Transcript Managing Clinical Pharmacy Services

Managing
Clinical Pharmacy
Services
John M. Allen, PharmD, BCPS, CPh
Pharmacy Clinical Coordinator
Medical Center of Trinity
Lesson Objectives

Differentiate between clinical and operational aspects
of institutional pharmacy

Describe the purpose of a hospital formulary

Discuss principles of formulary management

Describe the drug use evaluation process

Identify different types of pharmacy practice models

Describe the process for implementing new clinical
services
What are Clinical Pharmacy
Services?


Activities and processes that:

Ensure optimal therapeutic outcomes

Minimize adverse drug events (ADEs)

Promote cost-effective strategies
Can be provided in all health-settings

Not limited to institutional settings
Typical Reporting Structure
for Hospital Pharmacy
Director of
Pharmacy
Clinical
Coordinator
Clinical
RPhs
Operations
Coordinator
Pharmacy
Technicians
Pharmacy Practice:
Clinical and Operational Services
Pharmacy
Operations
Clinical
Services
Pharmacy
Practice
Case

Dr. Smith, chief of cardiology at your institution has
requested that a new cholesterol drug De-Clogo be
added to hospital formulary

The drug was recently approved by the FDA and has a
similar mechanism to other formulary alternatives

You as the Clinical Coordinator are asked to review and
present the drug at your hospital’s next Pharmacy and
Therapeutics (P&T) Committee meeting
What things should be considered when evaluating addition
of a new drug to formulary?
Formulary

List of approved medications that can be prescribed within
an organization

Goal of a formulary is to provide selected list of
medications that achieve rationale therapeutic outcomes


Minimize duplication

Reduce inventory burden

Generally, emphasize use of generic medications when possible
Can be categorized as closed vs. open

Mixed formulary is a hybrid of open/closed formulary
Open vs. Closed Formulary
Open



Offer all available
medications to be
prescribed to any
patient
Provide little control
over inventory
In purest sense, not
routinely used ($$$)
Closed

Only drugs on formulary
may be prescribed

Provides control on
medications used within
facility

Limits prescriber
autonomy
Mixed Formulary System

Most common type of formulary system used by
hospitals and hospital-systems

Allows flexibility within formulary

Generally, within mixed formulary lies three tiers

Open- Any drug on formulary may be prescribed for
any patient

Restricted- Medication is limited to specific patient
population or prescribers (i.e. Chemotherapy)

Targeted- Medication requires approval prior to
dispensing (i.e. Targeted antimicrobials  ID
physician or PharmD )
Formulary Management

When considering adding new agents to formulary, a
drug monograph is typically presented

Evidence-based review of medical literature

Standards exist to guide monograph development

Can be developed internally or from outside vendor

Facts and Comparison
Formulary Management:
Monograph Components
Joint Commission

Indication

Effectiveness

Drug Interactions

Potential for errors and
abuse

Adverse drug events
ASHP

Brand/generic names

FDA approval information

Pharmacology/MOA

FDA-approved indication

Non-FDA approved indications
(i.e. Off-label)

Dosage forms/storage

Pharmacokinetics

Special population

Pregnancy/Breastfeeding

Sentinel event advisories

Population served (i.e.
pediatrics)

Comparison of drug efficacy,
safety, convenience versus
therapeutic alternatives

Other risks

Clinical trials and critique


Cost
Med safety assessment (drug
interactions, monitoring, lookalike, sound-alike issues)

Financial analysis
Formulary Management
Things to Consider
Efficacy
Safety
Cost
Formulary Management
Things to Consider

Efficacy


Is Drug A better than current formulary options?

De-Clogo- 62% reduction in LDL (max dose)

Atorvastatin – 55-60% reduction in LDL (80 mg)
Safety

Are there additional safety concerns with the proposed new
agent vs. current formulary options


Myalgias similar between agents (10% vs. 9%)
Cost

Is the benefit worth the cost?

De-Clogo- $15.00/tablet

Atorvastain- $0.32/tablet
Formulary Management
Recommendations

Generally, after review of drug monograph, formulary
recommendations made

Formulary Decisions


Addition without restrictions

Addition with restrictions on prescribers, or patient types (i.e.
Criteria for use)

Addition with required approval prior to dispensing

Reject medication for formulary addition
6-to-12 month review for most new medications added to
formulary to ensure appropriate use
Formulary System


Policies and procedures which govern medication use
process

Policy- Course or plan of action

Procedure- Course of action intended to achieve a result;
provides details processes
Medication use process

Drug selection and procurement

Ordering and transcribing

Preparing and dispensing

Administration

Monitoring

Should be developed in collaboration with multidisciplinary
team (i.e. RN, MD, RD, RT, etc.) and evidence-based

Policies and procedures to be reviewed periodically
Pharmacy & Therapeutics (P&T)
Committee

Committee that oversees safe, effective, and responsible
medication use within hospital

Comprised of physicians, nurses, pharmacists, hospital
administrators, support staff, Hospital Quality

Medical committee NOT Pharmacy Committee

Conflict of interest should be disclosed annually


Stock investments, Research support, Speakers Bureau, etc.
Recommendations are subject to Medical Executive
Committee Approval
P&T Committee
Subcommittees


Provide expert advise on the development and monitoring
of processes for specific groups of drugs

Antimicrobial subcommittee

Anticoagulation committee

Pain management committee

Pediatrics committee
Subcommittees typically complete drug use evaluations
(DUEs) and develop evidence-based tools to guide
appropriate drug therapy

Criteria for Use

Orderset development

Education materials
Case

The Director of Pharmacy has asked you to evaluate
drug spend for the institution and look for opportunities
to reduce overall drug spend

You notice that Procrit (epoetin alfa) spend is increased
significantly from previous year

You suspect that Procrit utilization is increased due to
inappropriate use and have decided to complete a DUE
on Procrit
What things should you consider when completing a DUE?
Drug Use Evaluation

Term used synonymously with Medication Use Evaluation
(MUE)

Drug Use Evaluation required by The Joint Commission
to monitor safety of medications

Structured, quality improvement program designed to
promote appropriate, safe, and effective medication
use
Drug Use Evaluation
Examples of Medications/High-Risk
Medication Related Processes

Neuromuscular blocking agents

Anticoagulants

Insulin infusion

Sedation protocols

Stress Ulcer Prophylaxis

Albumin

Epoetin Alfa

Management of Clostridium Difficile Infection
Drug Use Evaluation
Process

Gain Organizational Authority and Assign
Responsibility

Identify areas of opportunity

Develop criteria and indicators for optimal use

Involve practitioners who practice in the setting

Collect data and evaluate utilization

Develop and implement plans for improvement

Monitor and assess plan for improvement
Pharmacy Practice Models

Describes how a pharmacy department's resources are
deployed to provide patient care

Includes pharmacists, technicians, automation, and
technology

Pharmacy Practice Model Initiative (PPMI), 2010

Sponsored by ASHP

Key opinion leaders in pharmacy practice

Conclusions centered on moving from pharmacy-centric to
patient-centric focus
Pharmacy Practice Model
Initiative: Recommendations

The imperative that all patients should have a right to
the care of a pharmacist

The characteristics, requirements, and challenges of
optimal pharmacy models

Advancing the application of information technology
in the medication-use process

Advancing the use of pharmacy technicians

Successful implementation of new pharmacy practice
models
Clinical Services
UHC 2010
All patients
Specialized Services

Med reconciliation

Anticoagulation management

Review of non-emergent
orders prior to first dose

Resuscitation teams

Parenteral nutrition
Develop individualized
treatment plans

IV to PO conversion
Antimicrobial stewardship

Daily monitoring of
medication profiles


Pharmacokinetic evaluation,
dosing, monitoring

Participation in patient
care rounds

Renal dosing adjustments

Collaborative drug therapy
management

Patient education on
preventing disease and
improving health



Educate patients on new
medications
Communicate discharge
plan to outside caregivers
Pharmacy Practice Models
Examples
Pharmaceutical
Care Model
Clinical Pharmacy
Model
Drug Distribution
Model
• Integrated
practice model
• Member of
interdisciplinary
team
• Includes most
pharmacists
• Patient-focused
• Rounding with
little distributive
functions
• Pharmacist acts
as consultant
• Requires
specialized
skillset
• Focus on quality
of care
• Medication order
focused
• No direct
patient care
• No involvement
in patient
outcomes
• Focuses on
timely delivery
Pharmacy Practice Models
Choosing a model

Depends on host of factors

Logistical issues

Utilization/deployment of pharmacy technicians

Automation/Technology

Pharmacist training

Scope of pharmacy practice

Standardized model not yet developed

Agreement in some aspects

Patient-centered care avoids/reduces med errors

Involvement in patient centered care improves
collaboration with physicians
Specific Practice Model:
Critical Care Pharmacy


Fundamental

Distributive

Order entry/verification
Desirable

Optimal

Assist providers with
therapeutic decision
making

Coordinate or direct
residency training

Formal nutrition consults

Respond to resuscitation
events

Develop new pharmacy
programs

Didactic lectures to
healthcare professionals

Perform clinical research

Develop implement ICU
policies/protocols

Present case reports
Specific Activities:
Critical Care Pharmacy

Prospective evaluation of
all drug therapy

Contribute to P&T
committee

Evaluation of
appropriateness of
therapy

Activities on costcontainment

Drug dosing adjustments

Monitoring and preventing
DDI and ADEs

Define goals of therapy

Documentation of services

Reporting of ADEs

Nutritional assessment

Provision of drug info


Participation in
educational and
institutional activities
Check compatibilities of
IV medications

Prevention and treatment
of life-threatening
infections

Safe and optimal use of
technology
Documentation of Services

Documentation shows diversity, effectiveness, cost
and outcome of activities

Outcomes of documentation

Establish additional clinical services

Expand roles of existing services

Assess new processes

Provide data for quality assurance or research

Accreditation purposes

Promotional reasons

Assessment of financial impact
Implementing New Services:
Overview

Four stages to developing plan for new
clinical services

Complete assessment of current clinical
services

Review of literature supporting clinical services

Development of clinical services

Implementation and assessment of new
services
Implementing New Services:
Assessment

Appraise current type of practice model

Assess performance of model


Number/Types of interventions

Type of direct patient care
Analyze productivity of pharmacists

Medication orders reviewed/verified

Clinical Interventions

Evaluate use of technology within
department/hospital

Review culture of physicians and nurses toward
pharmacy
Implementing New Services:
Review of current literature

Summary of literature regarding clinical pharmacy
service


Impact of pharmacist intervention
Identify and review pertinent health-system related
data

Patient outcome most associated with readmission rates

Patient outcomes associated with reduction in payment
from payors
Implementing New Services:
Development


Need clear vision and description of activities and
expectation

Mission statement

Job description with clear expectations for clinical
activities
Metrics need to be developed to demonstrate
effectiveness of clinical services

Should be developed in concert with key stakeholders

Example: Number/type of interventions, number of
patients educated, number of med recs completed, drug
cost avoided, time to verification
Implementing New Services:
Implementation

Most difficult phase

Should include timeline for implementation

Orientation and training of staff involved

Electronic/logistical updates

Development of infrastructure

Ongoing monitoiring and feedback to pharmacists about
clinical services

Ongoing shadowing and coaching of clinical pharmacists
Managing Clinical
Practitioners

Required duty of pharmacy management

Leadership and management skills

Requires understanding of roles and responsibilities

Self-reflection on state of clinical services

Maintenance of relationships with key hospital
personnel
Case Revisited

Dr. Smith, chief of cardiology at your institution has
requested that a new cholesterol drug De-Clogo be
added to hospital formulary

The drug was recently approved by the FDA and has a
similar mechanism to other formulary alternatives

You as the Clinical Coordinator are asked to review and
present the drug at your hospital’s next Pharmacy and
Therapeutics (P&T) Committee meeting
What things should be considered when evaluating addition
of a new drug to formulary?
Case Revisited


When considering a new agent for potential
formulary addition, drug monograph should be
presented, and the following should be
considered:

Efficacy

Safety issues

Cost-effectiveness
Based on review, De-Clogo should not be
recommended for formulary inclusion at this time

Lack of significant benefit compared to current
formulary options, and increased acquisition costs
Case Revisited

The Director of Pharmacy has asked you to evaluate
drug spend for the institution and look for opportunities
to reduce overall drug spend

You notice that Procrit (epoetin alfa) spend is increased
significantly from previous year

You suspect that Procrit utilization is increased due to
inappropriate use and have decided to complete a DUE
on Procrit
What things should you consider when completing a DUE?
Case Revisited

Review appropriate utilization of Epoetin alfa

KDIGO Clinical Practice Guidelines

Review appropriateness criteria with nephrologists

Collect data and evaluate the information

Develop opportunity for potential actions
Summary

Formulary management is a key aspect to promoting
safe, effective and responsible medication use within a
hospital

P&T Committee recommends formulary additions,
formulary deletions, and processes designed to improve
or guide medication use

Drug Use Evaluations are a tool used to observe and
identify opportunities to improve medication use

Various practice models exist each with different areas
of focus

Implementation of new clinical services should be
performed in a systematic way
Questions?
Email:
[email protected]