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Month: September 2017

All Opioids Now Subject to REMS – FDA Announcement

In July, FDA Commissioner Scott Gottlieb, MD, put the public and manufacturers on notice that the agency would soon require the IR opioid analgesics that are intended to be used in the outpatient setting to be subject to the same REMS requirements as the ER/LA opioid analgesics. On September 28, Dr. Gottlieb said the agency had now taken action and that 277 IR opioids would be subject to Risk Evaluation and Mitigation Strategy (REMS) requirements. FDA Announcement Public Comment Medscape Article   ...

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New Options for Treating Opioid Addiction

According to NIDA Director Dr. Nora Volkow, “NIH and NIDA are committed to an ‘all scientific hands on deck’ effort to end the opioid crisis in America by halving the time it takes to develop new medications to treat pain and addiction and reverse overdoses.” The goals of the new initiative range from innovative and ambitious new treatment approaches that will take some time to develop, such as vaccines or transcranial magnetic stimulation for pain and addiction, to goals that are relatively achievable in the short term, such as improved formulations of existing medications. New formulations of injectable buprenorphine...

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Important FDA Drug Safety Announcement

The U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks. They are requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs...

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Report on Behavioral Health, Opioid Misuse

Today, SAMHSA released the latest findings from the 2016 National Survey on Drug Use and Health (NSDUH), which provides the estimates on substance use and mental health in the United States, including the misuse of opioids. In 2016, there were 11.8 million people ages 12 or older who misused opioids in the past year. The majority of those individuals misused pain relievers rather than used heroin; 11.5 million people misused pain relievers and 948,000 were heroin users. View Report...

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Disaster Preparedness for Opioid Treatment

The North Carolina State Opioid Treatment Authority is encouraging all opioid treatment programs to review current policies and their ability to respond if a program is flooded or otherwise deemed unsafe due to storm damage, and ensure records are accessible to continue critical operations. Now is a good time to start testing manual dosing pumps and check flashlight batteries, in the event of power outage. They recommend that all OTPs have at least a 10-day supply of medications on hand and consider how your program will respond to patients who have been displaced. SAMHSA Disaster Planning Handbook (TAP 34) SAMHSA Disaster...

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