Re: Oxy shortage news
- From: Dr.Smith@xxxxxxxxxxxxxxxx
- Date: Wed, 18 Feb 2009 09:00:01 -0800 (PST)
On Feb 17, 9:11 pm, "OldGoat" <oldgoatm...@xxxxxxxxxxxxxxxxxx> wrote:
Thanks for that. At least one news outlet got it. Not a word from our so
called pain advocates. So I guess they all got their meds. I can also add
Arizona (thanks in Tucson) to the shortage list. But this does a pretty good
job of giving a reason for this. The DEA waited until New Years Eve to give
manufacturers their quota's? The FDA allow 4 OxyContin producers stop
production, which has been planned since 2006, without taking any action on
the shortages it would create?
They're (the FDA) is saying everything will be just ducky by mid March. Yea,
the people who knew this was coming for 3 years are telling us things will
be fine in 3 weeks. If this was insulin you couldn't keep it off the news..
We can't even get the people we donate to lobby for us to pay attention to
"JoeZ" <J...@xxxxxxxx> wrote in message
A little something I found... doing a search of 'shortage of oycodone'....
February 15, 2009
Scattered Oxycodone Shortages Reported
By John A. Gilbert & Larry K. Houck -
WMSN-TV Fox 47 of Madison, Wisconsin, recently reported that pharmacies
are experiencing difficulty obtaining oxycodone to fill their patients
prescriptions. Oxycodone, a schedule II opioid painkiller, is indicated
for patients suffering from moderate to severe pain. The report stated
that "[a] DEA spokesperson in Chicago says this is not a nationwide
shortage, and if pharmacies can't get supply, it's likely their
manufacturer has reached its quota."
While there may not be a nationwide oxycodone shortage, pharmacies and
hospitals outside Wisconsin have also been unable to obtain the drug.
Oxycodone has been reported in short supply in Oregon and Washington, as
well as in parts of California, Colorado and Maine.
The shortages have been attributed to several factors. Some have blamed
DEA for delaying the annual quota, giving manufacturers a late start.
Others have said that manufacturers have already hit their quota and were
forced to cease production. A recall by manufacturer Mallinckrodt and
cutbacks by Ethex have also purportedly contributed to the problem. One
pharmacy expert observed that a few years ago five companies manufactured
extended-release oxycodone and that four of the companies no longer
manufacture the drug.
Other than the statement by the DEA spokesperson in Chicago, there has
been no mention of the shortage by the agency. The Controlled Substances
Act ("CSA") requires DEA to establish quotas that control the quantity of
schedule I and II controlled substances that may be manufactured in the
United States in a calendar year. 21 U.S.C. § 826. DEA establishes an
annual aggregate quota for each schedule I or II substance. 21 U.S.C.. §
826(a). The agency assigns individual manufacturing quotas to
manufacturers of controlled substances such as oxycodone in bulk. 21
U.S.C. § 826(b). DEA issues procurement quotas that authorize
manufacturers to procure a basic class of schedule I or II substances to
make dosage forms. Manufacturers can only manufacture quantities within
their assigned manufacturing quota and they may only procure source
materials or manufacture dosage forms within their procurement quota.
Manufacturers apply for quotas in April of the year prior to the year of
the quota request.
DEA regulations require the agency to publish aggregate production quotas
on or before May 1 of each year, and individual procurement quotas and
individual manufacturing quotas on or before July 1, 21 C.F.R. §§
1303.11(c), 1303.12(c), 1303.21(a). The CSA requires DEA to establish
individual manufacturing quantities on or before October 1. 21 U.S.C.. §
826(c). DEA published the proposed aggregate production quotas for 2009
on November 7, 2008 and "established initial aggregate production quotas"
for 2009 on December 29, 2008.- Hide quoted text -
- Show quoted text -
Whether this is all just a delay in the pipeline, not enough mfrs., or
a snafu with one mfr. reaching their quota and no-one to take up the
rest, I think some letters to the new Surgeon General are in order.
If he has the president's ear and confidence, an executive order can
get things moving again, though there may still be some delay, and the
SG will be alerted to the problem for correction in the future. OG, I
know you don't have any faith in the system, but I think it has a
better shot than just alerting the media, whose response will be
skeptical at best. YMMV. JMO-ICBW.
Oh, the pain... THE PAIN...
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