Description
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS programs may require that healthcare professionals and patients perform extra measures to ensure the drug is used safely. These requirements may present challenges to mental health teams, result in unintended consequences on patient access or cause burden on various care team members such as prescribers, dispensers, those who monitor medication response and safety parameters, those who educate patients, or those assist with access to the medication. Because of these issues, it is important to examine REMS programs to assure they meet their intended purposes and do not cause unintended consequences for patients or healthcare providers. Thus, an evaluation of the REMS programs for three psychiatric medications (i.e., esketamine, olanzapine pamoate, and clozapine) was conducted in collaboration with the FDA Office of Surveillance and Epidemiology (OSE). Multidisciplinary healthcare professionals participated in focus group interviews to provide their perspectives on the impact on REMS programs on patient access, safe medication use, and health professional workload. Emergent themes from the focus group interviews included discussions on the value of the REMS programs, registration/enrollment processes and REMS websites, monitoring requirements, care transitions, and COVID-19 considerations. The present session will discuss the results of the focus group interviews, including the identified themes and recommendations. Conference participants will be engaged to discuss areas for improvement to the REMS programs for psychiatric medications. The speakers in the session will include two psychiatric pharmacists and a health services researcher.
Format
Recorded webinar.
This content was recorded during the APA 2023 Annual Meeting.
Learning Objectives
- Describe Risk Evaluation and Mitigation Strategies (REMS) and provide an overview of the REMS programs for three psychiatric medications: esketamine, olanzapine pamoate, and clozapine.
- Review a research protocol evaluating the three REMS programs.
- Describe the perspectives of different healthcare professionals from the evaluation of the REMS programs.
- Discuss recommendations and best practices for utilization of REMS programs for psychiatric medications so that members of the mental health team may better advocate for their clients.
Target Audience
Residents/Fellows, Psychiatrists, Psychologists
Estimate Time to Complete
Estimated Duration: 1.0 hours
Program Start Date: May 1, 2025
Program End Date: May 1, 2028
How to Earn Credit
Participants who wish to earn AMA PRA Category 1 Credit™ may do so after completing all sections of the course including the evaluation. After evaluating the program, course participants will be provided with an opportunity to claim hours of participation and print an official CME certificate (physicians) or certificate of participation (non-physicians) showing the completion date and hours earned.
Continuing Education Credit
In support of improving patient care, the American Psychiatric Association is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
The APA designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Faculty and Planner Disclosures
The American Psychiatric Association adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME activity — including faculty, planners, reviewers or others — are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Instructors
- Catherine Cooke, PharmD, MS, BCPS, PAHM
- Megan Ehret, PharmD, MS, BCPP
- Ray Love, PharmD, BCPP, FASHP
Planners
- Vishal Madaan, MD, Chief of Education and Deputy Medical Director at the American Psychiatric Association.
Accessibility for Participants with Disabilities
The American Psychiatric Association is committed to ensuring accessibility of its website to people with disabilities. Please contact the American Psychiatric Association at 202-559-3900, if you require assistance seven (7) business days prior to the start of a live webinar.
Technical Requirements
This internet-based CME activity is best experienced using any of the following:
- The latest and 2nd latest public versions of Google Chrome, Mozilla Firefox, or Safari
- Internet Explorer 11+
This Web site requires that JavaScript and session cookies be enabled. Certain activities may require additional software to view multimedia, presentation, or printable versions of the content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Acrobat Reader, Microsoft PowerPoint, and Windows Media Player.
Optimal System Configuration:
- Browser: Google Chrome (latest and 2nd latest version), Safari (latest and 2nd latest version), Internet Explorer 11.0+, Firefox (latest and 2nd latest version), or Microsoft Edge (latest and 2nd latest version)
- Operating System: Windows versions 8.1+, Mac OS X 10.5 (Leopard) +, Android (latest and 2nd latest version), or iOS/iPad OS (latest and 2nd latest version)
- Internet Connection: 1 Mbps or higher
Minimum Requirements:
- Windows PC: Windows 8.1 or higher; 1 GB (for 32-bit)/2 GB (for 64-bit) or higher RAM; Microsoft DirectX 9 graphics device with WDDM driver; audio playback with speakers for programs with video content
- Macintosh: Mac OS X 10.5 or higher with latest updates installed; Intel, PowerPC G5, or PowerPC G4 (867MHz or faster) processor; 512 MB or higher RAM; audio playback with speakers for programs with video content
For assistance: Contact educme@psych.org for questions about this activity | Contact learningcenter@psych.org for technical assistance