re: new federal law requiring drug contracts for opioids

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Alcie
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Date Joined Oct 2009
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   Posted 3/13/2011 7:12 AM (GMT -6)   
Chutz or anyone -
 
Re: the bit Chutz posted about "long-acting" opioids in Rhaeven's "drug contracts" thread- "mid-2011 will require documented evaluations (diagnosis, treatment plan, and objectives) before physicians initiate long-acting opioid therapy" -
What does "long-acting" include?  Is this only for long-term treatment, or can we still get a month's worth or a couple week's worth while we're waiting (often a month or two) to get in to see a pain doc?
 
Am I OK with my tramadol, but needing a contract, etc. for my extended release tramadol?  What about Vicodin for breakthrough pain?
 
Are other types of pain meds included?  Muscle relaxants, benzodiazepines?
 
Will PCPs be able to Rx Vicodin, tramadol, benzos as they do now?

Screaming Eagle
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Date Joined Sep 2009
Total Posts : 5005
   Posted 3/13/2011 7:28 AM (GMT -6)   
 
    Alice, where do you live? The way I read Chutz reply, is the new law will effect residents in Washington State.
 
      I just scanned over it, so maybe I missed some of it, but her statement clearly said a new Law in Washington State, and made reference to the "Long Acting" opioids.
 
     SE wink
       

Alcie
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Date Joined Oct 2009
Total Posts : 5029
   Posted 3/13/2011 12:46 PM (GMT -6)   
From the site Chutz linked on the drug contract thread:
"Legislative and regulatory responses to opioid prescribing are on the horizon. The FDA has proposed a new Risk Evaluation and Management Strategy (REMS) for opioids, but the REMS has not been approved yet, because an FDA committee wants stronger requirements, including mandatory physician education programs. And, in Washington State, a new law that takes effect in mid-2011 will require documented evaluations (diagnosis, treatment plan, and objectives) before physicians initiate long-acting opioid therapy.1 The law also will require written agreements signed by patients, periodic review of patients' progress, continuing education for physicians who prescribe long-acting opioids, and mandatory consultation with pain management specialists when physicians prescribe morphine equivalent doses exceeding 120 mg daily."

So I presume there will be federal legislation soon, in addition to the Washington State law that is coming in this summer.

I don't understand what is meant by "long-acting" opioids.
Alcie
 
 

Screaming Eagle
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Date Joined Sep 2009
Total Posts : 5005
   Posted 3/13/2011 1:37 PM (GMT -6)   
 
         
 
 
           I guess common sense would tell me that it means just what it says, ....Long acting..."extended release"
 
     Lets let some of the other members give their imput on it. Maybe Monday more of the members will be back from the weekend off. smilewinkgrin   I'm sure Straydog and or Chutz and some of the more experienced members can shed some sensable insight on this topic.
 
         Sorry, I just dont have the answer I guess your looking for, and my knowledge is limited on the new upcomming laws and what they really mean.
 
        Have a good day!
 
        SE wink

Tirzah
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Date Joined Jul 2008
Total Posts : 2317
   Posted 3/13/2011 6:44 PM (GMT -6)   
Just wanted to point out that some meds already require a REMS in all 50 states (Onsolis is one). My PM did one for me to be on that med & though it is a bit more time consuming -- waiting to start on a new med -- it's really not that horrible. He was already doing those things before the REMS was required, so all it was was turning in his thoughts about why I needed to be on Onsolis, what else had be tried without success & what we would consider a "successful" outcome. I also had a short form (different from a pain contract) to read through & sign that said (1) I understood the medication could be habituating, (2) I would not abuse or (3) sell the medication & (4) I would talk to my doctor if I had any problems with the medication.

I think it's too bad that we are having to go this route, but this really is to protect patients from ignorant doctors who give out serious, potentially dangerous pain meds as if they were candy. It ought to be applied to any medication that a patient is taking for a longer period of time, but I understand how that would be difficult to control/regulate. The thought, apparently, is that no one will be on long-acting meds for a couple of weeks & then stop. So ER docs setting a bone will not typically be required to complete a REMS. Only doctors who are treating patients for chronic pain.

Not perfect, IMHO, but it seems like a reasonable plan to me. The good doctors were already telling their patients not to abuse or sell meds, to talk to them about any problems, and what to expect (i.e., partial relief, not total elimination of our pain). The REMS are established to make sure all doctors follow those best practices. :)

Jim1969
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Date Joined Jul 2009
Total Posts : 2042
   Posted 3/13/2011 9:14 PM (GMT -6)   
While I can understand the motivation behind such a law/regulation I am also fearful of the possible "unintentional consequences" such a law can bring about.

In many areas it is already difficult enough to find doctors who will actually manage chronic, non cancerous, pain through pain medication and I wonder, once this goes into effect, how many doctors who do will simply say it is not worth the extra paperwork and oversight.
2 confirmed herniated lumbar discs. Spinal Arthritis. Spinal Stenosis, diabetic peripheral nueropathy.

Chutz
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Date Joined Jan 2005
Total Posts : 9255
   Posted 3/14/2011 12:35 AM (GMT -6)   
Hi~

It is my understanding that before long, like in the next year maybe, a federal law will require all kinds of documentation, testing and more paperwork doctors and patients taking "long acting" pain medication for noncancerous pain. In Washington state the powers to be got the jump on the deal and are implementing it before the federal agencies do. (I have some personal opinions here but will hold my tongue and be civil ) shocked tongue

But I think Alcie's question was a good one. Many of us have been around the medication world for quite a while whether it's us that takes it or someone in our family. So I found a good description for these types of pills on Wikipedia. Here it is for those interested.

Chutz

Time release technology, also known as sustained-release (SR), sustained-action (SA), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), modified release (MR), or continuous-release (CR or Contin), is a mechanism used in pill tablets or capsules to dissolve slowly and release a drug over time. The advantages of sustained-release tablets or capsules are that they can often be taken less frequently than instant-release formulations of the same drug, and that they keep steadier levels of the drug in the bloodstream.

Today, most time-release drugs are formulated so that the active ingredient is embedded in a matrix of insoluble substance(s) (various: some acrylics, even chitin; these substances are often patented) such that the dissolving drug must find its way out through the holes in the matrix. Some drugs are enclosed in polymer-based tablets with a laser-drilled hole on one side and a porous membrane on the other side. Stomach acids push through the porous membrane, thereby pushing the drug out through the laser-drilled hole. In time, the entire drug dose releases into the system while the polymer container remains intact, to be later excreted through normal digestion.

In some SR formulations, the drug dissolves into the matrix, and the matrix physically swells to form a gel, allowing the drug to exit through the gel's outer surface.

Micro-encapsulation is also regarded as a more complete technology to produce complex dissolution profiles. Through coating an active pharmaceutical ingredient around an inert core, and layering it with insoluble substances to form a microsphere you are able to obtain more consistent and replicable dissolution rates in a convenient format you can mix and match with other instant release pharmaceutical ingredients in to any two piece gelatin capsule.

Moderator on the Fibromyalgia and Chronic Pain forums
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White Beard
Forum Moderator


Date Joined Feb 2009
Total Posts : 3702
   Posted 3/14/2011 9:31 AM (GMT -6)   
My current pain management Doctor at the spinal pain clinic, I have been seeing him since 2005 or 2006, and I have been on contract wih him right from the beginning, and have had to do the monthly refill urine test each time, so I doubt that I will see any difference with my pain management, at least untill I sell my house and leave this area. However the changes does complicate things for me when I do leave the area! And it makes it that much harder for me to do so! I see this new new health care on the horizon as just adding to all the complications. It is really getting to be really scary times for all CP suffers!  I often wonder how this is all going to end up! I am afraid that we all might see some very painful times ahead!  I do hope I am wrong about that! But as we would say in my old military days,  I sure don't get a warm fuzzy feeling about it, with the way things have been going! 
 
White Beard
Moderator Chronic Pain
After spending nearly 22 1/2 years in the USAF, I retired in Sept, 1991. I then went back to school and became a licensed RN in 1994, and I worked on Oncology and then a Med Surg Unit, I became disabled in late 1999 and was approved SSD in early 2002!-- DDD, With herniated Disk at T-12 and L4-5. C5-C6 ACDF in Sep 2009, C6-C7 ACDF in Mar 1985, Osteoarthritis, Ulcerative colitis, Chronic Pain, Fibromyalgia, Complex Sleep Apnea, and host of other things to spice up my life!(NOT!) Medications:Oxycontin, Percocet, Baclofen, Sulfasalazine, Metoprolol, Folic Acid, Supplemental O2 at 3lpm with VPAP Adapt SV I am White Beard with a White Beard!
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