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Vics From 3 To 2


headbanger

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Below is just a small clip from a article. I'm sure many of us have already heard about this. It will be interesting to see how Big Pharma will react. Tighter controls equals less refills equals less profit to the drug companies.

 

 

 

The FDA says it will formally request in early December that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled.

 

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CH, I did not post the whole story, just a piece. Here is the article. I'm sure there are other articles out there with more info.

 

FDA wants restrictions on hydrocodone painkillers
Published October 25, 2013
Associated Press
  • Hydrocodone%20painkillers_AP_Oct%2025%20

    Hydrocodone bitartrate and acetaminophen pills, also known as Vicodin, are arranged for a photo at a pharmacy in Montpelier, Vt. (AP Photo/Toby Talbot, File)

The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.

The move comes more than a decade after the Drug Enforcement Administration first asked the FDA to reclassify hydrocodone so that it would be subject to the same restrictions as other addictive painkilling drugs. The FDA did not issue a formal announcement about its decision, which has long been sought by many patient advocates, doctors and state and federal lawmakers.

For decades, hydrocodone has been easier to prescribe, in part because it is only sold in combination pills and formulas with other non-addictive ingredients like aspirin and acetaminophen.

That ease of access has made it many health care professionals' top choice for treating chronic pain, everything from back pain to arthritis to toothaches.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. The ingredient is found in blockbusters drugs like Vicodin as well as dozens of other generic formulations.

It also consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the DEA, alongside oxycodone. Both belong to a family of drugs known as opioids, which also includes heroin, codeine and methadone.

Earlier this year the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

The FDA has long supported the more lax prescribing classification for hydrocodone, which is also backed by professional societies like the American Medical Association.

But the agency's top drug regulator, Dr. Janet Woodcock, said in a statement Thursday: "The FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

The FDA says it will formally request in early December that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled.

The Controlled Substances Act, passed in 1970, put hydrocodone drugs in the Schedule III class, which is subject to fewer controls. Under that classification, a prescription for Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified to Schedule II, patients will only be able to receive one 90-day prescription, similar to drugs like OxyContin. The drug could also not be prescribed by nurses and physician assistants.

The FDA's request for reclassification must be approved by officials in other agencies within the Department of Health and Human Services.

News of the FDA decision was applauded by lawmakers from states that have been plagued by prescription drug abuse, many who have been prodding the agency to take action for months.

"Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country," said Democratic Sen. Joe Manchin, in a statement. "Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities

Sen. Charles Schumer of New York noted that the FDA's own expert panel recommended the reclassification more than nine months ago.

"Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," Schumer said in a statement.

Still, Thursday's action immediately sparked criticism from some professional groups that said that the tighter restrictions could have unintended consequences, such as burdening health care workers and patients.

"The FDA's reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care," said Kevin Schweers, a spokesman for the National Community Pharmacists Association

 

http://www.foxnews.com/health/2013/10/25/fda-wants-restrictions-on-hydrocodone-painkillers/

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Fabulous. Another meaningless, expensive "initiative", manufactured by the bureaucrats, to justify their existence. So, reschedule hydro from an S3 to an S2? Oh, sure, that will DEFINITELY do the trick. Just like the entire "War on Drugs". Your tax dollars at work folks. Simply pitiful.

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Jewy, and while the FDA tries to crackdown, a drug company wants to introduce a 10mg hydro pill with no acetaminophen. Go figure.

 

 

http://www.10news.com/lifestyle/health/powerful-new-painkiller-zohydro-stirs-fears-of-overdose-addiction11122013

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The one w/out hydro is already available upon request from compounding pharms, at C 2. The proposal hasn't been approved, and I doubt the Doc lobbyist will let it happen. They may meet in the middle, with fewer refills or something, but around here many docs are not able to write C 2 already. Some people I know had to go from 0-pan-a or more-pheen to n0r-c0 from one visit to the next when doc lost C 2 license. That's my opinion as far as the rescheduling goes, but having patients put on C 3 instead of C 2 I know happened overnight to some Drs. 

 

Agree about war on drugs bs too. They should offer drug education just like sex ed imo. Seems the gov't would rather pay to educate after it's too late, like in prisons and jails.

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One of the sister companies where I work had an employee kill himself with Tylenol. He did just what you described and chugged a bottle of Tylenol and went into liver failure, coma, death. the hide by itself would be fine. We shouldn't have to lose our lives just to get a little dang relief!

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It's what the FDA requires for the C 3 level, apap that is. I've been using the same PM clinic for well over a decade and have taken every new item they offer, beginning with 0_C and lastly 0_P. The N0rc0 gave me best results but instead of poisoning me with apap they began scripting 30 mils of hide alone 4 x day. It's how I learned using a compounding pharm you could always get pure hide, they just never had discussed it because big pharms want to push their newest stuff out there.

 

The new stuff they are trying to, or maybe already did, get approval for (Z0H0 sp?) would just change it so all pharms had them. Hide works better for me than any other of the stuff, and I've tried them all over the last 15 years.

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One of the sister companies where I work had an employee kill himself with Tylenol. He did just what you described and chugged a bottle of Tylenol and went into liver failure, coma, death. the hide by itself would be fine. We shouldn't have to lose our lives just to get a little dang relief!

Exactly -- a doc once told me that accidental suicides frequently occur because the person felt relatively safe in "crying out for help" by downing a bottle of OTC pills. And as you say, liver failure, coma, death... all follow in pretty short order...

 

On the other hand, oh thank God our govt is once again looking out for us! Nanny-ism and prohibition have worked so well in the past, why wouldn't it continue? I already feel infinitely safer, and so well looked after! I could just burst into tears.

 

Meh. At least the last 6 words of the paragraph above are true.

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FYI for Fi@rlc@t users ~~~ I know not too many here use fi@c@t but thot it's worth posting ~ I'd heard Fi@ was it was going to be rescheduled in Jan. 2014. 

However, a friend who owns a smaller mom & pop type pharmacy told me they received notice on Nov. 21st that ALL formulations of Fioricet, both the old & new formulations, will be scheduled C-III as of November 22nd '13, so any OP's/IOP's could no longer legally sell it.

 

Nice to know they are given such a thoughtful time friendly heads up  <_< Reminds me of the almost overnight rescheduling of S@ma.

 

I've heard of many who've since ordered & received this just fine. 

I had placed an order 11/5 w/ MDAlig** who I'd used faithfully 4 many, many yrs. Not only did USPS mess up the shipping causing a delay, but the envelope finally arrived 11/22 empty, the day this rescheduling went into effect.

To add to the frustration, MDAlig** banned me. 

All could have been coincidental, but it's def. worth noting. 

 

I'd be interested to know if Fi@ users are ordering & receiving it as usual. Perhaps the pharmacy got that notice on Nov. 21, rescheduling went into effect Nov. 22 but Fi@ could be sold until the beginning of '14, tho IMHO, that sounds like a long shot. When S@ma was rescheduled, it was pulled & not sold, immediately.

 

Aloha to all ~  B)

M

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So, it did finally happen. I'll be interested to see what my PM doctor has to say about this on our next visit. I guess I'll have to change from 2 visits per year to 4. More expense for me and my insurance company. I guess the one benefit is that he'll have to script a 90 day supply at once as opposed to a 180 day supply that has to be refilled every 30 days. Still, this is a very negative turn of events.

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Wonder if this will have an impact on the price/availability from the sy guys.

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My feeling is that it will give SYs an excuse to raise their already high prices. but we need them and will have to pay the prices.

We will have to wait and see how this plays out.

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My feeling is that it will give SYs an excuse to raise their already high prices. but we need them and will have to pay the prices.

We will have to wait and see how this plays out.

Agreed, might want to stock up now, if you can. But big orders come with their own set of risks.

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Let's wait and see. The new rule goes into effect in 45 days. It will probably take a good 6 months to see how it affect the markets.

 

Ya know think about this. Its not like there is going to be a shortage. The Doc will probably write less scripts  since the refill option is gone. I'm not sure there will be a shortage, I think there actually may be an excess.

 

Any business, economics or finance people out here who care to make an guess at my assumption?. Hell just cause someone went to college doesn't make them smarter than non college graduates. I'll open this question go everyone on the board. We're all smart enough to take a crack plus everyone opinion here counts the same.

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