Opioid Policy Steering Committee
2017-818
2017-11-13 2017-11-17 2017-11-28 2017-11-28 2017-12-12 2017-12-19 2017-12-21 2017-12-22 2017-12-27 2018-01-04
FDA-2017-N-5608-0155 FDA-2017-N-5608-0156 FDA-2017-N-5608-0247 FDA-2017-N-5608-0251 FDA-2017-N-5608-0357 FDA-2017-N-5608-0394 FDA-2017-N-5608-0461 FDA-2017-N-5608-0490 FDA-2017-N-5608-0555 FDA-2017-N-5608-0721
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https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0155 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0156 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0247 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0251 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0357 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0394 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0461 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0490 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0555 https://api.regulations.gov/v4/comments/FDA-2017-N-5608-0721
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Please stop this witch hunt!!! I hope and pray none of you ever have to live like I do!!!  If these guidelines were put out just to family practice Drs then why has no one stepped up to tell these pain specialists to continue treating their pain pts... its heroin killing people!!! You are taking away someones only ability to function, without my meds I cant be a good wife and/or mother, Ive done back and neck injections and they dont help with my chronic everyday pain, I did physical therapy until it stopped working, these meds werent my first choice but they gave me my life back and now youre literally killing people because they see no hope anymore and they kill themselves because the pain is too much to handle, Im curled up in the fetal position when my pain isnt under control and not able to take care of my family and bawling my eyes out!!! The state and/or government shouldnt be this involved in a Dr caring for their patient and no two patients are the same either, its not a one size fits all  Hello, I am a medical professional, chronic pain sufferer and concerned citizen. It is well-known that the current crisis is fueled by heroin and illicit fentanyl more than pain medications and that we are repeating history. When we shut the pill mills down without offering any help to the patients who used them, we created a heroin epidemic that is the main source of overdoses today. Now, we are cutting off legitimate pain patients in the same manner without seeing the harm that does. After being abruptly cut off, these patients are in immense, unbearable pain and either commit suicide or buy fentanyl-laced prescription medications from street dealers, which causes them to overdose. Again, we are contributing to the opioid epidemic with short-sighted and overreaching policies.  Doctors are no longer prescribing these medications like they did in the past and are stopping entirely in some cases due to fear. We do not put the blame on a doctor if their diabetic patient goes against medical advice and is harmed due to noncompliance, yet we continue to prosecute pain management doctors when their patients harm themselves by going against medical advice. Why?When we do actually get treatment for chronic pain patients who have been cut off, we put them on opioid maintenance medications like Suboxone. So, we essentially take them off of their opioid maintenance program just to put them on a new, more expensive one and treat them like criminals. Again, why? The only way that we are going to solve this crisis is by focusing on the real problem: Addiction. Until we overhaul our addiction treatment and make it more affordable, less confusing and more effective, we will always have a problem with opioids. We need to stop focusing so much on legitimate patients who require these medications to be productive members of society and instead focus on helping those who are addicted. It does not matter how many guidelines or policies or laws you make regarding pain medications, none of them will do any good. So far, in fact, they have really only made things worse. Please, for the sake of Americans across this country, begin focusing your efforts and money on addiction treatment that actually works. Only then will anything change. Thank you.  After numerous surgeries over the years for severe endometriosis, I was left with chronic pelvic pain due to scar tissue (that is aggravated by prolonged standing) and a condition called Pudendal Neuralgia (nerve damage that causes severe pain in the groin, vaginal and anal area with any amount of sitting) making it unbearable for me to sit for longer than 20 minutes. In fact, I had to give up a good government job because of the pain and was largely bed-ridden until I got into a comprehensive pain management program.  For the past twelve years my pain has become manageable, and my life restored to some level of normalcy, with a number of pain medications that include opioids.  The dosage is low (from 10mg to 30mg of Oxycodone per day) and I am permitted to take them as needed, up to the aforementioned maximum dose, since my pain level varies from day to day depending on the nature and extent of my activity.  I would like to point out, however, that my dosage has not changed in the entire twelve years I have been on this treatment regimen.  Like so many other chronic pain sufferers, I do not...or should say dare not...abuse these medications as they mean the difference between a life worth living or wishing to die due to severe daily pain and activity restrictions.   While illegal drug abuse and addiction is certainly a situation that needs to be addressed, please DO NOT punish those of us who depend on these medications for chronic pain relief by imposing unreasonable regulations that tie the hands of the responsible and ethical medical professionals running comprehensive programs of carefully monitored pain management...such as the one I attended until the new burdensome regulations made it impossible for them to continue their practice and they were forced to close down.  Is it necessary, is it safe, to include acetaminophen to every hydrocodone pill?  Why cant you release an acetaminophen-free drug to reduce liver damage? I have have four back surgeries and have been on and off opiates for over 30 years. I all that time I have stayed around the same dose of my opiate medication for the past 10 years even though my back has gotten much worse. As you can image I have have had many non-FDA approved epidural (which none worked) NSAIDs that gave me 3 bleeding ulcers and 3 nights in ICU, PT, acupuncture,biofeedback and all other types of treatment, creams and braces. What I have found that allows me to get out of bed so I can live on my own is my opiate medication. My medication also helps me get to the store, helps me stand to fix my meals, exercise to keep my weight down and then to have enough relief to sleep when it is time too. The result that have been used have been faulse and we all know this is about money. Meanwhile you should ask you this question since these medications are so hard for people who really need them to get them prescribed to them why is more people dying each year from opiate overdoses? Basically the more the government gets involved in taking pain medication away from chronic pain patient and punsihing doctors who are treating us the more people who have died and will continue to do so. Get rid of the CDC requirement for chronic pain patients.Below is what I deal wih every day Please work on making more medication like Ultram and Nucynta, which are less likely to cause addiction, but still help chronic pain patients to function. Dont just turn your back on chronic pain patients without offering a solution. Please keep in mind that chronic pain patients are not the enemy, are not all abusers, misusers. Please keep chronic pain patients and their daily agony in mind when trying to solve this issue. Denying people relief who are in extreme pain is probably why a lot of people turn to obtaining them illegally. Yet, many doctors offices are doing just that, and offering no other solutions. That seems like it will just make the problem even worse, not better. And forcing people to suffer to an extreme because of someone elses actions seems cruel. People that are suffering from chronic pain such as Complex Regional Pain Syndrome which there is no cure for and is rated the highest pain level on the McGill Pain Scale are suddenly being told by their pain management doctors that their dose of pain meds will be lowered or are being cut off cold turkey. People with this disease are not abusing their meds, they are urine tested. These meds make it able for them just to get out if bed. Its not fair that the doctors have to be afraid of losing their licences. They should not be told how to treat their patients.This disease Complex Regional Pain Syndrome is known as the Suicide Disease because people cant take the pain anymore. It affects all the limbs, internal organs and much more. You have no idea how many have taken their lives already. People in their 20s, mothers and fathers, and many more. If the FDA and the Center for Disease Control keep dictating these rules to pain management doctors there is going to be a lot more suicides. We should not have to be punished for the real drug addicts. We do not choose to have this disease and should not have our pain meds be taken away. I know of hundreds already going through this. The pain management doctors should be able to treat their patients as they seem fit. Thank you A one size fits all dosing limit on opioids cannot be established. It fails to take into account the variations in individuals such as their condition, level of pain, genetic drug metabolism differences, and differences in ability to absorb in the GI tract. What suits one will never suit all. This needs to be left between the doctor and the patient to establish what is safe and effective for that individual and their needs. I am a multiple rare disease patient, who suffers from severe intractable pain caused by my conditions. I have Adhesive Arachnoiditis, Ehlers-Danlos Syndrome, Chiari Malformation 1.5, cerebellar slumping, CRPS, and chronic spontaneous cerebrospinal fluid leaks. A year and a half ago, my own pain management group forceable tapered all patients down to 90 mme. This took my own dosage, which I had been stable at for 8 years, down by 2/3rd. My pain became so severe that I could no longer function; I could not sleep, and when I did I had nightmares because of my pain. I could not even think; the pain was like a roar, and it drowned out even my own thoughts. It was not only terrible mentally; suffering that level of pain 24 hours a day had serious consequences for my physical health. The stress on my body caused my conditions to progress must faster, which meant losing the use of my arm and hand. I eventually finally left that pain practice when I reached a breaking point, and was very lucky to find a doctor willing to treat me as an individual. At that point, the constant stress of high pain had caused me to go into adrenal fatigue, and my cortisol level was close to 0. I had literally burnt out my adrenals, trying to withstand an inhuman level of suffering. Had I not gotten proper treatment for my pain at that time, I may have died.I tell you my story as an example of why arbitrary dosage limits are harmful. Access to effective pain treatment must be preserved for chronic patients.  The majority of chronic pain patients use their meds as prescribed. We deserve to be treated with respect. Please stop taking our meds away from us. This will only cause more suicides and more people to turn to street drugs for help.  I have been suffering with chronic pain for over half my life. Ive got years of MRIs showing Im getting worse, It took me awhile to start taking pain medication, I was grateful to be able to function and do what needed to be done. Now my medication has been cut drastically, I  am not able to move without pain, its unfortunate that people like me who suffer everyday, are now paying for people who have taken advantage just because. Its not right to have people such as myself to suffer, and are now bedridden due to the pain. What saddens me most of all is patients like me have turned to illegal drugs, and because they are unable to deal with the pain. Which in my case is now 24/7, I  refuse to go for the marijuana card because I do not like how it makes me feel. CBD oil does not help either and being financially unable to purchase it even if it did. Something has to be done, as I didnt put myself on the medications that helped me function. Now Im doing the best I can to raise my teenage son, which isnt much. The Dr. Im seeing now my appts are a 4 go 6 hr wait. He doesnt listen to me, I go in for trigger point injections 23 total and theyre painful they help a few hrs and are for fibromyalgia only. As for my other health conditions are being ignored. Please I need help as I dont know what else to do. 