William A. Miller, Pharm.D., MSc, FASHP, FCCP

Developing Clinical Pharmacy Services and Effective Pharmacy Leadership
William A. Miller, Pharm.D., MSc, FASHP, FCCP Professor Emeritus, University of Iowa

Presentation Objectives
At the conclusion of this presentation you will be able to Critically evaluate the effectiveness of your current practice model Construct a practice model that focuses on optimizing patient care outcomes and safety Use new strategies to expand clinical pharmacy services Consider changes in your leadership and management skills to improve your effectiveness

Management and Leadership
Ideally individuals in executive or director positions have both excellent leadership and manager skills Anyone can be a leader Leaders set the direction for the organization and influences people to follow that direction. Managers follow the direction for the organization and implement programs, and achieve goals and objectives set by leaders Leaders do the right thing and managers do things right Leaders set direction by developing a clear vision and mission, and conducting planning that determines the goals needed to achieve the vision and mission. They motivate or influence people by using various methods: facilitation, coaching, mentoring, directing, delegating, and rewarding

Differences Between Managers and Leaders [1]
The manager administers; the leader innovates. The manager is a copy; the leader is an original. The manager imitates; the leader originates. The manager focuses on systems and structure; the leader focuses on people. The manager relies on control; the leader inspires trust, The manager has a short-range view; the leader has a long- range perspective. The manager focuses on the bottom line; the leader has an eye on the horizon. The manager accepts the status quo; the leader challenges it. The manager is the classic good soldier; the leader is his or her own person. The manager does things right; the leader does the right thing.

Characteristics of High Performance Leaders
Clear vision Develop an administrative team with unity of purpose and values Surround themselves with other individuals who have complimentary skills Proactive versus reactive: Seek to expand circle of influence (Avoid saying “if only”) Good communications skills (Respected by able to disarm people and put at ease for communications) Build relationships with key leaders: administration, medical, nursing, etc. Value different perspectives: Good listeners Develop a positive departmental structure: openness, value of every staff member, Cultivates the “I and we will attitude” High performance expectations (model and expect of staff)

Which of the following is a false statement?
Pharmacy leaders set the direction for the department Leaders do things right and managers do the right thing Mangers have a short term view and leaders have a long term view Pharmacy leaders have a clear vision Pharmacy leaders build relationships with other hospital leaders

Strategic Planning Mission of the department of pharmacy
Vision for the department of pharmacy Values of the department of pharmacy Goals of the department of pharmacy Short term goals: annual (one to 2 years) Long term goals: 3 to 5 years Goals are broad: Establish decentralized pharmacy services Objectives aimed at achieving goals Example: Establish decentralized pharmacy services for all critical care services by 6/2011 Actions plans are detailed steps to achieve a specific objective with dates and accountable person Actions plans lead to implementation and achievement of goals and objectives

What are the barriers to further optimization of pharmacy services?
Perceived value of pharmacists as providers of patient care (“Providers”) Leadership Health care and pharmacy practice models Qualifications and credentialing of pharmacists as patient care providers Required standard of care: Best practices Present information technology/automation Funding of cognitive services

Strategies to Achieve Vision
Develop an organizational chart matched to vision Develop administrative team with shared values Hire competent staff for all positions Engage staff in planning and decision making Elevate qualifications for providers of clinical services: Residency, board certification Credential and privilege pharmacists: Scope of practice as patient care providers. Develop a pharmacy practice model matched to the vision Use automation and technology effectively

Strategies to Achieve Vision
Use pharmacy technicians to reduce pharmacist involvement in distributive and other technical duties Development systems to improve medication-use- systems Champion improvements for the medication-use- system Align clinical services with regulatory requirements and quality organizations Align clinical services with funding opportunities Align clinical services with institutional plans Align pharmacy practice model to medical practice model

Audience Participation
What strategy are you planning or presently implementation to increase the quality or quantity of clinical pharmacy services provided by your department?

What are the goals for clinical pharmacy services?
Assure optimal drug therapy outcomes Effective drug therapy Safe drug therapy Cost-effective drug therapy Assure pharmaceutical care is coordinated and provided collaboratively with other pharmaceutical care providers Assure effective relationships with patients that lead to patient involvement, understanding, adherence Assure efficient and patient focused delivery of care

What is the evidence of the value of clinical pharmacy services [2-8]
Abundant number of publications documenting the value of clinical services in inpatient and outpatient settings Most pharmacists in published studies were full time clinical pharmacists on interdisciplinary teams (i.e., generalists or specialists) and not pharmacy generalists in an integrated system (i.e., performing distributive as well as clinical functions) Need for research comparing integrated, hybrid and coordinated practice models

What is the Evidence for Specialization and Teams
Is specialized medical care better than care provided by generalists? Is interdisciplinary team care better than care provided by one discipline? Should pharmacists all have the same KSA or have different KSA? Should pharmacy teams be multidisciplinary like medical teams? (pharmacy generalists, clinical specialists, compounding specialists, informatics specialists, safety specialists) Can clinical pharmacy specialists have the same job description as clinical pharmacists?

What is the status of clinical pharmacy services in hospitals/health care systems? [9-11]
Variable: Comprehensive to minimal Comprehensive more likely in medium to large hospitals Diffusion of ADC for drug dispensing Diffusion of decentralized pharmacists but variable quality and quantity of clinical services provided. Adoption and diffusion of clinical pharmacy services has been slow

Adopter Categorization
Roger’s has characterized Adopters in 5 ways: Innovators (Venturesome) – obsessed with innovations – first one on the block – always showing off new toy Early Adopters (Respect) – Opinion leaders – Jump on after judicial decisions – others look to these people Early Majority (Deliberate) – Take longer to make decision – a sizable group that will keep the innovation moving, or if they don’t adopt it, then the innovation stalls or dies Late Majority (Skeptical) – peer pressure is needed for them to adopt – often adopt out of economic necessity or market pressure Laggards (Traditionalists) – Last to adopt – possess no opinion leadership – Laggard is not necessarily a bad or negative term. Survey they audience: 1) PDA’s, 2) text messaging on cellphone, 3) on cell phone It is not clear how institutions and individuals can be categorized, a priori, into these categories. Only after adoption of an innovation, can we categorize them. Rogers EM. Diffusion of Innovations

Diffusion of Innovations
B Shift the curve to the left A Move up the curve This brings us back to the diffusion of innovations curve. There is no good way to tell whether adoption of an innovation is moving up the curve, or shifting the curve to the left. It is a matter of feel, rather than science. To borrow from Malcolm Gladwell, what is the “tipping point” that facilitates adoption? It certainly requires a change in the environment to shift the curve to the left. Our research is attempting to learn more about these competing and also complementary objectives. An addition point to take away, is that no matter whether we are moving up the curve or shifting the curve, there will always be late majority and laggards (or traditionalists). Shifting the curve and moving up the curve both describe the timeline for diffusion of innovations. Rogers EM. Diffusion of Innovations

Core and Advanced Clinical Pharmacy Services
Core Clinical Pharmacy Services Medication profile review to identify and address drug related problems Target drug monitoring Provision of drug information as requested Participation in medical codes Participation in patient care unit team meetings Participation in drug policy development Medication reconciliation as needed Patient discharge counseling as needed

Core and Advanced Clinical Pharmacy Services
Advanced and Specialized Clinical Pharmacy Services Prospective or concurrent treatment planning through consistent participation on formalized interdisciplinary teams (rounds) Comprehensive medication therapy management through P&T approved protocols for monitoring drug therapy and changing drug therapy (hospital wide or department/division specific) or collaborative practice agreements Clinical specialists (usually PGY1 residency and PGY2 in specialized practice areas: Critical Care, Oncology, Transplantation, Cardiology, Infectious Diseases)

Health Care Reform Expansion of health care (Most agree about the benefits of expanding health care coverage) Reduction in health care costs: (All agree need to reduce costs of health care) A lot of the public want expanded health care benefits but don’t want to pay for it. No interest group wants to be negatively impacted

Impact of Health Care Reform on Clinical Pharmacy Services
Potential Opportunities Team based care (Medical Home Model, Accountable Care Organizations) Continuity/transitions of care/prevention of hospital readmissions/prevention Medication therapy management services and medication reconciliation Expanded use of technology and automation to improve safety and efficiency Implementation of new reimbursement models Testing of various models to deliver care (comparative effectiveness research) Need to take advantage of these opportunities as health reform moves forward An accountable care organization (ACO) is a type of payment and delivery reform model that starts to tie provider reimbursements to quality metrics and reductions in the total cost of care for an assigned population of patients. A group of coordinated health care providers form an ACO, which then provides care to a group of patients. The ACO may use a range of different payment models (capitation, fee-for-service with asymmetric or symmetric shared savings, etc). The ACO is accountable to the patients and the third-party payer for the quality, appropriateness, and efficiency of the health care provided. According to the Centers for Medicare and Medicaid Services (CMS), an ACO is "an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.

Impact of Health Care Reform on Clinical Pharmacy Services
Potential threats Inadequate funding of clinical services (fee for service or portion of funding provided to support patient care or a new reimbursement method) Impact of cost reductions on funding of clinical services (delayed implementation, reduction in services) Use of other providers to provide pharmaceutical care because of political and/or economic reasons

Which of the following statements is a false statement
Evidence of the value of teams is sufficient Evidence of the value of clinical pharmacy services is insufficient The diffusion of clinical pharmacy services, as an innovation, was quite rapid Inadequate funding of clinical pharmacy services as a part of health care reform is a potential threat to pharmacy The “Medical Home Model” may provide an opportunity to expand clinical services in ambulatory care settings

Pharmacy Practice Models [12-16]
Model is defined as “structural design of something” Organizational chart reflects the practice model or structure being used for the delivery of pharmacy services System A group of interacting, interrelated, or interdependent elements forming a whole A system for the delivery of pharmacy services reflects the practice model used Ideal Practice Model Allows achievement of the desired pharmacy service mission, goals and objectives while adhering to core values

Integrated, Coordinated and Hybrid Practice Models
Integrated model One pharmacist job description All pharmacists provide distributive and clinical services concurrently Pharmacists rotate to central and decentralized practice areas

Hybrid model Central and decentralized pharmacist roles under one job description: Selected central pharmacists assigned to decentralized role on a rotating basis Decentralized pharmacists may only focus on target monitoring and other clinical services, have concurrent distributive responsibilities and rotate to central area to staff

Coordinated model Multiple job descriptions with different roles and responsibilities: Centralize pharmacist, decentralized or clinical pharmacist, clinical specialist Pharmacists supportive of various roles, capable (not proficient) to perform different roles, and care is coordinated (team approach) to achieve common goals

Basis for Pharmacy Practice Models Used Today
Beliefs of pharmacy leadership which are based upon experiences, training, values and opinions of thought leaders and organizations Number and quality of staff Use of information technology and automation Nursing, physician and hospital administration beliefs and support

Basis for Pharmacy Practice Models Used Today
Consultant recommendations Politics Model development Evolve by adding clinical to distributive services Rarely redesign of existing model but tweek of existing Usually driven by beliefs and subjective opinions Lack of evidence-based research on effectiveness of practice models and metrics for staffing to make practice model design decision making more objective

Observations About Today’s Pharmacy Directors/Leaders
Similar goals for pharmacy services: Safe drug distribution and medication use system Quality clinical services Difference in service emphasis Safe drug distribution system maybe emphasized or viewed as being more important than influence on the quality of pharmaceutical care Are dispensing errors more significant than prescribing errors? As pharmacy clinicians with good leadership and management skills are appointed pharmacy directors will clinical services be emphasized?

Pharmacy Directors/Leaders
Different definitions of quality clinical services Target drug monitoring and cost reductions as outcomes (Often see in integrated models) Pharmacists on interdisciplinary teams share responsibility for drug therapy outcomes with physicians and other providers (Often see with coordinated models) Different assessment of the level of clinical services actually being provided by the department

Model 1(Integrated): Small community hospital
Director Pharmacists Central staffing rotation Decentralized staffing All pharmacist rotate to provide targeted drug monitoring and MTM. Disadvantage: KSA may be significantly different among involved pharmacists leading to variances in the quality of services provided.

Model 2(Hybrid): Small community hospital
Director Central Pharmacists Select Central Pharmacists: Targeted Monitoring and MTM Pharmacists who are selected some to perform targeted monitoring and MTM want to be more clinically involved and have better skills for this role.

Model 3 (Coordinated): Medium Sized Community Hospital
Director Assistant Director Central Pharmacy Coordinator Clinical Services Outpatient Services Outpatient Dispensing Pharmacists Central Decentralized Clinical Specialists Coordinator: Not viewed as a manager but a lead or team leader for clinical specialists. This model silos decentralized pharmacists from clinical specialists and is less likely to foster teamwork.

Model 4 (Coordinated): Medium Sized Community Hospital
Director Assistant Director Inpatient Services Outpatient Services Centralized Services/Lead Decentralized Clinical Pharmacists Clinical Specialists Central Pharmacists Outpatient Pharmacists

Model 5 (Coordinated) Large University or Community Hospital
CPO Director Inpatient Clinical Services Surgery Coordinator Critical Care Coordinator Medicine Coordinator Pediatric Coordinator Director Inpatient Operations Business Director Informatics Director Director of Education and Staff Development Director Ambulatory Services Outpatient Pharmacy Coordinator Clinical Services Coordinator Larger organization more diversification. Move manage down to patient care level by use of coordinators or team leaders.

Model 5 (Coordinated): Large University or Community Health System
CHIEF PHARMACY OFFICER Director Transplantation Services Medical and Surgery Oncology Services Team Leaders for Clinical Pharmacists and Specialists Pediatric Services Psychiatry Services Outpatient Services Central Inpatient Pharmacy Services Further organization Central Pharmacists Organizational chart mirrors medical organization. Directors of Children’s Hospitals and Cancer Centers want their own pharmacy director. Sometimes matrix to medicine and pharmacy. Team Leaders have more coordinating skills and not management skills. However, who does performance evaluations?

Model 7 (Coordinated) Large Health Care System
Chief Pharmacy Officer Director of Community Hospital Administrative Director Director of Ambulatory Pharmacy Services Director of Central Pharmacy Services Director of Inpatient Clinical Services Chief Pharmacy Officer within one large hospital and clinics sometimes but as in this example CPO over multiple hospitals. Sometimes CPO responsible for strategic planning, policy and other core pharmacy services like procurement, systems used but director delegated more authority and responsibility for individual units.

Advantages and Disadvantages of Practice Models
Advantages of Integrated Practice Models Recruitment of pharmacists to provide clinical services easier because larger applicant pool Scheduling of pharmacists easier Staff morale maybe enhanced because all pharmacists have the same responsibilities and status Greater percent of patients may receive core clinical services Disadvantages of Integrated Practice Models Minimal level of clinical services may result (e.g., new order review, target monitoring, drug information) Patient populations needing advanced patient care services maynot receive sufficient services Pharmacists may not become essential members of interdisciplinary teams and as a result miss opportunities to improve patient outcomes

Advantages and Disadvantages of Current Practice Models
Advantages of Coordinated Practice Models Pharmacists on interdisciplinary teams provide advanced/specialized clinical services as essential team members Clinical services provided to interdisciplinary teams better (specialized knowledge, skills and abilities; greater awareness of pertinent patient safety issues for the specific patient population, repetition/proficiency) Better use of pharmacist knowledge, skills and abilities (PGY1 and PGY2 residency training) leading to improved employee satisfaction Disadvantages of Coordinated Practice Models Creates scheduling problems Replacement of pharmacists more difficult Silos may develop and impair effectiveness of internal pharmacy team while enhancing interdisciplinary teams

Ideal Practice Model Requirements
Core clinical services should be provided to all patients. Specialized/advanced clinical services must be available to all patients requiring these services Clinical services should be consistently provided The model for the overall delivery of pharmacy services must be efficient, effective and coordinated (team approach). The model must fit the system used by the hospital and/or medical staff for delivering patient care. Providers of all pharmacy services must be competent. An appropriate mix of staff with needed KSA must be employed The model must result in a safe medication use system. The model must result in pharmacists being essential patient care providers and members of formalized interdisciplinary teams. Pharmacy residents must be included in the model as appropriate The model must result in a positive department culture, and high morale and retention rates.

Audience Participation
Briefly describe your current practice model and then answer the following questions. How have you assessed the effectiveness of your current practice model? How are you planning to change your practice model to further optimize patient care outcomes and safety?

Applying Principles of Systems to Develop a Pharmacy Practice Model
Containment (Subsystems): Practice models used by physicians and nurses need to be considered in deciding on pharmacy practice model Teaching hospitals with formalized interdisciplinary teams and house staff different than community hospital model with private physicians and no formalized teams Ripple Effect of Change: Changing the type of pharmacists hired for decentralized pharmacy positions affects outcomes of the whole system

Applying Principles of Systems to Develop a Pharmacy Practice Model
Synergy: If all parts of the practice model are working well and together, synergy is achieved (optimum drug distribution, patient care, drug policy and medication use systems)

Applying Principles of Systems to the Ideal Practice Model
Rule of the weakest link: Hiring a director who views pharmacy as a material management versus a clinical department affects mission and vision for patient care services to be provided by pharmacists Placing unqualified pharmacists in clinical roles impacts overall system (patient care outcomes diminished) Assigning a critical care pharmacist 50 patients or a decentralized pharmacist 150 patients to provide distributive and clinical services affects type and amount of cognitive services provided Rotating pharmacists to different areas (central, patient care) affects ability of pharmacists to become essential members of interdisciplinary teams

Factors Influencing Selection of the Best Pharmacy Practice Model
Different Perspectives on How to Design the Best Pharmacy Practice Model to Optimize Patient Outcomes Patient care effectiveness Patient care safety Efficiency of care (quality/costs) Balance of outcomes

Factors Influencing Selection of the Best Pharmacy Practice Model
Cognitive services to be provided Core clinical services Specialized/advanced clinical services Prospective involvement in establishing patient treatment plans versus routine monitoring Collaborative drug and disease state management Core and specialized/advanced services will need to change for pharmacy to continue to add value to health care Specialized/advanced services today will become future core services Specialized/advanced services in the future will be affected by advances in health care, new drugs, pharmacogenomics, advanced decision support systems

Model Effect on Cognitive Services Provided
Cognitive Domain Affective Domain Evaluation  Synthesis Analysis Application Comprehension Knowledge Characterization  Organization Valuing Responding Receiving Chart showing the two taxonomies they will be working with – brief description of the differences between levels of learning in cognitive domain – enough so they will know to pay attention to the difference between understanding and actually doing – Refer to handout sheet for example of goals with different levels of objectives MH 30 (Example of goal with EO’s and IO’s. Can also go to A-35 in this same book to show them the objectives with the criteria so they see that isn’t the same as the IO’s. Compare the IO’s in R1.1.1 in the example on page 30 with those in R One is at the comprehension level and the other at the evaluation level. TIME 10:20 15 MINUTE BREAK 1035

Practice Model Effect on the Level of Cognitive Services Provided
Reviewing routine orders: Low to medium Target drug monitoring: Low to medium Managing anticoagulation: Low to medium Developing best practice guidelines, protocols: High Determining best treatment plan for a critical care patient with multiple disease states: High

Factors Influencing Selection of the Best Practice Model
Patient care acuity and complexity Quaternary and tertiary care versus secondary care Type of patient care unit: Intensive care and emergency department, step down or intermediate care, general patient care Size of the inpatient or ambulatory patient population Size affects overall staff resources needed to provide comprehensive pharmacy services: inadequate staffing compromises level of clinical services.

Number of patients per clinical pharmacist or specialist Currently see150 to 30 for regular patient care units, ICUs: 60 to 10 The higher the patient number the less involved pharmacists are in the care of individual patients Lack of pharmacy metrics Miller Numbers for Optimal Clinical Services: ICUs 20 maximum, patient care units, 40 maximum Numbers affect the ability to use an integrated service practice model for all clinical pharmacists

Use of pharmacy technicians for order fulfillment Medication histories and reconciliation Tech-tech programs Routine clinical monitoring Use of automation and use of information technologies available to increase efficiency and safety of medication use systems CPOE Access to information: PC, Tablets, Remote Pharmacy computer system: SOAP, monitoring data, evidenced-based recommendations Use of ADC as unit dose carts Use of order scanning technologies Use of bar-coding and electronic-MARs Decision support

Physician and nursing practice models Interdisciplinary teams in teaching hospitals versus private practice model Hospitalist model Opinions of key leaders in the organization Pharmacy, medical, nursing and administrative leaders Are clinical pharmacists essential to patient care teams, desirable, or primarily valued as a drug information resource or for teaching medical residents? Opinions of professional organizations Physician organizations: Critical care, ID, transplant, oncology, pediatrics Pharmacy organizations: ASHP Best Practices, PPMI, and ACCP statements Organizational effectiveness research Research on best practice models

Practice Change Model: Conditions for Change [17]
Are the involved pharmacists capable of performing the new role? Will the proposed change be perceived as adding value to the jobs of the involved pharmacists? Will the perception by the involved pharmacists of the probability of value satisfaction from the role change be sufficient to gain their support? The pharmacists involved must not perceive the cost of the change in role as being significant. Involved pharmacists perception of the risk of making the change should be low.

Which of the following statements are false?
No one model is the best fit for all pharmacy organizations The number and quality of staff affects the pharmacy practice model selected by pharmacy directors Increased use of information technology and automation enhances patient safety and the delivery of clinical pharmacy services All pharmacists should have the same qualifications and job descriptions Chief Pharmacy Officers are more frequently appointed in large hospitals or health care systems

Summary: Determining the Best Practice Model for an Organization
Critically analyze the effectiveness and efficiency of your current practice model Design and implement a model that Optimizes the influence of pharmacy on patient care outcomes: effectiveness, safety and efficiency Is a good fit for your institution Is efficient, synergistic and coordinated

Summary: Determining the Best Practice Model for an Organization
Results in pharmacists being essential members of interdisciplinary teams Places the interests of pharmacy leaders or individual pharmacists secondary to what is the best model for your patients Develop metrics to evaluate the effectiveness and efficiency of your practice model and revise the model as needed

References Bennis W. On Becoming a Leader. Reading, MA: Addison-Wesley Publishing Company; 1989. Bond CA: Interrelationships among mortality rates, drug costs, total cost of care, and length of stay in United States Hospitals. Pharmacotherapy 2001;21 (2): Bond CA: Clinical pharmacy services, pharmacy staffing and the total cost of care in United States hospitals. Pharmacotherapy 2000;20(6):609-21 Bond CA: Clinical pharmacy services, hospital pharmacy staffing, and medication errors in United States hospitals. Pharmacotherapy 2002;22 (2): Economic evaluations of clinical pharmacy services Pharmacotherapy 1996; 16(6): Kaboli PJ, Hoth AB, et al.: Clinical pharmacists and inpatient medical care: a systematic review. Arch Intern Med 2006; May 8;166 (9): Bond CA, Raehl CL: Clinical pharmacy services, pharmacy staffing, and adverse drug reactions in United States Hospitals. Pharmacotherapy 2006 (6): Chisholm-Burns MA: US Pharmacists' Effect as Team Members on Patient Care: Systematic Review and Meta-Analyses. Medical Care: 2010; 48 (10):

References Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice and settings: Monitoring and patient education ; 67 (7): Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice and settings: Dispensing and administration ; 66 (10): Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing ; 65 (9): ASHP: PPMI (ASHP website). Accessed March 19, 2011. Zellmer WA. Pharmacy’s future: Transformation, diffusion, and imagination. Am J Health-Syst Pharm. 2010; 67: Knoer S, et. A;.: Lessons learned from a pharmacy practice model change at an academic medical center. Am J Health-Syst Pharm. 2010; 67: Abramowitz P: The evolution and metamorphosis of the pharmacy pratice model. Am J Health-Syst Pharm. 2009; 64: Breland B. Believing what we know: pharmacy provides value. Am J Health-Syst Pharm : 64: Dwyer CE. Managing people. In: Roven S, Ginsberg L, eds. Managing hospitals. San Francisco, CA: Jossey-Bass Publishers; 1991.

William A. Miller, Pharm.D., MSc, FASHP, FCCP

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