About the author: Adam D. Scioli, D.O., DFAPA, FASAM, FAOAAM is the Medical Director and Head of Psychiatry at Caron Treatment Centers.

For 30 years, we’ve been chasing a panacea for mental health, trying to find the right prescription or the right mix of medications as a substitute for comprehensive treatment. More and more, doctors prescribe medication alone, even though such medications should be supported by counseling.

The lack of qualified therapists is compounded by insurance companies making it even more difficult. It’s perceived that the pharmaceutical approach is less costly and more efficient. It’s easier to measure costs than quality.

We keep seeking the magic pill for behavioral and mental health — and there is no magic pill. The focus has swung too far towards stabilizing patients rather than getting them well. Getting well – having a good quality of life, being engaged in the community, maintaining strong relationships and, above all, finding meaning and purpose – requires time and effort.

Still, we keep looking for that labor-saving device. It’s not working. It’s getting worse. People are unhoused, living on the fringes, and dying of what have become known as the diseases of despair.

Here’s why we need to take a more comprehensive approach to behavioral health.

People cannot find or afford the help they need

Despite epidemic levels of psychological distress left in the wake of the pandemic, our mental health system has never been more difficult to access.

While it’s now law that health care insurance provides coverage for mental health care on par with more traditional medical health care, that’s not a reality for most people. They find their insurance plans only have a few behavioral health care providers in-network, so many people seeking care end up paying the full cost themselves or delay getting help.

Small wonder many people don’t seek counseling. Even for those willing to pay out of pocket, there are months-long waiting lists for an appointment. There are simply not enough psychiatrists, psychologists and other qualified mental healthcare workers to meet the demand.

There are huge gaps in how we educate and train health care practitioners on behavioral health

There is a disconnect among medical professionals in general, who often fail to consider behavioral health when working with patients.

Outside of those of us who work in the fields of mental health and addiction medicine, there are not enough providers who fully understand the implications of mental health, substance use disorder (SUD) or the combination of the two.

In my own work in SUD, I often see a lack of comfort among other specialties in caring for people with this disease. If the wrong drugs are used for anesthesia, for example, something as simple as a colonoscopy can risk reactivating someone in recovery. However, few anesthesiologists are trained to consider this as a factor in their preoperative evaluations.

This is a blind spot that can be easily rectified with a consult.

We emphasize stability over wellness, limiting the length of treatment

Compare this to the care we provide for an emergent disease like cancer. There’s an intensive period of evaluation and treatment for cancer, and then patients start on a treatment protocol that, in most cases, lasts several years, with surveillance for up to five years afterwards before a person is considered “cured.”

When we look at behavioral health care, instead of that comprehensive, intensive approach, we first jump to the least expensive and lowest level of care. Complete patient assessments and diagnostic testing are often limited and based solely on patient-reported symptoms without fully understanding the underlying pathology. This can lead to an incomplete or misdiagnosis, complicating further treatment. Only when someone “fails” that treatment do they graduate to more intensive care. Perhaps it’s the level of care that is failing the patients, not the patients who are failing.

There are no quick fixes.

We have siloed treatment of mental health and SUD

Substance use and mental health disorders are closely linked. Of the estimated 20 million adults in the U.S. with SUD, almost 40% also suffer from some form of co-occurring mental illness. The reverse relationship is also true, with nearly 20% of adults with a mental illness also having a co-occurring SUD.........

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Managing Difficult Encounters

R. Gregory R. Lande, DO, COL (Ret.), FACN, FAOAAM

Abstract:

Difficult doctor-patient relationships are a recognized aspect of modern healthcare, but the actual incidence, risk factors, ethical issues, and management strategies are less well-known. The author queried PubMed, ScienceDirect, and the Education Resources Information Center. The inclusion criteria consisted of the free-text terms “difficult patient” and “difficult client” and the Medical Subject Heading terms “patient participation” and “professional-patient relations” with searches further refined by focusing on adults, management, screening, and incidence among review and research articles published in academic journals in English. The author excluded articles focused on children, adolescents, and anger management. This study condenses a body of research spanning two decades and can help clinicians understand factors that contribute to difficult encounters, employ simple screening instruments, and implement management approaches that can minimize difficult encounters and maximize their successful resolutions. Based on the collected evidence, most doctor-patient relationships are trouble-free, but some, ranging between 10% and 20%, are dominated by difficulties of varying degrees and types.

Read the article.

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.

Read entire rule 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.

Related Information

• FDA Overdose Prevention Framework
• Information About Naloxone 
• Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse
• Consumer Update: Access to Naloxone Can Save a Life During an Opioid Overdose 

 

Professional Affairs and Stakeholder Engagement Staff | Office of Center Director
Center for Drug Evaluation and Research |Food and Drug Administration
10903 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.

https://www.asam.org/news/detail/2023/03/06/addiction-treatment-professionals-rally-for-solutions-at-2023-addiction-medicine-advocacy-conference

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.