New FDA Restriction on Narcotics!

[FidgetBoy]

F.D.A. to Place New Limits on Prescriptions of Narcotics

Published: February 9, 2009
WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John K. Jenkins, director of the F.D.A.’s new drug center.

“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,” Dr. Jenkins said in a news conference on Monday. “This is going to be a massive program.”

Hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.

The blame for this is shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold meetings with manufacturers, patient and consumer advocates, and the public to ask for advice on how to carry out the new control program, officials announced. The first meeting will be on March 3, and no immediate changes in access to the drugs is planned.

The 24 medicines under review had 21 million prescriptions written for them in 2007, to 3.7 million patients, Dr. Jenkins said. They are extremely effective in reducing pain, which many medical studies suggest is widely undertreated in patients suffering serious illness. (A complete list of the drugs is at www.fda.gov/cder.)

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. The F.D.A. has received reports of patients’ being prescribed such medicines to treat something as simple as a sprained ankle, he said. In such patients, the medicines can be dangerous.

Part of the problem is marketing. Several reports, for instance, have suggested that Purdue Pharma, the maker of OxyContin, helped fuel widespread abuse of the drug by aggressively promoting it to general practitioners not skilled in either pain treatment or in recognizing drug abuse.

The company has denied such a connection, but a holding company connected with Purdue and three top Purdue executives pleaded guilty last year to criminal charges that the company had misled doctors and patients by claiming for five years that OxyContin was less prone to abuse because it was a long-acting narcotic.

Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate.

The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.

Most of the drugs withdrawn over the last 20 years, however, were taken off the market because doctors continued to use the medicines in ways that the F.D.A. warned against.

For decades, the agency’s armory in these battles held only a popgun and a cannon — the popgun being the issuance of widely ignored warnings; the cannon being its ability to force a medicine’s withdrawal. But a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.

[FidgetBoy]

So I did a bit more research on this FDA decision this AM and the more I'm reading, the more concerned I'm getting. In the near future, the FDA will be requiring--

1.Health care providers who prescribe the drug have particular training or experience, or are specially certified;
2.pharmacies, practitioners, or health care settings that dispense the drug are specially certified;
3.the drug is dispensed to patients only in certain health care settings, such as hospitals;
4.the drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results;
5.each patient using the drug is subject to certain monitoring; or
6.each patient using the drug is enrolled in a registry (see section 505-1(f)(3) of the Act).

I have an appt with my doctor next week-- but this type of scrutiny and heavy documentation will likely cause him to think twice about treating my horribly bad RLS with oxycontin. The above also seems to insinuate we will need to have blood levels drawn or pee in a cup? Which is fine- but my God, how many more appts and doctors do we need to see to get what we need for our condition?

[Neco]

No, this is crap.. This is the kind of crap they are trying to pull with the whole free public health care plan.. On the news this morning there was debate about these kinds of things being snuck into the stimulus package that does anything but stimulate.

That is crap...bs.. poo.. NO. This is why I hate the idea of public health care and the idiots who will be running it.

I already can't get Methadone from the county because the psych guy doesn't have a license to prescribe it (yet he can prescribe Suboxone..wtf?)

This is more BS of punishing everyone because PATIENTS are being stupid, or specific doctors are routinely stupid.

All it is going to take is for one government slacker to look into MY PRIVATE MEDICAL RECORDS, and ban me from ever receiving painkillers again because of my past problems. All it will take is for my doctor to be required to take special expensive training and receive a likely expensive license (I just know its gonna cost money somehow) to force him into no longer prescribing me methadone, or having to go to a specific pharmacy that may be hugely expensive, or a Hospital that is hugely expensive.

The government has no right to tell me what I am allowed to receive. The government has NO RIGHT to tell my doctor how to treat my pain and suffering, OR how to do his job.

[jml945]

The only people they are going to hurt are those who actually NEED these meds. The druggies will get their drugs from other places besides health care providers.

You are exactly right Zach, this is exactly what we are going to be dealing with now that Obama and his team are priming us for public health care. They aren't going to do it all overnight either, they are using the so called "stimulus" package and other bills to slowly skeak it all in over time. Shameful.

[SquirmingSusan]

Oh, please! Do not let this degenerate into a bunch of idiotic political mudslinging. It will not be tolerated in this forum. Quit whining about how one political party has ruined your life (whichever one has) and get involved.

One way to help is to join the American Pain Foundation and start advocating for your rights to adequate pain control.

[Neco]

Wow, take a chill pill. No one said anything about politics or said anything remotely inflammatory about any one party or person... sheesh.

[FidgetBoy]

Politics not withstanding-- CNN just sent out a release with more info saying this likely will not go into effect until 4th quarter/end of this year. So we have some time to make our voices heard.

I would highly encourage everyone to contact the FDA, local and national Pain/RLS organizations (and perhaps congressmen?) to encourage RLS be listed as a viable diagnosis for opioid treatment. I have the feeling the FDA will not consider this justification for treatment otherwise...

[jml945]

My point was that withouth mentioning any political affiliations or individual leaders, in the next few years we will see a completely new health care system arise, one in which there will be a lot of "change", some good and some bad.

Some of the bad aspects of this new policy have already been metioned, and it will all arise because of a big expansion in our public health services, which means more regulations on what doctors can and cannot do, resulting in proper care for some being neglected in the name of safety and social responsbility. Those are the facts, unbiased and unprejudiced.

Susan, I hate to say it but advocating to the American Pain Foundation may help some individuals in their need but it won't change any sweeping government policy, especially something this big. It's just something we will all have to deal with.

[SquirmingSusan]

We'll all only have to deal with it if we all just quietly watch it happen. Who said that thing about, "all it takes for evil to triumph is for good people to do nothing."?

Get involved, write those letters to your congresspeople, join the APF (it's free) so that you get updates on what's going on in pain treatment.

Even the "Obamessiah" and his administration has to bow to public pressure.

[Aiken]

Hmm. I'm kind of torn.

I don't want anyone to be inhibited from, or hassled for, getting their meds. On the other hand, the FDA has a point. Methadone, for instance, can very easily kill you the first night you take it, if your doctor has prescribed too much, or if you have not understood its behaviors and risks on your own. I, and I recall at least Mia and maybe one other person, took too much the first night and it was scary. If I had taken even more, it might have been fatal.

I think the suggested methods are too draconian, but I agree that doctors should never prescribe any strong, long-duration opioid without being fully educated about the dangers and about how to try to keep patients from being stupid. We all know by now that many doctors are ridiculously ignorant, and that just doesn't fly when giving people something that, in only slightly larger doses, amounts to a deadly toxin.

I'm for doctor certification, as long as it's not a prohibitive process. Go in, take a class if you need it, take a test, get certified to prescribe extended-release opioids. That doesn't seem evil to me. The other stuff is overkill.

[jml945]

See, this is the way they will get doctors to stop prescribing methadone and other drugs.

First, I don't take methadone, and I don't plan on it. But if I need it I want to be able to take it because I know what RLS pain can be like. There is very little in this life that causes me extreme agony that makes me suicidal, but RLS can do that to me. So I will take whatever I have to.

Making doctors take "classes" seems like a great idea, but most won't want to bother. They have extremely busy schedules, and besides they already went through years of med school and fellowships and the like, which should have already taught them about all these dangers. And besides, it's just a bother, so if it's easier just to stop prescribing them they will take the easy way out 9 times out of ten. It's a subtle discouragement on the part of the FDA.

In regards to the dangers of methadone and other opiods, don't you think doctors of all people know about that? And these days doctors will do anything to not get sued, so they are already very hesitant to prescribe oxycontin or methadone to just anyone. This new restriction is going to take things that are already self restricted and make them one step removed away from a complete ban IMHO.

[SquirmingSusan]

I agree with you Aiken. I'm all for proper training of doctors who prescribe these drugs. I'm very sensitive to most meds, and a 5mg dose of methadone, if I hadn't been taking other opiods already, could have probably killed me. I'm an extreme case, but there are others like me. One size does NOT fit all with these drugs. There is no such thing as a universal "safe dose."

OTOH, doctors are already skittish enough about prescribing narcotics because they already have the DEA breathing down their necks. I can only imagine that these new regulations will make most doctors less willing to prescribe the pain relief that people need.

My own doctor was telling me that she won't prescribe more than 90 methadone tablets a month, because she said that above that amount if you don't have immaculate records, the feds come sniffing around. (Not her words, lol.) She said that it's very time consuming to keep all the records and documentation required to go over that amount.

This new policy sounds like the doctors will require all of those records and documentation, even at the lower doses.

This won't affect me directly because I already go to a pain clinic, and have to pee in a jar for them every 3 months so that they can document that I am, indeed, taking my methadone and not taking street drugs with it. It's not a big deal, except that I'm idealistic enough to think that the feds should stay out of my business.

Fortunately, many doctors ARE recognizing that opioids are an appropriate treatment for RLS. But whether or not that is written into the policy as an acceptable reason to prescribe narcotics? We need to find out, and if it's not, then change that.

[jml945]

Even the "Obamessiah" and his administration has to bow to public pressure.

Yes, he does but he will use his honeymoon period to get what he wants. This is why the media has made such a big deal about his "first hundred days" because it's when the public still has a favorable opinion of him and he can pass whatever he damn well pleases. After that it gets harder, especially when the economy is suffering. But I digress.

[SquirmingSusan]

Yes, but you can't possibly think that this new policy has anything to do with the Obama administration. He hasn't even been there a month and he's not that powerful to push something through like that. Nobody can make things happen that quickly in government. I'm guessing this has been worked on for a long time by the previous administration.

It seems like the Republicans have been historically more for the "war on drugs" than the Democrats, but I really have no idea. I certainly wouldn't go so far as to blame the new administration for this, without digging up the facts to support my opinion. Without the facts, it's just mudslinging, and most of us are really tired of that. (Especially us Minnesotans I think, in the aftermath of our senate election, which isn't finished yet. Both parties were horrible. Yuck.)

I don't think this has anything to do with the stimulus package either, or anything to do with the push for socialized medice. I'm sure it has to do with people who have lost loved ones to drug overdoses getting hysterical and lobbying for tighter controls on meds. If Americans could just generally get over having to blame someone else for their problems, things would be much easier. If someone overdoses, blame the doctor, blame the government, blame the doctor, but don't blame the person who took the pills...

The whole war on drugs makes me crazy. If I could only get a doctor to prescribe me those chill pills.

[Neco]

I think it does have to do with the stimulus, and government run healthcare. Because that is the specific issue that was being debated this morning on TV.

There is an unbelievably GROSS amount of pork and other crap written into the stimulus package, I'm sorry but the Democrats wrote it and cut the Republicans out. It's not Obama fault as he is nothing but a mouthpiece for congress and that is all he ever has been.. As soon as this bill came into being, it was trashed and loaded up with junk by Pelosi and her buddies, pure and simple, as far as I know the drafting was proxied out to her and her ilk.

And this does relate to public health care, because if this is the kind of judiciousness they use in one area of medicine, there is nothing to stop them from using it in another.. All they have to do is justify it with "But tracking everyones treatment will let us save money by weeding out ineffective medicines, or medicines used inappropriately!" and you know that is scary. WHo decides what an appropriate use is for a medication? How much pain do you HAVE to be in? they could interpret inappropriate as use anything off-label - which would almost the entire RLS community.