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199177 tn?1490498534

DEA has BUPRENORPHINE listed on there drugs and Chemicals of concern

Drugs and Chemicals of Concern

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BUPRENORPHINE
(Trade Names: Buprenex®, Suboxone®, Subutex®)

June 2009  
DEA/OD/ODE

Introduction:

Buprenorphine was first marketed in the United States in 1985 as a schedule V narcotic analgesic.  Until recently, the only available buprenorphine product in the United States has been a low-dose (0.3 mg/ml) injectable formulation under the brand name, Buprenex®.  Diversion, trafficking and abuse of other buprenorphine products have occurred in Europe and other areas of the world.
In October 2002, the Food and Drug Administration (FDA) approved two buprenorphine products (Suboxone® and Subutex®) for the treatment of narcotic addiction.  Both products are high dose (2 mg and 8 mg) sublingual (under the tongue) tablets: Subutex® is a single entity buprenorphine product and Suboxone® is a combination product with buprenorphine and naloxone in a 4:1 ratio, respectively.  After reviewing all the available data and receiving a schedule III recommendation from the Department of Health and Human Services (DHHS), the DEA placed buprenorphine and all products containing buprenorphine into schedule III in 2002.  Since 2003, diversion, trafficking and abuse of buprenorphine have become more common in the United States.

Licit Uses:

Buprenorphine is intended for the treatment of pain (Buprenex®) and opioid addiction (Suboxone® and Subutex®).  In 2001, 2005, and 2006, the Narcotic Addict Treatment Act was amended to allow qualified physicians, under certification of the DHHS, to prescribe schedule III-V narcotic drugs (FDA approved for the indication of narcotic treatment) for narcotic addiction, up to 30 patients per physician at any time, outside the context of clinic-based narcotic treatment programs (Pub. L. 106-310). This limit was increased to 100 patients per physician, for physicians who meet the specified criteria, under the Office of National Drug Control Policy Reauthorization Act (P.L. 69-469, ONDCPRA), which became effective on December 29, 2006.

Suboxone® and Subutex® are the only treatment drugs that meet the requirement of this exemption.  Currently, there are nearly 15,700 physicians who have been approved by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA for office-based narcotic buprenorphine treatment.  Of those physicians, approximately 13,150 were approved to treat up to 30 patients per provider and about 2,500 were approved to treat up to 100 patients.  More than 3,000 physicians have submitted their intention to treat up to 100 patients per provider.

IMS Health National Prescription Audit Plus data indicate that 3.54 million buprenorphine prescriptions were dispensed in the US in 2008, compared to 2.12 million prescriptions in 2007.

Chemistry/Pharmacology:

Buprenorphine has a unique pharmacological profile. It produces the effects typical of both pure mu agonists (e.g.,morphine) and partial agonists (e.g., pentazocine) depending on dose, pattern of use and population taking the drug.  It is about  20-30 times more potent than morphine as an analgesic; and like morphine it produces dose-related euphoria, drug liking, pupillary constriction, respiratory depression and sedation.  However, acute, high doses of buprenorphine have been shown to have a blunting effect on both physiological and psychological effects due to its partial opioid activity.

Buprenorphine is a long-acting (24-72 hours) opioid that produces less respiratory depression at high doses than other narcotic treatment drugs.  However, severe respiratory depression can occur when buprenorphine is combined with other central nervous system depressants, especially benzodiazepines.  Deaths have resulted from this combination.
The addition of naloxone in the Suboxone® product is intended to block the euphoric high resulting from the injection of this drug by non-buprenorphine maintained narcotic abusers.

User Population:

In countries where buprenorphine has gained popularity as a drug of abuse, it is sought by a wide variety of narcotic abusers: young naϊve individuals, non-addicted opioid abusers, heroin addicts and buprenorphine treatment clients.

Illicit Uses:  

Like other opioids commonly abused, buprenorphine is capable of producing significant euphoria.  Data from other countries indicate that buprenorphine has been abused by various routes of administration (sublingual, intranasal and injection) and has gained popularity as a heroin substitute and as a primary drug of abuse.  Large percentages of the drug abusing populations in some areas of France, Ireland, Scotland, India, Nepal, Bangladesh, Pakistan, and New Zealand have reported abusing buprenorphine by injection and in combination with a benzodiazepine.

According to the National Forensic Laboratory Information System (NFLIS), drug items/exhibits submitted and identified as buprenorphine in state and local laboratories increased from 229 in 2004 to 4,245 in 2008.  DEA laboratories identified 5 buprenorphine items/exhibits in 2004 and 49 in 2008.  Buprenorphine now ranks among the top 25 most frequently identified substances analyzed in federal, state, and local laboratories according to NFLIS.  According to the 2006 Drug Abuse Warning Network (New DAWN ED) survey, an estimated 4,440 emergency room visits were associated with buprenorphine misuse.

Control Status:

Buprenorphine and all products containing buprenorphine are controlled in Schedule III of the Controlled Substances Act.

Comments and additional information are welcomed by the Office of Diversion Control, Drug and Chemical Evaluation Section.  Fax 202-353-1263, telephone 202-307-7183, or Email ***@****
10 Responses
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983679 tn?1276833336
thank you avisg....I also found this very interesting
Helpful - 0
990521 tn?1311906308
Avis - I found the information very interesting.  Suboxone saved my life, but it was also my worst nightmare when it came time to get off of it - ended up costing me $6000 and over a month of suffering.  In the end, the detox was worth every cent.  I think back when I went on sub, docs were not very informed and they told their patients that it was easy to quit and mine even told me I could stay on it my entire life if I needed to.  Wrong!  Down the road, I can see suboxone being just as controlled as methadone in how it's dosed, I think it is just as dangerous and in some cases, causes more problems - that being said, just like methadone, suboxone does have it's place.  Very controversial.  Thanks for the post.
Helpful - 0
199177 tn?1490498534
August I totally agree there is a very low success rate in abstinence only programs.That's called white knuckling it and relapse is very prominent in people that use this method. That is why there is an absolute need for recovery care .I would still not be clean after two years .If i did not have a addiction therapist .However recovery care programs do not have to include an  opiate replacement to be successful .
Helpful - 0
Avatar universal
Great post Avisg...Knowledge is definitely power.As many above stated,people need to know what they are getting into...There is no miracle cure for addiction.As someone who chose to go the methadone route I can tell you I wish I would have known then what I know now....I certainly believe if I did,I would have made different choices....Kim
Helpful - 0
495284 tn?1333894042
COMMUNITY LEADER
Good thread avis.  Anytime we are prescribed a med we need to see the pros and cons of it.  Sub has been a life saver for many as has methadone but as avis said there are risks involved and people need to be aware of them.   There is no magic pill for addiction.....sara
Helpful - 0
199177 tn?1490498534
narco, Thanks like I said for some members sub has been great help but there are many risks that come long with it as well.You can never have to much knowledge
Helpful - 0
Avatar universal
thank you for your post.. I found it very interesting and informative...
Helpful - 0
199177 tn?1490498534
That is right GA we here so often that sub can not be abused and its like any other opeate can be abused .Just like it is said one of the reasons addicts should use sub is to give the brain time to heal .Suboxone works by giving the brain the opioid stimulation it craves but its not until the suboxone leaves the respeters that the brain can start to heal .
  There are time I recommend suboxone to some members sometimes its the right choice however it like methadone has its risks as well I personally would rather going into knowing the risks the finding them out after the fact .
Helpful - 0
222369 tn?1274474635
Every single drug that the Drug Enforcement Agency has ever seen diverted is on this list. I'd be surprised if it wasn't on their Drugs Of Concern list. Every other opiate is.
Helpful - 0
Avatar universal
I don't want to get into a "cut and paste" from web-sites contest here........however if I read this correctly it very definitely defines how to MIS USE Suboxone to reach a "high"  and how NOT to use as it was intended,  and this posting  is a benefit to others how??    There are other web sites  IE FDA that will display different data,  as will many other sources of information.  What I find so very sad, is some think they know more than the physicians and counselors and treatment centers that are working so diligently in combating this epidemic of opiate addiction.      There is a 10% chance of beating opioid addiction thru abstinence only programs......  that is a fact and a statistic which can easily be researched.    But again  why  on this forum was this post a necessity??   I want to see our children and others beat the addiction,  and there are a lot of alternatives, and whether I agree with the treatment of choice or not,  I would never be so sanctimonious to totally disregard a treatment that may have saved many lives....    I simply don't understand the intent  nor what this post meant   to  accomplish...
Helpful - 0
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