The Drug Enforcement Agency, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is issuing a temporary rule to extend certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID19 Public Health Emergency (COVID-19 PHE), in order to avoid lapses in care for patients.
The full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will remain in place through November 11, 2023.
If a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024.
According to the rule, ultimately, there will be a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion.
Read SAMHSA's release here.
March 29, 2023
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.
The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.
The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.
Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
The FDA granted the OTC approval of Narcan to Emergent BioSolutions.
Professional Affairs and Stakeholder Engagement Staff | Office of Center DirectorCenter for Drug Evaluation and Research |Food and Drug Administration10903 New Hampshire Ave
The American Osteopathic Academy of Addiction Medicine is a strategic partner of Addiction Treatment Professionals Rally for Solutions at ASAM’s 2023 Addiction Medicine Advocacy Conference.
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:
The proposed rules also would not affect:
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:
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:
Additional resources for practitioners can be found here:
The most current updates will be here: Removal of DATA Waiver (X-Waiver) Requirement | SAMHSA
· 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.
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
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
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