Chapter 4: Medication Management
products and therapies.
Terms and Definitions:
Closed formulary list of medications
which limits access of a practitioner to
some medications, limit drugs to
specific physicians
Drug formulary formulary is a
continually updated list of medications
Drug monograph written, unbiased
evaluation of specific medication
Drug therapy guidelines document
describing the indications, dosage
regimens for used of a specific
medication or medication clas
Drug use evaluation (DUE) process
used to assess the appropriateness of a
drug therapy by engaging in evaluation
of data
Diagnosis related DUE drug use
evaluation completed on patients
with specific disease state or
diagnosis
Prescriber-related DUE drug use
evaluation completed on patients
managed by specific physician
Drug-specific DUE drug use
evaluation completed on a drug
FOCUS-PDSA performance
improvement model used by hospitals
and health systems. Includes measuring
the output of the process and
modifying the process to improve the
outcome
Formulary restriction act of limiting
the use of specific formulary
medications to specific physicians based
on areas of expertise
Formulary system ongoing process
whereby a health care organization,
establishes policies on the use of
Health-system board committee of
hospital and community members
chosen to govern the affairs of hospitals
Medical executive committee
committee of hospital medical staff that
has the primary authority for act
related to self governance
Medication use review performance
improvement method that focus on
evaluating and improving medication
use process
Nonformulary agent medication that
is no part of the drug formulary
Open formulary list of medications
which has no limitations to access to a
medication by a practitioner
Order entry rules logic established
within the hospital info system
Outcome assessment systematic
process of evaluating the
appropriateness, safety, abd efficacy of
medication
Pop-ups info that appears on
computer monitor when specific
actions are taken
Stop orders physician orders that are
automiatically terminated
P&T committee establish stop
orders
Therapeutic class review evaluation of
group medications with an established
therapeutic class
Therapeutic equivalent drug products
with different chemical structures but
same pharmacological or therapeutic
class
Therapeutic interchange authorized
exchange of therapeutic alternatives in
accordance with previously established
 INTRODUCTION
Medication use management process
used to assure the safe and effective
use of drugs in a cost conscious manner
Formulary system key to medication
management in the health system
environment
FORMULARY SYSTEM
- List of medications routinely stocked by
health care system
- Developed in 1950, initially used to assure
that physicians had adequate and
consistent supply of medications for their
day to day needs.
Key purpose:
- Discourage the use of marginally effective
drugs
- Continually updated list of medications
and related information, representing the
clinical of pharmscists
Formularies fundamental to the
formulary system
- Ongoing process which evaluates
medication on ongoing basis
- Managed by P&T committee
Primary advantage:
- Provides a systematic method to review
scientific evidence
Disadvantage:
- Reduce the quality of care by limiting
access to clinically indicated medications
PHARMACY AND THERAPEUTICS COMMITTEE
- Oversight for medication management in
the health system
Organization
Committee policy recommending
body to medical staff thru medical
executive committee group of
hospital medical staff in charge of
institutional governance and
performance.
Health system board non medical
staff advisory committee of hospital
and community members
Meetings 4-6 times (60-90 mins)
Subcommittees:
Medication safety task force
charged with review of adverse
drug events and medication errors
Drug review panels focused on
particular specialty such as
cardiology and infectious disease
Medication use review task
monitor one or moe medicatioin
use review, evaluate the data and
development plans to optimize
specific drug use
Committee Membership
- Include pharmacists, nurses, physicians,
administrators, risk or quality
improvement managers
Medication management
multidisciplinary process, include
nonphysician members
Responsibilities
- Establish the formulary system
- Selects medications for formulary inclusion
- Evaluates medication use
- Prevents adverse drug reactions
- Evaluates drug therapy guidelines
 - Develops policies for handling medications
- Educates health professionals to optimal
use of medications
Formulary system maintenance
- Develops a list of medications for use in
organization
- Develop guidelines for optimal use of
medications
- Review the medication list
Medication Selection and Review
- Established methods for medications
selection and review
- Written medication review is prepared
from available literature
Medication selection critera:
Is it a duplication of existing
formulary agent?
How should it be used?
When I should it be used?
Who should use it?
Are there any special concerns?
Medication Use Evaluation (MUE)
- Methods for evaluating and improving the
medication use processes with the goal of
optimal patient outcomes
Key to the process:
Data to review
Action plan development
Follow up
Medication Safety Evaluation
- Evaluated thru adverse drug reaction
reports and medication error reports
(maybe local or global)
- Considered relative to the health system
population, resources and alternatives
- Used in considering whether a drug should
be added to the formulary, retained to
formulary, deleted from formulary
Drug Therapy Guidelines
- Listing of the indications, dosage regimens,
duration of therapy, models of
administration etc.
- Developed with oversight of practitioners
with expertise on the use of specific
medication or management of a disease
state.
- Put into practice via pre-printed physician
order sheet
- Result of a medication use review or
medication safety evaluation
Policy and Procedure Development
P&T committee responsible for
medication use in the hospital
- Development of guidelines, responsible for
the medication administration process
- Define the formulary managememt
process
Education
Newsletter employed to
communicate these decisions
- Include clinical information on drugs added
to the formulary, drug therapy , guidelines
developed and medication safety info
- Limited to 2-4 pages
REGULATORY AND ACCREDITING BODIES
- Require a P&T committee and define its
membership and responsibilities.
Regulatory bodies requiring:
 State Department of Health or
Board of Pharmacy
Accrediting bodies requiring this activity:
The Joint Commission
American Osteopathic Association
(AOA)
Commission on Accreditation of
Rehabilitation Facilities (CARF)
- These standards are dynamic and require
vigilance by the pharmacy to assure
compliance
PHARMACIST ROLE
- Pharmacists will guide the P&T committee
act to assure optimal medication
management
Establish P&T committee meeting
agenda
Analyze and disseminate scientific
Conduct drug use evaluation and
analyze data
Record and archive P&T committee
actions
Follow up with research
Communicate P&T committee
decisions
FORMULARY MANAGEMENT
Formulary foundation of the
formulary system
- List of medications available for use at
hospital or health system
- Includes dosage forms, strengths and
packages sizes
Patient care considerations include
medication efficacy and safety
Financial considerations cost of the
drug and cost associated with stocking
Open formularies no limitation to
access to a medication, generally large
Closed formulary limited list of
medications, limit to drugs to specific
physicians, patient care areas or disease
states via formulary restrictions
Formulary restrictions limitation of an
antibiotic to restricted status
Institute of Medicine (IOM) evaluated
the Veterans Administration (VA)
National Formulary
Food and Drug Administration (FDA)
defines the equivalence of individual
chemical entities or generic equivalents
Approved Drug Products with
Therapeutic Equivalence Evaluation
known as Orange Book
Therapeutic equivalents drug
products with different chemical
structure but are of the same
pharmacologic or therapeutic class and
have similar therapeutic effects and
adverse (Cephalosporins and histamine
2 blockers)
Therapeutic interchange authorized
exchange of therapeutic alternatives in
accordance with established and
approved written guidelines
P&T guidelines:
Pharmacist responsible for
selecting generically equivalent
products
Prescribers specify a specific
brand
P&T committee determines
therapeutic equivalents
Pharmacist responsible for the quality,
quantity and source of all medications
Formulary maintenance ongoing
process of assuring relative safety and
 efficacy of agents available for use in
the health system
Processes used in formulary maintenance:
New product evaluation
Therapeutic class review
Formulary changes
Nonformulary drug use review
New Product Evaluation
Generic name list officially approved
name of all chemical entities in the drug
product
Trade name list common trade names
of drug product
Therapeutic or pharmacologic class
state the pharmaceutical or therapeutic
class to which the agent belongs
Pharmacology describe the
mechanism of action and related
pharmacologic effects of drug
Pharmacokinetics describe how the
drug is handled by the body
Indications for use state the
indications approved for use by the FDA
Clinical studies describe clinical study
data supporting the indications for use
Adverse effects/ warning adverse
effects associated with drug and
frequency of occurrence
Drug interactions list drug drug and
drug-food interactions associated with
this agent
Dosage range list of dosage range for
a different routes of administration and
indication for the drug
Dosage form and cost list the dosage
form and strengths proposed for a
formulary addition
Summary summarize the info
provided in a single paragraph
Recommendation state the
recommendation and rationale for the
recommendation
References list of references used
Sources: American Hospital Formulary Service
Drug Information and Drug Facts and
Comparisons
THERAPEUTIC CLASS REVIEW
- Should not be so broad or all inclusive so
as to not be meaningful
- Might include new medical info, adverse
event profiles, purchase or use data and
cost
FORMULARY CHANGES
- Method for making additions and deletions
to the formulary
- May be written and verbal
Requirement:
Agent to be considered for addition
or deletion
Rationale for request
Alternative agents current in
formulary
NONFORMULARY DRUG REVIEW
- Prevent the erosion of the formulary
system by overuse of nonformulary agents
- Process should include a policy for the use
of nonformulary drugs..
DRUG USE EVALUATION
DUE systematic process used to
assess the appropriateness of drug
therapy by engaging in the evaluation
of data
 Medication Use Evaluation (MUE)
encompasses the goals and objectives
of DUE
- Emphasizes the need for a more
multifaceted approach to improving
medication use
- Established in 1980
- Provide ongoing structurd, organized
approach to ensure that drugs are use
appropriately
Outcome assessment used to describe
such programs
FOCUS-PDCA
F Find process to improve
O- Organize a team that knows the process
C- clarify current knowledge of process
U understand causes of process variation
S- select process improvement
Plan
Do
Check
Act
Thrombolytic high cost, high risk
Antibiotics high use
Diagnosis-related DUE identify
indications for which select drugs may
be appropriate for a given disease state
Prescriber- related DUE identify
specific physicians whom the P&T
committee has determined may use
certain drugs
Drug- specific DUE focus on specific
aspects of a select drug such as dose or
dosing frequency
MEDICATION USE POLICIES
- Critical in the management of medications
in the health care settings
Policies:
Formulary managements
P&T committee
Medication prescribing, dispensing,
administration
Formulary Management
Formulary policies include info on
who may use a specific agent, how drug
is added an deleted
Formulary restriction policy define
how items are selected for formulary
restriction
- Describe the method for a drug addition
and deletion as well as nonformulary drug
use.
PHARMACY AND THERAPEUTICS COMMITTEE
Medication Prescribing, Dispensing, and
Administration
Writing medication orders or
prescriptions defines practitioners
that may write medication orders in
concert with state and federal
regulations
Verbal orders defines who accept a
verbal order and the transcription
process of such an order
Stop orders defines the orders that
are automatically terminated, how the
prescriber is notified, if appropriate,
and the method for their reinstatement
Investigational drug orders defines
how investigational drugs are managed
in the health care system
Controlled substances define the flow
of controlled substances thru the health
care system
Generic and therapeutic substitution
defines how a drug is selected for
generic substitution and therapeutic
 equivalents approved by the P&T - Inclusion of information on prescribing,
committee. dispensing, administration of medications
Self-administration of medications in published formulary
defines the conditions and process for
Medication Use Guidelines
the administration of medication by the
patient in the hospital setting - Detail guidelines for medication use, which
Medication samples defines the are approved or endorsed by P&T
conditions and process for use of committee.
medication samples in hospital
Floor stock defines criteria for Publishing the Formulary
selecting agents for floor stock, process
- Must be published regularly.
for modifying the stock
Definition of order interpretation
defines meaning of specific types of
orders including sliding scale orders
Medication administration times
define specific medication
administration times and rules for
interpretation
Adverse drug reactions defines an
adverse, the reporting process,
monitoring methods
Ethers include pharmaceutical
representatives

PUBLISHED FORMULARY

- Provide information on the medications

approved for use

Medication List

Key element:

- List of medications approved for use,

entries for each medications and indexes
to facilitate use
Index assist the user in locating the
medication entry by generic name, both
generic and trade name entries

Medication Use Policy and Procedures