Abuse-deterrent Opioids are worth the Cost

[drusso]

http://econostats.org/estimating-the-net-economic-benefit-of-abuse-deterrent-opioids/

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[Ducttape]

This paper is a hypothetical work. Obviously it states that anise deterrent formulations save society $$$.

However...

http://archpsyc.jamanetwork.com/Mobile/article.aspx?articleid=2174541

This survey suggests that the abuse deterrent aspect is not enough and the significant portion continue to abuse. The economic paper seems to overstate potential cost savings, and base its numbers on two previous studies that used their own estimates.

The conclusion of the second article is worth pointing out because abuse deterrent formulations are inadequate by themselves - in fact so are policies that focus only on reducing supply.

 

[drusso]

This paper is a hypothetical work. Obviously it states that anise deterrent formulations save society $$$.

However...

http://archpsyc.jamanetwork.com/Mobile/article.aspx?articleid=2174541

This survey suggests that the abuse deterrent aspect is not enough and the significant portion continue to abuse. The economic paper seems to overstate potential cost savings, and base its numbers on two previous studies that used their own estimates.

The conclusion of the second article is worth pointing out because abuse deterrent formulations are inadequate by themselves - in fact so are policies that focus only on reducing supply.

Surveys aren't Science: Another conclusion from the the JAMA Psych article would be that there is a large unmet need for abuse-deterrent heroin.

ADF's aren't a one-size-fits-all solution, but are instead an important arrow in the quiver for reducing prescription drug abuse. ADF's do NOTHING to negatively impact analgesia for patients with legitimate indications for using the product *AND* make it harder for some addicts to abuse.

We are seeing a bend in the curve toward reductions of overdose and death in the opioid abuse epidemic in this country. Now is NOT the time to turn our backs on sensible public policies and technologies including enhanced monitoring, surveillance, crack down on cartels and importers, and prescriber education and awareness.

 

[Aether2000]

In my population abuse deterrent opioids are simply not affordable with up to 3/4 of the costs beibg passed on directly to the patient by insurance companies. Besides with the widespread availability of heroin at a cost of 1/3 of that of short acting meds i have to wonder how much it really matters

 

[101N]

Ballyhooing abuse deterrence is Pharma's attempt to change the subject in the midst of an opioid epidemic.

Abuse-deterrent Opioids: A Fraught Approach to an Epidemic
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By: Michael Ferguson
Sunday, March 01, 2015

Filed under: Regulatory & Compliance | Risk Management | Treatments & Techniques | Pain Management

Since 1999, the United States’ rapidly escalating epidemic of prescription drug abuse has directly correlated with a nearly 300 percent uptick in prescription painkiller sales, according to the CDC. abuse-deterrent formulations of some of these drugs are now available, but what problem are they addressing?


In 2008, prescription painkillers — opioid pain relievers — were involved in nearly 15,000 overdose deaths — more than the combined death count attributed to cocaine and heroin, the CDC notes. Nonetheless, in 2012, providers wrote 259 million prescriptions for these pain relievers for a broad range of conditions, the CDC reports.

As one strategy to curtail misuse, pharmaceutical companies are producing abuse-deterrent formulations of opioid pain relievers such as hydrocodone and oxycodone. In late 2014, the FDA approved Hysingla ER (hydrocodone bitartrate) to treat severe pain that requires daily, long-term opioid treatment.

Abuse-deterrent formulations, such as the one marketed in Hysingla ER, essentially prevent manipulating the drug, by crushing or chewing it, to deliver the maximum dose of the opioid immediately. The pills also form a thick hydrogel that inhibits preparing a crushed pill for injection.

Yet even as it announced approval of Hysingla ER, the FDA included disclaimers about the potential for misuse of abuse-deterrent opioids. While abuse-deterrent formulations may reduce overdose deaths resulting from injection or snorting, the strategy does not address oral consumption, the most common method of prescription drug abuse.

“My chief concern about abuse-deterrent opioids is that when you make pills harder to crush, snort or inject, you’re not making them less addictive,” says Andrew Kolodny, MD, Director of Physicians for Responsible Opioid Prescribing and Chief Medical Officer at Phoenix House, a drug and alcohol abuse treatment provider. “Almost everyone who develops the disease of opioid addiction — whether they’re the recreational user or pain patient — develops the disease through oral abuse.”

This is particularly evident in patients who are prescribed opioids for chronic pain but fail to gain sufficient relief, notes Lynn Webster, MD, Vice President of Scientific Affairs at PRA Health Sciences and past president of the American Academy of Pain Medicine.

“[Pain patients] tend not to manipulate but take in excess of what was prescribed in order to get pain relief, and the new forms will not prevent that from happening,” Dr. Webster says. “These forms will not prevent the most common method of abuse.”

When indicated — commonly for end-of-life analgesia and cancer-related pain — opioid pain relievers are exceptionally effective, but marketing these powerful medications as potentially “safer” versions of themselves carries possibly catastrophic consequences, some observers say.

“The problem with calling them ‘abuse-deterrent pills’ is that it gives people — including prescribers — the impression that the pill is safer and maybe less addictive,” Dr. Kolodny says. “If physicians think [an opioid] is somehow a less addictive pill because it’s being marketed as abuse-deterrent, they prescribe it for low-back pain when they really shouldn’t be giving an opioid for low-back pain.”

Perceiving the medications as safe, providers may lean on them to treat a number of chronic pain conditions because of their notable analgesic qualities, he adds. But for many chronic pain conditions, such strategies are fruitless.

“Opioids are lousy drugs for low-back pain, fibromyalgia and chronic headaches, not only because of the risk for addiction, but because they’re unlikely to work,” Dr. Kolodny says.

“We were misled by a very effective marketing campaign to believe that the compassionate way to help people with chronic pain was aggressive opioid prescribing, and that turned out not to be true.”
— Andrew Kolodny, MD, Director of Physicians for Responsible Opioid Prescribing, Chief Medical Officer at Phoenix House

Tennessee Health Commissioner John Dreyzehner, MD, MPH, FACOEM, says the medical evidence supporting opioid treatment for chronic conditions doesn’t add up.

“Despite what many were led to believe, there was never sufficient evidence — and still isn’t — for use of these highly addictive opioid medications for chronic benign pain,” Dr. Dreyzehner says. “For many patients, other modalities or medication such as a combination of acetaminophen and ibuprofen is a more effective and less abuse-prone pain reducer. By focusing on pills, we missed opportunities to better study pain itself and the use of other modalities to relieve it.”

The Physician’s Responsibility
The underlying issue of the prescription drug problem is addiction, and opioid abuse should be treated similarly to any other addiction. But when opioid pain relievers are indicated, responsible prescribing can reduce the likelihood of addiction.

“Opioids have significant risk, but in a subset of patients, the benefits do outweigh the risks,” Dr. Webster says. “It’s an assessment of needs and balancing that risk/benefit ratio to determine whether an opioid should be prescribed, and once prescribed, then patients need to be monitored very closely.”

Several screening mechanisms can help providers monitor patients for signs of drug abuse:

• Urine testing reveals the presence of other drugs in the system, potentially identifying patients with addiction problems, and also identifies whether patients are using their prescriptions.
• Close monitoring by a committed physician can help prevent addiction, but that is effective only if patients cooperate.
• Consulting a state’s prescription drug-monitoring program can identify “doctor shoppers” and drug seekers.

But because addiction, not drug abuse, is the public health issue, these mechanisms won’t stem the tide of the prescription drug epidemic, according to Dr. Kolodny.

Instead, the key to curbing opioid abuse is stopping it before it begins.

When it comes to addictive drugs, “instead of supply reducing demand, supply creates demand,” says Dr. Dreyzehner. “We have steadily increased the supply of these legal, highly regulated and controlled medications. We should not be surprised that demand has risen in virtual lockstep. This current epidemic will end when supply is constrained, current users stop and new users are not recruited.”

 

[drusso]

In my population abuse deterrent opioids are simply not affordable with up to 3/4 of the costs beibg passed on directly to the patient by insurance companies. Besides with the widespread availability of heroin at a cost of 1/3 of that of short acting meds i have to wonder how much it really matters

This is just another form of "adverse tiering" and its an effective way that insurance companies keep the sickest, highest utilizing patients off their books.

http://www.medscape.com/viewarticle/838896

In my state, ADF's are tiered unfavorably against more easily mis-used preparations. In fact, insurance companies often will require that patients "fail first" methadone and other drugs before approving a fentanyl patch, a butrans patch, abuse-deterrent buprenorphine/naloxone, etc.

Mandating your State's insurance commission or Department Consumer Affairs to require insurance companies to make ADF's cost neutral compared to other preparations levels the playing field for patients whose physicians judge that an ADF is indicated and medically necessary for them.

Physicians need to stop letting the insurance companies dictate to us what is safe, what is medically necessary, and what constitutes an adequate "trial of therapy" before we can prescribe potentially safer alternatives. If a prescriber makes a judgement (based upon PDMP review, third-party information, or direct inquiry) that an ADF is medically necessary, then the last thing that should come between the patient and the prescriber is an arduous pile of red-tape.

 

[Ducttape]

What I am saying (and 101N responded positively is that ADF are insufficient towards curbing opioid addiction as a society. Position papers that espouse dubious science such as the first, suggesting societal benefit, are inadequate towards fixing societal problem with addiction.

In fact I could argue that Big Pharma is using ADF in an obfuscating manner, making the average layperson and primary care doc believe that ADF will fix the issue but instead will really only serve to line Big Pharma's pockets...

 

[drusso]

What I am saying (and 101N responded positively is that ADF are insufficient towards curbing opioid addiction as a society. Position papers that espouse dubious science such as the first, suggesting societal benefit, are inadequate towards fixing societal problem with addiction.

In fact I could argue that Big Pharma is using ADF in an obfuscating manner, making the average layperson and primary care doc believe that ADF will fix the issue but instead will really only serve to line Big Pharma's pockets...

There are well delineated differences between abuse, misuse, and addiction. There will never be a pill to treat addiction. And, until there is, we must apply *all* tools at our disposal to stave off opioid-related over-dose deaths: Prescriber education, PDMP's, surveillance, IN/IM naloxone, drug addiction treatment, and most importantly illicit drug enforcement policy.

Never let better be the enemy of good. I think that its neither ethical nor prudent to wait for the ivory-tower endorsement of RCT's of ADF's in the midst of one of the worst overdose and death epidemics ever. To not see the value in a potentially life-saving technology like ADF results in real consequences in the trenches: Increased supply of easily abusable products feeding the addicts' reservoir of black market/diverted drugs.

“The hottest places in hell are reserved for those who, in times of great moral crisis, maintain their neutrality.” ― Dante Alighieri

 

[101N]

Big Pharma is using ADF in an obfuscating manner, making the average layperson and primary care doc believe that ADF will fix the issue but instead will really only serve to line Big Pharma's pockets...

2+

 

[Ducttape]

Never let better be the enemy of good.

But....

A good plan violently executed today is better than a perfect plan tomorrow.

to wit, we need to focus on limiting access to opioids for those who either do not have a true opioid-deficiency syndrome or those in whom the risk of misuse - personal or societal - is too great a cost.

ADF may do a bit, especially with access to unintended victims, but articles like the first are primarily turning society - and its focus - away from the above action into one of inaction.

 

[101N]

ADF's are little more an attempt by Pharma - and opioid enthusiasts - to distract attention away from where the US sits on this graph: https://ppsg.medicine.wisc.edu/chart

 

[emd123]

The main reason I think abuse deterrent opiates are good is because they're expensive. No that's not a misprint.

It's the exact fact that they're expensive that decreases their street value. That's the main reason all the abusers want Roxicodone 30 instead of oxycontin, now. Not because you can't abuse oxycontin anymore (of course you can, just put it in the mouth and swallow!) but because it costs too much for them to make the profit they want.

 

[Aether2000]

I view substance misuse, abuse, and addiction as a series of overlapping curves. ADF do nothing to prevent these since most people dont snort or crush short or long acting

 

[drusso]

I view substance misuse, abuse, and addiction as a series of overlapping curves. ADF do nothing to prevent these since most people dont snort or crush short or long acting

I think there's ample evidence against this: Addiction is a primarily neurobiological disorder. Abuse and misuse are INTENTIONAL behavioral actions committed with agency.

 

[drusso]

ADF's are little more an attempt by Pharma - and opioid enthusiasts - to distract attention away from where the US sits on this graph: https://ppsg.medicine.wisc.edu/chart

ADF's are a technology not a drug.

 

[Aether2000]

Perhaps but do we have the clinical tools to incisively determine a neurobehavioral biological disorder vs. substance abuse?

 

[drusso]

http://www.forbes.com/sites/cjarlot...o-they-play-in-prescription-opioid-addiction/

 

[Ducttape]

this has become a circular discussion. the Forbes article quotes the 2 articles we have discussed.

the economic paper saying it reduces abuse by opioids by 23% for commercial payors... and the other article states again that 25% will still abuse oxycontin... and a sizable portion just turn to heroin. i would argue that the economic paper is ignoring these 2 points, especially about the cost to society of these new heroin users.

 

[pastafan]

Congress Pressures FDA to Finalize Opioid Guidance
By Kristina Fiore, Senior Writer, MedPageToday
March 18, 2015
Additional Addictions Coverage
3/18/2015

The FDA will publish its long-awaited guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner's office threatened by Congress.

An amendment by Hal Rogers (R-Ky.) to the "Cromnibus" appropriations bill passed last Decemberrequires that the guidance be finalized by June 30, otherwise $20 million will be moved from the salaries and expenses section of the FDA Commissioner's office to its criminal investigations department to combat drug diversion.

Rogers is chair of the House Appropriations Committee.

"It's a lot of money and the FDA is going to respond to that," said Dan Mendelson, CEO of Avalere Health, a firm that tracks healthcare policy. "You always try to get rid of language like that because it does tie your hands."

Indeed, an FDA spokesperson told MedPage Today that the organization "is aware of the provision and we are working to finalize the guidance before the June 30, 2015 deadline."

Guidance for developing abuse-deterrent opioids has been a long time coming. It was initially released in January 2013, but the agency didn't hold a workshop on the draft document a 2-day meeting last October.

While it's unclear what the final language will be, the agency noted last fall that it plans to continue to evaluate approvals on a case-by-case basis -- citing the fact that the science of abuse-deterrence is still unsettled.

In the meantime, five opioids have been approved with abuse-deterrent labeling: Targiniq, Hysingla, and reformulated Oxycontin from Purdue Pharma, abuse-deterrent Embeda from Pfizer, and a reformulated version of Zohydro.

Zohydro, which is pure hydrocodone, was initially approved without any abuse-deterrence mechanism, setting off a firestorm of controversy.

Approvals of generic abuse-deterrent opioids have also been inconsistent; while FDA removed generics of OxyContin from the market once Purdue created an abuse-deterrent formulation, it did not do the same for Opana generics. The FDA did not give Endo Pharmaceuticals a label indication for abuse-deterrence for Opana.

 

[drusso]

Congress Pressures FDA to Finalize Opioid Guidance
By Kristina Fiore, Senior Writer, MedPageToday
March 18, 2015
Additional Addictions Coverage
3/18/2015

The FDA will publish its long-awaited guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner's office threatened by Congress.

An amendment by Hal Rogers (R-Ky.) to the "Cromnibus" appropriations bill passed last Decemberrequires that the guidance be finalized by June 30, otherwise $20 million will be moved from the salaries and expenses section of the FDA Commissioner's office to its criminal investigations department to combat drug diversion.

Rogers is chair of the House Appropriations Committee.

"It's a lot of money and the FDA is going to respond to that," said Dan Mendelson, CEO of Avalere Health, a firm that tracks healthcare policy. "You always try to get rid of language like that because it does tie your hands."

Indeed, an FDA spokesperson told MedPage Today that the organization "is aware of the provision and we are working to finalize the guidance before the June 30, 2015 deadline."

Guidance for developing abuse-deterrent opioids has been a long time coming. It was initially released in January 2013, but the agency didn't hold a workshop on the draft document a 2-day meeting last October.

While it's unclear what the final language will be, the agency noted last fall that it plans to continue to evaluate approvals on a case-by-case basis -- citing the fact that the science of abuse-deterrence is still unsettled.

In the meantime, five opioids have been approved with abuse-deterrent labeling: Targiniq, Hysingla, and reformulated Oxycontin from Purdue Pharma, abuse-deterrent Embeda from Pfizer, and a reformulated version of Zohydro.

Zohydro, which is pure hydrocodone, was initially approved without any abuse-deterrence mechanism, setting off a firestorm of controversy.

Approvals of generic abuse-deterrent opioids have also been inconsistent; while FDA removed generics of OxyContin from the market once Purdue created an abuse-deterrent formulation, it did not do the same for Opana generics. The FDA did not give Endo Pharmaceuticals a label indication for abuse-deterrence for Opana.

FDA needs to hear that insurance companies shouldn't prioritize cost (cheap generics) over patients lives.

 

[101N]

Fixed it for ya:

FDA needs to hear that Pharma shouldn't be allowed to prioritize profits over patients lives.

 

[drusso]

Fixed it for ya:

FDA needs to hear that Pharma shouldn't be allowed to prioritize profits over patients lives.

There are only two reasons why insurance companies adversely tier cheap generics and methadone over ADF's, buprenorphine/naloxone, and transdermal patches: Dollars & Cents.

Go to your CCO's P&T committee and ask for a CLINICAL justification for why methadone and IR oxycodone are preferred tier and ADF's are not...Dollars & Cents...

 

[Ducttape]

isnt the bottom line for insurance companies the almighty $$$? you are asking them to go against their organizational initiatives and aspirations.

and the bottom line for big pharma is also $$$. why has there been a rush to make ADFs within the past 2 years, if not because of the financial boom (see Purdue keeping Oxycontin a Brand drug).


i like to think that physicians are the only group that is not focused on $$$, but i am oft decieved...

 

[emd123]

isnt the bottom line for insurance companies the almighty $$$? you are asking them to go against their organizational initiatives and aspirations.

and the bottom line for big pharma is also $$$. why has there been a rush to make ADFs within the past 2 years, if not because of the financial boom (see Purdue keeping Oxycontin a Brand drug).


i like to think that physicians are the only group that is not focused on $$$, but i am oft decieved...

Only hospital-employed doctors are so pure of heart. They care not of money, and most have taken a vow of poverty.

 

[drusso]

FDA supports development of abuse-deterrent formulations as a priority:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM440713.htm

“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”

 

[101N]

Abuse deterrence gives the public - and you - a false sense of security. It does not translate to non-addicting. The risks of exposure to opioids are the same regardless of abuse deterrence.

Abuse deterrence is just a PHARMA sales job.

 

[drusso]

Abuse deterrence gives the public - and you - a false sense of security. It does not translate to non-addicting. The risks of exposure to opioids are the same regardless of abuse deterrence.

Abuse deterrence is just a PHARMA sales job.

I think that views are captured here:

http://www.bizjournals.com/portland...of-addiction-is-this-newly-approved-pain.html

For something "non-addicting," the science is evolving, but far beyond where it should be:

http://www.nature.com/npp/journal/v36/n1/full/npp2010137a.html

"The realization that different agonists binding to the same receptor can produce different actions has been variously called ‘biased agonism’, ‘functional selectivity’, and ‘ligand directed signaling’ (see Melief et al, 2010). On the basis of this concept, an analgesic κ-opioid that did not recruit arrestin might not produce dysphoria (Figure 1). A formulation of such a ligand, combined with a peripherally restricted κ-antagonist to block the constipating and diuretic effects, might result in the long-sought nonaddictive opioid analgesic. These are exciting times in the κ-world."

For something "abuse-deterrent," it is true that addicts will try to reverse engineer a solution as fast as innovators can engineer one. That speaks to another problem. Still, it is in my view, disgusting for *ANY* industry to point body counts and ask, "Who's winning?" I recently heard a insurance industry lobbyist say exactly that...

 

[Ducttape]

On the basis of this concept, an analgesic κ-opioid that did not recruit arrestin might not produce dysphoria (Figure 1). A formulation of such a ligand, combined with a peripherally restricted κ-antagonist to block the constipating and diuretic effects, might result in the long-sought nonaddictive opioid analgesic.

that was written in 2011. has anything come out yet?

i dont get something - do people use fentanyl for dysphoria specifically? the authors seem to equate the dysphoria produced by k-agonists, blocked by arrestin, as the major reason for addiction to opioids.morphine doesnt, fentanyl does recruit arrestin. but dont people become addicted to fentanyl, or is it only in my practice?

also, i dont see how blocking arrestin would prevent the development of tolerance or dependence, but i may be missing something else?


fyi, thats a pretty good looking dude who authored the first article! (in a non-sexual connotation, of course)

 

[drusso]

http://www.wsj.com/articles/fda-off...ng-opioids-less-prone-to-be-abused-1427913989

FDA Offers Guidance on Developing Opioids Less Prone to Be Abused
Agency hopes to encourage painkiller formulas that are more difficult to crush, inject or snort

By THOMAS M. BURTON
April 1, 2015 2:46 p.m. ET


The Food and Drug Administration issued a set of suggestions to help the drug industry develop new opioid painkillers that potentially would be less susceptible to abuse than current pills.

The federal agency said in its guidance document that it hopes to encourage painkiller formulations that are more difficult to crush, inject or snort to produce a more intense high. But the FDA acknowledged that even such abuse-deterrent versions of the pills aren't “abuse-proof.”

The tendency for addicts to use narcotic painkillers has turned into an epidemic in the U.S., with more than 16,000 people each year estimated to die from overdosing on opioid-based pills. The FDA has been struggling with the balance between making powerful painkillers available to patients with severe chronic pain, and yet limiting the drugs’ abuse potential.

“We hope that this guidance is going to provide an incentive for real abuse-deterrent products,” said Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA’s center for drug evaluation. “We hope industry will find that this guidance lays out a road map” for how to make abuse-deterrent drugs that will gain FDA approvals.

The FDA document recommends the types of studies that will be needed to prove a given drug can deter abuse. It suggests ways such research can be conducted and evaluated, and discusses labeling claims that will be allowed following such trials.

Agency officials said that about 30 drug manufacturers have come in to the FDA lately to talk with them about how to make abuse-deterrent products. Dr. Throckmorton said it is possible the agency can give priority review status to such applications, to speed them to the market.

Some physicians weren’t overwhelmed by the plan.

“It does very little,” said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “The ability of so-called abuse-deterrent formulations to have impact on our opioid abuse problems is limited.”

The FDA guidance document acknowledged the difficulty, saying, “because opioid products must in the end be able to deliver the opioid to the patient, there may always be some abuse of these products.”

In Dr. Kolodny’s view, some other fairly simple steps may be more effective. The agency, he contends, could take larger dosages off the market. Also, he said, it could prohibit marketing of such powerful narcotics for certain conditions such as low-back pain, which he said is responsible for about 60% of the people on opioids.

 

[Ducttape]

the FDA wants to make sure that the drugs are not being taken in a manner not commiserate with how it is supposed to be used. there is no way for the FDA to be able to affect the abuse rate for those patients who are addicted to the medication in its prescribed form.

it is helpful, but i fear the FDA's goals will only affect the tip of the iceberg,\ give Big Pharma much more money and resources, yet not impact the overall epidemic. what percentage of those who OD are actually snorting, shooting, or crushing pills, and what percentage are taking way too much and in combination with other drugs?

 

[drusso]

the FDA wants to make sure that the drugs are not being taken in a manner not commiserate with how it is supposed to be used. there is no way for the FDA to be able to affect the abuse rate for those patients who are addicted to the medication in its prescribed form.

it is helpful, but i fear the FDA's goals will only affect the tip of the iceberg,\ give Big Pharma much more money and resources, yet not impact the overall epidemic. what percentage of those who OD are actually snorting, shooting, or crushing pills, and what percentage are taking way too much and in combination with other drugs?

It's my observation that those opposing ADF's counter with the Straw Man argument that ADF's don't fix "the real problem." I don't think anyone believes there is any simple fix to "the real problem." "The real problem" is not one problem...it's an amalgamation of many problems. One of those many problems is the abuse and tampering of narcotics.

That's why I think that Dr. Kalodny has be very careful and "thread the needle" and say the evidence is "limited." You can't simultaneously be in FAVOR of reducing addiction but OPPOSED to reducing medication tampering.

I think this issue is a classic example of how physicians, as a group, F*ck themselves politically and professionally. We can't learn to speak with one voice...contrast that with the unions...they've got the "ONE VOICE" message mastered. Doctors would rather just take turns punching each other.

 

[Disciple]

I don't see the negative in abuse deterrent formulations other than cost. Those truly addicted or seeking to abuse opioids will specifically seek to avoid these products due to difficulty in obtaining the medication and difficulty in manipulating it. Even moreso if the product does not provide a rapid increase in plasma levels of the medication.

I don't see why one can't support development of these products and also support overall decreased use of opioids for chronic non-malignant pain.

Attack the problem from multiple angles.

 

[Ducttape]

i agree with both those opinions, but the FDA, Big Pharma, public policy are producing a diversionary tactic that implies that we can solve the "opioid epidemic" chemically with ADF. im sure the FDA and public policy dont truly believe that ADFs will fix the real problem. im sure Big Pharma believes that this duping of the public will improve their bottom line profit.

the common man will believe the truthspeak from Big Pharma - "what addiction or overdose, these new drugs stop it from ever happening!" - and public support towards reducing and appropriately managing overuse of opioids will go "poof" as public opinion changes from one of concern over opioids to one in which narcotics will again be requested ad infinitum by patients. it appears to be only a matter of time...

 

[Disciple]

I am skeptical the public will ever buy-in to the cognitive behavioral approach to chronic pain, given the entitlement mind-set in our society.

Here is how you accomplish the goal, despite what the public supports.

Make access to short acting oxycodone and Soma (and possibly methadone) for outpatient use in chronic non-malignant pain difficult. Encourage physicians to have a low ceiling (dosage and dosing frequency) for outpatient use of short-acting hydrocodone, and encourage appropriate use of state PDMP reports and urine screening, but a high threshold overall for initiating opioids for chronic non-malignant pain. Discourage physicians from concurrently prescribing benzodiazepines. If a long acting opioid must be used, use an abuse deterrent formulation. Over utilization of these expensive products will be avoided, as those looking to abuse opioids will stop taking the abuse deterrent formulation, or simply fail to fill the prescription.

Patients able to stay within these parameters may very well be successfully managed on long term opioid therapy. For the rest, treatment failure can be documented and opioids discontinued, with referral to a tertiary care center for treatment in a cognitive-behaviorally based functional restoration program--if only some actually existed.

 

[Ducttape]

yes, the public opinion is that of entitlement with opioids. physicians alone cant stand against that overwhelming tide to accomplish what you suggest.

have we, as a profession, really made that much of an indent on public health (with the exception of smoking, but that was really only after significant government intervention)?

Look at low fat/ gluten free/ low carb/ sugar free food, and diets based on that. Green tea extracts from Dr. Oz.
E-cigs.
Low alcohol beer.
State marijuana laws.

the American way is that we want it all. including their opioids.

ADFs may be just fluff that doesnt alter the fact that one is taking something bad that seems so good.

 

[Disciple]

We can only advise/counsel our patients, but cannot control their vices and behavior.

However, physicians hold the keys to legal opioids. Many states have enacted, or are enacting legislation requiring pain consultations for patients on MEDs variably ranging between 50-120mg daily.

Now, reign in pain physicians who are outliers, and there may be some progress, with or without buy-in from the public.

 

[pastafan]

We can only advise/counsel our patients, but cannot control their vices and behavior.

However, physicians hold the keys to legal opioids. Many states have enacted, or are enacting legislation requiring pain consultations for patients on MEDs variably ranging between 50-120mg daily.

Now, reign in pain physicians who are outliers, and there may be some progress, with or without buy-in from the public.

Consultation sounds good in theory but it isn't working in my area. Patients are referred for the mandatory one consultation to a pain doc. I just saw a patient this week that had been on decades of COT at levels up to 1400 MED now on over 300 MED since his new PCP has been weaning him. Patient was seen by another pain doc before me for his "consultation". The other doc did his usual series of injections that did nothing. He then sends a canned note to referring doc that MED should be reduced below 100 MED but gives absolutely no guidance to PCP on how to accomplish this or suggestions on how to help the patient. The law has been a revenue generator for those with a needle. Unfortunately, these pain doc are not the outliers in my area.

 

[101N]

JAMA Psychiatry. 2015 Mar 11. doi: 10.1001/jamapsychiatry.2014.3043. [Epub ahead of print]
Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United States: Lessons Learned From OxyContin.
Cicero TJ1, Ellis MS1.
Author information

Abstract
IMPORTANCE:
In an effort to reduce wide-scale abuse of the proprietary oxycodone hydrochloride formulation OxyContin, an abuse-deterrent formulation (ADF) was introduced in 2010. Although the reformulation produced an immediate drop in abuse rates, a definite ceiling effect appeared over time, beyond which no further decrease was seen.

OBJECTIVE:
To examine the factors that led to the initial steep decline in OxyContin abuse and the substantial levels of residual abuse that have remained relatively stable since 2012.

DESIGN, SETTING, AND PARTICIPANTS:
We used data from the ongoing Survey of Key Informants' Patients program, part of the Researched Abuse, Diversion and Addiction-Related Surveillance system that collects and analyzes postmarketing data on misuse and diversion of prescription opioid analgesics and heroin. For our survey study, patients with a DSM-V diagnosis of opioid use disorder and primary drug of abuse consisting of a prescription opioid or heroin (N = 10 784) at entry to 1 of 150 drug treatment programs in 48 states completed an anonymous structured survey of opioid abuse patterns (surveys completed from January 1, 2009, through June 30, 2014). A subset of these patients (n = 244) was interviewed to add context and expand on the structured survey.

MAIN OUTCOMES AND MEASURES:
In addition to key demographic measures, past-month abuse of opioids was the primary measure in the structured surveys. In the interviews, the effect of the introduction of the ADF on drug-seeking behavior was examined.

RESULTS:
Reformulated OxyContin was associated with a significant reduction of past-month abuse after its introduction (45.1% [95% CI, 41.2%-49.1%] in January to June 2009 to 26.0% [95% CI, 23.6%-28.4%] in July to December 2012; P < .001; χ2 = 230.83), apparently owing to a migration to other opioids, particularly heroin. However, this reduction leveled off, such that 25% to 30% of the sample persisted in endorsing past-month abuse from 2012 to 2014 (at study end [January to June 2014], 26.7% [95% CI, 23.7%-29.6%]). Among the 88 participants who indicated experience using pre-ADF and ADF OxyContin, this residual level of abuse reflects the following 3 phenomena: (1) a transition from nonoral routes of administration to oral use (38 participants [43%]); (2) successful efforts to defeat the ADF mechanism leading to a continuation of inhaled or injected use (30 participants [34%]); and (3) exclusive use of the oral route independent of formulation type (20 participants [23%]).

CONCLUSIONS AND RELEVANCE:
Abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including ADF technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country.

PMID:

25760692

[PubMed - as supplied by publisher]

 

[drusso]

JAMA Psychiatry. 2015 Mar 11. doi: 10.1001/jamapsychiatry.2014.3043. [Epub ahead of print]
Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United States: Lessons Learned From OxyContin.
Cicero TJ1, Ellis MS1.
Author information

Abstract
IMPORTANCE:
In an effort to reduce wide-scale abuse of the proprietary oxycodone hydrochloride formulation OxyContin, an abuse-deterrent formulation (ADF) was introduced in 2010. Although the reformulation produced an immediate drop in abuse rates, a definite ceiling effect appeared over time, beyond which no further decrease was seen.

OBJECTIVE:
To examine the factors that led to the initial steep decline in OxyContin abuse and the substantial levels of residual abuse that have remained relatively stable since 2012.

DESIGN, SETTING, AND PARTICIPANTS:
We used data from the ongoing Survey of Key Informants' Patients program, part of the Researched Abuse, Diversion and Addiction-Related Surveillance system that collects and analyzes postmarketing data on misuse and diversion of prescription opioid analgesics and heroin. For our survey study, patients with a DSM-V diagnosis of opioid use disorder and primary drug of abuse consisting of a prescription opioid or heroin (N = 10 784) at entry to 1 of 150 drug treatment programs in 48 states completed an anonymous structured survey of opioid abuse patterns (surveys completed from January 1, 2009, through June 30, 2014). A subset of these patients (n = 244) was interviewed to add context and expand on the structured survey.

MAIN OUTCOMES AND MEASURES:
In addition to key demographic measures, past-month abuse of opioids was the primary measure in the structured surveys. In the interviews, the effect of the introduction of the ADF on drug-seeking behavior was examined.

RESULTS:
Reformulated OxyContin was associated with a significant reduction of past-month abuse after its introduction (45.1% [95% CI, 41.2%-49.1%] in January to June 2009 to 26.0% [95% CI, 23.6%-28.4%] in July to December 2012; P < .001; χ2 = 230.83), apparently owing to a migration to other opioids, particularly heroin. However, this reduction leveled off, such that 25% to 30% of the sample persisted in endorsing past-month abuse from 2012 to 2014 (at study end [January to June 2014], 26.7% [95% CI, 23.7%-29.6%]). Among the 88 participants who indicated experience using pre-ADF and ADF OxyContin, this residual level of abuse reflects the following 3 phenomena: (1) a transition from nonoral routes of administration to oral use (38 participants [43%]); (2) successful efforts to defeat the ADF mechanism leading to a continuation of inhaled or injected use (30 participants [34%]); and (3) exclusive use of the oral route independent of formulation type (20 participants [23%]).

CONCLUSIONS AND RELEVANCE:
Abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including ADF technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country.

PMID:

25760692

[PubMed - as supplied by publisher]

Oregon Medicaid needs to stop adversely tiering ADF's, buprenorphine, and transdermal products:

http://www.hoodrivernews.com/news/2015/apr/11/another-voice-cost-vs-patient-safety/

 

[101N]

http://www.forbes.com/sites/matthew...-pills-pill-wont-stop-opioid-overdose-deaths/
Why Supposedly Abuse-Proof Pills Won't Stop Opioid Overdose Deaths

Comment Now
Pfizer PFE -0.43%, and Zogenix ZGNX -1.25%. But they’ve also become a huge public health problem, leading to record numbers of drug overdose deaths. In 2013, more than 16,000 people died of opiate analgesic drug overdoses, up from 4,000 a decade ago.

So when Purdue, the maker of the category-defining Oxycodone, asked to come by to show me the abuse-resistant technology in its new Hysingla pill, I was game: I hit it with a hammer, squeezed it with wire cutters, and soaked it in water. The pill was almost impossible to make into anything that you can snort or inject. But critics of these narcotic pills say that most patients take the pills by mouth, and that many who overdose initially got the medicines from their doctors, not from the black market. So is this new technology enough? Probably not.

Watch me try to destroy Hysingla, and talk to David Haddox, a Purdue executive, and Andrew Kolodny, who runs addiction treatment facility Phoenix House, in the video below, and watch to the end for my summation of why these new abuse resistant technologies, though neat, are not enough of a step to deal with what has become a giant public health problem.

 

[drusso]

http://www.forbes.com/sites/robertglatter/2015/04/20/new-abuse-deterrent-formulations-reduce-opiate-prescriptions-and-overdoses/


Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene ONLINE FIRST
Marc R. Larochelle, MD, MPH1,2; Fang Zhang, PhD1; Dennis Ross-Degnan, ScD1; J. Frank Wharam, MBBCh, BAO, MPH1
[+-] Author Affiliations
1Harvard Pilgrim Health Care Institute, Department of Population Medicine, Harvard Medical School, Boston, Massachusetts
2Section of General Internal Medicine, Department of Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts
JAMA Intern Med. Published online April 20, 2015. doi:10.1001/jamainternmed.2015.0914
Text Size: A A A
ABSTRACT
ABSTRACT | INTRODUCTION | METHODS | RESULTS | DISCUSSION | CONCLUSIONS | ARTICLE INFORMATION | REFERENCES
Importance In the second half of 2010, abuse-deterrent extended-release oxycodone hydrochloride (OxyContin; Purdue Pharma) was introduced and propoxyphene was withdrawn from the US market. The effect of these pharmaceutical market changes on opioid dispensing and overdose rates is unknown.

Objective To evaluate the association between 2 temporally proximate changes in the opioid market and opioid dispensing and overdose rates.
Design, Setting, and Participants Claims from a large national US health insurer were analyzed, using an interrupted time series study design. Participants included an open cohort of 31.3 million commercially insured members aged 18 to 64 years between January 1, 2003, and December 31, 2012, with median follow-up of 20 months (last follow-up, December 31, 2012).
Exposures Introduction of abuse-deterrent OxyContin (resistant to crushing or dissolving) on August 9, 2010, and market withdrawal of propoxyphene on November 19, 2010.
Main Outcomes and Measures Standardized opioid dispensing rates and prescription opioid and heroin overdose rates were the primary outcomes. We used segmented regression to analyze changes in outcomes from 30 quarters before to 8 quarters after the 2 interventions.
Results Two years after the opioid market changes, total opioid dispensing decreased by 19% from the expected rate (absolute change, −32.2 mg morphine-equivalent dose per member per quarter [95% CI, −38.1 to −26.3]). By opioid subtype, the absolute change in dispensing by milligrams of morphine-equivalent dose per member per quarter at 2 years was −11.3 (95% CI, −12.4 to −10.1) for extended-release oxycodone, 3.26 (95% CI, 1.40 to 5.12) for other long-acting opioids, −8.19 (95% CI, −9.30 to −7.08) for propoxyphene, and −16.2 (95% CI, −18.8 to −13.5) for other immediate-release opioids. Two years after the market changes, the estimated overdose rate attributed to prescription opioids decreased by 20% (absolute change, −1.10 per 100,000 members per quarter [95% CI, −1.47 to −0.74]), but heroin overdose increased by 23% (absolute change, 0.26 per 100 000 members per quarter [95% CI, −0.01 to 0.53]).
Conclusions and Relevance Opioid dispensing and prescription opioid overdoses decreased substantially after 2 major changes in the pharmaceutical market in late 2010. Pharmaceutical market interventions may have value in combatting the prescription opioid overdose epidemic, but heroin overdose rates continue to increase. Complementary strategies to identify and treat opioid abuse and addiction are urgently needed.

 

[Ducttape]

key line: "Complementary strategies to identify and treat opioid abuse and addiction are urgently needed."

why did they come to the conclusion that it was a pharmaceutical change that caused opioid dispensing to change? why not a change in prescription policy as advocated by SAMSHA or CDC?

after all, the extended-release oxycodone use increased, and that does not suggest a reduction in use of oxycontin.

 

[drusso]

Do health plans favor cheaper generic opioids over patient safety?

http://www.forbes.com/sites/cjarlotta/2015/06/17/does-medicare-favor-generic-opioids/

http://www.hoodrivernews.com/news/2015/apr/11/another-voice-cost-vs-patient-safety/