https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities

DEA extends many telemedicine flexibilities adopted during the COVID-19 PHE with appropriate safeguards

WASHINGTON - Today, the Drug Enforcement Administration announced proposed permanent rules for the prescribing of controlled medications via telemedicine, expanding patient access to critical therapies beyond the scheduled end of the COVID-19 public health emergency. The public will be able to comment for 30 days on the proposed rules.

The proposed rules – developed with the U.S. Department of Health and Human Services and in close coordination with the U.S. Department of Veterans Affairs – propose to extend many of the flexibilities adopted during the public health emergency with appropriate safeguards.

The proposed rules do not affect:

• Telemedicine consultations that do not involve the prescribing of controlled medications.
• Telemedicine consultations by a medical practitioner that has previously conducted an in-person medical examination of a patient.

The proposed rules also would not affect:

• Telemedicine consultations and prescriptions by a medical practitioner to whom a patient has been referred, as long as the referring medical practitioner has previously conducted an in-person medical examination of the patient.

The proposed rules would provide safeguards for a narrow subset of telemedicine consultations—those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a controlled medication. For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe:

• a 30-day supply of Schedule III-V non-narcotic controlled medications; 
• a 30-day supply of buprenorphine for the treatment of opioid use disorder

without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. The proposed rules are explained in further detail for patients and medical practitioners on DEA.gov.

“DEA is committed to ensuring that all Americans can access needed medications,” said DEA Administrator Anne Milgram.  “The permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”

“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” said HHS Secretary Xavier Becerra. “We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person. At HHS, we are committed to working with our federal partners and stakeholders to advance proven technologies and lifesaving care for the benefit of all Americans.”

The proposed telemedicine rules also further DEA’s goal of expanding access to medication for opioid use disorder to anyone in the country who needs it. “Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery, and also prevent drug poisonings,” said DEA Administrator Milgram. “The telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder.”

The full text of the proposals may be found here and here. The public has 30 days to review and comment on the proposals, which DEA will then consider before drafting final regulations. DEA is appreciative of the public’s feedback.

For more information on DEA’s continued efforts to expand access to medications used in treatment for those suffering from opioid use disorder, visit: DEA’s Commitment to Expanding Access to Medication-Assisted Treatment.

Additional resources for patients can be found here: 

• Is My Prescription a Controlled Medication? Controlled-Non Controlled List (dea.gov)
• Can My Medication be Prescribed through Telemedicine?  Controlled Substance Guidance (dea.gov)

Additional resources for practitioners can be found here:

• Proposed Rules Summary Telemedicine Rules Summary.pdf (dea.gov)
• Proposed Rules Highlights for Medical Practitioners Telehealth Highlights Medical Practitioners.pdf (dea.gov)

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Once the proposed rules are published, the Drug Enforcement Administration encourages that all comments be submitted through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments.  Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments.

The most current updates will be here: Removal of DATA Waiver (X-Waiver) Requirement | SAMHSA

Update on 1/25/2023:

·         Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill), removes the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder (OUD). With this provision, and effective immediately, SAMHSA will no longer be accepting NOIs (waiver applications).

All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law and SAMHSA encourages them to do so. SAMHSA and DEA are actively working on implementation of a separate provision of the Omnibus related to training requirements for DEA registration that becomes effective in June 2023. Please continue to check this webpage for further updates and guidance.

275 Annual Report

275 Annual Reports are no longer required or being accepted.

Current Updates, use this link:

Removal of DATA Waiver (X-Waiver) Requirement | SAMHSA

Overdose Prevention Task Force – National Toolkit for Advocacy

Authors: Erin L. Winstanley, Emily P. Thacker, Lyn Yuen Choo, Laura R. Lander, James H. Berry, Babak Tofighi

Abstract:

Background: While barriers to accessing buprenorphine (BUP) therapy have been well described, little is known about pharmacy-related barriers. The objective of this study was to estimate the prevalence of patient-reported problems filling BUP prescriptions and determine whether these problems were associated with illicit use of BUP. The secondary objectives included identifying motivations for illicit BUP use and the prevalence of naloxone acquisition among patients prescribed BUP.

Methods: Between July 2019 and March 2020, 139 participants receiving treatment for an opioid use disorder (OUD) at two sites within a rurally-located health system, completed an anonymous 33-item survey. A multivari- able model was used to assess the association between pharmacy-related problems filling BUP prescriptions and illicit substance use.

Results: More than a third of participants reported having problems filling their BUP prescription (34.1%, n = 47) with the most commonly reported problems being insufficient pharmacy stock of BUP (37.8%, n = 17), pharmacist refusal to dispense BUP (37.8%, n = 17), and insurance problems (34.0%, n = 16). Of those who reported illicit BUP use (41.5%, n = 56), the most common motivations were to avoid/ease withdrawal symptoms ( n = 39), prevent/reduce cravings ( n = 39), maintain abstinence ( n = 30), and treat pain ( n = 19). In the multivariable model, participants who reported a pharmacy-related problems were significantly more likely to use illicitly obtained BUP (OR = 8.93, 95% CI: 3.12, 25.52, p < 0.0001).

Conclusion: Efforts to improve BUP access have primarily focused on increasing the number of clinicians waivered to prescribe; however, challenges persist with BUP dispensing and coordinated efforts may be needed to system- atically reduce pharmacy-related barriers.

Read the Article

Earlier this year, the Centers for Disease Control and Prevention (CDC) reported that deaths from unintentional drug poisonings in the United States exceeded 100,000 in 2021. This is the largest number of overdose deaths ever recorded in a one-year period in this country. Further analysis of the data reveals that more than 75% of these overdose deaths were due to opioids.

Lancaster County has not been shielded from this national epidemic of opioid-related overdose deaths. During the 2020 calendar year, our county saw 143 deaths from unintentional drug poisonings, and opioids were implicated in 89% of those deaths. The broad consensus is that untreated, or inadequately treated, opioid use disorder (OUD) is a major factor underlying this crisis.

Our colleague Tara Tawil, MD, described the evolution of this epidemic over the past 30 years in the pages of this journal in 2019. In that article, which serves as useful background for this manuscript, Tawil also described treatment options for OUD, the emergence of buprenorphine in 2002, and efforts to increase prescribing of buprenorphine within the Penn Medicine Lancaster General Health network of primary care practices. Buprenorphine is a medication approved by the Food and Drug Administration (FDA) to treat OUD; the provision of the medication is associated with substantial reductions in all-cause mortality and opioid overdose deaths.

In 2020, the American Society of Addiction Medicine (ASAM) released a focused update to their National Practice Guideline (NPG) for the treatment of OUD.6 The release of this document was overshadowed by the COVID-19 pandemic and likely escaped the attention of many providers of buprenorphine treatment. These guidelines contain new recommendations and.... Read the full article.

Article: Pittsburgh Post-Gazette

James R. Latronica: Drug users have human rights, and they include harm reduction the state can supply

The news was grim. Overdose deaths in 2020 increased across the board, and rose a staggering 44% among Black individuals and 39% among American Indian and Alaskan Native individuals. Perhaps most surprisingly, overdose deaths were higher in areas where opioid treatment programs were available — Having “access” to health care does not mean being able to get it.

The root causes of this continued epidemic are manifold. As the medical community slowly comes to terms with the role that social determinants of health play in people’s lives, the role of marginalization and dispossession in driving this epidemic has become obvious and inescapable. In its latest report, for example, the Centers for Disease Control and Prevention notes that counties with higher income inequality suffered a disproportionate number of overdose deaths.

Increasing access to treatment for Substance Use Disorders is a critical part of this struggle, but people arrive to my clinic in various ways and not always in a predictable pattern. Not everyone is ready, able or willing to begin treatment at a given point in their life.

This is one reason we need increased harm reduction efforts. Medical and public health professionals engage in harm reduction efforts in many arenas. Seatbelts in cars are harm reduction. Medication for high cholesterol is harm reduction. Fatal motor vehicle accidents and heart attacks are devastating outcomes that relatively low-cost, high-impact primary interventions can prevent or mitigate.

Physicians call this type of intervention “preventive medicine.” As I’ll explain later it is an extension of human rights.

Two bills supporting effective harm reduction for people who use drugs are currently being considered in the Pennsylvania Legislature. The first, SB926, would permit the establishment of Syringe Service Programs in the commonwealth (They are already legal in 31 states and Washington, D.C.) Explicit legalization is important as these critical public health institutions operate in a legal grey area.

Syringe Service Programs have been shown to decrease overdose deaths, decrease the rate of blood-borne illnesses like hepatitis C and HIV, decrease the rate of discarded needles in the community and harm to first responders, and increases the rate at which people enter into formal treatment. They are a relatively inexpensive, overwhelmingly positive public health benefit.

The second, HB1393, which recently passed the full House unanimously, would permit the use of fentanyl test strips across the commonwealth. (They are now only legal within Philadelphia and Pittsburgh city limits). The strips allow people using substances to determine if fentanyl is present or not with a simple color-changing strip, similar to a pregnancy test.

This is critical as fentanyl is now present in nearly every substance available in the banned drug supply, and users of non-opioid substances are at enormous risk of overdose given the potency of fentanyl. Perhaps most importantly, with amended language, the bill would allow for the testing of a wide range of contaminants and poisons that are now pervasive in the banned drug supply. For example, a significant proportion of seized drugs contain xylazine,  an anesthetic used by veterinarians. Naloxone cannot reverse its effects.

Available evidence strongly supports interventions like providing syringes and ways to test the drug supply, but there is a deeper, more fundamental reason to legalize these measures. People do not deserve to suffer and die for using a given substance, especially when saving their lives is so easy to do. That is why I consider harm reduction efforts as a matter of basic human rights.

Human rights constitute an agreement and a promise: the agreement that humans have an immutable dignity that must be protected, and a promise that we strive together to construct and maintain institutions that ensure it. This is true whatever needs they have, even if many people look down on their needs. When we stigmatize harm reduction for people who use drugs, we’re telling them that their lives are not valuable, that they are worth less than other people.

Harm reduction efforts for people who use drugs are a moral and clinical good and should be argued for on their merits, without prevarication. Lives depend on the passage of the current bills and sufficient funding for harm reduction across the commonwealth.

James R. Latronica, DO, is an addiction specialist physician and public policy chair of the Pennsylvania Society of Addiction Medicine based in Pittsburgh. He can be found on Twitter @JamesRLatronica.

First Published July 28, 2022, 12:00am

Link to details.

“Of all the forms of inequality, injustice in health is the most shocking and the most inhuman because it often results in physical death."

Dr. Martin Luther King, Jr.

ORN acknowledges February as Black History Month. This, and every month, we recognize the contributions and sacrifices of Black people in the American story.

Preventing and treating substance use disorders in Black Communities is critical as rates of overdose deaths in these communities are outpacing other populations. Read more about ORN's Black Communities Workgroup's efforts here.

Medical School Addiction Medicine Curriculum: Designed for Medical Students by Medical Students

New medical school curriculum developed by winners of the Coalition for Physician Education in Substance Use Disorders (COPE) Medical Student Curriculum Challenge is now available to download at no cost.

The ORN-funded challenge had medical students use their knowledge and creativity to design learning resources related to the development of the skills and attitudes critical to providing care to persons with substance use disorders. From 36 submissions, there were 8 winners and 4 honorable mentions. Twelve curriculum designs are now available and free of charge on COPE’s website for use by medical schools across the country. See the list and instructions on how to download here.

For additional evidence-based resources on the prevention, treatment and recovery of opioid use, stimulant use and all substance use disorders, submit a request at OpioidResponseNetwork.org.

If an opportunity listed below sparks your interest but you are not sure how to begin or would like more information, email orn@aaap.org. We are here to help you!
All ORN trainings are provided at no cost. 
To coordinate a training designed specifically to meet your needs, submit a request today at OpioidResponseNetwork.org. 

Social Work Chat Live: Spiro Spero - February 28, 2022

This ORN-funded activity coordinated by the Boston Medical Center is a viewing of a play titled "Spiro Spero." Participants will watch the streamed play from 11:30am - 12:30pm ET on YouTube and then attend a talk-back following. Spiro Spero is a one woman play written and performed by a psychiatric nurse practitioner who specializes in addiction. It explores the lives of five people impacted by substance use disorder and their experiences in treatment, in the community, and in the healthcare setting. A talk back will occur immediately following the stream. Learn more. 

Virtual Training: Stimulants 101 - March 10, 2022

This ORN-funded training from the Boston Medical Center is designed to provide an overview of stimulant use disorders for all healthcare staff including providers, nurses, counselors and other non-clinical staff. The training reviews stigma, identifying stimulant overdose, managing acute stimulant intoxication, de-escalation techniques, and evidence-based treatment for people who use stimulants. Learn more. 

Virtual Training: Recovery Ambassador Training - March 22-24, 2022

This ORN-funded, Faces & Voices of Recovery, Recovery Ambassador Program is a free training that prepares individuals to advance public understanding and appropriate responses to addiction. The training program consists of Our Stories Have Power, Recovery Messaging, the Science of Addiction & Recovery and the Recovery Ambassador curriculum. Course material includes instruction in language and stigma, recruiting volunteers, building messages, organizing community action, engaging policymakers, raising money and effective advocacy. Learn more.

Reminder: On Demand Webinars Presented by Psychiatric-Mental Health Nurses 

New ORN-funded webinars from the American Psychiatric Nurses Association have been posted and are available to all at no cost. These include:

·     What’s in Grandma’s Medicine Cabinet? – Understanding Substance Use Disorders in Older Adults Explore how age-related physiological and social changes present unique challenges for the identification and treatment of this disorder.

·     Substance-Exposed Pregnancies: What to Know As They Grow Discover how substance use during pregnancy impacts maternal/fetal development and increases the neurological vulnerabilities of the neonate.

A Primer on Stimulant Use Disorder: A Growing Concern 

Examine neuroscience changes as a result of a substance use disorder, along with the signs and symptoms that often present with the diagnosis as well as potential treatment options.

Share our mission in your community!

Opioids, stimulants and other substances have created an unprecedented health crisis so the Opioid Response Network created an unprecedented response. As communities mobilize to address local need, we are here to enhance their efforts. Help us spread the word! Post the video below to your network's social channels. Encourage your network to tell us what they need via the simple request form at OpioidResponseNetwork.org.

orn@aaap.org  - 401-270-5900  -  OpioidResponseNetwork.org

The Commission on Combating Synthetic Opioid Trafficking, established under Section 7221 of the National Defense Authorization Act for Fiscal Year 2020, was charged with examining aspects of the synthetic opioid threat to the United States—specifically, with developing a consensus on a strategic approach to combating the illegal flow of synthetic opioids into the United States. This final report describes items involving the illegal manufacturing and trafficking of synthetic opioids, as well as the deficiencies in countering their production and distribution, and includes action items directed to appropriate executive branch agencies and congressional committees and leadership.

Read the report.

The CDC draft Clinical Practice Guideline for Prescribing Opioids (update to the 2016 Guideline for Prescribing Opioids for Chronic Pain) has posted in the Federal Register and the 60-day public comment period begins today. Public comment provides valuable insight from the populations that we serve. Please note that the 60-day public comment period will end on April 11, 2022.  CDC is committed to supporting safe and effective pain care options for patients. CDC’s National Center for Injury Prevention and Control (NCIPC) is in the process of updating the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. Both healthcare professionals and members of the public who experience acute or chronic pain have expressed interest in understanding the recommendations outlined in the draft updated Guideline, and CDC highly values public and partner engagement and feedback in this process. <Visit the Federal Register to provide your comments on the draft Guideline update>  Please see our webpage detailing the process of updating the Guideline. Encourage people you know who have direct experience with the role of opioids in pain care and the importance of the patient-clinician relationship to visit the Federal Register, review the draft update to the Guideline, and add their perspectives to the Federal Register Notice.

Submitting a Comment See below for instructions to submit a comment during the public comment period. More detailed instructions can also be found on the Federal Register Notice (FRN) webpage and in the FRN for this document.   To locate the FRN and view the draft of the updated Guideline, you can either:    Click on the direct link to the FRN in this email or Go to Federal Register.gov and search for "CDC's Guideline for Prescribing Opioids" or Document Number 2022-02802 To inspect the draft Clinical Practice Guideline and supporting documents, please go to this link and click "View More Documents:” https://www.regulations.gov/document/CDC-2022-0024-0002 To submit a comment to CDC, please view the methods outlined in the FRN under the "Addresses" heading and select which option you prefer: Electronic comments via the website Regulations.gov

Go to https://www.regulations.gov and search for "CDC Guideline for Prescribing Opioids" A comment button on the top left of the page will allow you to submit your comments via a webpage with step-by-step instructions

Mail

Directions for how to submit a comment through the mail are provided in the "Addresses" section of the FRN on FederalRegister.gov

To ask a question, click on the “For Further Information Contact” heading in the FRN for the agency official contact information.  General information about the process to provide a public comment can be found at the following links:   Federal Register: Reader Aids: Using FederalRegister.Gov Federal Register: Reader Aids: Videos & Tutorials