- Information about the new buprenorphine product from Orexo US. Posted August 2013
On July 3, 2013, Orexo US became the latest pharmaceutical company to add to the ever growing list of buprenorphine products.
Orexo received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv® (buprenorphine and naloxone sublingual tablets).
Zubsolv is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Zubsolv is due to be released in September 2013.
- Information about the appearance of fentanyl analogues. Posted July 2013
Many of you will remember the period from 2005 through 2007 when illicit fentanyl-laced heroin caused a great number of overdose deaths.
That was not the first time illicit fentanyl, also called fentanyl analogues, entered the drug market, and likely will not be the last.
Recently, small clusters of overdoses and overdose fatalities in a variety of communities, mostly in the eastern United States, have raised alarm.
Little is fully known about the situation but it appears fentanyl analogues are involved in at least some of the cases, and may be contaminating both
heroin and cocaine. More information about the current situation has been published by the CDC as a health advisory.
- Information about the national availability of PPD products. Posted July 2013
A shortage of tuberculin purified protein derivative (PPD; Tubersol® and Aplisol®) needed for tuberculosis testing
began in autumn 2012 when the supply of Tubersol® was interrupted. A shortage of Aplisol® ensued.
Although the production of Tubersol® has been restored, the two PPD products might not be available from all suppliers yet.
- The revised draft of Federal Guidelines for Opioid Treatment. Posted May 2013
The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT) is seeking
public comments on the revised 2007 SAMHSA Guidelines for the Accreditation of Opioid Treatment Programs. These guidelines
elaborated upon the Federal opioid treatment standards set forth under 42 CFR Part 8.
The revised Guidelines for the Accreditation of Opioid Treatment Programs, 2013 (PDF, 982 KB)
- Prescription Monitoring Program Presentation. Posted December 2012
The attached presentation on the use of prescription drug monitoring program information in OTP settings is provided for information purposes.
By posting, SAMHSA/CSAT is not suggesting that its content and recommendations are SAMHSA/CSAT approved or endorsed.
- Rule Provides Flexibility in Dispensing Buprenorphine for Opioid Addiction Treatment Posted December 2012
Today, SAMHSA issued a Federal rule to allow patients being treated through an Opioid Treatment Program (OTP) to receive take-home supplies of buprenorphine from an OTP in a more flexible manner.
Buprenorphine is a medication used in opioid addiction treatment. The regulation takes effect on January 7, 2013.
Under the rule change, OTPs will be permitted to dispense buprenorphine to eligible patients without having to adhere to previous length of time in treatment requirements. Currently,
OTPs require a person to be in treatment a certain amount of time before being given a multiple days' supply of medicine to take home.
The change in the rule will not affect requirements for dispensing methadone—the other opioid agonist treatment medication used by OTPs. SAMHSA based the change in the restrictions for
dispensing buprenorphine on several factors. These include differences in the abuse potential between methadone and buprenorphine, as well as the actual abuse and mortality rates (buprenorphine is lower in each instance).
- National Hepatitis Awareness Month. Posted May 2012
This letter is a brief reminder that May is National Hepatitis Awareness Month. An estimated 3.5–5.3 million Americans are living with chronic (lifelong) hepatitis B or hepatitis C virus infection.
Most of them do not know that they are infected, placing them at greater risk for severe, even fatal, complications from the disease and increasing the likelihood that they will spread the virus to others.
We encourage you to use Hepatitis Awareness Month to learn more about this “silent epidemic.”
- Winners of the 2012 Science to Service Awards. Posted February 2012
- Science and Service Awards for opioid treatment programs (OTPs) and office-based opioid treatment (OBOT) providers. Posted December 2011
SAMHSA announced its inaugural Science and Service Awards for opioid treatment programs (OTPs) and office-based opioid treatment (OBOT) providers on December 5, 2011.
This national awards program promotes excellence in the treatment of opioid addiction by honoring OTPs and OBOT providers using pharmacotherapy and other innovative approaches to enhance patient outcomes.
The OTP awards will be announced at the 2012 national conference of the American Association for the Treatment of Opioid Dependence (AATOD), and the OBOT awards will be announced at the 43rd Annual Medical Scientific
Conference of the American Society for Addiction Medicine (ASAM). A panel of experts will review the award applications and select five awardees from two categories: OTPs and OBOTs. All winners will receive a Science
and Service award and will be prominently highlighted on SAMHSA’s web site. The deadline for submitting a completed application, electronically or hard copy is Friday, January 13, 2012, at 5:00 pm, Eastern Standard Time.
For more information, please see SAMHSA Bulletin
- Methadone Mortality report for 2010. Posted November 2011
This report provides a brief summary of the presentations and discussions at the July 29-30, 2010 meeting, “Methadone Mortality: A 2010 Reassessment,” which was sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
The meeting brought together more than 90 epidemiologists, clinicians, educators, regulatory and enforcement officials, patient advocates, and policymakers for an in-depth reassessment of the current knowledge base on methadone-associated deaths and a review of progress in addressing the situation.
- Letter about State Prescription Drug Monitoring Programs (PDMPs). Posted October 2011
For an example see A Case Study on Using Prescription Monitoring Program Data in an Outpatient Addictions Treatment Setting
- Medication-Assisted Treatment for Opioid Addiction - 2010 State Profiles. Posted July 2011
- An Issue of The Morbidity and Mortality Weekly Report underscoring the increase in emergency department visists after use af a drug sold as "Bath Salts". Posted June 2011
- FDA ALERT: Naltrexone Injection Site Reactions. Posted August
- Hepatitis Infection in the
Treatment of Opioid Dependence and Abuse. Posted June 2008
SAMHSA guidance regarding labeling of take-home medication bottles. Posted May
2008 (PDF, 441 KB)
- Prescribing Courses:
Clinical Challenges in Prescribing Controlled Drugs. Posted May, 2008
- Abuse, Addiction, and Pain Relief: Time for Change. CME Activity.
Posted April, 2008
Report of the Consultation and Debriefing Meeting on the Response to Fentanyl-Related
Overdoses and Deaths, Washington, DC, August 2007 Posted April, 2008 (PDF, 330
Restatement of SAMHSA guidance to OTPs on take-home doses when program closed for
business (e.g., holidays) Posted January, 2008 (PDF, 149 KB)
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