FDA to Host Meeting on Patient-Focused Drug Development for Opioid Use Disorder

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The Food and Drug Administration (FDA) will host a public meeting April 17 on patient-focused drug development for opioid use disorder (OUD), in collaboration with the National Institute on Drug Abuse. The FDA is also working closely with patient advocacy and community organizations to encourage participation from people with OUD. The FDA is interested in learning patients’ perspectives on OUD, including the effects on their health and well-being that have the greatest impact on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for the disorder. The meeting will take place at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Room 1503A (Great Room), Silver Spring, Maryland, from 10 a.m. to 4 p.m.
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New Treatment Guidance Issued For Pregnant Mothers with Opioid Use Disorder

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The Substance Abuse and Mental Health Services Administration (SAMHSA) released new Clinical Guidance for Treating Pregnant and Parenting Women with Opioid Use Disorder and Their Infants. SAMHSA’s Clinical Guidance comes at a time of great need for effective opioid use disorder (OUD) treatment. In 2016, over 20,000 pregnant women reported using heroin or misusing pain relievers in the past month. Newborn babies of mothers who used opioids while pregnant are at risk of neonatal abstinence syndrome--a group of physical and neurobehavioral signs of withdrawal. “SAMHSA is filling an urgent need for reliable, useful, and accurate information for healthcare professionals working to treat opioid dependent mothers and their children,” said Dr. Elinore F. McCance-Katz, SAMHSA’s Assistant Secretary for Mental Health and Substance Use. “Ultimately, the steps explained in this guidance will help the mother and her infant safely receive treatment for opioid use disorder and neonatal abstinence syndrome.” The Clinical Guidance...
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Hospitals Overwhelmed With Treating Diseases Resulting From IV Drug Use

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Hospitals are struggling to deal with an overwhelming number of cases of diseases that result from intravenous opioid use, including hepatitis C, endocarditis and the antibiotic-resistant infection MRSA. Hepatitis C is the most common infectious disease that affects people with opioid use disorder, USA Today reports. Reported cases of the disease almost tripled between 2010 and 2015. Endocarditis—a condition in which the heart’s inner lining is inflamed—is a side effect of opioid addiction. Hospitalizations for endocarditis rose almost 50 percent from 2002 to 2012, at an average cost of $50,000 per patient. MRSA is the second most common co-occurring condition with opioid use disorder, the article notes. The cost of treating the infection is about $60,000 per patient.
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Patients Treated for Opioid Addiction in General Health System at Higher Risk of Death

Patients Treated for Opioid Addiction in General Health System at Higher Risk of Death
Patients treated for an opioid use disorder in a general healthcare system instead of an addiction treatment center face a higher risk of death, a new study concludes. Researchers at UCLA found patients treated for opioid addiction in primary care offices or hospitals are more than twice as likely to die than those treated in addiction treatment centers, according to HealthDay. “The high rates of death among patients with opioid use disorder in a general health care system reported in this study suggest we need strategies to improve detection and treatment of this disorder in primary care settings,” study lead author Yih-Ing Hser said in a UCLA news release. She noted that as opioid addiction has grown in the United States, people with opioid use disorders are increasingly being treated in primary care provider offices. The findings are published in the Journal of Addiction Medicine .
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HHS Announces New Actions To Combat Opioid Epidemic

HHS Announces New Actions To Combat Opioid Epidemic
U.S. Health and Human Services (HHS) Secretary Sylvia M. Burwell announced several new actions the department is taking to combat the nation’s opioid epidemic. The actions include expanding access to buprenorphine, a medication to treat opioid use disorder, a proposal to eliminate any potential financial incentive for doctors to prescribe opioids based on patient experience survey questions, and a requirement for Indian Health Service prescribers and pharmacists to check state Prescription Drug Monitoring Program (PDMP) databases before prescribing or dispensing opioids for pain. In addition, the department is launching more than a dozen new scientific studies on opioid misuse and pain treatment and soliciting feedback to improve and expand prescriber education and training programs. The actions announced build on the HHS Opioid Initiative, which was launched in March 2015 and is focused on three key priorities: 1) improving opioid prescribing practices; 2) expanding access to medication-assisted treatment (MAT) for opioid...
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Facing Addiction and The National Council on Alcoholism and Drug Dependence (NCADD) are proud to announce the merger of our organizations – creating a national leader in turning the tide on the addiction epidemic.
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