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New FDA Rules Could Cut Narcotics Prescriptions
February 10, 2009

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News Summary

New restrictions will be placed on prescription of two dozen powerful Schedule II narcotic drugs including OxyContin, methadone and morphine, the New York Times reported Feb. 10.

The new rules could lead to many doctors losing their prescribing rights of extended-release opioids that are addictive and have high potential for overdose and death if misused.

"What we're talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products," said John K. Jenkins, director of the drug center at the Food and Drug Administration (FDA). "This is going to be a massive program."

Jenkins said current FDA regulations have failed to prevent inappropriate prescriptions, overaggressive marketing, and drug misuse that have led to deaths and overdoses. On the other hand, Jenkins noted that the drugs are highly effective in reducing pain. Federal officials will meet with drug makers, consumer advocates and others in March to discuss policy changes.

The announcement may signal a more assertive role in regulating physician prescribing by the FDA, which traditionally has issued warnings but left control over the practice of medicine to state medical boards.  

COMMENTS ON THIS ARTICLE:

Posted by Lynn Miller on 11 Feb 09 02:45 AM EST
When oxycontin first came out in 1996 only pain doctors were allowed to prescribe it. The laws with the doctor were very strict. Then all of a sudden any doctor could prescribe it and the drug became dangerous. The pain doctors stopped prescribing it because they didn't want to deal with the hassle. so now who is going to prescribe it for the people who need it? Are they going to stop the people who need the drug from getting access to it? It was the governments fault for not staying strict and now the people have to suffer once again for their mistakes.

Posted by Dorothy Gager, LCSW on 11 Feb 09 09:15 AM EST
At least in this area, the term "pain doctor" has long been the code for someone who would prescribe whatever the "patient" requested, sometimes without ever actually seeing them. I'm not sure what the answer is, but it has to lie with those physicians who willingly make it possible for opiate addicts to get their drugs cheaply and legally without any regard for what is happening to the person's life. Can't drug stores or insurance companies find out which doctors and dentists prescribe inordinate amounts of opiates and then report them for random case reviews? The legitimate prescribers would have nothing to fear, and the others can be identified for training, treatment, and/or prosecution for insurance fraud and malpractice.

Posted by Steve C on 11 Feb 09 10:15 AM EST
Rather than simply recycle a story from NYT, it would be nice if Join Together would reference actual source documents in these news items. For this article, the source FDA document is here: http://www.fda.gov/cder/drug/infopage/opioids/default.htm What isn't clear from the synopsis here is that the FDA has made a decision to institute a "Risk Evaluation and Mitigation Strategy," as provided for in federal legislation passed in 2007. There have been no decisions about what the specific "strategy" will be, and no relevant regulations have yet been proposed.

Posted by Randy Millerd, RPh on 11 Feb 09 10:26 AM EST
The term that comes to mind is legal diversion. Ask any pharmacist who the pain doctors are in his or her area and these individuals can easily be identified. The problem is the medical boards tend to protect their own if a problem exists. This is one time the FDA has gotten it right; however, it will not fully address the problem of over prescribing unless a drug utilization review process is put in place to monitor the physicians who are properly trained to prescribe these narcotics. Medicaid has tried to address this problem with limited success using DUR to track overutilization and multiple doctor usage. Until an effective DUR is in place, drug seeking patients will continue to have a legal outlet for their needs.

Posted by Robert Curley, News Editor, Join Together on 11 Feb 09 11:45 AM EST
Steve, briefly summarizing news stories like this one from NYT -- "recycling," to use your term -- is the essence of the Join Together news service. However, you are correct that this story would have had added value if we had included (as we often do) a link to the original source material. We have now done so, and thanks for providing the FDA link!

Posted by Anonymous on 11 Feb 09 12:04 PM EST
As a chronic pain patient, I realize the situation from abusers is effecting the doctors prescribing pain meds. I went to six different pain specialists and clinics before I finally decided they were hurting more than helping. Now I use pain meds prescribed by only one doctor and we have a very close relationship about it. I work to take as little as possible and she knows that. She also knows I suffer serious nerve pain daily and can not function without her prescriptions. She has been reported by the pharmacy and we talked it over and she decided to keep prescribing them. I stay away from long acting pain meds as I find they do not work eventually and the tolerance goes up really fast. The short acting are more trouble but they let me know when they stop working so I take more only if I need it. Long acting meds get way out of hand and I had trouble myself just getting them to cover the pain without a break through med in between. Hope that gives a bit of an opnion. nina

Posted by Anonymous on 11 Feb 09 02:36 PM EST
The reason the federal goverment wants to leave it up to the states is because they can blame us but not have to pay for the oversight, Example a doctor can call in a script fot vicoden in californis and in Boston the have to mail it to them or give it to patient. EVery state has some crazy policy. Same reason why you could be on welfare in 3 states, the feds would not make a policy on how we figure out who just moved from where. THe feds want this then make them pay for it. Mail order you can get three months of morphine but only 30 days in a mass pharmacy is allowed, and god forbid you come 2 days early

Posted by Judy Lynne Cole on 11 Feb 09 05:44 PM EST
As a sufferer of bilateral permanent nerve and other damage, for 9 years I tried the medical pain prescriptions, including anti-convulsants. All any of the medications did was cut the edge on the nerve pain, almost destroy my liver and effectively impair my immune system. I found much more relief from continued heavy nutritional supplementation - some of which is PDR listed. Over an 18 month period of time of maximum dosing with a medically followed regimen with B vitamins, manganese and the PDR listed 8 essential amino acids (in a highly bioavailable form) my chronic pain level has dropped to 45% of what it was for nearly 17 years.

Posted by Steve Lefton on 19 Feb 09 08:35 AM EST
I was in a high speed car crash in 1979. Since then I have been on what I call "a Fool's errand;" it seems there is smaller legal exposure by not treating me than referring me to another doctor. Medical practitioners' practices should be a Not-for-Profit entity.

Posted by Stephen Buchness on 22 Feb 09 02:16 PM EST
As an addictions counselor and therapist with a chronic pain condition, I looked for non-prescription pain relief. Like Judy Lynne, I have found that vitamin supplementation and essential amino acid supplements reduced my chronic pain about 80%. It is not complete relief but it is bearable pain without the sedative/addictive consequence of opiates. Therapeutic Tapping has also added to my relief.

Posted by Debra R.N. on 29 Mar 09 02:02 AM EDT
Let me say that it is a crock to say that narcotics "don't help fibromyalgia pain". This is falacy and doctors are being taught wrong. Yes there are risks, but we should have the choice to relieve this pain. I am a fibro patient and have talked to literally hundreds of others with FM who say narcotics are the only thing that helps this horrible pain. It is a very painful illness and we should have the right to have pain relief when nothing else works. Nothing over the counter helps me at all. And Lyrica is NOT the miracle. (I tried it for over a year). STOP the false info. I never needed or asked for narcotics until my 40's when this pain took me over. I am not a drug seeker but pain relief seeker just as the majority of other FM patients. Debra R.N.

Posted by suzy on 03 May 09 09:39 PM EDT
Debra , you said exactly what I need to say. There are many doctors out there so afraid to rprescribe narcitics for FB patients it is causing many of us myself included to search out other job oppurtunities that are easier on our bodies as well as give up the things we enjoy doing because it is so hard to find a doctor who will treat our pain with narcotics. So here we are between a rock and a hard place. It is not fair to have to be made to feel as though we are nothing but drug seekers. SO unfair , so not true. It is the one few things that will really help this awful pain. I to am a pain releif seeker and finding it hard to get anyone to beleive me. Suzy.( I will keep fighting)

Posted by bonnie on 05 May 09 02:38 PM EDT
I sympathize with suzy and Debra - however, do you realize that OxyContin was never intended for chronic pain or immediate pain relief other than for "terminally ill cancer patients" only? Also, coming off a Methadone or Morphine dependence or worse, addiction, is absolutely horrendous, and a life-long struggle for most. You are trading in your pain for an addiction when using these drugs for any long-term treatment regimen. With OxyContin, it's all about the money - the first year they marketed this drug (when scripts written were around 300,000, they made $ 1.2 billion. Today, more than 6 million scripts are written each year - you do the math.

Posted by bonnie on 10 May 09 01:33 PM EDT
If you want the whole the story behind OxyContin and the trail of devastation and addiction this "wonder drug" has left behind - and is still causing - read "Pain Killer" by Barry Meier (journalist) and get a whole new perspective on big pharmaceudical co.s like Purdue. Also explains why the other drug companies (producing Vicodin, Percocet and Dilaudid) competing in the pain management business have "jumped on the ($$$$$$) bandwagon" after seeing the astronomical profits made from this opiate pain killer. Please stop "feeding the machine" - don't accept these drugs unless absolutely necessary - make an informed, educated decision. We are the consumers - it's up to us to stem the demand for these drugs - the supply will fall accordingly. We have let "Big Business" rule this country for way too long - and look where it's has gotten us. So, let's start with big pharma - send them a message - loud and clear - We do not want your highly addictive, deadly drugs, whose potential for abuse far outweigh their medicinal value. Develop safer, non-addictive drugs for chronic pain sufferers, so they won't have to trade in their pain for dependence and addiction, and pain killers that don't cause the euphoria that is so irresistible to our adolescents - and is killing them at rates never seen before!!!!

Posted by JANE DOE on 17 May 09 11:52 AM EDT
Yeah, Bonnie, I'll be sure not to accept any narcotic pain pills ("Feeding the Machine")...BULL! Its difficult ENOUGH just to FIND a dr that will give enough meds to get through a WEEK, much less a MONTH! This opiate withholding has got JUST RIDICULOUS, and because a few people abuse it (which is their personal right)then we ALL must suffer. Genuine pain or NOT! So what do we do? Cause Big Brother is watching more everyday- and the new, nosey script monitoring program is coming in July! When ALL pharmacies will be linked up- and know EVERY SCRIPT that one has ever got!!! This is BULLS#it, and should be STOPPED! What about our 'right to privacy'? This doesnt exist anymore, just as our rights in the U.S amendments are being stripped away from us as well! This nation is going to the DOGS...we're screwed. And ANY pain relief that we might have at the moment is going to be stripped from us as well with all these new laws/regulations popping up every freakin' day of our nosey communist government!!!! They have WAY too much control!

Posted by bonnie on 28 May 09 11:28 AM EDT
Jane - what you and others suffering with chronic pain should be fighting and advocating for is better pain meds. that don't lead to dependence and addiction. Form advocacy groups to force pharmaceutical co.s to develop these drugs. Purdue already did this years ago - added Nalexone to an opiate - something that blocks the euphoria that young people find irresistible. They did not make enough money on it, so they discontinued it. Creating addicts is much more profitable. And you are SO WRONG when you say that SOME people are abusing these drugs!!! Do the research, and ask around in your own neighborhood. Pain killers are currently THE MOST ABUSED and THE CHOICE of drugs for our young kids. They are in everyone's medicine cabinets - creating the MYTH that these drugs are SAFE. They are NOT! And they are killing more kids and people today than all of the illegal drugs combined. More women are in private rehabs today because of pain killers than ever before. I'm sorry, but PROTECTING our children is a priority for parents - YOU need to fight your own fight for better, SAFER drugs - you can make a difference. Read "The New Opium Epidemic" by Novus (Medical Detox Center) under their website.

Posted by anonymous on 30 May 09 08:16 PM EDT
Having fractured my lower spine 5 seperate times and now battling 2 tick diseases (lyme and babesia)am in severe pain 24/7 even w/supposed strong pain meds (feels like someone hitting me in the lower back w/a baseball bat over and over and over. the feds and states based on overpublicized cases in the media and anecdotal evidence rather than any statistical evidence have way overregulated pain meds. Chronic pain sufferers are treated as criminals and put through hell just to get meds and help. The only reason I put up w/all the BS is my 3 kids-have to be there for them-otherwise would have taken a long walk on a short peer years ago- Just my 2 cents worth on the issue.

Posted by Brown on 10 Jun 09 02:22 PM EDT
I have had chronic pain for over 12 years and been on every opoid and non-opioid there is out on the market. Opioids are a lat resort for me and my pain. Do I like being a slave to these medications...NO. I wish the pharmaceutical companies would come up with less of what the kids are looking for..A HIGH? They just aren't out there now. Why would the FDA pull the carpet until there is something that will insure that, we with real pain, we can get access to medications tha work. This isn't our fault. The FDA should have made these companies develope "non-high" drugs and then say..."ok now you have to switch". As it looks now a lot of long acting and short acting opioids (not narcotics that is a term reserved for illegal drugs) are going to be kaken off the market. I have a bad feeling with swing of the pendulem. Their high on their hourses and riding a wave of young deaths caused by pain medications. Mostly stolen, by the way, from their parents medicine cabinate. Hold on....this is going to be a long fight. Support your advocacy groups and remember to write letters to the FDA...not that it will help.

Posted by Profbam on 22 Jun 09 11:39 AM EDT
Those who abuse and the physicians who enable them will make it increasingly difficult for those with legitimate need to obtain and physicians with legitimate practices to prescribe appropriate pain relieving medications. A few years ago, I was consulted for a Federal criminal court case. The defendant had a leg crush injury and could not find any physicians who would give him more than Percocet for his pain. His request for amputation was turned down. So, he held up a FDIC covered bank, sat in his car and waited to be arrested. For the next ten years you are paying for his three meals, a cot, and oxycontin. What a wonderful world we live in.

Posted by anonymous on 23 Jun 09 04:51 PM EDT
Those of us with real pain and a real need of narcotic pain meds are suffering because of the abuse by the others, who are looking for a buzz. I am really getting tired of these new catch phrases such as Big Pharma...I realize the greed these companies have is real. I just feel so many zealots jump on these bandwagons and lump everything into these catch phrases and the individual can get lost in the process. And to those who think that joining adcocacy groups or letter writing will change things; I highly doubt it. Profbams'post is very telling of our society unfortunately.

Posted by Tracy on 20 Aug 09 03:06 PM EDT
I have a question regarding opiates. If the patient had been prescribed an opiate for post-op after surgery, can a doctor continue to prescribe them over the phone without seeing the patient (even if it's been 4+years? What are the rules for doctors

Posted by opiate laws on 20 Aug 09 03:13 PM EDT
If a patient was prescribed an opiate (such as Fentanyl)for post operative surgery, how often does the patient need to see the physician for refills? Can a patient just call the doctor for refills for up to 4+ years without a follow up or checkup for refills?

Posted by Diane on 25 Sep 09 08:07 PM EDT
It is unfair to punish pain-sufferers for pharmas greed and drug addicts. Also, just because some alternative tx works for some is no reason to deny the rest of us the pain relief that can only come from opiates. To say that using pain medication is a crutch is insulting. I am a diabetic and dependent on my insulin and, yes, I am a "slave" to it. So what? Pain relievers are just as necessary for my quality of life as insulin is. Furthermore, it is already a difficult and demeaning process for honest patients to receive adequate pain medication. I, too, suffered a severe injury in a car accident in 1998 and was prescribed opiates. I have also developed fibromyalgia and poly myalgia rheumatica. After suffering disabling pain for 5 years, my chiropractor found a pain specialist who helped me. I have NEVER abused my meds. I severely resent being treated like a criminal. Now I go to my GP but because of the federal oversight, he cannot prescribe the Rx regimen that the pain mngt specialist could. He modified the regimen as best he could, continuing my methadone. Long-acting opiates are essential for avoiding the pain spike that occurs between doses of short-acting meds. As every pain patient knows, it is very important to avoid letting pain meds wear off or you end up "chasing the pain" for a couple of doses just to catch up, which encourages overdosing. Doctors should be free to explore ALL possibilities in their search for adequate pain relief for their patients, without the fear of reprisals from the federal government. It is is NOT the govt's job to prescribe. How can they determine what is an appropriate regimen without intimately knowing the PATIENT?

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