Strategic Thinking in Pharmacy Clinical Affairs

1. Strategic Thinking in Pharmacy Clinical Affairs James G. Stevenson, PharmD, FASHP Professor and Associate Dean for Clinical Sciences Chair, Department of Clinical, Social and Administrative Sciences University of Michigan College of Pharmacy Chief Pharmacy Officer University of Michigan Health System

2. Creating the Future of Pharmacy and Healthcare • Clinical sciences and practice • 10-15 year time horizon • Rapidly changing healthcare environment and financing • Recognition of significant problems in the quality and safety of medication use • Rapidly evolving clinical and translational science • Disclaimer

3. Genetic Individualization of Drug Therapy • Pharmacogenomics • Goal to optimize efficacy and safety through understanding human genetic variability and its influence on drug response • Single gene and polygenic models • http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm • Over 110 drugs with labeled genomic markers • Significant opportunities • Clinician education • Clinical translational research • Application of results in clinical setting • Creation of pharmacogenomic testing and drug use policy

4. New Models of Care • Improved coordination across hospitals, health systems, community providers (including community pharmacies) • Projections for physician shortages to intensify over the next 15 years while aging population with health insurance will increase • Increase in team-based care • Increase in scope of practice of nurses, PAs, pharmacists (collaborative practice agreements and interdependent practice) • Increased transparency of results and costs

5. Transforming Healthcare Delivery • Significant financial pressures for long term sustainability of health care and global competitiveness • Emergence of bundled payment systems • Expanded health coverage of the population • Focus on payment for better results/quality • Value-based Purchasing • Clinical Process Indicators – largely medication-related • HCAHPS- Hospital Consumer Assessment of Healthcare Providers and System • Patient-Centered Medical Home Models • Accountable Care Organizations

6. VBP Opportunities for the Pharmacist • Process of Care/HCAHPS • Readmissions and 30-Day Mortality • Impact of evidence-based medication use (AMI, HF, PNE) • Hospital Acquired Conditions • Falls and Trauma (inappropriate medication use) • Manifestations of Poor Glycemic Control (hyperglycemia management) • CAUTI, CLABSI (antimicrobial stewardship) • Future measures proposed for potential VBP inclusion • Immunization (Pneumococcal and Influenza) • Healthcare Provider (HCP) Influenza Immunization Rates • Venous Thromboembolism (VTE) Measures (medication use) • Stroke Measures (STK) (medication use) • Clostridium difficile rates (antimicrobial stewardship) *Pain Management, Communication about Medications

7. Patient-Centered Medical Home (PCMH) AHRQ Definition • Patient-centeredThe primary care medical home provides primary health care that is relationship-based with an orientation toward the whole person. • Comprehensive careProviding comprehensive care requires a team of care providers. This team might include physicians, advanced practice nurses, physician assistants, nurses, pharmacists, nutritionists, social workers, educators, and care coordinators. ..linking themselves and their patients to providers and services in their communities. • Coordinated care The primary care medical home coordinates care across all elements of the broader health care system. Such coordination is particularly critical during transitions • Superb access to care • A systems-based approach to quality and safety AHRQ recognizes the central role of health IT in successfully operationalizing and implementing the key features of the medical home

8. Accountable Care Organizations (ACO) ACO Patient Centered Medical Home (Primary Care) Specialty Areas Inpatient Care and Transitions of Care Apply principles from PCMH and extend to specialty care/areas; integrate with inpatient care and transitions

9. Accountable Care Organizations (ACO)Shared Savings Program • Providers agree to be accountable for quality and cost of care for beneficiaries • ACO shares in the savings it achieves if it meets specified quality measures and cost controls targets • Demonstration projects have shown that with integrated approaches and coordination, significant reductions in cost of care can be realized

10. Key Strategies Considered by ACOs • Treat patients in best location • Utilize best practice guidelines • Utilize the expertise of team-based care • Avoid unnecessary admissions • Enhance data integration between providers/hospitals in all sites of care • Focus on chronic care of populations • Focus on preventative care, screenings, and wellness • Improve transitions of care

11. Importance of Medications • At least 2/3 of physician visits result in prescription medication • Chronic diseases managed primarily by drug therapy • Medicare beneficiaries have high utilization of medications and multiple chronic conditions • Medications major problem at transitions • Suboptimal use of medications can lead to excess costs in care, hospital admissions, ED visits

12. Key Medication-Related Measures in CMS Demonstration Project (Pioneer) • Diabetes • hemoglobin A1c • LDL • BP • Aspirin use • Controlling high blood pressure • Ischemic vascular disease • LDL • Aspirin use • Heart failure • Beta-blocker therapy for left ventricular systolic dysfunction • Coronary artery disease • Drug therapy for lowering LDL • ACE inhibitor or ARB for CAD and diabetes and/or LVSD • Influenza and pneumococcal vaccination

13. The Role of Pharmacists in ACOs • Critical role in assuring optimal outcomes related to medications: • Ensuring appropriate medication use • Reducing adverse drug events • Improving transitions of care • Preventing hospital readmissions • More optimal management of chronic conditions with lower total costs • Poorly developed in most ACOs currently

14. Pharmacist Integration into PCMH/ACO at UM • Developed a systematic and standardizedpharmacy practice model to provide comprehensivepatient care • Established collaborative practice agreements with physicians • Performing patient assessments • Ordering drug therapy-related lab tests • Administering drugs • Selecting, initiating, monitoring, continuing, discontinuing, and adjusting drug regimens • Developed new billing structure and process for service reimbursement

15. UM Pharmacist Practice Model • Embedded pharmacists in primary care clinics • Patient recruitment • Physician referral • Site-specific disease registries • Targeted interventions without referral • Collaborative practice agreements with delegated prescriptive authority • Diabetes, hypertension, hyperlipidemia • Scheduled patient visits/consults • Clinic visits (30 minutes) • Phone consults (15 – 30 minutes)

16. Therapeutic Interventions by Pharmacists (PCMH) Year 3: 2,674 interventions

17. Example of Impact on Clinical Measures • Diabetes Management by pharmacists • Results during Year 1 (ramp up) • Patients with baseline A1c > 7% (n=270) had a mean decrease of 0.8% (95% CI 0.6 to 1.0, p<0.001) • Patients with baseline A1c > 9% (n=118) had a mean decrease in A1c of 1.4% (95% CI 1.1 to 1.8, p<0.001)

18. Large Number of Medications in High Cost Patient Population Average number of medications Annual Health Care Cost

19. Opportunity to Develop Significant Pharmacist Roles • Pharmacists should be actively engaged within their health-system’s ACO initiatives • Pharmacists should be an integral part of providing team-based care (right person doing the right jobs) • Selection of most appropriate regimen • Modifying regimens as needed to achieve goals • Patient education/patient empowerment • Enhancing medication adherence • Targeted interventions for high risk populations • Create linkages between community pharmacy and health-systems and physician organizations

20. Opportunity to Develop Significant Pharmacist Roles • Create new services or expand existing programs • Chronic disease management • Polypharmacy • Adherence • Transitions of care • Educational needs of patients • Medication access issues • Case management of high risk populations • Impact clinical process of care measures, readmissions • Need for robust measurement of impact and dissemination of results (CSAS faculty)

21. New Payment Models • Bundling of physician, hospital payments; bundling of payments around acute events • Incenting improved quality and efficiency (pay for performance) • Improving population health • Paying for cost-effective treatments and services • Are we preparing our future practitioners with skills in quality improvement, population management, pharmacoeconomics and outcomes research?

22. Focus on Specialty Pharmacy Programs • Expensive, typically biologically derived, complex, and often injectable • Fastest growing segment of prescription drug spend (24% by dollar volume in 2011) • Restricted distribution results in fragmentation of care (not consistent with ACO principles) • Reimbursement and patient out-of-pocket challenges • Entry of biosimilars into the US market • Pharmacists in team-based care to improve clinical management, promote best outcomes, as well as generate margin for health system

23. Health Informatics and Automation • Improved HIT to improve care (“big data”) • Safety goals will not allow reliance on pharmacist “judgment” and human performance to the degree accepted today • Drug information provider role minimized – interpretation, application, and policy development role enhanced • Clinical decision support tools need to be enhanced/customized to realize benefits of significant national investments in HIT • Increased use of robotics, automation, end-product testing to improve safety • Are we preparing our future pharmacists adequately to utilize informatics and automation? • Where is the science behind the decisions being made with HIT related to medication use?

24. Significant Changes in Community Pharmacy Practice • Major changes in drug distribution models • Central fill • Expanded use of technicians/technology • 3rd class of drugs (e.g. ACOG recommendation on oral contraceptives) • Understanding of problems at transitions of care • ACO and PCMH models need to create effective hand-off’s and capacity to manage large numbers of patients • Explosion in point of care testing • Recognition of community pharmacist as a resource in improving population health • Need collaborative practice agreements, EHR access, documentation standards, new payment models that encourage coordination of care plans and goals

25. Renewed Interest in Sterile Products Compounding Practices • Morbidity and mortality from inadequate sterile compounding practices (e.g. NECC) • Increased focus on patient safety • Increased awareness of risks of hazardous drugs and biological therapies to healthcare workers • Commercialization of human gene therapies likely to be managed by pharmacy

26. Aligned Missions of Academic Medical Centers and Colleges of Pharmacy UMHS Mission • Excellence and Leadership in: • Patient Care/Service • Research • Education UM COP Mission • To prepare students to become pharmacists …who are leaders in any setting. The College achieves its mission by striving for excellence in education, service and research, all directed toward enhancing the health and quality of life of the people of the State of Michigan, the nation and the international community.

27. Best Practices for School of Pharmacy in Academic Health System • Integrate leadership with mutual goal setting -tripartite mission in mind; interdependence • Utilize faculty to develop new programs and to evaluate impact; disseminate best practices • Utilize health system resources to expand and hard-wire new programs • Integrate students and residents into pharmacy practice models • Work collaboratively to create models of team-based care (ACO, PCMH, etc.) • Utilize expertise to manage drug use policy issues for university employees and retirees; assure success of health system in new healthcare environment

28. Summary of Opportunities • Pharmacogenomics – clinical and translational science • Developing pharmacist role and demonstrating value in new healthcare models • Individual and population health • New community pharmacy roles • Expertise in pharmacoeconomics and health outcomes • Specialty pharmacy services • Health informatics and automation • Quality improvement and patient safety • Sterile products preparation • Academic medical center/college integration to support tripartite mission

29. References • Futurescan 2012: Healthcare Trends and Implications 2012-2017. The Society for Healthcare Strategy and Market Development. Health Administration Press. http://www.ache.org/pubs/redesign/product-catalog.cfm?pc=WWW1-2206 • Strategic Issues Forecast 2015, American Hospital Association. November 2010. www.aha.org/research/cor/content/2015CORSIF.pdf • 100 Top Hospitals CEO insights: Keys to Success and Future Challenges. August 2011. Thomson Reuters. http://100tophospitals.com/assets/CEOInsightsResearchPaper.pdf • Zellmer WA, ed. Pharmacy Forecast 2013-2017: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems. December 2012. Bethesda, MD: Center for Health-System Pharmacy Leadership, ASHP Research and Education Foundation. www.ashpfoundation.org/pharmacyforecast • Joint Commission of Pharmacy Practitioners. An Action Plan for the Implementation of the JCPP Future Vision of Pharmacy Practice. January 31, 2008