Activity Overview
Please read the following information about this continuing pharmacy education (CPE) activity before accessing the presentations 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 2 hours (0.2 CEUs) of continuing pharmacy education credit (ACPE activity #204-000-09-443-H03P).
Methods and Format
This is an online activity consisting of audio and slides for three presentations, a post-test, and an activity evaluation tool. Participants should claim continuing education credit for this internet-based educational activity only if they have not claimed credit for the live activity. Participants must view all presentations, take the activity post-test, and complete the course evaluation to receive continuing pharmacy education credit. A minimum score of 70% is required on the test for credit to be awarded, and participants may print their official statements of continuing pharmacy education credit immediately. The estimated time to complete this activity is 2 hours. This activity is provided free of charge.
Target Audience
This continuing pharmacy education activity was planned to meet the needs of pharmacists practicing in large and small health systems, as well as in ambulatory care, managed care, home care, long-term care, and academic settings. This activity would be particularly beneficial for pharmacists, clinical specialists, managers, decision makers, and educators who are interested in current regulatory considerations related to ensuring the safety of medications.
Activity Content
Click here to view an overview of the activity content.
Learning Objectives
After participating in this knowledge-based CPE activity, participants should be able to
- Discuss the FDA Amendments Act of 2007 (FDAAA) and implications for implementation in health systems for pharmacists and health-system pharmacy departments.
- List and discuss the components of a risk evaluation and mitigation strategy (REMS) including the factors taken into consideration by FDA in determining whether a REMS is required.
- Explain the impact of restricted drug distribution systems on patients and health systems including factors that determine the success of these systems.
- Describe the recent trends in the number of drugs with REMS requirements.
- Explain activities that are essential for pharmacists and pharmacies to manage REMS appropriately.
Faculty
James M. Hoffman, Pharm.D.,M.S., BCPSActivity Chair
Medication Outcomes and Safety Officer
St. Jude Children's Research Hospital
Memphis, Tennessee
[View Biography]
James Hoffman is Medication Outcomes and Safety Officer in the Pharmaceutical Department at St. Jude Children’s Research Hospital in Memphis, Tennessee. In his position, Hoffman leads medication use policy, medication safety, and research pharmacy services at St. Jude. Hoffman is also an assistant professor of clinical pharmacy at the University of Tennessee Health Science Center.
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 Masters 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.
Hoffman is a Board Certified Pharmacotherapy Specialist (BCPS). He is an active member of ASHP, serving on the editorial board of the American Journal of Health-System Pharmacy (AJHP) and on the Council on Pharmacy Practice. He has experience analyzing various aspects of national pharmaceutical use and policy. Since 2004, Hoffman has been the lead author of an annual AJHP publication on prescription drug expenditures. He has made local and national presentations on several topics, including biosimilars and follow on biologics, medication expenditure patterns, and medication safety.
Justine Coffey, J.D., LL.MDirector, Federal Regulatory Affairs
Government Affairs Division
American Society of Health-System Pharmacists
Bethesda, Maryland
[View Biography]
Justine Coffey is Director, Federal Regulatory Affairs, in the Government Affairs Division of the American Society of Health-System Pharmacists (ASHP). She has held this position since March of 2007. Her responsibilities include advocating ASHP’s positions on various issues before federal agencies whose regulatory and rulemaking authority impacts on health-system pharmacy. Ms. Coffey received her J.D. degree from American University, Washington College of Law and her LL.M. degree from the Georgetown University Law Center in Washington, DC.
Previously, Justine worked as a consultant, providing health policy consulting services to individual clients and advising state government agencies on federal and state laws, regulations, and policies that had an impact on Medicaid and other state programs. From 2002 to 2005, Ms. Coffey worked for the American Pharmacists Association, first as a policy and regulatory writer, and then as a senior policy analyst, which involved managing 340B Drug Pricing Program issues for the Health Resources and Services Administration Pharmacy Services Support Center.
JoAnn Stubbings, R.Ph., MCHAManager, Research and Public Policy
Ambulatory Care Pharmacy Department
University of Illinois at Chicago College of Pharmacy
Chicago, Illinois
[View Biography]
JoAnn Stubbings, R.Ph., MHCA, is Manager of Research and Public Policy in the Ambulatory Care Pharmacy Department at the University of Illinois (UIC) at Chicago College of Pharmacy. Ms. Stubbings is also Clinical Assistant Professor in the Department of Pharmacy Practice.
Ms. Stubbings is responsible for managing pharmaceutical policy issues that pertain to outpatient pharmacy services, namely healthcare reform, Medicare Part D, as well as special topics, such as Risk Evaluation and Mitigation Strategies. She chairs the Specialty Pharmacy Task Force for UIC’s Ambulatory Care Pharmacy Department. UIC has a growing specialty pharmacy practice and is experimenting with different models for both take-home and clinic-administered medications. Ms. Stubbings is also a member of the Specialty Pharmacy Task Force of the University HealthSystem Consortium in Oak Brook, Illinois.
Ms. Stubbings spent many years in the pharmaceutical industry and in managed car consulting. She brings a practical knowledge of pharmaceutical policy to her teaching and service. Her teaching portfolio includes courses in pharmacy services and reimbursement, pharmaceutical marketing, and mentoring of students and residents.She has been recognized by her students with many teaching awards. She is an advocate for health-system pharmacists and payment for pharmacy services.
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 Advantage requires that all individuals involved in the development of activity content disclose their relevant financial relationships and that conflicts of interest be identified and resolved prior to delivery of the activity.
The faculty and planners report the following relationships:
James M. Hoffman, Pharm.D., M.S., BCPS,
Dr. Hoffman declares that he has no relationships pertinent to this activity.
Justine Coffey, J.D., LL.M
Ms. Coffey declares that she has no relationships pertinent to this activity.
JoAnn Stubbings, R.Ph., MCHA
Ms. Stubbings declares that she has no relationships pertinent to this activity.
Catherine Klein, R.Ph.
Ms. Klein declares that she has no relationships pertinent to this activity.
This activity is supported by an educational grant from Roche.
Launch Presentation*
Introduction(10 minutes)
James M. Hoffman, Pharm.D., M.S., BCPS
A Primer on the FDA Amendments Act of 2007 — Implications for Pharmacists and Pharmacies(30 minutes)
Justine Coffey, J.D., LLM.
Key Components and Emerging Trends of Risk Evaluation and Mitigation Strategies (REMS)(30 minutes)
James M. Hoffman, Pharm.D., M.S., BCPS
Practical Applications, Challenges, and Opportunities in Implementing REMS(30 minutes)
JoAnn Stubbings, R.Ph., MCHA
*Allow additional time to complete the post-test and evaluation.
Download Post-Test
Click here to print the post-test for your reference. Please note that to be eligible for continuing pharmacy education credit, you must go to the ASHP Learning Center and complete the test online.
Additional Resources
For additional information about this topic or to sign-up to be notified when new resources are available,
visit http://www.ashpadvantage.com/fdaaa.
Planned and conducted by ASHP Advantage.
