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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)
0
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4
6
8
10
12
14
16
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16
Avera
ge n
um
ber
of
medic
ati
ons
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