© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings InstitutionImportance of Postmarket Safety Surveillance• All products have some risk• Monitor drugs ...
© 2012, The Brookings InstitutionSentinel Initiative: Public-Private Collaboration• Established by FDAAA (2007)• Requires ...
© 2012, The Brookings Institution       Timeline of the Sentinel Initiative                                          Feder...
© 2012, The Brookings Institution      Mini-Sentinel Partner Organizations                                                ...
© 2012, The Brookings InstitutionMini-Sentinel’s Distributed Data System               Source: U.S. Food and Drug Administ...
© 2012, The Brookings InstitutionExample of a Mini-Sentinel Assessment• Potential “signal” identified from FDA reports tha...
© 2012, The Brookings Institution      Cases of Celiac Disease in Users of Angiotensin II      Type 1 Receptor Blockers (A...
© 2012, The Brookings InstitutionOverview of Brookings Convening Activities      Activity              Description        ...
© 2012, The Brookings InstitutionPatient and Consumer Engagement ExpertWorkshop Participating Organizations•   AARP       ...
© 2012, The Brookings InstitutionPatient and Consumer Engagement ExpertWorkshop Objectives• Provide meeting participants w...
© 2012, The Brookings InstitutionPatient and Consumer Engagement ExpertWorkshop Key Takeaways• Educating the public about ...
© 2012, The Brookings InstitutionOpportunities for public engagement• FDA’s Office of Special Health Issues activities• Br...
© 2012, The Brookings InstitutionThank you!             14
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
© 2012, The Brookings Institution   FDA’s Sentinel Initiative andOpportunities for Public Engagement                      ...
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Daniel, greg brookings presentation cue meeting_20120601

  1. 1. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  2. 2. © 2012, The Brookings InstitutionImportance of Postmarket Safety Surveillance• All products have some risk• Monitor drugs throughout the product’s lifecycle• At the time of approval, clinical trials have demonstrated that the benefits of the product outweigh risks• Once the product is on the market, the product is used in more patients and in a more diverse population than was tested in clinical trials• With broader use, can also detect rare adverse events 2
  3. 3. © 2012, The Brookings InstitutionSentinel Initiative: Public-Private Collaboration• Established by FDAAA (2007)• Requires FDA to collaborate with public and private holders of data on medical product use and outcomes on a common strategy and methods for broad-based active surveillance• Set milestones for capacity for active surveillance: data drawn from care of 25 million patients by 2010, 100 million patients by 2012• 4 activities: – Mini-Sentinel – Observational Medical Outcomes Partnership – Federal Partners Collaboration – Brookings Convening Activities 3
  4. 4. © 2012, The Brookings Institution Timeline of the Sentinel Initiative Federal Partners Food and Drug Collaboration launched Mini- Mini- Amendments Sentinel Sentinel Act (FDAAA) able to able to FDA awards Brookings query data query data convener grant from 25 from 126 OMOP million million launched FDA awards HPHC Mini- people people Sentinel contract2007 2008 2009 2010 2011 2012 FDA awards 8 small project contracts Assessment Rapid evaluation Sentinel Initiative initiated: of drugs for announced myocardial smoking infarction and oral cessation and hypoglycemics cardiac outcomes
  5. 5. © 2012, The Brookings Institution Mini-Sentinel Partner Organizations 5 Institute for HealthSource: Mini-Sentinel
  6. 6. © 2012, The Brookings InstitutionMini-Sentinel’s Distributed Data System Source: U.S. Food and Drug Administration 6
  7. 7. © 2012, The Brookings InstitutionExample of a Mini-Sentinel Assessment• Potential “signal” identified from FDA reports that olmesartan might cause more celiac disease than other drugs in its class• Mini-Sentinel question: How many patients taking olmesartan had developed celiac disease compared to those taking other similar drugs for high blood pressure? Source: U.S. Food and Drug Administration 7
  8. 8. © 2012, The Brookings Institution Cases of Celiac Disease in Users of Angiotensin II Type 1 Receptor Blockers (ARBs) 0.080 Cases per 100 person 0.070 0.060 0.050 years 0.040 0.030 0.020 0.010 0.000 LOSARTAN IRBESARTAN OLMESARTAN TELMISARTAN VALSARTAN Cases 63 10 17 5 50 New users 235,630 40,071 81,560 24,596 153,159 ARBs: New users after >365 day washout; Celiac Disease: 1st dx code after >365 day without diagnosis. 8Source: Mini-Sentinel
  9. 9. © 2012, The Brookings InstitutionOverview of Brookings Convening Activities Activity Description Past Topics Roundtable Webinars Highlight pilot projects • Refer to: relevant to active www.brookings.edu/health/projects surveillance Expert Workshops Focused discussions of • Methods and infrastructure technical topics • Privacy and legal issues • Communications • Sentinel strategic review • Patient and consumer engagement Implementation Senior leaders of public • Potential organizational models Meetings and private organizations • Participation of private sector data discuss strategic partners and medical product developers implementation issues Public Stakeholder Large, annual meetings provide a forum to engage the public in Workshops dialogue about the direction of Sentinel’s activities 9
  10. 10. © 2012, The Brookings InstitutionPatient and Consumer Engagement ExpertWorkshop Participating Organizations• AARP • National Alliance for Hispanic Health• AIDS Action Baltimore • National Alliance on Mental Illness• Alliance for Aging Research • National Coalition on Health Care• American Cancer Society American Pain • National Health Council Foundation Center for Democracy and • National Research Center for Women Technology and Families• Consumers Union • National Womens Health Network• Crohns and Colitis Foundation of • PatientsLikeMe America • PFO Research Foundation• Fabry Support and Information Group • Mini-Sentinel Planning Board• FasterCures • Union of Concerned Scientists• Friends of Cancer Research 10
  11. 11. © 2012, The Brookings InstitutionPatient and Consumer Engagement ExpertWorkshop Objectives• Provide meeting participants with an overview of the Sentinel Initiative;• Discuss opportunities for further patient and consumer engagement; and• Discuss concrete next steps for evolving patient and consumer engagement. 11
  12. 12. © 2012, The Brookings InstitutionPatient and Consumer Engagement ExpertWorkshop Key Takeaways• Educating the public about Sentinel: – One tool in the tool box – FDA’s avenues for communicating information about drug safety concerns – Role of third part organizations to help raise the national understanding of Sentinel• Spectrum of patient and consumer informational needs – Mini-Sentinel website vs. FDA’s Drug Safety Communications – Role of third party organizations to help patients and consumers use information appropriately 12
  13. 13. © 2012, The Brookings InstitutionOpportunities for public engagement• FDA’s Office of Special Health Issues activities• Brookings convening activities: – Annual public meeting – Webinars• Information about drug safety concerns available through FDA’s Drug Safety Communications 13
  14. 14. © 2012, The Brookings InstitutionThank you! 14
  15. 15. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  16. 16. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  17. 17. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  18. 18. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  19. 19. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  20. 20. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  21. 21. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  22. 22. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  23. 23. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012
  24. 24. © 2012, The Brookings Institution FDA’s Sentinel Initiative andOpportunities for Public Engagement Gregory Daniel Fellow, Economic Studies Managing Director, Engelberg Center for Health Care Reform The Brookings Institution 2012 CUE Annual Membership Meeting June 8, 2012

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