Clinical Aspects of Pharmacy Education: Focus on Advanced Pharmacy Practice Experience Mort Goldman, Pharm.D., BCPS Director, Pharmacotherapy Services Department of Pharmacy Cleveland Clinic, Cleveland, Ohio USA

Objectives Cleveland Clinic and Department of Pharmacy overview Standards for clinical education and for Advanced Pharmacy Practice Experiences (APPEs) Community and ambulatory care APPEs Evidence that pharmacists make a difference Future directions for community pharmacy

Established Feb 21, 1921 - Four Physicians - MD Group Practice Physician Led Non-Profit Organization Group Practice Hospital / Clinics - Bring together diverse specialists to “think and act as a unit” Mission: “…care of the sick, investigation of their problems, and further education of those who serve.”

Staff 1,799 physicians and researchers 17,000 employees (main campus) (36,000 CCHS total) 120 specialties and sub-specialties 1,388 available beds; 94 operating rooms Patient Care Total Admits 52,561 Surgical Cases 73,986 Total OP Visits >3.2M

Education >1,000 Residents and Fellows in Training 59 accredited residency programs Lerner College of Medicine Research >$144.3 M Grants Awarded Federal, State, Private 3rd highest NIH funding

H Integrated Health System serving 5.1 million patients FHC Fairview Hospital Lakewood Hospital Lutheran Hospital Ashtabula County Medical Center Euclid Hospital Huron Hospital Hillcrest Hospital South Pointe Hospital Marymount Hospital FHC Elyria Family Health Center Westlake Family Health Center Lorain Family Health And Surgery Center Lakewood Family Health Center Strongsville Family Health and Surgery Center Brunswick Family Health Center Wooster Family Health Center Independence Family Health Center Solon Family Health Center Chagrin Falls Family Health Center Beachwood Family Health and Surgery Center Willoughby Hills Family Health Center Integrated Health System serving 5.1 million patients Cleveland Clinic 9 owned community hospitals 2 affiliate community hospitals 13 FHCs / 4 ASCs EPIC; My Chart

Toronto Health & Wellness Center -Sheikh Khalifa Medical City (Abu Dhabi, UAE) Toronto Health & Wellness Center Cleveland Clinic Abu Dhabi, UAE

Department of Pharmacy Mission The Department of Pharmacy is a clinical care department whose mission is to: ensure the provision of safe and optimal drug therapy outcomes in patients educate patients, healthcare practitioners and students about optimal drug therapy conduct and support drug-related research

Department of Pharmacy Vision The vision of the Department of Pharmacy is to: be a valued member of the CC patient care team make a unique contribution to high quality, cost-effective patient care, teaching and research be known for our service excellence to all of our customer groups have a local, state, and national reputation and leadership role resulting from the outstanding quality of our services and programs

Department of Pharmacy FY 2008 319 full time employees (FTEs); $22 million salary expense $127 million drug expense FTEs 154 exempt 165 technical / clerical Salary Expense 16.2M exempt 5.7M non-exempt Other expense $7.1M $420 GR $206 NR $55M CM $17 NI

Department of Pharmacy Inpatient Services (2008) 238 FTEs budgeted 2.23 million medication orders annually 6.94 million doses prepared & dispensed annually Hospital Outpatient Clinics, FHCs & ASCs (2008) 40 FTE budgeted 633K main campus clinic doses annually IP $225 GR $74.4 NR $43M Drug Expense $5.7M CM $-25M NI HOP $267 GR 98 NR 56 Drug Expense 43 CM 36 NI Chemo $169 GR (63%) 63 NR (66%) 33 Drug Expesne (59%) 28 CM (65%) 28 NI (78%) (12 FTEs)

Department of Pharmacy Ambulatory Pharmacies (2008) 57 FTE budgeted 386K prescriptions 10 locations including Florida Pharmaceutical Care Clinic (2008) 13 FTE budgeted >2,100 Active Patients >40,000 INR’s monitored OP Rx CC 296,380 Regional 89,970 Total 386,350 FTEs - CC 13 - Regional

Department of Pharmacy Research Section 5 dedicated FTEs Investigational Drug Service 350 total protocols Manuf, NIH, SWOG, CCG Drug Outcomes Research collaboration and publication with multiple medical departments Clinical and Practice Model outcome evaluation studies

Pharmacotherapy Section Acute Care Clinical Specialists Pharmaceutical Care Clinic Drug Information Research/Investigational Drugs Education 45+ employees including Pharm.D., R.Ph., RN, technical, clerical, and magnificent secretary

Acute Care Clinical Specialists Cardiology X2 Cardiothoracic ICU SICU MICU X2 NeuroICU Hematology/ OncologyX2 Infectious Diseases X2 Internal Medicine Nutrition Support Pediatrics X3 Transplantation X4

Department of Pharmacy Education (2008) 2 dedicated FTEs >350 CCF presentations/ inservices per year College Curriculum Faculty Lerner College of Medicine School of Podiatry ASHP Accredited Residencies Pharmacy Student Rotations Univ of Toledo, Ohio Northern, NEOUCOP High School Students

Residencies at Cleveland Clinic Pharmacy Practice (PGY1) Pharmacotherapy (PGY1/PGY2) Infectious Diseases (PGY2) Critical Care (PGY2) Hematology/Oncology (PGY2) Drug Information (PGY2) ????Community Pharmacy Residency (PGY1)

Pharmacists should be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes; and the key element required to move the toward this goal is clinical education

Automation and pharmacy technicians should be performing most if not all technical functions of drug dispensing Pharmacists contributions to patient care have been shown to be essential in hospitals and in the community and are cost effective (even profitable) Pharmacists are the drug experts

Pharmacy colleges must provide a robust clinical curriculum to assure that pharmacists have the skill necessary to take care of patients Pharmacists must take personal responsibility to enhance their clinical skills; Pharmacy organizations and colleges should provide continuing education to support this goal Pharmacy is a life-long learning process

Clinical Education ACPE Standards Provide patient care Promote health improvement, wellness, and disease prevention Design, implement, monitor, evaluate, and adjust pharmacy care plans that are patient-specific Provide population-based care in cooperation with patients, prescribers, and other members of an interprofessional health care team based upon sound therapeutic principles and evidence-based data, taking into account relevant legal, ethical, social, cultural, economic, and professional issues, emerging technologies, and evolving biomedical, pharmaceutical, social/behavioral/ administrative, and clinical sciences that may impact therapeutic outcomes Promote health improvement, wellness, and disease prevention in cooperation with patients, communities, at-risk populations, and other members of an interprofessional team of health care providers. Provide population-based care through the ability to develop and implement population-specific, evidence-based disease management programs and protocols based upon analysis of epidemiologic and pharmacoeconomic data, medication-use criteria, medication use review, and risk-reduction strategies

ACPE Guidelines for Pharmacotherapy Curriculum Begins to translate the basic sciences to patients Principles of clinical practice guidelines Integration of scientific knowledge in patient care decisions Application of evidence-based decision making to patient care Pain management and palliative care principles of clinical practice guidelines Interpretation in the clinical setting Used to reinforce basic science principles

ACPE Guidelines for Pharmacotherapy Curriculum Wellness and disease prevention Drug monitoring for positive and negative outcomes and disease monitoring Nonprescription drugs and dietary supplements Design of patient-centered treatment plans Identification of drug-induced diseases diagnostic tests in the diagnosis, staging, and monitoring of various disease states concepts of pain management and palliative care promotion of wellness and nonpharmacologic therapies disease prevention and monitoring nonprescription drug therapies dietary supplements design of patient-centered, culturally relevant treatment plans drug-induced disease

ACPE Guidelines Advanced Pharmacy Practice Experience (APPE) The true application of the pharmaco- therapy and basic science curriculum From book to bedside Practicing as a member of an inter-professional team Providing pharmacist-delivered patient care diagnostic tests in the diagnosis, staging, and monitoring of various disease states concepts of pain management and palliative care promotion of wellness and nonpharmacologic therapies disease prevention and monitoring nonprescription drug therapies dietary supplements design of patient-centered, culturally relevant treatment plans drug-induced disease

ACPE Guidelines for Advanced Pharmacy Practice Experiences (APPE) practicing as a member of an interprofessional team appropriateness of patient specific drug therapy recommending prescription and nonprescription medications, identifying and reporting medication errors and adverse drug reactions managing the drug regimen through monitoring and assessing patient information providing pharmacist-delivered patient care educating the public and health care professionals practicing as a member of an interprofessional team identifying, evaluating, and communicating to the patient and other health care professionals the appropriateness of the patient’s specific pharmacotherapeutic agents, dosing regimens, dosage forms, routes of administration, and delivery systems consulting with patients regarding self-care products recommending prescription and nonprescription medications, dietary supplements, diet, nutrition, traditional nondrug therapies, and complementary and alternative therapies identifying and reporting medication errors and adverse drug reactions

Clinical Education at Cleveland Clinic Provide advanced pharmacy practice experiences in hospital pharmacy, acute care clinical services, community pharmacy and ambulatory care for students at several Ohio colleges Typically one month rotations with pass/fail grading system

. . University of Toledo (UT) Ohio Northern University (ONU) Northeastern Ohio Universities College of Pharmacy (NEOUCOP)

Student Experiences offered at Cleveland Clinic Advanced Community Advanced Hospital Ambulatory Care Internal Medicine Cardiology ICU Medical, surgical, cardiothroacic, neurological, cardiac, pediatric, neonatal Transplant Liver, lung, heart, kidney Infectious Diseases Nutrition Support Drug Information Investigational drugs Pharmacoeconomics and Outcomes research

Community Pharmacy: Why is Clinical Education so Important? Pharmacists should be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes; and the key element required to move the toward this goal is clinical education Too many drugs and data for physicians to keep up with Pharmacists are the Drug Experts!! Patients are in the community!

Community/Ambulatory Clinical Education at Cleveland Clinic Community Pharmacy experiences allow significant patient counseling, and some directed disease state management Ambulatory care experiences allow direct patient care in the outpatient clinic setting Anticoagulation monitoring Diabetes care Hypertension and lipid management General mediation therapy management

Community APPE Experience Practices at Cleveland Clinic (ONU, UT) and NEOUCP sites Patient counseling OTC consultation Specialized services Immunizations – all Ohio Colleges train students in vaccination technique (they are permitted by law to administer particular agents to adults) Medication Therapy Management MTM based on specific criteria… number of meds, diseases, types of diseases.

Medication Therapy Management: Definition Continuity of pharmaceutical care Assessment of health status Formulating a medication treatment plan Selecting initiating modifying therapy Monitoring and evaluating response to therapy including safety and effectiveness continuity of pharmaceutical care among health care assessment of the patients health status Formulating a medication treatment plan Selecting initiating modifying therapy Monitoring and evaluating the patients response to therapy including safety and effectiveness Performing a medication review to identify resolve and prevent medication related problems

Medication Therapy Management: Definition Performing medication review to identify resolve and prevent drug related problems Documenting and communicating to patients other primary care providers Providing patient education and training Providing support to enhance adherence Coordinating medication therapy management services Documenting and communicating the essential information to the patients other primary care providers Providing patient education and training Providing information support services and resources designed to enhance patient adherence with his/her therapeutic regimens Coordinating and integrating medication therapy management services within the broader health care management services being provided to the patient

Community Pharmacy APPE Experience Medication histories, independently or part of MTM, OTC consults, etc Antibiotic call-back program (NEOUCOP) Drug Use Review Review dosing, drug interactions, etc. and make recommendations to physicians Answer drug information questions from patients and physicians

Challenges in Community Pharmacy Availability of medical information Continuity at the time of admission or discharge from the hospital Ability to document interventions or medication changes in the medical record Marketing – the public and professionals don’t know what we can do! Fill discharge rx’s Councel patients – hospital pharmacy vs community neither does a particularly good job E chart vs paper… no access cleve clinic op pharmacies…

What we can do in the Community: The Ashville Project To assess the clinical, economic, and humanistic outcomes of pharmaceutical care services provided in community pharmacies for patients with diabetes Pharmacists served as care providers Patient appointments included initial history, needs assessment and goal setting followed by monitoring, training and goal re-evaluation

What we can do in the Community: The Ashville Project HbA1C in range was 33% at base line and 85% in 14 months Significant improvement in LDL, HDL 10% decline in total costs 33% decline in inpatient costs 20 % increase in outpatient costs Glucometers, pharmacist fees, diabetes center costs, etc. Improved outcomes at decrease costs

What we can do in the Community: The Ashville Project Follow-up projects Long-term diabetes care Asthma care Hypertension and lipid management All have shown improvements of patient care at lower costs All performed by appropriate collaboration and referal in community pharmacies

J Am Pharm Assoc 2003;43:173-84 J Am Pharm Assoc 2003;43:185-90 J Am Pharm Assoc 2006;46:133-47 J Am Pharm Assoc 2008;48:23-31 Pharmacy Times 1998, October suppl

Community Pharmacy Future Directions Disease screening programs to help identify patients requiring in depth disease state management and MTM Blood pressure, Glucose, Lipid profile, HgA1c, Others Working with local physician groups and medical centers for improved referral process

Anticoagulation Clinic The Pharmacy Managed Anticoagulation Clinic (AC) is the largest single provider of anticoagulation monitoring services for the Cleveland Clinic Pharmacy AC services are available in 6 distinct locations throughout the Cleveland area Patient appointments are typically 10 minutes and include a point-of-care blood test during the appointment

Anticoagulation Clinic More than 3,000 anticoagulation patients referred by CC physicians received PCC medication management with ~40,000 INR tests in 2008 for all locations

Anticoagulation Clinic Economic analysis compared to non-pharmacist run anticoagulation services (1998) Cost avoidance of $300,000 Decrease risk/admissions for thrombosis and bleed Benefit to cost ratio of 1.5:1 Revenue producing service Working toward a budget neutral service

Anticoagulation Clinic APPE Experience Patient medication and medical history Asking specifically about concurrent medications, changes in medications, changes in health status, diet changes Finger stick for Point of Care Testing Place blood sample on the test strip

Anticoagulation Clinic APPE Experience Place test strip in the device Read and interpret results Adjust medication If result is unexpected, inquire again about health, drug, diet status changes Document all information in the electronic medical record

Anticoagulation Clinic Students learn to care for these patients How to recognize drug-drug interactions How to recognize food-drug interactions Dealing with minor bruising and bleeding Dealing with urgent patient situations Providing additional disease management to patients with multiple medical problems and multiple drug related problems

Patients with difficult-to-treat diabetes: Cleveland Clinic Pharmacy Referred to pharmacists in an internal medicine clinic Patients seen in clinic, and requested to return for follow-up with the pharmacist initially in 2-4 week intervals Pharmacist counsels patients on use of glucometer, medication adherence, diet, and symptoms of their disease Multiple parameters measured including HbA1C

Patients with difficult-to-treat diabetes: Cleveland Clinic Pharmacy Patient data reviewed for those who were followed by a pharmacist for at least 6 months with at least 3 visits Patients who were seen by the pharmacist had a significant decline in HbA1C of more than 2% decreasing their risk for cardiovascular disease, nephropathy and retinopathy

Patients with difficult-to-treat diabetes: APPE experience Review patient medical record for appropriate therapy, dosing, drug interactions, drug related problems History including compliance and diet Medication, diet, lifestyle counceling Medication adjustment Case presentations, “journal club”, lectures to health professionals

ACPE: Future Vision of Pharmacy Practice Vision Statement As experts regarding medication use, pharmacists will be responsible for: rational use of medications, including the measurement and assurance of medication therapy outcomes promotion of wellness, health improvement, and disease prevention design and oversight of safe, accurate, and timely medication distribution systems

ACPE: Future Vision of Pharmacy Practice Vision Statement Pharmacists will have the authority and autonomy to manage medication therapy and will be accountable for patients’ therapeutic outcomes

ACPE: Future Vision of Pharmacy Practice Vision Statement Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes