FDA Makes Labeling Changes for Opioid Painkillers

FDA Makes Labeling Changes for Opioid Painkillers

The Food and Drug Administration has announced long awaited labeling changes for prescription opioid medicines – changes that adopt many of the demands made in a citizens’ petition that called for major changes in the prescription guidelines for narcotic pain relievers.

The biggest change is that long term opioids would no longer be indicated for “moderate” pain.

The FDA said it was changing the labeling on all extended-release and long-acting (ER/LA) opioid painkillers “to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.”

bigstock-Prescription-Medication-1608757The updated labeling will state that ER/LA opioids are indicated for the management of severe pain only — “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

It was over a year ago that a group of doctors and public health officials, led by Physicians for Responsible Opioid Prescribing (PROP), petitioned the FDA to change the prescription guidelines for opioids.

Current labeling approves most opioids for “moderate to severe pain,” but the petitioners said that was an overly broad definition that encouraged physicians to prescribe powerful pain medications to patients who don’t really need them.  They wanted the word “moderate” dropped from the labeling requirements, so that opioids would only be indicated for treatment of cancer pain and severe non-cancer pain.

The new FDA labels drop the word “moderate” and will say that ER/LA opioids should not be indicated for “as-needed” pain relief. However, doctors would still be able to prescribe opioids “off label” for moderate pain.

The new labels will also warn doctors and patients that, because of the risks of addiction, abuse, overdose and death, the drugs should only be prescribed for patients for whom alternative treatment options are ineffective or inadequate for pain management.

The FDA rejected a PROP demand that long term opioid therapy be limited to 90 days.  An FDA letter to PROP giving its response in detail can be found here.

“These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

“This is a step in the right direction,” said Stuart Gitlow, MD, President of the American Society of Addiction Medicine, one of the original signers of the PROP petition.

“I think what we’ve got here is the beginning of a very slow movement toward utilization of these very strong opiates for only the most severe of cases, as opposed to their being utilized first-line for pain. But I don’t think we’re going to see any immediate changes in approach or utilization.”

The FDA will also require drug companies that make opioid pain medicines to conduct further studies to assess their risk of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.

In 2010, over 16,000 Americans died from painkiller overdoses, according to the Centers for Disease Control and Prevention. CDC officials say more than 70 percent of the overdose deaths were unintentional. In many cases, a combination of drugs was involved, such as painkillers taken with tranquilizers or alcohol.

“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” said FDA Commissioner Margaret Hamburg, MD.

“Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”

Many chronic pain patients were fearful that the PROP petition, if implemented, would deny them access to opioid pain medicines.

Dr. Gitlow told National Pain Report that’s unlikely to happen.

“I’m fairly positive about the FDA’s implementation because they made changes in the wording, which hopefully will have some impact on those prescribers who don’t have quite the knowledge or expertise as others. And it won’t tie the hands of those doctors who are both very comfortable and very skilled in their utilization of these medications,” Gitlow said.

“The FDA’s decision shouldn’t have any impact on those patients who are receiving long term high dose opiates with good effect. In other words, if they genuinely feel better, have functional improvement, have minimal breakthrough pain, have few side effects, and are responding better to this treatment than they were to alternative measures, then by all means they should stay on the medication.”

But Dr. Lynn Webster, President of the American Academy of Pain Medicine, fears some physicians and health insurers may over-react to the FDA decision.

“I fear that payers will use this as an excuse to deny treatment to people who need the medications.  I hope someone will be monitoring this,” Webster said in an email to National Pain Report.

“It is unclear how the FDA decision will impact the safe use of ER/LR formulations. Physicians may only prescribe to people with ‘severe’ pain, (but) that doesn’t mean it will be used as directed. People in severe pain often use more opioid than prescribed to escape their insufferable pain.  Limiting the label indication will not prevent this from happening.  Reducing harm from opioids requires much more than a change in label.  I am doubtful this will have much impact.”

Webster said he was pleased that the FDA will require drug makers to conduct post-marketing studies on the effectiveness and safety of ER/LR opioid formulations.  Webster said that was “long overdue”.

Authored by: Pat Anson, Editor

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ginbug

Walt, I too am working very hard to give pain patients a voice as we have all been forced in one way or another, to remain silent. While I very much support a patients right to choose, I also think that long term, high dose meds like oxycontin & methadone should always be a last resort choice. Many people and even docs, do not realize that the treatment for chronic pain is completely different than treating acute or postop. pain. Any doc should be able to treat temporary pain issues; but only docs that have had specialized education in treating pain, should be able to treat chronic pain. This is the primary reason that created this big problem we are now in. Over the last 10yrs., I have been educating myself on every aspect of these meds. along w/ learning all I can about pain condition, addiction, and all the laws/rules that go along with these issues. I have also found much better solutions than what they are doing right now.
The 1st thing they should do is to make all chronic pain patients to have a referral before going to a pain specialist/pain clinic and never allow a pain clinic or pain specialist to take walk ins! This is the way it already is w/ most specialists already. This change should not effect anyone that take short term meds or as needed meds like vicoden, norco, percocet, etc.. LA meds were not meant to be used as needed or for short term use; but it goes both ways as chronic long term pain should not be treated with meds ment for short term/acute pain without a lot of caution due to the tylenol that most contain which is much more damaging and dangerous than the narcotic. If you are truely a chronic pain patient and have not had any success w/ other treatments and are having to take your as needed meds such as norco at the max. allowed(like every 4-6 hrs.) per day, everyday, Then this is when you really need to discuss your options for switching to a LA drug. I just do not understand why so many are so upset about this label change on LA drugs as I think that these types of meds should have always been for severe long term or terminal pain. Maybe if those labels had been there from the beginning and docs as well as patients educated about LA drugs and about what types of pain they should or should not be used for. then maybe it would not be so hard for those of us that really needs these meds !

k

Well my dr office told me its a law in Fl are you in Florida? if not your lucky. I even asked the dept of health and they also showed me the statute. I am sick of this. AGAIN couldnt get it filled and being forced to work now and my pain is unbearable. I should be on disability and got denied even though they approved me with LESS conditions in 2008 but icoujldnt stay on it due to havING TO WORK. i had no choice. like now, except now im making$9 an hour isntead of $19 and have lost my car and everyone i cared about. I am about tobe thrown out of apartment since i cant afford to live on $9 an hour

dmsmith

to K in florida….my dr had never ever given me any meds for break through pain and i need it….i dont get high off this stuff…i wish my pcm could/would prescribe i am tired of being treated like a criminal, abuser, and what ever else….ua’s every month, visits every month shots every 3 months…i get some relief but no RELIEF if u know what i mean. im just tired of all this that we have to go through….its terrible.. 🙁

I’ve been under a pain mgt specialist for years for chronic, severe pain. He has NEVER prescribed long acting/slow release (LA/CR )opiate to me to be taken as prn. That would be irresponsible because a lot of pts. don’t know extended release medication can build up in your system if taken every time a person thinks they need it. They should ALWAYS be prescribed as every 8 hours, every 12 hours, once a day, etc. Some medical (physical) diagnoses cause real, severe pain with no end in sight and usually worsens over the years. It’s not thinking you have pain because your pain pills ran out. You aren’t chasing euphoria or in a stupor after taking opiates. I take both long term and quick release (action) opiates and I have NEVER, EVER had one tiny moment of any kind of euphoria, any feeling of being high, pleasantness or anything like that (even in the beginning) I don’t get fuzzy, etc. Not even sleepy. I drive and work. A lot of cancer pts. who take high does of opiates also drive and work with their drs.’ knowledge and permission. If you have credible severe pain, there is no euphoria – just enough relief from pain to allow you to function decently on good days. There are many activities you have to miss/give up even on good days. There are still really rough days despite medication. I use other modalities, like physical therapy exercises, meditation, relaxation tapes, biotherapy (need a dr. to teach you that), aroma therapy, etc. The medications take the edge off my pain, bringing it from a 9/10 out of 10 on the rating scale to about a 6-7. On a good day I may get it down to 5/10. That is not euphoria. I still don’t sleep because of pain. I don’t take more of either slow or quick release meds to see if I can get my rating down further, because I know it would be too much. Besides hard on the liver and kidneys, it slows your breathing when you take too much and then your heart isn’t happy. That’s when people die. They take enough to sleep and then don’t always wake up. A good dr. decides the “as needed” duration of pain meds. NOT THE PATIENT ! If some drs. have been prescribing long term meds letting the pt decide when it is needed, then SHAME ON THEM. If they frequently increase the dose or shorten the time frame of quick release opiates, then SHAME ON THEM. If they don’t drug test their pts. regularly to see how much opiate is in their pts. systems, then SHAME ON THEM. It is the drs that should be policed, perhaps having pharmacists turn in scripts that are written inappropriately to the FDA or governing body. Make drs. send in proof that they have urine or blood tested their pts. for opiate levels. Social Security has developed a system for people on Medicare for drs. to share… Read more »

I have been on pain management for past 4 yrs due to auto accident 20 yrs ago that left me with a chronic compression fracture in my back. Itake my medicine only when needed as prescribed & am drug tested every 2 months & have never ran out of my meds before my next visit or ever failed a drug test!! Yet we are all considered the same as drug abusers anytime we have to go to the ER or by our pharmacists. I wish there was a way to seperate the good from the bad, maybe they should spend more time & money trying to find thebreal druggies as opposed to wastimg our time when we live minute to minute in chronic pain!!

k

does this mean that my pain dr can no longer FORCE ME to be seen every 28 days since there is no more law making them prescribe long acting pain meds? and i should be able to get 3 refills for norco? their excuse the last year has been its a LAW im required to be seen 28 days because they are required to prescribe me a schedule 2 long acting med, which nobody will even fill majority of the time. been blowing $200 a MONTH now meds are higher too for over a YEAR NOW! ridiculous.

A B Lyne

The changes may be detrimental to sever chronic pain afflicted such as the RSD/CRPS pts who require higher doses of pain meds & variations of many meds to attempt to control this horrific condition. Not sure if the panel who implemented this really understand the ramifications of this dystrophy. We pray more people become aware of how bad RSD/CRPS is & are willing to HELP us rather than hinder us from treatment, meds, & by most a cure for this. We attempt to educate as long as people are willing to listen.

Libbee Ral

Wow, the FDA responded to a citizens petition? What have they done with all the petitions requesting that the much safer, much more effective medicine, marijuana, be legalized. We wouldn’t have any of these issues with that drug.

LYNNE NORRIS, If you take the time and read the language, it makes sense. it is IN NO WAY LIMITING ANYONE ACCESS TO PAIN MEDICINE. What it has done is this. if you have Pain severe enough to need er/la meds then it is ok to have them, in other words it is up to you and your doctor to decide…Plain and simple… Think if it had gone the other way, then you would really be crying, so would I. I Have been at the front of this fight since day one, giving tens of thousands of pain people a voice at the FDA, standing up against prop and Dr Kolodny. our Group presented at the fda hearing, led a nationwide petition to stop this, and i am very happy that the FDA finally did their job. we need to address addiction and abuse, and if this helps than perfect! if we all don’t work together on the bigger issue, we will lose our access to what we need to function….so I hate saying this, but for those that are still mad and feel this is wrong, think about the way it could have gone, and try and find ways to help the bigger problem because i promise that from this day on pain patients and junkies will be linked together in an unfair way until the problem with prescription med abuse is solved. So everyone that takes these meds daily because they need them should get on board and try and stop the abuse before the abuse stops them!

k

This makes NO SENSE!!! In FLORIDA for the last 2 years my pain dr has been telling me it is a LAW! that a LONG ACTING MED is to be prescribed with a breakthru med! so was that a lie?:

Donna M. Harker

I am in so much pain an it never goes away the most pain pills prescribed at one time here is 15 pills to be taken 1 to 2 pills 3 times a day, this is how they prescribe opiates in Iowa.It sucks because you can never get enough to get ahead of your pain and it rarely makes a difference because if you took the pills 2 at a time 3 times a day that gives you 2 days and 3 pills left how is that going to make any difference?I have noticed that even though there are more ways to prove many of the chronic pain conditions are real the less we have to combat them.We have no one that will say hold it this is severely limiting for chronic pain patients, and they need to be protected from this rule.Its very disheartening to see every avenue of relief being blocked by the government.I can assure you that I wouldn’t have an accidental overdose on the medicine as I don’t like taking any medicine so I take the least possible as do most of the people I know who suffer with chronic pain.Keep shutting down the avenues for us to get relief and there may be many who get no relief of any kind, as doctors and pharmacies are losing their licences and are now afraid to either prescribe or even fill a prescription for pain medicine,it may well turn into the worst decision the FDA has made so far.Think about how an animal reacts when cornered with no way out,I think we will see more and more pain patients in that very position very soon.

Sue

I am livid over this. I suffer from Fibyromyalgia and TGN both which cause sever pain and it is difficult to exsist without medication. Now it is going to get harder and harder to get relief from the pain. it is not fair to punish everyone because some abuse it. We are not all drug addicts and some of us actually need the medications!!!!!

Jess

It’s already difficult enough to find someone willing to prescribe these medications even if a patient truly needs them, I can only imagine how much worse it will get from here. I’m 24, I have multiple conditions that cause chronic, debilitating pain. I’ve been treated like a seeker, an addict, a criminal, and a liar. I have to drive 45 minutes away to a clinic in another city once every 2 months to get my pain medication. I have to sign a contract and submit to drug screening annually. I can only imagine the fun new hoops I will have to jump through.

Holly Wrinkle

This is the, absolute, WORST decision ever made on behalf of chronic pain patients. Most of the accidental overdoses are from people with pain that is so under-managed and ignored that they’re not capable of functioning properly, even in terms of remembering when their last dose of medication was (even ones who write it down are prone to forgetting they wrote it down, or where they wrote it down at, which is why when I was on medication after my last surgery I had an alarm set that went off every 4 hours to let me know I could take more). I have been in pain every single day of my life for the last 9 years without a break. The only time I’m given pain medication is when I end up in the ER because my family members are so horrified by seeing me in the state I’m in, and then I end up suffering still because I’m too terrified that if I take even one pill that I’ll be screwing myself when I need that pill worse at a later date. My Dr.s all send me to pain management specialists because they say that my pain is beyond their abilities to treat, and pain specialists tell me that they “don’t treat that kind of pain” that I’m “too young to have chronic pain” that “opiates should only be used by terminal patients with cancer” and that my “regular doctor should be treating for that type of pain” which just means that no matter where I turn there is no help. It means that I ENVY the terminal cancer patients because not only do they have relief, they know that if their treatment fails, their pain will end soon because they get to die. There is absolutely no cure for my issues, and it’s a condition with a vicious cycle that always results in surgery as a desperate attempt to subdue it, and the more surgery you have the worse your condition gets because it feeds off of the damage caused by surgery. I know that I will be in pain, and that my pain will get worse, and that any treatment I try will fail and can only provide temporary relief at best. I truly ENVY those with that terminal sentence on them because they get the suffering to END, while people like me are ignored and told to spend the rest of their lives suffering, even when there is solid, medical proof that the amount of pain you live with has caused irreversible damage to their heart and stomach. This uninformed, irresponsible and simply stupid decision will only make the abuse of controlled substances rise because patients with chronic pain who can’t get treated will turn to illicit means of getting relief out of desperation. There will be more unintentional deaths from mixing medications because those suffering won’t even know what to look for interactions with, and drug dealers will lace the medication with harmful substances that… Read more »

Donna Davis

I think this is going to cause a huge problem for people who have to have pain meds to live a normal life. Most people who abuse these meds do it for a short time and move to street drugs. Most the overdoses are from the same people and they usually overdose because of a cocktail of drugs and other things. I am so sick of the government and Insurance companies playing my doctor. I think ER should be sued when you go in and pain and they do nothing for you but treat you like an addict, I have been misdiagnosed by so many ER doctors which have cause me to have to live off pain pills to begin with. I have the right to live without pain, and the right to be treated with respect. This just tells me that a group of people who do not suffer from Fibromyalgia and think it’s all in our heads, it trying to find away to stop us from living a normal life. As far as the insurance companies, they have no business what so ever telling me what I can or cannot have. Somebody needs to step in here before we end up with a bunch of doctors afraid to treat us with the meds we require.

Robby

“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” said FDA Commissioner Margaret Hamburg, MD.

I know one person that died of an unintentional overdose, I had warned her to be careful and not mix meds, but she was in so much pain. She was just trying to get some relief. At the same time I know three people that committed suicide because they could not get the pain meds they needed, because their doctors were afraid to write the prescriptions because of the FDA and the risk of losing their license. So I find the above statement to be total BS.
I have three chronic illnesses that cause chronic pain, severe pain. There are a lot of days that I want to die because the pain is so severe. However, my doctor has told me that she can not give me any more meds, because she does not want to deal with a Federal investigation. I have had a spinal cord stimulator implanted to help control the pain, and it helps a good bit, for the lower half of my body. But, does nothing for the upper half, where I have a good bit of pain also.
I have been dealing with all of this for so long that I understand what the doctors go through with the guidelines and reporting requirements. I do what I can to make things easier on my doctor, she takes care of me, I try to take care of her. I just wish she had the freedom to give me the pain meds I need so that I don’t have too spend three or four days a week unable to get out of bed.
Normally I would not wish what I go through on my worst enemy, but I wish the members of PROP could spend one day, just one day living through what I live through every day. If they did I promise they would not be trying to make it harder for people to get the meds they need.

Rainey

Opiates are not good. Opiates are not evil. They are just one of many tools used to treat chronic pain. Their use has benefits and it also has consequences. Each person in pain has to decide.

ginbug

If I am reading & understanding this correctly, I do not see where they are putting these restrictions on any as need pain med. It only talks about extended release that will have the label change. Meds like oxycontin, methadone, mscontin,etc.. Should never be given on a as need basis as that is not what they were made to be. If anyone has been put on them for anything other than long term chronic or terminal pain or as needed, then they were mis prescribed. There are many strong pain meds that work well for as needed or acute pain. I also agree that going on er pain meds. should always be considered as a last resort when all other treatments have not worked. Many enter in to er meds. way too lightly by both patients and doctors. Docs and patients need to be educated on these meds and really think long and hard before going on them. They also need to consider the impact on their lives if they go on er meds. as there are so many issues physically and socially. Once it is determined that a patient’s pain is legitimately chronic instead of acute, then they need to weigh their options. If they have a condition that will cause long term or life long pain, then an er pain med would not only be a better choice; but is also a lot less dangerous & damaging than a pain med for as needed or acute pain like vicoden or percs. as taking those type of pain meds daily and long term due to the tylenol in them, which can and will cause massive liver damage! I found this out the hard way and it really does not take much or very long to do it. The biggest concern of all of this was the limit to 90 days they wanted. Thank God, that the fda rejected it!! I just hope that this will help docs to properly prescribe and not create new addicts and allow those that are legit chronic pain patients to be able to get the meds they need without the doc being in fear of treating them as he will have this new guideline for protection. We will just have to wait and see what impact, good or bad, that this will have!

Walt, I would like a little clarification on your opinion, and what makes you feel this way. I have no problem with the labeling criteria; I think that was long overdue. But how can you be so sure that it will in no way limit access, and who is going to decide the individual “really needs” the meds?

I see my doctor leaving the field one day, and getting a new doctor who doesnt know me and “doesnt believe in” my illness. They’re still out there, you know, the nonbelievers in chronic unseen pain. If another doctor came in and put me on NSAIDS again I think I would lose my mind. Like most of us chronic pain sufferers, I monitor my medications very closely. I talk to my doctor about any irregularities that might come up. Yes, I’m dependent on these medications, but I am not addicted. I dont wake up first thing in the morning thinking ‘Yay! Its med time!’ As a matter of fact I am working on decreasing my dosages as we speak, just to see how much pain I still have. The last thing I need is some twit at Obamacare or a new doctor telling me that if my pain is at a 5 today, I dont need these meds. Ive ran this rodeo before. Some people are still doing it now. You go from pain doc to neurologist to therapy to psychiatrist to find an answer, and before you know, it, you’ve been labeled a doctor-shopper. Now, docs will look at your records and you’re as good as doomed. Ive lived with my chronic pain issue since 1989.I was 32, much too young. Ive been accused of being crazy, depressed and more. I finally did get to include depression on my list of illnesses because I could’nt find any relief, until a doctor trusted me, and we sat down and had ‘that’ conversation. Trading almost certain addiction for a chance at a halfway normal life. I ended up with neither but something somewhat in between, that I could bear.

I see a government that could’nt tell the truth in front of God. That’s why I’m so skeptical of anyone’s excitedness. I see the black market thriving and getting bigger than ever, and their customers wont be the normal junkies they usually have. And I see the suicide rate, especially older women, going up significantly. Who knows, maybe that’s what they want. But if I end up in as much pain as I had 20+ years ago, and I have to go through the rigamarole and jump through the hoops again for treatment I honestly deserve, this lady will be outta here. I WON’T go through that again. I pray that you’re right. Thanks for your time.

Jacquline ford

I don’t see that this will affect many pain management patients. However, I believe that it would be so much better to let patients with chronic pain take their meds “as needed” instead of every so many hours, everyday. If they are worried about addiction then they might want to look into that. There are days that I don’t need my medication every 4 hours but to stick with the rules of my pain doctor, I have to take them. This is what results in addiction and I certainly don’t like the idea of being addicted to an opioid at such a young age. What do I have to look forward to? Years and years of taking opioids. There are people responsible enough to take pain meds only when they need them. This is something they should examine. Current pain management programs breed addicts. The new law is not going to do anything useful.

Julie Golemon

This is only going to make Chronic pain patients with legit painful illnesses more difficult to receive opiods of any kind. The DEA; Government;Medicaid; pain management dr’s
that I went to were supposed to write pain meds with of course in combination with other treatments. No, no, no, it seems now when you go to a pain Dr. specialist for Pain Management (supposed to be your end of the road treatment) but some say they don’t write pain meds of any kind. Mmmmmmm….let’s see now if this makes sense…Pain Management= pain better controlled or better quality of life…HA! HA! Sure it does….NOT!!
Where else can you go for help with pain issues and help , not addicted… never have… never will. I pass all my blood tests and urine tests, just need something to help me along with my tremendous pain level to be able to function to do the simple things in life. What’s so wrong in that. Animals when they are in pain, they can’t talk and tell the vet, so their pain is considered inhumane if not treated right away. Aren’t we as humans at least a bit more important than animals then? Next thing you know we will be be euthanized because we aren’t important enough. I have to roll my records around on a dolly but my medical proof and test results as well as diagnosis sure don’t seem to mean anything unless you have CANCER PAIN, not fair. I am not against Cancer patients at all, just that my pain is just as important to my well being as a human who doesn’t want to have to stay in bed crying and moaning in pain all day and miss out on life. Surely everyone can relate to that?

Kimberly Miller

So you’re a patient who suffers from a disease that’s painful, keeps you tied to the bathroom, and won’t let you sleep through the night EVER. Not a real disease, you might say. Wrong. This nightmare, while not as painful as cancer, is interstitial cystitis. It has been compared to a dialysis patient with regard to quality of life. What can be done, one might ask. Well, one answer would be extended-release opioids. This disease starts to be painful about 10 minutes after the patient gets rid of the urine that’s burning like acid due to the lining of the bladder having been destroyed from what? Nobody knows. Since the kidneys deposit urine in the bladder every 7 seconds, the cycle repeats relentlessly.

Extended-release opioids could provide an IC patient with a life away from the bathroom. It’s not a cure, but there is no cure. This disease can ruin lives and not having the option of ER opioids, well it’s condemning some people to a life of hell. Just one of the diseases that’s not cancer, but could benefit from the drugs we just essentially took off the table.

Brandi

I think that clear labeling is good and it allows for more understanding of medications and their use. I have difficulty understanding how this will help patients suffering in chronic pain. It is still the Medical Doctor who will decide if someone is “worthy” of pain medication, if their pain is “bad enough”. If the doctors are very conservative or fearful of prescribing these medications, the patient will suffer or will seek another doctor. Pain is also very unpredictable. Some days or even weeks are good for some people…however, there are times where they suffer grossly and become incapacitated. So, because they have more good times than bad…will this make it harder for them to get the treatment that could help? I am “lucky” in a manner of speaking. I have a severe and disabling condition that is easily diagnosed. I am able to receive long term medication for round the clock pain. I have never abused my medications and I comply with all my doctors requests. Without pain medication, I cannot even bathe on my own. With pain medication, I am able to care for most of my basic ADL’s, activities of daily living. I am used to being treated like a malingerer and an addict from the get go. I have been refused treatment at an Emergency Room the moment I mentioned chronic pain patient. I was there for an unrelated condition which happened to be causing disabling issues and, I was without medical care due to a recent move between states. I had a letter from my previous provider and a print out of my prescription use from my state Prescription board. It did not matter. I went for 3 months without medication and without a medical provider. I wanted to die. There will always be addicts, there will always be people who abuse the system to get what they want. it won’t matter how you label the medications or, how hard they are to get for “normal” pain patients. I have read many, many journal quality articles that show and state only about 10% of people who use pain medications become addicts/malingerers. Yes, it is true that 100% of people who use regular pain medications will become addicted physically, chemically…but, there IS a difference between “addiction” and dependence. As a former social worker, I am very active in the chronic pain community. I can tell you, without a doubt, that if these medications were to be strictly given to terminal patients or limited to 90 days…the rate of suicide would jump dramatically. I can name dozens of people, including myself, who are otherwise healthy adults with positive outlooks and joy in their heart. These are the same people, who if left without medical care and uncontrolled pain, would take their own life than live the rest of it stuck in bodies that are constantly in agony. I support medical responsibility, I support patient responsibility. I would like to see more emphasis on a criteria and pain… Read more »

Lynn

And they took Darvocet off the market for what reason? Even after figuring out it was the generic that caused so many problems. Generic are not equal to the real thing. I just found that out with Celebrex and Meloxicam – I can take Celebrex and Meloxicam caused my blood to thin so much I could touch myself and get a red bruise.

Janice Reynolds

Agreed it is a Victory of sorts; however the terms moderate and severe are judgmental and have little place in pain management. Not all persistent pain starts out where interventions other than opioids can manage it. As always management should include non-opioids and adjuvant medications as well as non-pharmaceutical interventions which can decrease or eliminate the need for opioids yet these interventions are frequently not paid for by insurance (and out of reach without insurance).

It seems to still leave in a gray area the pain patient whose symptoms wax and wane, from mild, to moderate to severe. I would think that would place opiates in the as needed category, which is being eliminated. If a patient has a 30 day supply and only refills every 60-90 days for example, that seems like responsible use that may be denied.

This is an absolute Victory for the pain Community! and this will in no way limit the access to the people who truly need these medications.It has restored some respect for the FDA because of all the government pressure to adopt the PROP Petition. Now the many people in Pain can worry about the only treatment that helps restore some quality of life! Prop should be ashamed that they even started this fight! I for one am Glad it is over and can now focus my time to stopping Arachnoiditis…Thank you Pat for telling it straight and giving ASAP a public forum!!