Regulate Labeling of Opioid Analgesics - CLOSED
cder closed
2013-07-29 2013-05-08 2013-04-10 2013-02-27 2013-02-20 2013-02-27 2013-02-27 2013-04-10 2013-02-20 2013-02-20
FDA-2012-P-0818-0789 FDA-2012-P-0818-0784 FDA-2012-P-0818-0774 FDA-2012-P-0818-0759 FDA-2012-P-0818-0715 FDA-2012-P-0818-0758 FDA-2012-P-0818-0771 FDA-2012-P-0818-0775 FDA-2012-P-0818-0697 FDA-2012-P-0818-0719
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https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0789 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0784 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0774 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0759 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0715 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0758 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0771 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0775 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0697 https://api.regulations.gov/v4/comments/FDA-2012-P-0818-0719
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na With all of the news hype about the number of overdose deaths, which as a researcher I have evaluated by actually reading the documents cited rather than merely accepting a citation as supporting a contention, the lost truth is the never decreasing number of people in chronic pain whose suffering underpins this ongoing and not particularly scientific debate.  That some patients develop hyperalgesia does not speak to the multitudes who do not. That some people misuse and abuse opioid and other medications does not address the multitude who do not.  Lost in this controversy of vested interests and fear, of prosecution or ignorance or regulatory overload, are the multiple thousands of people who benefit from chronic opioid therapy, and beyond benefiting are able to live functional and productive lives.  This proposal ignores the reality that different people have profoundly different tolerances to medications. Pain, in its daily reality is vastly different than it is in theory to some faceless person miles if not thousands of miles away. It is not an imagined event but, rather, a neurobiological cascade with damaging long term consequences which are as dangerous as this now uncontrolled fear of overdose so reminiscent of the fears of Prohibition and the ever escalating war on drugs which we have long since lost.  Quite frankly, it fits well with managed care with guidelines determined by non-healthcare professionals. However, that is not medicine. It is time to return some autonomy to the doctors who have spent the necessary years in learning to treat suffering, as well it is time to stop reacting and start thinking. It is time to stop twisting statistics to meet the needs of biased arguments and instead start being honest about what is the underlying problem. Surely, there are very few doctors truly acting as the diversion to the streets that everyone from law enforcement to professional licensing boards claims exist. This is too important for the game of act-react. I emphatically support PROPs petition. Opioid label changes are needed so that FDA can prevent drug companies from making false claims that opioids are proven safe and effective for chronic, non-malignant pain.  Label changes will also reduce overprescribing by sending a clear message to the medical community that benefits may not outweigh risks when opioids are prescribed long-term and in high doses.As an emergency physician, I feel the medical community has been falsely informed for the last 2 decades.  We have created a culture of pain and disability prompted by the drug makers and by pain societies.  Because of this we are in the midst of an epidemic of opioid dependency which is leading to alarming numbers of deaths and social disruption.  Please change the labeling so we can reverse this most disturbing trend.  We owe it to our patients and their families. Gratefully,Aaron Wohl, MDPracticing Emergency PhysicianLee Memorial Health SystemFort Myers, FL I DO NOT support the PROP petition. I have worked as a nurse practitioner in pain management for almost 15 years. I have seen countness patients improve their quality of life with the multidisciplinary treatment options we offer. I have also seen countless patients continue to work that would have ended up on disability. Pain medications are not evil. The evil is the greed of some physicians who see pain management as a profit making business. Physicians who do not have training in pain management (GYN MDs, general surgeons, etc) who have no business doing pain management just like the physicians I work (board certified in anesthesia and pain mgmt) for have no business doing brain surgery. Pain medications are beneficial when done correctly with the right screening, the right degree of monitoring and the right degree of follow-up. Some of these practices are just pill mills and have not real f/u or assessment of risk to prescribe meds. And not every patient is addicted, which is the position addictionologists take with this issue. They have always thought pain meds were evil and shouldnt be used but they see the negative part of opiate abuse and not the positive benefits that it offers. Saying opiates can only be used for 90 days is going to hurt many innocent patients who a benefitting from pain management. The answer is not stopping prescribing but allowing only trained pain management physicians to practice this specialty--not anyone who wants to say they are pain management and to only allow physician owners of pain management practices to ensure that they are not just for profit centers. Taking away a viable treatment option for legitimate patients is cruel. How will these people feel if they need chronic pain management for a legitimate diagnosis in the future and they are limited to 90 days worth of medications. This is a cutting off the nose to spit the face reaction to this public health problem. Given the huge number of addicts who innocently just wanted to be rid of physical pain, intelligent, professionals including medical professionals, something has to be done. I believe the changes in prescribing suggested will help. Ultimately, the docs and nurses need to be much more aware of the long term ramifications to their patients as they write the prescriptions and give appropriate guidance as as the hand over that piece of paper. I completely support PROPs petition.  Over prescribing is a major problem in our area and done by good doctors who are not given full information by the drug companies.I am a pain physician and now spend most of my time trying to get patients off of narcotics prescribed by well meaning physicians.  Re labeling is the minimum we can do.John Hart, DO  I am a Nurse, Hospital Administrator of over 26 years in the military where I served as an Auditor making sure medical contracts from medical supplies, Doctor care, prescriptions, medications and Manufacture contracts were in compliance with JACHO and the terms of the contract and laws were upheld.In my limited duty, I found over six million dollars in error in contracts, Nursing contracts, and medication charges from manufacture.NOW why does this petition effect me ? I am disabled by a severe disease requiring a three level spinal fusion (taking three discs out of my vertabrae replacing with BAK cages) and I have two rods and seven long screws sticking me.An approved procedure, Spinal Injections which the FDA does not  approve for spinal injection was used on me over twenty times along with eight myelograms and I acquired arachnoiditits from the multiple procedures with an unapproved medication in the epidural spaces. Recently this medication was shown to get fungi, and I was told that I had to have those injections first before I could be on medication management !!! I am sorry for the loss of lives of overdoses but these people should have intervention no Physicians.Some of the staff of this petition knew their family was mentally sick, being a physician she could have him commited, not blame opoid dosing. So DO I SUFFER with decreased dosageto account for the deaths of people who knew better and will get it somewhere and kill themselves. There are warnings on the medication inserts. Realize that you are taking pain relief away from Millions to pacify your inadequecy to have programs to assist addicts. Free Pot laws, Death laws for people to kill themselves while you are supposedly wanting responsible opoid dosages (less than manufacturerdoses/PDR dosages) does not make sense. So the uncontrolled pain patients come to Oregon and Washington State and ask for assisted suicide, Nice Policy-You are a death sentence for me. I am deeply concerned about changing the wording of this document to delete the word moderate and add caps nto the amount of medication a patient may have and the amount of time they may take a medication.  A person is the best judge of their pain and they have the right to excellent treatment.  We should not deny them treatment because their pain is moderate.  It is already difficult enough for the to procure their medication without making it more difficult.I urge you not to change this rule.Thank you for your time.  I am against this change for these reasons:1.  Not everyone can take the same dose, our bodies are not all the same.2.  Chronic Intractable pain never goes away, we live with it for life.3.  Addiction and dependency are two different things, we are not drug addicts, we have no quality of life without the medication.4.  Without medication, most of us can no longer work or take care of our families, we are confined to beds or chairs, unable to have quality life.5.  It is a provable fact that untreated or under treated chronic intractable pain patients often end up divorced, unable to work, have trouble interacting with their children and do commit suicide.6.  To see what a person can accomplish with the right medications, please read this:  http://www.foresttennant.com/pdfs/905-Feature-JFK-Tennant.pdf7.  Most patients who take opioids only take them because other medication does NOT work for them.8.  How can physicians decide what is right for a patient when they have never seen or treated them?9.  Do you consider it to be humane to let people suffer in terrible pain because some can not follow directions or blame innocents for their family member taking medication illegally? 10. Do we blame a gun when someone uses it to kill someone?11. Do we blame the car when the driver is drunk and kills a family while driving that car?12. There are NO new studies on this matter,  Physicians for Responsible Opioid Prescribing are using data that is old and incomplete.  They are not concerned about chronic intractable pain patients, their spokesman has publicly said we are not important.13. I agree with PROMPT (Professionals for Rational Opioid Monitoring  Pharmaco Therapy)  You received a petition from them on this matter as well.14. Chronic intractable pain is not a picnic to live with, in many ways it is like a baby, you have to live your life around it.  Some days we cant even get out of bed because the pain is so bad, others we are moving around barely.   I strongly support the petition submitted by the Physicians for Responsible Opioid Prescribing.  As a physician who has provided treatment for opioid dependence for the last 4 years, I can attest from first hand experience that ever greater numbers of patients are coming to treatment after becoming dependent on pills that were originally prescribed by a physician.  Label changes will raise provider awareness that we have no data to support long term or high dose opioids for chronic pain, which should reduce the number of people exposed to these powerful chemicals.More important, as a physician who provides primary care to patients with chronic pain, I believe that our patients have a right to know that no data supports the use of long term or high dose opioids.  Label changes, and the consequent public announcements surrounding them, will facilitate this in a way that simple provider education cannot.  FDA regulations allow direct to consumer advertising on behalf of pharmaceutical companies selling their wares, they should do more to promote direct to consumer messages about what the scientific evidence for the use of these drugs really states.