FDA Concerns over TIRF-REMS and Rethinking Access Program

[biDOC]

*TIRF-REMS = Transmucosal Immediate Release Fentanyl - Risk Evaluation and Mitigation Strategy

^Patient, Provider, and Pharmacy is required to register with TIRF-REMS Access Program

(e.g. Abstral, Actiq, Fentora, Lazanda, Onsolis, Subsys)

FDA rethinking TIRF-REMS* after nationally renowned Pain Specialists is investigated by FDA Criminal Investigations after discovery that physician was second highest paid promoter/speaker/representative for Subsys in the country and wrote for the most RXs for Subsys in the state while forging PTs' signatures^.

How will this effect prescribers' ability to manage breakthrough pain in appropriate patients?

How will this affect PTs' analagesia in the future?

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[Aether2000]

"Appropriate patients" are cancer patients with moderate to severe pain who are already opioid tolerant. The TIRF-REMS requires the physician sign a form that he understands this, registers patients and physicians, but has no teeth to restrict their access if the doctor decides to irresponsibly use transmucosal and transbuccal fentanyl like a home IV injection of fentanyl for non-malignant "breakthrough pain" in a manner contraindicated to both TIRF-REMS and the package insert. I agree the program should change, and more resemble the program to access thalidomide.

 

[lobelsteve]

http://www.fdanews.com/ext/resources/files/2016/08/08-26-16-InsysComplaint.pdf?1504431172

Buried somewhere in the FDA policy manuals is a mechanism that there can be a civil fine. I believe it is a max of $250,000 penalty but unsure if it has ever been levied.

https://www.casewatch.org/board/med/gordon/accusation_2015.pdf

California has or can levy fines of $600. But also put you in jail for 180 days for Rx issues. It would be simple to use this case as a gateway to prosecuting off label use of TIRF-REMS drugs.

 

[biDOC]

"Appropriate patients" are cancer patients with moderate to severe pain who are already opioid tolerant. The TIRF-REMS requires the physician sign a form that he understands this, registers patients and physicians, but has no teeth to restrict their access if the doctor decides to irresponsibly use transmucosal and transbuccal fentanyl like a home IV injection of fentanyl for non-malignant "breakthrough pain" in a manner contraindicated to both TIRF-REMS and the package insert. I agree the program should change, and more resemble the program to access thalidomide.

Thank you for filling in some more details regarding TIRF-REMS Requirements for those not familiar with the Program.

I agree, way too many physicians were writing off-label for TIRF-REMS medications (e.g. for migraines; which, we are all well aware, or should be if not, that narcotics are counterintuitive in managing migraines), which is their prerogative, and also why the TIRF-REMS Program was implimented, as prior to, any physician could write for immediate release fentanyl.

It is of note to mention that there still are very few non-cancer PTs that do require this route of administration of narcotics that is unique to fentanyl; these cases are both accepted by TIRF-REMS and some insurance providers (though the indication is VERY narrow).

-biDOC

 

[biDOC]

http://www.fdanews.com/ext/resources/files/2016/08/08-26-16-InsysComplaint.pdf?1504431172

Buried somewhere in the FDA policy manuals is a mechanism that there can be a civil fine. I believe it is a max of $250,000 penalty but unsure if it has ever been levied.

https://www.casewatch.org/board/med/gordon/accusation_2015.pdf

California has or can levy fines of $600. But also put you in jail for 180 days for Rx issues. It would be simple to use this case as a gateway to prosecuting off label use of TIRF-REMS drugs.

Thank You for the links and comments. I believe they are valiable in educating medical students in the safe prescribing of narcotics and off-label prescribing.

Unfortunately, it is very difficult to monitor off-label prescribing, making it a challenge to cease the dangerous and/or negligent use of off-label prescribing; this is why the TIRF-REMS Program was implimented, and is being re-evaluated, as it does not cover off-label prescribing currently.

That is as far as I can comment on the Subsys investigation.

-biDOC

 

[Aether2000]

It all began a long long time ago in a galaxy far far away...
Self-treatment with oral transmucosal fentanyl citrate to prevent emergency room visits for pain crises: patient self-reports of efficacy and utility. - PubMed - NCBI

 

[biDOC]

It all began a long long time ago in a galaxy far far away...
Self-treatment with oral transmucosal fentanyl citrate to prevent emergency room visits for pain crises: patient self-reports of efficacy and utility. - PubMed - NCBI

Am very familiar with article. Thank you for posting it, as you are correct--if I recall, it was published 14 or 15 years ago.

I agree in TIRF's therapeutic ability; however, unfortunately my research has shown this is more of an issue of illicit use of these medications that has tightened up controls, scared physicians into prescribing narcotics at all on an contiously rising curve, raised prices at an exponentially rising curve, and all while PTs'* quality of life has been rapidly falling at a very steep curve.

*Assumption: PTs' DX meets criteria for chorionic opiate management (criteria = psyological ailment that has been deemed chronic, no surgical option, failure of alternative techniques, failure of narcotic alternative medication, opiate tolerant, confirmed medical diagnosis(es) w/ hard data, pass psychological assesment by pain psychologist, board certified anesthesiologist with sub speciality in main management determination that chronic opiate pain management is clinically indicated, appropriate, safe, and recommended)

 

[Aether2000]

It may be more controversial now than in 3 decades as to who is an appropriate candidate for long term opioid therapy, but it seems only fringe docs use transmucosal fentanyl for non-malignant breakthrough pain now. I am currently reading some studies from multidisciplinary pain clinics across the country published in NIDA Research Monographs in 1982, and even then it was noted in most cases, taking new patients off opioids or severely reducing the dosage improved pain, function, and psychometrics.

 

[SeniorWrangler]

There are two parts of this problem:
1) drug companies who market their products inappropriately (probably because the appropriate market is too small to make a profit with)
2) docs who prescribe them inappropriately
#1 and #2 are small numbers of people, and it is predictable that a national education program is not going to prevent everybody in a small group from doing stuff we don't like.

Targeting those people might be more successful:
The docs sometimes go to jail or lose their license, but not often.
The drug companies pay fines, but nobody every goes to jail, and I assume this is a cost of doing business which is factored into their accounting.

 

[biDOC]

[ERROR]

 

[Ducttape]

im sorry, im confused.

are you saying that under any of those circumstances it would be appropriate to use transmucosal fentanyl?????


outside of an end-of-life, purely palliative pain condition, (or extremely short term immediate release use for tolerating radiation therapy for cancer - tho a PICC line and IV fentanyl is 100x more preferable),. there is no role of transmucosal fentanyl for any chronic pain state.