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Abstract Following the approval of Epidiolex® (cannabidiol; CBD) for the treatment of seizures associated with Lennox–Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC), healthcare professionals (HCPs) have had substantial experience in treating patients with Epidiolex. However, confusion still remains among HCPs, caregivers, and patients regarding dosing, drug interactions, safety monitoring, and differentiation between Epidiolex and nonapproved CBD products. To establish consensus recommendations for Epidiolex treatment optimization in LGS, DS, and TSC, a panel of seven HCPs with expertise in epilepsy was convened. Panelists participated in a premeeting survey based on a literature review of Epidiolex for the treatment of LGS, DS, and TSC, and survey responses were compiled for discussion. A modified Delphi method was used to assess agreement among panelists regarding recommendation statements following two rounds of discussion. Panelists identified two broad themes – overcoming barriers to initiation and optimization of treatment for seizures associated with LGS, DS, and TSC – for consensus guidelines. Accurate identification of patients with these rare epilepsies is critical for optimization of Epidiolex treatment. Providers should differentiate Epidiolex from nonapproved CBD products and set expectations for the therapeutic effect and safety/tolerability of Epidiolex. Initial target dose and titration rate should be individualized by baseline variables, prior response to antiseizure medications, and therapeutic goals. Awareness of strategies to manage adverse events and concomitant medications, including drug–drug interactions, is critical. Tracking response to the maximum tolerated dose is an important measure of effectiveness. These consensus recommendations provide real‐world experience from neurology HCPs with experience in prescribing Epidiolex and can inform optimal use of Epidiolex for the treatment of seizures associated with LGS, DS, and TSC. Plain language summary Epidiolex® (cannabidiol) is approved for treating seizures in Lennox–Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Although healthcare professionals have experience in treating patients with Epidiolex, there is a need for better understanding of dosing, drug interactions, and safety of this drug. Therefore, a group of epilepsy experts developed guidelines for best practices in Epidiolex treatment. Two main areas were identified: overcoming barriers to starting Epidiolex and considerations related to Epidiolex dosing. Within these areas, topics, including correct disease identification, managing adverse events, and determining individualized dose, were discussed. These guidelines provide real‐world experience to inform optimal Epidiolex use.

By Eric Gidal, Munachim Amah, Javier Espinosa, Richard Frailing, Ellen Oliver, Clara Reynen, and Kaden St Onge. As we contend with the environmental degradation of our waters and the fragmenting of our communities that such degradation both exhibits and accelerates, we need to draw on the arts and the humanities as much as we do on hydrology, engineering, politics, and law.

BACKGROUND AND OBJECTIVES: Mood, anxiety disorders, and suicidality are more frequent in people with epilepsy than in the general population. Yet, their prevalence and the types of mood and anxiety disorders associated with suicidality at the time of the epilepsy diagnosis are not established. We sought to answer these questions in patients with newly diagnosed focal epilepsy and to assess their association with suicidal ideation and attempts. METHODS: The data were derived from the Human Epilepsy Project study. A total of 347 consecutive adults aged 18-60 years with newly diagnosed focal epilepsy were enrolled within 4 months of starting treatment. The types of mood and anxiety disorders were identified with the Mini International Neuropsychiatric Interview, whereas suicidal ideation (lifetime, current, active, and passive) and suicidal attempts (lifetime and current) were established with the Columbia Suicidality Severity Rating Scale (CSSRS). Statistical analyses included the t test, χ2 statistics, and logistic regression analyses. RESULTS: A total of 151 (43.5%) patients had a psychiatric diagnosis; 134 (38.6%) met the criteria for a mood and/or anxiety disorder, and 75 (21.6%) reported suicidal ideation with or without attempts. Mood (23.6%) and anxiety (27.4%) disorders had comparable prevalence rates, whereas both disorders occurred together in 43 patients (12.4%). Major depressive disorders (MDDs) had a slightly higher prevalence than bipolar disorders (BPDs) (9.5% vs 6.9%, respectively). Explanatory variables of suicidality included MDD, BPD, panic disorders, and agoraphobia, with BPD and panic disorders being the strongest variables, particularly for active suicidal ideation and suicidal attempts. DISCUSSION: In patients with newly diagnosed focal epilepsy, the prevalence of mood, anxiety disorders, and suicidality is higher than in the general population and comparable to those of patients with established epilepsy. Their recognition at the time of the initial epilepsy evaluation is of the essence.

Background and objective: Commercially available cannabidiol (CBD) products are increasingly being used for medicinal purposes, including for the treatment of various neurological conditions, but there are growing concerns around adherence to quality control measures that protect consumers. This study was conducted to assess the purity and label accuracy of commercially available CBD products.Methods: Commercially available CBD products were chosen from the open stream of commerce in the United States based on formulations as a tincture, gummy, vape, or topical product. Cannabinoid concentrations were analyzed to verify label accuracy including “full spectrum,” “broad spectrum,” and “CBD isolate” claims on the product label. Analysis for the presence of contaminants included evaluation for heavy metals, pesticides, and residual solvents. Labeled and actual total amounts of CBD and levels of impurities such as heavy metals, residual solvents, and pesticides were measured.Results: A total of 202 CBD products (100 tinctures, 48 gummies, 34 vape products, and 20 topicals) were chosen to represent a broad sample in the United States. Of the products tested (full spectrum, n = 84; broad spectrum, n = 28; CBD isolate, n = 37), 26% did not meet the definition for product type claimed on the packaging. The majority of products (74%) deviated from their label claim of CBD potency by at least 10%. Heavy metals were detected 52 times across 44 of the 202 products tested, with lead being the most prevalent heavy metal. Residual solvents were detected 446 times across 181 of 202 products, with the highest concentrations reported for hexane, m/p-xylene, methanol, and o-xylene. Of 232 pesticides tested, 26 were found 55 times across 30 products. A total of 3% of heavy metals, 1% of residual solvents, and 1% of pesticides violated >1 regulatory threshold.Discussion: This study demonstrated that the majority of commercially available CBD products tested within the current study are inaccurately labeled. Heavy metals, residual solvents, and pesticides were found in several products, some of which violated regulatory thresholds. Thus, uniform compliance with CBD quality control measures is lacking and raises consumer protection concerns. Improved regulatory oversight of this industry is recommended.

Following the approval of Epidiolex® (cannabidiol; CBD) for the treatment of seizures associated with Lennox–Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC), healthcare professionals (HCPs) have had substantial experience in treating patients with Epidiolex. However, confusion still remains among HCPs, caregivers, and patients regarding dosing, drug interactions, safety monitoring, and differentiation between Epidiolex and nonapproved CBD products. To establish consensus recommendations for Epidiolex treatment optimization in LGS, DS, and TSC, a panel of seven HCPs with expertise in epilepsy was convened. Panelists participated in a premeeting survey based on a literature review of Epidiolex for the treatment of LGS, DS, and TSC, and survey responses were compiled for discussion. A modified Delphi method was used to assess agreement among panelists regarding recommendation statements following two rounds of discussion. Panelists identified two broad themes – overcoming barriers to initiation and optimization of treatment for seizures associated with LGS, DS, and TSC – for consensus guidelines. Accurate identification of patients with these rare epilepsies is critical for optimization of Epidiolex treatment. Providers should differentiate Epidiolex from nonapproved CBD products and set expectations for the therapeutic effect and safety/tolerability of Epidiolex. Initial target dose and titration rate should be individualized by baseline variables, prior response to antiseizure medications, and therapeutic goals. Awareness of strategies to manage adverse events and concomitant medications, including drug–drug interactions, is critical. Tracking response to the maximum tolerated dose is an important measure of effectiveness. These consensus recommendations provide real‐world experience from neurology HCPs with experience in prescribing Epidiolex and can inform optimal use of Epidiolex for the treatment of seizures associated with LGS, DS, and TSC. Plain language summary: Epidiolex® (cannabidiol) is approved for treating seizures in Lennox–Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Although healthcare professionals have experience in treating patients with Epidiolex, there is a need for better understanding of dosing, drug interactions, and safety of this drug. Therefore, a group of epilepsy experts developed guidelines for best practices in Epidiolex treatment. Two main areas were identified: overcoming barriers to starting Epidiolex and considerations related to Epidiolex dosing. Within these areas, topics, including correct disease identification, managing adverse events, and determining individualized dose, were discussed. These guidelines provide real‐world experience to inform optimal Epidiolex use. [ABSTRACT FROM AUTHOR]

Objective: Telehealth in epilepsy care is not new. During the COVID-19 public health emergency, telehealth became more readily used to deliver epilepsy care. However, a summarized guidance of use in caring for people with epilepsy utilizing telehealth is needed. Methods: Existing literature was reviewed to provide guidance on various aspects of telehealth. Billing aspects are reviewed. Recommendations and considerations along with benefits and barriers to telehealth are provided. Results: Telehealth can be a preferred delivery route of care for people with epilepsy in specific situations. Examples include psychiatric complaints, medication management, and follow-up visits for noncomplicated epilepsy care. In addition, telehealth is useful for patients who need postoperative visits, are not able to travel, or live in residential facilities. In-person care may be more suitable for patients who are medically complex, have language barriers or difficulty with resource access, hearing impaired, or have neurostimulation devices where remote monitoring or programming options are infeasible. Discussion: Telehealth care for people with epilepsy can be a useful and important method of care delivery. It should remain an option for providers to use in epilepsy clinical care. It is important for the neurology provider to understand the benefits, billing, and barriers to providing telehealth. [ABSTRACT FROM AUTHOR]

Background: Patients experiencing alcohol withdrawal often receive care on inpatient mental health units. Registered nurses on one such unit had several concerns and questions about the existing alcohol withdrawal symptom management order set. To address these issues, a multidisciplinary team including nurses, psychiatrists, and pharmacists was formed. Objectives: The aims for this project were to review and revise the existing order set, educate staff, implement the changes, and evaluate outcomes. Methods: The Plan–Do–Study–Act quality improvement framework guided the project. Five phases were completed to revise the order set and implement: a survey of nurses on the unit, community practice evaluation, and order set revisions. A simulation escape room facilitated nursing education. Patient records were reviewed to identify adverse events. Results: Diazepam replaced lorazepam as the primary medication choice, and a front-loading protocol was added. Order set clarity was improved, education increased nursing staff confidence to competently complete a patient assessment with the Clinical Institute Withdrawal Assessment Alcohol Scale Revised, and no adverse patient events occurred after implementation. Conclusion: A revised order set for symptom management of patients experiencing alcohol withdrawal reflected up-to-date evidence while maintaining patient safety. All nurses agreed the revised order set was clear and easy to follow; pharmacists and physicians were satisfied with the revisions. Implications for leaders include having a multidisciplinary team, sufficient resources to answer clinical questions, and regular discussions by all involved disciplines to review any adverse events as well as newly published evidence. Close monitoring of patients early in implementation is recommended to detect adverse events [ABSTRACT FROM AUTHOR]

Some patients with epilepsy experience seizure clusters, which may be defined as 2 or more seizures occurring within 24 hours. Left untreated, seizure clusters increase the risk for physical injury and may progress to status epilepticus, irreversible neurologic injury, and death. Rescue therapy is based on benzodiazepine treatment. Prompt, appropriate use should be specified in patients' individualized seizure action plans. Most seizure clusters occur outside the hospital setting. The ideal rescue therapy allows for easy and quick administration by a nonmedical person, which may minimize the need for intervention by emergency medical personnel or transportation to the hospital. In the 2 decades before the approval of 2 intranasal benzodiazepines in 2019 and 2020, rectal diazepam was the only route of administration approved by the US Food and Drug Administration specifically for seizure clusters. Each of the approved intranasal formulations has a unique profile. Both offer a convenient and socially acceptable route of administration. Recognition of seizure clusters and timing of proper administration are key to successful use of rescue therapy. Pharmacists' counseling plays an important role in reinforcing when and how to appropriately administer rescue therapies and the importance of consistently using rescue treatment when indicated to promote effective management. This review includes resources for pharmacists, patients, and caregivers; reviews currently available treatments; and discusses seizure action plans that support effective treatment of seizure clusters. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to ascertain the natural history and patterns of antiseizure medication (ASM) use in newly diagnosed focal epilepsy patients who were initially started on monotherapy. Methods: The data were derived from the Human Epilepsy Project. Differences between the durations of the most commonly first prescribed ASM monotherapies were assessed using a Cox proportional hazards model. Subjects were classified into three groups: monotherapy, sequential monotherapy, and polytherapy. Results: A total of 443 patients were included in the analysis, with a median age of 32 years (interquartile range [IQR] = 20–44) and median follow‐up time of 3.2 years (IQR = 2.4–4.2); 161 (36.3%) patients remained on monotherapy with their initially prescribed ASM at the time of their last follow‐up. The mean (SEM) and median (IQR) duration that patients stayed on monotherapy with their initial ASM was 2.1 (2.0–2.2) and 1.9 (.3–3.5) years, respectively. The most commonly prescribed initial ASM was levetiracetam (254, 57.3%), followed by lamotrigine (77, 17.4%), oxcarbazepine (38, 8.6%), and carbamazepine (24, 5.4%). Among those who did not remain on the initial monotherapy, 167 (59.2%) transitioned to another ASM as monotherapy (sequential monotherapy) and 115 (40.8%) ended up on polytherapy. Patients remained significantly longer on lamotrigine (mean = 2.8 years, median = 3.1 years) compared to levetiracetam (mean = 2.0 years, median = 1.5 years) as a first prescribed medication (hazard ratio = 1.5, 95% confidence interval = 1.0–2.2). As the study progressed, the proportion of patients on lamotrigine, carbamazepine, and oxcarbazepine as well as other sodium channel agents increased from a little more than one third (154, 34.8%) of patients to more than two thirds (303, 68.4%) of patients. Significance: Slightly more than one third of focal epilepsy patients remain on monotherapy with their first prescribed ASM. Approximately three in five patients transition to monotherapy with another ASM, whereas approximately two in five end up on polytherapy. Patients remain on lamotrigine for a longer duration compared to levetiracetam when it is prescribed as the initial monotherapy. [ABSTRACT FROM AUTHOR]