FDA and BBCIC Approaches to Modernizing Post-Market Drug Safety Surveillance

ACPE UAN #:  0233-0000-16-058-H04-P 

Release Date: December 19, 2016

Expiration Date:  October 5, 2019

Activity Type:    Knowledge-based

Contact Hours:  1.5

Activity Fee:  Member:  $15        Non-Member: $30

Target Audience: Pharmacists who practice in managed care settings.

Activity Overview

The Food and Drug Administration (FDA) and the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) recognize the importance of monitoring approved drugs for post-marketing safety and effectiveness. In fact, the FDA is rapidly modernizing its surveillance tools to better monitor, detect, and communicate these safety issues. Furthermore, the BBCIC will draw on these FDA infrastructure improvements. 

This session will help managed care decision makers understand how the FDA’s and BBCIC’s work will address the current information needs of physicians and patients. In addition, they will be introduced to modern surveillance techniques, including such recent advances as Active Risk Identification and Analysis (ARIA) component of the Sentinel System, Tree Scan and other new approaches to pattern discovery, and the use of social media in adverse event monitoring. 

Learning Objectives:  

At the completion of this activity, participants should be able to:

  1. Discuss the FDA’s regulatory framework for post-marketing drug safety monitoring.
  2. Describe the FDA’s two main post-marketing data systems, the FDA Adverse Event Reporting System (FAERS) and the Sentinel System, as well as efforts to modernize post-marketing drug safety monitoring.
  3. Explain how the FDA is exploring other types of “real-world evidence” to enhance post-marketing drug safety monitoring.
  4. Discuss the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) active surveillance plan and how it will address physician and patient biosimilar information needs.

Schedule of Educational Activity

This activity consists of an audio recording, pre-test assessment questions (not required to pass or continue), post-test questions (required to pass with a score of 70% or higher) and a specific activity evaluation. 

CPE Requirements:   

Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at AMCP Nexus 2016. 

CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor.  Please allow 72 hours for processing and posting in your NABP account.

To receive credit for an online activity you must:

  • Review the full content of the activity.
  • Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
  • Complete a specific activity evaluation.

System Technical Requirements/Viewing Requirements: System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities you should have a basic comfort level using a computer and navigating web sites.  View the minimum technical and system requirements for continuing education online learning activities.

The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

As an accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of continuing pharmacy education (CPE) activities.  It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias.

Mary C. Baker, PharmD, MBA
Senior Director, Payer and Channel Marketing
Philadelphia, Pennsylvania

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-16-058-H04-P 1.5 Contact Hours October 05, 2016 - October 05, 2019