New Eligibility Requirements for Buprenorphine Prescribing

What’s happening – With the opioid crisis continuing unabated, HHS has released new guidelines that should help increase access to opioid use disorder (OUD) treatment. By removing a few barriers, the updated regulation makes it easier for clinicians to prescribe buprenorphine, which can help reduce opioid cravings and withdrawal symptoms.

Under the new provisions, which took effect April 28, 2021, healthcare providers who are state-licensed and are already registered with the DEA to prescribe controlled substances, can apply for a waiver to prescribe buprenorphine to up to 30 patients without first having to meet training, counseling, and ancillary service requirements.

Why it’s complicated – While prescribers who qualify can apply for the new waiver to eliminate the federal training requirements for prescribing buprenorphine, they must still meet state laws that govern supervisory requirements and prescription durations.

Reports & Perspectives –

  • SAMHSA provides a quick-start guide for providers on buprenorphine and how to prescribe it for patients.
  • NPR provides a Q&A with Nora Volkow, director of the National Institute on Drug Abuse, looking at why the new opioid-prescribing guidelines are significant and how they will increase access to treatment for patients in need.
  • The American Dental Association unpacks the new guidelines for members and provides resources for dentists to do their part in addressing the opioid epidemic.
  • Practical Pain Management provides perspective on the updated guideline for clinicians and advanced practitioners treating patients with chronic pain.
  • @DrSarahWakeman (addiction medicine specialist) tweets: “Practical tips for submitting NOI for x-waiver w/o doing training under new practice guidelines…”
  • @AlosaHealth (nonprofit organization supporting HCPs) tweets: “Only 1 in 10 patients with #OUD initiate buprenorphine within 1 year of diagnosis’ adherence to therapy after initiation is low, suggesting important gaps in care.”

In practice – How to administer buprenorphine. Considerations for prescribing benzodiazepines when the patient is on opioids.

FDA: Lamotrigine for Bipolar Disorder, Seizures, Linked to Cardiovascular Risks

What’s happening – People with heart disease who take lamotrigine (Lamictal), a medication used to treat both seizures and bipolar disorder, may be at risk for experiencing heart arrhythmias, according to the FDA. Patients most at risk include those with heart failure, valvular heart disease, congenital heart disease, and a host of other heart conditions. FDA warns that people who other sodium channel blockers may be at increased risk of arrhythmias as well.

Why it’s noteworthy ­– The updated FDA warning makes it important for prescribers to weigh the treatment benefits of lamotrigine with potential risks to individual patients.  This is not the first serious side effect linked to lamotrigine. In 2018, cases of a rare but life-threatening immune system reaction called hemophagocytic lymphohistiocytosis (HLH) were found to be associated with the drug, prompting FDA to issue a prior warning.

Reports & Perspectives –

  • The International League Against Epilepsy (ILAE)/American Epilepsy Society (AES) Task Force shared the results of their exploration of the cardiac effects of lamotrigine; their report provides guidance for prescribers on minimizing risk.
  • Emilio Perucca, co-chair of the ILAE/AES task force points out that the extent of the problem is limited enough that clinicians do not have to stop prescribing lamotrigine at this point.
  • MedPage Today reports that the FDA is now exploring the safety of other medicines in the same drug class as lamotrigine to determine if they may cause similar side effects.
  • The Epilepsy Society reveals that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is investigating what prompted the FDA warning on
  • @DMG_AZ (District Medical Group/a nonprofit health care organization) tweeted the warning: “@FDA published drug safety info on Lamictal (lamotrigine): Studies show increased risk of heart problems in patients with heart disease..”
  • @PPHIRx (Pharmacists Public Health Initiatives) tweeted the FDA warning and noted: “Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease…”
  • @MichiganPoison (Michigan Poison Center at Wayne State University) says: “FDA Drug Safety Communication: Lamotrigine which is commonly used to treat seizure disorders, depression, and bipolar disorder linked to heart rhythm issues…”

In practice – Our consumer sister site offers background on lamotrigine. More on diagnosing bipolar disorder.

Psy-Q Challenge

Should clinicians ask patients taking antipsychotics to watch for signs of tardive dyskinesia?

Get the Answer

Tardive Dyskinesia Symptoms and Patient Awareness

Patients who take certain medications, such as antipsychotics, to treat psychiatric disorders or to manage gastrointestinal diagnoses may experience tardive dyskinesia (TD), which causes twitching or uncontrollable movements in different parts of the body. A research team recently explored patient awareness of TD symptoms; the results were presented in a poster session by Meyer et al at a meeting hosted by the American Association of Neuroscience Nurses (AANN). (Disclosure: the study was supported by Neurocrine Biosciences which manufacturers the VMAT2 valbenazine.)

The team looked at how people perceived TD in different body regions, and also considered whether the original diagnosis for which they were being treated impacted their awareness of symptoms. Among patients taking a VMAT2 inhibitor for symptoms of tardive dyskinesia (VMAT2 inhibitors are considered a first-line therapy), 92% reported recognizing TD symptoms. Results demonstrated no significant differences in symptom ratings by patients with schizophrenia or schizoaffective disorder compared to those with other psychiatric diagnoses such as a mood disorder. Clinicians did, however, report that those patients whom they rated to have more moderate to severe TD symptoms did have increased awareness of these symptoms. (More on symptom identification in our Psy-Q Challenge with Joseph Goldberg, MD, above)

A related study published in Psychiatry Online looked at different treatment methods for TD and discovered that the greatest outcomes occur with early assessment and identification of TD. Further, a study in Neurology led by Citrome L (who discloses support from Neurocrine) revealed that patients diagnosed with TD taking valbenazine had improved Abnormal Involuntary Movement Scale (AIMS) Item 8 scores (which measures a clinician’s assessment of symptom severity). The researchers concluded that using Item 8 (a sum of items 1–7 is usually the primary efficacy measure) may be an effective way to assess TD severity.

 Reports & Perspectives—

  • The College of Psychiatric and Neurologic Pharmacists (CPNP) provides videos that illustrate how providers can conduct AIMS assessments of patients to identify the presence and/or severity of TD.
  • The Canadian Journal of Psychiatry shares in-depth treatment recommendations for TD.
  • Nursing2021 offers a checklist to help health care providers monitor for movement-related disorders.
  • @CMEInstitute (accredited provider of CME) tweets: “What should you rule out to diagnose tardive dyskinesia (TD)? How do treatment options differ? In this journal CME activity, Drs Citrome and Saklad team up to review the best clinical strategies…”
  • @GovLarryHogan (Governor of Maryland) shares: “During this #TDAwarenessWeek, we are illuminating Government House blue tonight to bring awareness to approximately 600,000 American living with Tardive Dyskinesia.”
  • @neiglobal (Neuroscience Education Institute) shares: “Check out our latest #CME NEI Podcast episode on Tardive Dyskinesia…”

In practice – A guideline update to treating schizophrenia.

Last Updated: Aug 26, 2021