Dr. Mortimer Fein is back to examine the reality of opioid safety against the ironic reality of money, politics, and government regulation. While Fein sure hit the mark, lawmakers seem very far away from the bullseye. Thank you for another great contribution Dr. Fein.
There has never been a safer time to prescribe opioids for chronic pain.
There has never been a safer time to prescribe opioids for chronic pain.
This is a true irony. At a time when media and government reports lump heroin and illicit opioid overdoses with deaths from legitimately used prescription opioids and have made opioid medications seem more dangerous than virtually anything on the planet, innovations in opioid products, availability of opioid overdose antidotes, assessment tools, adherence monitoring and acceptance of nonmedical aspects of pain treatment, many of the puzzle pieces are in place to deliver opioid therapy in the safest possible way. The realization of the need to avoid or at least exercise extreme caution in the use of polypharmacy, in particular the concurrent use of opioids and benzodiazepines (and to obtain sleep studies to make sure that any apnea is addressed) could strike a blow against overdose as can the growing use of buprenorphine for pain. All of these elements now in place, if orchestrated adeptly, can help make opioid therapy as safe as it can be.
The one thing that is still not in place is reimbursement for any piece of the above, really: for the physician/prescriber time, thought, other FTE time, urine drug testing and monitoring, products with safeguards etc etc. Indeed one of the heads of a major insurance carrier had the temerity to get up at an FDA meeting in which guidance was being developed for abuse deterrent formulations for generic opioid products and say essentially, “good work on all the ingenuity and innovation pharma guys but alas we won’t be covering these since there is no evidence that they work.” No evidence that they work. I would like people like that to volunteer to participate in a randomized trial testing whether or not jumping out of an airplane with a parachute is safer than without. Indeed, I would like them to be “randomized” to the placebo arm.
The CDC has further enshrined the use of short acting opioids as the therapeutic choice along with other shortcuts such as artificially low state morphine equivalent daily dose limits, labelled by therapeutics experts as “pseudoscience”, all conspire to further constrain the individualizing of therapy helping propel us toward a time when the remnants of opioid therapy will be so impotent that fewer will have the potential to benefit while many of the negative outcomes continue. Along with confining regulations and layers of hassle, clinicians can feel like they are being squeezed to death in a media/law enforcement/regulatory iron maiden – the spikes slowly, painfully, squeezing the life out of their efforts to relieve suffering.
It can be argued that when the opioid revolution first was set in motion it was initially done so in centers of excellence with expert clinicians, more resources and less pressure on the system. The rest of the healthcare system was unprepared in so many ways for 400-500% increases in opioid prescribing. Dishonest parties came out of the woodwork to exploit the gaps and they didn’t have to do it clandestinely either. These were gaps that you could drive a truck or even fly an Oxycontin Express through. Despite the multitude advances only partially catalogued above the rhetoric has not kept pace and there’s been little to no changes in policy to reflect the progress.
In the end those really being subjected to an almost medieval cruelty are those with chronic pain, suffering in a fashion not unlike the famous 1941 self portrait of Frida Kahlo above left, The Broken Column, depicting her chronic pain in an abstract reference to an iron maiden with a corset and nails sticking into her face and body.
Many pain patients feel their vitality being slowly and painfully squeezed out of them just as THE Iron Maiden sang in Wasted Years, “Can’t ease this pain so easily.” I suspect for people in chronic pain there is not even a hint of irony in this iron maiden at a time when it has arguably never been safer to prescribe opioid medications.
In over 16 years Suboxone was the only medicine which completely took away my pain of 24/7 trigeminal neuropathic pain and trigeminal deafferentation pain (and sensations) yet I was told Suboxone can only be given for a limited time for opioid addiction. Meanwhile I struggle with 4800 mg/day of gabapentin, 1500 mg/day of Keppra along with baclofen, Fentynal patch, Hydrocodone 10’s and Xanax and still hurt 24/7. The article mentions buprenorphine being used for pain. Is this new or only in some states?
Ginger; Without knowing all the details it’s difficult to comment on this list of drugs and doses versus buprenorphine alone. If there are no other factors, it’s hard to believe.
But allow me to clarify; there is no limitation on Suboxone use for opioid abuse disorder. When brand name Suboxone is prescribed for pain (outside of the FDA labeling), there also is no limitation at least by Federal Regulation. Tennessee has a state regulation that precludes prescribing Suboxone off-label for pain; this is explained in detail within a previous blog here called Painfully Buprenorphine. The blog specifically states, “Buprenorphine is used for pain at doses much lower than for treatment of opioid dependence. FDA approved formulations for pain include Buprenex® (injection), Butrans® (transdermal), and BelbucaTM (buccal). Products approved for opioid dependence include Zubsolv® (SL), Suboxone® (SL, Film), and Bunavail® (buccal) and are co-formulated with naloxone.”
Tennessee has been irresponsible in the minds of many when it comes to buprenorphine products that are specifically FDA approved for pain rather than an opioid abuse disorder. To better answer your question, you will be interested in a letter I wrote to DEA Acting Administrator, Dr. Chuck Rosenberg dated 8/18/2016 asking for clarification on prescribing buprenorphine products that are specifically FDA approved for this purpose. A response letter was sent back to me dated 11/14/2016 from DEA Assistant Administrator, Diversion Control Division from Louis Milione. And while that letter had many distractors within the content, it did answer the question by stating “The general registration requirement applicable to all practitioners (registration under 21 U .S.C. § 823(t)) applies to a practitioner who dispenses buprenorphine for the legitimate treatment of pain in the usual course of professional practice. No additional DEA registration is required for such purpose.”
I trust this will help clarify all of your issues and provide you with the necessary knowledge to discuss these misinterpretation of law and regulation with your prescribing medical provider.
I would like to also refer all pain docs, patients and other compassionate folks to the growing body of evidence that the DEA in cooperation with pharma distributors actually created and perpetuated the diversion problem. Here’s two articles:
https://www.washingtonpost.com/investigations/how-drugs-intended-for-patients-ended-up-in-the-hands-of-illegal-users-no-one-was-doing-their-job/2016/10/22/10e79396-30a7-11e6-8ff7-7b6c1998b7a0_story.html?utm_term=.ed7010d29535
http://www.wvgazettemail.com/article/20161218/GZ0115/161219508
Never thought about it that way but the argument that there has never been a safer time to prescribe opioids really IS true. Way more is known than in the early years and doctors have the ability to learn from past mistakes prevent those outcomes from reoccurring. The Cochrane systematic review from 2010 showed that patients without risk factors for addiction DO have an addiction rate that’s very low (0.27%) and is actually very close to the earliest estimates that have drawn so much scrutiny for their design. Cytochrome p450 and Mu Opioid Receptor testing identify which drugs are most likely to help individual patients and provide a pathological reason to back needs for higher doses. Add to that understanding that hormone imbalances make opioids less effective and then being able to actually fix this is another positive. This is really the message that doctors and their patients need to hear after a drumbeat of bad news that’s gotten louder and louder as patients have been tapered or taken off medication at an ever-increasing rate.
Very true. The scrutiny, reimbursements and pre-authorization process for legitimate pain management is a major burden for any provider, and the consequences are that less health care providers will be involved in prescribing opioids, resulting in a huge unmet need and access problem.
For anyone who is concerned with or affected by restriction of opioid pain relief, there is a must-read paper “Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use” by Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM; and Andrew Lazris, MD. This paper demolishes the CDC guidelines on prescription of opioids in chronic pain as unscientific, biased, and founded on hysteria. Other papers now coming to light establish beyond any doubt that the consultants’ working group at CDC which wrote this atrocity were guilty of outright fraud and malfeasance.
The only ethically sound response to the CDC Guidelines must be immediate withdrawal. Re-writing of the practice guideline should be taken out of CDC altogether and executed by the American Academy of Pain Management with participation by pain patients themselves.
See https://medium.com/@stmartin/neat-plausible-and-generally-wrong-a-response-to-the-cdc-recommendations-for-chronic-opioid-use-5c9d9d319f71#.61wlr4elm
Thank you Dr Fein.
Well said.
Pain Is a terrorist,
Opiate refugees are not reading
Suicides soaring.
It’s a public health crisis