Can pain pumps reduce oral opioid consumptions?

[drusso]

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onlinelibrary.wiley.com

"Our study showed 81.5% of patients with chronic noncancer pain reduced their average daily opioid dose immediately prior to or in the 395 days following implantation of an intrathecal drug‐delivery system. Overall, 43% of patients discontinued systemic opioids following implantation of an intrathecal drug‐delivery system, with discontinuation associated with significantly lower costs from a payer perspective in the one‐year postwashout time period. Patients on lower systemic opioid dose levels (morphine milligram equivalents of 1‐50 mg/day) were two times more likely to discontinue systemic opioid therapy relative to patients on high doses prior to start of intrathecal drug‐delivery system therapy (morphine milligram equivalents ≥90 mg/day). However, we observed only minimal dose reduction prior to start of intrathecal drug‐delivery system therapy in this study population. Our results suggest a need for broader adoption of opioid weaning and/or discontinuation protocols prior to start of intrathecal drug‐delivery system therapy to maximize probability of complete systemic opioid discontinuation with intrathecal drug‐delivery system therapy and to maximize cost savings in this patient population. Furthermore, complete systemic opioid discontinuation could decrease diversion, addiction, opioid overdose, and overdose‐related deaths."

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[Orin]

The best part of that study is that it is a retrospective review prior to the CDC guidelines and the workflow shenanigans.

Critically speaking however, they do start with a cohort of 9000 or so devices that turns into a cohort of about 600. A good bit of that was exclusion for cancer, old devices, not taking opioids, and lack of followup in the insurance database, but it still brings this to 600/1300.

I suspect this isn't representative of most provider's findings, although it is consistent with my experience with the therapy.

 

[Ducttape]

1. retrospective.
2. supported by industry. 2 of the authors are employed by Medtronics.
3. 13 month duration of study. long term compared to most opioid studies but this seems awfully short for someone getting an implanted device.
4. out of 3374 patients, 221 had pump removed.
5. more telling, 465 patients out of 1154 had no ITP refills on their pumps, suggesting that over 1/3 of patients were not getting intrathecal opioids
6. I cannot specifically tell if the MED or the prescriptions provided include the intrathecal opioid therapy. the methods do not discuss the dosage of opioid through the ITP - I worry that MED of the ITP opioids were not included in analysis.
7. cost savings are relative - some people discontinued opioids, saving possibly $11,000. sounds great, except not included in this is the fact that the pump itself may cost what $30,000.... so no cost savings at all. and those who continued opioids had an increase in $30,000 over baseline.

encouraging study but it will be misconstrued to recommend that all patients get an ITP...

 

[Ferrismonk]

Implanted pain pump for 1-50 MMED? Wtf?

Maybe I'm being naive, but I'm shocked people are still putting in opioid pumps for noncancer pain. Aren't we all trying to wean opioids?

 

[Orin]

1. retrospective.
2. supported by industry. 2 of the authors are employed by Medtronics.
3. 13 month duration of study. long term compared to most opioid studies but this seems awfully short for someone getting an implanted device.
4. out of 3374 patients, 221 had pump removed.
5. more telling, 465 patients out of 1154 had no ITP refills on their pumps, suggesting that over 1/3 of patients were not getting intrathecal opioids
6. I cannot specifically tell if the MED or the prescriptions provided include the intrathecal opioid therapy. the methods do not discuss the dosage of opioid through the ITP - I worry that MED of the ITP opioids were not included in analysis.
7. cost savings are relative - some people discontinued opioids, saving possibly $11,000. sounds great, except not included in this is the fact that the pump itself may cost what $30,000.... so no cost savings at all. and those who continued opioids had an increase in $30,000 over baseline.

encouraging study but it will be misconstrued to recommend that all patients get an ITP...

Implanted pain pump for 1-50 MMED? Wtf?

Maybe I'm being naive, but I'm shocked people are still putting in opioid pumps for noncancer pain. Aren't we all trying to wean opioids?

Reg 1. This is old retrospective data but it give you an idea of systemic opioid exposure in the presence of a device. This is before this whole low dose monotherapy thing became vogue.
Reg 2. The lead author is also a speaker for MDT
Reg 3. It's as long of a f/u as the SPACE study...
Reg 4. a 7% explant rate is similar/equivalent to the SCS rate and if it's in the first 12 months it is often infection related
Reg 5. They excluded folks that didn't get a refill recorded
Reg 6. The MEDs are just systemic. MEDs of intrathecal therapy is a made up number though.
Reg 7. A pump costs about $10k. It's not as expensive as SCS which runs in the 20 - 30k range, although I've seen insurance charges in the 100k range for some IPGs. I guess it would be good to know what the costs of untreated chronic pain are, but I'm not sure how that happens in our culture.

Reg the weaning opioids, intrathecal therapy lets you get the analgesia without the systemic risk. Targeted delivery reduces the diversion risk. It reduces the O/D risk. It's the carrot at the end of the wean.

 

[SeniorWrangler]

1 year is not a long time to follow a patient with a pump.

 

[deleted131481]

1 year is not a long time to follow a patient with a pump.

In fellowship I trained at a place where they used to do a fair number of pumps but in recent years had steered away from them except cancer pain.

I did a number of dye studies, nuclear studies, interrogating, etc for patients that had pumps for 10+ years that had clotted or needed troubleshooting. Some patients seemed to be doing reasonably well but they didn't seem any better than the non-pump patients.

Anecdotal but I learned quickly I wanted no part in pumps. I manage one baclofen pump currently.

 

[Aether2000]

We only implanted pumps if there were to be a severe restriction in the oral opioids after implantation- that was the deal given to the patients up front before implantation. Consequently, many of our patients with IT pumps took no oral opioids.

 

[Ligament]

Before my time, I heard that a pump refill would pay a clinic around $3600. Remember refills happen multiple times per year at least. Again, before my time, but I think the pump refill business is where the money was at.

 

[Ducttape]

Reg 1. This is old retrospective data but it give you an idea of systemic opioid exposure in the presence of a device. This is before this whole low dose monotherapy thing became vogue.
Reg 2. The lead author is also a speaker for MDT
Reg 3. It's as long of a f/u as the SPACE study...
Reg 4. a 7% explant rate is similar/equivalent to the SCS rate and if it's in the first 12 months it is often infection related
Reg 5. They excluded folks that didn't get a refill recorded
Reg 6. The MEDs are just systemic. MEDs of intrathecal therapy is a made up number though.
Reg 7. A pump costs about $10k. It's not as expensive as SCS which runs in the 20 - 30k range, although I've seen insurance charges in the 100k range for some IPGs. I guess it would be good to know what the costs of untreated chronic pain are, but I'm not sure how that happens in our culture.

Reg the weaning opioids, intrathecal therapy lets you get the analgesia without the systemic risk. Targeted delivery reduces the diversion risk. It reduces the O/D risk. It's the carrot at the end of the wean.

But... you do not reduce diversion risk.

In all the charts of pump patients looking to transfer care to me (I don’t take them but do look at the charts and will see them after they are weaned) , in zero out of roughly 100 is there a UDS done.

In addition, it is a fallacy that there are no systemic effects from intrathecal opioids.

Drug-related side effects of long-term intrathecal morphine therapy - PubMed

The utilization of intrathecal morphine administration for cancer and intractable non-malignant chronic pain represents an important leap forward in pain management. Yet, a wide variety of non-nociceptive side effects may also occur in susceptible patients. The side effects due to intrathecal...

www.ncbi.nlm.nih.gov

to loosely paraphrase someone here... it’s the drug.

and a made up number... technically, all MED besides morphine is a made up number. Yet we do have some reasonable comparisons between IT and epidural and IV dosing based on Ob anesthesia observed effects...

 

[drusso]

But... you do not reduce diversion risk.

In all the charts of pump patients looking to transfer care to me (I don’t take them but do look at the charts and will see them after they are weaned) , in zero out of roughly 100 is there a UDS done.

In addition, it is a fallacy that there are no systemic effects from intrathecal opioids.

Drug-related side effects of long-term intrathecal morphine therapy - PubMed

The utilization of intrathecal morphine administration for cancer and intractable non-malignant chronic pain represents an important leap forward in pain management. Yet, a wide variety of non-nociceptive side effects may also occur in susceptible patients. The side effects due to intrathecal...

www.ncbi.nlm.nih.gov

to loosely paraphrase someone here... it’s the drug.

and a made up number... technically, all MED besides morphine is a made up number. Yet we do have some reasonable comparisons between IT and epidural and IV dosing based on Ob anesthesia observed effects...

I think "it's the drug" has been debunked. Even the person who used to say that would disagree with you now.

Study Finds Only 1.3% of Overdose Victims Had Opioid Prescription — Pain News Network

By Pat Anson, PNN Editor It’s long been a popular belief that prescription opioids fueled the nation’s opioid crisis and play a major role in overdose deaths. The CDC’s 2016 opioid guideline says as much. “Sales of opioid pain medication have increased in parallel with overdose deaths,” the guidel

www.painnewsnetwork.org

https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/opioid-treatments-chronic-pain-draft-report.pdf

 

[Baron Samedi]

Pumps are more trouble than they're worth on the clinician side.

 

[lobelsteve]

I thought it was the person and not the drug.

 

[Ducttape]

I think "it's the drug" has been debunked. Even the person who used to say that would disagree with you now.

Study Finds Only 1.3% of Overdose Victims Had Opioid Prescription — Pain News Network

By Pat Anson, PNN Editor It’s long been a popular belief that prescription opioids fueled the nation’s opioid crisis and play a major role in overdose deaths. The CDC’s 2016 opioid guideline says as much. “Sales of opioid pain medication have increased in parallel with overdose deaths,” the guidel

www.painnewsnetwork.org

https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/opioid-treatments-chronic-pain-draft-report.pdf

um.... your second article clearly posits that there is no long term benefit from chronic opioid therapy. what was the point of posting this?

Key messages
•Opioids are associated with small improvements versus placebo in pain and function and increased risk of harms at short-term (1 to <6 months) followup; evidence on long-term effectiveness is very limited and there is evidence of increased risk of serious harms that appear to be dose-dependent.
•At short-term follow up, evidence showed no differences between opioids versus nonopioid medications in improvement in pain, function, mental health status, sleep, or depression.
•Evidence on the effectiveness and harms of alternative opioid dosing strategies and the effects of risk mitigation strategies is lacking, though provision of naloxone to patients might reduce the likelihood of opioid-related emergency department visits, a taper support intervention might improve functional outcomes compared to no taper support, and co-prescription of benzodiazepines and gabapentinoids might increase risk of overdose.
•No instrument has been shown to be associated with high accuracy for predicting opioid overdose, addiction, abuse, or misuse

as to your first point, as i have noted multiple times in the past, it is the exposure to prescription opioids that leads some to use of illicit drugs, which are killing them. my point all along has been Don't Start.

Dont Start would lead to fewer people primed towards opioids and subsequent addiction, and Dont Start would reduce the volume of diverted drugs by reducing the overall numbers of opioids prescribed and subsequently diverted.

 

[drusso]

um.... your second article clearly posits that there is no long term benefit from chronic opioid therapy. what was the point of posting this?



as to your first point, as i have noted multiple times in the past, it is the exposure to prescription opioids that leads some to use of illicit drugs, which are killing them. my point all along has been Don't Start.

Dont Start would lead to fewer people primed towards opioids and subsequent addiction, and Dont Start would reduce the volume of diverted drugs by reducing the overall numbers of opioids prescribed and subsequently diverted.

Ugh. I hate it when you don't read the references I post. You shouldn't be so lazy. What they found for long-term use was:

In other words, "we need more studies..."

And, you still haven't accepted the fact that the data for the "drug vs person" question is swinging back toward the person. That is, the Big Take Home Message from the Opioid Epidemic is that if some people take opioids they will become addicts and overdose and die. Others just get constipated and probably develop hyperalgesia. The real problem is that doctors are not good at predicting what will happen to who.

Never confuse populations for the person sitting across from you in an exam room. If you do, your Simmelweis is showing...

 

[Orin]

But... you do not reduce diversion risk.

In all the charts of pump patients looking to transfer care to me (I don’t take them but do look at the charts and will see them after they are weaned) , in zero out of roughly 100 is there a UDS done.

In addition, it is a fallacy that there are no systemic effects from intrathecal opioids.

Drug-related side effects of long-term intrathecal morphine therapy - PubMed

The utilization of intrathecal morphine administration for cancer and intractable non-malignant chronic pain represents an important leap forward in pain management. Yet, a wide variety of non-nociceptive side effects may also occur in susceptible patients. The side effects due to intrathecal...

www.ncbi.nlm.nih.gov

to loosely paraphrase someone here... it’s the drug.

and a made up number... technically, all MED besides morphine is a made up number. Yet we do have some reasonable comparisons between IT and epidural and IV dosing based on Ob anesthesia observed effects...

I'm sorry, does a UDS reduce diversion risk?

Systemic effects do happen, it just minimizes some of them. The morphine equivalent analgesia of 1 mg of Morphine IT being 300 mg orally, is a useless number to add to the MME risk.
1 mg of IT Morphine does not have the same risk profile as 300 mg PO.

Even if you were to say throw out the whole class of drugs (opioids), then use the other on label agent ziconotide.

It's not the device.

Pumps are more trouble than they're worth on the clinician side.

This is the problem. It's not worth it to most clinicians to deal with the 'stress' as compared to the ease/profit from a block, ablation, or SCS

 

[Ducttape]

i read the entire study. and twice again today.


as stated before, in the key messages: evidence on long-term effectiveness is very limited and there is evidence of increased risk of serious harms that appear to be dose-dependent.

you are making an assumption that they are saying that we need more studies. im not coming to that same assumption. what dose to use once someone has decided to start COT, yes. but thats not the point im making.


here is the blurb on long term opioid use:

As in the prior AHRQ report, we identified no long-term (>1 year) RCTs of opioid therapy versus placebo. One new cohort study found no association between long-term opioid therapy versus no opioids and pain, function or other outcomes.23 New observational studies were consistent with the prior AHRQ report in finding an association between use of prescription opioids and risk of addiction,24 overdose,24 fractures,25-27 falls26,28and cardiovascular events;29 a new study also found an association between opioid use and risk of all-cause mortality.29 New observational studies were also consistent with the prior AHRQ report in finding associations between higher doses of opioids and risks of overdose, addiction, and endocrinological adverse events;24,25,28-31 new studies also found an association between higher dose and increased risk of incident or refractory depression.32,33 Effects of longer duration of opioid exposure varied across outcomes, from increasing risk (all-cause mortality, depression) to decreasing risk. Limited evidence indicated an association between co-prescription of gabapentinoids34-36 or benzodiazepines37 -39 and increased risk of overdose, with most pronounced risk occurring soon after initiation of these medications.

here are the conclusions:

Implications and Conclusions:
Our review has implications for clinical and policy decision making. Findings support the recommendation in the 2016 CDC guideline8 that opioids are not first-line therapy and to preferentially use nonopioid alternatives, based on small short-term benefits, increased risk of harms (including serious harms such as opioid use disorder and overdose) and similar benefits compared with nonopioid therapies. Evidence on long-term benefits remains very limited, and additional evidence confirms an association between opioids and increased risk of serious harms that appears to be dose-dependent. Most clinical and policy decisions regarding risk mitigation strategies and opioid dosing strategies for chronic noncancer pain must still be made on the basis of weak or insufficient evidence, and research on the effectiveness of different opioid prescribing methods and risk mitigation strategies remains a priority

i suppose you think that we need more research as to whether to use chronic opioid therapy based on this line: "research on the effectiveness of different opioid prescribing methods and risk mitigation strategies remains a priority". a tenuous argument at that.

however, the rest of the position paper clearly states that 1. opioids are not a first-line therapy 2. supports the CDC guidelines 3. evidence for long term use is very limited 4. long term use has increased risks.

 

[Ducttape]

Orin, im not arguing against ITP per se, but arguing against chronic opioid therapy through any method. im not "against" prialt or baclofen.

i would hazard to guess that any anesthesiologist who has done OB anesthesia and given a dose of IT morphine will disagree with your statement that route mitigates risk. they arent giving 10 mg morphine IT for their spinal, but 0.3 mg, right? dont we adjust doses for all the opioids based on efficacy, and, in the case of fentanyl, dont all traditional methods of giving fentanyl - IV, topical, orally/sublingual - cause potential harm?

 

[SeniorWrangler]

I haven’t been able to find the study I’m thinking of, but it showed over years that pump patients developed tolerance and escalated doses just like oral patients.

 

[Orin]

i would hazard to guess that any anesthesiologist who has done OB anesthesia and given a dose of IT morphine will disagree with your statement that route mitigates risk. they arent giving 10 mg morphine IT for their spinal, but 0.3 mg, right? dont we adjust doses for all the opioids based on efficacy, and, in the case of fentanyl, dont all traditional methods of giving fentanyl - IV, topical, orally/sublingual - cause potential harm?

Everything has a potential for harm, especially good intentions.

I can guarantee you I have never given a dose of IT morphine as slowly as an intrathecal pump does. We dose reducing IT boluses of morphine it because the magnitude of the brainstem respiratory effect is greater intrathecally than systemically. We're not dose reducing it because it causes constipation. We stress about a late rostral spread of it.

We adjust doses based on efficacy for sure. It's more efficacious on the right part of the cord. You can get away with a lot less. It doesn't mean the risk of it intrathecally is the same.

There's some great experimental work by Bernards and modeling by Linninger that talk about the differences in delivery/etc. This is from the Krames Neuromodulation text, 2nd edition, chapter 67.

I agree though. Chronic opioid therapy should be a last line option, but if I have to pick between systemic and intrathecal, I would opt for intrathecal 80% of the time.

 

[Ducttape]

Possibly... but that is not what I hear when I’m talking to these ITP pump patients that have to find someone to refill their high dose IT opioids because their implanting doc a. Discharged them b. Cut them off c. Got arrested....

 

[Baron Samedi]

Just a story:

I got bamboozled hard during fellowship when a "pain provider" at another hospital sent me a cancer patient for a pump implant. They assured me that after the implant and immediate post-OP care, they would do the aftercare, titration, refills, etc.

Patient comes, gets his pump -- other provider refuses to take him back, stating that they won't see him until he is on a stable dose for at least 6 weeks. This literally is unachievable in cancer patients. The poor patient has to spend his last few months of life commuting 2 hours each way several times weekly to our tertiary care center for dose adjustments, driving right by the office he was referred from 10 minutes from his home. I was seeing him as a walk-in between all the other work of the day over the span of a couple months. I spent more time and effort on that guy than any other patient during fellowship. He was very grateful for his care and I felt that I positively impacted his quality of life before his death this spring, but boy did I feel wronged and exhausted at the end of it.

I won't implant another pump for a while, and definitely without heaps of support in a facility that is accustomed to managing them.

 

[Ferrismonk]

Before my time, I heard that a pump refill would pay a clinic around $3600. Remember refills happen multiple times per year at least. Again, before my time, but I think the pump refill business is where the money was at.

Same here. Also, I've heard that the billing has changed such that the clinic must pay for meds upfront and bill after the injection rather than bill then deliver to clinic. This means that you get a little money for each refill ($120?) but if the patient dies before the refill or something else goes wrong before refill, you eat that cost (maybe close to $1000). This is a big deal.

 

[callmeanesthesia]

Did a ton of pumps in fellowship. Mostly for cancer pain. Definitely saw it change the lives of patients with intractable pain from metastatic pancreatic cancer. Now out in private practice without a cancer center feeding those patients, it doesn’t seem worth it to do pumps. The results for non-cancer pain were hit or miss, and I saw some real train wrecks that I personally wouldn’t touch with a 10 foot pole, who unsurprisingly did terribly.

 

[BobBarker]

I have an oncologist as an office mate. She isn’t terribly busy but has never had anyone in intractable pain, would ever need a pump, and rarely prescribes opioids at all.

 

[TIVAndy]

I have an oncologist as an office mate. She isn’t terribly busy but has never had anyone in intractable pain, would ever need a pump, and rarely prescribes opioids at all.

this is interesting. depends on the stage and type of metastasis, also location of metastasis. i think a pt with stage 4 disease even without significant pain will eventually develop significant pain towards end of life especially with spine mets. lot of oncologists do not deal with palliative care and they only see pts up until - well up until they can tolerate chemo/radiation etc. the real deterioration is dealt with palliative ppl

 

[Laryngospasm]

I’ve done quite a few pumps, implants, managed, removed, revised, replaced catheters. These patients were easily 25% of the trouble I had during that time while being 5% of my patients if that. I would say that every true emergency I had was due to some type of pump issue during my time with pump therapy.

Have I seen them work and work well? Absolutely! Have I seen patients try to withdraw very concentrated doses of opioid from the pump resulting in infections? Yes. Have I seen patients almost die from a pocket fill that almost wasn’t recognized in time? Yes. Have I seen patients just drop off the radar and not come for pump refills? Yes And it’s not a good result. Have I had patients move and not be able to find a doctor and have to return every few months from across the country for refills? Yes.
They will absolutely develop tolerance over time to the point that you can’t concentrate the drug anymore and you will need to see them sooner and sooner for refills. Insurance used to pay well for refills but when you account for the decreased compensation and time for a refill as well as keeping up with ordering meds and getting them delivered to multiple practice locations for multiple patients on the right day almost certainly they are a money loser. And while you might get them off opioids prior you will find they will be back begging for more sooner or later. There is a euphoria from PO that you don’t get from IT that they will miss. If you refuse they will get them wherever they can and you can’t just shut off the pump, you will be stuck slowly weaning them over several months. There were in fact so many problems that I will never do them again. I was fortunate to be able to get away from that practice and will no longer participate in pump therapy.

 

[lonelobo]

those 5% were only 25% of your problems....you must have an unusual population ...should be closer to 95%

 

[Orin]

I agree that bad things happen and I've seen them as well. I will say that the old way of using and managing the device led to many issues. The microdose monotherapy work is rather straight forward and simplifies many of the scary events.

It seems the well has been poisoned for most, but in my practice the monotherapy/control workflow pump are not the headaches. The paucity of providers is part of the problem for sure.

 

[SommeRiver]

I went to MedTronic course in California run by a female in NorCal who did a ton of pumps. It was bizarre. I wonder what the number of pumps per provider is that overwhelms a practice?

 

[Orin]

I went to MedTronic course in California run by a female in NorCal who did a ton of pumps. It was bizarre. I wonder what the number of pumps per provider is that overwhelms a practice?

There was someone running a "control workflow" population of 2 provider:~1000 pumps

 

[SommeRiver]

There was someone running a "control workflow" population of 2 provider:~1000 pumps

Northern California?

 

[drusso]

There was someone running a "control workflow" population of 2 provider:~1000 pumps

Good luck trying to sell that practice downstream!