HRSA s Patient Safety and Clinical Pharmacy Services Collaborative The 12th Annual 340B Coalition Conference July 15, 2

1. 1 HRSA’s Patient Safety and Clinical Pharmacy Services CollaborativeThe 12th Annual 340B Coalition ConferenceJuly 15, 2008 Denise H. Geolot, Ph.D., R.N. Director, Center for Quality Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) Collaborative Co-Director Jimmy Mitchell, R.Ph., MPH, MS Director, Office of Pharmacy Affairs HHS, HRSA Collaborative Co-Director

2. 2 What is the Collaborative? Improve health outcomes, increase clinical pharmacy services, and improve patient safety Rapid improvement method Leading practices come from the field

3. 3 The Challenge Increasing numbers of Americans with multiple chronic health conditions. Use of medications is the most common approach for the treatment of chronic conditions whose associated costs and human burden continue to grow In alignment with HRSA Core Measures, specifically in Diabetes, Cardiovascular, and HIV screening ADEs are leading cause of death and injury in the US costing billions Aging population, more medications - polypharmacy IOM: To Err is Human Literature supports use of clinical pharmacy services to improve health outcomes, enhance patient safety and create cost savings – current lack of integration Increasing numbers of Americans with multiple chronic health conditions. Use of medications is the most common approach for the treatment of chronic conditions whose associated costs and human burden continue to grow In alignment with HRSA Core Measures, specifically in Diabetes, Cardiovascular, and HIV screening ADEs are leading cause of death and injury in the US costing billions Aging population, more medications - polypharmacy IOM: To Err is Human Literature supports use of clinical pharmacy services to improve health outcomes, enhance patient safety and create cost savings – current lack of integration

4. 4 Institute of Medicine Findings on Patient Safety and Errors Medication Errors are Most Common Injure 1.5 Million People Annually Cost Billions Annually “…for every dollar spent on ambulatory medications, another dollar is spent to treat new health problems caused by the medication.”

5. 5 Why a Patient Safety & Clinical Pharmacy Collaborative? “The [Senate Appropriations] Committee further encourages HRSA to establish a pharmacy collaborative to identify and implement best practices, which may improve patient care by establishing the pharmacist as an integral part of a patient-centered, interprofessional health care team.” 2007 & 2008 Senate Appropriations Committee Reports Encourage Pharmacy Collaborative. FY 2007 and FY 2008 Senate Appropriations Committee Reports Collaboration with external and internal stakeholders Major pharmacy organizations, 340B Coalition members and others Contract with Mathmatica Policy Inc. FY 2008 Senate Appropriations Committee Report Program Management-…Committee commends HRSA for working with stakeholders to develop recommendations and implementt cost effective clinical pharmacy services to improve patient health outcomes as components of federally qualified health centers, rural hehospital programs, academic medical centers, Indian Health Service programs, Ryan White programs, and all HRSA supported programs in which medications play an integral part of patient care. The Committee looks forward to receiving a report of these activities. The Committee strongly encourages HRSA to continue to develop and implement cost effective clinical pharmacy programs in all aof the various safety net providers settings. The Committee further encourages HRSSA to establish a pharmacy collaborative to identify and implement best practices, which may improve patient care by establishing the pharmacist as an integral part of a patient-centered, interporfessional health care team. FY 2007 and FY 2008 Senate Appropriations Committee Reports Collaboration with external and internal stakeholders Major pharmacy organizations, 340B Coalition members and others Contract with Mathmatica Policy Inc. FY 2008 Senate Appropriations Committee Report Program Management-…Committee commends HRSA for working with stakeholders to develop recommendations and implementt cost effective clinical pharmacy services to improve patient health outcomes as components of federally qualified health centers, rural hehospital programs, academic medical centers, Indian Health Service programs, Ryan White programs, and all HRSA supported programs in which medications play an integral part of patient care. The Committee looks forward to receiving a report of these activities. The Committee strongly encourages HRSA to continue to develop and implement cost effective clinical pharmacy programs in all aof the various safety net providers settings. The Committee further encourages HRSSA to establish a pharmacy collaborative to identify and implement best practices, which may improve patient care by establishing the pharmacist as an integral part of a patient-centered, interporfessional health care team.

6. 6 HRSA’s Commitment Support programs to provide the best and safest care in the Nation Take previously supported Collaboratives with documented improvements to the next level

7. 7 HRSA Pharmacy Programs Pharmacy services are growing rapidly

8. 8  Improve Health Outcomes Improve Patient Safety Increase High Quality, Cost-Effective Pharmacy Services Focusing on implementing effective patient safety principles and clinical pharmacy services. Fewer errors, fewer injuries, less harm Increased compliance w/ NQF guidelines Possible reductions in size & number of tort claims Optimal utilization of clinical pharmacists and clinical pharmacy services across multiple providers of care Maximizing and enhancing medication use management Focusing on implementing effective patient safety principles and clinical pharmacy services. Fewer errors, fewer injuries, less harm Increased compliance w/ NQF guidelines Possible reductions in size & number of tort claims Optimal utilization of clinical pharmacists and clinical pharmacy services across multiple providers of care Maximizing and enhancing medication use management

9. 9 The overlap also gives us the backbone of the PSPC. We are looking for leading practices in these areas and building these practices around our team. The overlap also gives us the backbone of the PSPC. We are looking for leading practices in these areas and building these practices around our team.

10. 10 So on the ground at the sites, this is what we want to see happen. A patient enters into the system where clinical pharmacy services are delivered as a major component of car. We will then measure the results and outcomes of that integrated care through optimization of health outcomes and limiting adverse events. So what is the value in this……System improvements in pharmacy services will improve outcomes and safety for your patients across a broad range of chronic conditions. …we’re ready to go beyond improvements one disease at a time! Integrated Clinical Pharmacy Services and Improved Patient Safety Lead to Better Patient Health Outcomes AND Chronic Disease serves as a marker for detecting improvement in the system So on the ground at the sites, this is what we want to see happen. A patient enters into the system where clinical pharmacy services are delivered as a major component of car. We will then measure the results and outcomes of that integrated care through optimization of health outcomes and limiting adverse events. So what is the value in this……System improvements in pharmacy services will improve outcomes and safety for your patients across a broad range of chronic conditions. …we’re ready to go beyond improvements one disease at a time! Integrated Clinical Pharmacy Services and Improved Patient Safety Lead to Better Patient Health Outcomes AND Chronic Disease serves as a marker for detecting improvement in the system

11. 11 Evolving into the Future We’re ready to go beyond improvements one disease at a time! Evidence that system improvements in pharmacy will improve overall outcomes for patients Target high risk patients across a broad range of chronic conditions

12. 12 Milestones: We’ve Come a Long Way FastSpring 2007 – Summer 2008 Study Phase Identified High Performers Conducted 34 site visits Compiled Leading Practices Convened Expert Panel Engaged Partners Leadership Coordinating Council Sponsored State Leadership Meeting Implementation Phase Enrolled Teams Faculty Selected

13. 13 Support for Collaborative HRSA Leadership, Bureaus and Offices National Faculty and HRSA Team Leadership Coordinating Council of National Partner Organizations State-Based Organizations Again, a special thank to HRSA Leadership and Office and Bureaus for their continued support.Again, a special thank to HRSA Leadership and Office and Bureaus for their continued support.

14. 14 Who are some of Our National Partners? Apexus/Prime Vendor Program NASTAD …and many others

15. 15 Study Phase What are the leading practices? Where do they come from?

16. 16 Primary criteria Clinical outcomes data - EVIDENCE Data demonstrating effectiveness of their patient safety and pharmacy services Innovative patient safety and pharmacy services models Implemented in outpatient primary care settings Secondary criteria Regions which had clusters of 3–4 organizations that met the above criteria Regional representation Site Selection Criteria

17. 17 Site Visits 34 Sites included in the sample Site visits with 30 high-performing organizations in 7 regions of the country Telephone visit with 4 organizations in additional regions

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19. 19 Wouldn’t you want to implement a service that gets these kinds of comments from providers and patients? And someone that produces the outcomes you see here today? Clinical Pharmacy Services added to the health care team improve patient safety and health outcomes. The details of the strategies described here are in the change package the PSPC is finalizing. Enroll your teams and let the change package guide you to implementing services that improve patient care! Wouldn’t you want to implement a service that gets these kinds of comments from providers and patients? And someone that produces the outcomes you see here today? Clinical Pharmacy Services added to the health care team improve patient safety and health outcomes. The details of the strategies described here are in the change package the PSPC is finalizing. Enroll your teams and let the change package guide you to implementing services that improve patient care!

20. 20 Organization Types

21. 21 Characteristics of Participating Organizations

22. 22 Site Observations

23. 23 High Performer Joshua Feldmann, RPh, PharmD Mercy Family Pharmacy

24. 24 How did we capture the leading practices from the sites?

25. 25 What would a change package look like when we take stock of everything we observe to be working and map it out?What would a change package look like when we take stock of everything we observe to be working and map it out?

26. 26 The Change Package Menu of Promising Action Items for Testing and Adapting for Use by Teams in Their Home Settings How are we going to do this? A menu of recipesHow are we going to do this? A menu of recipes

27. 27 What’s In a Change Package? Strategies Plans for Achieving an End: System-Wide Improvement Change Concepts Approaches Found to Be Useful in Developing Specific Ideas for Changes That Lead to an Improvement Action Steps Specific Ideas to Implement Each Change Concept What exactly is this “Change Package”? How do we organize all this information? Strategies Each Change Concepts includes a recipe of action steps Action Steps are nuts and bolts of making substantive shifts in how we deliver careWhat exactly is this “Change Package”? How do we organize all this information? Strategies Each Change Concepts includes a recipe of action steps Action Steps are nuts and bolts of making substantive shifts in how we deliver care

28. 28 What Forms the Basis for the Change Package? Existing Research & Literature Leading Practices of High Performers Expert Panel Experiences of Collaborative Teams We’re mining the information that’s already published Investigating real world examples through site visits Then we’re going one step beyond that – we’ve found that improvements in the real-world are valuable because the data show they work. Teams will modify/refine as they use the Change PackageWe’re mining the information that’s already published Investigating real world examples through site visits Then we’re going one step beyond that – we’ve found that improvements in the real-world are valuable because the data show they work. Teams will modify/refine as they use the Change Package

29. 29 Data Analysis Qualitative data analysis software Themes and strategies coded using inductive analysis techniques Change Package content updated iteratively Nine versions of the Change Package presented by the study team Each version increased in specificity and clarity

30. 30 Strategies: What We’ve Learned Leadership Commitment: Develop organizational relationships that promote safe medication-use systems and optimal health outcomes Measurable Improvement: Achieve change using the value and power of data- driven improvements Integrated Care Delivery: Build an integrated health care system across providers and settings that produces safety and optimal health outcomes Safe Medication Use Systems: Develop and operate by safe medication-use practices Patient-Centered Care: Build a patient-centered medication-use system Within these five strategies we are proposing change concepts -Saw them across all or 5/6 visited sites, -with evidence that they are linked to success. First cutWithin these five strategies we are proposing change concepts -Saw them across all or 5/6 visited sites, -with evidence that they are linked to success. First cut

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32. 32 The Work of the Collaborative Create Expectation That Each Team Begins by Addressing a Change Concept Under Each Strategy Use the Improvement Model (Plan/Do/Study/Act) to test specific actions in their environment

33. 33 Implementation Phase Q: How do we spread these leading practices? A: TEAMS with support from FACULTY

34. 34 Who Are the Faculty? Majority are from leading practice sites from study phase Mix of leaders, physicians, pharmacists, nurses, and others Innovators and “early adapters” Voice of the Change Package Peer leaders to inspire change by showing the way

35. 35 Examples of other possible team members include outpatient ambulatory care clinicians and leaders, HIV and Women’s Health Organizations, state and local health departments, social services, mental health, home care and other non-physician staff who participate as part of an extended primary healthcare team. Examples of other possible team members include outpatient ambulatory care clinicians and leaders, HIV and Women’s Health Organizations, state and local health departments, social services, mental health, home care and other non-physician staff who participate as part of an extended primary healthcare team.

36. 36 Team Participants ~ 91 teams Over 300 organizations Teams average 3+ organizations Over 500 participants will participate in the Learning Sessions

37. 37 Team Participants 42 states represented (including HI and PR) 7 teams from Massachusetts 5 each: Ohio New Jersey Louisiana All geographic areas represented

38. 38 Participating Teams

39. 39 Team Examples: Target Populations

40. 40 Team Configuration Examples CHC + Disproportionate Share Hospital + Rural Health Clinic + Community Pharmacy HIV Clinic + Critical Access Hospital + Women’s Health Clinic Multiple CHCs + Disproportionate Share Hospital and their associated clinics Rural Health Clinic + Hospital + School/College of Pharmacy

41. 41 Opportunity or Risk? What are the constants? one example of a flow for a patient ... with diabetes (walk them through the steps)What are the constants? one example of a flow for a patient ... with diabetes (walk them through the steps)

42. 42 What are the constants? what do all the steps have in common? --- prescription writing!!What are the constants? what do all the steps have in common? --- prescription writing!!

43. 43 RISK What are the constants? why are these conditions for a disaster?What are the constants? why are these conditions for a disaster?

44. 44 OPPORTUNITY a solution to the hand off reality could be .... self-management and clinical pharmacy services. This is only one of many ways you could map this out.a solution to the hand off reality could be .... self-management and clinical pharmacy services. This is only one of many ways you could map this out.

45. 45 Teams Include: Clinical pharmacists Nurses Physicians Other primary care clinicians QI staff Administrators Senior Leaders More!!

46. 46 The goals and work of the collaborative and engage senior leader support. Work to align with other community partners who care for the same patients to work across organizations to address improved medication use systems. Support travel team to participate in four learning sessions and provide release time for day-to-day work of the collaborative. Measure and track progress, test improvement opportunities, share successes and learnings, and implement evidence-based improvements. Commit to the overarching Aims of the Collaborative Commit time and effort to testing and adapting changes Attend all 4 Learning Sessions (some may be State or Regional) and pay for their travel Measure and track progress and share activities and results with their senior leaders and other teams Bring all organizations on a given team in alignment and action around continuity of care Bring their organizations’ senior leader(s) to a designated Learning Session The goals and work of the collaborative and engage senior leader support. Work to align with other community partners who care for the same patients to work across organizations to address improved medication use systems. Support travel team to participate in four learning sessions and provide release time for day-to-day work of the collaborative. Measure and track progress, test improvement opportunities, share successes and learnings, and implement evidence-based improvements. Commit to the overarching Aims of the Collaborative Commit time and effort to testing and adapting changes Attend all 4 Learning Sessions (some may be State or Regional) and pay for their travel Measure and track progress and share activities and results with their senior leaders and other teams Bring all organizations on a given team in alignment and action around continuity of care Bring their organizations’ senior leader(s) to a designated Learning Session

47. 47 Team Example Tracey Cole, RPh Pharmacy Director Holyoke Health Center

48. 48 How Does the PSPC Create Improvements? 16 month rapid learning model Focused on improving health outcomes Led by an expert faculty and national leaders Creates community of learning Learning Sessions and Action Periods are venues for change Improvements are tracked and shared for mutual benefit 18 month rapid learning model Creates a community of learning, bringing together inter-professional teams from multiple organization types Focuses on improving health outcomes by focusing on improved patient safety and clinical pharmacy services. Collaborative learning is accomplished by using learning sessions, action periods, Web training and listservs to measure, report and track improvement. Led by an expert faculty poised to help test and implement successful practices.18 month rapid learning model Creates a community of learning, bringing together inter-professional teams from multiple organization types Focuses on improving health outcomes by focusing on improved patient safety and clinical pharmacy services. Collaborative learning is accomplished by using learning sessions, action periods, Web training and listservs to measure, report and track improvement. Led by an expert faculty poised to help test and implement successful practices.

49. Learning Collaborative Process

50. 50 This is not a research project but an improvement project.This is not a research project but an improvement project.

51. 51 Repeated Use of the PDSA Cycle As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent. As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent.

52. 52 Repeated Use of the PDSA Cycle As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent. As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent.

53. 53 Repeated Use of the PDSA Cycle As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent. As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent.

54. 54 Repeated Use of the PDSA Cycle As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent. As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent.

55. 55 Repeated Use of the PDSA Cycle As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent. As you can see, multiple PDSA cycles are needed to test a single change. When a change is tested with multiple PDSA cycles, each cycle brings the change a little closer to being a permanent part of how things are done As we learn more from each test our ability to predict its results gets better. When it is possible to predict the results and it’s the result we want, it is time to consider making the change permanent.

56. 56 Key Benefits of Team Participation in the PSPC It’s the Right Thing to Do for the Patients We Serve Safer More and improved Clinical Pharmacy Services Improved Health Outcomes Reduces and Manages Risk Builds on and Takes Prior Experience to a New Level Works across organizations in a community Goes beyond improvements in one disease state

57. 57 Key Benefits of Team Participation in the PSPC Gain expertise in creating linkages and partnerships across organizations using patient-centered approach Exposure to Cutting Edge People and Methods on Quality Improvement, Leadership & Change Management Chance to Be A Part of a Major National Movement in a Rewarding All Teach, All Learn Environment Access to expert faculty and technical assistance to develop and test high leverage changes

58. 58 The Work of the Collaborative Teams are Major Locus of Change Change Package is Recipe Book for Change Strategies – Change Concepts – Action Items Plan – Do – Study – Act cycles for creating change Introduced and Led by a Faculty of Their Peers Drawn from the field Articulate leading practices that get results Change Package is dynamic Each team is a locus of change for their community of practice Fine-tuned and fluidChange Package is dynamic Each team is a locus of change for their community of practice Fine-tuned and fluid

59. 59 What to Remember….. Improve health outcomes, increase clinical pharmacy services, and improve patient safety Rapid Improvement Approach Leading practices from field

60. 60 Timeline July 2008: Faculty Meeting August 2008: Learning Session 1 Fall 2008: Action Period 1 December 2008: Learning Session 2 Winter 2008-09: Action Period 2 Spring 2009: Learning Session 3 Summer 2009: Action Period 3 Fall 2009: Learning Session 4 Improved Patient Outcomes!

61. 61 PSPC Information HRSA Website www.hrsa.gov/patientsafety Questions? patientsafety@hrsa.gov HRSA Knowledge Management System www.healthdisparities.net