Hydrocodone combos now a schedule II

[UpRegulated]

Bad news for PA's, NP's that can't prescribe schedule II's, and more red tape for those who can.

 

http://www.medscape.com/viewarticle/830287

 

[FBIDoc]

From http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0822.htm

 

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-389]

Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.

DATES: This rule is effective October 6, 2014.

[KMD16]

Goes in full effect in 45 days.

[True Anomaly]

Don't forget also that Tramadol is now a schedule IV drug

[EMEDPA]

I have sch 2 DEA everywhere I work so this doesn't effect me, but I realize some folks work in states with 3-5 only. That sucks because now the best you can write for is t3 for fxs/burns/etc without cosig.

time to get working on sch 2 DEA in those states.

[Guest Paula]

My 2 state licenses allow schedule II.  I agree with getting sch II DEA in those states without it but I believe it will be a battle.  

[Gordon, PA-C]

There's a day coming down the pipeline when all providers who want schedule II are going to have to take extra training.  A few states are already considering it.

 

That sucks when the 5% of bad/idiot providers ruin it for everyone else.

 

 

[ventana]

We providers created this nightmare

 

We were unable to fix it on our own (stop writing them)

 

so the DEA stepped in

 

 

I am glad for this - not for my own practice as it is going to much harder in a house call practice, as I can't just "schedule them to come into the office" and at the same time the patients are physically unable to  "come into pick up a script"

 

Honestly a great thing, and almost all the negative is removed if they simply allow for e-prescribing of the meds........

[Guest Paula]

e-prescribing would be so much easier.  It could reduce fraud too and a patient wouldn't  be able to alter a script.  Plus with it going directly to a pharmacy the pharmacy has the original script.......just not our original signature.  There are ways to e-sig and have it be legal but it would take moving mountains to use a common sense approach.

[Hawkfish]

There's a day coming down the pipeline when all providers who want schedule II are going to have to take extra training.  A few states are already considering it.

 

That sucks when the 5% of bad/idiot providers ruin it for everyone else.

 

You do now in Washington State.

 

http://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/HealthcareProfessionsandFacilities/PainManagement

[EMEDPA]

You do now in Washington State.

 

http://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/HealthcareProfessionsandFacilities/PainManagement

this only applies to chronic pain management, not acute.

[Guest Paula]

Ha ha it goes into effect on PA day.

[shani26]

At my clinic Vicodin was the most prescribed medication- and we have dentistry, urgent care, Ob/gyn, peds, family medicine, HIV medicine and a suboxone program( last two don't get Vicodin obviously)... I agree with the previous post especially when it comes to family medicine- this makes my job easier against drug seekers and those who simply refuse to do what they are supposed to to get better. Out of all of our chronic pain issues that we have on our panel- only a small amount actually qualify for Vicodin or controlled medication. There is one physician who is going to have a problem with this especially because  he has a lot of chronic pain patients on his panel- and incidentally always catching people misusing drugs.

[CAAdmission]

That sucks because now the best you can write for is t3 for fxs/burns/etc without cosig.

T3? You might as well use tic-tacs!

[ventana]

T3? You might as well use tic-tacs!

 

 

have to disagree there

 

T3 metabolized to morphine

 

morphine certainly works well

 

 

 

Hydrocodone/Acetaminophen Not Superior to Codeine/Acetaminophen for Acute Pain

Nancy A. Melville

March 13, 2014

PHOENIX, Arizona — Hydrocodone/acetaminophen (Vicodin, AbbVie) was not superior to codeine/acetaminophen (Tylenol #3, McNeil) in acute pain relief reported by patients 24 hours after being discharged from the emergency department, according to a new study.

While Vicodin is the most popularly prescribed opioid in emergency departments, the drug and other hydrocodone combination formulations are under consideration by the US Food and Drug Administration (FDA) for rescheduling from a Schedule III drug to a more tightly regulated Schedule II drug. New York State has already made the change.

With Tylenol #3 representing a potentially ideal alternative, researchers sought to compare the 2 drugs — and found existing evidence was scant.

"The reason we conducted this study was because there was very little evidence supporting the superiority of Vicodin over Tylenol with codeine, despite its heavy preference in the emergency department setting," said lead author Andrew K. Chang, MD, MS, an associate professor of clinical emergency medicine at the Albert Einstein College of Medicine and attending physician at Montefiore Medical Center, Bronx, New York.

"There was no significant difference in side effects, [and] our results showed that Vicodin failed to provide superior pain relief compared to Tylenol with codeine."

The findings underscore that clinicians should consider prescribing Tylenol with codeine instead of Vicodin when discharging nonelderly patients with acute extremity pain from the emergency department, but Dr. Chang noted an important caveat: patients in groups known to not metabolize codeine normally.

"It's important to be aware that there are codeine hypermetabolizers — for example, up to 30% of African/Ethiopians, who rapidly metabolize codeine to morphine and hence can develop respiratory depression and even death," he cautioned. "At the same time there are some patients who cannot metabolize codeine at all, and hence receive no analgesic effect."

The study — which did not receive outside funding — was presented here at the American Academy of Pain Medicine (AAPM) 30th Annual Meeting.

Opiate-Naive Patients

For the double-blind study, Dr. Chang and his colleagues randomly assigned nonelderly, opiate-naive emergency department patients who had presented with acute traumatic extremity pain to a 3-day supply of hydrocodone/acetaminophen (5/500 mg; n = 88) or codeine/acetaminophen (30/300 mg; n = 93).

The researchers contacted the patients a median of 26 hours after discharge and asked for their 0 to 10 numeric rating scale pain scores just before and 2 hours following the most recent ingestion of the drug.

They found that the pain score before the most recent dose of pain medication was the same for both groups: 7.6. A high pain score was expected as that would prompt patients to take the prescribed pain medication. Patients reported the mean decrease in the pain scores 2 hours after pain medications to be 3.9 in the hydrocodone/acetaminophen group and 3.5 in the codeine/acetaminophen group, for a between-group difference of only 0.4.

"Both medications decreased pain scores by approximately 50%," the authors write. "However, hydrocodone/acetaminophen (Vicodin [5/500]) failed to provide clinically or statistically superior pain relief compared to codeine/acetaminophen (Tylenol#3 [30/300])."

Adverse events, mainly drowsiness, dizziness, and nausea, were not clinically or statistically different between the groups, the authors note.

The study also is being published in the March issue of Academic Emergency Medicine.

The authors noted that they found just 1 other trial, from the University of Pittsburgh, Pennsylvania, comparing the 2 drugs in an emergency setting. That study also showed no significant difference in the mean or median pain scores between 2 groups of patients taking either of the medications over 48 hours following ED discharge for acute musculoskeletal pain.

"It was surprising to find so few studies comparing hydrocodone/acetaminophen to codeine/acetaminophen for acute pain, including in the emergency department setting," Dr. Chang said.

"I think the reason for this is that in general, emergency physicians have the impression that Tylenol with codeine is a far inferior pain medication when compared to Vicodin."

"Impressions are not evidence-based, however, and our study questions that long-standing belief," he said.

Deep-Seated Perceptions

Andre P. Boezaart, MD, agrees that Vicodin's popularity over other alternatives is largely a matter of deep-seated physician perceptions.

"My personal opinion is that this is purely a marketing and cultural issue," said Dr. Boezaart, professor of anesthesiology and orthopedic surgery in the Division of Acute and Peri-operative Pain Medicine at the University of Florida College of Medicine in Gainesville.

"[Vicodin] is marketed in the US as a serious drug that one uses for serious pain. Common perceptions meanwhile suggest that Tylenol is a safe and mild drug given to children with fevers and colds and used for mild headaches, and is not a serious drug to use for real pain," he told Medscape Medical News.

Patients with acute pain who learn they are receiving Tylenol may have the impression that they are not being treated with a true pain medication, Dr. Boezaart said.

"We experience this every day when we prescribe the very effective [every 6 hours] scheduled [intravenous] Tylenol 1000 mg to patients with severe acute pain," he said. "Patients will be quick to tell you that their pain is real and will not respond to a mild drug like Tylenol."

For that reason, Dr. Boezaart suggested that the name "Tylenol" even be dropped from the formulation of codeine and acetaminophen and replaced with something else.

"The company manufacturing Tylenol #3 would do the population a great favor if they changed the name to something that does not contain the word 'Tylenol,' but something that suggested treatment for serious pain, and then actively market it for that purpose."

In the absence of a name change, studies such as Dr. Chang's can help establish the drug's efficacy in comparison with its more popular competitor, Dr. Boezaart said.

"This is certainly the first study that I am aware of that compares Vicodin (5/500 mg) with Tylenol (30/300 mg)," he said.

"Every instinct would dictate that the latter should be a safer choice, but only further studies like this one by Chang et al would clarify this claim."  

The study did not receive funding. Dr. Chang and Dr. Boezaart have disclosed no relevant financial relationships.

American Academy of Pain Medicine (AAPM) 30th Annual Meeting. Abstract 163. Presented March 8, 2014.

Acad Emerg Med. Published online March 13, 2014. Abstract

 

Medscape Medical News © 2014  WebMD, LLC 

[cc56]

I read an article (quickly) about California trying to pass a new law.  It would require a prescriber to use CURES (Schedule drug monitoring database) before being able to prescribe controlled meds.  I like the idea behind it.  I personally check 99.99% of patients who call in for a narcotic refill.  I do not check patients who come into the clinic unless I have a funny feeling.  I just find it funny how one side is screaming "Pain the 5th vital sign... you have a right for your pain to be adequately controlled" and the other side screaming " abuse of narcotics... 99% of all the norco made in the world is consumed in the USA.... tens of thousands killed by pain meds".  When it comes down to it the training I got was "listen to your patient and they will tell you if they have pain, just go off of that basically" 

 

In the end I see people prescribing larger amounts  "#50 with one refill" V.S. "#100".  At least with the 50 the patient had to go back to the pharmacy to get the other 50, if it was too quick the pharmacist could stop it.  Now they get all 100 and then we learn they have a problem.    Don't get me started on reimbursement being tied to patient satisfaction, and studies showing higher prescribers of narcs have better patient satisfaction scores! 

[EMEDPA]

  Don't get me started on reimbursement being tied to patient satisfaction, and studies showing higher prescribers of narcs have better patient satisfaction scores! 

we have one doc who went from  worst to first in pt satisfaction scores by deciding to write percocet for anyone who wanted it for 1 year. true story.

[rev ronin]

The funny thing about the above study is that it's already out of date--5/500 is essentially gone from my supply chain, and I never used it anyways.  I wonder if 5/325 might actually be inferior to 30/300 codeine?

[jen0508]

Hopefully my state will change law to allow PA's to write for schedule II, though i doubt this will happen any time soon SMH, this sucks for ED PA's.

[Febrifuge]

e-prescribing would be so much easier.  It could reduce fraud too and a patient wouldn't  be able to alter a script.  Plus with it going directly to a pharmacy the pharmacy has the original script.......just not our original signature.  There are ways to e-sig and have it be legal but it would take moving mountains to use a common sense approach.

My state has this, but Sched II and I think III need a hard copy with signature in non-black ink, as well. Honestly it works well, I think. Some seekers believe me when I explain how much of a pain it is. }:)

[Febrifuge]

I read an article (quickly) about California trying to pass a new law.  It would require a prescriber to use CURES (Schedule drug monitoring database) before being able to prescribe controlled meds.  I like the idea behind it.  I personally check 99.99% of patients who call in for a narcotic refill.  I do not check patients who come into the clinic unless I have a funny feeling.  I just find it funny how one side is screaming "Pain the 5th vital sign... you have a right for your pain to be adequately controlled" and the other side screaming " abuse of narcotics... 99% of all the norco made in the world is consumed in the USA.... tens of thousands killed by pain meds".  When it comes down to it the training I got was "listen to your patient and they will tell you if they have pain, just go off of that basically" 

 

I was "brought up" with the idea that pain is subjective but real, and should be treated, at least in the ER setting while the person is in your care. I still hold to that, and fractures almost always get at least offered the 'good stuff.'

 

And I run almost everyone through the state database (which now is able to check several other states!) if they come in with a pain complaint in the first place. I do this before I ever lay eyes on the patient. My "funny feeling" about potential abuse is also on a hair trigger, based on experience. Coming to see me, but there are no records of you in our system? You live 35 miles away on the other end of town entirely? You came in 15 minutes before closing time? If your complaint is pain-related, I'm running you through the database like everyone else. If not, and you just casually mention it during the visit, I'm looking you up before I do anything. It just takes a minute.

[cc56]

I prescribe narcs due to being in Ortho.  Every surgery patient gets norco 10's, some get percs, and occasionally oxycontins (not all 3 same time).  I set the expectation early that you will be getting off the stuff.  If you come in and tell me NSAIDs don't work and tramadol doesn't work, only norco 10's... My radar goes up and I usually check.  I also may just presribe a few norco 5's for low back pain.  Usually it is NSAIDs, PT, and flexeril.  The last bit of medicine is talking up your treatments and encouraging that it will work. 

[GetMeOuttaThisMess]

The one thing that I don't understand is how the human population over the past 30 years all of a sudden has more severe pain with the same types of injuries that were being dealt with then and they seemed to do just fine with nothing more than hydrocodone 5 mg. four times a day, at max.  "But we weren't satisfactorily addressing their pain" some would say.  If that were the case then why weren't they calling the office to make us aware of it?  I could easily count on one hand the number of times my SP in spine pulled out his schedule II pad to write a prescription for patients over a year's period of time.

 

I guess that I got up on the wrong side of the bed this morning (my wife would concur) but I think that we've led patients to believe that "no pain" is the standard of care, which IMO is a wrong impression.  Life hurts.

[Febrifuge]

 

...Life hurts.

 

Well-said. I think it's cultural, and I guess that means it makes sense that it seems to have shifted since we were younger.

 

I also see a lot of people who have viral URIs, for example, and they seem to be having a tough time grasping the concept of a URI being something that lasts 1 to 2 weeks, instead of just a couple of days. I have a speech I've worked on over a long time, explaining that most of us have immune systems so well-tuned, we can catch a little bug, have it bounce off us in 48 hours, and feel only a little mild inconvenience. This has become our usual, and we have started to think of that as what it means to "be sick."

 

But it's not. A couple times a year, we catch something - still a virus, but new to us, something we don't have antibodies for yet - and it puts us through the ringer. "I've been sick for 5 days now, I'm never sick that long, it must be serious, give me antibiotics," they will say. But the logic is flawed, and the conclusion is wrong. People are just not used to being sick for real, and something you'll get over in time feels like something you might die from. The trick is finding a professional and compassionate way to say "suck it up, Buttercup, you'll be fine."

[PACdan]

I guess that I got up on the wrong side of the bed this morning (my wife would concur) but I think that we've led patients to believe that "no pain" is the standard of care, which IMO is a wrong impression.  Life hurts.

 

This. Through a confluence of modern technology, popular/science fiction media, and aggressive drug advertising; people believe that medicine can eliminate pain. If I recall, only the United States and New Zealand allow pharmaceutical companies to market as aggressively as they do. The populous is unable to grasp that with all the medicine that is available, there isn't a 'magic bullet' pill to take away 100% of their pain. I'm sorry, but that's called being numb, not alleviated. Pain, to a specific degree, let's you know you're still alive. But we have created a culture where almost ANY mount of pain is interpreted as a problem which must be corrected with drugs. And to not do so is harming the patient, and makes you an uncaring clinician.

 

This 1987 ad sums up a lot of what's wrong on many levels: