The Modernization of Clozapine: A Recapitulation of the Past in the United States and the View Forward.

PURPOSE: Although clozapine was Food and Drug Administration (FDA) approved more than 3 decades ago, major barriers and gaps in knowledge continue to prevent its effective and safe use. We review modern-day problems encountered with clozapine in the United States (US). METHODS: Information surrounding current administrative, clinical, research, and technological gaps or barriers related to clozapine use in the US was reviewed. FINDINGS: The history of how clozapine became FDA approved likely contributes to gaps in knowledge. The frequency of safety warnings added to the FDA prescribing information may add to fears about clozapine, as evidence by numerous published survey studies. The clozapine Risk Evaluation and Mitigation Strategy (REMS) program has been modified several times in the last decade, causing access and safety issues for patients, which are discussed. Evidence may suggest that the FDA REMS requirements for hematologic monitoring are too cumbersome, and there may be ability to safely loosen requirements. The COVID-19 pandemic brought forth the ability for extended interval monitoring but also greater awareness of the clozapine-inflammation interaction. Newer guidelines published describe considerations in personalizing clozapine titration based on principles of ethnopsychopharmacology. Emerging technologies to support the use of clozapine are not widely available. IMPLICATIONS: Clozapine is a unique life-saving drug but it is underused in the US, despite its established efficacy. The 2021 REMS changes led to significant difficulties for providers and patients. We highlight the importance of the clozapine-inflammation interaction, therapeutic drug monitoring, and the ability for individual care based on patient-specific factors. There is an urgent need for advancing technology used for clozapine monitoring, evaluating barriers created by REMS, and establishing consistent practices throughout the US.

Clinician Satisfaction with Rapid Adoption and Implementation of Telehealth Services During the COVID-19 Pandemic.

Background: To examine clinician perspectives on the acceptability, appropriateness/suitability, and feasibility of video telehealth as a way to deliver mental health services during the COVID-19 pandemic. Materials and Methods: Mental health clinicians were surveyed with 27 Likert questions, using previously validated measures, on satisfaction and implementation experience with video telehealth visits between March and June 2020. Results: A total of 112 of 193 clinicians completed the survey (58.0%), including psychiatrists, psychologists, trainees (i.e., residents and fellows), advanced practice providers, and licensed mental health counselors. Clinicians reported high levels of acceptability, feasibility, and appropriateness of video telehealth; they also reported high levels of satisfaction with video telehealth visits. Seventy-nine and a half (79.5%) reported that their patients seemed highly satisfied with video telehealth visits, and 107 (95.5%) of clinicians responded that they would like video telehealth visits to represent at least 25% of their practice in the future. Discussion: Mental health clinicians showed positive attitudes toward the implementation of video telehealth visits, high levels of satisfaction with this care, and indicated strong interest in continuing this modality as a significant portion of clinical practice. Conclusions: This study demonstrates the ability of mental health clinicians to embrace new technology to expand access to care during the COVID-19 pandemic. Results indicate that telemental health is likely to be an integral part of clinic practice in the future.