Opioid Policy Steering Committee prescribing intervention – exploring a strategy for implementation; Public Hearing; Request for Comments
2018-03-12 2018-03-27 2018-03-27 2018-02-12 2018-01-02 2018-01-26 2018-02-12 2018-02-12 2018-02-12
FDA-2017-N-6502-0334 FDA-2017-N-6502-0409 FDA-2017-N-6502-0501 FDA-2017-N-6502-0075 FDA-2017-N-6502-0015 FDA-2017-N-6502-0046 FDA-2017-N-6502-0117 FDA-2017-N-6502-0121 FDA-2017-N-6502-0126
04:00:00 04:00:00 04:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0334 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0409 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0501 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0075 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0015 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0046 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0117 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0121 https://api.regulations.gov/v4/comments/FDA-2017-N-6502-0126
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Im disabled spinal chord injury + tbi, w/spinal chord degeneration since 1982. Im submitting info on behalf of chronic, terminally ill and intractible pain patients across my state. My daily regime faces a number of challenges, and thats fine. However the difference between being completely bed ridden with daily home health care for most basic needs or leading a productive life as a contributing citizen is adequate pain management. Ive been under the care of the best in nation.Most of us have been screened by no fewer than 4 specialists in pain management and abide by contracts /or monitoring programs for safety. Thats also fine. If you research, youll learn intractible, chronic and terminally ill pain patients are not addicts, Addiction is a seperate disease. We and our doctors know you do not care to learn the difference, do not care if a percentage of disabled patients are left to suffer and die in coming years, but we do! Most of us have battled years to regain mobility, and ability over disabilities in an ablist society. We have the same rights to be heard, be treated as most appropriate regardless of required opioid dosages or brands. We the disabled persons have fought for the right to equal access, and a level playing field, so we may partake in lifes work, play and liberties. Our requirement for daily medication is; and should be viewed no differently than, a diabetic requiring insulin. Our Doctors, not our government, are best trained to know the best treatment plan(s). I do not doubt heroin from Afghanistan may be plaguing the black market, or illicit fentanyl may be a problem, however to limit our access to needed medication is misguided and cruel. Our pain management clinics are already multi tiered top level trained professionals in thier field serving only candidates carefully screened, monitored and appropriately treated. You work for us. It took many of us years to reenter the workplace and to advocate for a level playing field for ourselves and others. You have a duty to see that not one single patient with documented pain loses their access to  required medications. No one who has not attended Medical School and further specialized in pain management/anesthesia per our USA medical doctors licensing and specialization criteria should attempt to overreach in determining appropriate patient care without guidance from the same. Patients are suffering, and more will suffer with any further cut backs to an already austere program. Thank You for your time. Both of my sons are diagnosed with Sickle Cell disease. Now my younger son is 17 years old and only in the last 2 years he was offered a pain relaxer which works so much better for his pain. Everywhere we go its an arguement. Doctors are deciding to push these drugs on us even if we dont want them. Here in Newark, NJ advocating has become so hard on us. It is life and slow death for us please. The Sickle cell community is only Allowed to have  morphine, oxycodone, dilaudid or fentinyl. WhY? Please hear me. My oldest son is a sophmore at LIU Post. He seems mentally slower. Classwork takes everything he has to give physicalky and mentally. The hospitals act blind to other pain management  options. I am so sad. All I want is my family to survive. And live and thrive our American dream. Now I run Lion Hearts the Michelle Reinoso Foundation. To benefit youth and famies fighting Sickle cell disease. My mother was a fantastic nurse, always put her full trusr in he4 practitioners. Medicine has not made significant progress in this field in many years. Transitioning medicayion should be offered but its not. With these being the only options patients suffering painful crisis are labeled as addicts for asking for the medication prescribed to them. These opiods cause nueral damage, joint damage, delayed comprehension and depression. The beain builds a tolerance to these opioids so always needing more for relief. This just sad at every turn. My organization is anti narcotic. We want to bring patient advocasy, get well badkets, healthy lifestyle and sincere understanding. PLEASE hear us!!! lionheartsofnj.org  As a member of Families for Intractable Pain Relief (FIPR) and both a medical professional (PharmD) and a Severe Intractable Pain Patient myself, I strongly support the following FIPR response listed below regarding the Opioid Policy Steering Committee Prescribing InterventionFIPR position:  We have no problem with a policy that requires written justification above a set opioid prescription threshold, whether that be 90 MMED per CDC Guidelines or 80 MMED from another guideline.  However, we oppose any attempt to further specify threshold amounts by clinical indication, i.e. specific diagnosis or set of symptoms.   Every patient is unique.  An opioid dose that works well for one patient may be inadequate for another patient with the same clinical indication and may constitute over-medication for still a third patient.  Determination of appropriate dose is best left to the judgment and discretion of qualified pain physicians in consultation with the patient and family members.  Documentation should become part of the patients medical chart to be retained by the physician.  We should not impose additional requirements upon physicians to provide certain forms or documents to insurance payers.  The physicians treatment plan should reflect his or her seasoned judgment and insurers should be required to pay for what is prescribed.ONE SIZE WILL NEVER FIT ALL.  STOP TRYING TO ACHIEVE UNIFORM DOSING.  IT WILL ONLY CAUSE HARM.  My further response is listed below in the files provided. United States Pharmacopeia request for extension on the commenting period People with chronic pain should not be denied medication that can improve their ability to function and give them some quality of lifesyle rather than be laid up in bed or stuck in a chair and then develop other illness due to inactivity.  Pain increases stress and inhibits healing and the ability to have a meaningful life. People become depressed.  It is cruel to deny anyone the right to pain relief.  You will see undermedicated post surgical patients getting increased blood clots, atelectasis and pneumonia because they wont want to move due to pain.  The height of the opiod epidemic according to the opening statements in painweek 2017 was around 2010-12.  Everyone should listen to that on youtube, because pain doctors are standing up for the rights of their patients as well.  And now there is no distinction between deaths from heroin and fentanyl or illegal drugs from those obtained by prescription and not diverted.  The news and papers lump them all as opioid deaths in an effort to imply it is prescription medication. It makes the numbers look skewed in what the reason is if it all appears as opioid deaths.  People who have been taking pain medication for a while for chronic pain are less likely to overdose than opioid naive people.  Most will never misuse their meds, ask for early refills or do anything except take them directly as ordered.  Yet these proposed rules punish everyone in an effort to catch a few.  There has been heroin on the streets for a very long time and yet i hear very little in how the effort to stop illegal drug trafficking has improved.  But to punish people that do everything right in their treatment as an effect to show some improved statistic number winning the opioid epidemic is sad.   As a chronic pain patient, I have to speak out on the current state of healthcare in the USA. When you need a primary care physician, you make a call to see if they are accepting new patients, the first question they use to ask was do you have insurance?. Now the first question is, are you currently taking pain medicine? or we do not prescribe pain medicine.  Did you know that urgent care facilities have signs posted as soon as you walk in stating we do not prescribe narcotics. The number one complaint/ailment that cause people to seek medical attention is pain. We are living longer, a blessing or a curse? The facts will come out, the war on drugs will not be won because they are targeting the wrong people! Chronic pain patients, the disabled  elderly do not abuse their medication. We are randomly drug tested, submit to random pill counts,  visit our doctors office every month for refills. We want to have a quality of life  have tried every available treatment to address our pain. The fact is, opioids are excellent pain reducing medication when taken correctly. Let our doctors treat us. When I read of another incident where a chronic pain patient was unable to find a doctor, or their medication was greatly reduced due to the CDC guidelines, or even worse, they have been cut off  cannot find a doctor who is willing to prescribe pain medicine  has committed suicide. These stories are every day occurrences  no one seems to care. Please understand the difference in chronic pain patients  drug addicts. Its really quite easy, chronic pain patients want to live  work  contribute to society. The drug addict wants to escape life, they know they could die but their need to get high rules their life. The addicts will always abuse as they go to the streets for their drugs. The statistics are very misleading. The people that have overdosed  will continue to, are using heroin  fentanyl. The term opioid epidemic is incorrect  has caused harmful, irrefutable damage for the chronic pain patient. Until you understand  verbalize in correct terminology the responsible drugs that are killing people, nothing will change. You will continue to hurt the very vulnerable of our population. Stop this now before more innocent die in agony when there is legal, effective medication that helps. My name is Laura, Im 33, and permanently disabled from Ehlers Danlos syndrome and Fibromyalgia, occipital neuralgia, CCI and a permanent injury to my left SI joint from being hit by a drunk driver.  Im housebound  the pain is so bad. My pain is at a level 7-8 avg daily, but without my medications, I literally cannot function at all. Im literally bedridden without them- so even the little help they give is better than nothing. And the ones Im on are the only that help! Ive tried everything else, as well as physical therapy to keep what little strength I have, which I wouldnt be able to cope with, without them. Being that I have EDS many other medications Ive tried I cannot metabolize normally- and that is why the others havent worked and I am now on the ones I am. Please consider there are many of us like this out there. We arent addicts but just those who need help and sometimes, these meds are the only thing that help keep us even slightly functional to take care of ourselves. Dear Sir.Ill be 62 soon,I have lived in pain many yeas now ,I hurt my back at the Gym back in 1994 we are now in 18.I was 34 years old I did  ok till 95 downhill from there but I did not want to go on pain meds. I suffered  so  Had all the best DrsSo I was to office to office trying to fine something that would help now we are not Jhon on T.V.   that got out of  bed with a back sore and he takes Alive . This pain is so very bad my right leg feels like its on fire the left foot no feeling ,from my belly around my right hip and down the leg into the foot excuse please my hand writing for I have to stand up sitting is not good to me !  Anyway I had surgery in 99 Dr. Simeone at Jeff did it . I was so happy Ill be a new woman not in time I was much worst tried everything injections, Radio F , did it all because I was afraid to go on meds. Well in got so bad I could not  get out of bed anymore my mother did everything for me house work helping me into the bathroom From getting all the needles oh I tried the S.C.S test   There was not hope pain like this you think how can it be so bad never did I think i would feel this kind of pain till I was going to die. 1994 till 2004 now I cant get out of bed or sit take a bath. 2004 I seen and he was the real thing Dr. had to put me on meds.   My hubby always said Thank the Lord your on meds. I think you be gone now I have R.S.D Aracknoisi scar around the L/5 nerve roots. Well this is hurting many in pain cancer , anything Why do they want to see people dye ??? Because they are cant take it .And the opening up of Heroin clinics wait till they are deart I cant see that and people with chronic pain, cancer gets no help locking Drs up   ??? Put them in jail sorry Myself and more like me are killing themselves, My meds. are all most gone Im standing to write this all Im saying is there had to be a better way need to go but Docs even wanted to put the morphine   pump in me I said no the meds. may not work they told me. You have no clue  about pain you much have this  debilitating pain to understand I need help why dont the news tell the side of people in pain and how it is killing many 65 pain groups on Face book there is one very sad people that have lost their loved one due to suicide. Losing more now ! I dont think anyone cares Im I right?/ Without Im in bed 24/7 there is no Quality to life at all Please help make a better way? Dr.s no what they are doing something has to be done I cant live in 10 pain everyday can you ?This is not coming from me all pain people I dont hurt no one Please I need help with everything When I walk I have to use a cane wheeling chair would be no good because I cant sit in my meds. I did have Quality but now Im in bed very hard  to live like this.The sick  Disabled it looks to me no one cares, This is very backwards I lost my Dr, I had for 15 years he was there for 40 Then seen a new one he got out of it he was not going to see his people in pain and let me tell you this pain is so bad and unforgiving . Please, Please Help Me .Thank You For Your Time,I cant stand anymore would love to see someone face to face!!!.renee Steiger  Please consider the law abiding pain sufferers when deciding to punish us for the abuse and illegal acts of others.If it wasnt for my pain  medication I would not have been able to continue to work and raise my two sons as a single mother.One is now a United States Marine and the other Suma Cum Laude graduate working to restore the California desert while waiting for his opportunity to serve this great nation. 