The Impact of Clinical Pharmacy Service Integration into the Medical Home

1. The Impact of Clinical Pharmacy Service Integration into the Medical Home Kathleen Johnson, Pharm.D., MPH, Ph.D. Professor and Chair, Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics & Policy Steven Chen Pharm.D., FASHP Associate Professor, USC School of Pharmacy Co-Chair, HRSA Patient Safety & Clinical Pharmacy Services Collaborative 2.0

2. Objectives • Provide examples of effective Medication Therapy Management and other clinical pharmacy services • Share data regarding impact on expenses and resources • Share health outcome and medication safety results

3. Pharmacists’ Roles in Health Care-Improve Use and Safety of Pharmaceuticals • Prevention • Provide general health and drug education to consumers and providers, • Educate consumers and caregivers in self-management of disease • Screen for disease presence • Administer immunizations • Drug Therapy Interventions and Treatment • Provide emergency contraception treatment • Assure nonprescription drug use appropriateness • Adjust medication for organ failure or other patient specific issues • Make and recommend therapeutic adjustments based on disease control • Resolve drug therapy problems (Continued)

4. Pharmacists’ Roles in Health Care-Improve Use and Safety of Pharmaceuticals • Disease State Management • Manage high risk, uncontrolled patients referred from MD to pharmacist to improve disease control • Provide specialized care to specific patient groups (geriatrics, HIV, cardiovascular disease) • Quality Assurance Programs • Assure Best Practices/Evidence Based Medicine applied • Monitoring for Medication Safety and Cost-Effectiveness • Individual patients • Populations of patients in hospitals and/or within health plans enrollees • Drug Information • General, special populations-geriatric, pediatric

5. Models of CPS/MTM Outpatient Setting • Population focus –telephone interventions (low hanging fruit) • Clinical pharmacists work in MD office (P4P, Chronic Disease Management) • Clinical pharmacists integrated in medical homes/clinics • Community Pharmacist – in the Pharmacy

6. Pharmacist Medication Therapy ManagementNOT a new concept / practice • Kaiser Permanente1: since early 1980’s • Heart failure, diabetes, hypertension, chronic kidney disease, anticoagulation, geriatrics, asthma, dyslipidemia, HIV, etc… • ↓ mortality, morbidity, ED, visits • ↑ quality of care • 1 pharmacist saves 2x salary annually; requires 1 pharmacist per 8-9 primary care MDs (adult clinics) • Veterans Affairs: since 1960’s • Private medical groups • Pharmacy Benefit Management companies • July 2010: Resource Guide from Patient-Centered Primary Care Collaborative 1 Personal Communication, Dennis Helling, Kaiser Colorado

7. Safety Net Clinics and Comprehensive Pharmacy Services Goals: 1) 340B purchasing 2) PAP Programs 3) MTM/DSM South Central Family Health Clinic T.H.E. Clinic JWCH Institute at the Weingart 5 QueensCare Clinics aSafety Net Clinics are public, private and philanthropic providers who provide services to patients that are uninsured, vulnerable, and otherwise unable to get needed health care. aLevin, Hurd, et al. “Introduction to Public Health in Pharmacy, 2008”

8. Safety Net Clinics - 2.7 million uninsured in Los Angeles Sources: a HRSA Uniform Data System Client Level Data for T.H.E. Clinic, Inc. (2000) b South Central Family Health Center (2002), c Weingart Medical Clinic (2002), d QueensCare Census Tract zip code 90027 (2000) e Los Angeles County Department of Health Services, Health District Profiles (2006)

9. Pharmacists in Clinics Providing Care to Uninsured Patients • Responsibilities: • High risk patients referred to pharmacist for disease management (MTM) (collaborative prescribing) • Dispensary – safe medication dispensing; medication counseling • Education for other providers; formulary management, drug information, treatment protocols/algorithms

10. USC Pharmacy Programs-Process MD writes referral for clinical pharmacy services MD sees need for clinical pharmacy services Patient maintains periodic f/u visits with MD Patient makes appointment to see Pharm.D. Patient is enrolled in active clinical/DSM pgm

11. Identify potential Rx-related prob’s Consult w/ primary provider PRN Interview patient, apply assessment skills PRN Provide f/u care to ensure successful outcome Order labs, Rx’s, consults PRN per protocol Document activities Pharmacist-run Disease-State / Medication Therapy Management Programs: Responsibilities Diabetes Dyslipidemia Hypertension Heart failure Asthma

12. Disease Management / Medication Therapy Management - Progress Patient Visits, 10/04-9/08

13. Foundation Partnerships to Launch or Spread Clinical Pharmacy Services • HRSA: $140,000 grant (2003) • Community Pharmacy Foundation: $50,000 (2004) • QueensCare Foundation: • $300,000 for 3 years (2004) • $1,100,000 for 3 years (2006) • $450,000 for • UniHealth: • $405,000 for 3 years (2004) • $405,000 for 3 years (2005) • $350,000 (2010)

14. Dispensary Management Goals • Dispensary organization & inventory management • Computerization • Patient profiles, track dispensing, drug interaction monitoring, multilingual sigs, patient education information, inventory management • Automation • 340B drug purchasing program & Patient Assistance Program (PAP) • Formulary development

15. Annualized cost savings for all clinics: ~$700,000 Cost Savings-Dispensary Management, Computerization (1 FTE pharmacist) • Clinic A • 26% savings, average $4,000 - 5,000 / month • $85,000 over 3.5 months (297 PAP submissions) • Clinic B • 40% savings, $8,000 - 10,000 / month • Clinic C • $18,000 / month (230 PAP submissions)

16. Outcomes of Pharmacist Intervention in Diabetic Safety Net Clinic Patients • Objective: • To evaluate the impact of pharmacist services on outcomes of diabetic patients compared to patients receiving usual care in matched safety net clinics without a pharmacist • Outcomes Evaluated: A1C, blood pressure, lipids, appropriate medication use, and quality of care indicators

17. Study Sites Observational Research • Pharmacist Services • JWCH Institute Medical Clinic at the Weingart Center • QueensCare Family Clinics • South Central Family Health Center • Comparison Group / “Usual care” • LA Mission Clinic • QueensCare Family Clinics (clinics where patients not receiving pharmacist care) • East Valley

18. Pharmacist Intervention N=392 Usual Care N=312 A1c > 9 in enrollment period; Age > 18; N=325 A1c > 9 in enrollment period; Age > 18; N=310 Visit more than twice N=224 Visit more than twice N=265 Had a visit +30 to +750 days after index date N=222 Had a visit +30 to +750 days after index date N=262 Patient Enrollment and Follow-upN=484 Had 1 visit Had 1 visit Men 52% African Am 27% Smoker 27% Men 52% African Am 15% Smoker 21% Challenge: Parolees and other transient populations

19. Data Collection • Demographics • Age, gender, ethnicity • Health Insurance • Medicare, MediCal (Medicaid in Calif), None • Baseline Health Status and lab tests • A1C, blood pressure, lipid levels, smoking, height, weight, co-morbid chronic conditions • Medication Orders • Diabetic, cholesterol and blood pressure-lowering drugs as well as all other medications including aspirin

20. Study Population at Baseline

21. Study Population at BaselineClinical Characteristics

22. Results • Clinical Measures: • Pharmacist group had: • Larger (significantly) mean changes in A1c than Usual care • Larger (significantly) drop in mean BP than Usual Care • Larger (significantly) drop in mean LDL Cholesterol • Quality of Care Indicators: • Larger percentage with appropriate medication use (Aspirin, Statins, Insulin)

23. Results: Quality of Care Indicators

24. Results: Blood Glucose ControlA1C Result at Baseline and Last Visit * * 1.1 drop A1c overall 2.7 drop A1c overall (20% < 8) (52% < 8)* (6% <7) (19% < 7)* 11.04 10.7 9.6 8.3 * p<0.0001

25. Results: LDL Lipid ControlResult at Baseline and Last Visit * * 47% at goal 80% at goal* 111 117 107 85.2 35% at goal 41% at goal * p<0.0001

26. Overall Impact of Pharmacist Intervention on Individuals with Diabetes

27. Impact of A1c Changes • 1% reduction in mean A1c was associated with(1): • 21% reduction in risk of any end point related to diabetes • 21% reduction in death related to diabetes • 14% reduction in heart attack • 37% reduction in microvascular complications (blindness, kidney disease, nerve damage) • Next step is to do a cost effectiveness analysis. Other studies have shown 2x pharmacist salary in total savings per year for each pharmacist (Kaiser data) (1) Stratton et al, British Medical Journal 2000: 321:405-412

28. Pharmacist Interventions Provided to Diabetic Patients1. Problems2. Interventions3. Results/Outcomes Rory O’Callaghan Pharm.D. Pharmacy Practice Resident- Ambulatory Care USC School of Pharmacy

29. METHODS: Problem Groups = Medication safety = Legal / dispensing = Quality of care = Cost

30. 502 Problems Identified by Pharmacists in 222 patients Quality of Care 68% Medication Safety 27% $ Cost Legal / dispensing <1%)

31. 502 Total Interventions Provided by Pharmacists (N=222 patients)

32. 135 Medication Safety Interventions:Made by Clinical Pharmacists(27% of Interventions) Number of Interventions Related To Medication Safety

33. Outcomes from 135 Medication Safety Related Interventions

34. Addition of Clinical Pharmacist to Health Care Team Improves Access to Health Care • Physician time saved by having the pharmacist: • Provide medication counseling & dispense medications • Provide MTM for the most difficult-to-treat patients • Increases physician access for new patients • Increases physician availability for existing patients needing frequent follow-up • Specialty services – eg psychiatry can be supported by clinical pharmacist specialist in psychiatry • Recent ED and hospitalization improvement at CCH-positive impact of clinical pharmacy services compared to clinics with no clinical pharmacy services

35. JAMA, 10/2/02“Effectiveness of pharmacist care for patients with reactive airway disease” (Agency for Healthcare Research & Quality) • 12-month randomized controlled trial of asthma care for ~1,100 patients with obstructive airway disease provided by 36 community pharmacies vs. control • Results: ~2x  rate of hospitalizations & ED visits in the pharmacist care group vs. control (??) What is wrong with this study?

36. JAMA, 10/2/02: What went wrong?? • Patient recruitment method: Failed to target high-risk patients (>14,000 patients invited to participate based on whether any asthma or COPD-related Rx was filled in prior 4 months) • COPD not excluded (~40% of study population)- not same treatment approach as asthma • Pharmacist not given opportunity to intervene in drug therapy • Pharmacist issues: • Comprehensive patient database available only to P-care pharmacists accessed only ~50% of the time • No competency exam following training, “…not universally enthusiastic about this expanded role.”

37. 2008 2007 APHA 2009

42. Expansion to Government Focus: Health Resources and Services Administration (NIH) Patient Safety & Clinical Pharmacy Collaborative http://www.hrsa.gov/patientsafety/ One of our faculty is helping lead this effort! Contact Steve Chen chens@usc.edu for info

43. Aim of HRSA’s Patient Safety & Clinical Pharmacy Collaborative “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.”

44. ~ 70 Safety Net Clinics in Year 1~120 Clinics in Year 2 The process

45. HRSA Collaborative Teaching 4 live 2-day learning sessions for all participating teams (CEOs, CMOs, physicians, pharmacists, etc.) Leadership Commitment Measurable Improvement Patient Centered Care Safe Medication Use System Integrated Care Delivery 45

46. What Quality Improvement Information will Teams Share with HRSA? • Medication Safety: Potential /Adverse Drug Events • Number of adverse drug events (ADEs) • Number of potential adverse drug events (pADEs) • Health Outcomes for High Risk Population of Focus (specific to each team) using standardized measures (e.g., A1C > 9%, BP, LDL, etc.)

47. Early Results in Health Outcomes from PSPC N~300 N~1,800 N~1,130

49. Health Status Markers: “Under Control”All Aligned with National Standards of Care

50. pADE rates fell 60%, from 0.75/patient to 0.3/patient • ADE rates fell 50%, from 0.12/patient to 0.06/patient PSPC 2.0, from 44 teams