washingtonpost.com
U.S. Is Working to Make Painkillers Harder to Obtain
Patients May Suffer as DEA Battles Abuse

By Marc Kaufman
Washington Post Staff Writer
Sunday, February 15, 2004; Page A03


The Drug Enforcement Administration is working to make one of the nation's most widely prescribed medications more difficult for patients to obtain as part of its stepped-up offensive against the diversion and abuse of prescription painkillers.

Top DEA officials confirm that the agency is eager to change the official listing of the narcotic hydrocodone -- which was prescribed more than 100 million times last year -- to the highly restricted Schedule II category of the Controlled Substances Act. A painkiller and cough suppressant sold as Lortab, Vicodin and 200 generic brands, hydrocodone combined with other medications has long been available under the less stringent rules of Schedule III.

The DEA effort is part of a broad campaign to address the problem of prescription drug abuse, which the agency says is growing quickly around the nation. But the initiative has repeatedly pitted the agency against doctors, pharmacists and pain sufferers, and it is doing so again with the hydrocodone proposal.

Pain specialists and pharmacy representatives say that the new restrictions would be a burden on the millions of Americans who need the drug to treat serious pain from arthritis, AIDS, cancer and chronic injuries, and that many sufferers are likely to be prescribed other, less effective drugs as a result.

If the change is made, millions of patients, doctors and pharmacists will be affected, some substantially. Patients, for instance, would have to visit their doctors more often for hydrocodone prescriptions, because they could not be refilled; doctors could no longer phone in prescriptions; and pharmacists would have to fill out significantly more paperwork and keep the drugs in a safe. Improper prescribing would carry potentially greater penalties.

The DEA says the change is necessary because hydrocodone is being widely misused -- with a 48 percent increase in emergency room reports of hydrocodone abuse from 1998 to 2001. The drug, a semisynthetic chemical cousin of opium, produces a morphine-like euphoria if taken without a medical purpose but generally does not produce a similar "high" in patients with severe or chronic pain. Hydrocodone was one of several prescription painkillers that radio talk show host Rush Limbaugh acknowledged last year that he was addicted to.

"Hydrocodone is one of the most abused drugs in the nation," said Christine Sannerud, deputy chief of the drug and chemical evaluation section of the DEA. "The agency thinks it would be wise to move it to Schedule II, because that would help a lot in terms of reducing abuse and trafficking."

DEA officials would not say when they might begin the process of changing the schedule, but other federal officials said they understand that the DEA wants to act soon.

Under the federal Controlled Substances Act of 1970, the DEA places all narcotic or mind-altering drugs into one of five "schedules," and the medications are more or less available based on the potential dangers they pose and benefits they provide. Morphine-based hydrocodone, when combined with aspirin, acetaminophen or other common analgesics, has been a Schedule III drug since the act went into effect.

The DEA effort comes as the agency is already embroiled in a dispute with many pain specialists over the use -- and alleged overprescribing -- of another powerful painkiller, OxyContin. Scores of doctors have been arrested on felony charges of conspiracy, drug trafficking and even murder in connection with their prescribing.

Although the agency says the prosecutions are needed to shut down "pill mills" and stop unscrupulous doctors, many pain specialists say that the agency has become overzealous and that some doctors are refusing to prescribe needed painkillers because they fear DEA investigation.

"Rescheduling the drug will bring more hoops and barriers to getting access to the drugs, and it may prevent some minimal amount of abuse," said Richard Payne, president of the American Pain Society. "But my concern is that it will come at the cost of denying access to thousands of patients."

Susan Winkler of the American Pharmacists Association said her organization is concerned that the "ripple effects" would be substantial and negative.

"Our members and doctors would have increased liability if [hydrocodones] are rescheduled, and that will inevitably reduce prescribing," she said. "We urge the DEA to make sure their decision is based on science and will make the situation better, not worse."

Reflecting the complexity of the issue, the Florida legislature tightened rules on hydrocodone in 2000. At the request of state enforcement officials, lawmakers made the same change that the DEA wants. But in 2001, after patients and health care providers protested loudly, Florida repealed it.

The process of changing the classification of a controlled drug is cumbersome and time-consuming and involves a formal review by the Food and Drug Administration, a listing in the Federal Register and a public comment period. The DEA, however, has the final authority.

The DEA's Sannerud said hydrocodones have become an increasing problem as the number of Americans taking the drug skyrockets. According to statistics from IMS Health, which collects information about prescription drugs, the number of hydrocodone prescriptions rose from about 80 million in 1999 to 100 million in 2002. That is about four times as many prescriptions as are written annually for oxycodone, the active narcotic in the high-profile drug OxyContin.

Hydrocodone has been made for decades but, because most brands are less profitable off-patent drugs, it is generally not heavily marketed. Two generic versions, distributed by Tyco Healthcare/Mallinckrodt and Watson Pharmaceuticals Inc., were listed by IMS Health as the third and sixth most prescribed drugs in the nation last year.

Sannerud said the DEA has contacted several companies that make hydrocodone and not heard any strong opposition to a schedule change. Several of the larger manufacturers, however, said in interviews they were not aware of DEA's plans.

Sannerud said her agency took up the issue because of a citizen's petition filed by a doctor in upstate New York, Ronald Dougherty.

The doctor, who runs an inpatient drug recovery center outside Syracuse, said he had sent letters for years urging the rescheduling annually.

"With all the focus on OxyContin, the abuse of hydrocodones has been very underappreciated," said Dougherty, who remarked that almost a quarter of his patients are addicted it.

Charles Cichon, president of the National Association of Drug Diversion Investigators Inc., representing both law enforcement and prosecutors, said his group has urged rescheduling for years.

"This is widely accepted to be the nation's most abused prescription drug, and a big reason why is that it's Schedule III and can be called in by a doctor," he said. "That opens the door to a lot of abuse."

But John T. Farrar, a pain specialist at the University of Pennsylvania and a consultant to the FDA advisory panel on analgesics, said taking away a doctor's ability to call in a hydrocodone prescription would have serious consequences for patient care.

"There's really no substitute that doctors would be allowed to call in," Farrar said. "That means many patients would probably be getting other Schedule III drugs that are less effective for their pain, while drug abusers will just find another source."

Freaking DEA Nazis!!!!!! I just love having Big Brother decide what is best for me. Don"t these fools realize that just changing the shed # on a drug doesn't stop availabitlty. If I had the desire and the money I can get all the Oxycontin I want on the street. Not to mention herion or coke or just about any other drug you would care to name. All they do by making it harder for caring Drs to prescribe is put it on the street in the hands of dealers and eventually make criminals out of descent people who need it.

they think they know all, well we are people in pain, they must not live with pain every day why dont they just leave us alone? i think this will only get bad, now they are trying to get fedex and ups to stop taken packages, what a mess

This is typical of the DEA. Guess they do not have enough to worry about. What *** me off is that we are not hurting anyone, nor are we selling or pushing. We are using this to live a productive pain free life. Sure there are some unethical people out there but no matter what you are dealing with you will find that. (what about the stock exchange?) They should stay out of this and let us decide what is right for us. If someone is "pushing" them illegelly then deal with that. This doenst hurt the those types of people. They always find a way to get the drugs, stealing, etc. It only hurts the honest people trying to manage the daily pain in their lives. Stay out of my life! This is supose to be a free country.

Dewie

Well you all need to tell your senators how you feel. If we just sit here and bitch among ourselves we will not change anything!! Let me see if I can find some links to complain to!

Contact Links for you state senators


http://capwiz.com/eprescribe/home/



And for the Watson Company

The Link to Watson Labs is to contact them to see how they FEEL about their NUMBER 1 MED. being rescheduled!!!!........Maybe a letter writing to get them to use their lobby power......


http://www.watsonpharm.com/contactus.asp


LETS GIVE THEM HELL!!!

if they could just figure out a way to get in on the profits they would leave it alone,,,,most of them are alcoholics anyways,,,they just need a way to get in on it,,,think,,,hard,,,,how can we help them.,,,,hmmmmm? I bet they would never consider changing valiums or xannies,,cause that keeps there wives off there backs.

This is their last hope at stopping OP's.

I urge everyone to contact their representatives but I doubt it will do any good. The DEA does whatever they want whenever they want and the agency itself is based off unconstitutional and unjust laws.

Dear Chris of NorcoWorldwide:

What are your thoughts re: the article on the DEA efforts to Sched II Hydrocodone? I would be very interested in hearing your perspective. If it would be politically problematic (and bad business) to voice your thoughts I would understand but otherwise you have a different perspective than the rest of us.

Thanks.


JEG

had to

im going to check into writing the senator. this is b.s
im really mad at all the crap thats going on in this world.. watch in a few yrs they are going to try to make everything seg.ii drug. they need to get a life

Check out the links blondie posted. They offer a great way to voice your concern and or position on this matter with just a couple of clicks with your mouse.

I personally sent the following message both electronically and snail mail way using this link.

http://capwiz.com/eprescribe/home/

I am a 43 year old heavy equipment operator/construction worker with a messed up back from an auto crash 20+ years ago and a lifetime of hard honest work.
I depend entirely on hydrocodone/tylenol medicine known as Vicodin for daily relief and nighttime pain free rest.
Without these meds, I cannot sleep because of back pain and it has made my quality of life more than just bearable, but enjoyable. I now have the freedom to enjoy pain free family time after work instead of just lying on the bed writhing in pain.
Please do not allow the DEA to change the schedule of these meds from schedule III to schedule II.
Please support my access to quality US based online pharmacies who carry the hydrocodone prescriptions, and doctors who will prescribe them for the legitimate pain management needs of myself and the many thousands upon thousands of other people in our country who would suffer with unbearable pain if the above laws change or are passed.

How long does it take for them to do something like this? Are we talking years or something in the near future?? This is absolutely the worst thing that could happen, worse then them just going after op's. I have a dentist that calls in vicoden, no question, if you have a toothache after hours. What the heck could he call in if this passes, tylenol and codeine? That stuff is useless for anyone older than 15!! If this happens I can't even imagine what my life would become...I can just picture the news article...."Since the DEA changed hydrocodone to schedule II there is much less abuse of the drug....in other news, since the DEA changed hydrocodne to a schedule II drug the suicide rate in the US has more than tripled..." I can take ultram if I have to for wd's, but just last week I tried to take only ultram for a week to see if I could stop using hydro...it kept wd's at bay, but was pretty useless for my pain, and by the end of the week it wasn't doing anything for me at all...it seems like you build a tolerance to ultram quicker even than with hydro...I can't imagine what my life would become without hydro and OP's...I would also like to hear Chris' opinion on this matter...I'm sure it wouldn't be good for his business...at least it wouldn't ruin his whole life though!!!We ALL have to do something about this NOW, we CANNOT let them do this to us!!!! I always said I wouldn't wish this pain on my worst ememy, I take it back now...I wish that every person in the DEA would have to feel like we do, that would change their minds pretty quick...if that happened, I'd bet that oxy would become a schedule I in no time!

I'm hoping the DEA is just posturing on this. They can have the image of wanting to crack down on drug abuse, then the pharmaceutical lobbiest, MDs, dentist, pharmacist and all us law abiding citizens with chronic pain, can participate in open hearings on how bad this idea is.

However, I do feel a desire to stockpile.

My 2 cents.

Susan

Unfortunately the DEA has a lot of power and often times when it comes to scheduling substances sides against its only panel of judges and scientific advisors.

Now the re-scheduling of Hydrocodone is a very unique position. Generally the DEA request a schedule change to outlaw a substance because of its safety. Taking it from unscheduled or non-controlled to a schedule 1. Chemicals or medicines have to have certain characteristics to be labeled a schedule 3, 4 or 5 and it mainly depends on its medical value and abuse potential.

If the DEA wants to they could hold an emergency hearing and immediately suspend the use of a substance. This is normally good for 30 days and gives both supporters and opponents ample time to make their case (jk). After this the substances is prohibited. (This is if they wanted to ban a substance)

It�s obvious that telemedicine is one of the main reasons why they want to try this approach since it�s really the only thing they can do to stop "reckless" prescribing. They cannot regulate the internet, or the States or even the Drs so if they go after the med. Well, it was bound to happen. Like the rest of you I�m very concerned about this and interested in its outcome.

However, like was mentioned in the article Drs will now have huge amounts of liability and with that comes money. Writing your congressman may be futile since the DEA answers to no one. The only thing that could stop this is $$$.