Buprenorphine

The Drug Addiction Treatment Act of 2000 (DATA 2000)

The Drug Addiction Treatment Act of 2000 (DATA 2000) expands the clinical context of medication-assisted opioid addiction treatment by allowing qualified physicians to dispense or prescribe specifically approved Schedule III, IV, and V narcotic medications for the treatment of opioid addiction in treatment settings other than the traditional Opioid Treatment Program (i.e., methadone clinic). In addition, DATA 2000 reduces the regulatory burden on physicians who choose to practice opioid addiction therapy by permitting qualified physicians to apply for and receive waivers of the special registration requirements defined in the Controlled Substances Act. more

SAMHSA Sponsored Buprenorphine Physician Clinical Support System (PCSS)

The SAMHSA-funded PCSS is a national network of trained physician mentors with expertise in buprenorphine treatment and skilled in clinical education designed to assist practicing physicians in incorporating into their practices the treatment of prescription opioid and heroin dependent patients using buprenorphine.—www.pcssb.org

What's New Section

HOT TOPICS In Buprenorphine Treatment

A webinar series offered by the American Psychiatric Association as part of the CSAT-Funded Physicians Clinical Support System-Buprenorphine (PCSS-B). This webinar on February 14, 2012 will be presented by Dr. Marjorie C. Meyer. This webinar's topic is "Buprenorphine Treatment During Pregnancy." Click here for more information. Register at https://www2.gotomeeting.com/register/461550554.

A recording of each webinar is available for on-demand viewing at www.pcssb.org. Click on the Hot Topics Webinars tab. CME credit is not currently provided for these one-hour sessions. Please contact pcssb@psych.org for further information regarding the webinar series.

Clinical Report on Neonatal Drug Withdrawal

The American Academy of Pediatrics published a clinical report on Neonatal Drug Withdrawal. This publication includes information on both methadone and buprenorphine. Click here to read the publication.

Department of Defense is proposing to remove the prohibition to use addictive drugs in the maintenance treatment of substance dependence in TRICARE beneficiaries

Click here to read the federal register notice and comment.

Statement from Reckitt Benckiser

“Reckitt Benckiser Pharmaceuticals Inc. is discontinuing distribution and sale of Subutex® tablets as we believe that mono product (product containing buprenorphine alone with no naloxone) creates a greater risk of misuse, abuse and diversion, and while other mono product may be available on the market, we are concentrating our efforts around less abusable products in order to protect patients, communities and access to treatment.” Click here to read the letter from Reckitt Benckiser.

SAMHSA recommends use of State Prescription Drug Monitoring Programs

SAMHSA encourages physicians, physician assistants, nurse practitioners, pharmacists, other Staff in Opioid Treatment Programs (OTPs) and DATA-Waived Physicians to utilize State Prescription Drug Monitoring Programs (PDMPs) as an additional resource to maximize safety of patient care pursuant to applicable state guidelines. The illicit use of prescription drugs (i.e. opioids, stimulants, and sedatives) is a major public health problem. In addition, prescription drug issues affect patients in OTPs. Click here to read the letter.

AOAAM is now offering Half & Half Trainings

The American Osteopathic Academy of Addiction Medicine invites you to join us for a webinar training on the Office-Based Treatment of Opioid Dependence utilizing Buprenorphine. This webinar training, in conjunction with a 4 hour online study, will provide the required 8 hours needed to obtain the waiver to prescribe Buprenorphine in the office-based setting. Click here for more information.

2009 National and Metropolitan area estimates of drug-related emergency department visits from the Drug Abuse Warning Network

SAMHSA has just released the 2009 National and Metropolitan area estimates of drug-related emergency department visits from the Drug Abuse Warning Network. The short report "Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits" summarizes the key findings and is available at: http://oas.samhsa.gov/2k10/DAWN034/EDHighlights.cfm in html and pdf format. Some findings of note include:

In 2009, there were nearly 4.6 million drug-related emergency department (ED) visits of which about one half (49.8 percent, or 2.3 million) were attributed to adverse reactions to pharmaceuticals and almost one half (45.1 percent, or 2.1 million) were attributed to drug misuse or abuse
In 2009, ED visits resulting from the misuse or abuse of pharmaceuticals occurred at a rate of 405.4 visits per 100,000 population compared with a rate of 317.1 per 100,000 population for illicit drugs
ED visits involving misuse or abuse of pharmaceuticals increased 98.4 percent between 2004 and 2009, from 627,291 visits in 2004 to 1,244,679 visits in 2009
ED visits involving adverse reactions to pharmaceuticals taken as prescribed increased 82.9 percent between 2005 and 2009, from 1,250,377 visits in 2005 to 2,287,273 visits in 2009
Data tables containing detailed estimates are available at the DAWN website and are available in html and Excel.

National estimates: http://dawninfo.samhsa.gov/data/
Metropolitan area estimates: http://dawninfo.samhsa.gov/data/default.asp?met=Met

Buprenorphine treatment in pregnancy: less distress to babies

NIH study compares buprenorphine to methadone in opioid addicted pregnant women.

Babies born to women addicted to opioids fare better when their mothers are treated with either the addiction medication buprenorphine or methadone than babies whose mothers are not treated at all. In this comparative effectiveness trial, buprenorphine was found to be superior to methadone in reducing withdrawal symptoms in the newborns, according to a recent study funded by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health. The study, conducted by a multi-disciplinary team of researchers from North America and Europe, was published today in the New England Journal of Medicine. Click here to view the entire NIH press release on this study.

FDA approves injectable drug to treat opioid-dependent patients

The U.S. Food and Drug Administration approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment. Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006. To view the FDA press release in its entirety, click here.

Food and Drug Administration approves a new Suboxone sublingual film product

On August 30, 2010, the Food and Drug Administration approved a new Suboxone sublingual film product. The sublingual film is approved for use in the maintenance treatment of opioid dependence when used as part of a complete treatment plan to include counseling and psychosocial support. Additional information on the approval requirements (post approval requirement for a clinical trial on QT prolongation, Risk Evaluation and Mitigation Strategy) can be found in the FDA approval letter. Click here to view the FDA approval letter. Information on the availability of the product may be found on the manufacturer’s website. http://www.suboxone.com/hcp/Default.aspx

Teva Announces Buprenorphine HCl Sublingual Tablets Approval

On Friday, May 7, 2010, Teva Pharmaceuticals USA announced that the U.S. Food and Drug Administration has granted final approval for the Company’s Abbreviated New Drug Application (“ANDA”) for Buprenorphine HCl Sublingual Tablets 2 & 8 mg. Teva’s Buprenorphine HCl Sublingual Tablets are the AB-rated generic equivalent of Reckitt Benckiser’s Subutex® and are indicated for the treatment of narcotic addiction.

Teva intends the commercial launch to occur later this month. To learn more about Buprenorphine HCl Sublingual Tablets prescribing information, please call 1-800-227-7522.

From Medscape Medical News
For Prescription Opioid Dependence, Relapses Associated With Shorter Treatment Course

May 24, 2010 (New Orleans, Louisiana) — In persons dependent on prescription opioids, tapering with buprenorphine during a 9-month period, whether initially or after a period of substantial improvement, led to nearly universal relapse in the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study, presented here at the American Psychiatric Association 2010 Annual Meeting. Click here for the article. Note: In order to access this article you will need to sign up for a FREE MedScape account, if you do not have one already.

Buprenorphine Favoured Over Methadone for Opiate Addiction in Pregnancy: Presented at ACOG

SAN FRANCISCO — May 19, 2010 — A recent study in Maine among women addicted to opiates has found that buprenorphine is safer for neonates than traditional treatment with methadone. Use this link to view the article.

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Treatment Improvement Protocol

Increase Patient Limits

2005 SAMHSA Evaluation of the Impact of the DATA Waiver Program

2006 Report On Diversion and Abuse of Buprenorphine

Drug Enforcement Administraton (DEA)

DATA Physician Locator

SAMHSA and DEA issue letter on prescribing Suboxone/Subutex in opioid treatment programs

CSAT Director Informs Physicians of Increase in Patient Limits

CSAT Director Notifies Physicians of a New Feature to the SAMHSA Buprenorphine Physician and Treatment Program Locator

CSAT Director Advises Physicians of Concerns Regarding Buprenorphine

CSAT Director Encouraging Physicians to Sign-Up for the Buprenorphine Physician and Treatment Program Locator

Follow this RealMedia link to view a Public Service Announcement (PSA) on office-based opioid addiction treatment featuring former Surgeon General Dr. C. Everett Koop.

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