I need some serious help - please advise. IT opioid delivery

[epidural man]

To start off, please read this article:

Doctor and Office Manager Indicted in Scheme to Defraud Medicare, Manufacture and Distribute Fentanyl

Dr. David J. Smith, a pain management physician, and his office manager, Julia Ann Oertle, are charged in a federal grand-jury indictment with perpetuating a long-running scheme to commit healthcare fraud and to manufacture and distribute adulterated fentanyl.

www.justice.gov

Patient comes to our hospital to the IM clinics. The IM doctor calls us for some help. The patient (who is a patient of Dr Smith) has a pump that has run out. The pump/doctor notes says that she is getting 6.6 mg A DAY of fentanyl IT. She was on 8.5 mg a few months ago.

Now, she needs help.

My suggestion was she needs to be admitted to the ICU and sedated with Precedex with some (how much, I have no idea) hydromorphone IV. Give her b-blockers, Zofran and hopes she doesn't die.

Thoughts?

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[pmrmd]

All I know is that I’d be way over my head dealing with this patient.

 

[epidural man]

All I know is that I’d be way over my head dealing with this patient.

Exactly!

I was like - "I am not trained for this. My fellowship must of been crap because I have no idea how to handle this."

 

[willabeast]

Suggestion - call the manufacturer of the pump. they probably not only know what to do, they might even send someone to help. they hate getting in legal hot water just as much as we do. document profusely.

 

[Agast]

Have you imaged her catheter and confirmed it’s actually intrathecal? I noticed in the press release they said the doctor was prescribing large amounts of oral pain meds in addition to the high dose pumps. I’ve seen patients like that who needed high dose oral meds because it turned out their catheter had pulled out to sub Q. I would try a dye study or Xray or something to confirm she needs a ton of narcotic before you hit her with a massive dose of opioids.

 

[epidural man]

Have you imaged her catheter and confirmed it’s actually intrathecal? I noticed in the press release they said the doctor was prescribing large amounts of oral pain meds in addition to the high dose pumps. I’ve seen patients like that who needed high dose oral meds because it turned out their catheter had pulled out to sub Q. I would try a dye study or Xray or something to confirm she needs a ton of narcotic before you hit her with a massive dose of opioids.

This is a great suggestion.

I will also reach out to Medtronic. To me, they need to be indicted along with Dr Smith. They knew about his shenanigans for years and have done nothing and said nothing.

Also, you've seen patients like this? With this high of dosages? If after you imaged and it WAS intrathecal, how did you manage?

 

[callmeanesthesia]

Milligrams. A day. Of fentanyl. Intrathecal.

Yeah, in all seriousness, above suggestions of “punt to manufacturer” and “ICU admit” are probably best. Just make sure you don’t get stuck with the inevitable consult from the ICU team.

I’d also add that according to the indictment, it was adulterated and he was overstating the amount of fentanyl. If possible, when you check the catheter also aspirate out some med and have the lab analyze it’s concentration?

 

[Agast]

This is a great suggestion.

I will also reach out to Medtronic. To me, they need to be indicted along with Dr Smith. They knew about his shenanigans for years and have done nothing and said nothing.

Also, you've seen patients like this? With this high of dosages? If after you imaged and it WAS intrathecal, how did you manage?

In the case I was thinking of, they were on standard pump concentrations at the higher end of rate, but also on like oxycodone 15mg QID. That raised a few eyebrows but the lady seemed sincere so she got taken back for a dye study. The catheter ended up being coiled in her back. My attending said the pump had not been anchored.

I avoided pumps as soon as I got out of fellowship so I don’t have any other bright ideas. But I don’t think this patient will die from massive withdrawal. It’ll suck but they’ll get over it. Sedation, IV opioids, clonidine, ativan, lomotil, symptom management.

 

[TIVAndy]

great tertiary care case. go to UCSD! joke aside, pt probably needs ICU monitoring for overdose/underdose. recommend doing detox a bit rapidly in the icu. perhaps transition to suboxone. if still needing some opioid and can't get off completely.

 

[deleted131481]

Let them get Suboxone in rehab.

Or give them fentanyl PCA in ICU .

I hate pumps.

 

[MitchLevi]

She's going to have to withdraw.

Call the manufacturer - Best advice given so far IMO.

The drugs mentioned above (benzos, clonidine, baclofen). I'd use a few doses of methadone in addition to those meds.

You have to wonder if that fentanyl she was getting was actually fentanyl. If he manufactured his own fentanyl, you have no idea how accurate that dosing regime is...

Good luck, and this ain't your fault.

 

[SpineandWine]

1) do dye study to ensure in IT space 2) calculate OMEs and try to give with 33% or so reduction with taper regimen while in ICU (if you’re doubting fentanyl concentration, can always ask pharmacy if they can refract med) 3) agree with withdrawal protocol of some sort 4) PUNT it as far away from you as possible

 

[lobelsteve]

Have you imaged her catheter and confirmed it’s actually intrathecal? I noticed in the press release they said the doctor was prescribing large amounts of oral pain meds in addition to the high dose pumps. I’ve seen patients like that who needed high dose oral meds because it turned out their catheter had pulled out to sub Q. I would try a dye study or Xray or something to confirm she needs a ton of narcotic before you hit her with a massive dose of opioids.

First: do no harm. (to your career). Seeing this patient entangles you in this insanity.
Block consult, turf to University setting.

 

[Ducttape]

interrogate the pump.

have patient go to ER and meet her there to check the pump, see how much is left, and if it has truly run out.

remember, the patient will hear beeping - it has not run out yet.

if she has truly run out even a day ago, then it may be a moot point putting her in the ICU - she is already out and going through or has gone through withdrawal.

in the ER, do a COWS. if there is still med left in the pump, calculate how much and see if you can titrate down the existing dosage. i would suggest you do this with a rep.

and then start induction with buprenorphine.

 

[kstarm]

I tried to find the article but couldn't this morning, but there is one out there. It turns out you do not need very much oral opioid (relatively) to manage IT pump withdrawal. I have had a couple of cases over the years at the hospital and initially thought I had to do the 300/1 oral to intrathecal morphine conversion and did the ICU thing with precedex. It turns out you need much less oral opioid than that to manage withdrawal. I have used oxycodone 15mg q4h and that worked fine which conversion-wise was many times less than the oral to IT as above. I would think bupe would work even better. In this case I think there has been really good advice. The pump needs to be queried and see if anything is left. If empty then it probably is moot and you watch and manage symptoms and likely covert to bupe. IF something left (and you have no idea what that actually is in there) I would vote for refilling it with saline so that it still functions and then manage withdrawal/convert to bupe. All the punting seems really reasonable too.


EDIT: It isn't the exact article I was looking for but has some similar findings, including managing IT opioid withdrawal with clonidine only with good success.

 

[epidural man]

Turns out, the pump stopped working a week ago.

That makes things a lot easier.

I will still want to interrogate the catheter and pump however.

You may ask - why didn’t I know that yesterday?

Well the answer is because I took the call from the resident while I was in the run-up area in the cockpit getting a lesson in a Skylane 182RG (trying to get my complex and high performance endorsements) and I could barely hear anything. After the flight when I called back, they failed to mention the week issue.

Now you may ask “why the hell were you in a plane when you were on-call?” That is an excellent question. I can only answer, I shouldn’t have been. However, in my defense, in the 15 years or so I’ve been doing this, I get a call after I leave for the day about twice a year. I felt the odds were in my favor. But alas, they obviously weren’t that day.

 

[drrosenrosen]

First: do no harm. (to your career). Seeing this patient entangles you in this insanity.
Block consult, turf to University setting.

Glad to see I'm not the only person thinking "I wouldn't touch this case with a ten foot pole!"

 

[Ducttape]

Turns out, the pump stopped working a week ago.

That makes things a lot easier.

I will still want to interrogate the catheter and pump however.

You may ask - why didn’t I know that yesterday?

Well the answer is because I took the call from the resident while I was in the run-up area in the cockpit getting a lesson in a Skylane 182RG (trying to get my complex and high performance endorsements) and I could barely hear anything. After the flight when I called back, they failed to mention the week issue.

Now you may ask “why the hell were you in a plane when you were on-call?” That is an excellent question. I can only answer, I shouldn’t have been. However, in my defense, in the 15 years or so I’ve been doing this, I get a call after I leave for the day about twice a year. I felt the odds were in my favor. But alas, they obviously weren’t that day.

you are not responsible for the failures of another doctor's practice.

dont be so hard on yourself. you were probably up there the same amount of time some docs take to poop.

no need to give her anything other than hand holding, maybe a little tizandine and ibuprofen.


fwiw, i would kill the pump.

 

[TheLoneWolf]

Good to hear that most of the withdrawal had likely occurred by now.



Also reminds me why I absolutely hated pumps in residency and fellowship. I turned down a job interview at Brown University a few years back just because they mentioned it is "pump heavy" and neurosurgeons loved to place them but refused to manage them.



Never looked back.

If she was actively withdrawing, I would recommend this go to the university hospital, have them interrogate the pump, dye study, Yada yada

 

[Ferrismonk]

In my town we have one old (70+) pain guy in solo practice who does a ton of pumps. We still refill a few legacy pumps, but those are rare and we don't do implants. If one of our pumps need replacement, the either go to this other pain guy or the patient is sent to a teaching hospital about 1.5 hours away. There is significant concern in the local pain community what to do when this doc retires/expires. There is no good solution for these nightmare situations.

 

[Ferrismonk]

"The indictment alleges that beyond providing patients with adulterated fentanyl, Smith violated the applicable standards of care by, among other things, prescribing materially excessive quantities of fentanyl, prescribing unnecessary oral opioid medications in conjunction with pain-pump medication, and installing pain pumps in patients without proper assessments for patient need."

On a side note, this is somewhat concerning as well. While I don't agree that orals are usually needed when someone has a pump, is this considered an offense worthy of indictment?

 

[epidural man]

"The indictment alleges that beyond providing patients with adulterated fentanyl, Smith violated the applicable standards of care by, among other things, prescribing materially excessive quantities of fentanyl, prescribing unnecessary oral opioid medications in conjunction with pain-pump medication, and installing pain pumps in patients without proper assessments for patient need."

On a side note, this is somewhat concerning as well. While I don't agree that orals are usually needed when someone has a pump, is this considered an offense worthy of indictment?

It’s a good question.

This guy has been a problem in this town for many years. Now that he is in jail, I assume the community will struggle to deal with his MANY patients.

 

[Agast]

Glad to see I'm not the only person thinking "I wouldn't touch this case with a ten foot pole!"

"Lookit what we got here, a twelve-foot pole for you!" - hospital admin

 

[Agast]

Honestly, if she didn't end up in the hospital with withdrawals during that week, that catheter tip is *definitely* not intrathecal OR she was getting saline infused. I would just do a quick and easy Xray first and check the lateral view.

 

[kstarm]

"The indictment alleges that beyond providing patients with adulterated fentanyl, Smith violated the applicable standards of care by, among other things, prescribing materially excessive quantities of fentanyl, prescribing unnecessary oral opioid medications in conjunction with pain-pump medication, and installing pain pumps in patients without proper assessments for patient need."

On a side note, this is somewhat concerning as well. While I don't agree that orals are usually needed when someone has a pump, is this considered an offense worthy of indictment?

I guess it would come down to what "unnecessary" is. I think If you have someone on 6mg of fentanyl intrathecally you have answered the question: "Is this pain responsive to opioids?", and that further opioids are unnecessary.

 

[VA Hopeful Dr]

Turns out, the pump stopped working a week ago.

That makes things a lot easier.

I will still want to interrogate the catheter and pump however.

You may ask - why didn’t I know that yesterday?

Well the answer is because I took the call from the resident while I was in the run-up area in the cockpit getting a lesson in a Skylane 182RG (trying to get my complex and high performance endorsements) and I could barely hear anything. After the flight when I called back, they failed to mention the week issue.

Now you may ask “why the hell were you in a plane when you were on-call?” That is an excellent question. I can only answer, I shouldn’t have been. However, in my defense, in the 15 years or so I’ve been doing this, I get a call after I leave for the day about twice a year. I felt the odds were in my favor. But alas, they obviously weren’t that day.

Local FP ALWAYS went flying when he was on call. Seriously, planned his airplane days around the call schedule. Consensus is he just liked to say "I'll call back in an hour, I'm flying an airplane right now".

As long as you're not that guy, you're fine.

 

[nvrsumr]

this thread incited lot of PTSD from fellowship

 

[Orin]

I do a lot of this in my academic silo. I'll tell ya that IT opioids don't really cause the problems that IT baclofen or clonidine do with withdrawal generally. When they do fail, they normally behave like opioid withdrawal, but they often don't have a lot of the systemic signs. If it's really IT, the medication builds up around the catheter tip so your withdrawal phenotype is more central and easily managed with systemic medications +/- sympatholytics +/- symptom treatment. Their pain will suck, but that's why pumps almost always come back for replacements.

Part of the reason may definitely be that a lot of pumps are not always IT so do the catheter access port study. In this case, lets just assume the dude is getting 6.6 mg/day of fentanyl. That's 6600 mcg/24 h ~ 275 mcg/h which is three 100 mcg/h fentanyl patches if the catheter is mostly leaking IM.

You can admit them, but you can also manage it at home with oral agents if they're safe for it.

I would definitely interrogate the pump and suck the reservoir out to make sure it's really empty. I've had people tell me it ran out a week ago and really the alarm started a week ago, but they had a 2 - 4 week buffer. I would figure out what their CV risk is for dealing with the sympathetic surge.

If you're feeling kind and trust them, start them on low doses of methadone or fentanyl patches. If you're not trusting, admit them for PRN dosing and vital checks with titration upward.

Most importantly though, realize there is still high dose fentanyl in the pump tubing even if it the main reservoir has run out.
Don't overdose the patient by restarting it. Understand how to do a bridge bolus.

Generally I offer to fill it with saline and run it at a target of minimum rate with a bridge bolus of 25-50% to give them a two step wean off.

Again, academic place so I'm just trying to clean these trainwrecks up as they generally didn't ask for a pump to be put in, but I understand the fears and medicolegal risks here.

 

[nvrsumr]

Masterclass @Orin

 

[Ligament]

Orin great input.

OP: have a high index of suspicion of the validity of the medications supposedly in the pump. For all you know it could be mostly saline. Also agree, this guy sounds super sloppy so high chance the cath tip not intrathecal.

Sounds like a complete mess, best of luck to you.

 

[epidural man]

Orin great input.

OP: have a high index of suspicion of the validity of the medications supposedly in the pump. For all you know it could be mostly saline. Also agree, this guy sounds super sloppy so high chance the cath tip not intrathecal.

Sounds like a complete mess, best of luck to you.

It all worked out okay. I hope the patient does well in her endeavors. I think you are right that she did not have what was indicated in that pump.

We didn’t do the hard stuff (side port study or a rotor study - do people still do those?). She did fine an a standard PCA and ketamine infusion for a few days. My fear is she got well treated so I think she will present to our ER frequently.

 

[Laryngospasm]

Glad to see I'm not the only person thinking "I wouldn't touch this case with a ten foot pole!"

Yeah the road to hell being paved with good intentions comes to mind