Feb 12, 2009

FDA Further Pain Control Medications Regulations

My Friends... Please read the below, and help with this cause. Thanks so much... Pam "Rhia" Steele
An outrageous nightmare all needing pain meds! Please let's do something!

Here is a petition I have created that will be delivered to the FDA and
President Obama.

Please join me if you choose in getting this issue out there and let
them know how we as those that suffer in chronic daily pain feel.

The link below will lead you to the petition site. You will see the
petition called Pain Control around the middle of the page with my
picture beside it. I urge you if you are a pain sufferer or a care taker
to help take action so we do not lose our medications we need.

Pain Control


Thanks so much! Rhia If you have questions feel free to email me.


http://www.nytimes.com/2009/02/10/health/policy/10fda.html


If you never read another news article again, this one you truly need
to
read. If we allow the FDA to further restrict our prescription pain
> medications, and mine, like many are on this list, we could be in a
> world of horrible, nightmarish pain, and not be able to get our
> medications! They are supposed to be making it less complicated for
> those of us in true pain, yet the FDA now is trying to leave it in the
> hands of the pharmaceutical companies rather than our own doctors. It
is
> bad enough now that we fight between doctors, insurance companies, and
> the pharmacies as it is! I could not believe my eyes when I read this.
> Please take time to look over this article, and think about what we
can
> do as a group, plus other people we know to get the word out that this
> needs to be dealt with before the FDA meets the first part of March.
> Whether it be a petition, the signing of letters, or whomever we need
to
> find to take our cases to, we definitely need to act and act now!
>
> Here is the Article from the link above. I am further looking into it
at
> the American Pain Society also, and if you find more information
please
> email me or post. We cannot allow our very lives in the hands of these
> people.
>
> Rhia
> F.D.A. to Place New Limits on Prescriptions of Narcotics (courtesy of
> the New York Time Health Page)
>
> 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.

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