Managing formularies

1. Managing Formularies
Principles of a Sound Drug
Formulary System
A.Bahnassi PhD RPh CDM
Fall 2011
1
‫المستشفى‬‫أدوية‬‫دليل‬
‫البهنسي‬ ‫أنس‬ ‫الدكتور‬

2. LEARNING OBJECTIVES
After completing this lecture, students should be
able to:
1. Describe the purpose of a system in managing
medication use in institutions.
2. Discuss the organization and role of the
pharmacy and therapeutics committee.
3. Explain how formulary management works.
4. List the principles of a sound formulary system.
5. Define key terms in formulary management.
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3. Formulary Management
• Formulary
– Definition: A continually updated list of
medications and related information, representing
the clinical judgment of physicians, pharmacists,
and other experts in the diagnosis and/or
treatment of disease and promotion of health.
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4. Formulary Management
• Formulary system management
– Definition: An ongoing process whereby a health
care organization, through its physicians,
pharmacists, and other health care professionals,
establishes policies on the use of drug products
and therapies, and identifies drug products and
therapies that are the most medically appropriate
and cost-effective to best serve the health
interests of a given patient population.
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5. Formulary Management
• Formulary system management
– Theory: a well designed formulary can guide
physicians to prescribe the safest and most
effective agents for treatment of a particular
condition.
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6. Formulary Management
• Objectives
– Decrease drug cost
– Assure high quality care
– Provide information on drug products
– Provide information on organizational
policies/procedures
– Development of institution specific
guidelines/protocols
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7. Formulary Management
• Purpose for ongoing management
– Removal/addition of drugs from/to the market
– Changes in hospital policies/procedures
– New clinical information available
• Clinical trials
• Guidelines
• Safety
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8. Formulary Management
• Advantages
– Ensure quality and
appropriateness of drug
use
– Educational for staff
regarding most effective
agents
– Economic benefits
• Disadvantages
– Only reduces cost
– Compromises patient
care
– Limits physician
prescribing authority
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9. Formulary Management
• Principles
– Drug product selection
• Comparison of all aspects of an agent to that of similar
medications.
• Should be based on scientific evidence
• Consider effectiveness, safety and cost
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10. Formulary Management
• Principles
– Formulary Maintenance
• Addition/deletion
– Newly approved agents
– New information available (i.e. safety, efficacy)
– Tracking use of nonformulary agents
• Single drug review
– Compare single drug to other drugs that are similar
– Focus is on a single drug
• Therapeutic class review
– Compares/contrasts all the agents in a single class
– Focus is not on a single drug
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11. Drug Product Selection
• Development of a drug monograph
– Purpose: to evaluate various medications to
ensure that patients receive drugs that are
safe,therapeutically effective and cost effective
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12. Drug Product Selection
• Development of a drug monograph
– Preparation
• Identify drug to evaluate
• Determine if there are similar agents on formulary
• Obtain background information
– Clinical and safety information
– Indications
– Cost
– Clinical trials
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13. Drug Product Selection
• Development of a drug monograph
– Components
• Summary page
• Introduction
• Pharmacology
• Pharmacokinetics
• Clinical efficacy
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14. Drug Product Selection
• Development of a drug monograph
– Components (cont)
• Adverse effects
• Drug Interactions
• Cost and dosage
• Conclusion/Recommendations
• References
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15. Drug Product Selection
• Points to consider – addition to formulary
– Clinical effectiveness, safety, and cost
– Comparison to similar agents
– Comparison to standard therapies
– Advantages/disadvantages
– Niche
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16. Drug Product Selection
• Generic Substitution:
– Definition: The substitution of drug products that
contain the same active ingredient(s) and are
chemically identical in strength, concentration,
dosage form, and route of administration to the
drug product prescribed.
Approved Drug Products with Therapeutic Equivalence Evaluation
the Orange Book
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
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17. Drug Product Selection
• Therapeutic Alternate:
– Definition: Drug products with different chemical
structures but which are of the same
pharmacological and/or therapeutic class, and
usually can be expected to have similar
therapeutic effects and adverse reaction profiles
when administered to patients in therapeutically
equivalent doses.
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18. Drug Product Selection
• Therapeutic substitute:
– Definition: The act of dispensing a therapeutic
alternate for the drug product prescribed without
prior authorization of the prescriber.
This is an illegal act because only the prescriber
may authorize an exchange of therapeutic
alternates.
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19. Drug Product Selection
• Therapeutic Interchange
– Definition: Authorized exchange of therapeutic
alternates in accordance with previously
established and approved written guidelines or
protocols within a formulary system.
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20. Drug Product Selection
• Therapeutic interchange
– Elements for successful implementation
• P&T approval
• Scientific/clinical evidence
• Medical staff education
• Mechanism to implement interchange
• Maintenance
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21. Drug Product Selection
– Therapeutic interchange process
• Substitute generic for brand
• Give individual agents in place of combination product
• Switch from intravenous to oral antibiotics
• Change to different agent in same class
• Interchange may be automatic or may require
notification
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22. Therapeutic Interchange
• Advantages
– Reduced inventory
– Hospital saves money
– Encourages compliance
with formulary
• Disadvantages
– Confusing to patients
– Patients may think that
drugs are NOT equally
effective
– Preferred product may
change based on
contracts
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23. Nonformulary Agent
A medication that is not a part of the drug
formulary. This may be due to the medication
not being considered for formulary addition or
the medication being considered but the P&T
committee choosing not to add it.
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24. Formulary Management Process
Pharmacy
Staff
Medical Staff Professional
Staff
Medical Executive Committee
Health System Board
P&T Committee
• Meets 6 times/yr
• Review and act on
recommendations
• Formulate Implementation
Drug Review
Panel
Safety
Committee
Medical and Hospital Staff Notification
Medication
Use Review
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25. P&T
Committee
Drug Review Panel
• Focused on a particular
specialty such as cardiology
or infectious disease and
review drug products and
guidelines in their area of
specialty.
Drug Safety Committee
• Charged with review of
adverse drug events and
medication errors, their
trending, and development
of plans for prevention.
Medication Use Review
• Monitor one or more
medications use reviews,
evaluate the data and
development plans to
optimize specific drug use.
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26. Guiding Principles of a Sound Drug
Formulary System
Formulary system decisions are based on
scientific and economic considerations that
achieve:
 Appropriate
 Safe and
 Cost-effective drug therapy.
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27. Clinical decisions are based on
 Assessing peer-reviewed medical literature, including randomized
clinical trials (especially drug comparison studies),
pharmacoeconomic studies, and outcomes research data.
 Employing published practice guidelines, developed by an
acceptable evidence-based process.
 Comparing the efficacy as well as the type and frequency of side
effects and potential drug interactions among alternative drug
products.
 Assessing the likely impact of a drug product on patient
compliance when compared to alternative products.
 Basing formulary system decisions on a thorough evaluation of the
benefits, risks, and potential outcomes for patients; risks
encompass adverse drug events (adverse drug reactions and
medication errors, such as those caused by confusing product
names or labels).
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28. Economic considerations include:
 Basing formulary system decisions on cost
factors only after the safety, efficacy, and
therapeutic need have been established.
 Evaluating drug products and therapies in terms
of their impact on total health care costs.
 Permitting financial incentives only when they
promote cost management as part of the
delivery of quality medical care. Financial
incentives or pressures on practitioners that may
interfere with the delivery of medically
necessary care are unacceptable.
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29. P&T Committee Membership
Even though it is called the Pharmacy and
Therapeutics committee, representation on the
committee often includes physicians, nurses,
and respiratory therapists given their roles
within the medication use process. The
collective efforts of all of the disciplines is
needed to achieve optimal health outcomes.
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30. Responsibilities
• Establishes and maintains the formulary system.
• Selects medications for formulary inclusion by considering the
relative clinical, quality of life, safety, and pharmacoeconomic
outcomes. Decisions should be balanced to all of the above.
Decisions should include consideration of continuity of care (e.g.,
local health plan formularies).
• Evaluates medication use and related outcomes.
• Prevents and monitors adverse drug reactions and medications
errors.
• Evaluates or develops and promotes use of drug therapy guidelines.
• Develops policies and procedures for handling medications to
include their procurement prescribing, distribution, and
administration.
• Educates health professionals to the optimal use of medications.
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31. Formulary System Maintenance
The committee develops a list of medications for
use in the organization. They may also develop
guidelines for the optimal use of the
medications and/or for specific disease
management.
They review the medication list and guidelines
on a regular basis to assure that it is current and
meets the needs of the medical staff and
patients.
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32. Medication Selection and Review
The committee should have established methods for
medication selection and review.
A written medication review is prepared from available
literature.
The review should be unbiased, as should the discussion
of the review.
Meeting participants (committee members and guests)
should be required to discuss any conflict of interests
prior to discussion of the drug or drug class.
Medication selection criteria should include medication
efficacy, safety, and cost.
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33. Barriers to Optimal Formulary Decisions
 Physicians experience with the drug under
consideration.
 Physicians preference of other agents.
 Detailing by pharmaceutical representatives.
 Unpublished or anecdotal studies and reports.
Selection criteria should be such to minimize
these barriers
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34. Medication Safety Evaluation
Medication safety is evaluated through adverse
drug reactions reports, and medication errors
reports.
 These reports can be local or global.
 The impact of these reports should be
considered relative to the health system
population, resources, and alternatives.
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35. Drug Therapy Guidelines
Listing of the indications, dosage regimens,
duration of therapy, mode(s) of administration,
monitoring parameters and special considerations
for use of a specific medication or medication class.
 These guidelines are developed with the
oversight of practitioners with expertise in the
use of a specific medication or management of
a disease state.
 The guidelines are often put into practice via a
pre-printed physician order sheet placed in the
patient chart or computerized order set.
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36. Drug Therapy Guidelines
 The development of drug therapy guidelines is often the result
of a medication use review or medication safety evaluation.
 A review of this data may indicate that the drug is not being
used in an optimal manner with regard to patient selection,
dosage, frequency, route, length of therapy, or a combination.
 The development and implementation of drug therapy
guidelines may foster the safe, efficacious and cost effective
use of selected drug products.
 Education of the professional and medical staff to these
guidelines is critical to their success.
 Just as important is a method for routine review of the
guidelines to assure they are current.
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37. Policy and Procedure Development
 The development of guidelines on historically
pharmacy related topics of medication procurement,
selection, and distribution.
 Medication administration process which includes
determining what medications are administered in
specific locations for the hospital (i.e., intensive care
unit) or under specific conditions (i.e., by
chemotherapy certified nurse).
 Finally, they define the formulary management
process, specifically, guidelines for the evaluation of
medications by the P&T committee, frequency of such
review, maintenance of the medication list, etc…
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38. Education
 The P&T committee must communicate its
actions to health-system staff and physicians.
 A newsletter is often employed to communicate
these decisions.
 The newsletter may also include clinical
information on drugs added to the formulary,
drug therapy guidelines developed, and
medication safety information available.
 The success of a newsletter may be limited by
the format and content.
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39. The pharmacist role in the formulary
management process
 Establish P&T committee meeting agenda.
 Analyze and disseminate scientific, clinical, and health
economic information regarding a medication or
therapeutic class for review by the P&T committee.
 Conduct drug use evaluation and analyze data.
 Record and archive P&T committee actions.
 Follow-up with research when necessary.
 Communicate P&T committee decisions to other
health care professionals such as pharmacy staff,
medical staff, and patient care staff.
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40. Formularies
Open
Formulary
Closed
Formulary
A list of medications which
has no limitation to access
to a medication by a
practitioner.
A list of medications which
limits access of a
practitioner to some
medications. It may limit
drugs to specific physicians,
patient care areas, or
disease states via formulary
restrictions.
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41. The act of limiting the use of
specific formulary medications
to specific physicians based on
areas of expertise (e.g.,
cardiology), patient disease
state (e.g., acute myocardial
infarction), or location (e.g.,
operating room).
Formulary Restriction:
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42. Guidelines to generic and therapeutic
interchange
The pharmacist is responsible for selecting
generically equivalent products in concert
with FDA regulations.
Prescribers may specify a specific brand if
clinically justified. The decision should be
based on pharmacologic and/or therapeutic
considerations relative to the patient.
The P&T committee determines therapeutic
equivalents and how they are processed.
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43. Formulary Maintenance
The ongoing process of assuring relative safety and
efficacy of agents available for use in the health-
system.
Processes used in formulary maintenance
include the following:
 New product evaluation
 Therapeutic class review
 Formulary changes (rationale for retaining or
deleting an agent from the formulary)
 Nonformulary drug use review
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44. New Product Evaluation
Pharmacists have the opportunity to assume a
leadership role in the selection of agents to the
formulary.
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45. Drug Utilization Review
Process used to assess the appropriateness of
drug therapy by engaging in the evaluation of
data on drug use in a given health care
environment against predetermined criteria and
standards.
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46. Drug Use Evaluation (DUE) vs.
Medication Use Evaluation (MUE)
• A systematic process used to assess the appropriateness of drug
therapy by engaging in the evaluation of data on drug use in a given
health care environment against predetermined criteria and
standards. Medication use evaluation (MUE) encompasses the goals
and objectives of DUE in its broadest application, with an emphasis
on improving patient outcomes.
• Use of MUE rather than DUE emphasizes the need for a more
multifaceted approach to improving medication use.
The differences between MUE, DUE, and outcomes assessment are arbitrary.
Nevertheless, these definitions have evolved in response to a tendency for some
pharmacists to only see medication use as it relates to the world of pharmacy. Therefore,
compliance with formulary restrictions, pharmacy policies and procedures, and other
processes are sometimes emphasized over the actual outcomes achieved by patients.
Redefining terminology can refocus efforts of medication use evaluation toward achieving
the goal of positive patient outcomes.
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47. Drug Use Evaluation
FOCUS-PDCA
 Find process to improve
 Organize a team that
knows the process
 Clarify current
knowledge of the
process
 Understand causes of
process variation
 Select process
improvement
 Plan
 Do
 Check (or Study)
 Act
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48. Antibiotic Prophylaxis for Surgery Patients (PDCA Model)
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49. Summary
• The pharmacist plays a critical role in the
management of medication use in the health-
system.
• As the drug expert, the pharmacist can assure
safe, efficacious, and cost effective drug use
through the formulary system.
• Ongoing formulary maintenance and routine drug
use evaluations are key elements in this process.
• Focused consideration of medication safety in all
medication related discussions optimizes
formulary system management.
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