drug related behavior to the patient's other physicians, and if there is illicit drug use other than MJ I will be contacting their offices directly.

I have definitely noticed that truly random and less frequent toxing yield a greater % of aberrant drug related behavior being discovered when a tox is performed in my patient population - even those I believed to be taking medications as prescribed 😱

 

[mille125]

From data collected from my own patients a few years ago: I tested mainly for suspicious behaviors - those with moderate or high risk. These were not iniital patient visit UDS,only from F/U. About 150 tests collated.

13% showed full compliance - what I wrote for was in their system, nothing I did not write for was in their system, no illegals.

Around 50% did not have the meds I prescribed in their system.
40% had meds I did not prescribe in their system.

25% had illegals in their system. Much of it (15% of the total) was MJ.
Of those who tested positive for MJ,on f/u screening over the next 6 months, more than 70% of them tested positive again.

95% of the "unexpected" results were met with disbelief and BS. Excuses, denials, anger, etc. "I have no idea how that cocaine got in there!" "What? I didn't take oxycodone!" "Doc, your test is wrong!" 5% or so admitted their wrong doing, only after confronted with the results.

I gave people second chances, even third chances. Almost every single one blew it. Subsequent testing would again be inconsistent with prescribing. They would be caught going to other docs for pills. They would lose prescriptions, etc.

This convinced me opioids are not for the masses. It simply is not worth it to spend so much time being a policeman and arguing with probable addicts. Excuses you cannot disprove but you don't believe. Promises to adhere to the previous promise to adhere to the opioid agreement. All lipservice.

Better screening before prescribing may improve these numbers somewhat. There is always room for improvement.

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....

 

[Aether2000]

In the past, we did targeted drug screening, with around 70% showing abberrant behavior. Currently we are engaged in a complete testing of everyone in the practice. The number of people taking illicits is around 15%, and nearly all marijuana, although I found a 65 year old taking methamphetamine (confirmed on GC/MS). There were 2 patients taking cocaine, 4 total methamphetamine....actually lower than I anticipated. What was striking was the number that came up positive for methadone and suboxone not being prescribed. It also illustrated extensive sharing of drugs by husband-wife...and we will stop prescribing for one, then ultimately for the other within a month when they blow it.
Recurrent abberrant behaviors are common.....it is a societal failure of recognition of personal responsibility and a deliberate and calculated subterfuge. This population is a pain in the butt. My overall practice will probably shrink by 25% over the next few weeks....

 

[PMR 4 MSK]

My overall practice will probably shrink by 25% over the next few weeks....

While your workload will likely be reduced by at least 50%...

 

[ghost dog]

In the past, we did targeted drug screening, with around 70% showing abberrant behavior. Currently we are engaged in a complete testing of everyone in the practice. The number of people taking illicits is around 15%, and nearly all marijuana, although I found a 65 year old taking methamphetamine (confirmed on GC/MS). There were 2 patients taking cocaine, 4 total methamphetamine....actually lower than I anticipated. What was striking was the number that came up positive for methadone and suboxone not being prescribed. It also illustrated extensive sharing of drugs by husband-wife...and we will stop prescribing for one, then ultimately for the other within a month when they blow it.
Recurrent abberrant behaviors are common.....it is a societal failure of recognition of personal responsibility and a deliberate and calculated subterfuge. This population is a pain in the butt. My overall practice will probably shrink by 25% over the next few weeks....

This is an interesting topic.

I would be interested in hearing from an American perspective, particularly with regards to how your regulatory bodies recommend approaching drug screening and opioid contracts.

At present, urine drug screening and opioid contracts appear to have a
Grade C evidence based recommendation behind them:

“When using urine drug screening (UDS) to establish a baseline measure of risk or to monitor compliance, be aware of benefits and limitations, appropriate test ordering and interpretation, and have a plan to use results. (Grade C).”

“A treatment agreement may be helpful, particularly for patients i) not well known to the physician or ii) at higher risk for opioid misuse. (Grade C).”

HOWEVER, I should note that I was peer assessed recently and got blasted for not piss testing absolutely EVERYBODY (which I now do). Previously I had urine drug screened those at moderate to high risk for aberrant opioid behavior (as based on the opioid risk tool).

 

[ghost dog]

From data collected from my own patients a few years ago: I tested mainly for suspicious behaviors - those with moderate or high risk. These were not iniital patient visit UDS,only from F/U. About 150 tests collated.

13% showed full compliance - what I wrote for was in their system, nothing I did not write for was in their system, no illegals.

Around 50% did not have the meds I prescribed in their system.
40% had meds I did not prescribe in their system.

25% had illegals in their system. Much of it (15% of the total) was MJ.
Of those who tested positive for MJ,on f/u screening over the next 6 months, more than 70% of them tested positive again.

95% of the "unexpected" results were met with disbelief and BS. Excuses, denials, anger, etc. "I have no idea how that cocaine got in there!" "What? I didn't take oxycodone!" "Doc, your test is wrong!" 5% or so admitted their wrong doing, only after confronted with the results.

I gave people second chances, even third chances. Almost every single one blew it. Subsequent testing would again be inconsistent with prescribing. They would be caught going to other docs for pills. They would lose prescriptions, etc.

This convinced me opioids are not for the masses. It simply is not worth it to spend so much time being a policeman and arguing with probable addicts. Excuses you cannot disprove but you don't believe. Promises to adhere to the previous promise to adhere to the opioid agreement. All lipservice.

Better screening before prescribing may improve these numbers somewhat. There is always room for improvement.

In regards to the screening process and how this would yield a better result, here's a Cochrane review on the subject:

What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-related behaviors? A structured evidence-based review.


Pain Med. 2008 May-Jun;9(4):444-59.


DESIGN: This is a structured evidence-based review of all available studies on the development of abuse/addiction and aberrant drug-related behaviors (ADRBs) in chronic pain patients (CPPs) with nonmalignant pain on exposure to chronic opioid analgesic therapy (COAT). OBJECTIVES: To determine what percentage of CPPs develop abuse/addiction and/or ADRBs on COAT exposure.



METHOD: Computer and manual literature searches yielded 79 references that addressed this area of study. Twelve of the studies were excluded from detailed review based on exclusion criteria important to this area. Sixty-seven studies were reviewed in detail and sorted according to whether they reported percentages of CPPs developing abuse/addiction or developing ADRBs, or percentages diagnosed with alcohol/illicit drug use as determined by urine toxicology. Study characteristics were abstracted into tabular form, and each report was characterized according to the type of study it represented based on the Agency for Health Care Policy and Research Guidelines. Each study was independently evaluated by two raters according to 12 quality criteria and a quality score calculated. Studies were not utilized in the calculations unless their quality score (utilizing both raters) was greater than 65%. Within each of the above study groupings, the total number of CPPs exposed to opioids on COAT treatment was calculated. Similarly, the total number of CPPs in each grouping demonstrating abuse/addiction, ADRBs, or alcohol/illicit drug use was also calculated. Finally, a percentage for each of these behaviors was calculated in each grouping, utilizing the total number of CPPs exposed to opioids in each grouping.


RESULTS: All 67 reports had quality scores greater than 65%. For the abuse / addiction grouping there were 24 studies with 2,507 CPPs exposed for a calculated abuse/addiction rate of 3.27%. Within this grouping for those studies that had preselected CPPs for COAT exposure for no previous or current history of abuse /addiction, the percentage of abuse/addiction was calculated at 0.19%. For the ADRB grouping, there were 17 studies with 2,466 CPPs exposed and a calculated ADRB rate of 11.5%. Within this grouping for preselected CPPs (as above), the percentage of ADRBs was calculated at 0.59%. In the urine toxicology grouping, there were five studies (15,442 CPPs exposed). Here, 20.4% of the CPPs had no prescribed opioid in urine and/or a nonprescribed opioid in urine. For five studies (1,965 CPPs exposed), illicit drugs were found in 14.5%.


CONCLUSION: The results of this evidence-based structured review indicate that COAT exposure will lead to abuse/addiction in a small percentage of CPPs, but a larger percentage will demonstrate ADRBs and illicit drug use. These percentages appear to be much less if CPPs are preselected for the absence of a current or past history of alcohol / illicit drug use or abuse/addiction.

 

[mille125]

This is an interesting topic.

I would be interested in hearing from an American perspective, particularly with regards to how your regulatory bodies recommend approaching drug screening and opioid contracts.

At present, urine drug screening and opioid contracts appear to have a
Grade C evidence based recommendation behind them:

“When using urine drug screening (UDS) to establish a baseline measure of risk or to monitor compliance, be aware of benefits and limitations, appropriate test ordering and interpretation, and have a plan to use results. (Grade C).”

“A treatment agreement may be helpful, particularly for patients i) not well known to the physician or ii) at higher risk for opioid misuse. (Grade C).”

HOWEVER, I should note that I was peer assessed recently and got blasted for not piss testing absolutely EVERYBODY (which I now do). Previously I had urine drug screened those at moderate to high risk for aberrant opioid behavior (as based on the opioid risk tool).

This is an area that is gray and open to interpretation. Most people would test every patient on opioids at some point. One thing that I have noticed after being in this business for awhile is that no one can predict who is going to be positive for aberrancy. I have had UDS's positive for cocaine, THC, or other interesting things in several occasions on folks in the 80 plus crowd as well as "upstanding citizens" like other docs, lawyers, teachers, etc. Screening that is based on what you perceive to be moderate to high risk is not only inadequate but also discriminatory.

Most agree to test every patient on opioids at some point. The question is at what frequency. Personally, I feel testing every patient at every visit is overkill. If a patient has no aberrency on three consecutive tests why test so frequently. Testing needs to be medically necessary (you can get a ding for this as well). Most docs seems to test at least every 2-4 months as well as all new patients on opioids. However, there is no standard of care on this.

 

[ghost dog]

This is an area that is gray and open to interpretation. Most people would test every patient on opioids at some point. One thing that I have noticed after being in this business for awhile is that no one can predict who is going to be positive for aberrancy. I have had UDS's positive for cocaine, THC, or other interesting things in several occasions on folks in the 80 plus crowd as well as "upstanding citizens" like other docs, lawyers, teachers, etc. Screening that is based on what you perceive to be moderate to high risk is not only inadequate but also discriminatory.

Most agree to test every patient on opioids at some point. The question is at what frequency. Personally, I feel testing every patient at every visit is overkill. If a patient has no aberrency on three consecutive tests why test so frequently. Testing needs to be medically necessary (you can get a ding for this as well). Most docs seems to test at least every 2-4 months as well as all new patients on opioids. However, there is no standard of care on this.

I agree with what you say.

I assess a patient's likelihood to demonstrate aberrant opioid behavior / opioid abuse as judged ( in part ) by the opioid risk tool. This is a (somewhat) evidence based tool:

http://www.lifetreeresearch.com/media/articles/ORT.pdf

Webster LW. Pain Medicine 2005; 6(6): 432-442

A low volume study conducted by Dr. Lynn Webster: Of the low-risk patients
(0 - 3 score ORT ), 17 out of 18 (94.4% ) did not display any aberrant behavior. Of the high-risk patients (8 or higher ORT) , 40 out of 44 (90.9%) did display an aberrant behavior.

I wouldn't say using the ORT is discriminatory behavior on my part.

Do you folks use the ORT? Or another instrument?

 

[Tenesma]

I don't use ORT...

I just don't recommend narcotics for patients with
1) criminal histories (easy to check up on state defendant search website)
2) hx of doctor shopping (easy to check up on state prescription monitoring program)
3) non-specific symptoms without a good sense of an underlying nociceptive problem
4) who are under the age of 40

this significantly cuts down on the need for urine tox screens...

we (as a profession) are using/advocating Utox screens as a way of "monitoring" the chronic narcotic patient population - when in fact, we are always constantly praying it shows up positive for an illicit substance so that we can discontinue the narcotic...

i believe it should be the other way around, our risk assessments should occur before narcotic initiation or before the decision to maintain on chronic opioids...

patients are non-compliant with medications anyway, so what makes you think patients are compliant with their narcotics??

 

[Jcm800]

i have said this so many times before, but i rarely initiate narcotics due to my philosophy on them. However, every now and then, i start to think perhaps I am too jaded and my own PERSONAL viewpoint is skewing my judgement for the use of opiates in the general population, until...

i read this board. Then i am 100% convinced again that opiates are more or less nonsense for the typical patient that wants them. If a seasoned provider who appears to be have the best interest of his patients in mind (i assume this about most people on this board) is going to have a practice "shrink" by 25% buy screening the entire practice, why do we keep asserting that these "medications" are appropriate. Now of course in specific instances they are, but lets be realistic, if he have to screen so heavily and have a huge percentage that are non-compliant, what does that say. I understand the counterpoint, "we need to screen better initially, or have better screening tools" but i will argue even a huge percentage of those that "pass" our screening tools, ultimately have "aberrant" behavior, and thus in my opinion, should not be on chronic opiates. Thus even further decreasing the number of appropriate patients.

i am down to so few narcotic patients i could loose them ALL and would not know it...the ones that i recommend and accept, dont pass the screening, the others say "hell no, i will deal with this pain before i become an addict" like any normal coping person would do...

it is too bad that prescribing opiates can result in a 1 minute monthly follow up that can be seen by an NP and generate the same as a real follow up. If there was a separate code for it, that reimbursed less, we would see a lot less prescriptions out there. The opposition could say the same to me about procedures, i guess.

 

[101N]

You can be parsimonious up front, or hyper-vigilant on the back end. But, if you ignore aberrant behavior you end up with an epidemic of abuse.

Portnenoy and Passik bear a lot of responsibility for our current problems.

“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.

 

[Tenesma]

When i did prescribe narcotics - i did all of the urine testing, did all of the random pill counts, criminal checks, all the strict rules - included psychological screening... as soon as I stopped writing narcotics, my procedure volume dropped by 30%...

why?

it turns out that my superb screening tools did not weed out all the abusers/diverters - and most of them would get the injections with the hope of getting a continued supply of narcotics... they thought it was a good tit for tat --- i was completely depressed by this realization - patients would actually get injections just for the prescriptions...

now in my current practice, without narcotics, i don't have to deal w/ that crap...

 

[SSdoc33]

so........much........work.........

i can understand if you are doing a whipple and saving someone's life. but for questionable returns and patients that act like children and have utter disdain for you? no thanks.

 

[101N]

as soon as I stopped writing narcotics, my procedure volume dropped by 30%...

I had this same discussion @ ISIS about 5yrs ago. A guy I know well said point blank: "Opioids are good for business". I'm no pollyanna but I - like you - have to disagree, I see it as pandering for financial gain.

IMO this issue has arisen due to a failure of leadership in academic setting and within the various pain guilds. Back in the 80s & 90s when the mission of pain management lurched from post-traumatic, post-operative, and cancer to non-malignant pain a paradigm shift occurred. These audiences are different and none of the thought leaders spoke out and said: Hey wait a minute.

 

[PMR 4 MSK]

so........much........work.........

i can understand if you are doing a whipple and saving someone's life. but for questionable returns and patients that act like children and have utter disdain for you? no thanks.

That perfects sums up my experiences with opioids and chronic pain. 👍

I had this same discussion @ ISIS about 5yrs ago. A guy I know well said point blank: "Opioids are good for business". I'm no pollyanna but I - like you - have to disagree, I see it as pandering for financial gain.

IMO this issue has arisen due to a failure of leadership in academic setting and within the various pain guilds. Back in the 80s & 90s when the mission of pain management lurched from post-traumatic, post-operative, and cancer to non-malignant pain a paradigm shift occurred. These audiences are different and none of the thought leaders spoke out and said: Hey wait a minute.

Opioids are not good for business. When I bought into Portnoy's and Passik's (saw them speak at many conferences) "opioids for everyone!" philosphy, I ended ujp with a practice bogged down by opioids. 90% or more of patients were on them. Cancer pts were 1% of my practice. Another 1% had another terminal illness. 50% + was Medicare, 25% or more was Medicaid. It was so much paperwork and documentation even when the patients were not in the office, and then arguing with these "children" when they were in the office why I was not going to raiuse their Oxycontin dose from 80 mg TID to 120 QID. Or why I would not just let them take 2 percocet every 4 hours. Or why they didn't "need my Somas". And why exercise would help them, or counseling, or SSRIs, etc. They didn't want to hear it. They only wanted to hear "Sure, I'd love to be your new prescriber! How much would you like?"

Then you need more people to help with the police work. Checking state databases, calling pharmacies, following up on allegations by other patients or anonymous phone calls. All this costs money.

And all for patient who will turn on you the instant you don't give them everything they want. Dirty UDS = wean? Now you have to answer the state board as to why your patient called them claiming you "turned them into an addict."

Just not worth it. Kudos to those of you who do it. I burned out on it.

2 weeks ago I saw a pt I believe I posted on - bipolar, fibro, migraines, a host of somatic syndromes, on hydrocodone 10 mg 6-8 per day. I recommended weaning off the opioids, getting into counseling, getting a home exercise program. Yesterday whe followed up with the rheumatologist in my office she sees, told the MA "I never when see that @$$hole again! He wanted to take my pain pills away from me! Told me I was crazy and needed to get my head examined! He said I was fat and lazy and needed to get my 'fat ass off the couch'."

They only hear what they want to hear.

 

[101N]

That perfects sums up my experiences with opioids and chronic pain. 👍




Opioids are not good for business. When I bought into Portnoy's and Passik's (saw them speak at many conferences) "opioids for everyone!" philosphy, I ended ujp with a practice bogged down by opioids. 90% or more of patients were on them. Cancer pts were 1% of my practice. Another 1% had another terminal illness. 50% + was Medicare, 25% or more was Medicaid. It was so much paperwork and documentation even when the patients were not in the office, and then arguing with these "children" when they were in the office why I was not going to raiuse their Oxycontin dose from 80 mg TID to 120 QID. Or why I would not just let them take 2 percocet every 4 hours. Or why they didn't "need my Somas". And why exercise would help them, or counseling, or SSRIs, etc. They didn't want to hear it. They only wanted to hear "Sure, I'd love to be your new prescriber! How much would you like?"

Then you need more people to help with the police work. Checking state databases, calling pharmacies, following up on allegations by other patients or anonymous phone calls. All this costs money.

And all for patient who will turn on you the instant you don't give them everything they want. Dirty UDS = wean? Now you have to answer the state board as to why your patient called them claiming you "turned them into an addict."

Just not worth it. Kudos to those of you who do it. I burned out on it.

2 weeks ago I saw a pt I believe I posted on - bipolar, fibro, migraines, a host of somatic syndromes, on hydrocodone 10 mg 6-8 per day. I recommended weaning off the opioids, getting into counseling, getting a home exercise program. Yesterday whe followed up with the rheumatologist in my office she sees, told the MA "I never when see that @$$hole again! He wanted to take my pain pills away from me! Told me I was crazy and needed to get my head examined! He said I was fat and lazy and needed to get my 'fat ass off the couch'."

They only hear what they want to hear.

1+

Listen up youngsters on this forum.

Do not go down the Portnoy, Passik, Joranson pathway.

 

[lobelsteve]

as soon as I stopped writing narcotics, my procedure volume dropped by 30%...
.

I know practices built entirely on this principle. I find it equivalent to sex for drugs.

 

[Aether2000]

Playing the devils advocate....there are several studies showing long term benefit of opioid treatment in improved function and pain control whereas the only long term studies with positive outcomes in interventional pain are spinal cord stim, IT pumps, and radiofrequency medial branch neurotomy in the 10% of those with facet disease that meet the rigid criteria to perform RF. All other studies involving steroid injections show at most short term benefit associated with weight gain, immune system compromise, throwing diabetes and hypertension out of control, steroid psychosis, and possibly producing osteoporosis. So based on the studies, why would anyone use exclusively interventional pain techniques?

 

[101N]

Playing the devils advocate....there are several studies showing long term benefit of opioid treatment in improved function and pain control whereas the only long term studies with positive outcomes in interventional pain are spinal cord stim, IT pumps, and radiofrequency medial branch neurotomy in the 10% of those with facet disease that meet the rigid criteria to perform RF. All other studies involving steroid injections show at most short term benefit associated with weight gain, immune system compromise, throwing diabetes and hypertension out of control, steroid psychosis, and possibly producing osteoporosis. So based on the studies, why would anyone use exclusively interventional pain techniques?

Thin your herd.

 

[Aether2000]

But the question stands: with the costs of interventional pain being 10 times higher than non-interventional pain, and given only short term relief with interventional pain techniques, how can a strictly interventional pain practice be justified? This is precisely the question insurers are asking, and unless we have a better answer than "medication patients are troublesome, reimburse less, and we don't want to be bothered with them", then insurers will chop interventional pain off at the legs.

 

[101N]

how can a strictly interventional pain practice be justified?

I don't feel it can. I think not prescribing is, in some instances, simply inhumane. My argument is more subtle than simply no opioids for anyone.

If you document and respond to UTS and aberrant behavior I think you will
thin the herd to more reasonable levels. I also think that we need to treat diseases, not symptoms. Not all pain is equal.

 

[powermd]

2 weeks ago I saw a pt I believe I posted on - bipolar, fibro, migraines, a host of somatic syndromes, on hydrocodone 10 mg 6-8 per day. I recommended weaning off the opioids, getting into counseling, getting a home exercise program. Yesterday whe followed up with the rheumatologist in my office she sees, told the MA "I never when see that @$$hole again! He wanted to take my pain pills away from me! Told me I was crazy and needed to get my head examined! He said I was fat and lazy and needed to get my 'fat ass off the couch'."

They only hear what they want to hear.

Studies are studies... this is the reality of "medication management". We all have a pretty good sense of what is possible with interventional management. In MANY cases simple injections of local and steroids in the right place seems to lead to substantial relief. Vertebroplasty wasn't abandoned because one study showed it was ineffective. The study itself was questioned, even by the author, who still does v-plasty. The problem isn't the interventions, it's the way they're studied.

 

[sweetalkr]

why don't we take our patients on jerry springer, and confront them on national tv, then give them a live UDS with analysis and see what the truth is. we could make great $ and great prime time tv

 

[Aether2000]

Even Jerry Springer has basal standards, as low as they may be. I can't imagine some of my patients being invited to his show 🙂

 

[Jcm800]

Playing the devils advocate....there are several studies showing long term benefit of opioid treatment in improved function and pain control whereas the only long term studies with positive outcomes in interventional pain are spinal cord stim, IT pumps, and radiofrequency medial branch neurotomy in the 10% of those with facet disease that meet the rigid criteria to perform RF. All other studies involving steroid injections show at most short term benefit associated with weight gain, immune system compromise, throwing diabetes and hypertension out of control, steroid psychosis, and possibly producing osteoporosis. So based on the studies, why would anyone use exclusively interventional pain techniques?

i didnt say exclusively interventional techniques was the way to go... i said that opiates are nonsense for the VAST majority of patients. but we are a completely over-narced population who willingly (whether this is admitted to themselves or not) allow inappropriate patients to stay on opiates, or start them on them, because it is easier and more lucrative then doing the right thing. When appropriate, sure use them. THe problem is, it is a "gift that keeps on giving" (kinda like spinal fusion) and is abused by many a "pain doctor". it is easy to do and is profitable.

How difficult is it manage opiates? sure you you can say "i am screening people, and i am watching doses, testing uring, watching out for signs of addiction, etc" but its like saying I only prescribe BPH medications and calling yourself a "prostate doctor" not a urolgist, they do surgery. I do non-operative urology. Im a prostate doctor. Its ludicrous to think that writing one type of medication can be a "field of medicine".

One can delude themselves into thinking opiates are appropriate in almost any case, but what i am saying is that if opiates generated only yearly visits and reimbursed at a value of the actual work it takes for a refill (virtually nothing), there was no skin in the pharmaceutical game, virtually no one would do it for the headache and stress it carries with it. Definitely not some FP or ER doc that starts writing scripts and calls themselves a pain doctor. SOmeone else said before, but why are their multiple paths yet into this field, multiple boards. It needs to be ACGME fellowship trained, board certified by the AMBS are the only ones that call themselves pain docs. And most of these doctors, are heavily interventional. we cant know everything there is to know in the field of "pain management" but a guy that writes prescriptions for pain medication is not a pain doc. or maybe they are, and the guys that did a ACGME accredited fellowship that practice primarily interventional pain, and prescribe when appropriate should be called something else...

Everyday a pain doctor asks, when is it NOT GONNA BE WORTH it do this... how many times do you hear someone say "i can always go back to anesthesia, or i can always do inpatient rehab"

all the time.

i dont know if this has anything to do with anything anymore...

 

[mille125]

But the question stands: with the costs of interventional pain being 10 times higher than non-interventional pain, and given only short term relief with interventional pain techniques, how can a strictly interventional pain practice be justified? This is precisely the question insurers are asking, and unless we have a better answer than "medication patients are troublesome, reimburse less, and we don't want to be bothered with them", then insurers will chop interventional pain off at the legs.

Direct costs to the insurance company may be higher but what about the direct and indirect costs of opioids. Addiction, diversion, endocrine imbalance, unnecessary ER visits, constipation, death, etc. etc. What about the costs of this? It is a extraordinary cost....

I feel that in some patients interventions are the most appropriate treatment and in some patients its opioids.

 

[ghost dog]

Playing the devils advocate....there are several studies showing long term benefit of opioid treatment in improved function and pain control whereas the only long term studies with positive outcomes in interventional pain are spinal cord stim, IT pumps, and radiofrequency medial branch neurotomy in the 10% of those with facet disease that meet the rigid criteria to perform RF. All other studies involving steroid injections show at most short term benefit associated with weight gain, immune system compromise, throwing diabetes and hypertension out of control, steroid psychosis, and possibly producing osteoporosis. So based on the studies, why would anyone use exclusively interventional pain techniques?

This reminds me of a back pain consult I see a few days ago.

A doc (who I wasn't familiar with) refers me a patient who , as it turns out, is taking Oxycontin five (5) times a day. Yup, we all know where this is going.

She tells me she's get's "80% relief" from the Oxy's, but looking at her BPI all her functional indices are in the 8-9 / 10 range for impairment. Allrighty then...

She is running out 2-3 weeks early on her monthly script. But hey, no reason for the family doc to not renew the Oxys x 3 years , right?

And, she is chewing her percocet...which has been going on for the past 5 years.

The referral note ( I swear) : "Back pain: ++ Use of pain meds"

I guess this is my bad for not calling this pharmaceutical genius for more info.

Serenity now. 😱

 

[hyperalgesia]

Playing the devils advocate....there are several studies showing long term benefit of opioid treatment in improved function and pain control whereas the only long term studies with positive outcomes in interventional pain are spinal cord stim, IT pumps, and radiofrequency medial branch neurotomy in the 10% of those with facet disease that meet the rigid criteria to perform RF. All other studies involving steroid injections show at most short term benefit associated with weight gain, immune system compromise, throwing diabetes and hypertension out of control, steroid psychosis, and possibly producing osteoporosis. So based on the studies, why would anyone use exclusively interventional pain techniques?

I'm not sure we're getting the whole picture from current studies. If you examined every opioid pill I ever prescribed and followed it and looked at how much good it did (improve function, decrease physical pain, etc.) and compared that to how much harm it did (ended up taken by a kid, ended up as a component to someone's OD, contributed to an MVA, violence, caused a serious medical side effect, etc). I don't think I'd be very proud with the outcome if all these things are considered. If I ask the same question about the interventions I've done, I feel pretty good about them.

 

[lobelsteve]

I'm not sure we're getting the whole picture from current studies. If you examined every opioid pill I ever prescribed and followed it and looked at how much good it did (improve function, decrease physical pain, etc.) and compared that to how much harm it did (ended up taken by a kid, ended up as a component to someone's OD, contributed to an MVA, violence, caused a serious medical side effect, etc). I don't think I'd be very proud with the outcome if all these things are considered. If I ask the same question about the interventions I've done, I feel pretty good about them.

Maybe you need to borrow a good patient?

This man is 76 y/o. I have inherited him on a MSO4 pump at 20mg/day and Lortab qid when he was 73. We weaned and explanted. He had a vertebroplasty. He gets MBB's and RF every 6 months (rotate between T10-L1, and L2-5, left/right). Currently on MSContin 60 tid and MSIR 15mg tid prn. Farming is down from 5-10 acres 10 years ago to 1 acre. He used to sleep through the OV and his wife would talk. Now he is bright eyed and pain is controlled. Can't wait for tomatoes to get dropped off.

 

[Aether2000]

In order for interventional pain to continue to exist, we need to generate the data necessary to support the specialty when there are much cheaper alternatives available and given our not so stellar outcomes by our own studies. The costs of opioid abuse/side effects accompanying opioid prescribing in a pain clinic have not been quantified. Perhaps that would be a great place to start.....
Ultimately our existence will be determined by bean counters that are interested in the least expensive intervention. If we cannot get the prices down by avoiding hospital based injections, stopping the nonsense of out of network $3-5K charges for a self owned surgery center use fee for injections, and excessive use of injections then we are doomed. But what I perceive is that interventional pain usage has exploded and that as regulators approach the imposition of draconian reductions, rather than seeing studies to justify our approach, I see physicians (and CRNAs) doing as many procedures as they can before the door closes. We really need standards of care, not wavering guidelines, not opinions, but consensus based standards of care that we would be willing to stand up in court and defend. It is a long road to cover in the very short time that remains.....

 

[PMR 4 MSK]

In order for interventional pain to continue to exist, we need to generate the data necessary to support the specialty when there are much cheaper alternatives available and given our not so stellar outcomes by our own studies. The costs of opioid abuse/side effects accompanying opioid prescribing in a pain clinic have not been quantified. Perhaps that would be a great place to start.....
Ultimately our existence will be determined by bean counters that are interested in the least expensive intervention. If we cannot get the prices down by avoiding hospital based injections, stopping the nonsense of out of network $3-5K charges for a self owned surgery center use fee for injections, and excessive use of injections then we are doomed. But what I perceive is that interventional pain usage has exploded and that as regulators approach the imposition of draconian reductions, rather than seeing studies to justify our approach, I see physicians (and CRNAs) doing as many procedures as they can before the door closes. We really need standards of care, not wavering guidelines, not opinions, but consensus based standards of care that we would be willing to stand up in court and defend. It is a long road to cover in the very short time that remains.....

The guidelines are being defined for us (occ med, state of Washington, etc.) Pain medicine has failed to either study it's own procedures or police it's own ranks. Both will be the downfall of the field.

Medicaid is also doing this. In a previous practice, I had a multi-discsiplinary pain clinic, with in-office injection suite, counselor, PT (and for a few months a chiropractor). I swear I had the secret to pain management with those people - we could get most anyone functional and in less pain without much opioids. But Medicaid would not pay for counseling for adults, paid less for PT than I had to pay the PT to work, would not pay for in-office injections, would not cover chiro and would only cover generics - i.e. no Lyrica, SSRIs, SNRIs, etc. But damned if they would not cover vicodin, with absolutely no limits. Want to give your patient 1000 pills per month? They'll pay for it. Soma? Sure. Xanax? You bet. Restoril? Got it covered. Much to the dismay of a large % of my practice, I dropped Medicaid when they stopped paying for counseling.

The other problem with this was very few patients wanted what I had to offer. For those who accepted it, we did great work. For the rest it was "Why ain'tcha gonna gimme my pain pills, doc?" Or after a 20 minte discussion on chronic pain, PT, exercise, counseling, non-opioid meds, I'd get "Ok, but are you gonna gimme something for pain?" It was a losing, uphill battle, and I surrendered.

 

[hyperalgesia]

Maybe you need to borrow a good patient?

I'll take him!

 

[mille125]

In order for interventional pain to continue to exist, we need to generate the data necessary to support the specialty when there are much cheaper alternatives available and given our not so stellar outcomes by our own studies. The costs of opioid abuse/side effects accompanying opioid prescribing in a pain clinic have not been quantified. Perhaps that would be a great place to start.....
Ultimately our existence will be determined by bean counters that are interested in the least expensive intervention. If we cannot get the prices down by avoiding hospital based injections, stopping the nonsense of out of network $3-5K charges for a self owned surgery center use fee for injections, and excessive use of injections then we are doomed. But what I perceive is that interventional pain usage has exploded and that as regulators approach the imposition of draconian reductions, rather than seeing studies to justify our approach, I see physicians (and CRNAs) doing as many procedures as they can before the door closes. We really need standards of care, not wavering guidelines, not opinions, but consensus based standards of care that we would be willing to stand up in court and defend. It is a long road to cover in the very short time that remains.....

First and foremost we need a plan which we currently do not have. I would suggest..

1) We need to construct studies comparing injections to opioids and looking at ALL adverse outcomes. I think that there would be a clear winner here. Opioids do help some patients and I have some in my practice whose life has been changed. I do not feel like PMRMSK or Tenesma on this I respect their feelings.

2) We need to press a limitation on the types of provides who can do these procedures. This would decrease cost and increase efficacy overnight. Even though there are some bad docs in our ranks, the vast majority of the unnecessary procedures are being done by the untrained. The procedures need to be limited to fellowship trained anes,PMR,neuro, and psych docs. We also need to come up with strict guidelines that are reasonable. All of this is defeated if we have someone in our ranks who continues to do the series of three. Expect pushback for surgeons and radiologists. However, I think that we have a good case.

 

[Tenesma]

algos - you mentioned data to show long-term support. Please share, as the only data i know of are a handful of studies that go beyond 6 months... in fact, there is tons of retrospective data showing the ill-effects of chronic opioid use.

the practices that drive me nuts are the ones that provide a 30 day rx for percocet/vicodin post-procedure for post-procedural pain... isn't the whole point of the procedure NOT to have post-procedural pain

i hate to sound like an ass --- and algosdoc, i really respect your opinion/experience... but I find that most pain doctors who rx narcotics to non-terminal non-cancer pain are buying into a false sense of security w/ these patients... EVEN if you weed out the diverters and blatant abusers, a significant proportion of the patients you maintain on narcotics are 1) non-compliant 2) non-adherent 3) and likely end up relying on the narcotics for failed coping mechanisms.

I see about 850-1000 consults per year - of which >40% are for pharmacologic evaluations. I would say less than 5 consults per year are appropriate for narcotics
1) clear nociceptive process
2) functional improvement
3) no abherrant behaviors
4) and typically, WANT to come off narcotics.

mille: i respect your point of view as well. If these narcotic patients whose lives are transformed are doing so great why are they still in your practice, why not turn them over to PCP to manage? I would think a PCP would be glad to take back improved patients on a stable regimen that will allow for regular EM visits?

 

[Aether2000]

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.

Sandner-Kiesling A, Leyendecker P, Hopp M, Tarau L, Lejcko J, Meissner W, Sevcik
P, Hakl M, Hrib R, Uhl R, D├╝rr H, Reimer K.

Department of Anaesthesiology and Intensive Care Medicine, Medical University,
Graz, Austria.

OBJECTIVE: The aim of this study was to assess safety and efficacy of fixed
combination oxycodone prolonged release (PR)/naloxone PR in terms of both
analgesia and improving opioid-induced bowel dysfunction (OIBD) and associated
symptoms, such as opioid-induced constipation (OIC), in adults with chronic
non-cancer pain.
STUDY DESIGN: These were open-label extension studies in which patients who had
previously completed a 12-week, double-blind study received oxycodone PR/naloxone
PR for up to 52 weeks. The analgesia study assessed pain using the modified Brief
Pain Inventory-Short Form (BPI-SF). The bowel function study assessed
improvements in constipation using the Bowel Function Index (BFI).
RESULTS: At open-label baseline in the analgesia study (n = 379), mean score [+/-
standard deviation (SD)] for the BPI-SF item 'average pain over the last 24 h'
was 3.9 +/- 1.52, and this remained low at 6 months (3.7 +/- 1.59) and 12 months
(3.8 +/- 1.72). Mean scores for BPI-SF item 'sleep interference', and the BPI-SF
'pain' and 'interference with activities' subscales also remained low throughout
the 52-week study. In the bowel function study (n = 258), mean BFI score (+/- SD)
decreased from 35.6 +/- 27.74 at the start of the extension study to 20.6 +/-
24.01 after 12 months of treatment with oxycodone PR/naloxone PR. Pain scores
also remained low and stable during this study. Adverse events in both extension
phases were consistent with those associated with opioid therapy; no additional
safety concerns were observed.
CONCLUSION: Results from these two open-label extension studies demonstrate the
long-term efficacy and tolerability of fixed combination oxycodone PR/naloxone PR
in the treatment of chronic pain. Patients experienced clinically relevant
improvements in OIBD while receiving effective analgesic therapy.

 

[Aether2000]

Pain Pract. 2010 Sep-Oct;10(5):416-27. doi: 10.1111/j.1533-2500.2010.00397.x.

Long-term safety and tolerability of tapentadol extended release for the
management of chronic low back pain or osteoarthritis pain.

Wild JE, Grond S, Kuperwasser B, Gilbert J, McCann B, Lange B, Steup A, Häufel T,
Etropolski MS, Rauschkolb C, Lange R.

Upstate Clinical Research Associates, Williamsville, New York, USA.

BACKGROUND: Tapentadol is a novel, centrally acting analgesic with 2 mechanisms
of action: µ-opioid receptor agonism and norepinephrine reuptake inhibition. This
randomized, open-label phase 3 study (ClinicalTrials.gov Identifier: NCT00361504)
assessed the long-term safety and tolerability of tapentadol extended release
(ER) in patients with chronic knee or hip osteoarthritis pain or low back pain.
METHODS: Patients were randomized 4:1 to receive controlled, adjustable, oral,
twice-daily doses of tapentadol ER (100 to 250 mg) or oxycodone HCl controlled
release (CR; 20 to 50 mg) for up to 1 year. Efficacy evaluations included
assessments at each study visit of average pain intensity (11-point numerical
rating scale) over the preceding 24 hours. Treatment-emergent adverse events
(TEAEs) and discontinuations were monitored throughout the study.
RESULTS: A total of 1,117 patients received at least 1 dose of study drug. Mean
(standard error) pain intensity scores in the tapentadol ER and oxycodone CR
groups, respectively, were 7.6 (0.05) and 7.6 (0.11) at baseline and decreased to
4.4 (0.09) and 4.5 (0.17) at endpoint. The overall incidence of TEAEs was 85.7%
in the tapentadol ER group and 90.6% in the oxycodone CR group. In the tapentadol
ER and oxycodone CR groups, respectively, TEAEs led to discontinuation in 22.1%
and 36.8% of patients; gastrointestinal TEAEs led to discontinuation in 8.6% and
21.5% of patients.
CONCLUSION: Tapentadol ER (100 to 250 mg bid) was associated with better
gastrointestinal tolerability than oxycodone HCl CR (20 to 50 mg bid) and
provided sustainable relief of moderate to severe chronic knee or hip
osteoarthritis or low back pain for up to 1 year.

 

[Aether2000]

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.

Webster LR, Brewer R, Wang C, Sekora D, Johnson FK, Morris D, Stauffer J.

Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah 84106, USA.
[email protected]

CONTEXT: Morphine sulfate and naltrexone hydrochloride extended release capsules
contain extended-release pellets of morphine with a sequestered naltrexone core
(MS-sNT). Taken whole, as intended, morphine is released to provide pain relief;
if tampered with by crushing, naltrexone is released to mitigate subjective
effects of morphine.
OBJECTIVES: This open-label study assessed long-term (12-month) safety of MS-sNT
in patients with chronic, moderate to severe pain.
METHODS: Safety assessments included determining adverse events (AEs), laboratory
assessments, and the Clinical Opiate Withdrawal Scale (COWS). Analgesic efficacy
was assessed (diary) as worst, least, average, and current pain using an 11-point
numeric scale (0=none; 10=worst).
RESULTS: Of 465 patients receiving one or more doses, 160 completed the study.
Most patients (81.3%) experienced one or more AEs, most commonly constipation
(31.8%) or nausea (25.2%). Thirty-three patients (7.1%) reported serious AEs; one
patient's severe gastrointestinal inflammation and colitis were considered
possibly study drug-related. Most discontinuations (30%) occurred in the first
month, most often because of AEs (23.7%). There were no clinically relevant
changes in laboratory results or vital signs, and no clinically significant
electrocardiogram changes deemed study drug-related. During each visit after Week
1, 5% or fewer patients had COWS scores indicating mild withdrawal symptoms
(range, 0%-4.8%). Five patients, who did not take the study drug as instructed,
had scores consistent with moderate withdrawal. MS-sNT yielded statistically
significant improvements from baseline in mean scores for all pain diary items
for all visits, except Week 1 for least pain.
CONCLUSION: In this study population, when MS-sNT was taken as directed for
chronic, moderate to severe pain for up to 12 months, most AEs were typical
opioid-related side effects. Mean COWS scores remained low, indicating lack
of*withdrawal symptoms and appropriate transition off the study drug at
completion.

 

[Aether2000]

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.

Fine PG, Messina J, Xie F, Rathmell J.

Department of Anesthesiology, Pain Management Center, Suite 200, 615 Arapeen
Drive, University of Utah, Salt Lake City, UT 84109, USA. [email protected]

CONTEXT: Breakthrough pain (BTP) is highly prevalent in patients with chronic
cancer and noncancer pain, commonly requiring treatment with short-acting or
rapid-onset opioids. This is the first report of an analysis of long-term safety
from combined clinical trials of a rapid-onset transmucosal formulation of
fentanyl, the fentanyl buccal tablet (FBT).
OBJECTIVES: This long-term (18-month), open-label study assessed the safety and
tolerability of FBT for the treatment of BTP in a large cohort (n=646) of
opioid-tolerant patients receiving around-the-clock (ATC) opioids for persistant
noncancer pain.
METHODS: This was a long-term, multicenter, open-label safety study that accepted
patients naïve to FBT (new patients) as well as rollover patients from one of two
previous short-term, randomized, placebo-controlled studies involving
opioid-tolerant adults with chronic noncancer pain. All patients gave written
informed consent, and the study was conducted according to Good Clinical Practice
and with Independent Ethics Committee or Institutional Review Board approval.
RESULTS: During maintenance treatment, 70 of 646 patients (11%) discontinued
because of adverse events (AEs), 69 of 646 (11%) because of withdrawn consent,
and 57 of 646 (9%) because of noncompliance. A total of 571 of 646 patients (88%)
had one or more AEs; most were mild to moderate in intensity and typical of AEs
associated with opioid use in a noncancer chronic pain population. Serious AEs
were seen in 118 of 646 patients (18%); most were considered by the investigators
to be unrelated or unlikely to be related to FBT. There were six deaths (three
myocardial infarction, two cardiac arrest, and one pneumonia) that were
considered by investigators to be unrelated or unlikely to be related to FBT.
There were two reports of accidental overdose contained within nine reports of
nonfatal overdose (FBT and/or ATC and/or other medications). Four patients had
AEs of abuse or drug dependence, two in association with FBT. Drug withdrawal
syndrome occurred in 23 patients after discontinuation of FBT alone or in
combination with other opioids. Secondary assessments showed that average pain
ratings, as assessed by the Brief Pain Inventory, remained relatively stable
throughout the study and that consistent improvements were noted in functional
measures.
CONCLUSION: FBT was generally safe and well tolerated, with self-reported
functional improvement observed in most of the opioid-tolerant patients with BTP
in association with chronic noncancer pain.