Implementation of Risk Minimization Action Plans (RiskMAPs) to Support
Quality Use of Pharmaceuticals: Opportunities and Challenges
June 25-26, 2007

The Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA) are announcing a 2-day joint public workshop entitled "Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges.'' This public workshop is intended to seek constructive input from a wide range of stakeholders, including clinicians, pharmacists, patients, third party payers of care, the pharmaceutical and biotechnology industries, researchers, and innovators in health information technology, to help in the development and implementation of mechanisms to minimize the risks of pharmaceuticals with unusual safety and patient monitoring concerns.

• When: June 25 and 26, 2007, from 8:30 a.m. to 5 p.m.
• Where: The public workshop will be held at the Agency for Healthcare Research and Quality (AHRQ), 540 Gaither Rd., John M. Eisenberg Bldg., Rockville, MD 20850.
  • Map and Directions
    
• Federal Register notice [PDF] [HTML]
• Meeting Agenda
• Summary of Public Workshop
• Transcripts [Day 1 ] [Day 2 ]
• Presentations
  • An Overview of RiskMAPs, Mary Willy, Ph.D., FDA
  • Improving Drug Safety: A systems approach, Brian L. Strom, M.D., M.P.H., University of Pennsylvania
  • Panel 1: Patient Advocacy/Consumer Groups, Terry Toigo, R.Ph., M.B.A., FDA
    • RiskMaps - Multiple Myeloma, Ken Makowka, Multiple Myloma Support Group
    • Implementation of RiskMAPs to Support Quality Use of Pharmaceuticals: Opportunities and Challenges, Cheryl Bloom, former moderator, MS internet support forum
  • Panel 2: Providers and Payers Perspective
    • Payer Perspectives on Improving Medication Safety, Carole Flamm, M.D., M.P.H., Blue Cross Blue Shield Assoc.
    • The Kaiser Permanente Approach for Implementing Quality, Outcomes Based Prescription Drug Use, Richard A. Wagner, Pharm.D., Kaiser Permanente
    • Smart ePrescribing (eRx): Some lessons from the Department of Veterans Affairs, Peter Glassman, MBBS, M.Sc., Veteran’s Administration
    • Primary Care and the RiskMAP System: The Diamond-Coal Interface? Wilson D. Pace, M.D., American Academy of Family Physicians
  • Panel 4: Industry Perspective
    • RevAssist & S.T.E.P.S. Risk Management Strategies: Experience and Perspective, John Freeman MSc BSc LLB (Hons), Celgene Corp.
    • Tysabri (natalizumab) Risk Management Plan, Carmen Bozic , MD, Biogen Idec Inc
  • Panel 5: Evaluation Perspective
    • Challenges in the Evaluation of RiskMAPs, Anne Trontell, M.D., M.P.H., AHRQ
    • Evaluating the Dofetilide Risk Management Program, Nancy M. Allen LaPointe, PharmD, Duke University
    • Optimizing Use of Drugs-UPHS Drug Use and Effects Program, Brian L. Strom, M.D., M.P.H., University of Pennsylvania
    • Evolution of the WBC Monitoring Program for Clozapine, Judith A. Racoosin, M.D., M.P.H., FDA
  • Panel 6: Research and Possible Future Directions for Risk Management Tools
    • Lessons Learned from Drug-Drug Interactions: Implications for risk management, Daniel C. Malone, R.Ph., Ph.D., University of Arizona
    • Effective Healthcare Information Technology to Improve Medication Safety, Steven R. Simon, M.D., M.P.H., HMO Research Network CERTs
    • European Medicines Agency Risk Management Systems, Murray M. Lumpkin, M.D., FDA
    • RiskMAPs, Jean Slutsky, AHRQ
  • Panel 7: Summary
    • Implementation of Risk MAPs: Summary of Day One Hugh Tilson, M.D., M.P.H., Dr.P.H., CERT
    • Implementation of Risk MAPs: Cross cutting issues from both days , Hugh Tilson, M.D., M.P.H., Dr.P.H., CERT
  • Public Session
    • Implementation of Risk Minimization Action Plans to Support Quality Use of Pharmaceuticals: Opportunities and Challenges, Richard Gliklich, M.D.
    • Economic tool - compliance required as criteria for drug reimbursement from national health insurance in Taiwan, Li-Ling Liu
    • Lessons Learned in the Design and Implementation of Opioid RMPs, Patricia Robinson, M.D., MS; Aparna Mohan, M.D., Ph.D., Johnson and Johnson

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Date created: May 24, 2007; updated September 18, 2007

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