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New FDA guidelines for pain medications
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ayla930 posted:
I received a letter from my pain management clinic giving their patients a "heads up" about what to expect to happen. According to them, the FDA has set new guidelines for maximum amount of medications that can be prescribed to non-cancer patients. They assured me/their patients that those of us on high doses of medication would be tapered down slowly. According to what they stated the new guidelines are, my medications will be cut more than in half. I have been in pain management for 10 years and have no idea how I am going to be able to continue to work if these changes are made. Has anyone else heard of these new guidelines? I can't find anything when I try to search it on the internet.
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greenponder responded:
Very scary! The FDA is not my doctor. I have the same concern as you do, except my concern is not how to continue to work, but to continue to live (bearably). You can email me at wenttowoodstock[at>yahoo.com
 
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annette030 responded:
First, read what the FDA says for real at their own website. I hate to say it, but many doctors say someone else is making them do it when no one is.

Keep in mind that the FDA is a federal entity and whatever they say applies to the whole country, not just your doctors office.

Take care, Annette
 
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blessedladyptl replied to annette030's response:
annette is correct. For example, some drs will tell patients that it is the law that they have to do tox screens or have to see a patient every 30 days. The truth us that there are no laws that require tox screens, they are urged, but they are not required by law. A dr can write a rx for a Schedule II meds for 3-30 day supply. The law requires a dr see a patient at least every 90 days if the dr is prescribing for non cancer related pain.

Perhaps you can ask your dr to give you a copy of the FDA's new set of guidelines. The majority of patients don't questions it when their drs tell them something. Many yrs ago, I had a dr who told me that refills weren't allowed on a med due to new state laws. I had also heard him telling other patients the same thing. I told him that I was active in politics and that I happened to know that no such law had been passed in our state, then I went on to tell him the laws that had been passed that dealt with pain management. He said, "well, you're right, but most of my patients don't keep up with that."
 
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ayla930 replied to blessedladyptl's response:
My clinic is reported to be one of the best in the State and I have had really good luck with them the last 6 years, and believe me, I have been to some others that weren't. They suggested bringing in questions when I come to my visit and I will definitely take your advise about asking to see the guidelines, even though they spelled out what they were for each medication in the letter. It is all I can do to make it through a day of work now, and I don't know how I will do it with the cut in meds. Even though they assured the patients they would not drastically cut the meds all at once so no one should have to suffer withdrawal symptoms, my concern is that my condition(s) are degenerative. If the maximum is less than half of what I am prescribed now, what do I do as I continue to degenerate???
 
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blessedladyptl replied to ayla930's response:
Would you mind sharing some of what the letter says regarding the maxium prescribing limits and the name of the meds. If you aren't comfortable with that, it's fine. I'm just curious.
 
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cweinbl responded:
I suspect that either you've been given inaccurate information, or that you may have misinterpreted it. The FDA has not, to my knowledge, implemented any act that reduces the amount of medication that a non-cancer chronic pain patient can receive.


The FDA may have to deal with the new form of Hydrocodone, which has faced a torrent of criticism in the media, by addiction treatment professionals and by some physicians. However, that should not be of much concern as virtually no chronic pain patient is using it yet.


The FDA has been exploring the idea of reducing the number of pills/patches/injections of opioid medication that a patient can receive in one Rx. Please note that this will not reduce the number of pills or the dosage that you will receive. It would, if approved (and that by no means is certain), mean that you might need to switch from a 90-day supply to a 60-day supply. You would still receive the same dosages that you currently have, or even potentially a higher dosage- and in the course of a year, you would still receive the same number of pills/patches, etc. You just might not be able to receive a 90-day supply all in one batch. Again, I emphasize that is not yet a decision by the FDA - only a possible proposal.


Finally, please be aware that many physicians today fear going on a DEA watch-list more than they are motivated to treat their patient's chronic pain. Thus, you'll see some physicians making up "FDA rules" as an excuse to lower their opioid prescriptions and remaining under the FDA radar. This clearly violates the Hippocratic Oath that each medical student promises to obey as they earn their MD.


Some physicians may use this FDA "lie" as an excuse to stop prescribing opioids completely, referring all chronic pain patients to injection mills and pain management programs. That would be horrendous for the millions of chronic pain patients who have had failed experiences with pain management and prefer to have their family doctor prescribe all of their medications.


In my opinion, this is the only real danger facing chronic pain patients today - being denied opioids by a family doctor or internist and being forced into a pain management program that may have Draconian rules and dispassionate practitioners.
cweinbl
csw2@bex.net
 
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finn2 responded:
I haven't heard a thing like that from my pain management doctor, I'm interested in exactly what the letter said were the new guidelines and concerning which medications. I take 15 mg Oxycodone 4 or 5 a day as needed and 15 mg. morphine 3 times a day. I'm urine tested 2, sometimes 3, times a year. My doctor is in the Maryland. What state are you in?
 
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blessedladyptl responded:
ayla930, There is one thing I thought of, but if you're not on Medicaid, then it does not matter. Each State can set limits on certain meds for those on Medicaid. But, that is regulated by State Medicaid and nothing Federal. I am Not saying each state does, but some do.
 
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blessedladyptl responded:
ayla930, sorry I didn't remember this earlier. Medicare Prescription Part D has begun to crack down on overutilization of opioids. But, there aren't any definations regarding what defines overutilization.


Medicare Part D Overutilization Monitoring System-
http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/HPMSmemo_MedicarePartDOverutilizationMonitoringSystem011714.pdf
 
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finn2 replied to ayla930's response:
Can you tell us what the guidelines were and for what meds? The ones they spelled out in the letter they sent you. Thanks. [a class="template-reply-post" id="exchange-post-enabled_A1" style="color: rgb(0, 102, 153); cursor: pointer;" onclick="LoginCreatePost(this,'pain-management-exchange','3'); return false;">
 
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finn2 replied to finn2's response:
Sorry, I don't know where all that gobbly gook came from in my other post.
 
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ayla930 replied to finn2's response:
Thank you all so much for your responses to my post. I am not ignoring your requests for details in the letter I recieved. I haven't had access to a computer, just my phone. I spent a lot of time researching the FDA website and the State of Alabama's legislative website and can find NOTHING that supports what the letter states. As soon as I get to my office and have access to my computer and scanner, I will answer all of your questions. Thanks for your understanding and all of your responses. It is too difficult from this little keyboard on my phone.
 
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ayla930 replied to ayla930's response:
I am going to post this in 2 or 3 parts. I decided it was easier just to copy and paste the contents of the letter. "Over the last few years there has been increased scrutiny on the prescribing of pain medications for chronic non-malignant (non-cancer) pain. Many national medical societies have developed guidelines for the maximum daily dose of pain medication a patient can be prescribed, as well as other, central nervous system depressants (anxiety medications and muscle relaxers). Additionally, the State of Alabama has passed legislation increasing the regulations on pain management clinics. Insurance companies are also creating their own standards (which are, in some cases stricter than the state and national guidelines) for covering prescribed pain medications. The FDA has already placed limits on the maximum "safe" doses of all medicines. All of this along with other governmental forces (DEA, Affordable Care Act, etc.) seem to be driving these regulations.
In order to comply with these standards, your medicines may have to be changed or the quantities reduced or instructions altered. This will not apply to everyone as most of our prescriptions are within FDA recommendations. For those patients on high doses of medicines, or what are recently considered to be "dangerous" combinations of medicines, we will adjust, change or taper your medicines over a period of time. There will not be an abrupt decrease in your medication and any taper may take weeks to months to complete. Rest assured, we will also work as hard as we can to find a medication regimen along with other treatment options that will adequately control your pain. We will also use genetic testing that helps determine which medicines work best for you and which ones to avoid. This will allow us to make better decisions for your pain medicines. Some patients may find these changes upsetting and over-restrictive. As always, you have every right to seek a second opinion from another pain physician. I think you will find that all pain doctors will have very similar practice policies. If you do seek a second opinion, please let us know what they recommend. Please do not call the office about this as it will be addressed with you at length at your office visit. We simply cannot handle the anticipated call volume associated with everyone's questions. Please feel free to ask questions and discuss your specific issues at your next office visit.
These regulations will cause a statewide and nationwide change for all pain clinics. Primary care physicians in Alabama will probably not continue to provide pain management services at all because of the new state legislation. We have examined the requirements and recommendations very closely and are going to reasonably and responsibly follow them. Our goals will be for you to achieve the best pain relief with the most function within the required guidelines. We understand that some of you may be unhappy with the thought of this initially but we will do our best to work with you to make the medicine changes as smooth as possible. Your patience and understanding will also help make this transition easy. In the end, for the patients on high doses of pain medicines, you will have your pain better controlled with less side-effects.
 
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ayla930 replied to finn2's response:
There has been interest to know what these new guidelines are. Basically, for pain medicine, the maximum total daily dose has to be equal to 200mg of Morphine or less. Obviously, everyone is not on Morphine. Listed below are the approximate amounts or FDA maximums for commonly prescribed pain medicines. Remember, this is the maximum if you are taking this medication alone. If you are on two or more different pain medications, the total dose of all pain medicines must be 200 mg morphine equivalents or less. There are other issues that will affect the maximum amount of pain medicine that can be prescribed per day as well. If you are over 65 years old there may have to be dosage adjustments and some drugs (not just pain medicines) are prohibited. If you are takings other central nervous system depressants (muscle relaxers such as Soma and Baclofen, or anti-anxiety medications such as Valium, Xanax, Ativan, Klonopin, etc), your total pain medicine dose would also have to be reduced. All of this will be specifically discussed with you at length at your next office visit.
Morphine (MS Contin, MSIR, Avinza, Kadian) - Max 200 mg total per day Hydrocodone (Lortab, Norco) - Max 200 mg total per day
Oxycodone (Oxycontin, Percocet, Endocet, Roxicodone, OxylR) - Max 200 mg total per day
Oxymorphone (Opana, Opana ER) - Max 80 mg/day
Hydromorphone (Dilaudid, Exalgo) - Max 32 mg/day
Fentanyl patch (Duragesic) - Max 100 meg patch every 2-3 days
Methadone - Max 60 mg per day
Again, for most of our patients, none of this will affect your treatment in any way. For those who are on high doses of pain medicine, we thought it important that you were aware of what was coming in advance. Please know, that we will do everything in our power to keep you as comfortable as possible as we make these necessary changes. It might help to write down your questions as you think of them over the next days, weeks or months until your appointment and bring them with you to your appointment.
Thank you for trusting us with your pain care,
I don't think I misunderstood what the letter says. I haven't gone into my medical condition(s) yet, but in a nut shell I have DDD, facet joint disease, multiple bulging discs and bone spurs on almost every level. I have had 4 herniated disks, which resulted in fusions at C5-6, C6-7, a diskectomy at T1-T2. Then last summer my lower back started to join in on the fun and the L5-S1 herniated resulting in a microdiskectomy in late August. I still have severe sciatic pain due to more bulging in the L5-SI and "severe" lumbar stenosis. L3-4 and L4-5 also bulging. Please ignore my spelling mistakes, it's the end of a very long day at my computer at work and don't have time to look up the correct spelling. My appointment to discuss my "plan" is tomorrow. I am going to spend this evening writing down questions. I am also going to ask to see a copy of the guidlelines. I don't understand this.. I have been totally satisfied with this pm clinic. Oh, just so you know, I don't just get meds. I also have RFL on C3-C8 medial branch nerves every 6 months, which do help in the cervical area. So far two injections in the lumbar region, a caudel epidural and an SI injection that did not help at all. My current dosages for the past six years are 100 mg MS Contin 3 times a day, 30mg oxicodone 4 times a day for breakthrough pain, 6 mg zanaflex 4 times daily and 300 mg neurontin 3 times daily.Yes, I still work, but don't have a choice. I am a widow and cannot live on what I would receive in disability. I finally have a job that will give me a pension after 10 years of employment. I still have 7 years to go. I don't know how I would/will make it if they cut these meds in half. I actually trusted my doctors completely until this happened.


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