Risk Evaluation and Mitigation Strategies (REMS): Ensuring Access and Safe Use of Pharmaceuticals with Special Concerns
Activity Overview
Please read the following information about this continuing pharmacy education (CPE) activity before accessing the presentation using links located at the bottom of this page.
Accreditation for Pharmacists
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 1 hour (0.1 CEU) of continuing pharmacy education credit (ACPE activity #0204-0000-13-440-H03-T).
Target Audience
This continuing pharmacy education series was planned to meet the needs of pharmacy technicians in a variety of settings, and it would be particularly beneficial for pharmacy technicians, supervisors, and educators who are interested in learning about REMS.
Activity Content
Risk evaluation and mitigation strategies (REMS) have become an established medication safety mechanism. REMS can have a variety of components such as medication guides, communication plans, or elements to assure safe use. In some cases, REMS facilitate continued access to innovative medications with serious risks that otherwise would not be available. As REMS have become a common feature of the medication use process, it is important for pharmacy technicians to understand the rationale for the development of REMS and their potential components.
This educational activity is designed to educate pharmacy technicians about REMS for drugs dispensed by pharmacies in any practice setting. By understanding specific requirements of approved REMS programs and the challenges they can present, pharmacy technicians can contribute to the successful implementation of REMS. Practical strategies pharmacy technicians can take to assist in managing REMS requirements will be described.
Learning Objectives
After participating in this knowledge-based educational activity, participants should be able to
- Define Risk Evaluation and Mitigation Strategies (REMS) and the rationale for their development.
- Identify key features of REMS, including their structure, potential components, and the selection process.
- Describe trends in the number of drugs with REMS requirements and how REMS have changed since they took effect in 2008.
- Identify challenges and opportunities REMS present to pharmacies.
- Explain practical approaches to proactively and effectively implement REMS, including the proper distribution of medication guides.
Faculty
James M. Hoffman, Pharm.D.., M.S., BCPS
Medication Outcomes and Safety Officer
Associate Member, Pharmaceutical Sciences
St. Jude Children’s Research Hospital
Memphis, Tennessee
Dr. James M. Hoffman, Pharm.D., M.S., BCPS, is Medication Outcomes and Safety Officer and Associate Member in Pharmaceutical Sciences at St. Jude Children’s Research Hospital in Memphis, Tennessee. Dr. Hoffman is also an associate professor of clinical pharmacy at the University of Tennessee Health Science Center. In his position at St. Jude, Dr. Hoffman leads medication use policy, medication safety, and research pharmacy services.
Dr. Hoffman received both his Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees from the Philadelphia College of Pharmacy. In addition, he received a Master of Science degree in pharmacy administration from the University of Wisconsin-Madison. He also completed a residency in pharmacy administration and a fellowship in outcomes research at the University of Wisconsin Hospital and Clinics.
Dr. Hoffman is a Board Certified Pharmacotherapy Specialist (BCPS). He is an active member of the American Society of Health-System Pharmacists (ASHP), including serving on the Council on Pharmacy Practice, in the ASHP House of Delegates, and on the editorial board of the American Journal of Health-System Pharmacy (AJHP). He is currently a Director-at-Large for the Section of Pharmacy Practice Managers Executive Committee. Additionally, he has served on committees for other national organizations, including the National Quality Forum and the National Comprehensive Cancer Network (NCCN). In 2011, he served on the NCCN biosimilars work group, and he was the senior author of the group’s white paper on biosimilars published in the Journal of the National Comprehensive Cancer Network. Dr. Hoffman also has extensive experience analyzing various aspects of medication use and policy. Since 2004, he has been a lead author of the annual special feature in AJHP that projects medication expenditures.
Disclosure Statement
In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on presentations.
All faculty and planners for ASHP education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.
The following faculty and planners have no relationships pertinent to this activity.
James M. Hoffman, Pharm.D., M.S., BCPS
Sylvia Q. Banzon, B.A., CPhT, CQIA, HACP, PMP, TFCSHP
Edna Bowser, CPhT
Rebecca B. Brewer, CPhT
Al Carter, Pharm.D., M.S.
Angela Cassano, Pharm.D., BCPS, FASHP
Donna Hamilton, R.Ph, MBA
Mary McHugh, R.Ph.
Bradley Miller, CPhT, PhTR
Erin M. Ryman, B.S., CPhT
Rita Shane, Pharm.D., FASHP, FCSHP
Angela Triggs, R.Ph.
ASHP staff has no relevant financial relationships to disclose.
Methods and Format
This activity is available in three formats:
- Web-Based CE. An online activity consisting of audio and slides (optional PDF handout with slides):
Launch Presentation - Podcast. An audio-only version of the presentation that can be downloaded to your computer or portable MP3 player (optional PDF handout with slides)
Launch Podcast - Monograph. E-publication
Launch Monograph
Participants must complete the entire activity, take the activity assessment and evaluation to receive continuing education credit. A minimum score of 70% is required on the test for credit to be awarded. A copy of the assessment test is provided as a study aid in the handout. CE credit will be reported directly to CPE Monitor. The estimated time to complete this activity is 1 hour (allow additional time to complete the assessment and evaluation).