Recommendations to the FDA About How to Improve Chronic Pain – Part Two

Recommendations to the FDA About How to Improve Chronic Pain – Part Two

By Ed Coghlan.

The testimony submitted to the FDA by Terri A. Lewis PhD NCC for the July 9 public meeting for Patient-Focused Drug Development on Chronic Pain might also be viewed as the “voice of the chronic pain patient.”

That’s because her testimony was driven by the results of a survey that Dr. Lewis prepared and distributed in cooperation with the National Pain Report.

Nearly 1700 persons – patients, care partners and providers – representing all 50 states opined that much is wrong in how chronic pain is being treated in this country. For a summary of the barriers to care, read part one of this report.

In her testimony, the long-time clinical educator in the field of Rehabilitation and Mental Health who is also a care partner for a family member, outlined some solutions.

Here is what she recommended to the FDA.

Recommendation 1. Evidence based care and treatment protocols that are consistently employable across care continuum locations, based on medical necessity criteria and outcome evaluation.

As states implement regulations forcing people into pain clinics and away from their primary care and specialty care providers (who may have provided long term care), this forces individuals with multiple chronic morbidities into a care model that for many is inappropriate and which may result in harms. Few board-certified anesthesiologists have experience with rare and complex disease progression and few have interacted effectively with palliative care. These are also unfamiliar with patient histories and are often consumed with fitting them into an interventional pain or surgical model whether or not it is appropriate. Further, the adoption of CDC guidelines (March 2016), and the poorly understood opioid street drug crisis expressed in overdoses and suicides (now becoming clearly an illicit drug problem) has created a problem of ‘one-upsmanship’ by states that have adopted treatment criteria based on very flawed and harmful logic applied to everyone as an opiate naïve user and without regard for the range of individual needs. This has removed judgment from physicians and tied the hands of clinicians to make effective clinical decisions. It is now the case that physicians are forced to treat to the regulation as opposed to treat to appropriate levels of health care needs. I have personally stated over and over this many months that the need to treat the person has become lost in treating labels which have little ability to inform care. This forces out harmful care based on stereotypes, stigma, and flawed data that has negative harms attached and we are observing this injured effort to flow through the entire system.

Recommendation 2. Create cross cutting regulatory approaches to reduce barriers to access, reduce paperwork, increase communication between providers.

It is very difficult to receive care across state lines, across systems, between care systems, and across the progressive slide toward disability in this fractured system. The handoff from short term disability, workman’s compensation and the like is fraught with difficulty for the chronic care population and traps them into shortfalls of care based not on a disease model but a return to work model. The imposition of Medicaid work rules is likely to increase problems of handoff for a complex population that employers often want to avoid. States are under capacitated to ascertain how people with chronic illness will fit into this emerging paradigm.

Recommendation 3. One set of overarching insurance regulations – Medicare, Medicaid, VA, Workman’s compensation, state pain regulations to reduce duplication, gaps, waste and harms.

Definitions between programs are inconsistent, create gaps, and have differing expectations for eligibility. They need to be aligned to create a seamless set of criteria focused on a lifespan model of care rather than an acute medical model of care delivery. The onset of disease is no respecter of state borders. Part D prescription formularies should be uniform and consistently applied across disease progression and flow through all contracted insurers consistently. At this time, it is difficult to ferret out effective indicators when input variables create enormous confounds in our understanding of results, outcomes, and impact. Drug development cannot effectively proceed in this contaminated environment.

Recommendation 4. Create unfettered pharmacy access across state PDMP agreements that allocates medications to be dispensed based on medical necessity criteria.

For instance, Lupus is Lupus everywhere one goes. Multiple Sclerosis has a course that is known and it includes lesions on the nerve sheath that generate extreme pain. Neurofibromatosis generates tumors on the nerve tracks. A person who has had a spinal fusion with subsequent onset of Arachnoiditis will always experience intractable pain. Whether one lives in West Virginia or Nevada, one should have the same expectations for care that is consistently supported across insurance plans and state regulations. State regulators, insurance companies and pharmacies should not be free to dictate who will receive proven evidence-based medication supports and nor should this be left to pharmacy clerks in corporation pharmacies to parse out who will be lucky enough to get their prescription filled. The same is true for any number of the chronic diseases reported here. This requires federal policy directives to assure a seamless system.

Recommendation 5. Monitor for effective insurance implementations, provider capacity, and training which are often mistaken as red flags by a fractured system of a care.

Currently red flags are raised by simply being chronically ill and requiring the use of complex medications. This needs to be remedied. It should not be a crime to be gravely ill and policies that reinforce stigma based on consumer characteristics or payment sources pose unnecessary barriers as they rely on individual judgment applied by persons who have little knowledge on many levels.

Recommendation 6.  Nondiscrimination in coordination of care, minimum access requirements within state regulations as part of Federal state plan requirements for public health.

No provider with a Medicare number should be allowed to discriminate in care. Abandonment of patients should be closely examined by the federal and state governments. The federal government should create an indicator for federal state public agreements that track this as a function of the public health system. This tracking should include the functioning of Medicare A, B, C and Part D plans. Capitation by Advantage plans is a particularly grievous issue for persons with complex care needs and dual-eligibles in Medicaid.

Recommendation 7. Support for physician training and flexible implementations across treatment locations – community, hospital, assisted living, nursing home.

Physicians should have the ability to reconfigure their care provision to meet individuals where they are. Serving persons who need palliative care within the acute care model or forcing them into higher expense models for care delivery is absurd. It is well understood that palliative care is a model that leads to better quality of life at lesser cost for affected individuals. Supporting palliative care with adjunctive supports that widen the insurance payer system reduces reliance on higher cost prescriptions and health care utilization while improving community function for many. Insurers should be required to contract with physicians who can serve persons with chronic care needs through a continuum of integrated medical home models – community located, in home, palliative care, assisted living, nursing home, hospice, hospital.

Recommendation 8.  Move to ICD-11 as quickly as possible to correct logical flaws in ICD-10 that negatively impact data collection about the impact of healthcare practices visited upon persons with multiple chronic comorbid conditions.

I will spend some weeks yet on analysis in this area. It is my goal to correlate reported comorbidities with ICD-10 body system criteria and self-reported interventions. However, based on a preliminary evaluation, there is enough data to raise this question – does the logic in the ICD-10 and electronic health record implementation actually contribute to errors of care and duplicative costs? Comparing ICD-10 to ICD-11 is important because it clears up some of the diagnostic difficulties associated with chronic disease and related symptoms that include pain.

To register for Public Meeting on Patient-Focused Drug Development for Chronic Pain, click here.

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Authored by: Ed Coghlan

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Thanks for sharing the valuable post! The assessment and treatment of chronic pain will continue to be one of the most common functions of a health care provider. To move beyond an over reliance on opioid medications, the addiction and pain research communities must unite with chronic pain patients to increase the evidence base supporting non-opioid analgesic strategies.

Alvin

Ignorance is Bliss. I wanted to post a letter I sent to the Board of Pharmacy regarding an incident that happened to me last August. Good documentation but it really needs to go to a good attorney. Can’t find one. In summary an auditor for the board of pharmacy coherced my pharmacist to call all of my doctors to say that I did not have ALS or Cancer and should not be receiving Fentanyl patches. This caused my pain management doctors to pull my script. I have Failed back syndrome and Arachnoiditis. i am also a workers compensation patient. To date my new doctor says he is getting to the point where the pressure is so great that he won’t be able to write a script for my pain management. Workers Comp also wants me off all pain medication. They want me off in four weeks. My spine surgeon says fentanyl patches is the only medication that will help. I have tried everything legal for pain relief including a Spinal Cord Stimulator. I really pray that someone will listen. I hope they are tracking the suicide rates amongst the abandoned patients.
Screwed in California.

Paul have you tried kratom ? It saved my life when I got cut off from 150mg a day oxycodone with no taper and was praying for death. Some people say kratom
leaf powder doesn’t work for them. But I’ve not found anybody who has taken 2 OPMS GOLD extract 200mg capsules and not gotten relief. They cost $11 a pill so I can’t afford them. The only other high powered extracts I’ve tried are Magnum Opus Botanicals pure red alkaloid and Caleb’s Concentrates pure gold extract. They run about $35 a gram. Gaia’s Black Diamond extract is only $3 a gram. That’s what I use now. Kratom cost me $1 to $2 a day. A pain specialist costs over $350 plus pharmacy cost. I have no income and no insurance so I do good to come up with $10-$20 a week for kratom. Hope it’s OK to tell people about kratom on this site. I mentioned brands because people who think it doesn’t work may commit suicide not knowing that there was kratom extract pill = 77.43mg morphine if they can afford it and a cheaper extract that only cost a couple of $ a day that provides almost as much relief. Please don’t delete this post. If you must delete the brands. Fine.

Kelley

I am excited to see somone doing something, but im confused, as i dodnt read anything about what we pain patient are dealing with everyday, are there going to stories,? Stories about suicides,? About Dr abandonment? Pharmacys refusing meds,? Its like everything i read, seemed more about insurance

Rita KIMBEL

Thank you for all you are doing, lately I’ve been just frustrated and having the feeling of despair that nothing is going to change no matter how many letters or phone calls pleading for help. I was dropped off oxycontin beginning 2017 because of CDC recommendation and United Healthcare along with CVS Refusing to fill my scripts. My family doctor was stopped from treating me and he had my pain under control completely. I’m a palliative care spinal cord injury patient of 15 years with an implant of neurostimulator for 13 years now. My pain meds now take 3 hours to kick in and the millegrams are too low to help so I’m asking my pain doctor to up the millegrams next month. I travel 60 miles to his office, my family doctor is 3 miles from my home. Everyone and everything has changed for me in this effort to eliminate pain, what’s changed for me is the cost, time and energy to find out I’m back to the same pain as 15 years ago. But with out you fighting for us, I might have given up, what keeps me going is hearing people like you do care about what’s happening to us, please keep up the fight for me. I’m here if I can help you in any way.

Paul

Looking at the other comments, I have to say that the way it is run is to increase profits at the expense of life of the parents not only here in the USA but throughout the world. Also if people do not fit into some neat little mold as is the truth with anything that is living, they are often treated in such a way that it soon results in their death withing a matter of a few years and rarely exceeding decades.

What too many refuse to understand is that the leading causes of death and loss of peoples willing to go on are Pain and inability to function. Interestingly enough the things that are best for treating both are the most highly regulated not only here in the USA but worldwide.

Also medicine is not designed to help all in the current form, but only there to improve the lives and existence for those that have the money to pay for it. Sadly that is very few people overall. As such those that are smart enough to be able to treat themselves to make their lives better they are treated as people that are drug abusers, as it is seen as a loss of income if people are allowed to be able to help themselves with problems. That is because the majority of people are seen and desired to be treated as the cash cow and chattel of the largest of the multinational corporations.

I will say what doctors that know what they are doing say, surgery is a danger to life if not used properly, and the same applies to medications. However it is often difficult to find doctors that know how to properly use medications, and those doctors that do are very hard to get appointments with unless you pay all the cost out of pocket. We can’t depend on our insurance to help us to be able to go on with life with the current models and regulations that are so large that most are unable to fully understand it.

Paul

I agree with what Ed Coghlan wrote. That is because the system the way it is designed is not to help people live their life, but to stand in the way of people being able to live life. Also the problems are endemic throughout all medicine. Often I have found that doctors do not listen and are there to prevent me from being able to live in this world. I have many conditions that have been diagnosed, and yet there are many mistakes in what is listed and how things are evaluated. There is no consistency, and the way many doctors are treating problems are only things that I see as a threat to my basic life and ability to function. I have Asthma, CPOD, and I have never smoked, I have never had a desire to want to have to take any medications, but seen as a drug seeker. I will only take things that help me with my ability to be able to breath, not hurt so bad that I would be better off dead, not feel so worn out and confused that I am as a result of a physical attack at work by some moron with a firearm, and infections that do not go away. I am constantly plagued by mucus. I want all of those to go away and more so I can feel and function normally, but that necessitates the use of medications, that if I were not having the problems all the time I would never remember to take. I often forget to take things that even allow me to be able to breath, and then have to do something about it often at the last few minutes where if I do not I will no longer be alive.

I often see the medical system the way it is designed is not to save lives anymore than to get them or their families to cough up all of the money that they possibly can. We have a broken system that is bazaarly complicated, and more difficult to understand than medicine to someone without a degree in medicine. Also it causes more suffering and deaths as a result of the way that it is working than if it did not exist at all. Often it is to keep as many regulators employed going after things that do not help the public at large, nor does it save money but cause the cost to be the highest possible in the world.

I would really like to see a system that is designed to be transparent, and has government regulation to make sure that people are getting care that they need along with making sure that what they buy is what is listed on the label, and the research that is done on medications is not related to a financial interest, but improvement in the heath and lives of all even if an unknown problem.

Notasheep

Wow. All who understood this article stand up, or rather raise their hand…….nope don’t see one hand. I am also well educated and well confused. Guarantee the committee will not get it either. Oh they will pretend to so as not to appear stupid in front of the other members, but they won’t get it either. I saw not one mention of PAIN. Enough said.

I agree 100% with Jan Poole. Plus , the government does not do anything to help. They take away what works for us. Its not our responsibity for those overdosing and dying. why aren’t the government going after the big boys bring in heroin. they are afraid so they go after the innocent people in need of help and helpless. This is how our government works. I bet their families have the pain relief they need. am I right.

A. MacKenzie

Totally agree with Jan Poole that these recommendations were difficult to make sense of. Personally, anytime I hear the word “palliative” my skin crawls … I certainly hope that the concerns about restrictions on opioid use are NOT driven by Medicare and Medicaid’s desire for continued access to morphine for hospice care. I was shocked at how readily doctors were willing to prescribe an opioid for my mother with dementia … she did need pain care and I was happy for her to get a buprenorphine patch, but the ease of getting these drugs for her was so out of line with my own experience of the push back I have recently encountered simply because I take a low dose of tramadol/apap for fibromyalgia. My experience with her being forced onto hospice with only a diagnosis of dementia and weight loss and their protocol of morphine + sedative was very eye-opening and alarming.

Rhea Bullock

“Recommendation 8. Move to ICD-11 as quickly as possible to correct logical flaws in ICD-10 that negatively impact data collection about the impact of healthcare practices visited upon persons with multiple chronic comorbid conditions.”

Seriously? This will literally take YEARS! We don’t have years.

Lori T.

Did anybody hear the news that the state of Tennessee is shutting down dozens and dozens of pain clinics? Not only that but doctors in all states are taking a very hard look at their futures, many are retiring early, some are moving to different professions. Pain patients do not have the TIME for all this muckity muck, they will be losing their lives to suicides! So all the Herculean efforts that Dr. Terri Lewis is speaking about will all be for not. We as pain patients can barely afford a few days at best without our medication and our doctors. We don’t have the TIME for the recommendations that are proposed. All of us with chronic pain are stressed to the max right now, just wait till Jan. 1, 2019. That is when the real S is going to hit the Fan. Why can’t the powers that be, our 1 and only 1, advocate who is supposed to be making recommendations for the pain community, just say STOP! Let’s not change ANYTHING until we get this thing right for the pain community.

William Dorn

As long as the government is involved in medicine we will suffer. Step 1 leave doctors alone. Step 2 let doctors honor their oath again do no harm. Step 3 go after the real problem illegal drugs. Step 4 do away with the CDC guidelines. One size does not fit all. Its not rocket science. Do these four steps and people would not be suffering and taking their own lives.

Jan Poole

Until there is some type of provision to prevent the DEA from prosecuting physicians, all of the above is meaningless because the biggest problem is that doctors will NOT prescribe opioids for fear of professional security, PERIOD!!! Why do the people trying to help us NOT get that?

Doctors are leaving primary care in droves. I believe Dr. Terri Lewis has the best of intentions, but I could barely understand her recommendations because they were written in PHD intellectual doublespeak, and I have a college degree in education. First things first: Get the government out of healthcare. DEA, CDC, STATE BOARDS, ETC. Educate the FDA and everyone else that opioids are good drugs, only side effect is constipation. And that there are no good alternatives.

Google The European Position Paper On Appropriate Opioid Prescribing, Dec. 19, 2016. Table 1 The 10 Misconceptions and Hard Facts about Opioids and present them to the FDA. Until the stigma about Opioids is reversed, Chronic and Intractable Pain Patients will continue to suffer and Commit SUICIDE.

I don’t know if I can add my two cents. But here it is.

I have been treated close to twenty years for chronic pain with a combination of opioids and a benzodiazepine for CRPS and failed spinal surgeries.
I was forced off the combination because of the CDC guidelines and a doctor who would not treat me because of the combination.
I can no longer feel my feet when I walk as my nervous systems are so out of control.
I have also taken myself down on as much opioids as possible to “fit” under the 90 mg cdc guideline. Haven’t gotten there yet.

At 65 years old I am truly suffering from this media hysteria and mis information.

Something has to stop this freight train before any more harm is done.

All the rules and regulations that I have followed for twenty years to be treated for chronic pain. Doing all that was asked of me for twenty years. Waiting for the final curtain call when my pain doctor walks away from this nonsense
And I wouldn’t blame him.
There is no other medication prescribed that has had more restrictions placed on it.
Patients with legitimate pain doctors who have abided to every rule and regulation should not be subjected to this witch hunt. Yet we are stigmatized and suffering from mis information portrayed by news media, government and people in general.
Yes there is a drug problem. Yes people are dying from overdose. But those people do not want help. They will carry on with their addiction regardless. There will always be drugs for those who will sell their souls for a high

Legitimate people in pain will loose their right to fight pain. Acute, chronic? Drying up pain medication is not the answer to this problem.

JACKIE Cutler

“A lot of ignorance on many levels”…
Mr Coghlan expresses, cogently, the perspective of those who are the most affected in this “rule,-making-gone-amuck” environment which flies in the face of medical reason.

I expect the tide will turn only as conditioned by looking back, in the future, on the carnage wrout by current rules.

As the sausages say to the eggs, “I’ve made significantly more contribution to this meal than you: why does my message carry such little weight??”
The answer, of course, is “”POLITICS”.

And why, praytell, is the medical professional getting by (to date) in shoveling off any liability on the drugmakers, whom they claim “misled them” into over- prescribing opiates to begin with?

Same answer: political expediecy.

Thank you for your efforts, Mr. Coghlan.