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Psychotropic REMS Programs: Benefits, Challenges, and Implementation

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Activity Dates: 04/16/2023 - 04/16/2026

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Session Time and Location

The live session is complete.

Target Audience

If you are a pharmacist, nurse practitioner, or other health care professional involved in the comprehensive medication management of individuals living with mental health and/or substance use disorders, we invite you to participate in this online course.

Session Summary

The Risk Evaluation and Mitigation Strategy (REMS) was developed by the FDA in 2007 to ensure safe use of medications with serious safety concerns and that benefits outweigh risks. However, it comes with challenges due to the lack of standardization of requirements across various REMS programs. Some REMS programs restrict who can prescribe the medication whereas others require laboratory tests prior to dispensing, creating a challenge for users and emphasizing the importance of understanding each individual REMS program. Pharmacists are medication experts that are responsible for the safety of medications, which means they need to play an active role in REMS implementation and management. While the FDA mandates requirements of the REMS programs, it is left up to pharmacists and health systems to implement processes in their system and this can be challenging due to the complex requirements. This gap in knowledge is detrimental for pharmacists who have a unique advantage to implement and oversee these programs.

Course Requirements

To receive ACPE credit for this session, you must:

  • Sign in (or create a FREE account).
  • Register for this course.
  • Review the full content of the activity and reflect upon its teachings.
  • Complete the post-test at the end of the activity no later than the closing activity date.
  • Complete the evaluation at the end of the activity.
  • If necessary, complete the post-test retest no later than the closing activity date.
  • Receive a passing grade (70%).
  • Provide the necessary details in your profile to ensure correct reporting by AAPP to CPE Monitor.

Upon successful completion, ACPE credit is reported within 24 hours to CPE Monitor although transcripts can be retrieved by participants online in their ACPE Transcript.

Faculty Information

Mary Borovicka, PharmD, BCPP

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Learning Objectives

  1. Assess benefits and challenges with the use of REMS programs.
  2. Compare REMS program requirements between different psychiatric medications.
  3. Recommend necessary actions to ensure adherence to psychiatric medication REMS requirements.

Continuing Education Credit and Disclosures

Activity Dates: 04/16/2023 - 04/16/2026
ACPE Contact Hours: 1
ACPE Number: 0284-0000-23-004-H04-P (Knowledge)
Nursing Credit Reminder: Note that ACPE credit is accepted for ANCC Certification Renewal and AANPCB advanced practice provider content. For specific questions related to your organization's acceptance of ACPE continuing education units, please contact your organization directly.

ACPEThe American Association of Psychiatric Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

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