Strategic Thinking in Pharmacy Clinical Affairs

James G. Stevenson, PharmD, FASHPProfessor and Associate Dean for Clinical Sciences

Chair, Department of Clinical, Social and Administrative SciencesUniversity of Michigan College of Pharmacy

Chief Pharmacy OfficerUniversity of Michigan Health System

Creating the Future of Pharmacy and HealthcareClinical sciences and practice10-15 year time horizonRapidly changing healthcare environment

and financingRecognition of significant problems in the

quality and safety of medication useRapidly evolving clinical and translational

scienceDisclaimer

Genetic Individualization of Drug TherapyPharmacogenomics

Goal to optimize efficacy and safety through understanding human genetic variability and its influence on drug response

Single gene and polygenic modelshttp://www.fda.gov/Drugs/ScienceResearch/Research

Areas/Pharmacogenetics/ucm083378.htmOver 110 drugs with labeled genomic markersSignificant opportunities

Clinician education Clinical translational research Application of results in clinical setting Creation of pharmacogenomic testing and drug use

policy

New Models of CareImproved 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 increaseIncrease in team-based careIncrease in scope of practice of nurses, PAs,

pharmacists (collaborative practice agreements and interdependent practice)

Increased transparency of results and costs

Transforming Healthcare DeliverySignificant financial pressures for long term

sustainability of health care and global competitiveness

Emergence of bundled payment systemsExpanded health coverage of the populationFocus 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 ModelsAccountable Care Organizations

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)

Medication Related Process of Care Measures

Medication Related HCAHPS Measures

FFY 2013

(11 of 12) (2 of 8)*

FFY 2014

(11 of 13) (2 of 8)*

FFY 2015

(9 of 11) (2 of 8)*

*Pain Management, Communication about Medications

Patient-Centered Medical Home (PCMH) AHRQ Definition

Patient-centered The primary care medical home provides primary health care that is relationship-based with an orientation toward the whole person.

Comprehensive care Providing 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

Accountable Care Organizations (ACO)

ACO

Patient Centered Medical Home(Primary Care)

Specialty Areas

Apply principles from PCMH and extend to specialty care/areas; integrate with inpatient care and transitions

Inpatient Care and Transitions of Care

Accountable Care Organizations (ACO)Shared Savings ProgramProviders agree to be accountable for quality

and cost of care for beneficiariesACO 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

Key Strategies Considered by ACOsTreat patients in best locationUtilize best practice guidelinesUtilize 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

wellnessImprove transitions of care

Importance of MedicationsAt least 2/3 of physician visits result in

prescription medicationChronic diseases managed primarily by drug

therapyMedicare beneficiaries have high utilization of

medications and multiple chronic conditionsMedications major problem at transitionsSuboptimal use of medications can lead to

excess costs in care, hospital admissions, ED visits

Key Medication-Related Measures in CMS Demonstration Project (Pioneer)Diabetes

hemoglobin A1c LDL BP Aspirin use

Controlling high blood pressureIschemic 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

The Role of Pharmacists in ACOsCritical role in assuring optimal outcomes

related to medications:Ensuring appropriate medication useReducing adverse drug eventsImproving transitions of carePreventing hospital readmissionsMore optimal management of chronic

conditions with lower total costsPoorly developed in most ACOs currently

Pharmacist Integration into PCMH/ACO at UMDeveloped a systematic and standardized pharmacy practice

model to provide comprehensive patient 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 regimensDeveloped new billing structure and process for service

reimbursement

UM Pharmacist Practice Model

Embedded pharmacists in primary care clinicsPatient 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)

1338

523

357

245

211

increased dose

added medica-tion

decreased dose

Year 3: 2,674 interventions

Therapeutic Interventions by Pharmacists (PCMH)

Example of Impact on Clinical MeasuresDiabetes 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)

$20,000-50,000 (n=147) $50,000-80,000 (n=76) $80,000-110,000 (n=55) $110,000-140,000 (n=34)

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Annual Health Care Cost

Large Number of Medications in High Cost Patient Population

Opportunity to Develop Significant Pharmacist RolesPharmacists should be actively engaged within

their health-system’s ACO initiativesPharmacists should be an integral part of providing

team-based care (right person doing the right jobs)Selection of most appropriate regimenModifying regimens as needed to achieve goalsPatient education/patient empowermentEnhancing medication adherence Targeted interventions for high risk populations

Create linkages between community pharmacy and health-systems and physician organizations

Opportunity to Develop Significant Pharmacist RolesCreate new services or expand existing programs

Chronic disease managementPolypharmacyAdherenceTransitions of care

Educational needs of patients Medication access issues

Case management of high risk populationsImpact clinical process of care measures,

readmissionsNeed for robust measurement of impact and

dissemination of results (CSAS faculty)

New Payment Models

Bundling of physician, hospital payments; bundling of payments around acute events

Incenting improved quality and efficiency (pay for performance)

Improving population healthPaying for cost-effective treatments and

servicesAre we preparing our future practitioners with

skills in quality improvement, population management, pharmacoeconomics and outcomes research?

Focus on Specialty Pharmacy ProgramsExpensive, typically biologically derived, complex,

and often injectableFastest 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

challengesEntry of biosimilars into the US marketPharmacists in team-based care to improve clinical

management, promote best outcomes, as well as generate margin for health system

Health Informatics and AutomationImproved 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 safetyAre 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?

Significant Changes in Community Pharmacy PracticeMajor changes in drug distribution models

Central fillExpanded use of technicians/technology3rd class of drugs (e.g. ACOG recommendation on oral contraceptives)

Understanding of problems at transitions of careACO and PCMH models need to create effective hand-

off’s and capacity to manage large numbers of patientsExplosion in point of care testingRecognition of community pharmacist as a resource in

improving population healthNeed collaborative practice agreements, EHR access,

documentation standards, new payment models that encourage coordination of care plans and goals

Renewed Interest in Sterile Products Compounding PracticesMorbidity and mortality from inadequate

sterile compounding practices (e.g. NECC)Increased focus on patient safetyIncreased awareness of risks of hazardous

drugs and biological therapies to healthcare workers

Commercialization of human gene therapies likely to be managed by pharmacy

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.

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

Summary of Opportunities

Pharmacogenomics – clinical and translational scienceDeveloping pharmacist role and demonstrating value in

new healthcare modelsIndividual and population healthNew community pharmacy rolesExpertise in pharmacoeconomics and health outcomes

Specialty pharmacy servicesHealth informatics and automationQuality improvement and patient safetySterile products preparationAcademic medical center/college integration to support

tripartite mission

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