Subutex and Suboxone: Questions and Answers By The FDA

February 17, 2014

Introduction By Terence T. Gorski: I have been receiving many questions about my opinion about the use of Suboxone and Subutex in the treatment of opiate addiction. I have mixed feelings, depending upon how it is used.

When Suboxone was originally developed as a joint effort between SAMHSA its subsidiary NIDA and Reckitt Benckiser Pharmaceuticals Inc. The motivations was to find a more effective maintenance medication for opiate addicts that could replace methadone maintenance and be administered and managed by physicians in their offices. Subutex and Suboxone are the first narcotic drugs available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate dependence that can be prescribed in a doctor’s office. This change will provide more patients the opportunity to access treatment.

Suboxone can be used as a part of multi-modality treatment, but it was developed to be a stand-alone treatment managed by physicians. With the implementation of the Affordable Care Act (ACA), Suboxone fits in perfectly with the government’s agenda to integrate addiction treatment into routine medical practice.

I am pleased that the government recognizes opiate addiction as a medical problem that requires treatment within the general health care system. I am disappointed that physicians are being trained to be the sole providers of Suboxone Treatment and that a comprehensive biopsychosocial assessment and multimodality treatment is not strongly recommended or required as part of the treatment.

I have heard many reports from opiate addicts that Suboxone has helped them because it reduces or eliminates craving and does not produce a state of euphoria if it more is taken the prescribed. I might add, that most opiate addicts recovering with only Suboxone that  have talked to have experimented on “bad days” to see if they can get high by taking ore than prescribed. Most report that they can’t. Some, however, have had a relapse when they went out and get some other drug to get them through the bad period.

Subutex and Suboxone are also used as opiate detox medications in some programs.

Suboxone can create a euphoric high and many people report tolerance with long-term use. As result it is an addictive drug of abuse that must be used cautiously. It has a street value and is showing up more frequently as a drug of abuse in people seeking treatment. 

I believe that any new medication that can help people addicted to opiates and other drugs is a good thing. It is short sighted, however, to build the use of any addiction medication around a purely medical model that does not encourage or require a brief course (about 90 days) of addiction counseling. This addiction-counseling program includes:

(1) A biopsychosocial evaluation determines the severity of addiction and related problems

(2) Develops a sober social support to help patients to develop a new set of sober and responsible friends.

(3) Teaches life, a recovery, and relapse prevention skills;

(4) Helps to rebuild relationships on the job, at home, with extended family members, and friends.

These addiction-counseling programs can be delivered flexibly on an outpatient basis. Many addiction professionals offer services n ear many Suboxone Doctors and they could form a valuable collaboration for the benefit of the patient. It is also possible for Suboxone Doctors you include addiction professionals in the practice. This would expand services, increases patient retention, and add an additional revenue stream.

With these comments in mind, here are some of the FAQ questions about Suboxone on Subutex developed by NIDA.

1. What are Suboxone and Subutex?

Subutex and Suboxone are medications approved for the treatment of opiate dependence. Both medicines contain the active ingredient, buprenorphine hydrochloride, which works to reduce the symptoms of opiate dependence.

2. Why did the FDA approve two medications?

Subutex contains only buprenorphine hydrochloride. This formulation was developed as the initial product. The second medication, Suboxone contains an additional ingredient called naloxone to guard against misuse.

Subutex is given during the first few days of treatment, while Suboxone is used during the maintenance phase of treatment.

3. Will most prescriptions be for the Suboxone formulation?

Yes, Suboxone is the formulation used in the majority of patients.

4. How are Subutex and Suboxone different from the current treatment options for opiate dependence such as methadone?

Currently opiate dependence treatments like methadone can be dispensed only in a limited number of clinics that specialize in addiction treatment. There are not enough addiction treatment centers to help all patients seeking treatment. Subutex and Suboxone are the first narcotic drugs available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate dependence that can be prescribed in a doctor’s office. This change will provide more patients the opportunity to access treatment.

5. What are some possible side effects of Subutex and Suboxone?

(This is NOT a complete list of side effects reported with Suboxone and Subutex. Refer to the package insert for a more complete list of side effects.)

The most common reported side effect of Subutex and Suboxone include:

  • cold or flu-like symptoms
  • headaches
  • sweating
  • sleeping difficulties
  • nausea
  • mood swings.

Like other opioids Subutex and Suboxone have been associated with respiratory depression (difficulty breathing) especially when combined with other depressants.

6. Are patients able to take home supplies of these medicines?

Yes. Subutex and Suboxone are less tightly controlled than methadone because they have a lower potential for abuse and are less dangerous in an overdose. As patients progress on therapy, their doctor may write a prescription for a take-home supply of the medication.

7. How will FDA know if these drugs are being misused, and what can be done if they are?

FDA has worked with the manufacturer, Reckitt-Benckiser, and other agencies to develop an in-depth risk-management plan. FDA will receive quarterly reports from the comprehensive surveillance program. This should permit early detection of any problems. Regulations can be enacted for tighter control of buprenorphine treatment if it is clear that it is being widely diverted and misused.

8. What are the key components of the risk-management plan?

The main components of the risk-management plan are preventive measures and surveillance.

Preventive Measures include:

  • education
  • tailored distribution
  • Schedule III control under the Controlled Substances Act (CSA)
  • child resistant packaging
  • supervised dose induction

The risk management plan uses many different surveillance approaches. Some active methods include plans to:

  • Conduct interviews with drug abusers entering treatment programs.
  • Monitor local drug markets and drug using network areas where these medicines are most likely to be used and possibly abused.
  • Examine web sites.

Additionally data collection sources can indicate whether Subutex and/or Suboxone are implicated in abuse or fatalities. These include:

  • DAWN—The Drug Abuse Warning Network. This is run by the Substance Abuse and Mental Health Services Administration (SAMHSA) which publishes a collection of data on emergency department episodes related to the use of illegal drugs or non-medical use of a legal drug.
  • CEWG—Community Epidemiology Working Group. This working group has agreed to monitor buprenorphine use.
  • NIDA—National Institute of Drug Abuse. NIDA will send a letter to their doctors telling them to be aware of the potential for abuse and to report it if necessary.

9. Who can prescribe Subutex and Suboxone?

Only qualified doctors with the necessary DEA (Drug Enforcement Agency) identification number are able to start in-office treatment and provide prescriptions for ongoing medication. CSAT (Center for Substance Abuse Treatment) will maintain a database to help patients locate qualified doctors.

10. How will Subutex and Suboxone be supplied?

Both medications come in 2 mg and 8 mg strengths as sublingual (placed under the tongue to dissolve) tablets.

11. Where can patients get Subutex and Suboxone?

These medications will be available in most commercial pharmacies. Qualified doctors with the necessary DEA identification numbers will be encouraged to help patients locate pharmacies that can fill prescriptions for Subutex and Suboxone.

12.      Where can I go for more information?

Go to the Subutex/Suboxone webpage

Contact the CSAT Buprenorphine Information Center at 866-BUP-CSAT, or via email atinfo@buprenorphine.samhsa.gov or http://buprenorphine.samhsa.gov/

 


California’s Draught And Food Inflation

February 14, 2014

ca-drought-cause-1_76539_990x742DON’T BE SURPRISED IF THE PRICES OF PRODUCE SKYROCKET IN THE NEXT SIX MONTHS. If the California draught, now two years old, continues the inflation in farm products could double or triple current prices within a year.

Thomas M. Kostigen for National Geographic
PUBLISHED FEBRUARY 13, 2014
http://news.nationalgeographic.com/news/2014/02/140213-california-drought-record-agriculture-pdo-climate/

Two years into California’s drought, Donald Galleano’s grapevines are scorched shrubs, their charcoal-colored stems and gnarled roots displaying not a lick of life. “I’ve never seen anything like this,” says Galleano, 61, the third-generation owner of a 300-acre vineyard in Mira Loma, California, that bears his name. “It’s so dry … There’s been no measurable amount of rain.”

California is is two years into its worst drought since record-keeping began in the mid 19th century, and scientists say this may be just the beginning. B. Lynn Ingram, a paleoclimatologist at the University of California at Berkeley, thinks that California needs to brace itself for a megadrought — one that could last for 200 years or more.

Given that California is one of the largest agricultural regions in the world, the effects of any drought, never mind one that could last for centuries, are huge. About 80 percent of California’s freshwater supply is used for agriculture. The cost of fruits and vegetables could soar, says Cantu. “There will be cataclysmic impacts.” (Related: “Epic California Drought and Groundwater: Where Do We Go From Here?”)

What’s causing the current drought?

Ingram and other paleoclimatologists have correlated several historic megadroughts with a shift in the surface temperature of the Pacific Ocean that occurs every 20 to 30 years—something called the Pacific Decadal Oscillation (PDO). The PDO is similar to an El Nino event except it lasts for decades—as its name implies—whereas an El Nino event lasts 6 to 18 months.

Cool phases of the PDO result in less precipitation because cooler sea temperatures bump the jet stream north, which in turn pushes off storms that would otherwise provide rain and snow to California. Ingram says entire lakes dried up in California following a cool phase of the PDO several thousand years ago. Warm phases have been linked to numerous storms along the California coast.

How long the current California drought will last is anyone’s guess. The Santa Ana Watershed Project Authority is stymied by that uncertainty. “We need to import water, and we need to know how much we can move around,” she says. Some 4.5 million people rely on that southern California water supply, including ranchers and farmers.

 


What Is A Political Decision?

February 4, 2014

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By Terence T. Gorski, Author

“Every decision is a political decision. Will water come out of your kitchen faucet when you turn it on? The answer depended on political decisions! Will the waste products go down the drain when you flush your toilet? This also depends upon political decisions! Will the waste products flushed down the toilet come out in the kitchen sink? That again depends upon political decisions.
“If the current trends of ill-conceived political decisions regarding alcoholism and addicts continues, it is only a matter of time before the waste products of too much punishment and too little treatment will start to flow into the kitchen sinks of our communities.” ~ Senator Harold Hughes, Deceased. In a private conversation with Terence T. Gorski in 1985. Senator Hughes authored the legislation that founded NIAAA and NIDA.


Telling The Truth To Addicted Friends

February 4, 2014

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By http://www.cenaps.com, Author
February 3, 2014

I care enough to tell you the truth, even when you don’t want to hear it. When most people avoid saying what you don’t want to hear, I whisper the truth annoyingly in your ear. When others blow smoke up your ass so you won’t get mad, I blow truth into you mind even when it makes you enraged. I would rather upset you than watch you die.

You are in trouble. You don’t even know what the problem is. That’s why your solutions that you have been working so hard at  are failing so miserably at building your life.

You’re an addict playing with poison because you mistakenly believe no one will get hurt. It feels good now, so what’s the problem. You tell yourself: “I can make a lot of money selling it, so why bother with school and getting a job. Besides, it aces me feel good and costs nothing because I pay for my own off of the profits.” Well, here’s the down side.

Addiction isn’t just about alcohol and drugs.
It is about being around dangerous and destructive people
who somehow manage to convince you that they are living the good life. 

You could have died or gone to jail many times. Every time you get into cars with drug-using and drug-dealing assholes who pretend to be your friends, you are putting yourself at risk. These are not good people. They are using and manipulating you. They don’t care if you live or die. You’re just one more replaceable running buddy. One more patsy they can use, manipulate, and then throw on the trash heap. You are one cog in their machine of destruction and death. As I said, they are not good people. They use, manipulate, hurt, and even kill people. Most overdose deaths are the result of the poison they sell mostly to kids that don’t know any better.

  • What is it in you head that makes you do these incredibly dangerous and stupid things?
  • Why are you drawn to addicts and criminals? Why do you want to try to win by playing the loser’s game?
  • What is that something in your head that keeps fucking you up?

These are the question you need to deal with. If you refuse to face it, things will keep getting worse.

So think about these things carefully:

  • What makes you trust obvious criminals and professional losers?
  • What makes you keep using drugs that cause you problems?
  • Why do you keep living a lifestyle that bring hell-fire down on your head?
  • What motivates you keep hurting those who love you the most while working hard to please those who don’t care about you?

Could it be that you’re addicted? Addiction isn’t just about alcohol and drugs. It is about the addictive and irresponsible thinking that drives you to be around dangerous and destructive people who somehow manage to convince you that they re living the good life.

LIVE SOBER — BE RESPONSIBLE — LIVE FREE

GORSKI BOOKS

 


Understanding Relapse and Relapse Prevention

February 2, 2014

By Terence T. Gorski, Author
August 18, 2006

imagesRelapse is more than just using alcohol or drugs. It is the progressive process of becoming so dysfunctional in recovery that self-medication with alcohol or drugs seems like a reasonable choice.

The relapse process is like knocking over a line of dominoes.  The first domino hits the second, which hits the third, and soon a progressive chain reaction has started.  The sequence of problems that lead from stable sobriety to relapse are similar to those dominoes, with two differences.  First, each domino in the line (i.e. each problem that brings us closer to substance use) gets a little bit bigger and heavier until the last domino, or problem, in the sequence is 10,000 pounds.  As this 10,000 pound domino begins to fall on us, it is too heavy for us to handle alone.  The second difference is that the problems circle around behind us.  So when the last domino or problem falls, it hits us from behind when we’re not looking.

So here we are, moving along in recovery.  We encounter one small problem.  No big deal!  Then we encounter another problem.  Soon a chain reaction begins.  The first problems are so small that we can easily convince ourselves they’re no big deal.  We look the other way and start doing other things.  All of a sudden a huge problem falls on us and causes serious pain and injury.  We need to make the pain go away and we reach for old reliable – the magical substances that always helped us with our pain in the past.  We’ve now started drinking and drugging.

The answer to avoiding relapse is to learn how not to tip over the first domino, and take care of the little problems in life.  Another part of the answer is to develop an emergency plan for stopping the chain reaction quickly, before the dominoes start getting so big and heavy that they become unmanageable.

The Relapse Process

The progression of problems that lead to relapse is called the relapse process.  Each individual problem in the sequence is called a relapse warning sign.  The entire sequence of problems is called a relapse warning sign list.  The situations that we put ourselves in that cause or complicate the problems are called high risk situations.

It’s important to remember that we don’t start drinking and drugging because of the last problem in the sequence.  We start drinking and drugging because the entire sequence of problems got out of control.  Let’s look at this process:

Step 1: Getting Stuck In Recovery

Many of us decide that alcohol or drugs are a problem, stop using, and put together some kind of recovery plan to help us stay sober.  Initially we do fine, but then we hit a problem that we are unwilling or unable to deal with.  We stop dead in our tracks.  We are stuck in recovery and don’t know what to do.

Step 2: Denying That We’re Stuck

Instead of recognizing that we’re stuck and asking for help, we use denial to convince ourselves that everything is OK.  Denial makes it seem like the problem is gone, but it really isn’t.  It just goes under ground where we can’t see it.  We keep investing time and energy in denying it which results in a buildup of pain and stress.

Step 3: Using Other Compulsions

To cope with the pain and stress, we begin to use other compulsive behaviors. We may begin overworking, over-eating, dieting, or over-exercising. We can get involved in addictive relationships and distract ourselves with sex and romance.  These behaviors make us feel good in the short run by distracting us from our problems.  But they do nothing to solve the problem.  We feel good now, but we hurt later.  This is a hallmark of all addictive behaviors.

Step 4: Experiencing A Trigger Event

Then something happens.  It’s usually not a big thing.  It’s something we could normally handle without getting upset.  But this time something snaps inside.  One person described it this way: “It feels like a trigger fires off in my gut and I go out of control.”

Step 5: Becoming Dysfunctional On The Inside

When the trigger goes off, our stress increases, and our emotions take control of our minds.  To stay sober we have to keep intellect over emotion.  We have to remember who we are (an addicted person), what we can’t do (use alcohol or drugs), and what we must do (stay focused upon working a recovery program).  When emotion gets control of the intellect we abandon everything we know, and start trying to feel good at all costs.

Relapse almost always grows from the inside out.  The trigger event makes our pain so severe that we can’t function normally.  We have difficulty thinking clearly.  We swing between emotional overreaction and emotional numbness.  We can’t remember things.  It’s impossible to sleep restfully and we get clumsy and start having accidents.

Step 6: Becoming Dysfunctional On The Outside:

At first this internal dysfunction comes and goes.  It’s annoying, but we learn how to ignore it.  On some level, we know something is wrong, but we keep it a secret.  Eventually we get so bad that the problems on the inside create problems on the outside.  We start making mistakes at work, creating problems with our friends, families, and coworkers, start neglecting our recovery programs.  Things just keep getting worse.

Step 7: Losing Control

We try to handle each problem as it comes along but miss the growing pattern of problems.  We never really solve anything.  It’s just band-aid after band-aid.   Then we look the other way and try to forget about the problems by getting involved in compulsive activities that will somehow magically fix us.

This approach works for a while, but eventually things start getting out of control. As soon as we solve one problem, two new ones pop up.  Life becomes one problem after another in an apparently endless sequence of crisis.  One person put it like this: “I feel like I’m standing chest deep in a swimming pool trying to hold three beach balls underwater at once.  I get the first one down, then the second, but as I reach for the third, the first one pops back up again.”

We finally recognize that we’re out of control.  We get scared and angry.  “I’m sober!  I’m not drinking!  I’m working a program!  Yet I’m out of control.  If this is what sobriety is like – who needs it?”

Step 8: Using Addictive Thinking

Now we return to addictive thinking.  We begin thinking along these lines:  “Sobriety is bad for me, look at how miserable I am.  Sober people don’t understand me.  Look at how critical they are.  Maybe things would get better if I could talk to some of my old friends.  I don’t plan to drink or use drugs, I just want to get away from things for a while and have a little fun.  People who supported my drinking and drugging were my friends.  They knew how to have a good time.  These new people who want me to stay sober are my enemies.  Maybe I was never addicted in the first place.  Maybe my problems were caused by something else.  I just need to get away from it all for a while!  Then I’ll be able to figure it all out.”

Step 9:  Going Back To Addictive People, Places, And Things

Now we start going back to addictive people (our old friends), addictive places (our old hangouts), and addictive things (mind polluting compulsive activities).  We convince ourselves that we’re not going to drink or use drugs.  We just want to relax.

A client in one of my groups said he wanted to go to a bar so he could listen to music and relax while drinking soft drinks.  An old-timer in the group asked:  “If you told me you were going to a whore house to say prayers, do you think I’d believe you?”

Step 10: Using Addictive Substances

Eventually things get so bad that we come to believe that we only have three choices – collapse, suicide, or self-medication.  We can collapse physically or emotionally from the stress of all our problems.  We can end it all by committing suicide.  Or we can medicate the pain with alcohol or drugs.  If these were your only three choices, which one sounds like the best?

At this stage the stress and pain is so bad that it seems reasonable to use alcohol or drugs as a medicine to make the pain go away.  The 10,000 pound domino just hit.  We’re dazed, and in tremendous pain.  So we reach out for something, anything that will kill the pain.  We start using alcohol and drugs in the misguided hope it will make our pain go away.

Step 11: Losing Control Over Use

Once addicted people start using alcohol or drugs, they tend to follow one of two paths.  Some have a short-term and low consequence relapse.  They recognize that they are in serious trouble, see that they are losing control, and manage to reach out for help and get back into recovery.  Others start to use alcohol or drugs and feel such extreme shame and guilt that they refuse to seek help.  They eventually develop progressive health and life problems and either get back into recovery, commit suicide, or die from medical complications, accidents, or drug-related violence.

Other Outcomes Of The Relapse Process

Some relapse prone people don’t drink.  They may say “I’d rather be dead than drunk” and they either attempt or commit suicide.  Others just hang in there until they have a stress collapse, develop a stress related illness, or have a nervous breakdown.  Still others use half measures to temporarily pull themselves together for a little while only to have the problems come back later.  This is called partial recovery and many people stay in it for years.  They never get really well, but they never get drunk either.

What I have just described is called the relapse process and it’s not uncommon.  Most recovering people periodically experience some of these warning signs.  About half can stop the process BEFORE they start using substances or collapse from stress.  The other half revert to using alcohol or other drugs, collapse from stress related illness, or kill themselves.

It’s not a pretty picture.  No wonder we don’t want to think or talk about relapse.  It’s depressing.  The problem is that refusing to think or talk about it doesn’t stop it from happening.  As a matter of fact ignoring the early warning signs makes us more likely to relapse.

But there is hope.  There is a method called Relapse Prevention that can teach us to recognize early warning signs of relapse and stop them before we use alcohol and drugs, or collapse.

Books and Takes On Relapse Prevention|
http://www.relapse.org


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