Krista M. Scardina, PharmD Program Management Officer Office of Pharmacy Affairs HHS, HRSA Improvement Co-Advisor

Denise H. Geolot, PhD, R.N. Director, Center for Quality Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) Collaborative Co-Director Krista M. Scardina, PharmD Program Management Officer Office of Pharmacy Affairs HHS, HRSA Improvement Co-Advisor

! Improve health outcomes, increase clinical pharmacy services, and improve patient safety! Rapid improvement method! Leading practices come from the field

! Increase in multiple chronic conditions! Aging population - polypharmacy! ADEs leading cause of death and injury IOM Report! Lack of integration of clinical pharmacy services

! 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.

Report Finds a Heavy Toll From Medication Errors -New York Times, 2006 Doctor-Patient Bond Frays After Medical Mistake -Forbes, 2007 State Confirms Medical Error In Hospital Death Of Teen -Channel 3000, Wisconsin, 2006 Accidental Overdoses in the Home Soaring -The Washington Post, 2007

Committed to saving and enhancing thousands of lives a year by achieving optimal health outcomes and eliminating adverse drug events through increased clinical pharmacy services for the patients we serve.

! Support programs to provide the best and safest care in the Nation! Take previously supported collaboratives with documented improvements to the next level

Patient Safety Pharmacy Collaborative Patient Patient Safety Safety Integrated Patient Care Services Clinical Pharmacy Services QUALITY Health Health Outcomes Outcomes

! Study Phase! Identified High Performers! Conducted 34 site visits! Compiled Leading Practices The Change Package! Convened Expert Panel! Engaged Partners! Leadership Coordinating Council! Sponsored State Leadership Meeting! Implementation Phase! Enrolled Teams! Faculty Selected

! 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 datadriven 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

! Teams are Major Locus of Change! Change Package is Recipe Book for Change! Introduced and Led by a Faculty of Their Peers! Create Expectation That Each Team Begins by Addressing a Change Concept! Use the Improvement Model (Plan/Do/Study/Act) to test specific actions in their environment

! 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

Who Are the Teams?! Teams of providers (multi-disciplinary)! Multiple organizations within communities! Defined patient population

! ~ 80 teams! Over 300 organizations! Teams average 3+ organizations! 42 states represented (including HI and PR)! Over 300 participants attended Learning Session # 1! Over 500 expected at Learning Session # 2

! Improvement efforts organized around regular Learning Sessions! Teams come together for several days to learn about leading practices! The PSPC will convene a total of four Learning Sessions

! Follow the Learning Sessions! Teams return home to apply what they have learned! Use the Model for Improvement,! A fast paced, iterative improvement method! Continuous, small scale, rapid testing leads to adaptation of leading practices to fit local conditions

! 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

Select Topic Planning Group Identify Change Concepts Enroll Participants Prework LS 1 PDSA=Plan, Do, Study, Act LS= Learning Session AP=Action Period A S P AP1 D LS 2 A S P AP2 D Listserv Filming Rapid Sharing Team Reporting LS 3 Supports Site Visits & Conference Calls Web site Leadership Coordinating Council A P S AP3 D LS 4 Adapted from IHI Breakthrough Series Collaboratives IHI.org

! Improve health outcomes, increase clinical pharmacy services, and improve patient safety! Rapid Improvement Approach! Leading practices from field

July 2008: Faculty Meeting Aug 14-15, 2008: Learning Session 1 Fall 2008: Action Period 1 Dec 3-4,2008: Learning Session 2 Winter 2008-09: Action Period 2 April 2009: Learning Session 3 Summer 2009: Action Period 3 Fall 2009: Learning Session 4

HRSA Website www.hrsa.gov/patientsafety Questions? patientsafety@hrsa.gov HRSA Knowledge Gateway www.healthdisparities.net

Arthur Martinez, MD, MSHA Chief Clinical Officer, El Rio Health Center Sandra Leal, PharmD, CDE President, Association of Clinicians for the Underserved Consultant, HRSA Pharmacy Services Support Center Clinical Pharmacy Supervisor, El Rio Health Center

! 74,526 patients served! 288,149 patient encounters! 27% patients uninsured! 47% patients on Medicaid! 54% patients at or below federal poverty level! 38% patients under 15 years of age

! Approached by the University of Arizona College of Pharmacy! New Entity/New Midlevel! El Rio CHC/Arizona! Population Focus! Poly-pharmacy Knowledge

! Right Person! For Patients! For Medical Staff! Buy-in from Medical Staff

! I do not want:! Someone to take over my patients! To be forced to share my patients! Someone to provide medical care I do not agree with

! Voluntary Internal Referral System! Clinical Protocols

! Emphasize quality outcomes with comprehensive assessments and treatment plans! Determine and track outcome measures to validate quality! Patient and provider satisfaction surveys! Physician profiling

! Process! A1C Testing! Retinal Exam! LDL Screening! Monitoring for Nephropathy! Outcomes! Poor A1C control! LDL Level < 130 mg/dl

Provider Without Sandra With Sandra Total Process Outcome Total Process Outcome SL 5.17 3.33 1.83 JV 4.45 3.14 1.32 5.5 3.5 2 JE 4.09 2.65 1.43 5 3.75 1.25 DS 4.18 2.82 1.35 5 3 2 NF 4.2 2.67 1.53 6 4 2

! Quality Outcomes! Share Results! Residency Training

! In August 2001! El Rio Clinic provided a pharmacist managed diabetes (DM) clinic! Comprehensive Pharmacy Services Grants awarded by the Office of Pharmacy Affairs (OPA) a component of the Health Resources and Services Administration Healthcare Systems Bureau (HRSA)

! OPA emphasizes:! Importance of comprehensive pharmacy services being an integral part of primary health care! Comprehensive pharmacy services include:! Patient access to affordable pharmaceuticals! Application of "best practices" and efficient pharmacy management! Application of systems that improve patient outcomes through safe and effective medication use

! Opportunities opened with Arizona Statue 32-1970! Pharmacists prescriptive authority! Collaborative agreements with providers and patients created

! Major cause of morbidity and mortality! Cost: $174 billion dollars in 2007! Personal cost to patients Opportunities to improve care:! Quality measures (HEDIS)! Lipid management! Blood pressure management

Diabetes EPIDEMIC: Early 20th Century Diabetes EPIDEMIC: Early 21st Century 11y 9m, 347 pounds http://. www.dchstx.org

! To evaluate changes in clinical parameters and medication use! Improve comprehensive access to diabetes care! Access database created in 02/02 for patient tracking pivotal to success of program

! Data collected! Demographics! Medical history! Medications! Labs! Vitals! Preventative Services! SOAP notes to print for chart

! Day before appointment-thorough review of chart for baseline! Foot exam/monofilament test! Review of diabetes, blood pressure, lipids including goals and previous lab work! Initiate self-testing! Ophthalmology referral! Smoking cessation counseling! Aspirin! Depression Screening! Update vaccinations! Assessment of health literacy

Interview, Medication Reconciliation, Disease State Management, Appropriate Medication Selection, Polypharmacy Review, Self-Management Education, Medication Access Addressing High Risk Issues

Changes in Recommended Annual Follow-up Screenings

Changes in Metabolic and Blood Pressure Measures: Baseline to Follow llow-up Parameter # Pts Baseline (Mean) FU (Mean) Diff. 95% CI P-value TC (mg/dl) 613 198 170 28 23 to 32 <0.001 TG (mg/dl) 613 247 187 71 38 to 104 <0.001 HDLc (mg/dl) 610 45 43 2 1 to 2 0.001 LDLc (mg/dl) 588 108 91 17 13 to 19 <0.001 SBP (mm/hg) 602 124 118 6 4 to 8 <0.001 DBP (mm/hg) 602 75 69 6 4 to 6 <0.001 A1C (%) 614 10 8.1 2% 1.7 to 2 <0.001 Gluc (mg/dl) 602 210 165 45 36 to 54 <0.001 BMI (kg/m 2 ) 599 32.8 33.8 1-2 to -0.1 <0.036 GFR 609 83 79 4-6 to -2 <0.001

0 Diabetes- Related Mortality All-Cause Mortality Myocardial Infarction Peripheral Microvascular Vascular Disease Disease 10 20 14% 14% 21% 30 40 50 All P<.0001 43% 37% A1C = glycosylated hemoglobin; UKPDS = United Kingdom Prospective Diabetes Study. Adapted from Stratton IM et al. BMJ. 2000;321:405-412.

Changes from Baseline to Follow-Up for Patients on ASA and ACEIs/ARBs* 90 patients with ASA contraindication; 81 patients with ACEI/ARB contraindication; 11 patients with statin contraindication

! Pascua Yaqui and El Pueblo clinical pharmacist added! Pharmacy practice residency! Improved quality of life for patients as documented by measurable parameters and self-report! American Society of Health-System Pharmacists (ASHP) Best Practices Award! National Association of Community Health Centers (NACHC) 2007 Innovative Research in Primary Care Award! Several publications including:

Publications Chronic Kidney Disease Risk Reduction in a Hispanic Population Through Pharmacist-Based Disease-State Management Leal S, Soto ML. Advances in Chronic Kidney Disease, Vol 15, No 2 (April), 2008: pp 162-167. doi:10.1053/j.ackd.2008.01.007 Appropriate Advancement of Type 2 Diabetes Therapy Meneghini L, Kennedy L, Koff R, Kuritzky L, Leal S, Peterson K, Zamudio V Current Clinical Practice 1(1): 19a-30a, October 2007. http://www.jfponline.com/pdf/5610/5610accp_supplement1.pdf The Role of Rapid-Acting Insulin Analogues and Inhaled Insulin in Type 2 Diabetes Sandra Leal, Richard N. Herrier, and Marisa Soto Insulin 2007; 2: 61-67. http://dx.doi.org/10.1016/s1557-0843(07)80017-0. Improving Quality of Care in Diabetes through a Comprehensive Pharmacist-Based Disease Management Program Sandra Leal, Jon J. Glover, Richard N. Herrier, and Anthony Felix Diabetes Care 2004 27: 2983-2984. http://care.diabetesjournals.org/cgi/content/full/27/12/2983 Pharmacist-led vs Physician Diabetes Drug Management Elizabeth G. Hogan. Sandra Leal, Marion Slack, and Dave Apgar Hospital Pharmacy Europe May/June 2006: 16-17. Evaluation of HRSA's Clinical Pharmacy Demonstration Projects Volume 1: Synthesis Report Final evaluation report of the Clinical Pharmacy Demonstration Projects (CPDP) managed by OPA. The purpose of these projects was to examine the effects of expanded access to clinical pharmacists and comprehensive pharmacy services on the health outcomes of medically underserved populations. This report is an evaluation of expanded access and improved outcomes due to the Clinical Pharmacy Demonstration Projects. ftp://ftp.hrsa.gov/bphc/pdf/opa/cpdpvolume1finalreport.pdf November 30, 2004 Volume II: Case Studies Presents five case studies of Clinical Pharmacy Demonstration Project networks whose experience may prove beneficial to other Community Health Centers and providers exploring the potential for clinical pharmacy service. El Rio s Demonstration Project is highlighted. ftp://ftp.hrsa.gov/bphc/pdf/opa/cpdpvolume2finalreport.pdf November 30, 2004 Medications, Rationing, and Health Care: The Role of Pharmacists in Bridging the Gap Sandra Leal, PharmD, CDE Journal of Health Care for the Poor and Underserved 16.3 (2005) 418-420. Pharmacists Disease State Management through a Collaborative Practice Model Sandra Leal, PharmD, CDE & Marisa Soto, PharmD Journal of Health Care for the Poor and Underserved 16.2 (2005) 220-224. Changing the Face of Pharmacy Rx for Access Volume 2 Issues 5 p.2, MedPin (Medicine for People in Need), July/August 2005.