Role of Clinical Pharmacists in Disease State Management

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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

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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

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BUMED Requirement

• Navy Medicine (NAVMED) Policy 06-011
• Disease Management Programs
• Asthma
• Diabetes
• Breast Health
• Dental Health
• MedIG Checklist

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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

Academy of Managed Care Pharmacy
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Collaborative Drug Therapy Management (CDTM)
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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

Pharmacotherapy 2003231210-1225.
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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

Pharmacotherapy 2003231210-1225.
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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

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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

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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

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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

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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 patients 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

American College of Clinical Pharmacy
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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

American College of Clinical Pharmacy
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Other roles

• Clinical pharmacist researchers generate,
  disseminate, and apply new knowledge that
  contributes to improved health and quality of life

American College of Clinical Pharmacy
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The Process

• Pharmacists find a physician
• Physicians find a pharmacist
• Discuss the role the pharmacist will play
• Each commands credentialing committee determines
  pharmacists scope of practice
• Not necessary, but strongly encouraged to have
  collaborative practice agreements with providers

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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

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Identify a Need

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

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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

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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

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Develop Patient Care Protocols

• Develop practice-specific standards for care
• Network with colleagues
• Base protocols on national standards
• Sample Protocol

Pharmacotherapy 2003231153-1166. Pharmacy Times
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Market the Service

• Market to physicians, clinic champions and
  patients
• Share the benefits of the service 11 and at
  staff meetings
• Marketing ideas include flyers, posters, and
  mailings

Pharmacotherapy 2003231153-1166. Pharmacy Times
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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

Council on Credentialing. AJHP 20015869-76
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Pharmacists 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)

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Pharmacists CredentialsCertificates

• Certificate Programs
• State associations
• Colleges of pharmacy
• Regional AHECs
• 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

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Provide Care and Document Outcomes

• Provide pharmaceutical care
• Document the visit appropriately for the level of
  service provided
• Evaluate humanistic, financial and therapeutic
  outcomes

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Supporting Evidence

• American Pharmacists Association
• Listed by disease state
• Referenced primary literature

www.aphanet.org
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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

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The Asheville Project

• 1997 2007
• 2 self-insured employers
• Many spin-off projects
• gt 900 patients
• Diabetes
• Asthma
• Hyperlipidemia
• Hypertension
• Depression pilot study

J Am Pharm Assoc. 20034317384.
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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

J Am Pharm Assoc. 20034317384.
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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
  (lt 7 ) also ? at each follow-up
• gt 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

J Am Pharm Assoc. 20034317384.
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The Asheville ProjectDiabetes 5 Year Results

• Costs shifted from inpatient and outpatient
  physician services to Rxs, 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 (19972001) for
  one employer group
• Estimated increases in productivity estimated at
  18,000 annually

J Am Pharm Assoc. 20034317384.
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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

J Am Pharm Assoc. 200646133147.
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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

J Am Pharm Assoc. 200646133147.
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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

J Am Pharm Assoc. 200646133147.
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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 othernot 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

Pharmacy Times June 2005.
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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

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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

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Additional Supporting Evidence

• Clinical Pharmacy Services associated with
  decreased mortality rates
• Pharmacist-provided drug use evaluation (4491
  reduced deaths p0.016)
• Pharmacist-provided in-service education (10,660
  reduced deaths, p0.037)
• Pharmacist-provided ADR management (14,518
  reduced deaths, p0.012)
• Pharmacist-provided drug protocol management
  (18,401 reduced deaths, p0.017)

Pharmacotherapy 200727(4)481493.
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Additional Supporting Evidence

• Clinical Pharmacy Services associated with
  decreased mortality rates
• Pharmacist participation on the CPR team
  (12,880 reduced deaths, p0.009)
• Pharmacist participation on medical rounds
  (11,093 reduced deaths, p0.021)
• Pharmacist-provided admission drug histories
  (3988 reduced deaths, p0.001)

Pharmacotherapy 200727(4)481493.
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Billing Incident To Physician Services

• An option for pharmacists practicing in a
  physicians 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

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Billing Incident To Physician Services

• Criteria for use
• The service must be an integral, although
  incidental, part of the physicians professional
  service
• commonly furnished in physicians office
• Provided under direct supervision of a physician
• Provider must be a contractural worker

www.cms.hhs.gov/manuals/pm_trans/R1764B3.pdf
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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