ISPOR RISK BENEFIT MANAGEMENT SPECIAL INTEREST GROUP (RBM)

CHAIR
Dennis Raisch PhD, RPh, Professor, College of Pharmacy, University of New Mexico

GOAL
Identify and describe the links between RBM and health outcomes research in public policy and health care decision-making to assure the safe and effective use of pharmaceutical products and devices.

Risk Benefit Management SIG Activities and Accomplishments

CURRENT PROJECTS

• Risk Benefit Monitoring Worldwide Working Group
  Chair: Jayashri Sankaranarayanan PhD
  Team members: Arthi B. Chandran MPH, BA; Roland Marcus BS; Sanjoy Roy PhD; Ashish Parekh BS, MS; Alfred Sackeyfio RPh, BSc
  Description: An overview of current websites of regulatory agencies worldwide that provide guidelines and policies for RBM monitoring.
  
  
• Metrics & Methodologies to Quantify Risks & Benefits Working Group
  Co-Chairs: John Doyle DrPH; Jeff J. Guo BPharm, PhD
  Team members: Brett Hauber PhD; Shital Kamble MS, MMS, PhD(c); Yvonne Lis PhD; Wendy Toler PharmD, PhD(c)
  Description: There is a lack of standardized metrics/methodologies to quantify risks & benefits. Paper will discuss the quantitative methods, their limitations, address problems, such as feasibility given the limitations and new developments toward a standard metric.
  
  
• Direct to Consumer Advertising (DTCA) and its Relationship to Risk Benefit Management Working Group
  Chair: Ashish Parekh BS, MS
  Team members: Joyce Addo-Atuah PhD; Ibrahim Al-Abbadi PhD, MBA, Bpharm; Rodrigo Deantonio MD, MSc; Roland Marcus BS; Alfred Sackeyfio RPh, BSc
  Description: Opinion review on how RBM is incorporated into DTC. These papers will discuss direct to consumer advertising in light of the recent FDA guidelines and clarify the effect DTCA has on communicating risks and benefits to patients and how this would impact the patient-provider interaction. This group is developing three manuscripts for publication:

1. DTCA information channels MS
   Authors: Alfred Sackeyfio RPh, BSc; Joyce Addo-Atuah PhD; Ashish Parekh BS, MS
   Topic: Compare and contrast the channels by which consumers to receive prescription information.
2. DTCA Patient-Provider MS
   Authors: Rodrigo Deantonio MD, MSc; Roland Marcus BS
   Topic: How patient-provider relationships have changed as a result of DTCA.
3. DTCA Effectiveness MS
   Authors: Ibrahim Al-Abbadi PhD, MBA
   Topic: Compare the effect of DTCA and its effectiveness in markets where it is permitted (USA, New Zealand) vs. markets where it is not allowed (EU).

• A Comparison Across Industries of Risk Benefit Management Practices Working Group
  Chair: Tony Lockett MD, PhD, MBA
• Head to Head comparison of EMEA to US RBM Guidelines Working Group  
  Co-Chairs: Yvonne Lis PhD; Jeff J. Guo, BPharm, PhD; Tony Lockett MD, PhD, MBA
• Risks and Benefits of Health Care Treatments and Policies:  Appraisals by Experts in Health Outcomes Research Working Group
  Chair: Dennis Raisch PhD, RPh