National Academies Releases Report on Opioid Prescribing for Acute Pain
The National Academies of Science released on Thursday a consensus report on the current framework used to identify appropriate, evidence-based opioid prescribing for episodes of acute pain. Through comprehensive review of existing prescribing guidelines, NAS utilized the best practices to develop recommendations for indication-specific prescribing and suggested research focuses for future consideration. Findings from the report can be used for state and federal partners along with those engaged in the healthcare delivery system.
On the release of the report, FDA Drug Center Director Dr. Janet Woodcock was quoted, “We recognize the critical role that health care providers play in addressing the opioid crisis – both in reducing the rate of new addiction by decreasing unnecessary or inappropriate exposure to opioid analgesics, while still providing appropriate pain treatment to patients who have medical needs for these medicines… That’s why it’s important that we re-examine how opioid analgesics are being prescribed and help to ensure that health care providers – who are the gatekeepers to prescription opioid analgesics – are provided with the most current and comprehensive guidance on the appropriate management of pain.”
Articles & Resources
FDA Newsroom – Statement on National Academies of Sciences, Engineering, and Medicine Report on Framing Opioid Prescribing Guidelines for Acute Pain
National Academies Press – Framing Opioid Prescribing Guidelines for Acute Pain
STAT News – National Academies Outlines Opioid Guidelines, Aiming to Make Approach to Prescribing More Consistent
New Research Indicates Most Opioid Overdose Deaths are Accidental
Researchers from Columbia University, NIDA and CDC published a research letter in the Journal of the American Medical Association this week following a comprehensive review of retrospective data from the National Vital Statistics System for opioid overdose deaths. Their findings indicated that, between 2000 and 2017, the number of opioid related overdose deaths per 100,000 rose nearly seven times as compared to slightly more than double for suicides. In 2017, it was estimated that more than 90% of overdose deaths were unintentional compared to 4% classified as suicides (down from 9% in 2000). Some of these changes are attributed to the significant rise in prevalence of synthetic opioids such as fentanyl as well as rising heroin use and difficulties in overdose classification by coroners.
Articles & Resources
Associated Press – Most U.S. Opioid Overdose Deaths Are Accidental, 4% Are Suicides
Journal of the American Medical Association – Trends in Intentional and Unintentional Opioid Overdose Deaths in the United States, 2000-2017
FDA Raises Concern Around Potential Adverse Events Associated with Gabapentinoids
On Thursday, the U.S. Food and Drug Administration released two documents highlighting newly identified risks associated with the use of gabapentinoids, both in their standalone use or in conjunction with prescribed opioids or other central nervous system depressants. Individuals on these types of medications or with pre-existing pulmonary disease are at greater risk for respiratory-related issues amid greater utilization of these products. As part of these findings, FDA is now creating new warnings for gabapentinoids regarding risks of respiratory depression while also requiring gabapentinoids manufacturers to conduct further research around abuse potential and risks for respiratory depression.
Following these updates, FDA CDER Deputy Director for Regulatory Programs Douglas Throckmorton, MD, noted, “Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death. In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects. We are also requiring the drug manufacturers to conduct clinical trials to further evaluate the abuse potential of gabapentinoids, particularly in combination with opioids, with special attention being given to assessing the respiratory depressant effects.”
Articles & Resources
FDA In Brief – FDA Requires New Warnings for Gabapentinoids About Risk of Respiratory Depression
FDA Drug Safety Communication – Serious Breathing Problems: Neurontin, Gralise, Horizant, and Lyrica
What We Read Last Week
Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.
Articles & Resources
New York Times – Purdue Pharma Payments to Sackler Family Soared Amid Opioid Crisis
NPR – Sacklers Withdrew Nearly $11 Billion from Purdue as Opioid Crisis Mounted
Vox – We have a Solution for the Opioid Epidemic. It’s Dramatically Underused
University of Michigan Institute for Social Research – National Adolescent Drug Trends in 2019: Findings Released
Associated Press – Walk-in Clinics for Opioid Addiction Offer Meds First, Fast
Mike Bloomberg 2020 – Tackling the Opioid Epidemic
Sen. Grassley Newsroom – Grassley Partners on Bill to Stop Flow of Drugs to Pill Mills
CMS Newsroom – CMS Awards Funding to Combat Opioid Misuse Among Expectant Mothers and Improve Care for Children Impacted by the Crisis
Modern Healthcare – States Score $200M from the CMS to Combat Maternal Opioid Abuse
Department of Justice – Owner of Detroit-Area Health Care Clinics Sentenced to Prison for a Diversion Scheme Involving 500,000 Pills of Oxycodone and Other Drugs
Department of Justice – Pennsylvania Doctor Pleads Guilty to Fraud and Drug Importation Charges
Department of Justice – West Virginia Medical Doctor Sentenced to Prison for Unlawfully Distributing Opioids
Food and Drug Administration – [UPDATED] Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse
Government Accountability Office – The Office of National Drug Control Policy Should Develop Key Planning Elements to Meet Statutory Requirements
U.S. Attorney for the Middle District of North Carolina – Rowan County Doctor Sentenced for Unlawful Distribution of Prescription Opioids
U.S. Attorney for the Eastern District of Wisconsin – Milwaukee Medical Doctor and Clinic Office Manager Convicted of Unlawfully Distributing Opioids
U.S. Attorney for the Southern District of New York – Manhattan Doctor Pleads Guilty To The Illegal Distribution Of Oxycodone And Fentanyl Resulting In Patient’s Overdose
U.S. Attorney for the Central District of California – Operator of Long Beach Medical Clinic Sentenced to More Than 3 Years in Federal Prison for Selling Prescriptions for Powerful Opioids
U.S. Attorney for the Western District of Virginia – Norton Doctor Pleads Guilty to Illegally Prescribing Prescription Drugs
U.S. Attorney for the Southern District of West Virginia – Meds2Go Express Pharmacy, Inc. Pleads Guilty to Money Laundering in Connection with Drug Diversion Scheme
This Week’s Calendar – See You in 2020!
Good morning all and welcome to the final Weekly Opioid Policy Report for 2019! The House and Senate are on recess through the remainder of the year. Wishing everyone a safe and relaxing holiday break and a happy and healthy New Year!
Questions about the above content can be directed to Matthew.Rubin@FaegreBD.com.