Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office
The Federation of State Medical Board has updated the Model Policy regarding DATA 2000 and treatment of opioid addiction in the medical office. The recommendations were adopted as policy by the House of Delegates of the Federation of State Medical Boards of the United States, Inc., April 2013. Click here to read the policy in its entirety.
Emergency Department Visits Involving BuprenorphineIn brief a short report found that:
The report can be viewed in its entirety by clicking here.
- Emergency department (ED) visits involving buprenorphine increased substantially from 3,161 in 2005 to 30,135 visits in 2010, as availability of the drug increased
- In 2010, most buprenorphine-related ED visits were classified as nonmedical use of pharmaceuticals (52 percent, or 15,778 visits), followed by patients seeking detoxification or substance abuse treatment (24 percent, or 7,372 visits) and adverse reactions (13 percent, or 4,017 visits)
- Buprenorphine-related ED visits involving nonmedical use of pharmaceuticals increased 255 percent from 4,440 visits in 2006 to 15,778 visits in 2010
Study Finds Persons Who Fill Buprenorphine Prescriptions Have Higher Rates of Medical Conditions Associated with Pain and Comorbid Psychiatric Disorders
Patients who fill buprenorphine prescriptions have higher rates of medical conditions associated with acute and chronic pain, according to a study of three large insurance claims databases. The most frequently diagnosed medical disorders among patients who filled buprenorphine prescriptions for Subutex®, Suboxone®, or buprenorphine hydrochloride sublingual were back problems (42%), other connective tissue disease (24%), and other non-traumatic joint disorders (20%), compared to less than 10% for each of these disorders among patients not filling a prescription for Buprenorphine. Click here to view the report in its entirety.
CSAT Director Informs Physicians on Final Regulation Affecting the Operation of SAMHSA-Certified Opioid Treatment Programs
The Federal Opioid Treatment regulations codified under 42 CFR Part 8, have been modified to reflect changes in the way buprenorphine products may be dispensed by OTPs.
These changes go into effect on January 7, 2013. Click here to review the regulation.
Statement from White House Drug Policy Director on Federal Register Notice Providing Physicians More Discretion in Treating Opioid Addiction with Buprenorphine
R. Gil Kerlikowske, Director of National Drug Control Policy, issued the following statement regarding a new rule allowing opioid treatment programs more flexibility in dispensing buprenorphine. The rule removes restrictions on the time a patient needs to be in treatment before receiving take home medicine.
Click here to read the statement.
One-Half of Buprenorphine-Related Emergency Department Visits for Nonmedical Use
Slightly more than one-half (52%) of the estimated 30,135 buprenorphine-related emergency department visits in the U.S. in 2010 were for nonmedical use of the drug, according to data from the Drug Abuse Warning Network (DAWN). Click here to view the Weekly FAX from the Center for Substance Abuse Research.
Media Reports on Buprenorphine Diversion
There were a total of 186 media reports of buprenorphine misuse or diversion from January 1 to August 31, 2012, according to an update of an informal analysis first conducted by CESAR in 2011 (see CESAR FAX, Volume 20, Issue 33). The most common types of media reports were of persons possessing (56%) or selling (25%) buprenorphine, often along with other drugs such as prescription opioids and benzodiazepines, marijuana, heroin, and cocaine. There were also reports of smuggling into correctional institutions (14%), diversion by theft and fraud (8%), and use by children (3%). More than one-third (35%) of the media reports involved other drugs and approximately one-fifth (19%) involved other crimes, including trafficking of other drugs, burglary, and robbery. Massachusetts had the highest number of media reports (39), followed by New York (24), Maine (19), Pennsylvania (15), Kentucky (14), and New Hampshire (14). Below is a list of the 27 states and one territory that had at least one buprenorphine media report in the first eight months of 2012, the total number of media reports per state, and a brief description of one of the media reports. The full list of media reports is available here.
Reckitt Benckiser Pharmaceuticals Inc. Submits Citizen Petition to U.S. FDA Requesting Action to Mitigate Risk of Pediatric Exposure with Opioid Dependence Treatment
Reckitt Benckiser Pharmaceuticals Inc. issued a Citizen Petition today to request the U.S. Food and Drug Administration (FDA) to require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence to implement national public health safeguards involving pediatric exposure educational campaigns and child resistant, unit-dosed packaging to reduce the risk of pediatric exposure. Click here to read more.
Buprenorphine Now More Likely Than Methadone to Be Found in U.S. Law Enforcement Drug Seizures
Buprenorphine is now more likely than methadone to be found in law enforcement
drug seizures that are submitted to and analyzed by forensic laboratories across the country.
Click here to view the Weekly
FAX from the Center for Substance Abuse Research.
SAMHSA Releases a New Advisory – Sustained Release Naltrexone for Opioid Dependence
Naltrexone is a non-opioid medication that is approved for the treatment of opioid dependence. Naltrexone is an opioid receptor antagonist; it binds to opioid receptors, but instead of activating the receptors, it effectively blocks them. Through this action, it prevents opioid receptors from being activated by agonist compounds, such as heroin or prescription pain killers, and is reported to reduce craving and prevent relapse. As opposed to other medications used for opioid dependence (methadone and buprenorphine), naltrexone can be prescribed by any individual who is licensed to prescribe medicine (e.g., physician, doctor of osteopathic medicine, physician assistant, and nurse practitioner). Both the oral daily form and the monthly injectable monthly extended-release form (Vivitrol®) are FDA approved for treatment of opioid dependence. Vivitrol® was approved by FDA for this indication in 2010.
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.
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.
Notice of Inspection of Controlled Premises
A Notice of Inspection of Controlled Premises (Form DEA-82) must
be signed prior to a DATA 2000 inspection. It includes a statement of physicians'
rights as well as an authorization to inspect the controlled premises. Use this
link to go to a copy of a blank notice form.
Generic Buprenorphine Products
The Buprenorphine Products Manufacturers Group (BPMG) supports updated information on the availability of generic buprenorphine products and manufacturers. This information can be found on the website of the Buprenorphine-containing Transmucosal Products for Opioid Dependence (BTOD) Risk Evaluation and Mitigation Strategy (REMS).
SAMHSA Issues Nationwide Public Health Alert Concerning Life Threatening Risk Posed by Cocaine Laced with Veterinary Anti-Parasite Drug
September 18, 2009SAMHSA is alerting medical professionals,
substance abuse treatment centers, and other public health authorities about the risk that
substantial levels of cocaine may be adulterated with levamisolea veterinary
anti-parasitic drug. As of this date, there have been approximately 20 confirmed or
probable cases of agranulocytosis (a serious, sometimes fatal blood disorder),
including two deaths, associated with cocaine adulterated with levamisole.
The number of reported cases is expected to increase as information about cocaine
adulterated with levamisole is disseminated. Use this
link to go to the letter.