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FDA Unveils Sweeping Changes to Opioid Policies

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Topic: FDA Unveils Sweeping Changes to Opioid Policies
    Posted: Feb/05/2016 at 3:47pm

FDA Unveils Sweeping Changes to Opioid Policies

Megan Brooks

February 04, 2016

In response to the ongoing opioid abuse epidemic, top officials at the US Food and Drug Administration (FDA) today announced plans to reassess the agency's approach to opioid medications.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Robert Califf, MD, the FDA's Deputy Commissioner for Medical Products and Tobacco, said in a news release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

The plan is further outlined in an article published online today in the New England Journal of Medicine.

"Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents," write Dr Califf and coauthors Janet Woodcock, MD, and Stephen Ostroff, MD, also from the FDA. "Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable. As the public health agency responsible for over-sight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us."

The multicomponent plan will focus on policies aimed at reversing the epidemic, while still providing pain patients access to effective medication. Specifically, the FDA plans to:

* Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public-health effects;

* Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;

* Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;

* Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to those of the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;

* Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;

* Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;

* Improve access to naloxone and medication-assisted treatment options for patients with opioid-use disorders; and

* Support better pain-management options, including alternative treatments.

The FDA says they will seek guidance from outside experts in the fields of pain management and drug abuse. The agency has already asked the National Academy of Medicine to assist in developing a framework for opioid review, approval, and monitoring that balances an individual's need for pain control with considerations of the broader public-health consequences of opioid misuse and abuse.

The FDA says it will convene independent advisory committees made up of physicians and other experts when considering approval of any new opioid drug that does not contain abuse-deterrent properties. The agency will also convene a meeting of its standing Pediatric Advisory Committee to provide advice on a framework for pediatric opioid labeling and use of opioid pain medications in children.

The FDA also plans to tighten requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids, an action, they say, that will generate the "most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death."

Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States.

"Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence," Dr Califf said in the FDA statement. "It's time we all took a step back to look at what is working and what we need to change to impact this crisis."

"Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis," US Health and Human Services (HHS) Secretary Sylvia M. Burwell, said in the news release. "The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS."

Last spring, HHS announced a major initiative to address the opioid abuse epidemic in the US. The initiative focuses on informing opioid prescribing practices, increasing the use of naloxone, and using medication-assisted treatment to move people out of opioid addiction.

The FDA says it will provide updates on progress with the goal of sharing timely, transparent information on a regular basis.

NEJM. Published online February 4, 2016. Abstract



 




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My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/05/2016 at 3:49pm
The above article should be read by everyone taking opioid medications.  The changes proposed are going to affect those of us who live with non-cancerous CP, and it is looking that it will get increasingly hard to get the medications needed for a good quality of life.   I DO agree about including other measures and alternative treatments, but many long term CP patients need more than that--------as we always say here, it takes a multi-dimensional approach.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Bailey Quote  Post ReplyReply Direct Link To This Post Posted: Feb/05/2016 at 4:34pm
Wow.

What are the better pain management options they're suggesting I wonder?
DDD C3-C6 with multiple osteophytes causing both moderate foraminal and canal stenosis and flattening and impinging on the spinal cord
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/05/2016 at 6:13pm
Yes Bailey - I agree - what are these better pain management options?
 
Thanks for posting this information Stevie - we need to keep abreast of these paranoid attitudes because they affect all of us - even in other countries where the approach is more tolerant
 
Until recently I had not realised how many different alternative methods I was using to control my pain - a long talk with my pain specialist relieve her mind that I was not just relying on medication -
 
But when it is required - we do need chemicals to help relieve the pain we endure - a Quality of Life is important and I wonder if that right is included in the US Constitution.
 
Also - I ask myself often - and now out loud - are the organisations that make it so hard for people with non-cancer pain to understand that over-use, abuse and addiction taking drugs voluntarily - or if they are seriously addicted - they started voluntarily - no one forced those drugs down their throats -
 
And those of us who need opiates and opioids to have a Quality of Life very likely would rather NOT have these drugs - but need them for a very different reason. We want to get on with our lives using these chemicals - not hide from life abusing them.
 
And when it comes to dependence - of course we are - we are dependent on opioids to get on with our lives - as are diabetics, epileptics, asthmatics, people with high blood pressure etc - I am sure people who take medication for anything would rather not - and only take it for the reason it is prescribed.
 
Thanks again for putting this up here - I am repeating myself - I know - but it seems horribly cruel that people with unbearable pain have to suffer so much.
 
And another thought just occurred - people die in motor vehicle accidents - but there is not thought about taking all cars off the roads because of death and serious injury.
 
I don't drive because of my medication and the spasms I have in my spine - I don't think this is responsible - and it is inconvenient to say the least - but it is my choice
 
Thanks again Stevie
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Feb/07/2016 at 3:45am
I am writing my senators and congressmen to block this action by the Obama administration.  Hopefully the damage can be reversed by the next POTUS.
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/07/2016 at 4:43am
I am glad you are doing that Jeff - I can't to much about the situation in the US from Australia - except support people and offer suggestions

But - I would like to know if there is a right for people to have a Quality of Life in your Constitution.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Seratigram6 Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 10:23am
How can anyone that does not suffer from chronic pain make the appropriate recommendations or guidelines for correct management of opiods?  Why are we categorized with people who abuse opiods? Quality of life is afforded to many of us who require the use of opiods to manage our debilitating pain.  Will these new guidelines afforded us the ability of proper pain management or deny us what is required to allow us to function daily with some relief of our chronic pain.  I suffer from spinal stenosis, several bulging discs in my lumbar, thoracic spine and spurring of my cervical spine.  Depression and sadness are part of anyone's life as we try to accept a life that robs us of the joy that anyone without chronic pain enjoys.  What gives the CDC the right to issuing guidelines that may negatively affect our quality of life? 

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 11:26am
I agree.  It's beyond frustrating the way things are headed, and I'm afraid that it will only continue to get worse before it gets better. 

IMO, if people want to abuse these drugs and suffer the consequences of overdosing, it's not OUR problem, and we shouldn't be classified as abusers because we are taking our medications as prescribed and appropriately.

Things have gotten to the point in some States where the Insurance Companies are deciding whether or not to fill prescriptions for drugs that affect the CNS in the elderly.  Despite them being prescribed by a health care professional.  And, if the patient offers to pay cash and not go through insurance, they raise the prices so high that people can't afford them.

The answer?  Write to legislators and complain-------many Dr's hands are tied, and are as frustrated as their patients.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dbarbeau48 Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 2:02pm
Our Massachusetts governor is proposing to make it a law that no prescription can be written for no more than one week if it's for opioids. That's ridiculous .
Five knee surgeries from 1970 to 2000. Knee replacement in 2000.Spinal stenosis surgery in May of 2002. Diagnosed with Pseudogout in 2005, effecting hands, knees, and shoulders. Emergency surgery in March of 2006 for spinal infection of L 2 and L 3. During surgery, discovered I had Cauda Equina Syndrome. Spine became unstable after surgery and had 360 fusion with 10 pedicle screws, plates and rods in April of 2007. Retired early as a high school principal. Recently, have had trigger finger surgery on both hands as well as surgery for severe bi-lateral Carpal Tunnel disease.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 4:15pm
Originally posted by dbarbeau48 dbarbeau48 wrote:

Our Massachusetts governor is proposing to make it a law that no prescription can be written for no more than one week if it's for opioids. That's ridiculous .



OMG.  In Arizona it's one month.  No refills.  Must pick up a new hand written Rx each time.  That's bad enough.  But ONE WEEK?  Just crazy.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 4:38pm
I guess they want us to commit suicide so we aren't a burden on the health system any longer.

No, it is because a small number of people abuse narcotics and rather than deal with the issue with precision guided bombs, they carpet bomb us with B-52s.  Its just easier and cheaper to pass general laws that effect everyone than deal with the dealers who create such problems.  Maybe if we had laws for them like Singapore has.
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Seratigram6 Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 5:17pm
That is absolutely pathetic.  I come from Massachusetts and could never move back if he gets his way.  He does not know how to differentiate substance abuser's from those of us with legitimate chronic pain.  Write to your senators and representatives regarding this terrible decision.  Too bad the Governor doesn't suffer from all the health issues you are going through.  I originally lived in Framingham, MA and moved to NC in 2004.  I am so sorry that this deleterious decision has been made in my once home state.
Sincerely,
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 5:42pm
Barbara,

What are NC laws now regarding dispensing narcotics?  Do you have to get a new RX without refills on a monthly basis?

I am an RN and went to Duke to become a PA.  I am interested in what is happening all over the country.  Our membership is world wide and everyone faces different problems regarding narcotic prescribing.  And, it seems that the tougher it gets in the States, the harder in Canada, the UK and Australia to mention only several of the countries of our membership.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Hangingon Quote  Post ReplyReply Direct Link To This Post Posted: Feb/08/2016 at 8:19pm
I live in Georgia and have to get new prescription every month for my opoids. Also go thru the pee test randomly. And I can't get them from a Pa only the doctor.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/09/2016 at 12:20am
I don't think I would fare too well in some US States
I take 40 mg BD and I need 2 scripts for a 4 week supply - one for 30 mg tablets and one for 10 mg tablets - so there's two per month and sometimes 4 because there are more than 28 days in a month
Then I need a script for morphine injections every 5 weeks.
My pain specialists recommends my narcotics to the Health Department for a permit for my medication and my GP writes my scripts authenticated by phone quoting numbers he holds for these
This does not always work smoothly - but overtime I have informed myself with all the ins-and-outs of this rigmarole
However - it's nearly 21 years since all this started - and I always have my mind prepared this could change
 
However - it's 10 years since I had an anti-tetanus injection - and I collect cat scratches from my furry mate from time to time - and horses grazed up here until some years back - and I get orb-spider bites from time to time - and the are poisonous dirty bites.
 
So I asked for my booster - my doctor looked it up in the computer - 10 years - fine - all done - I only had to ask 
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dbarbeau48 Quote  Post ReplyReply Direct Link To This Post Posted: Feb/09/2016 at 8:54am
Currently in Massachusetts, you get a one month script for narcotic prescriptions and have to go to the doctor's office for a refill (like Stevie). Going once a week, if it passes, would certainly be a burden. I also thinking of people who had major surgery, and somehow have to get to their doctor once they are home from the hospital. I'll say it again, ridiculous.
Five knee surgeries from 1970 to 2000. Knee replacement in 2000.Spinal stenosis surgery in May of 2002. Diagnosed with Pseudogout in 2005, effecting hands, knees, and shoulders. Emergency surgery in March of 2006 for spinal infection of L 2 and L 3. During surgery, discovered I had Cauda Equina Syndrome. Spine became unstable after surgery and had 360 fusion with 10 pedicle screws, plates and rods in April of 2007. Retired early as a high school principal. Recently, have had trigger finger surgery on both hands as well as surgery for severe bi-lateral Carpal Tunnel disease.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Seratigram6 Quote  Post ReplyReply Direct Link To This Post Posted: Feb/09/2016 at 9:06am
NC allows us to get a prescription for opiods every month. We must either go to our CRPS specialist to pick up the script or they give us three individual scripts.  We have a random drug test yearly.  The insurance carrier intervenes and denies certain medications such as Hysingla due to costs.  When we pick up our meds at the pharmacy, we must show a photo ID before getting the medication. I go to a privately owned pharmacy to get my meds filled and try to avoid the Rite Aids, Walgreens etc.  I am extremely upset about the sweeping changes in Opiod policies and am frightened that they will continue to confuse us with real drug addicts who use these meds to get high and not for pain relief. 
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I've been using CVS for my prescription refills for years. I've always been treated with respect and dignity and don't have to show any photo ID. My insurance company changed the plans, and I could get my meds cheapest at Walgreens. No way----I know what went on with Walgreens in Florida and the last I heard they weren't even allowed to carry certain opioids. I'll pay more to go to the CVS on my corner where I'm known and cared about.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote tkay Quote  Post ReplyReply Direct Link To This Post Posted: Feb/09/2016 at 3:45pm
Some how I feel all our health care Insurance and now the medications for pain will turn our lives into survival of the fittest.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Feb/10/2016 at 12:41am
I use CVS for all but the Class II stuff which I find easier to get from my pain doc's pharmacy.  But I agree it is worth the delta over Walmart.
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

Please donate to help Chronicpainsite.com continue to help others.
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I switched to CVS from Rite Aid and found out they where charging way more for some of my meds. And there generics where a whole lot worse. Cvs has gone out of there way to help me get meds I couldn't get elsewhere.
I worry about one thing from all of this , an increase of suicides. But that might be what they want in the first place.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/10/2016 at 4:56pm
Hi Tammie
 
I believe you are right - the "fittest" will be those with the most money who can pay for their medication or those who are in pain they can endure - however bad the pain is. These people will not survive because they are the most physically fit.
 
Though being physically fit decreases as the length of the untreated pain goes on.
 
And Elizabeth
 
It's an ironic thing - one reason that people want to stop the use of opioids is because people can die from them - and yet - untreated chronic pain can cause a person to become so desperate they might take their own lives
 
I wish could read what I deleted - sometimes I can vent away happily and know I can hit delete - I'm just letting you know I got really satirical about the whole situation for short while there
 
 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Troy Quote  Post ReplyReply Direct Link To This Post Posted: Feb/12/2016 at 2:51pm
I came very very close to ending my life before I found a doctor that cares. He after a few years left to go to another state. I went to my second Doctor and he was so good thorough but had me on a anxiety pill when needed! I was tested repeatedly over the years w/ no problems. I would go in for my drug test and all was good except a couple of time my anxiety pill didn't show up in urine. He said I was misusing  them and said I would have to find another Dr. He never said I had to have them in my system or get in trouble, especially anti-anxiety pills. I was on pain meds as well and for Cholesterol so he dropped me with no warning I would need ant-anxiety in urine too!! I loved him as my Doc!! He was thorough in tests and well being upkeep! His nurse would hold back scripts for pain up to a week after he would sign it! I would call to get it and Skip the nurse would yell loudly at me that I already got it. This all happened leading up to him letting me go! When another nurse found it and contacted me skip said she didn't do anything wrong it was me "The Patient" I never got snappy with them nor would I mention it to my Doc!! and cause trouble I felt coming my way anyway. I am one of the sufferers that's for real! I am not sure what all Skip put in my records or told My Doc! He was one of the best I miss him terribly!   My 3rd Doc now is a women and is sweet but just starting! Her thoughts are to take down an all my meds. I have told her I can't live like I was before I CAN'T I was ready to end my life until my wife said I got you a doctor  as she held back tears! that was my first Doctor. I loved him to. He cared about my pain  and real suffering I was going through! One day he was gone. I then found my second Doc I loved as well because he cared. I feel he trusted his nurse more when it came to me and the little problem Skip and I had that just got worse and her meaner to me. I had finally leveled out to where Pain wasn't my constant focus it was back to living a life with family and I felt me coming back!  I wasn't depressed and my pain was where I could deal with it and live nicely Sorry her Back to my third Doctor I have now as of maybe a year as of 01/12/2016  I again follow the rules religiously as I do my directions on my scripts she gives me everything to a T. She has taken me down from a 10mg pain pill  2 months later 7.5mg pain to a .5 mg pain pill. These were used for my break through pain pill . She is gradually breaking me back down little by little to where it has caused thought in my head years ago when I could get no help. I have asked her to be honest with me as I would as well with her  I told her the last drop in mg made a change in a negative  way! I guess she didn't care. My nerves are getting worse as well as my anger because of the pain starting back more frequent and worse She has also mentioned my my Pain pill and it's a major pain med. My wife is getting upset as well as I am because I told her I will never be that person I was before going to my first pain Doctor which actually saved my life my wife did too by getting me in to see him. I don't want to die but I refuse to be treated like I am these junkies out for a high! I have all the proof in my back that shows I am not lying I AM NOT AN ABUSER I AM IN CHRONIC INTRACTABLE PAIN !!!  I want help from a Doctor that can tell by my records , blood test, urine test,exray's I am the real deal. Even my new woman Doctors nurse claimed I couldn't get my main med Because I had got it early. She wouldn't lok back through transactions  and said I'm not arguing with you to me. I went to my Pharmacy I always use and they gave me my hand out from their computer showing I was on time every time for 6 months. It showed every script from them and the dates that were correct on my part. The Doc office staff messed up. I didn't want to take the fall this time!! I have always been straight with my Doctors, but this was my first stand up for me this time and don't let them degrade me down to a junky because I am not a Junky I am in pain. I find it cruel and very unusual punishment for them to treat me like this when I am an honest  Person In PAIN!!! While being upfront 100% with each of them! I don't want to die, but the rate of pushing me down like I am trash that looks for meds. on the streets like druggies do It's a disgusting thing for a medical doctors do to human beings in pain. If the Docs are so brilliant why is it they treat real pain patents like scum? Were they not trained well enough to recognize real from fake or just get enjoyment  watching people suffer. I proved to the nurse I wasn't trying to pull a quick DRUG BLANKET over her eyes!!  I believes it shows the quality of Interns and Doctors are out for the recognition of being a doctor and us Patients are the Scum in their eyes we are beneath them!! I truly thought Doctors and nurses cared about people that are it real pain! I hope This is isn't my last post. I had no one to talk to  including my doctor or nusreI though they took an oath to help people don't drive them back to suicide/thoughts.  If it happens I hope they at least think about what could have been do instead of break me down to this level that I haven't even thought of until I came to her help. Maybe she's an end of life Doc And I did not know or she didn't make clear! This feels like the end of mine so I have not one thank you to them You're my Doctor, why are you making me feel worse  IT'S MEAN !!!!!!!!!!!!!!
I'm in true Chronic/Intractable Pain! I don't play games with meds. I use them to live and not want to die!I feel I am going backwards again
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/12/2016 at 7:26pm
Hi Troy
 
We all need to vent at times - and I am glad that you have done so - it is a terrible burden to carry around - and we all know what you are talking about regarding pain medication - to some degree or another
 
It s a terrible thing to be pushed around like that - but we are hear to listen - we hear you - and we will accept you and vindicate you - you will not be alone again
 
We have an emoticon here Shot which I thought of the moment you talked about that nurse holding back your scripts that were already signed by your doctor and got you into trouble. Your nurse is a nurse from Hell - really - and they do exist
 
I live in Australia and things are much easier here - people do get screened for drugs and alcohol in their blood if they were when involved in a Motor Vehicle Accident - and I daresay for other unruly behaviour - but we don't get tested for the drugs we SHOULD have in our system
 
It begs the question when they tested you for anti-anxiety drugs and found you had not been taking them - would this not be a good thing? It seems randomly crazy to think you were selling them when you might have "done the right thing" and taken less
 
But after reading the book The Painful Truth I do know a little more about the treatment of people with chronic pain in the US. It is incredibly unfair to be treated that way - and concerns everyone here that people are treated the way you have been -
 
So - although I am terribly sorry about your pain and what you are going through - I am very glad you have shared your story
 
Other people will be along soon - and they might have something more useful to add - but you will be supported here - that is what we are here for - the support of people with chronic pain -
 
We all know this is a horribly untreated disorder
 
Merlin
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Troy Quote  Post ReplyReply Direct Link To This Post Posted: Feb/13/2016 at 7:48pm
Hi Merlin That nurse emoticon was perfect for that nurse! I am a little scared now because my pain is worsening with lower doses of my Hydrocodone! I was used to to a certain amount 3 times daily my doc cut it in half by now actually more! I can feel as time goes on I am weaker and hurting. I still am on my main pain killer 2x daily but these were for breakthrough pain. Now it isn't working and I am a bit depressed. I didn't do anything but follow orders all along and I am being punished as abusers are a getting there so called fixes as I am down in more pain because of the abusers. I wanted to thank you for your kind response!! I hope to speak with you soon. Thank you  again, Troy
I'm in true Chronic/Intractable Pain! I don't play games with meds. I use them to live and not want to die!I feel I am going backwards again
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/14/2016 at 5:12am
Hi Troy
 
It does seem horribly unfair that the people who abuse drugs go on getting their "fix" and those of us who have been honest have trouble getting the relief we need for something resembling a Quality of Life
 
But I think drug addicts have horrible lives - truly -
 
It is usually very quiet in here over the weekends - but there will be more people coming along - and I know you are frightened as your pain is building up again on a reduced dose -
 
And that must feel horrible
 
But you are not alone - we have all had troubles with our medication at some time - maybe only a few times or maybe often - and it saddens me that it is also traced back to paranoia in the people who don't have pain but make a lot of rules about it
 
That's not sensible - but here we are
 
I might drop in later -
 
Merlin
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Post Options Post Options   Thanks (0) Thanks(0)   Quote tkay Quote  Post ReplyReply Direct Link To This Post Posted: Feb/14/2016 at 12:22pm
I was talking to my neighbor yesterday. Her husband is in chronic pain from a back injury and arthritis through out his body. He is not able to do much when it is cold outside.

Anyway, she was talking how is just not able to go out and do things like he was before. I said unfortunately I believe it will get worse if Legislation decided to things. She told me in Michigan a person can only get a thirty day supply per prescription. It is terrible.

Why not three months?

I don't have the money to go to the doctor when I am ill with the deductible I have! To do it every month would be horrible.

At the moment, I am still only using effexor, celebrex and occasionally lyrica.

My pain levels have been at a 5 for over a year and six months, I haven't had any lyrica for a year. I was told I rely too heavily on medication to lower my pain.

I am active, I was told to exercise more(course that is when I was an office manager), with my current part time job I walk through a store several times in a half hour. It has no effect on my pain level.


At the moment I
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Hangingon Quote  Post ReplyReply Direct Link To This Post Posted: Feb/14/2016 at 1:43pm
I honestly don't know of anyone that can get more then a months supply of the heavy pain meds anymore. I have to get from Dr every month I pay 40 for the doctor and 10 for the med. There's just no way around it now. So basicly I am paying 50 bucks a month for my pain med. Its ridiculous to me but I don't see it getting any better.
I saw a thing on news on my computer where that Warren lady says they should try weed on people with pain so if its enough for them to have relief maybe we can stop people getting addicted to it. And it also might help people get off of addiction. Sounds like a smart way to do things to me, but doubt if it will ever happen. The pharmaceutical companies would not like that.
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I mean't stop people getting addicted to opoids.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/14/2016 at 3:31pm
For the many years we have been running this site, I once again will attempt to clarify addiction and physical dependence.

People who have a predilection to addiction are going to want substances of any kind that give them a "high".  People who use medications to treat chronic, intractable pain don't get "high".  Generally, they have side effects that are quite unpleasant and only take what is absolutely needed to get some sort of relief from pain. 

Anyone who uses medications, and especially opioids, DO become physically dependent upon the drugs within 3 weeks of continued use.  This does NOT mean that they are "addicted".  It means that in order to stop the use of the drugs, they will need to wean off in order to avoid unpleasant side effects.

People who are out to become "addicted", will use increasingly higher amounts of whatever substance they can get in order to get that "rush"/"high".

It is unconscionable to me that anyone who sees their health care professional on a regular basis should or would have to "pay" each month to see that person in order to pick up a hand written prescription.  My Internist sees me at 3-6 month intervals for regular check-ups.  I also have a yearly PE which includes complete lab work.  I have never had to pay to pick up a monthly Rx.  And, if that was the case, I would be looking for a new Dr/PA/NP.   

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Hangingon Quote  Post ReplyReply Direct Link To This Post Posted: Feb/14/2016 at 4:50pm
well apparently where I live that's how it is, been to 4 different pain management places and there all the same. I cannot get my prescriptions without seeing the Dr. once a month. I have to have an actual apt with the Dr to get them no matter what here.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Feb/15/2016 at 2:50am
I have to see the doctor every month to get my prescriptions too, but given the alternative I'll go through the 3 hour torture process.

High?  I want to take some politician, bash their fingers with a hammer, give them a pain pill, then ask if they feel "high" yet.

Catch the pushers, follow them up the illegal drug distribution chain, and make sure none of them ever see the light of day again.  Then leave the rest of us and our doctors alone.  
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/15/2016 at 7:20am
The needing to actually "see" the Dr, PA, or NP seems to be prevalent among Pain Management Dr's, and not necessarily done for those treated by Internists. But, the laws are in place, and in the States I'm unaware of any opioid that can be prescribed for more than a month and refills are no longer allowed. The only exception may be Tramadol, but schedules and classifications are changing so quickly it's hard to keep up from State to State.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dbarbeau48 Quote  Post ReplyReply Direct Link To This Post Posted: Feb/15/2016 at 9:03am
Stevie, you are right about Tramadol, it comes with refills. Like you, I do not have to see my doctor every month to get my refill prescription of Percocet. I send in my request through the patient portal, get a call later that day telling me the Rx is ready to be picked up, get it and drop it off at the pharmacy. Total comes to $10.
For those that have to make an appointment with the doctor, are you being examined or just there for the doctor to hand you the Rx?
 
Dick
Five knee surgeries from 1970 to 2000. Knee replacement in 2000.Spinal stenosis surgery in May of 2002. Diagnosed with Pseudogout in 2005, effecting hands, knees, and shoulders. Emergency surgery in March of 2006 for spinal infection of L 2 and L 3. During surgery, discovered I had Cauda Equina Syndrome. Spine became unstable after surgery and had 360 fusion with 10 pedicle screws, plates and rods in April of 2007. Retired early as a high school principal. Recently, have had trigger finger surgery on both hands as well as surgery for severe bi-lateral Carpal Tunnel disease.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/15/2016 at 9:27am
That is exactly what I do, Dick.  Use my patient portal, get a call that the Rx is up at the desk to be picked up and only pay for the prescription.  And yes, Tramadol can still be refilled in AZ as well.  Thanks, and I too would be interested in knowing exactly what the Pain Management Dr's are "doing" every month in order to hand over the Rx.

Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/15/2016 at 6:05pm
I have to pay to see my GP but I will get as many scripts as I need and an injection if one is required. He has told me that he needs to see how his patients are before writing scripts - and fair enough - it has been hard work breaking in a new doctor in after my GP of 35 years retired.

I was seeing him for every injection until I saw my pain specialist again a couple of weeks back - now I have been seeing the locum doctors again and that doesn't cost me anything - and it doesn't cost me anything to see my pain specialist either

It's pointless saying how much I pay because of the difference between the AUD and the USD - but I pay much less for my medication - Medicare pays for half of my doctors visits and most of the cost of my medication is under the Pharmaceutical Benefits Scheme.

As for seeing a GP - it is better to go to a practice that charges - the doctors there are committed to their work and stay - so I get to see the same 2 doctors who know me - if I went to a Bulk-Bill Clinic I would see them for free but I wouldn't know who and I would be waiting for anything up to several hours - whereas I get seen very quickly at the clinic where I go

I don't get any repeats on the medication that I have regularly except for Panadeine Forte and I get 5 repeats on that and it lasts me for well over 6 months - but it depends on each person I think but I used to get Tramadol with 2 repeats and later - no repeats - but I don't get that now

It seems less complicated here - but there is a lot of other paperwork going on behind the scenes

Jeff - in Australia they are doing their best to get the big guys up the chain in organised crime - they crims they catch are easily replaced -

And Dick - my doctor doesn't just hand me my scripts - he asks me a lot of questions - and he knows I am seeing a psychologist - part of the reason is pain - and Medicare pays for some of that too -

I think this doctor I am seeing now is very forward thinking and has the best in mind for his patients - it was just hard getting used to him in the beginning
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Todd Quote  Post ReplyReply Direct Link To This Post Posted: Feb/16/2016 at 8:17am
This is an outrage!!!! Politicians are putting us in the same basket as abusers with statements like " the numbers of deaths from opioids exceeds ..."
Can't they attack the problem at the problem and not wrap all opiate patients in with criminals?

I am terribly offended by being included with substance abusers. I was once a raging alcoholic needing it (vodka) 24 hrs a day. I was an abuser and addict! I know first hand what that is and what it means. It is a whole different world from needing medication so you can get out of bed to make a sandwich.

I hope we as suffering patients relying on opiates have a PAC in Washington fighting for our identity as people trying to have a normal life and that there are already measures in place to keep our use of Meds in check. My dr's office accidentally gave me too many scrips for my fentanyl last month. Like 2 months too many. I think my surgery and stay in hospital had to do with it. I still can't do anything with them! Even if I wanted to, the insurance won't let it through and the pharmacy computer is tied to DEA system which will not let them process more than one a month. Maybe if there was a a crooked pharmacist somewhere he could fill it for cash but that just doesn't exist anymore. At least around my neck of the woods.

Merlin and some others had good points. There needs to be a clear distinction in the minds of politicians between the patients and the abusers. Death toll numbers should be separated into abuse deaths and deaths caused by prescribed use of the drug. This would open some eyes I think and help make a clear difference between "us and them".
It's a possibility!
Just ask me
Just out of (Dec21) surgery for instrumented L5 lamenectomy/fusion to S1, decompress L234, clean up stenosis in several areas, remove bone spurs, harvest bone for fusion and screw it all together lol
Chronic inflamation of SI joint, stenosis, L5 Spurs, degenerative disc 4,5.1. Several other disk issues, Bi-Lateral Total Hip repl.for idiopathic necrosis, degenerative disc in all cervical joints, fractured C7 (unhealed), Rebuilt lower right tib/fib/coxic/ancle/foot from trauma, Idiopathic systemic/autoimmune issue causing inflammation in various joints and eyes. RA neg HLA B27 neg, Sed rate high and C-Reactive high
Major anxiety and depression / Bi-Polar disorder (maybe,I disagree). When fractured C7 lived in a halo for 6 mos. no fun at all
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/16/2016 at 6:27pm
Thanks Todd
 
I just thought - a brand new idea in my mind -
 
Drug addicts abuse drugs and
 
Politicians abuse people who need opioids for chronic pain.
 
Those of us who need medication for chronic pain are at least honest - and I don't like being dumped in with drug addicts either - and yes - we suffer
 
And drug addicts are not honest - but I believe their lives are worse than ours - because their need is not honest and they fall into abuse of drugs and then into a hell of getting what they need for entirely different reasons
 
But that doesn't make me like people who abuse drugs -
 
But I have no idea how anyone can sort out the sheep from the goats - my old GP told me that some people are incredibly deceptive - and with all his years of experience he still did not like writing scripts for people he did not know
 
And my current GP - who I have known for years - was uneasy when he took over my case - but seeing him regularly for medication for over a year now and having an MRI has made it easier for him - but still - I am taking so much less medication and this does not make my life any easier - but at least I am pleased with myself for cutting back and proving that I need more than I take - though my pain can vary for a zero to an 8 pain-wise within seconds at times
 
But let's think for a moment about the politicians - why are they in the world of running a country? What makes them take the world of a politician?
 
Could it be - money?
 
Yes - like everyone else they think of their hip-pocket - but they are running a country and even have a treasurer to take care of the books for them - oh my -
 
They have to please all of the people all of the time and that is impossible - so depending on their left or right opinions - they hit out at the most vulnerable - the wealthy or the poor
 
And we with the pain fall into the leftist camp - and this does not make life easier when we have lost so much of what we used to have - we have lost our income, our work and every thing I have read on these boards has been a loss that is devastating to the person who has lost it -
 
However here we are - things are easier in Australia - in 1996 - the year a lumbar specialist gave me the good news and the bad news after the MRI - there was a law passed to give people with chronic pain access to narcotics to give us a Quality of Life
 
I often wonder how people can go about getting that in other countries.
 
No one dependent on narcotics for the relief of chronic pain for a Quality of Life should be lumped in the junkies
 
But once many of those "junkies" started their lives of hell with chronic pain but abused their medication - and I think that is part of the problem.
 
Others started to enjoy the high and get away from something in their lives and find themselves in a different kind of hell
 
So - sorting all this out is a nightmare - and people with chronic pain suffer - and no honest person should be treated this way.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Feb/16/2016 at 8:52pm
I personally detest narcotics.  I lock mine in a safe and have a method of tracking every pill so no visiting relative or anyone on a trip can take mine, but it is a real pain in the rear.  Also, if I screw up and take a pill too early, I get a severe case of itching and the same applies during surgeries.  I also wake up out of oxygen if they do too much and in pain if they do too little, so my body is like Goldilocks.  It has to be just right. Finally the ongoing constipation that you have to battle every day of your life.  And I have to go through a brutal 2-3 hour appointment every 28 days for the rest of my life and submit to annual random drug testing that my insurance doesn't cover in full.

Despite all of the drawbacks, we depend on these medications for quality of life, and even with the medicines, it is no cake walk living with chronic pain.  I had to give up 90% of the things I enjoy including my job / career due to chronic pain so while others have it worse (I could have been paralyzed), we don't need our own government adding to our torture.
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

Please donate to help Chronicpainsite.com continue to help others.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/28/2016 at 6:58pm
I chat with the Practice Manager at the clinic where I am well supported with my chronic pain - and seeing as I have read The Painful Truth I gave her my copy as some kind of "Pay It Forward" thing - hoping the doctors at the clinic will read this as well
 
For the best part of over 35 years I have been a patient at that clinic - and I have had a few doctors who have been problematic - most of the time I have had the best of care
 
I know we can bring the horse to water but we cannot make it drink - but at least - in this case - I have given the Practice a good book on the subject and maybe it will be read and maybe it will help
 
I can hope - we can hope - that the information that chronic pain is a medical dis-ease that needs treatment and not condemnation is one thing we can do the smallest thing we can - and at least we have done something - and not nothing
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/29/2016 at 11:20am
This is the "latest" fall out from the original article I posted earlier this month about the FDA making sweeping changes to Opioid Policies:

FDA Call to Action on Opioids Met With Skepticism

Alicia Ault

February 23, 2016

The US Food and Drug Administration's (FDA's) recent announcement that it would re-evaluate its labeling and review policies for opioids seems to be largely a political move designed to fend off congressional critics, say pain management and addiction medicine specialists.

The agency's action plan, announced on February 4, included a call for a re-examination of the risk-benefit paradigm for opioids, changes to immediate-release opioid labeling, improved access to naloxone, and new advisory committee meetings to address pediatric approval issues and any new opioid that does not have abuse-deterrent properties.

"It's obviously a reaction to the pressure they're getting from Congress," Edward Michna, MD, director of the Pain Trials Center at Brigham and Women's Hospital and instructor at Harvard Medical School, Boston, Massachusetts, told Medscape Medical News. Dr Michna, a board member of the American Pain Society, said he believes the FDA's plan doesn't go much beyond what it has already been doing.

Andrew Kolodny, MD, executive director for Physicians for Responsible Opioid Prescribing, said he believed that the FDA announcement was prompted by several senators announcing that they would block a vote on the nomination of Robert Califf, MD, for FDA commissioner. "This is, at least in part, a public relations effort," Dr Kolodny told Medscape Medical News.

Dr Califf's nomination was unanimously approved by a Senate committee in January. But a handful of senators then announced "holds" on the confirmation — an informal process that lets their colleagues know that they would filibuster the nomination when it went to the floor for a vote. Sen. Edward J. Markey (D-Mass) and Joe Manchin (D-WVa) both gave impassioned speeches opposing his nomination because of what they said was the FDA's weak response to opioid misuse.

The agency's plan did not alleviate concerns, said Sen. Markey, who vowed in a statement to continue his opposition "until the FDA commits to convene advisory committees of outside experts for all its opioid approval decisions."

The FDA's proposals are "a step in the right direction, but they are not enough given the devastating impact that opioid abuse and overdose death has had on our country," said Sen. Manchin, in a statement of his own.

The FDA declined a request for interviews for this report. In a call with reporters announcing the opioid plan, Dr Califf said it was not a direct response to the senatorial holds. However, he said, "it's fair to say we heard what Congress had to say."

On February 22, the Senate voted 80 to 6 to invoke cloture and move forward with Dr Califf's nomination as FDA commissioner, surpassing the 60 votes needed to invoke the procedure, and removing the holds that had been put on the proceedings. Senators Manchin and Markey were among those who voted "no" for cloture.

Despite the opposition, the Senate confirmed Dr Califf as FDA Commissioner earlier today.

Congressional outrage began building in 2013, when the FDA approved the long-acting opioid single-entity hydrocodone bitartrate extended-release capsules (Zohydro ER, Zogenix). An advisory committee had voted 11-2 against approval, citing concerns about abuse.

Sen. Manchin specifically cited the Zohydro decision as an example of an agency misstep. He and Sen. Markey also said that advisory panels should have been convened for a number of more recent opioid approvals, including two in 2014: hydrocodone bitartrate ( Hysingla ER , Purdue Pharma) and oxycodone hydrochloride and naloxone hydrochloride extended-release tablets ( Targiniq ER , Purdue Pharma).

Members of Congress have also criticized the agency for its 2015 approval of OxyContin (Purdue Pharm) for pediatric use, a decision made without the input of a panel of outside experts.

Dr Michna called reactions to that approval "political grandstanding." He believes the agency followed the letter of the law in soliciting pediatric studies and carefully weighing the risk-benefit profile before awarding approval.

The FDA will now hold additional Pediatric Advisory Committee meetings to address opioid use in children and panel meetings for any opioid not in an abuse-deterrent form. That does not go far enough for the senators. "I believe the FDA should use the advisory committee's expert advice for all opioid medications, including abuse-deterrent formulations, which are just as addictive and can be just as deadly as non-abuse deterrent opioids," said Sen Manchin.

He also called on the FDA "to commit to adhering to the recommendations that the advisory committee puts forward."

Advisory panels for non–abuse-deterrent opioids are "totally meaningless" because all the opioids in development incorporate abuse-deterrent properties, said Dr Kolodny, who is also medical director of Phoenix House, New York, New York, a national nonprofit addiction treatment agency.

And abuse-deterrent forms don't discourage the most common way opioids are abused — orally, Kelly Clark, MD, president-elect of the American Society of Addiction Medicine (ASAM), told Medscape Medical News. "There is not an abuse deterrent for that approach," she said.

The FDA's call to action "is extremely important," given that opioid overdose is the leading cause of injury-related death, with 19,000 deaths a year, said Dr Clark. Two million Americans had a substance use disorder involving prescription pain relievers in 2014, and more than four million Americans over age 12 years reported current nonmedical use of pain relievers, according to the Substance Abuse and Mental Health Services Administration.

ASAM applauds the FDA's proposal to consider a risk evaluation and mitigation strategy (REMS) program for immediate-release opioids, said Dr Clark. The organization has sought an extension of REMS — put in place for long-acting opioids in 2012.

Dr Michna, who is also director of the Pain Trials Center at Brigham and Women's Hospital, agreed that REMS should be applied to all opioids. The FDA had taken on long-acting forms first because they were perceived to be the biggest problem, he said.

"I am not so critical of the FDA," said Dr Michna, adding that he thought the agency was on top of the opioid problem before other government entities.

What More Can the FDA Do?

Dr Kolodny thinks the FDA dropped the ball years ago by allowing almost unbridled marketing of opioids. "The bulk of prescribing is for conditions where the benefits don't outweigh the risks," he said.

The agency will be consulting with its Science Board and with the National Academy of Sciences to review the risks and benefits of opioids — which could be a "game changer," said Dr Kolodny, as it might end up narrowing the conditions that are appropriate for prescribing.

Dr Michna said he looks forward to getting more evidence to help guide prescribing, including which patients may be appropriate candidates for long-term use, and whether such use might be harmful. The FDA will require such long-term studies.

But he also said that physicians should be compensated for additional time spent on screening patients for risk for misuse and addiction and following up, including checking on prescription drug monitoring programs.

Dr Kolodny and Dr Clark, however, believe that there's no such thing as a screen to detect who might get into trouble with opioids.

Repeated exposure is what puts someone at risk for addiction, said Dr Kolodny. "We shouldn't teach prescribers we can turn [opioid use] into something that's safe and effective," he said, adding that he believed the class was not safe and effective for most conditions.

Dr Clark agreed. "The primary risk factor for a person to become addicted to opioids is they're human," she said.

Dr Michna reports that he has consulted for Purdue, Teva, and INSYS. Dr Kolodny and Dr Clark have disclosed no relevant financial relationships.




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My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Hangingon Quote  Post ReplyReply Direct Link To This Post Posted: Feb/29/2016 at 3:26pm
Have to be a lawyer to understand this all it does is confuse me. So basicly what is it saying? Does this mean it went thru?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Stevie Quote  Post ReplyReply Direct Link To This Post Posted: Feb/29/2016 at 4:13pm
The first paragraph pretty much says it all: The US Food and Drug Administration's (FDA's) recent announcement that it would re-evaluate its labeling and review policies for opioids seems to be largely a political move designed to fend off congressional critics, say pain management and addiction medicine specialists.

This appears to be a politically charged situation lead by several Senators blocking the nomination of the new FDA commissioner "Andrew Kolodny, MD, executive director for Physicians for Responsible Opioid Prescribing, said he believed that the FDA announcement was prompted by several senators announcing that they would block a vote on the nomination of Robert Califf, MD, for FDA commissioner."  However, Dr. Califf was approved in a vote a few days ago.

However, things are still up in the air, and the political atmosphere will continue.  It's dependent upon anyone and everyone reading this to reach out to their Senators and particularly the people mentioned in this article and write to them to discuss how important it is for narcotic prescriptions to continue to be given to long term, non cancerous chronic pain patients who suffer on a daily basis and even after long term treatment didn't become "addicted".  Physically dependent, yes.  But we all know here the difference between the two and it appears that it is up to those of us who live with these conditions to educate those who seem completely uneducated to the difference, and yet seem determined to make sure that we can't receive the treatment we need and deserve.




Please donate to help Chronicpainsite.com continue to help others.

My journey with chronic pain began over 30 years ago, while as a young nurse working spinal rehab, I injured my back lifting a patient. I am now fused from L2-S1. I have multiple thoracic and cervical issues. I'm a retired RN/PA and I know and understand the frustrations on both ends of the treatment spectrum of dealing with CP. It's been my goal since 2008, when we started this site, to reach out and help as many people in pain as possible. We will continue the fight as long as we can. Please, if you can help us continue to help you and others, donate. Thank you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Merlin Quote  Post ReplyReply Direct Link To This Post Posted: Feb/29/2016 at 6:16pm
Hi Elizabeth - thanks for asking the question - I find it hard to read too

Thanks for putting this information up too Stevie - I will analyse this later - but it seems to me that whoever wrote this article is trying to say something without actually saying it.

But it is up to all of us where ever we are to not just let what ever happens happen without doing what ever we can to let our plight and dissatisfaction be known

Yes - write to politicians - we all have this right - we may get nowhere - but if we act in whatever small way we can - we will at least go down fighting

The internet is a wonderful place to start - we have access to info that a few years ago we would have had to walk for miles or even go to another country to find out.

I forget where I read this little comment - but it is a good one

"If you want to change the world - start from where you are right now"

So let's start!!!!

We really need our Chronic Pain Site flag to wave.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Apr/13/2016 at 6:55pm
I wrote my Congressman and here is the response I received by email:

"As you may know, the Center for Disease Control (CDC) released a set of guidelines for physicians that recommend opioids not be prescribed to patients suffering from chronic pain. This recommendation stems from data that indicates a dramatic increase in opioid addiction in recent years. The CDC reports that both the sale of prescription drugs and the amount of opioid overdose deaths in the United States have quadrupled since 1999.
 
Moreover, the U.S. Food and Drug Administration (FDA) has developed an Opioids Action Plan that lays out a variety of strategies to reduce opioid abuse, including the development of advisory committees designed to create awareness about the addictive properties of opioids and explore alternative treatment options for those who rely exclusively on opioids for pain management.
 
Notwithstanding the foregoing, I tend to defer this type of decision to individual freedom and choice rather than government dictate.
Please know that I will keep your views in mind should legislation on this issue come to the House floor for a vote.
 
Again, thank you for sharing your insight on this issue. Please feel free to contact me again in the future."
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Jeff Quote  Post ReplyReply Direct Link To This Post Posted: Apr/13/2016 at 6:57pm
Everyone who suffers chronic pain needs to take action and write your Senators and Congress members.  Together we can help shape the future in a way that doesn't rob us of the medicines we need for quality of life that would otherwise be taken from us.
Ankylosing spondylitis & osteoporosis -> compression fractures -> facet & ligamentum flavum hypertrophy-> stenosis -> spinal cord & nerve root compression -> cervical myelopathy & radiculopathy -> bruise & deformation of my spinal cord -> incomplete spinal cord injury -> postlaminectomy syndrome of cervical region. Cervical laminectomy & fusion decompressed my cord but I now have severe chronic pain. Pain meds = Oxycontin, Percocet, Lyrica, Soma, Cymbalta, Voltaren Gel, & Ketamine pain cream. 11 surgeries including 5 orthopedic & 1 neurosurgery.

Please donate to help Chronicpainsite.com continue to help others.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Quaver Quote  Post ReplyReply Direct Link To This Post Posted: Apr/14/2016 at 10:32am
I wish you all the very best of luck with this! I am very fortunate to be a Brit living in the UK. My thoughts and prayers are with you all.
PLEASE DONATE TO CHRONIC PAIN SITE! SO THAT WE CAN CONTINUE TO HELP CHRONIC PAIN SUFFERERS


CPS SUPPORT BRITISH & UK RESIDENT
Severe chronic pain in lower back. Lumbar Spinal Stenosis, Scoliosis, DDD. Hypermobility in ankles caused most problems. Bilateral trochanteric bursitis Osteoarthritis in spine, wrists and hands. Golfer's Elbow. L4-L5 L5-S1 spinal fusion plus cage support and titanium spacers April 2008. Nov 2010, accident in shower caused compression fracture of L2. Missed by A&E. Functional lumbar spine stenosis from herniated disc at L3/L4 July 2015 XLIF discectomy plus XL-TDR very successful! Miraculous improvement in mobility! Hashimoto's syndrome, Depression, High Blood pressure, Fibromyalgia, Raynaud's Syndrome.
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