Petition for FDA to reconsider approving Zohydro.

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Id rather have 50mg zohydro than oxy 80, msc 100, fent 100, or opana 40.

Why dont we take away high doses first.

Agree, but do we really need any new opiates at all?

We need a moratorium on new opiates for 10 years.
 
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Agree, but do we really need any new opiates at all?

We need a moratorium on new opiates for 10 years.

I don't think so. I'd like it to rotate my well assessed, reviewed, and appropriate folks over to to get their MSO4meq lower. If someone is on Oxy 40 tid I can switch to Zohydro 50 bid (due to cross-tolerance ;)) It's another tool in the bag and it will lower meq across the board while providing same pain relief. PCP starts patient on Norco 10mg and gets them to 4x per day or more. If and when appropriate and can make 4-6 pills go to 2 pills per day.
 
Pros: Less pills on the street if doctors can control their prescribing, stops the roller coaster ride of blood levels with norco
Cons: chewing them will give patient a buzz, same problems that the original oxycontin had, no advantage over Exalgo, will be very expensive and on a high tier, if covered at all.

I was very surprised the FDA approved it given their disapproval of generic oxycontin....if I were a betting man, I would surmise someone on the FDA is on the take.
 
What I'd like to know is if Zohydro has biphasic pharmacokinetics like the original Oxycontin.

After reformulation in 2010, nobody has been asking me for Oxycontin 80mg tabs. Now they just ask for roxicodone 30's or 60's and Soma/benzos.
 
What I'd like to know is if Zohydro has biphasic pharmacokinetics like the original Oxycontin.

"Though the narcotic in Zohydro ER is designed to be released slowly over 12 hours, pleasure-seekers will be able to crush it, chew it or mix it with alcohol to unleash its full punch at once."

""While the current formulation of Zohydro ER does not have abuse-deterrent or tamper-proof features, we have started the development of an abuse-deterrent formulation and are committed to advancing the program as rapidly as possible," said a statement from Zogenix, the company that makes Zohydro."


http://www.jsonline.com/watchdog/wa...se-concerns-b99128369z1-229484621.html?ipad=y

After reformulation in 2010, nobody has been asking me for Oxycontin 80mg tabs. Now they just ask for roxicodone 30's and Soma/benzos.

That tells you a lot right there, doesn't it? Consider taking a pledge not to prescribe those three (roxicodone, soma, benzos) in your practice (except 1-2 pill, one-time benzo dose pre-MRI, or pre-procedure).
 
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Because of the FDA decision to not approve generic oxycontin and permit the name brand to keep their patent until 2025, they will have held a patented FDA approved drug for 31 years. This is obscene. Roxicodone costs 5% as much as Oxycontin, and more and more insurance companies are figuring this out, denying oxycontin. Affordable alternatives include roxicodone, MS Contin, methadone, fentanyl patches, or hydromorphone. Nucynta, suboxone, butrans, Exalgo, or any long acting morphines (Kadian, etc) are not covered by most insurances. Therefore many patients around the country are being placed on obscene amounts of short acting oxycodone. A recent referral from a PCP (we did not accept the patient) had the patient taking 20- 30mg tabs roxicodone a day. It is out of control prescribing of short acting opioids. Partially due to actions of the FDA.
 
Therefore many patients around the country are being placed on obscene amounts of short acting oxycodone.

It is more than insurance coverage that's driving this in my neck of the woods. In many - if not most - instances it's patient preference and physician familiarity/culpability.
 
I Rx a lot of oxycodone in all strengths. From 5-30mg. Mostly bid, rarely qid (up to 5 of my patients). UDS, visits every 30-60 days, database checks, and documentd functional improvement or the med gets reduced or stopped. I have a 93 y/o on 3-4 oxy30's per day. She plays bingo, does ADL's. Not yet palliative care. She is fiesty. And pees in a cup at least 4x per year. No side effects. Problems?
 
The majority of the oxy 30's that I'm seeing are going to 40y/o's with LBP, FMS, HA etc. I don't have any patients on Oxycodone 30 IR, why would
I when I can prescribing a tamper resistant product with less euphoria and risk?
 
Therefore many patients around the country are being placed on obscene amounts of short acting oxycodone.

It is more than insurance coverage that's driving this in my neck of the woods. In many - if not most - instances it's patient preference and physician familiarity/culpability.

Agree. Anytime I have a patient requesting a cash pay eval, it's invariably to request Roxicodone and Soma. If they're only using hydrocodone products or a few Percocet, the PCP usually will not refer them.

In my community, for some PCPs in the urban areas, it is their preferred regimen. Dumbfounded by this.

On the other hand, after the reformulation of Oxycontin, I stopped seeing the massive/rapid dose escalation that had been commonplace with this drug.
 
I Rx a lot of oxycodone in all strengths. From 5-30mg. Mostly bid, rarely qid (up to 5 of my patients). UDS, visits every 30-60 days, database checks, and documentd functional improvement or the med gets reduced or stopped. I have a 93 y/o on 3-4 oxy30's per day. She plays bingo, does ADL's. Not yet palliative care. She is fiesty. And pees in a cup at least 4x per year. No side effects. Problems?

It's the exception that proves the rule. That type of patient is the absolute least likely to have a problem with a formulation switch or opiate rotation. Of course, until the phone call comes later, from the angry family member with a vested interest in the prescription being switched back to Roxicone 30mg, #120.
 
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Agree. Anytime I have a patient requesting a cash pay eval, it's invariably to request Roxicodone and Soma.

Are they as happy to pay cash for a UDS q3 months and updated imaging or diagnostics if needed to establish "legitimate medical need" as required by the DEA?
 
Dose is an indepent risk factor that vigorous downstream surveillance measures can't adequately mitigate against. Surveillance measures may make you feel better, and look good in the event of a board review, but it's a false sense of security. If you are prescribing > 120MED with regularity you are putting your patients at risk regardless of how many pill cnts, UDS, or f/u visits you are performing.
 
Dose is an indepent risk factor that vigorous downstream surveillance measures can't adequately mitigate against. Surveillance measures may make you feel better, and look good in the event of a board review, but it's a false sense of security. If you are prescribing > 120MED with regularity you are putting your patients at risk regardless of how many pill cnts, UDS, or f/u visits you are performing.

I agree, in general about dose, but I take a slightly different view as to why dose is so important. I don't think it's the dose itself that affects the patient, but:

The highest risk patients that affect the dose.

We all know that with slow dose titration, the human bodies' ability to develop tolerance and adjust to very, very high doses of opiates is profound. In laboratory-like conditions, there is no ceiling to opiate dose, and very high doses can be tolerate if slowly titrated and doses are taken regularly without variation. The key is, "laboratory-like conditions." Patients don't live in a vacuum or in laboratory-like conditions.

Most importantly, and this is something that may have been said, but I haven't heard said out there:

Dose is a marker for the highest risk, and the patients least appropriate for opiate treatment in the first place.

Just think about how someone ends up on ultra-high dose opiates, like the patient Algos mentioned, on 20-30 Roxicodone per day (assuming 30mg). That doesn't occur in isolation, in a short period of time or likely under the care of a single prescriber, usually. Often times these are patients that may in fact have legitimate medical need and are started on an opiate at some point. At some point they develop tolerance and the dose is increased. At some point, tolerance develops again and dose is increased to a certain level. At some point the physician reaches the ceiling of his comfort zone on dose. At this point, one of two things are going to happen. Either the patient realizes that they're on a much higher dose of opiates than they started on, they still have some pain, and always will have some and that they're satisfied with some pain relief at the dose they're at. They realize their pain control will never be 100% perfect, even with endless dose titrations. They maintain on this low or moderate dose long term. That's one type of person, and a very reasonable person.

The other, is the person who just cannot level off and stay at a dose, any dose. It may have nothing to do with addiction, diversion or anything nefarious. They just want more pain relief and want just one more dose increase, stronger or different medicine to bring it. No matter what the dose, tolerance develops and that magical feeling of "zero pain" just never stays around.

So they become dissatisfied, and they switch doctors. Naturally, they find one comfortable with the doses they're on and more importantly, comfortable with the one thing they've know to reduce their pain, at least temporarily, in the past: further dose increases and a belief that opiates in some form are the default solution. The cycle continues to repeat, with endless dose escalation, repeated tolerance development, and dissatisfaction when the pain relief wears off. Therefore, such patients, who probably are the very worst candidates for chronic daily opiates to begin with self-select for the highest doses, due to their propensity to repeatedly develop tolerance combined with the least realistic expectation of a 100% pain-free life. Ultimately once they hit the ceiling of any particular doctors dose comfort zone, they look for a doctor who will do the only thing they believe and have been told, will reduce their pain: more and stronger opiate medications.

This can all occur in patients with completely legitimate medical need, combined with a well intentioned doctor that believes that opiates, if titrated slowly and carefully enough with the proper monitoring do not have or need a dose limit. This cycle is most likely to be perpetuated in those most insistent upon more medication, in greater doses, more frequently. It is least likely to occur in someone with the tendency or capability to accept and deal with soome level of pain, and that there is a limit to what an opiate can do at any dose. Throw in a poorly trained or unscrupulous doctor, combined with a patient who's doing their best to hide an addiction, and you accelerate the cycle dramatically and have a recipe for disaster.

So, in conclusion, if you want to reduce risk, yes, lower dose or have dose limits such as 120mg MED. You'll absolutely see risk reduction in your population, but not necessarily in any given patient. What you will see, is a risk reduction in your patient population, because those that are already higher risk and therefore on higher doses, will leave your patient population and move on to one that is more risk tolerant, or move on to another source of opiates entirely. Ultimately, you select out the highest risk population by taking the highest doses off the table, and are left with a much more stable, and lower risk group of patients.
 
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Dose is an indepent risk factor that vigorous downstream surveillance measures can't adequately mitigate against. Surveillance measures may make you feel better, and look good in the event of a board review, but it's a false sense of security. If you are prescribing > 120MED with regularity you are putting your patients at risk regardless of how many pill cnts, UDS, or f/u visits you are performing.

Is there data linking intensity of adherence monitoring activities to complications and death? I ask because I just submitted a grant to study it in a health services context. I couldn't find one reference speaking to the assertion you made....
 
The assertion I made is that dose is an independent risk factor for undesirable outcome. There is alot of resistance to that assertion here.

The effects of surveillance measures on outcome is separate issue and certainly worth studying. My point is that, when dose is high enough, even the
best surveillance measures won't mitigate the risk.
 
What's so special about Roxicodone that makes it so desirable over other short acting oxycodone formulations i.e. percocet, oxycodone, percodan, tylox, endocet?
 
What's so special about Roxicodone that makes it so desirable over other short acting oxycodone formulations i.e. percocet, oxycodone, percodan, tylox, endocet?

The Tylenol in those preps does not eliminate, but dose limits the abuse potential, compared to any of the short acting preps without Tylenol. Yes, any opiate is abusable, but 80mg of Percocet 10/500 puts one at the toxic dose of Tylenol already (8 tabs = 4,000 mg Tylenol). The people that abuse these medicines know the Tylenol will kill you before the opiates even will. To remove the Tylenol, they have to go through a process called "cold water extraction" to chemical extract the Tylenol. Yes, such medicines are still abusable, but as you can imagine, that's an epic PITA, when you can just move on down to the next doctor that will prescribe the stuff that can be crushed, snorted or injected IV without having to chemically alter it, ie, roxicodone (or any short acting oxycodone without Tylenol and without the newer abuse deterrent OxyContin formulation).

http://forum.opiophile.org/showthread.php?45-cold-water-extraction

Again, to be the one guy in town that doesn't prescribe the #1 most abusable prescription pill with the highest street value at all, for any reason, is not a bad thing in this day and age.
 
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The assertion I made is that dose is an independent risk factor for undesirable outcome. There is alot of resistance to that assertion here.

The effects of surveillance measures on outcome is separate issue and certainly worth studying. My point is that, when dose is high enough, even the
best surveillance measures won't mitigate the risk.

I'm only interested in complications (ED visits for overdose and death) as a function of adherence monitoring intensity across different venues not treatment outcome---stratifying high and low adherence monitoring practices and looking for overdose and death. It will be simple enough to post-hoc analyses looking at dose equivalents between high and low adherence monitoring sites.
 
Wouldn't you think that those practices that provide the most intense down-stream monitoring would also perform the most strenuous risk stratification at the frontend? I'd venture that the physicians who are savvy enough to understand the risks downstream, are also savvy enough to risk stratefy at the front end. I think what your study will confirm is that doctors who don't perform surveillance also don't risk stratify.
 
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Wouldn't you think that those practices that provide the most intense down-stream monitoring would also perform the most strenuous risk stratification at the frontend? I'd venture that the physicians who are savvy enough to understand the risks downstream, are also savvy enough to risk stratefy at the front end. I think what your study will confirm is that doctors who don't perform surveillance also don't risk stratify.

Risk stratification is part and parcel of adherence monitoring. I don't see how to do one without the other...though I'm sure it happens. My preliminary data is that the community practice, especially in rural areas, is not uniform with respect to either risk stratification nor adherence monitoring.
 
1st visit patient is told I don't write for Roxy, Oxycontin, Soma, or Methadone. If that isn't satisfactory, I may not be the right doc for you.
 
EMD123: I think your argument is mostly correct. The majority of unintentional ODD are in white males ages 40 -50. Thus,
the majority of unintentional ODDs probably represent a risk stratification failure on the part of the prescriber. They shouldn't have
gotten the prescription to begin with, let along a high dose.

We have a very good opioid prescribers group down state in OR. (drusso has mentioned them in the past.) I was reviewing their last
meeting minutes and one of the top comments on the benefits of the group was "Mr. nice guy is gone." When PMDs start doing UDS
and talking to experts, they start risk stratifying more vigorously and realize who shouldn't have gotten the script to begin with. When
that person does get the script sometimes even the most aggressive downstream vigilance cant rescue them from themselves. Establishing
who NOT to prescribe to at the outset will probably save a lot more lives than REMS.

1. http://www.cdc.gov/mmwr/preview/mmwrhtml/su6203a27.htm
2. http://www.ncbi.nlm.nih.gov/pubmed/23070654
 
EMD123: I think your argument is mostly correct. The majority of unintentional ODD are in white males ages 40 -50. Thus,
the majority of unintentional ODDs probably represent a risk stratification failure on the part of the prescriber. They shouldn't have
gotten the prescription to begin with, let along a high dose.

We have a very good opioid prescribers group down state in OR. (drusso has mentioned them in the past.) I was reviewing their last
meeting minutes and one of the top comments on the benefits of the group was "Mr. nice guy is gone." When PMDs start doing UDS
and talking to experts, they start risk stratifying more vigorously and realize who shouldn't have gotten the script to begin with. When
that person does get the script sometimes even the most aggressive downstream vigilance cant rescue them from themselves. Establishing
who NOT to prescribe to at the outset will probably save a lot more lives than REMS.

1. http://www.cdc.gov/mmwr/preview/mmwrhtml/su6203a27.htm
2. http://www.ncbi.nlm.nih.gov/pubmed/23070654

Many PCP's still find it difficult to incorporate risk stratification and adherence monitoring for chronic pain treatment into the daily rigamarole of primary care practice. They may hold on to "tar-baby" patients that they should have referred on long ago. Some also have problems "switching hats" from patient advocate and to surveillance cop. There not skilled at facilitating "crucial conversations." A few have co-dependency issues around prescribing that are problematic in a whole other way. Hence, what I see is intellectual buy-in but lack of execution. It is a tall a order for an average PCP to incorporate what we ask them to do in order to be "safer" prescribers. If you want to move the needle on actual clinical behavior, you have to show them more than aggregated population type outcomes. You have to vividly demonstrate how specific clinical behavior protects them, their patients, and their practices.
 
Excellent discussion!!! We are seeing a tsunami of patient referrals since the new opioid prescribing laws took effect. Some of what has been prescribed by PCPs without ever working the patient up is terrifying. One today: Opana ER 40mg BID plus roxicodone 30mg 8 per day. Patient wants more opioids. Chart shows 31 year old with "low back pain" that is not painful to palpation, never had a MRI or lumbar xray (she is fully insured by commercial insurance), never had surgical referral, never had a neurological physical exam, and has been prescribed almost exclusively opioids in escalating doses for the past two years without ever checking the PMP or a UDS.
 
A
The majority of the oxy 30's that I'm seeing are going to 40y/o's with LBP, FMS, HA etc. I don't have any patients on Oxycodone 30 IR, why would
I when I can prescribing a tamper resistant product with less euphoria and risk?

Agree, I see no logic in it.
 
1st visit patient is told I don't write for Roxy, Oxycontin, Soma, or Methadone. If that isn't satisfactory, I may not be the right doc for you.

I get why not Roxicodone, soma and methadone, but why not OxyContin? With the newer tamper resistant formulation (I know, not tamper proof) it seems no worse than any of the other long actings, or is it just the stigma/name recognition from the previous easily abused formulation?
 
Increasingly patients are no longer afforded the possibility of extended release affordable opioids. Oxycontin is being dropped by one insurance formulary after another due to $$$$$ or placed on tier 4 or 5 to the point the out of pocket costs are hundreds of dollars a month. Same for Opana ER, Exalgo, Kadian. There are times financially patients are forced by their insurers into accepting a medication that is not tamper resistant or is short acting. In an ideal world everyone that is being treated with opioids long term would be predominantly with tamper resistant long acting opioids, but the reality is that this option has been priced out of the market.
 
That's just crap. So they don't want us to do any procedures and they don't want us to prescribe any abuse deterrent medications but when the patient OD's it's our ass that gets burned....makes a lot of sense. We need to get levorphanol back out there. It's a safer methadone
 
Excellent discussion!!! We are seeing a tsunami of patient referrals since the new opioid prescribing laws took effect. Some of what has been prescribed by PCPs without ever working the patient up is terrifying. One today: Opana ER 40mg BID plus roxicodone 30mg 8 per day. Patient wants more opioids. Chart shows 31 year old with "low back pain" that is not painful to palpation, never had a MRI or lumbar xray (she is fully insured by commercial insurance), never had surgical referral, never had a neurological physical exam, and has been prescribed almost exclusively opioids in escalating doses for the past two years without ever checking the PMP or a UDS.

My heart goes out to you. My state is curently centering on 120MED, which is hard enough when they come to you as a conscript on upwards of 250MED.

This is the thankless heavy lifting.
 
That's just crap. So they don't want us to do any procedures and they don't want us to prescribe any abuse deterrent medications but when the patient OD's it's our ass that gets burned....makes a lot of sense.

No, they want you to have hour long pseudo-psyche sessions with the patient,

and then not do any procedures or prescribe anything.
 
Abuse deterance seems to work:

http://www.nejm.org/doi/full/10.1056/NEJMc1204141

Effect of Abuse-Deterrent Formulation of OxyContin
N Engl J Med 2012; 367:187-189July 12, 2012DOI: 10.1056/NEJMc1204141

Share:
Figure 1AFIGURE 1Effect of Abuse-Deterrent OxyContin., the selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse-deterrent formulation to just 12.8% 21 months later (P<0.001). Simultaneously, selection of hydrocodone and other oxycodone agents increased slightly, whereas for other opioids, including high-potency fentanyl and hydromorphone, selection rose markedly, from 20.1% to 32.3% (P=0.005). Of all opioids used to “get high in the past 30 days at least once” (Figure 1B), OxyContin fell from 47.4% of respondents to 30.0% (P<0.001), whereas heroin use nearly doubled.

Interviews with patients who abused both formulations of OxyContin indicated a unanimous preference for the older version. Although 24% found a way to defeat the tamper-resistant properties of the abuse-deterrent formulation, 66% indicated a switch to another opioid, with “heroin” the most common response. These changes appear to be causally linked, as typified by one response: “Most people that I know don't use OxyContin to get high anymore. They have moved on to heroin [because] it is easier to use, much cheaper, and easily available.” It is important to note that there was no evidence that OxyContin abusers ceased their drug abuse as a result of the abuse-deterrent formulation. Rather, it appears that they simply shifted their drug of choice.

Our data show that an abuse-deterrent formulation successfully reduced abuse of a specific drug but also generated an unanticipated outcome: replacement of the abuse-deterrent formulation with alternative opioid medications and heroin, a drug that may pose a much greater overall risk to public health than OxyContin. Thus, abuse-deterrent formulations may not be the “magic bullets” that many hoped they would be in solving the growing problem of opioid abuse.


Theodore J. Cicero, Ph.D.
Matthew S. Ellis, M.P.E.
Washington University in St. Louis, St. Louis, MO
[email protected]

Hilary L. Surratt, Ph.D.
Nova Southeastern University, Coral Gables, FL
 
i actually attended a talk given by a DEA representative in December 2012 who outrightly stated that regardless of the oxycontin change (and it hadnt occured yet), that this shift to heroin was going to occur/was inevitable.

according to him, finances and ease of access, because an increasing supply of heroin from South America was going to overwhelm the US. i think he specifically mentioned Columbian...
 
Afghanistan. Due to elimination of the Taliban, that prohibited farmers from growing poppies, and the complacency of the Afhani government, the crop there was a record this year....50% larger than last year, and larger than any time in history. Once again US government intervention has had unintended consequences...
 
Our data show that an abuse-deterrent formulation successfully reduced abuse of a specific drug but also generated an unanticipated outcome: replacement of the abuse-deterrent formulation with alternative opioid medications and heroin, a drug that may pose a much greater overall risk to public health than OxyContin. Thus, abuse-deterrent formulations may not be the “magic bullets” that many hoped they would be in solving the growing problem of opioid abuse.

Umm...yeah...unanticipated to whom? Things not looked for are rarely found. Common sense is that, if you stop putting food out for the raccoons, they'll hit the garbage cans.
 
No, they want you to have hour long pseudo-psyche sessions with the patient,

and then not do any procedures or prescribe anything.
I did that today. Very unpleasant for the patient as well as myself. Shoot, I just drank half a bottle of wine to chill out..... this job has waaaayyyy too many hazards. From the drug seekers to the extremely anxious it grinds to the core on some days..... @#$#@#@#!@#$!%$%^#$%
 
Afghanistan. Due to elimination of the Taliban, that prohibited farmers from growing poppies, and the complacency of the Afhani government, the crop there was a record this year....50% larger than last year, and larger than any time in history. Once again US government intervention has had unintended consequences...
yes but hasnt most heroin from afghanistan historically gone to Europe and Asia, not the US? reading the most recent stats i could find, and what this DEA rep claimed, it seems that roughly 65% of US heroin supply comes from south america, not afghanistan.
 
Traditionally yes, but as I understand it (either CNN or NBC news) the supplies are exploding from Afghanistan. For many years there was little heroin coming from there due to the Taliban. The DEA agent is probably quoting data from a few years ago before the US Government turned over the governing reins to the Afghanis, who have not intervened in attempting to stop this plague. After all, it is a profitable operation, funded by the US public, and represents the outcome of unencumbered capitalism that we exported to them.
 
I will NEVER write for the current version of Zohydro.
 
Meeting with the zohydro rep Friday. He is soooo excited to chat. Cracks me up... I mean really, no abuse deterrent mechanism in the drug? Are they crazy
 
Meeting with the zohydro rep Friday. He is soooo excited to chat. Cracks me up... I mean really, no abuse deterrent mechanism in the drug? Are they crazy

I don't get why they couldn't be bother to do that. I have some patients who do much better on hydrocodone than oxy or morphine. I'd feel better about extended release hydrocodone, if they attempted a decent abuse deterrent.
 
I don't get why they couldn't be bother to do that. I have some patients who do much better on hydrocodone than oxy or morphine. I'd feel better about extended release hydrocodone, if they attempted a decent abuse deterrent.

Opiophile cracked new OxyContin in a week.
 
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