Role of Clinical Pharmacists in Disease State Management

1. Role of Clinical Pharmacists in Disease State Management Amy M. Lugo, PharmD, BCPS, CDM Clinical Coordinator Clinical Specialist, Internal Medicine Department of Pharmacy National Naval Medical Center Bethesda, Maryland

2. Objectives Review the BUMED requirement for disease state management Describe how pharmacists can assist in your disease management programs Define the roles and responsibilities of a clinical pharmacist Provide evidence supporting the use of pharmacists in disease management programs Discuss the credentialing process for clinical pharmacists and provide a sample collaborative practice agreement

5. BUMED Requirement Navy Medicine (NAVMED) Policy 06-011 Disease Management Programs Asthma Diabetes Breast Health Dental Health MedIG Checklist

6. Disease State Management A continuous, coordinated, evolutionary process that seeks to manage and improve the health status of a carefully defined patient population over the entire course of a disease A successful DSM program achieves this goal by identifying and delivering the most effective and efficient combination of available resources Encompasses the entire spectrum of health care Includes prevention efforts as well as patient management after the disease has developed

8. Collaborative Drug Therapy Management (CDTM) �A collaborative practice agreement between one or more physicians and pharmacists wherein qualified pharmacists working within the context of a defined protocol are permitted to assume professional responsibility� for certain tasks

9. Collaborative Drug Therapy Management (CDTM) Tasks include: Performing patient assessments Ordering and evaluating drug therapy-related tests Selecting, initiating, monitoring, continuing and adjusting drug regimens Assessing patient response to therapy Counseling and educating a patient on medications Administering medications

10. Collaborative Practice Collaborative Drug Therapy Management (CDTM) 43 states have some form of CDTM or collaborative practice Authority is generally incorporated in the state pharmacy practice act Describes the authorized scope of practice

11. Pharmacists in the Navy Licensed Independent Practitioners (LIP) BUMEDINST 6320.66E BUMEDINST 6320.66D No requirement for collaborative practice agreement No requirement for notes and orders to be co-signed by physicians Scope of practice determined by individual commands

12. Components of a Collaborative Practice Agreement A pharmacist agrees to work with prescriber(s) under a written, signed agreement Agree to perform certain patient care functions under specified conditions The pharmacist must possess the knowledge, skills and ability to perform the authorized functions Determination of competence is usually left up to the individuals who are party to the agreement

13. Components of a Collaborative Practice Agreement Authority to document activities in a medical record Accountability for the same quality measures for all those involved in the collaborative agreement Provisions to allow compensation for drug therapy management activities

14. Roles and Responsibilities of a Clinical Pharmacist Assuring safe, accurate, rational and cost-effective use of medications Engage in collaborative practice with other healthcare practitioners for the purpose of improving care and conserving resources Make patient-focused transitions into and out of acute care practice settings, ambulatory care or alternative site settings with the patient�s best interest in mind Possess in-depth knowledge of medications that is integrated with a foundational understanding of the biomedical, pharmaceutical, sociobehavioral, and clinical sciences

15. Roles and Responsibilities of a Clinical Pharmacist To achieve desired therapeutic goals, the clinical pharmacist applies evidence-based therapeutic guidelines, evolving sciences, emerging technologies, and relevant legal, ethical, social, cultural, economic and professional principles Assume responsibility and accountability for managing medication therapy in direct patient care settings, whether practicing independently or in consultation/collaboration with other health care professionals Within the system of health care, clinical pharmacists are experts in the therapeutic use of medications Routinely provide medication therapy evaluations and recommendations to patients and health care professionals

16. Other roles Clinical pharmacist researchers generate, disseminate, and apply new knowledge that contributes to improved health and quality of life

17. The Process Pharmacists � find a physician Physicians � find a pharmacist Discuss the role the pharmacist will play Each command�s credentialing committee determines pharmacists� scope of practice Not necessary, but strongly encouraged to have collaborative practice agreements with providers

18. Medication Management Services Identify a need Build support for services Determine the focus of the service Develop patient care protocols Market the service Receive additional training if needed Provide care and document outcomes

19. Identify a Need Focus group discussions Networking with opinion leaders Surveys of physicians within a practice Identify high risk patients Identify costly disease states

20. Build Support for Services Identify practice champions Build relationships with key people such as nurses, billing specialists, and lab personnel Market what you can do for patients

21. Determine the Focus of the Service Use needs assessment data to decide what services will be offered Determine how you can enhance what services are already being provided Other Considerations Your patient population Pharmacy staff expertise BUMED requirement and MedIG checklist

22. Develop Patient Care Protocols Develop practice-specific standards for care Network with colleagues Base protocols on national standards Sample Protocol

23. Market the Service Market to physicians, clinic champions and patients Share the benefits of the service 1:1 and at staff meetings Marketing ideas include flyers, posters, and mailings

24. Receive Additional Training Council on Credentialing published definitions of credentialing in 2001 Opportunities include additional education through residencies, traineeships, certificate programs, and CE Certification examinations include BPS, CGP, disease management, and various multidisciplinary examinations

25. Pharmacist�s CredentialsCertifications Pharmacists need to demonstrate that they possess the knowledge to manage certain disease states Board of Pharmaceutical Specialties BCPS, BCOP, BCPP, BCNSP, BCNP Diabetes Certified Diabetes Educator (CDE) Certified Disease Manager (CDM) Asthma Certified Asthma Educator (AE-C)

26. Pharmacist�s CredentialsCertificates Certificate Programs State associations Colleges of pharmacy Regional AHEC�s National associations National meetings (APhA) Pharmacy-Based Immunization Delivery Pharmaceutical Care for Patients with Diabetes Pharmacy-Based Lipid Management OTC Advisor: Pharmacy-Based Self-Care Services Delivery Medication Therapy Management Services in Your Community

27. Provide Care and Document Outcomes Provide pharmaceutical care Document the visit appropriately for the level of service provided Evaluate humanistic, financial and therapeutic outcomes

28. Supporting Evidence American Pharmacists Association Listed by disease state Referenced primary literature

29. Supporting Evidence Precedents Veterans Health Administration VHA Directive 2003-004 Department of the Army AR 40-68, Chapter 7, Subparagraph 8 North Carolina 21 NCAC 46.3101 Clinical Pharmacist Practitioner Maryland 12-6A-01 � 12-6A-10 Drug Therapy Management

30. The Asheville Project 1997 � 2007 2 self-insured employers Many spin-off projects > 900 patients Diabetes Asthma Hyperlipidemia Hypertension Depression pilot study

31. The Asheville Project Patients have co-pays waived Patients must see their pharmacist at least monthly Pharmacists are paid for their time Results ? total health care costs per pt per yr ? work productivity

32. The Asheville ProjectDiabetes 5 Year Results N = 187 Mean A1c ? at all follow-ups, with more than 50% of patients demonstrating improvements at each time The number of patients with optimal A1c values (< 7 %) also ? at each follow-up > 50% showed improvements in lipid levels at every measurement Patients with higher baseline A1c values or higher baseline costs were most likely to improve or have lower costs, respectively

33. The Asheville ProjectDiabetes 5 Year Results Costs shifted from inpatient and outpatient physician services to Rx�s, which ? significantly at every follow-up Total mean direct medical costs ? by $1,200 to $1,872 per patient per year compared with baseline Days of sick time ? every year (1997�2001) for one employer group Estimated increases in productivity estimated at $18,000 annually

34. The Asheville ProjectAsthma Data Asthma program implemented in 1999 2 self-insured employers N = 207 Outcome measures FEV1 Asthma severity Symptom frequency Presence of an asthma action plan Asthma-related emergency department/hospital events Changes in asthma-related costs over time

35. The Asheville ProjectAsthma Results All measures of asthma control improved and were sustained for as long as 5 years FEV1 and severity classification improved significantly Asthma action plans ? from 63% to 99% ED visits ? from 9.9% to 1.3% Hospitalizations ? from 4.0% to 1.9% Spending on asthma medications increased

36. The Asheville ProjectAsthma Results Asthma-related medical claims ? and total asthma-related costs were significantly lower than the projections Direct cost savings averaged $725/patient/year Indirect cost savings were estimated to be $1,230/patient/year Missed/nonproductive workdays ? from 10.8 days/year to 2.6 days/year Patients were 6 times less likely to have an ED/hospitalization event after program interventions

37. Keys to Success in Replicatingthe Asheville Model Focus on the patient and desired outcomes Include all �stakeholders� in planning and implementation Maintain open communication, sharing information in a timely fashion Ensure that the role of each team member is clear Health care team members should be supporting each other�not duplicating efforts Respect, integrity, trust, and excellence of each provider Coordination of patient referrals Education of patients and providers Aligned incentives for seeking and providing care

38. Clinic Reengineering Carved out or carved in Pharmacotherapy clinic vs. diabetes clinic Obtain AHLTA training and become familiar with clinic operations Continuously educate physicians and support staff about pharmacy services Actively seek referrals to fill clinic spots

39. Credentialing Process Required Documents BUMEDINST 6320.66E - Core privileges BUMEDINST 6320.66D - Supplemental privileges Optional Documents Peer review evaluation form Performance Assessment Review (PARs) Protocol/Collaborative practice agreement Clinical specialist position description Supporting evidence

40. Additional Supporting Evidence Clinical Pharmacy Services associated with decreased mortality rates Pharmacist-provided drug use evaluation (4491 reduced deaths p=0.016) Pharmacist-provided in-service education (10,660 reduced deaths, p=0.037) Pharmacist-provided ADR management (14,518 reduced deaths, p=0.012) Pharmacist-provided drug protocol management (18,401 reduced deaths, p=0.017)

41. Additional Supporting Evidence Clinical Pharmacy Services associated with decreased mortality rates Pharmacist participation on the CPR team (12,880 reduced deaths, p=0.009) Pharmacist participation on medical rounds (11,093 reduced deaths, p=0.021) Pharmacist-provided admission drug histories (3988 reduced deaths, p=0.001)

42. What do a pharmacist and a mechanic have in common? Not enough!What do a pharmacist and a mechanic have in common? Not enough!

43. Billing �Incident To� Physician Services An option for pharmacists practicing in a physician�s office Not an option for pharmacists who provide services in a community pharmacy Allows physicians to bill for services provided by non-physicians Specific criteria for use Very controversial, List providers that can MD must be in same �SUITE�Very controversial, List providers that can MD must be in same �SUITE�

44. Billing �Incident To� Physician Services Criteria for use: The service must be �� an integral, although incidental, part of the physician�s professional service� �� commonly furnished in physicians� office� Provided under direct supervision of a physician Provider must be a contractural worker

45. Summary Evidence has shown that pharmacists� involvement in disease management improves outcomes Pharmacists are uniquely positioned to play a role in disease state management We can help commands meet BUMED requirements Publishing and presenting our successes will support future endeavors