End of Oxycontin?

[Disciple]

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Members do not see this ad.

Is Oxycontin finished?

http://www.medscape.com/viewarticle/556381


Well, at least I have an excuse when patients come in specifically asking for it.

"I can't prescribe you that stuff. Don't you watch the news?"


Our Oxycontin rep canceled lunch this week. I'll be quite surprised if he shows up at the office ever again.

 

[Aether2000]

Physicians wrote more than 6 million prescriptions a year for oxycontin. A 630million dollar fine may sting a little, but really not too much considering the income derived from the drug. The AWP of 20mg oxycontin is $2.57. Considering the majority of prescriptions according to several studies are for TID dosing, then the monthly wholesale income would be around $231 per month per patient. Multiply that x 6 million and the wholesale income would be around $1.3 billion each month. The 600million is not an insignificant fine, but relatively speaking, it is but a trifle.

 

[Disciple]

I was thinking, finished from a "bad publicity" standpoint.

I personally don't like to use it and tried to avoid using it prior to this fine being handed out.


Maybe this will really get the PCPs thinking.

 

[Ligament]

Is this this same as Oxycottin?

 

[lobelsteve]

I think it is a wonderful drug and only as abusable as any other long acting opioid. 650 million is nothing compared to the billions Purdue made on the drug and with the patent now respected from the generic manufacturers, it will increase in profit again over the next 6 years.

When Pain Docs are not wanting to use this medicine, they are ignorant.

Question 1: Does this patient hurt?
Question 2: Do they ned a long acting opioid?
Question 3: What meds have they tried already?

If you think they will abuse their Oxycontin and not their Kadian, Avinza, MSContin, Opana then you are an idiot.

The jury is still out on the patches. I'd like to think they have a lower abus potential due to the greater difficulty in extracting the medication out. Of course a hairdryer will do wonders on skin coated with BenGay and a frsh patch applied.

If your patient hurts and you believe them- you should use any and all medications at readonable doses and quantities to allay their pain. Otherwise go back to sticking tubes down their throats or watching them get PT/OT/ST.
(genius cap)

 

[Mister Mxyzptlk]

Some factoids:

Oxy is abused more than the MSO4 preps. I am not sure why. It might be because if you crush an Oxy tablet you get all the drug at once, whereas I think with the MSO4 products you have to do an extraction to get an IR form. It might also be that MSO4 doesn't penetrate the BBB as well. That is why heroin is more popular than morphine - the quality of the rush is related to the rapidity of the rise in tissue levels. Same with Xanax vs Valium. Xanax penetrates faster and is the benzo drug of choice.

People definitely abuse patches. There have been numerous deaths. Some were caused by people who handled the goo inside and absorbed it through the skin. Others were people who tried injecting it. It is very hard to figure out the dose because the goo is so concentrated and in a used patch it is of variable concentration. There have been reports of heroin being cut with fentanyl, which goes to show how relatively easy it is to get it vis-a-vis heroin.

OxyContin and heroin pretty much compete for the same niche in the street market. When people can't get heroin they buy Oxy and vice-versa. This has caused a price drop in heroin, and a 3x increase in potency over the years (now 12%) in order to bring a bag of heroin into line with the street cost of an equipotent dose of Oxy.

The #1 drug of abuse in this country is hydrocodone, not a C-I or C-II. Although the Oxy problem is important, that is not where most of the unit doses on the street come from.

Prescription drug diversion nows exceeds heroin and cocaine combined as the #1 drug problem in this country.

 

[Disciple]

My personal anecdotes match up with Gorback's statistics.

The patients I've had who have escalated their dosages have done so with Oxycodone or Hydocodone.

I've yet to have patients referred to me by PCPs on huge doses Morphine, but have had many referred on high doses of Oxy and/or Hydrocodone (5-10mg tabs) in the 12-20 tabs daily range.

So far, with patients who have admitted obtaining prescription drugs on the street, it's been Oxy or Hydrocodone.

Yes, I've had one patient who "chewed" her used patches and true addicts can abuse anything, but I feel that in many cases we almost encourage it with certain medications.

If I remember correctly, part of the above mentioned law suit alleged that Purdue fabricated some of the data regarding the time-released nature of the medication, and I always wondered why my Oxycontin rep had such a hard time producing the graphs that backed up his claim that the drug did not "dose-dump" 40% of the medication in the first hour.

I believe my patient's hurt, but I also believe that pain relief and "feeling good" don't always have to go together.

 

[cdwhitemd]

In my experience, getting a patient off Oxycontin is hard as hell. I'd much rather wean them off MSO4 or methadone. It is said that withdrawl from Oxy is worse than withdrawl from heroin. At least heroin w/d is fast and furious. Oxy w/d is long and furious

 

[lobelsteve]

There is a lot of "in my experience" thrown aroun in this thread.
I am unaware of any studies showing that opioid X is more addictive than opioid Y. Hydrocodone is more prevalent in the DAWN data due to the number of scripts compared to other opioids- has anyone restratified the abuse risk based on number of DAWN events versus number of units prescribed?

Don't get me wrong, Oxycontin has great street cred- but it isn't any different than Percocet or OxyIR.

Also, the heroin cut with fentanyl that produced 100's of deaths in Phila and Chicago as well as other places had nothing to do with the patches. This fentanyl came from a home brew and not from big Pharma.

I've never had a problem tapering any medication for any patient. I just put down my pen. (depending on why they are getting tapered- some get slow tapers lasting uptp 3 months (complaint patients with risk for substance use disorder who had a problem a could fix), some get rapid tapers lasting 1 week, some get kicked to the curb)

 

[Tenesma]

an opioid is an opioid is an opioid is an opioid....

just when you think a drug is safe, you find out the opposite is true.

When i was training in Boston, I found out that methadone was becoming more and more abused (in fact the street value of methadone was $1/mg equal to oxycontin's street value of $1/mg)....

and when you look at the ASIPP data fentanyl is not a big profit maker for the street - instead dilaudid has the best "re-sale" value on the street.

bottom line any narcotic can be abused... even SUBOXONE!!!! look at all the suboxone deaths in europe... even the incorporated naltrexone didn't matter - because the junkies didn't mind feeling like crap for an hour until the high kicked in and lasts several hours (what they did is take the suboxone formulation and melt it into IV format).

if you sit back and look at the evolution of drugs we as pain physicians have become the legal drug dealers to society and Purdue et al. have become our suppliers (except in this scenario the suppliers are making all the profit and the dealers are left with the problems)... the only good news is our risk of getting shot is a bit lower...

there is no perfect narcotic, there is no narcotic that has less abuse potential (despite what suboxone and ultram reps tell you)... and the idea of alternating everybody switching to methadone has revealed the flaws in methadone (QT prolongation, etc...).

lobel... your point that pain docs who don't want to use this medication are ignorant is a bit of a generalization. Maybe those pain docs you are referring to have seen enough disasters to know that giving somebody narcs ain't always the answer.

if you talk to addiction psychiatrists the average statistic that they mention (i haven't seen the literature on this) is that 20% of drug addicts started off with pain meds for back pain....

i think the better focus of this thread should be

1) how can we better screen patients?
2) how can we better guide patients w/ chronic opiates?

the steps i have taken

1) every new patient/consultation has a narcotic list from the state Prescription Monitoring Program in their file before I see them. That way I know exactly who has some underlying issues (doctor-shopping, multiple fills, multiple pharmacies, etc...)
2) i have criteria for weaning people off chronic opiates (no evidence of improved functionality, no evidence of improved pain, evidence of abuse/diversion, evidence of non-compliance with other medical recommendations, etc...)

on average i wean off about 80% of chronic opiate patients i see, 15% of chronic opiate patients don't agree w/ wean and never come back and bad-mouth me, and 5% i strongly encourage chronic opiate use. Keep in mind, that I do all of this without prescribing narcotics. So far, the feed back from the local PCPs has been excellent and even though I am primarily a "block jock" I see about 2-3 opiate consultations per day for my advice. The good news is that slowly and surely we (PCPs and me) are driving the drug problem patients out of the medical community here

a new phenomenon in my state is requests for "medical marijuana" for chronic pain.... ie: pt says "i got chronic pain and have tried everything and marijuana removes all of my pain, can I have a medical marijuana card please?" I still haven't figured out what to do with those patients, so any advice is appreciated.

 

[Disciple]

an opioid is an opioid is an opioid is an opioid....

just when you think a drug is safe, you find out the opposite is true.

When i was training in Boston, I found out that methadone was becoming more and more abused

I've heard that as well. You're right, those you mention as "junkies" can abuse anything. If the good stuff is not available, they'll abuse whatever they can get their hands on.

Those are the types of patients I try not to accept into the practice or at the very least, do not recommend any opiates. I don't run into these patients too often.

It is the other patients who are not "junkies" but have alot of psychological baggage or who are suseptible to pseudoaddiction that I may treat with opiates, but will try to keep away from Oxycontin, OxyIR, Percocet, greater than 4 Vicodin/day, etc., as well as Benzos, Soma, even Ambien.

Why tempt fate?

 

[Disciple]

Don't get me wrong, Oxycontin has great street cred- but it isn't any different than Percocet or OxyIR.

I should clarify my above post. I haven't had patients escalate their dosages on OxyIR, Percocet, MSIR, etc. because I avoid using these medications whenever possible.

I guess it's not Oxycodone in particular that I'm against, but meds that are quick release and cause a good deal of euphoria. Oxycontin just happens to be one supposed long-acting medication that I lump in with the short-acting preparations.

I still use Hydrocodone products to test the waters with alot of patients. If they go above 4-5/day or escalate dosages without consulting me first, I try to switch them to a long-acting preparation. Most of these people are not "addicts" or "street-junkies", but are prone to Pseudoaddication for various reasons. Choosing the wrong medications for these patients is like dangling a carrot in front of their faces.

 

[Disciple]

a new phenomenon in my state is requests for "medical marijuana" for chronic pain.... ie: pt says "i got chronic pain and have tried everything and marijuana removes all of my pain, can I have a medical marijuana card please?" I still haven't figured out what to do with those patients, so any advice is appreciated.

I usually tell them that they'll have to get their card somewhere else, and that if they choose to use it (legally), I won't agree with it (because there is no way for me to monitor their usage), but I will continue to treat them. I also tell them that my education/training did not teach me how to use this substance to manage pain in a safe/controlled manner.

 

[sdn1977]

an opioid is an opioid is an opioid is an opioid....

just when you think a drug is safe, you find out the opposite is true.

When i was training in Boston, I found out that methadone was becoming more and more abused (in fact the street value of methadone was $1/mg equal to oxycontin's street value of $1/mg)....

and when you look at the ASIPP data fentanyl is not a big profit maker for the street - instead dilaudid has the best "re-sale" value on the street.

bottom line any narcotic can be abused... even SUBOXONE!!!! look at all the suboxone deaths in europe... even the incorporated naltrexone didn't matter - because the junkies didn't mind feeling like crap for an hour until the high kicked in and lasts several hours (what they did is take the suboxone formulation and melt it into IV format).

if you sit back and look at the evolution of drugs we as pain physicians have become the legal drug dealers to society and Purdue et al. have become our suppliers (except in this scenario the suppliers are making all the profit and the dealers are left with the problems)... the only good news is our risk of getting shot is a bit lower...

there is no perfect narcotic, there is no narcotic that has less abuse potential (despite what suboxone and ultram reps tell you)... and the idea of alternating everybody switching to methadone has revealed the flaws in methadone (QT prolongation, etc...).

lobel... your point that pain docs who don't want to use this medication are ignorant is a bit of a generalization. Maybe those pain docs you are referring to have seen enough disasters to know that giving somebody narcs ain't always the answer.

if you talk to addiction psychiatrists the average statistic that they mention (i haven't seen the literature on this) is that 20% of drug addicts started off with pain meds for back pain....

i think the better focus of this thread should be

1) how can we better screen patients?
2) how can we better guide patients w/ chronic opiates?

the steps i have taken

1) every new patient/consultation has a narcotic list from the state Prescription Monitoring Program in their file before I see them. That way I know exactly who has some underlying issues (doctor-shopping, multiple fills, multiple pharmacies, etc...)
2) i have criteria for weaning people off chronic opiates (no evidence of improved functionality, no evidence of improved pain, evidence of abuse/diversion, evidence of non-compliance with other medical recommendations, etc...)

on average i wean off about 80% of chronic opiate patients i see, 15% of chronic opiate patients don't agree w/ wean and never come back and bad-mouth me, and 5% i strongly encourage chronic opiate use. Keep in mind, that I do all of this without prescribing narcotics. So far, the feed back from the local PCPs has been excellent and even though I am primarily a "block jock" I see about 2-3 opiate consultations per day for my advice. The good news is that slowly and surely we (PCPs and me) are driving the drug problem patients out of the medical community here

a new phenomenon in my state is requests for "medical marijuana" for chronic pain.... ie: pt says "i got chronic pain and have tried everything and marijuana removes all of my pain, can I have a medical marijuana card please?" I still haven't figured out what to do with those patients, so any advice is appreciated.

I agree with your premise...an opioid is an opioid, etc.

And, your concept of getting your state's Prescription Monitoring Form is also great. But, not all states have this yet. Some have used their grant $$ for other efforts.

I was explaining this issue to my daughter who is an MSIII & is doing her psych rotation. She was with the on-call resident today & saw about 10 addictive patients who had psych sx. She was wondering how all this could be possible since many of the abused drugs are rx only.

I tried to explain, but she & I are in different states, so here are some issues in CA.....narcotics & other abusable drugs are available online easily. Also....the doctor shoppers will use "other" names to avoid the CA Controlled Drug Monitoring program. They see the physician - fill out the paperwork, have what appears to be a valid insurance card, workmen's comp stuff, etc....will get the first rx & sometimes a second rx before the physician's office realizes the name, phone number, insurance & address are all fake.

In that time.....the pt has visited 3 ER's, 4 or 5 dentists, a couple of podiatrists & gotten all manner of controlled drugs - some not "so" usable for the really addicted - T3 for instance. But...when the rx is brought to the pharmacy & the pt requests brand name only ..... and "oh, I'll pay cash" - then I know ..... this pt is not going to use it. They sell the brand name for high $$$ & buy generic oxycontin or whatever online. The name is fake, in fact - I have one pt I won't even take my time to talk to because he has tried to use 4 names in 4 years with me. But - he always comes in when the relief pharmacist is on. The name doesn't appear often enough on the State Program to send up any red flags.

But...I do have physicians I won't fill rxs for - they are the ones who will give a narcotic rx for an office visit. I NEVER see any rx from these guys other than opioids - no gabapentin, tricyclics, NSAIDS, etc.....only opioids & sometimes Lomotil! So...their pain formulary is a bit limited.

I agree - Dilaudid is making a comeback. It used to be really big as a street drug about 20 years ago - its easily diluted & injected - like MSIR without too many problems. Pts are actually starting to ask for this & oxycodone rather than Norco, Lortab, Vicodin (generics) because they've been hearing about the liver/APAP issues so they get switched on somewhat valid reasons. The ones who are followed by pain physicians don't seem to get into trouble - its the other ones - who are followed by PCPs who seem to slip easily.

I don't think oxycodone cr (which is generic Oxycontin) is going away - in fact....the brand name stuff is not used too much (unless you have a "seller" & I won't order it unless its DAW-1). The company will get its hands slapped for misleading product information, but the reality is, there are too many other generic manufacturers to remove it from the market.

The newest "fad" here is Actiq - go figure. Its expensive, but kids like it so its worth a lot streetwise.

 

[mille125]

an opioid is an opioid is an opioid is an opioid....

just when you think a drug is safe, you find out the opposite is true.

When i was training in Boston, I found out that methadone was becoming more and more abused (in fact the street value of methadone was $1/mg equal to oxycontin's street value of $1/mg)....

and when you look at the ASIPP data fentanyl is not a big profit maker for the street - instead dilaudid has the best "re-sale" value on the street.

bottom line any narcotic can be abused... even SUBOXONE!!!! look at all the suboxone deaths in europe... even the incorporated naltrexone didn't matter - because the junkies didn't mind feeling like crap for an hour until the high kicked in and lasts several hours (what they did is take the suboxone formulation and melt it into IV format).

if you sit back and look at the evolution of drugs we as pain physicians have become the legal drug dealers to society and Purdue et al. have become our suppliers (except in this scenario the suppliers are making all the profit and the dealers are left with the problems)... the only good news is our risk of getting shot is a bit lower...

there is no perfect narcotic, there is no narcotic that has less abuse potential (despite what suboxone and ultram reps tell you)... and the idea of alternating everybody switching to methadone has revealed the flaws in methadone (QT prolongation, etc...).

lobel... your point that pain docs who don't want to use this medication are ignorant is a bit of a generalization. Maybe those pain docs you are referring to have seen enough disasters to know that giving somebody narcs ain't always the answer.

if you talk to addiction psychiatrists the average statistic that they mention (i haven't seen the literature on this) is that 20% of drug addicts started off with pain meds for back pain....

i think the better focus of this thread should be

1) how can we better screen patients?
2) how can we better guide patients w/ chronic opiates?

the steps i have taken

1) every new patient/consultation has a narcotic list from the state Prescription Monitoring Program in their file before I see them. That way I know exactly who has some underlying issues (doctor-shopping, multiple fills, multiple pharmacies, etc...)
2) i have criteria for weaning people off chronic opiates (no evidence of improved functionality, no evidence of improved pain, evidence of abuse/diversion, evidence of non-compliance with other medical recommendations, etc...)

on average i wean off about 80% of chronic opiate patients i see, 15% of chronic opiate patients don't agree w/ wean and never come back and bad-mouth me, and 5% i strongly encourage chronic opiate use. Keep in mind, that I do all of this without prescribing narcotics. So far, the feed back from the local PCPs has been excellent and even though I am primarily a "block jock" I see about 2-3 opiate consultations per day for my advice. The good news is that slowly and surely we (PCPs and me) are driving the drug problem patients out of the medical community here

a new phenomenon in my state is requests for "medical marijuana" for chronic pain.... ie: pt says "i got chronic pain and have tried everything and marijuana removes all of my pain, can I have a medical marijuana card please?" I still haven't figured out what to do with those patients, so any advice is appreciated.

You and I have discussed this point ad nauseum in other threads so I will keep my comments brief. Steve was spot on in his assessment. You are just a pain doc who is uncomfortable with prescribing opioids. Just admit it. You said you "encourage 5% of your patients" to use chronic opioids to treat their pain. I imagine that you see some improvement in their function. Yet, you still wont prescribe them. Just admit that you are basing your medical judgements on fear.....This is the point that I made in the last thread.......

 

[mille125]

I think it is a wonderful drug and only as abusable as any other long acting opioid. 650 million is nothing compared to the billions Purdue made on the drug and with the patent now respected from the generic manufacturers, it will increase in profit again over the next 6 years.

When Pain Docs are not wanting to use this medicine, they are ignorant.

Question 1: Does this patient hurt?
Question 2: Do they ned a long acting opioid?
Question 3: What meds have they tried already?

If you think they will abuse their Oxycontin and not their Kadian, Avinza, MSContin, Opana then you are an idiot.
The jury is still out on the patches. I'd like to think they have a lower abus potential due to the greater difficulty in extracting the medication out. Of course a hairdryer will do wonders on skin coated with BenGay and a frsh patch applied.

If your patient hurts and you believe them- you should use any and all medications at readonable doses and quantities to allay their pain. Otherwise go back to sticking tubes down their throats or watching them get PT/OT/ST.
(genius cap)

take notes on the bold points, tenesma.....


Concerning abuse of fentanyl patches....Contrary to popular belief, they can be abused and abusers have thought of many creative ways to do it (frozen "chicklettes"). If anything, it has a lesser potential of diversion but not abuse.

 

[Disciple]

I don't think oxycodone cr (which is generic Oxycontin) is going away - in fact....the brand name stuff is not used too much (unless you have a "seller" & I won't order it unless its DAW-1). The company will get its hands slapped for misleading product information, but the reality is, there are too many other generic manufacturers to remove it from the market.

You don't think that what's going on with the settlement is enough to scare most PCPs into not using it or using it infrequently?

The newest "fad" here is Actiq - go figure. Its expensive, but kids like it so its worth a lot streetwise.

Of course. Great for the clubs.

I'm not too worried about Actiq. None of the insurers I deal with will authorize it. Same with Fentora.

 

[lobelsteve]

You don't think that what's going on with the settlement is enough to scare most PCPs into not using it or using it infrequently?



Of course. Great for the clubs.

I'm not too worried about Actiq. None of the insurers I deal with will authorize it. Same with Fentora.

If I could figure out how to break the quotes apart I would.

PCP's should be uncomfortable prescribing opioids. I just set up a company that will provide pain medicine services to a large medical specialty group. My first 2 months are going to their clinics and providing small group lectures to 3-4 docs at a time. They are all going to get the lectures I gave Emory's PMR fellows on meds, abuse, addiction, UDS, diversion, diagnosis, exam, physiology, etc (not interventional). I want them to be uncomfortable before the lecture series and comfortable after the lecture series. They also get my cell number for immediate consult assistance.

Point two: Actiq and Fentora have such immediate onset of actions compared to other noninjectables that they will become favorites on the street no matter what. I'm in Atlanta and we just had a truck full of several million dollars worth of drugs stolen. I believe it was Fosamax and Cosopt.
Diversion from our Rx's accounts for 16.8% of all pills "for nonmedical use" SAMHSA 2006 data.

Also, from the PROTECT slide deck, Alpharma:

Dosage Units of Opioids Lost or Stolen—7.65 Million Units
Key points
Oxycodone and hydrocodone account for almost 75% of all lost or stolen controlled substances in 2003 (DEA)

Supplemental notes
The authors submitted a Freedom of Information Act request to the DEA to obtain data from Form 106 Report of Theft or Loss of Controlled Substances
An electronic database was provided with annual data for all controlled substances from 2000 to 2003 with analyzable data from registrants in only 22 Eastern states, representing 53% of the US population
Theft/losses were primarily from pharmacies (89.3%)
In 2003 alone, a total of 7,652,099 dosage units of controlled substances were lost or stolen, of which 1,834,717 (24.0%) dosage units were for the 6 opioid analgesics evaluated in the study; fentanyl, hydromorphone, meperidine, methadone, morphine, and oxycodone
As a comparison, hydrocodone accounted for 3,995,402 dosage units (52.2%) lost or stolen in 2003, more than twice the amount of the 6 other drugs combined
Data for the 6 drugs selected by the investigators: meperidine = 0.5%, fentanyl = 0.6%, methadone = 1.4%, hydromorphone = 2.5%, morphine = 2.7%, and oxycodone = 16.3%

Reference for notes
Joransen DE, Gilson QAM. Drug crime is a source of abused pain medications in the United States. J Pain Symptom Manage. 2005;30:299-301.

 

[ampaphb]

I don't think oxycodone cr (which is generic Oxycontin) is going away - in fact....the brand name stuff is not used too much (unless you have a "seller" & I won't order it unless its DAW-1). The company will get its hands slapped for misleading product information, but the reality is, there are too many other generic manufacturers to remove it from the market.

Then you really need to read the paper more - ALL the generic manufacturers have settled with Purdue, and are no longer manufacturing the CR formulation.

http://www.purduepharma.com/pressroom/app/news_announc/ss_pr.asp

 

[sdn1977]

Then you really need to read the paper more - ALL the generic manufacturers have settled with Purdue, and are no longer manufacturing the CR formulation.

http://www.purduepharma.com/pressroom/app/news_announc/ss_pr.asp

Nope - actully the two major generic "houses" Teva & Endo have agreed to halt sales by the end of the year. This is over a patent dispute & goes on all the time. Often...it gets resolved by agreeing to a settlement before the actual halt occurs (hmmm....the loratidine/Claritin, fluoxetine/Prozac, sertraline/Zoloft patent infringments of a few years back.) Sometimes...it doesn't & the generic gets halted, but only until the full patent life expires, which can vary. The most recent example of this is Plavix & Apothetec's generic product & is one of the very few which have actually halted sales for now. Oddly...the Plavix sales have still fallen......

The other "settlement" issue is the one with Purdue over misleading marketing - being too forward in promoting its "off-label" use of q8h vs the approved q12h use. This is the one that involves the large settlement with 25 states. The $19.5 million is a large sum, but won't do away with Purdue or Oxycontin - it will just sting the shareholders. But...they knew this when they decided to pursue this line of marketing.

The patent dispute may or may not allow time either for a settlement or an ANDA to be filed. But....Teva has experience in this arena - it won patent infringement lawsuits many times - the most recently against GSK in generic Relafen, Augmentin & Organon's Remeron.

So...when the generic finally does go off market, if it does in Dec....the wholesaler will again stock Purdue's product (it does not now) & all will be well again.

 

[sdn1977]

You don't think that what's going on with the settlement is enough to scare most PCPs into not using it or using it infrequently?



Nope - I think they'll just be more reluctant to prescribe it q8h. They'll stick with the q12h as the labeling indicates & not go off-label. They'll leave that for the pain or hospice prescribers (hopefully).

 

[ampaphb]

Nope - actully the two major generic "houses" Teva & Endo have agreed to halt sales by the end of the year. This is over a patent dispute & goes on all the time. Often...it gets resolved by agreeing to a settlement before the actual halt occurs (hmmm....the loratidine/Claritin, fluoxetine/Prozac, sertraline/Zoloft patent infringments of a few years back.) Sometimes...it doesn't & the generic gets halted, but only until the full patent life expires, which can vary. The most recent example of this is Plavix & Apothetec's generic product & is one of the very few which have actually halted sales for now. Oddly...the Plavix sales have still fallen......

The other "settlement" issue is the one with Purdue over misleading marketing - being too forward in promoting its "off-label" use of q8h vs the approved q12h use. This is the one that involves the large settlement with 25 states. The $19.5 million is a large sum, but won't do away with Purdue or Oxycontin - it will just sting the shareholders. But...they knew this when they decided to pursue this line of marketing.

The patent dispute may or may not allow time either for a settlement or an ANDA to be filed. But....Teva has experience in this arena - it won patent infringement lawsuits many times - the most recently against GSK in generic Relafen, Augmentin & Organon's Remeron.

So...when the generic finally does go off market, if it does in Dec....the wholesaler will again stock Purdue's product (it does not now) & all will be well again.

Actually,

"The agreement permits Teva to continue sales of its generic version of OxyContin at least through March 31, 2007",

and

"The parties also have agreed to propose to the Court a consent judgment holding that Endo is infringing the Purdue patents and prohibiting Endo from infringing sales after December 31, 2006."

 

[sdn1977]

If I could figure out how to break the quotes apart I would.

PCP's should be uncomfortable prescribing opioids. I just set up a company that will provide pain medicine services to a large medical specialty group. My first 2 months are going to their clinics and providing small group lectures to 3-4 docs at a time. They are all going to get the lectures I gave Emory's PMR fellows on meds, abuse, addiction, UDS, diversion, diagnosis, exam, physiology, etc (not interventional). I want them to be uncomfortable before the lecture series and comfortable after the lecture series. They also get my cell number for immediate consult assistance.

Point two: Actiq and Fentora have such immediate onset of actions compared to other noninjectables that they will become favorites on the street no matter what. I'm in Atlanta and we just had a truck full of several million dollars worth of drugs stolen. I believe it was Fosamax and Cosopt.
Diversion from our Rx's accounts for 16.8% of all pills "for nonmedical use" SAMHSA 2006 data.

Also, from the PROTECT slide deck, Alpharma:

Dosage Units of Opioids Lost or Stolen—7.65 Million Units
Key points
Oxycodone and hydrocodone account for almost 75% of all lost or stolen controlled substances in 2003 (DEA)

Supplemental notes
The authors submitted a Freedom of Information Act request to the DEA to obtain data from Form 106 Report of Theft or Loss of Controlled Substances
An electronic database was provided with annual data for all controlled substances from 2000 to 2003 with analyzable data from registrants in only 22 Eastern states, representing 53% of the US population
Theft/losses were primarily from pharmacies (89.3%)
In 2003 alone, a total of 7,652,099 dosage units of controlled substances were lost or stolen, of which 1,834,717 (24.0%) dosage units were for the 6 opioid analgesics evaluated in the study; fentanyl, hydromorphone, meperidine, methadone, morphine, and oxycodone
As a comparison, hydrocodone accounted for 3,995,402 dosage units (52.2%) lost or stolen in 2003, more than twice the amount of the 6 other drugs combined
Data for the 6 drugs selected by the investigators: meperidine = 0.5%, fentanyl = 0.6%, methadone = 1.4%, hydromorphone = 2.5%, morphine = 2.7%, and oxycodone = 16.3%

Reference for notes
Joransen DE, Gilson QAM. Drug crime is a source of abused pain medications in the United States. J Pain Symptom Manage. 2005;30:299-301.

Interesting info - I'll look at the reference when I get time.

What is odd is the statement that theft/loss was primarily from pharmacies - where were the other 10.7% from (physician offices, wholesalers, urgent care centers...)

Who else keeps it?

Also....it would be interesting to look at the data to see what % that 7.6 million lost doses tranlates into out of the whole # distributed.

Finally, this report doesn't really address the actual diversion of drugs which have been dispensed off an rx. My definition of lost or stolen means I have to submit a form to the DEA which indicates I have no documentation to cover any product which is gone. To me...that's different from controlled rxs diverted after being obtained by legal or illegal (false rxs) means. That is the very, very hard number to quantify.

 

[Disciple]

You don't think that what's going on with the settlement is enough to scare most PCPs into not using it or using it infrequently?



Nope - I think they'll just be more reluctant to prescribe it q8h. They'll stick with the q12h as the labeling indicates & not go off-label. They'll leave that for the pain or hospice prescribers (hopefully).

Hmmm...

In my experience, most PCPs dislike writing for opiates. They usually refer to pain docs not to figure out what's wrong, but to take over management of the opiates.

I didn't really believe this until I found out more than a few of my patients were referred to surgeons or Neurologists (for the headache patients) for evaluation and diagnosis and to me (simultaneously) just for the opiates.

I would think that all this bad press would give PCPs a perfect excuse not to write for Oxycontin.

 

[drusso]

I think that all this simply underscores that opioids are dangerous just as many, many things in medicine are dangerous. It's all the reason why that the decision to initiate treatment with long-acting opioids should be only be made after thoughtful consideration, diagnostic work-up, review, and tied clear treatment outcomes, functional restoration, multimodal treatment, etc. Leave opioid Rx in the hands of the experts, ie pain physicians, not EDs, mid-levels, and PCPs.

 

[Tenesma]

mille... geez you won't give me a break...

why do I have to prescribe narcotics????? The PCPs and Referring surgeons don't seem to care and still send me tons of patients...

I have geared my practice towards the interventional approach to low back pain - I really don't have time to spare for the patients who are interested in narcotics.... In fact, if I wanted to I could make my clinic an injection-only clinic at the flip of a switch and actually make even more money/day - instead of being stuck in an exam room with a narcotic patient for 45 minutes... I see narcotic patients as a service to the PCPs who are pissed as hell at how much narcotics their patients are on (after seeing "pain docs") and want to know about other viable options...

what does that have to with fear??? dude it doesn't take much "b a l l s" to prescribe 80mg of oxycontin TID... in fact, it is easier to prescribe narcotics then it is to convince patients that oxycontin isn't the way to treat back pain in a "disabled" 29 year old who has a benign looking spine and exam...

it doesn't mean I can't have a well-informed opinion on narcotics...

I guess an orthopedic surgeon who doesn't do shoulder surgeries but renders consultations on whether shoulder surgery is appropriate or not must be living in fear...

you don't implant IT pumps - ergo you must be living in fear...

yeah... whatever...

 

[sdn1977]

Actually,

"The agreement permits Teva to continue sales of its generic version of OxyContin at least through March 31, 2007",

and

"The parties also have agreed to propose to the Court a consent judgment holding that Endo is infringing the Purdue patents and prohibiting Endo from infringing sales after December 31, 2006."

That's quite odd - I just dispensed Endo's brand yesterday - we purchased it last Friday & I ordered it for today. We'll have to see what comes in.

I've got Teva's brand also on hand...that was purchased a week ago.

Someone must not have told Teva & Endo😉

Seriously, both IMPAXX (who is the holder of DAVA a generic house) & Purdue have requested the patent infringment case be dismissed & it was granted in May in New York. That agreement allows DAVA to be a distributor until June 14 with the rights to resume future limited production for an undisclosed & limited period of time in the future. So...DAVA will be the sole generic for the next months (after current available other generic stock is used up).

Where do you think Purdue will get the $19.2million for its misleading marketing settlement if not from patent infringement penalties or sales of its own product? Certainly not from shareholders!!!

 

[ampaphb]

.

 

[Aether2000]

It would be interesting to know how many shareholders there are given it is a private, non-traded company.
As I understand it, when the supplies of the generics by Endo and Teva are gone from the supply chain, they will not be replenished by these companies...

 

[mille125]

mille... geez you won't give me a break...

why do I have to prescribe narcotics????? The PCPs and Referring surgeons don't seem to care and still send me tons of patients...

I have geared my practice towards the interventional approach to low back pain - I really don't have time to spare for the patients who are interested in narcotics.... In fact, if I wanted to I could make my clinic an injection-only clinic at the flip of a switch and actually make even more money/day - instead of being stuck in an exam room with a narcotic patient for 45 minutes... I see narcotic patients as a service to the PCPs who are pissed as hell at how much narcotics their patients are on (after seeing "pain docs") and want to know about other viable options...

what does that have to with fear??? dude it doesn't take much "b a l l s" to prescribe 80mg of oxycontin TID... in fact, it is easier to prescribe narcotics then it is to convince patients that oxycontin isn't the way to treat back pain in a "disabled" 29 year old who has a benign looking spine and exam...

it doesn't mean I can't have a well-informed opinion on narcotics...

I guess an orthopedic surgeon who doesn't do shoulder surgeries but renders consultations on whether shoulder surgery is appropriate or not must be living in fear...

you don't implant IT pumps - ergo you must be living in fear...

yeah... whatever...

i am not picking on you with this question (i am just curious)......what percentage of the time do you do anesthesia versus pain and are you fellowship trained?

 

[lobelsteve]

It would be interesting to know how many shareholders there are given it is a private, non-traded company.
As I understand it, when the supplies of the generics by Endo and Teva are gone from the supply chain, they will not be replenished by these companies...

I heard that the supply chain was not the limiting step in the equation. I believe the generic mfg companies have a stop date and they are pinned to a market place percentage that if reduced, they cannot go to the previous level on. That is the main reason Purdue came out with $50 vouchers 2 months ago. If they can shrivel the marketfor the generic mfg companies, the profit margins for these companies will drop below the distribution costs and they will have to stop production.

 

[Aether2000]

Interesting!!!!!
Perhaps I should allot additional slots in my coin operated drug dispensing machine in my lobby to Oxycontin name brand rather than generic in the future. It is a bit cumbersome I suppose to require 1744 quarters for a one month's supply of the drug.

 

[Tenesma]

mille

i no longer do anesthesia (my clinic is too busy)

i am fellowship-trained and board certified

i am private practice without any academic ties...

 

[PainDr]

on average i wean off about 80% of chronic opiate patients i see, 15% of chronic opiate patients don't agree w/ wean and never come back and bad-mouth me, and 5% i strongly encourage chronic opiate use. Keep in mind, that I do all of this without prescribing narcotics. So far, the feed back from the local PCPs has been excellent and even though I am primarily a "block jock" I see about 2-3 opiate consultations per day for my advice. The good news is that slowly and surely we (PCPs and me) are driving the drug problem patients out of the medical community here.

I find it hard to believe that 80% of your pts should be weaned. To be honest, it sounds like your REAL goal is giving PCPs an excuse for discontinuing opioids. So, of course they love you and of course, they're going to send them for procedures...what other options do they have? Perhaps your population is vastly different than mine, but probably 80% of my pts are elderly and have severe spinal pathology. They get procedures and PT, but many also truly need opioids. I don't know why you're so opposed to opioids, but if you're going to be that biased, maybe you SHOULD just be a "block jock". Better to do that than deny pts the medication they need. I know...you're the one evaluating them...not me, but still, 80% seems excessive.

 

[mille125]

I find it hard to believe that 80% of your pts should be weaned. To be honest, it sounds like your REAL goal is giving PCPs an excuse for discontinuing opioids. So, of course they love you and of course, they're going to send them for procedures...what other options do they have? Perhaps your population is vastly different than mine, but probably 80% of my pts are elderly and have severe spinal pathology. They get procedures and PT, but many also truely need opioids. I don't know why you're so opposed to opioids, but if you're going to be that biased, maybe you SHOULD just be a "block jock". Better to do that than deny pts the medication they need. I know...you're the one evaluating them...not me, but still, 80% seems excessive.

amen to that

 

[Tenesma]

yeah... that statistic does sound kinda high - but i only have 2 years of data so far.

the interesting thing about the elderly is that many come to me because they want to come off opioids... they are tired of manually disimpacting themselves... they are tired of feeling cloudy/confused all the time...

here is a classic example of a narcotic patient that gets sent to me:
40 yo w/ chronic daily headaches since the age of 20 - on full disability (her husband is on disability as well - go figure), the only thing that works for her are higher and higher doses of oxycontin. "everything" else has been tried. Has been with multiple neurologists, and a different PCP every year - all because of "personality" conflicts. Her latest PCP wants some recommendations... all her work-up has been negative... she insists that the interview be done in a darkened room as she is VERY sensitive to light...
I tell her that she has demonstrated treatment failure w/ narcotics and that she needs to be weaned off (she falls into my 95% category of non-narcotic candidates)... it doesn't help that i saw her at the beach last weekend (of course she tried to hide).

I think the reason my statistics are so high is that I am in an area with a huge "disability" population with very high narcotic use... and very few people meet my criteria for chronic opioid use...

my rule of thumb:

1) chronic noci-ceptive pain or chronic inflammatory pain or cancer pain - no behavioral/psychosocial red flags, usually have good outcomes w/ opioids...

2) visceral pain or chronic pain without clear organic etiology or chronic "musculoskeletal" pain - not so good...



PainDr... you are absolutely right. The PCPs love it because they get to wean off narcotic patients based on my recommendations... But you have to look at it from the PCP point of view. Who are they sending to me??? They are NOT sending me the 92 yo w/ bony mets on vicodin... They are NOT sending me the 55 yo w/ chronic non-union of an ankle fracture on oxycontin/oxyIR... They are NOT sending me the 75 yo w/ severe scoliosis/severe degen. spine disease on MSIR... the narcotic patients they are sending to me are the ones that 1) always get their prescription stolen 2) constantly are harrassing their front office 3) show no improvement on opioid therapy, 4) involved in another slip&fall lawsuit at the grocery store and demanding more narcs, etc... So again, maybe that is why my statistics are so lop-sided.

this represents my situation and my view - and by no means am I anti-opioids... It is all about patient selection... Just like stims - they aren't for everybody.

and I definitely couldn't sleep at night if I felt that I was denying somebody something they need...

Algosdoc - i'd be curious as to your approach since you are an interventionalist with a well-rounded clinic with quite a few more years experience...

 

[Aether2000]

Regarding oxycontin, I am never comfortable prescribing it knowing the number of pharmacies in my area that are robbed of oxycontin in lieu of cash, but I suppose I should take some solace in knowing they have to steal it from the pharmacy rather than being received through subterfuge posing as chronic pain patients. Since it is now more expensive and the name brand is a tier II or III drug, I write less and less prescriptions for the drug.

The legitimate chronic pain population with capability of self control is integrally intermingled with a population of chronic pain patients that are substance abusers, drug diverters that sell your prescribed medication for $$$, and hard core addicts that will do anything for narcotics. Most chronic pain patients have some element of psychological aberration, so I weigh the degree and type of derangement present before prescribing opiates. Nearly 90% of my patients come to me already receiving narcotics, if not from the PCP, then from the neurologist, surgeon (presurgery), physiatrist, etc. Rarely are any of my patients placed on narcotics by a rheumatologist....interesting.
Usually the patient will receive standard diagnostic blocks on their second visit, then we discuss frankly the risks of further interventions attempting to balance the finances, social situation, activity level, capability of functioning in a work environment, etc with the efficacy/safety/cost factors for a given procedure. Some of my patients will continue receiving narcotics for months or even years before we engage in further procedures, but the patients must not exhibit any substance abuse or diversion symptoms while receiving these drugs. My practice is busy performing procedures (with an average of about 150 a month now including advanced procedures), but the size of the practice is such that it is nearly self sustaining by patients being evaluated for further diagnostics, new patients, and patients already in the practice calling to ask for specific procedures. If we employ narcotic therapy, it is done against the backdrop of strict controls on medication use and with the consequences of abuse or diversion spelled out in advance. We also insist on some type of functional or psych therapies. Some of the functional therapies such as an exercise program may be employed without additional expense but is done at home. We weigh every patient on each visit. Sometimes intensive therapy is required on an outpatient clinic setting. Overall, I am satisfied with our population but sometimes they suddenly spiral out of control with no warning with respect to their prescription opiate use. Fortunately this is rare. We monitor all schedule II prescriptions by monthly face to face visits with patient self assessments (written) placed on each chart. We check any inconsistencies in their drug use and prescription fills, their level of consciousness and orientation, and have them certify they have received no illicit drugs nor are doctor shopping among other items checked.
Overall I am satisfied with the screening for opiate prescribing that is being employed.

 

[Tenesma]

algos you bring up a very good point - most of the patients coming for consultations are already on narcotics from their PCP/surgeon/psychiatrist/dentist/podiatrist/whatever, there is no real indication for us to "have to" take over that prescription.

How do you guys feel when you get a consultation on a narcotic patient w/ 20yrs of chronic pain (has been to all the local pain clinics) and the PCP sends them to you with just enough pills to run out by the time they see you - at which point the patient now expects you to take over??? i know the feeling....

Admittedly if I were in a truly competitive market, i'd say thank you and ask for more...

 

[Aether2000]

We know it is a dump, but is often perpetrated by PCPs that don't have the setup to appropriately monitor patients receving these medications...
Not happy about the PCP making the referral, but even less happy about the other pain docs that started them on these drugs and would not continue seeing them (unless there were substance abuse /diversion issues)

 

[VentdependenT]

Wait till they get their hands on SR Hydromorphone.

 

[drusso]

We know it is a dump, but is often perpetrated by PCPs that don't have the setup to appropriately monitor patients receving these medications...
Not happy about the PCP making the referral, but even less happy about the other pain docs that started them on these drugs and would not continue seeing them (unless there were substance abuse /diversion issues)

Agreed. Opioids need to be part of a package of services. PCP's and non-pain trained specialists rarely have the resources or interest in developing the infrastructure in their practice to support this level of care.

The whole opioid issue reminds me of the gun debate: Guns aren't dangerous, but bad people with guns are! PCPs simply can't do a good job with opioid RX because of the other demands of their practice.

 

[Ligament]

Agreed. Whats up Dave! Where are you going to work? Shoot me a PM.

Agreed. Opioids need to be part of a package of services. PCP's and non-pain trained specialists rarely have the resources or interest in developing the infrastructure in their practice to support this level of care.

The whole opioid issue reminds me of the gun debate: Guns aren't dangerous, but bad people with guns are! PCPs simply can't do a good job with opioid RX because of the other demands of their practice.

 

[Tenesma]

http://www.painphysicianjournal.com/2007/may/2007;10;479-491.pdf

this should make for some interesting reading...

 

[lobelsteve]

http://www.painphysicianjournal.com/2007/may/2007;10;479-491.pdf

this should make for some interesting reading...

If interesting you mean poorly written....

I take offense in the abstract as well as some of the content.

From the abstract: "Of course, opioids may cause addiction, but the "principle of balance" may justify that "…efforts to address abuse should not interfere with legitimate medical practice and patient care."

" OF COURSE, OPIOIDS MAY CAUSE ADDICTION" This should have been edited out as it is plainly incorrect.


From the article: "A key paper reporting hospital
rates of addiction was taken out of context and widely
used to support an extremely low rate of addiction
(0.03%) (1)."

Clearly referring to Porter and Jick NEJM 1980- This was a letter to the editor consisting of 101 words (11 lines, 1 paragraph). It is the most referenced addiction "article". Please follow this link to see a copy of the entire article. I'm glad she came out on the right side criticizing the letter. Note that this "article" would not wipe the ass of anybody who knows anything about EBM. They had 11,882 patients and none had any addiction problems prior to their survey and 4 developed addiction problems based on the data they collected. It is fair to say that we all believe the incidence of opioid abuse in the general population is 7% (+/-3%).

Other than these 2 key points, the article was adequately written. If anyone is ready to publish, I'll happily tear you a new one before it hits the press.

 

[Tenesma]

1) most articles in "pain physician" are poorly written (unfortunately) from an EBM point of view... just look at who does the peer-review - it is always the same club

2) i thought it was interesting in the sense that there is a growing feeling about the use of opioids in chronic pain

3) addiction: most people don't get addicted to narcotics unless they have pre-existing addiction issues - like most alcoholics say: "once an alcoholic always an alcoholic"... the statistics are meaningless really because they are inaccurate...

4) tearing somebody a new one: what's your point?

EBM in pain medicine sucks - not because there aren't any good researchers... it is because our patients are all over the place when it comes to reporting pain scales/functional improvement - we don't even have adequate pain scales yet...

 

[epidural man]

Some factoids:

Oxy is abused more than the MSO4 preps. I am not sure why.

Oxycontin has 10% quick release, 90% sustained release - that may be why - people get a quick high.

 

[Mister Mxyzptlk]

Oxycontin has 10% quick release, 90% sustained release - that may be why - people get a quick high.

I doubt it. The way OxyContin is abused entails crushing it, which makes the whole tablet immediate release. They usually either snort it or inject it.

I think intact Oxy is more like 30% IR, 70% CR, not 10/90.

 

[epidural man]

I doubt it. The way OxyContin is abused entails crushing it, which makes the whole tablet immediate release. They usually either snort it or inject it.

I think intact Oxy is more like 30% IR, 70% CR, not 10/90.

You probably are right - I had always heard 10% quick release. I think the rep told me that.

 

[Aether2000]

Purdue reps contend that it is 10/90. Competitors contend that it is 30/70. I have asked each for data on this but after several years and many inquiries, it has not been forthcoming from Purdue nor from their competitors.

 

[ampaphb]

Oxycontin has 10% quick release, 90% sustained release - that may be why - people get a quick high.

Actually, that wouldn't be terrible. It is really closer to 40% quick release, 60% sustained.