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Fight Petition to Eliminate Opioid Treatment
A radical group of doctors and law enforcement have submitted a petition to the FDA that would effectively eliminate treatment of chronic pain with opioids. The maximum treatment would be 3 months and the amounts prescribed very limited despite the amount of pain suffered or the amount of medication you currently receive. You may read the petition here: http://www.citizen.org/documents/2048.pdf
And respond to the FDA here: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001
In your response you need to note how much the pain medications help reduce your pain and how they have improved your function. This is a very serious petition and will impact pain management across the country if it is enacted, causing millions to suffer.
And respond to the FDA here: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001
In your response you need to note how much the pain medications help reduce your pain and how they have improved your function. This is a very serious petition and will impact pain management across the country if it is enacted, causing millions to suffer.
Before everyone panics, understand this post originated in 2012.
I've had spine problems for over half of my life. Thirty-five years ago, when I first began seeking treatment, the idea of treating non-terminal (cancer) pain with opiate-based analgesics was controversial.
However, research into the nature of pain, and the identification of chronic pain as a disease came to light in the 1990s. For 20 years, the field of pain medicine has achieved legitimacy, and treatment is much more compassionate when it comes to those of us who live with chronic pain.
For those of you who are worried, my recommendation is to first find a pain doctor who is a fellow of a pain management program. These doctors usually have training in the physiology of pain, and interventional pain management. These are the doctors who will support you if reactionary pressures force changes in current pain practice.
Second, get involved politically. Join the National Pain Foundation (http://www.thenationalpainfoundation.org/), and the American Pain Society (http://www.americanpainsociety.org/)
Keep up with current thinking by following sites like the National Pain Report. (http://americannewsreport.com/nationalpainreport/).
And by all means, every pain patient needs to become knowledgeable in their medical condition and treatment options. Fortunately, the internet is filled with information. Sites like http://www.spineuniverse.com have plenty of information for spine patients like me. There are other sites for people who suffer from other pain syndromes like CRPS, peripheral neuropathy, arachnoiditis, Chron's disease, pancreatitis, or whatever. Find them, joint them, and help keep them strong. They're fighting for your right to adequate pain treatment. When it comes to getting treatment for chronic pain, the people who become their own advocates have the best outcomes.
There will always be attempts by various groups of "responsible" citizens to prevent people like us from accessing opiate-based analgesics. The paranoia created by our government is very successful. Americans fear "drugs" like a southern preacher fears sin. Only a responsible, educated patient base can combat the propaganda of the prohibitionists.
There are 100 million of us who suffer from pain in America, and 1.5 billion who suffer around the world. We will not be denied, but individuals may suffer. I can assure you that each individual will get the best possible treatment only if you are willing to assume responsibility for an active part of your medical care. It's really up to you.
I've had spine problems for over half of my life. Thirty-five years ago, when I first began seeking treatment, the idea of treating non-terminal (cancer) pain with opiate-based analgesics was controversial.
However, research into the nature of pain, and the identification of chronic pain as a disease came to light in the 1990s. For 20 years, the field of pain medicine has achieved legitimacy, and treatment is much more compassionate when it comes to those of us who live with chronic pain.
For those of you who are worried, my recommendation is to first find a pain doctor who is a fellow of a pain management program. These doctors usually have training in the physiology of pain, and interventional pain management. These are the doctors who will support you if reactionary pressures force changes in current pain practice.
Second, get involved politically. Join the National Pain Foundation (http://www.thenationalpainfoundation.org/), and the American Pain Society (http://www.americanpainsociety.org/)
Keep up with current thinking by following sites like the National Pain Report. (http://americannewsreport.com/nationalpainreport/).
And by all means, every pain patient needs to become knowledgeable in their medical condition and treatment options. Fortunately, the internet is filled with information. Sites like http://www.spineuniverse.com have plenty of information for spine patients like me. There are other sites for people who suffer from other pain syndromes like CRPS, peripheral neuropathy, arachnoiditis, Chron's disease, pancreatitis, or whatever. Find them, joint them, and help keep them strong. They're fighting for your right to adequate pain treatment. When it comes to getting treatment for chronic pain, the people who become their own advocates have the best outcomes.
There will always be attempts by various groups of "responsible" citizens to prevent people like us from accessing opiate-based analgesics. The paranoia created by our government is very successful. Americans fear "drugs" like a southern preacher fears sin. Only a responsible, educated patient base can combat the propaganda of the prohibitionists.
There are 100 million of us who suffer from pain in America, and 1.5 billion who suffer around the world. We will not be denied, but individuals may suffer. I can assure you that each individual will get the best possible treatment only if you are willing to assume responsibility for an active part of your medical care. It's really up to you.
1 Comments
I see a pain management doctor and I have for years. I am disable, I take my medication as should I never ask for refills o never ask for higher dose. I have already been lowered twice because of the government. I am not smoker or drinker, but I can not live on pain i can’t and I want. You guys as the government think by taking our meds away and lowering to a point they want help our pain. You will have more people dying by doing illegal drugs. Your not solving anything your making it worst. My pain meds is the only thing that helps me bare my pain to get through the Days. It’s America, we should have free will and your not stoping the the ones that abuse drugs that’s on them not on me or those that want to
Live a pain free life as best as they can to enjoy life as much as they can. I can’t take any more pain, and I am terrified of going through the pain I know that I will go through and I am afraid I want be able to handle it and end up on something worst to just live without pain you can make someone be responable and you can stop those that want to do illegal drugs there’s no way. You are hurting generally good people that take their meds as prescribed and should not be limited to what you think we should have. You should be thankful that your not one of the ones that live in pain daily and that’s disabled. Stop taking our rights away. Not all pain doctors are crooks not all pain doctors are heartless I know my pain doctor is not one that gives out medication to those that don’t meed itZ lease leave us a long before you end up with more so is that on your conscience because people cannot be in pain and they will not live in pain. you will help more people in pain turn to illegal drugs and alcohol on top of it if you keep taking our right away as human beings. Until walk a mile in someone shoes don’t judge don’t judge their pain don’t And stop thinking you know what’s best because I do not know what is best for us and you have no idea what you are about to start by taking our doctors rights away at our rights away and what medicines we can have and how many pills we can take daily because y’all think y’all can control the illegal drugs on the street you gonna kill more people and it would dare is going to be on yawls your conscience which I don’t know if you’ll even have a conscience or you wouldn’t be doing this. and stop thinking you know what’s best because I do not know what is best for us and you have no idea what you are about to start taking our doctors rights away at our rights away and what medicine we can have and how many pills we can take daily because y’all think y’all can control the illegal drugs on the street you gonna kill more people and its going to be on yawls your conscience which I don’t know if the government even has a conscience or you wouldn’t be doing this . Sorry for my grammar, I am just sacred and upset about my future and others that’s respoanbke and being perunished by the government the land of what once was the free. You can’t change the ones that does drugs for the high they will find another way.
Live a pain free life as best as they can to enjoy life as much as they can. I can’t take any more pain, and I am terrified of going through the pain I know that I will go through and I am afraid I want be able to handle it and end up on something worst to just live without pain you can make someone be responable and you can stop those that want to do illegal drugs there’s no way. You are hurting generally good people that take their meds as prescribed and should not be limited to what you think we should have. You should be thankful that your not one of the ones that live in pain daily and that’s disabled. Stop taking our rights away. Not all pain doctors are crooks not all pain doctors are heartless I know my pain doctor is not one that gives out medication to those that don’t meed itZ lease leave us a long before you end up with more so is that on your conscience because people cannot be in pain and they will not live in pain. you will help more people in pain turn to illegal drugs and alcohol on top of it if you keep taking our right away as human beings. Until walk a mile in someone shoes don’t judge don’t judge their pain don’t And stop thinking you know what’s best because I do not know what is best for us and you have no idea what you are about to start by taking our doctors rights away at our rights away and what medicines we can have and how many pills we can take daily because y’all think y’all can control the illegal drugs on the street you gonna kill more people and it would dare is going to be on yawls your conscience which I don’t know if you’ll even have a conscience or you wouldn’t be doing this. and stop thinking you know what’s best because I do not know what is best for us and you have no idea what you are about to start taking our doctors rights away at our rights away and what medicine we can have and how many pills we can take daily because y’all think y’all can control the illegal drugs on the street you gonna kill more people and its going to be on yawls your conscience which I don’t know if the government even has a conscience or you wouldn’t be doing this . Sorry for my grammar, I am just sacred and upset about my future and others that’s respoanbke and being perunished by the government the land of what once was the free. You can’t change the ones that does drugs for the high they will find another way.
I HAVE MULTIPLE ISSUES REQUIRING LONG-Term narcotic & other controlled substances. They are all documented by my over 15 yrs of treatment. I'm strongly opposed to passing laws which will interfere in allowing me to have quality of life & would rather die than live in pain. I don't solely rely on meds for my pain & use many multiple other homeopathic/osteopathic forms of treatment so I'm NOT seeking these meds for "recreational purposes!"
Thank you fir the article this pretty much answers my question about why...after all these years the pharmacy did not want to fill my husband's prescription.
Please if you are against this bull Petition, a small advocacy group have created a Petition against PROP, you can read and sign here http://www.change.org/petitions/please-help-to-stop-prop-s-petition
We are over 1100 strong as of 9/10/2012, we need more signatures before we submit to FDA..Please everyone help in this fight!
I suffer intractable Chronic Pain 24/7 due to a rare spinal cord disease called ARachnoiditis, there is no cure nor treatment for this disease..Opioids are our only treatment..This disease is called the silent epidemic, b/c you can only get it from Doctor's...I got it thru an ESI, (epidural injection in my spine)
Thank You
We are over 1100 strong as of 9/10/2012, we need more signatures before we submit to FDA..Please everyone help in this fight!
I suffer intractable Chronic Pain 24/7 due to a rare spinal cord disease called ARachnoiditis, there is no cure nor treatment for this disease..Opioids are our only treatment..This disease is called the silent epidemic, b/c you can only get it from Doctor's...I got it thru an ESI, (epidural injection in my spine)
Thank You
The thing that GOOD healthcare professionals understand and share with patients is this:
There is a difference between ADDICTION and PHYSICAL DEPENDENCE.
Am I physically dependent on several of my medications? YES. Not just the typical meds (like the Vicodin and Xanax)...I am physically dependent on my thyroid medication, as well. My body NEEDS it!
But, am I ADDICTED? Do I constantly need an increased dosage? Do I doctor shop or lie to get more pills? NO NO NO!
Any healthcare professional who does NOT understand the difference between the two has no business treating patients with chronic pain.
~Blessings~
There is a difference between ADDICTION and PHYSICAL DEPENDENCE.
Am I physically dependent on several of my medications? YES. Not just the typical meds (like the Vicodin and Xanax)...I am physically dependent on my thyroid medication, as well. My body NEEDS it!
But, am I ADDICTED? Do I constantly need an increased dosage? Do I doctor shop or lie to get more pills? NO NO NO!
Any healthcare professional who does NOT understand the difference between the two has no business treating patients with chronic pain.
~Blessings~
Keep searching for the right combinations of things to help your pain. I tried a new drug in January that eliminated the pain in my forearm, though I still continue to have very bad pain in my wrist and hand. I did have terrible side effects so I couldn't continue it but they believe the relief in the arm is permanent and that the rest of the pain I'm stuck with. Unless they come up with some new treatments/meds.
I also think you should have called your doctor and told them about the theft. You shouldn't have had to endure the pain and terrible withdrawals because of someone else. I have had pain meds stolen when my purse was taken. I had to report it to the police and pay out of pocket for the new script but I at least was able to get the new script.
I also think you should have called your doctor and told them about the theft. You shouldn't have had to endure the pain and terrible withdrawals because of someone else. I have had pain meds stolen when my purse was taken. I had to report it to the police and pay out of pocket for the new script but I at least was able to get the new script.
"People that haven't had chronic pain sometimes think they know what it's like but unless you've lived it, you have no idea."
EXACTLY. I am as yet "undiagnosed chronic facial pain" that is to say I have been diagnosed with a dozen things, taken the meds/treatments only to find that nope those were not right. Each specaist I have seen has claimed it is somethhing in their specialty:/ But then when nothing works they wash their hands of me.
So I go to my pain dr and they try to help me manage my pain. I have only found one person I know that gets what I am going through....because she has fibro a friend from hs. The rest....don't get it. I had one nurologist as he was washing me out that "it must be in my head" from the stress of having two kids and being a homeschooling mama. Made me want to SCREAM.
I know there are people that abuse persciption drugs I have known a few(one was a gal that lives down the street she is struggling right now to pay for food. Her kids always come to my home hunger REALLY hungery and I feed them. I have looked after them when she did not come home that type of thing. Two weeks ago she came over asked for somethng she knew I would have to leave the room for then left. The next day I counted out my meds and 38 were missing. There was NO chance it was someone else. She stole them from my purse! I think she has a real problem....and I was in pain and withdrawl for days because of what she did)
BUT MANY really are dependent on medication to get through the day because of REAL pain....so all those very well educated that think we should "suck it up" because of some that are abusing meds is just insane to me. If they were to succed in our medications it will end many peoples lives. They will not be able to function for their families/jobs. It floors me they would be that cruel to people who have been through so much already.
Plus many people would be forced to turn to illegal drugs to control their pain. It has no plus side.
Thanks for reading. Take care.
EXACTLY. I am as yet "undiagnosed chronic facial pain" that is to say I have been diagnosed with a dozen things, taken the meds/treatments only to find that nope those were not right. Each specaist I have seen has claimed it is somethhing in their specialty:/ But then when nothing works they wash their hands of me.
So I go to my pain dr and they try to help me manage my pain. I have only found one person I know that gets what I am going through....because she has fibro a friend from hs. The rest....don't get it. I had one nurologist as he was washing me out that "it must be in my head" from the stress of having two kids and being a homeschooling mama. Made me want to SCREAM.
I know there are people that abuse persciption drugs I have known a few(one was a gal that lives down the street she is struggling right now to pay for food. Her kids always come to my home hunger REALLY hungery and I feed them. I have looked after them when she did not come home that type of thing. Two weeks ago she came over asked for somethng she knew I would have to leave the room for then left. The next day I counted out my meds and 38 were missing. There was NO chance it was someone else. She stole them from my purse! I think she has a real problem....and I was in pain and withdrawl for days because of what she did)
BUT MANY really are dependent on medication to get through the day because of REAL pain....so all those very well educated that think we should "suck it up" because of some that are abusing meds is just insane to me. If they were to succed in our medications it will end many peoples lives. They will not be able to function for their families/jobs. It floors me they would be that cruel to people who have been through so much already.
Plus many people would be forced to turn to illegal drugs to control their pain. It has no plus side.
Thanks for reading. Take care.
I don't know how to end opioid abuse either, and I know it's a terrible cross to bear for so many. But eliminating pain control for chronic pain patients isn't going to do it. People that haven't had chronic pain sometimes think they know what it's like but unless you've lived it, you have no idea.
Finally some good news :)!!!!! If all the GOOD doctors out there could feel comfortable speaking up about the necessity of these medications in the treatment of their patients, this petition would be reduced to ashes in a day. Sadly, our doctors already feel like their are working with one hand tied behind their back - and under constant scrutiny for doing what they KNOW is right for their patients.
I don't know how to end opioid abuse. What I DO know is the PROP petition is NOT going to do it.
I don't know how to end opioid abuse. What I DO know is the PROP petition is NOT going to do it.
Sadly, the PROP people and Lawmakers looking to make a name for themselves will attack the doctors on our side.
They'll be called drug pushers, terrible people, etc. All to push them out and make them stop helping us.
It won't do a damn thing to stop illegal opiate abuse, but they'll pretend it does.
They'll be called drug pushers, terrible people, etc. All to push them out and make them stop helping us.
It won't do a damn thing to stop illegal opiate abuse, but they'll pretend it does.
That is indeed true. There is also a new organizations of doctors and pharmacists that submitted their own petition against PROP with signatures and all. Dr. Jeffrey Fudin is leading up the group called PROMP. Info is in one of the blog links that I posted above also you can find more info at http://updates.pain-topics.com
The letter written by the ACPA was very well written and really put the whole PROP petition into question.
There are many doctors against PROP and that are fighting for us!
femmy
The letter written by the ACPA was very well written and really put the whole PROP petition into question.
There are many doctors against PROP and that are fighting for us!
femmy
The American Academy of Pain Medicine released a letter to the FDA on the PROP petition, and are asking the FDA to jettison the Prop petition because of a number of false assertions by PROP
well said tuesday. envyab sounds like another "nurse" who floats on these boards. my guess she has changed her "handle" based on her text speak responses just to get a reaction. i pay her no mind. take care..
hello tuesday: i was going to respond to envy (envy ab i think gives us all a hint that this nurse is "special " and qualified to judge others) and also seems to relish doing so. But! you said it all to her so much better than i could. thank you tuesday for being an active parent connected to the school and children as that is the highest calling. shanti shanti shanti om
You wrote:
"I've been Nurse 12 yrs & have treated u guys, u rely on way too many meds and that's why there trying to outlaw it, it's all in ur mind quit whining to ud doctor & get a job and quit popping pills, it crap when u do what's asked and follow instructions we get in trouble cause of u all"
Who are you talking to? You are here because you, too, take prescription pain killers. Is your pain all in your mind? I can tell you, mine is NOT. Do you rely way too much on your medications? I don't - I balance the pharmacology approach with exercise, proper nutrition, and lifestyle choices.
Also, what makes you think that everyone else here is sitting around, NOT working, and just "popping pills"? I take care of my three children, have a great relationship with my husband of 14 years, work part-time as the Coordinator of Religious Education for my church, volunteer at my kids' school several times a week (I am the Room Parent for both of my elementary-aged children, on the four person Academic Booster committee for my middle schooler, and I ride the bus to EVERY field trip for all of my kids), and I actually LIVE with my pain...I do not just suffer through it. Pain management makes that all possible.
I do not "whine" to my doctors. I have to say that as a nurse, your approach to chronic pain patients worries me. You are hostile here to people LIKE YOURSELF. I am sure you HAVE had terrible experiences dealing with drug-seekers. But, because of those, I would think that you would understand why those of us who do NOT drug-seek hate the label. If anything, I would think you would be happy to meet people like us - people who are in the same boat as you and ARE responsible about our healthcare.
You also wrote:
"if u take more than 3 different pain meds& still need something to sleep or for anxiety u r also 1 of the **** ups"
Wow, that's pretty harsh. You can thank God that you DON'T have a panic disorder...but I do. I take Vicodin 7.5/750 (3x daily) for my chronic pain, along with Savella (an anti-depressant specifically designed and prescribed for people with fibromyalgia), Lexapro, and my Xanax (4x daily) for my panic disorder with agoraphobia and anxiety. In addition, I have promethazine (50mg 3x daily) for the intense nausea associated with my pain and chronic migraines. It also works as a symbiotic drug, helping the pain medication work better. My pain and my anxiety are closely linked. My psychiatrist and my physician confer regarding my treatment because of this.
I'm sorry you have become so jaded that you cannot see that there are LOTS of people out there who DO follow their pain management plans. Maybe through this site you can see that WE are NOT your enemy...and that the same may be true for your patients. The nurses at my physician's office, my psychiatric center (my therapist is located there, as well), and my pain management clinic are, for the most part, absolutely wonderful. They know me and they know what kind of patient I am. They are my advocates when my regular doctor is gone and the doctor filling in is not familiar with my case. They genuinely care about me and I appreciate them immensely. I hope you are able to be that person for the patients under your care.
My mother worked as an LPN for most of my life growing up (she now works in the school system - but she has always kept her license updated). She is the one who taught me that the BACKBONE of any medical facility (be it a hospital, a nursing home, a physician's clinic, etc...) is the NURSING STAFF. And she is right.
Peace & Blessings to you.
"I've been Nurse 12 yrs & have treated u guys, u rely on way too many meds and that's why there trying to outlaw it, it's all in ur mind quit whining to ud doctor & get a job and quit popping pills, it crap when u do what's asked and follow instructions we get in trouble cause of u all"
Who are you talking to? You are here because you, too, take prescription pain killers. Is your pain all in your mind? I can tell you, mine is NOT. Do you rely way too much on your medications? I don't - I balance the pharmacology approach with exercise, proper nutrition, and lifestyle choices.
Also, what makes you think that everyone else here is sitting around, NOT working, and just "popping pills"? I take care of my three children, have a great relationship with my husband of 14 years, work part-time as the Coordinator of Religious Education for my church, volunteer at my kids' school several times a week (I am the Room Parent for both of my elementary-aged children, on the four person Academic Booster committee for my middle schooler, and I ride the bus to EVERY field trip for all of my kids), and I actually LIVE with my pain...I do not just suffer through it. Pain management makes that all possible.
I do not "whine" to my doctors. I have to say that as a nurse, your approach to chronic pain patients worries me. You are hostile here to people LIKE YOURSELF. I am sure you HAVE had terrible experiences dealing with drug-seekers. But, because of those, I would think that you would understand why those of us who do NOT drug-seek hate the label. If anything, I would think you would be happy to meet people like us - people who are in the same boat as you and ARE responsible about our healthcare.
You also wrote:
"if u take more than 3 different pain meds& still need something to sleep or for anxiety u r also 1 of the **** ups"
Wow, that's pretty harsh. You can thank God that you DON'T have a panic disorder...but I do. I take Vicodin 7.5/750 (3x daily) for my chronic pain, along with Savella (an anti-depressant specifically designed and prescribed for people with fibromyalgia), Lexapro, and my Xanax (4x daily) for my panic disorder with agoraphobia and anxiety. In addition, I have promethazine (50mg 3x daily) for the intense nausea associated with my pain and chronic migraines. It also works as a symbiotic drug, helping the pain medication work better. My pain and my anxiety are closely linked. My psychiatrist and my physician confer regarding my treatment because of this.
I'm sorry you have become so jaded that you cannot see that there are LOTS of people out there who DO follow their pain management plans. Maybe through this site you can see that WE are NOT your enemy...and that the same may be true for your patients. The nurses at my physician's office, my psychiatric center (my therapist is located there, as well), and my pain management clinic are, for the most part, absolutely wonderful. They know me and they know what kind of patient I am. They are my advocates when my regular doctor is gone and the doctor filling in is not familiar with my case. They genuinely care about me and I appreciate them immensely. I hope you are able to be that person for the patients under your care.
My mother worked as an LPN for most of my life growing up (she now works in the school system - but she has always kept her license updated). She is the one who taught me that the BACKBONE of any medical facility (be it a hospital, a nursing home, a physician's clinic, etc...) is the NURSING STAFF. And she is right.
Peace & Blessings to you.
This petition calls for drug makers of opioid medications to strike the term "moderate" from the labeling and only specify the medication for severe pain. Additionally, they request that the label state that the medication is only for use for up to 3 months in cases of chronic non-cancer pain (CNCP). Lastly, the petition requests the use of no more than 100 mg of morphine equivalent dosing per day, which is not very much medicine when tolerance begins and requires an increase in dosage to achieve the same initial pain relief.
This labeling essentially strikes recommended use for CNCP patients as acute pain is deemed chronic after it persists for 3 months. So once the pain shifts over to chronic pain, all of sudden the labeling suggests that it is no longer appropriate for you. I completely disagree with the approach that the Physicians for Responsible Opioid Prescribing (PROP) are taking to curb Prescription Drug Abuse in America. If this petition is accepted and adopted by the FDA, it WILL hurt pain patients. Even though doctors will STILL be able to prescribe the medications off-label, the new labeling will curtail doctors from prescribing and make them think twice before begin opioid treatment for chronic pain.
Off-label for example: Neurontin (aka Gabapentin) is an anti-convulsant prescribed for the treatment of epilepsy but many doctors prescribe it off-label to treat neuropathic pain as it has been shown effective for the treatment of those types of conditions. Prescriptions for opioids after 3 months would be considered off-label prescribing. Additionally, prescribing more than 100 mg of morphine equivalent would be considered off-label prescribing as well.
To give you an idea of how much 100 mg of morphine is in terms of oxycodone, it is about 60 mg of oxycodone a day. The issue with the morphine equivalency limit is that there are various conversion factors out there for converting from one opioid to another. Some conversion tables suggest that oxycodone is 2 times stronger than morphine but that includes a factor of cross tolerance which carries the assumption that a lower equivalent dose will work for your pain as your body isn't used to the new chemical but not all people respond well to conversions that take into account cross tolerance and because of that, many end up with withdrawal symptoms. Without cross tolerance factored in, oxycodone is about 1.5 times stronger than morphine. So work would need to be done to adopt a universal conversion table to make sure everyone on the same leveling plane as between the two strength conversions of oxycodone, there is a 10 mg difference in oxycodone allowed per day based on 100 mg morphine equivalency.
There is also the possibility that the label change could change what, when, and how much insurance will cover for opioid medications when they are prescribed off-label. We all know that it is nearly impossible to get insurance to approve Actiq or Fentora for the treatment of non cancer pain as the label states "for the treatment of cancer pain".
The key flaw of this petition is that currently there have been no clinical trials of opioid treatment past the 3 month mark as the FDA has only required 12 week clinical trials for drug approval. So currently there isn't any accurate medical evidence that shows opioids effective after 3 months so there is no way to argue to the FDA that opioids are unsafe or ineffective after 3 months. And many of us here at MH have been taking our opioid medications for a year or 5 years or longer and can testify that the medications are still effective. So this petition is VERY premature and the evidence presented by PROP is shotty (at best) so it is very likely the FDA will tell them to do more research and come back with more accurate claims.
I have submitted my comment to the petition on the FDA website and I encourage all of you to do the same. They will read all of the comments at the petition hearing and they do take the public's grievences into consideration.
There are many doctors and pharmacists that are against this petition and are working very hard towards a denial of the petition by the FDA. There are several websites below that you can visit to read an excellent dissertation against the petition and a blog where doctors and pharmacists are going head to head on the issue. And yes, you can post your comments on the blogs on both the websites I listed below.
In all honesty, I would not be too concerned about this petition getting passed by the FDA. The FDA rarely if at all acts on the request of these types of minor petitions that they receive frequently. However, this petition is just the beginning of a movement against the treatment of chronic non cancer pain with opioid medications so I recommend that all of us remain vigilant and when future changes make their way to the FDA or DEA for approval, we need to make our voices heard. If they don't hear from us, they will think that we either accept the proposed changes or just don't plain care either way.
I will say that I have a fantastic PCP that I know will still prescribe my medications off-label and at the dosages required to control my pain but I posted my comment to the FDA to support all chronic pain patients out there that are following the rules and are undertreated or not treated at all. As I know, I was in that position awhile ago and it isn't a fun position to be in. Especially, when you have a career to hold down along with being parent to children.
So just to make it clear, I am completely against this petition. Limiting access to opioid medications for chronic non cancer pain is not the answer to the prescription drug abuse problem in America.
Here are the website links:
http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html
http://paindr.com/label-changes-for-opioids-for-or-against/
You can view your comments by clicking the link next to the "Docket ID" on the website below. Next check the box that says "Public Submission" and the comments will load up in the box below. I have posted a link to the website where you can view your comments directly. It does take some time for your comments to be posted, so check back frequently.
http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=25;po=0;D=FDA-2012-P-0818
femmy
This labeling essentially strikes recommended use for CNCP patients as acute pain is deemed chronic after it persists for 3 months. So once the pain shifts over to chronic pain, all of sudden the labeling suggests that it is no longer appropriate for you. I completely disagree with the approach that the Physicians for Responsible Opioid Prescribing (PROP) are taking to curb Prescription Drug Abuse in America. If this petition is accepted and adopted by the FDA, it WILL hurt pain patients. Even though doctors will STILL be able to prescribe the medications off-label, the new labeling will curtail doctors from prescribing and make them think twice before begin opioid treatment for chronic pain.
Off-label for example: Neurontin (aka Gabapentin) is an anti-convulsant prescribed for the treatment of epilepsy but many doctors prescribe it off-label to treat neuropathic pain as it has been shown effective for the treatment of those types of conditions. Prescriptions for opioids after 3 months would be considered off-label prescribing. Additionally, prescribing more than 100 mg of morphine equivalent would be considered off-label prescribing as well.
To give you an idea of how much 100 mg of morphine is in terms of oxycodone, it is about 60 mg of oxycodone a day. The issue with the morphine equivalency limit is that there are various conversion factors out there for converting from one opioid to another. Some conversion tables suggest that oxycodone is 2 times stronger than morphine but that includes a factor of cross tolerance which carries the assumption that a lower equivalent dose will work for your pain as your body isn't used to the new chemical but not all people respond well to conversions that take into account cross tolerance and because of that, many end up with withdrawal symptoms. Without cross tolerance factored in, oxycodone is about 1.5 times stronger than morphine. So work would need to be done to adopt a universal conversion table to make sure everyone on the same leveling plane as between the two strength conversions of oxycodone, there is a 10 mg difference in oxycodone allowed per day based on 100 mg morphine equivalency.
There is also the possibility that the label change could change what, when, and how much insurance will cover for opioid medications when they are prescribed off-label. We all know that it is nearly impossible to get insurance to approve Actiq or Fentora for the treatment of non cancer pain as the label states "for the treatment of cancer pain".
The key flaw of this petition is that currently there have been no clinical trials of opioid treatment past the 3 month mark as the FDA has only required 12 week clinical trials for drug approval. So currently there isn't any accurate medical evidence that shows opioids effective after 3 months so there is no way to argue to the FDA that opioids are unsafe or ineffective after 3 months. And many of us here at MH have been taking our opioid medications for a year or 5 years or longer and can testify that the medications are still effective. So this petition is VERY premature and the evidence presented by PROP is shotty (at best) so it is very likely the FDA will tell them to do more research and come back with more accurate claims.
I have submitted my comment to the petition on the FDA website and I encourage all of you to do the same. They will read all of the comments at the petition hearing and they do take the public's grievences into consideration.
There are many doctors and pharmacists that are against this petition and are working very hard towards a denial of the petition by the FDA. There are several websites below that you can visit to read an excellent dissertation against the petition and a blog where doctors and pharmacists are going head to head on the issue. And yes, you can post your comments on the blogs on both the websites I listed below.
In all honesty, I would not be too concerned about this petition getting passed by the FDA. The FDA rarely if at all acts on the request of these types of minor petitions that they receive frequently. However, this petition is just the beginning of a movement against the treatment of chronic non cancer pain with opioid medications so I recommend that all of us remain vigilant and when future changes make their way to the FDA or DEA for approval, we need to make our voices heard. If they don't hear from us, they will think that we either accept the proposed changes or just don't plain care either way.
I will say that I have a fantastic PCP that I know will still prescribe my medications off-label and at the dosages required to control my pain but I posted my comment to the FDA to support all chronic pain patients out there that are following the rules and are undertreated or not treated at all. As I know, I was in that position awhile ago and it isn't a fun position to be in. Especially, when you have a career to hold down along with being parent to children.
So just to make it clear, I am completely against this petition. Limiting access to opioid medications for chronic non cancer pain is not the answer to the prescription drug abuse problem in America.
Here are the website links:
http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html
http://paindr.com/label-changes-for-opioids-for-or-against/
You can view your comments by clicking the link next to the "Docket ID" on the website below. Next check the box that says "Public Submission" and the comments will load up in the box below. I have posted a link to the website where you can view your comments directly. It does take some time for your comments to be posted, so check back frequently.
http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=25;po=0;D=FDA-2012-P-0818
femmy
I just commented on that petition. I don't even get medications for my awful pain yet and I know this is the worst idea ever.
90 day limits for those with CHRONIC pain? Is that a joke?
90 day limits for those with CHRONIC pain? Is that a joke?
The group consists of out of touch academics that use residents or other doctors to do the actual patient care. These are elitist think tank wonks that either don't care, haven't a working knowledge of real world medicine, or are completely insensitive to the suffering of pain patients. Their allegation that these changes will not affect a doctors ability to prescribe is not only naive but demonstrates a dangerous lack of knowledge about insurance rules and the current regulatory environment. These changes absolutely positively will result in absolute maximums being imposed by insurance and by state medical boards.
I found a site that states the following:
Here is the crux of their argument -
"The petition calls for changing the labels to eliminate the word "moderate," and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain."
However, it went on to state -
"The changes would not affect a doctor's ability to prescribe off-label, just such promotion by drug companies, said Sydney Wolfe, MD, director of the health research group at Public Citizen."
"The label change setting the maximum dose at the equivalent of 100 mg of morphine means that it would apply mainly to higher doses of the drugs, which also are the most dangerous, said Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing. That's about equal to 14 tablets of Vicodin or 13 tablets of Percocet a day, said Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn. Someone taking twice-a-day, 80 mg of Oxycontin, which is made by Purdue, also would be over that limit, he said."
Here is the link:
http://www.medpagetoday.com/PainManagement/PainManagement/33900
I currently take Vicodin 7.5/750 3x daily for my fibromyalgia and chronic upper back pain, so the changes would not affect me. However, I know it WILL affect many others who have to deal with more intense pain/conditions than I do.
OH - and there were only THIRTY SEVEN doctors/watch group representatives who signed the petition presented to the FDA for consideration. So, I don't know if they really have enough pull to get the changes made - especially when the pharmaceutical companies will be fighting it every step of the way!! For once I am HAPPY for the billions of dollars that the drug companies have for lobbying!!!
Here is the crux of their argument -
"The petition calls for changing the labels to eliminate the word "moderate," and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain."
However, it went on to state -
"The changes would not affect a doctor's ability to prescribe off-label, just such promotion by drug companies, said Sydney Wolfe, MD, director of the health research group at Public Citizen."
"The label change setting the maximum dose at the equivalent of 100 mg of morphine means that it would apply mainly to higher doses of the drugs, which also are the most dangerous, said Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing. That's about equal to 14 tablets of Vicodin or 13 tablets of Percocet a day, said Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn. Someone taking twice-a-day, 80 mg of Oxycontin, which is made by Purdue, also would be over that limit, he said."
Here is the link:
http://www.medpagetoday.com/PainManagement/PainManagement/33900
I currently take Vicodin 7.5/750 3x daily for my fibromyalgia and chronic upper back pain, so the changes would not affect me. However, I know it WILL affect many others who have to deal with more intense pain/conditions than I do.
OH - and there were only THIRTY SEVEN doctors/watch group representatives who signed the petition presented to the FDA for consideration. So, I don't know if they really have enough pull to get the changes made - especially when the pharmaceutical companies will be fighting it every step of the way!! For once I am HAPPY for the billions of dollars that the drug companies have for lobbying!!!
I was told by my primary care, whom I respect tremendously, that beginning in 2013 in MA that narcotics were going to begin being used only for 4 reasons. Two were things I never heard of. One is metastatic cancer (odd, couldn't a tumor that hadn't spread cause horrific pain?) and the other is post-op pain, and that will be limited to two weeks. Supposedly this will start with state-aided insurances and then likely Blue Cross/Blue Shield and then others will follow.
My PCP is very knowledgeable. She prescribes my pain medication. I tapered off over a year period, basically because I didn't like the side effects, my pain wasn't effectively controlled, and I was on so much at such high doses I was afraid that at some point they'd never control my pain if I had something seriously acute occur.
Right now I do as needed. I'm deciding whether to go back to a new pain management program or to stay where I'm at. I don't want to ever taper like I had to before.
My PCP is very knowledgeable. She prescribes my pain medication. I tapered off over a year period, basically because I didn't like the side effects, my pain wasn't effectively controlled, and I was on so much at such high doses I was afraid that at some point they'd never control my pain if I had something seriously acute occur.
Right now I do as needed. I'm deciding whether to go back to a new pain management program or to stay where I'm at. I don't want to ever taper like I had to before.
Only the naive could possibly conclude that this petition would not lead to a ban on opioids. The petitioners are saying 1. there is a 100mg limit on medication and 2. that medication should be given only 3 months. Chronic pain by definition begins after 3 months. So chronic pain would be eliminated from opioid prescribing. The assertion that this is simply a mere suggestion in the package insert is ludicrous given the state Medicaid and insurer adoption of the exact language in drug package inserts are being used to determine payment for medications. A person needs more meds outside what is in the package insert- too bad. Many of the major insurers are now simply denying payment for anything above what is written in the package insert. Medicare itself (not the companies administering part D) has started enforcing this in some areas. And then there is the issue about doctors prescribing "off label" which the naive misanthropes at PROP contend is not an issue. It is a huge issue. Ask your doctor if they would prescribe Actiq for you for non-cancer pain. The vast majority will not because it is "off label" and they are risking their license by doing so. This era of hyperregulation of opioids by states have doctors running scared and most are not going to snub the regulators that control their medical license to practice by prescribing opioids off label. Don't believe the backpeddling nonsense put out by the extremists at PROP that don't have a clue as to how the real world works. I guarantee passage of this absurd attempt to stop opioid deaths by cutting off all opioids via the back door will injure and torture chronic pain patients. Ask the pain patients in Washington state how they are enjoying restrictions on the opioids prescribed and you will get an ear full.
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