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Chapter 4: Medication Management Medication management is a

multidisciplinary process
Key Terms & Definitions
Drug monograph written, unbiased Responsibilities
evaluation of a specific medication ; drug Establish & maintain the formulary
name, therapeutic class, pharmacology, system
indications, clinical trials, ADE, drug Select medications for inclusion by
interactions considering clinical, quality of life, safety
& pharmacoeconomic outcomes
The Formulary System Evaluates med use outcomes
ongoing process whereby a HCO establishes Monitors adverse drug reactions
policies on the use of drug products & therapies Develops policies & procedures for
Drug Formulary continually updated handling medications
list of medications & related info, Educate health professionals
representing the clinical judgment of Formulary System Maintenance
RPh, physicians & other experts in Review medication list & guidelines on a
treatment of disease & promotion of regular basis
health Medication Selection and Review
List of medications routinely stocked Established methods for medication
developed in the 1950s as a selection & review
management tool ; discourage the use of Med.selection criteria: med efficacy,
marginally effective drugs & treatments safety & cost
Element of a system that includes med. Barriers to optimal formulary decisions
Use policies, PT&C, med use evaluation, o Physician experience w/ drug &
& formulary management preference
Advantage: provides a systematic o Detailing by pharmaceutical
method to review scientific evidence on company representatives
clinical effectiveness in drug selection o Unpublished / anecdotal studies
decision Medication Use Evaluation ( MUE )
Disadvantage: overly restrictive Method for evaluating & improving med-
formulary, limited access to medications use process w/ the goal of optimal
patient outcomes
Pharmacy & Therapeutics Committee Foundation of med-use process
Organization o Establish a specific criteria for use
o Review for compliance ; Routine
Committee is a policy recommending
review of data
body to the medical staff
Key to process timely data to review,
Medical executive committee grp of the
action plan development , follow up
hospital medical staff in charge of
Medication Safety Evaluation
institutional governance & performance ;
w/ primary authority for activities related Evaluated through adverse drug reaction
to self governance & performance reports & medication error reports
improvement Drug Therapy Guidelines
Health-system board - non-medical staff Listing of the indications, dosage
advisory committee of hospital members regimens, duration of therapy, mode of
& community members that governs the administration, monitoring parameters &
affairs of hospital special preacautions
Subcommittees / task forces facilitate Developed w/ the oversight of
meeting efficiency practitioners w/ expertise in the
o Medication safety review of management of disease
adverse drug events & med errors o Use of pre-printed physician order
o Medication use review sheet
performance-improvement Policy and Procedure Development
method that focuses on Medication administration process
evaluating & improving med-use Medications administered in specific
processes for optimal pt outcomes locations
o Drug review panels review drug Education
in an area of specialty ( cardiology Newsletter that includes clinical info on
) drugs
Presentation at meetings, health-system
Committee Membership website
RPh, nurses, physicians, administrators,
risk / quality improvement managers Regulatory & Accrediting Bodies
RB: State Dept of Health , Board of o Therapeutic class review
Pharmacy evaluation of a group of
AB: TJC , AOA, Commission on medications w/ an established
Accreditation of Rehabilitation Facilities therapeutic class ; indication for
( CARF ) use, dynamics, ADE, drug
interactions
Pharmacist Role o Formulary changes
Establish P&T committee meeting o Nonformulary drug use review
Analyze & disseminate scientific, clinical
information New Product Evaluation ( standard
Conduct drug use evaluation elements )
Record & archive P&TC committee Generic name name of all chemical entities
Trade name
actions
Therapeutic / Pharmacologic Class
Follow-up w/ research
Pharmacology mechanism of action &
Communicate PTC decisions to other
pharmacologic effects
health care professionals Pharmacokinetics how drug is handled by
the body, onset of effect, serum half-life,
Formulary Management metabolic considerations, route of excretion
Open Formularies generally large, no Indications for use
limitation to access to a medication Clinical studies clinical study data
Closed formularies limited list of supporting indications for use ( statistical
analysis, outcomes, info on patient info )
medications to specific physicians,
Adverse effects/ warnings methods to
patient care areas, disease states via reduce , risk & benefit of drug therapy,
formulary restrictions precautions in pregnancy, etc
Drug interactions drug-drug, drug-food
Formulary Restrictions act of limiting the Dosage range dosage range for diff routes,
use fo specific formulary medications to age, hepatic function
specific physicians based on areas of Dosage form and cost table listing
expertise comparable agents may be useful in
Institute of Medicine ( IOM ) evaluated formulary addition
Summary
the Veterans Administration ( VA )
Recommendation formulary addition,
National Formulary impact on health care restriction, deletion
costs in six closed or preferred class of References peer-reviewed primary literature
drugs
FDS defines the equivalence of indiv Therapeutic Class review
chemical entities or generic equivalents Should not be too broad or all inclusive
o Approved Drug Products w/ New medical info, adverse event profiles,
Therapeutic Equivalence Orange purchase or use data
Book Objective; have the optimal agents w/in
Therapeutic Equivalents
each consideration
o Drug products w/ diff chemical
structure but same pharmacologic
Formulary Changes
/ therapeutic class and effects
Process to continually update the
( ex. 1st gen. cephalosporin ,
formulary must be established
histamine-2 blockers )
Submission of request for making
Therapeutic Interchange
o Authorized exchange of additions & deletions ( agent to be
therapeutic alternatives in added/deleted, rationale for request,
accordance w/ previously alternative agents )
approved guidelines ; must
include dosage strength, Nonformulary Drug Review
frequency, & route of Nonformulary agent medication not
administration part of drug formulary ; not considered
Guidelines for generic substitution but P&TC choosing to add it
o RPh is responsible for selecting Automating medication prescribing
generic drugs ; P&TC determines process
therapeutic equivalents o Computerized prescriber order
o Prescribers may specify a specific entry
brand if clinically justified o Order Entry Rules logic
Formulary maintenance ongoing established w/in the hospital info
process of assuring relative safety & system order entry module to
efficacy of agents available for use notify prescribers of adverse
o New product evaluation effects ; include weight based
dosing, laboratory tests, allergy Clarify current knowledge
checks Understand causes of process
o Pop-ups info that appears on a variation
Select process improvement
computer monitor when a specific
Plan ; Do ; Check ( or study ) ;
actions are taken ; may contain
Act
clinical info about med use, drug Medication use criteria
interactions o Diagnosis-related DUE criteria
identify indications for w/c select
Drug Use Evaluation ( DUE ) drugs may be appropriate for a
Systematic process used to assess the given disease
appropriateness of drug therapy by o Prescriber-related DUE identify
engaging in the evaluation of data on specific physicians whom the
drug use P&TC has determined may use
Medication Use Evaluation ( MUE ) certain drugs
encompasses the goals & objectives of o Drug-specific DUE focus on
DUE in its broadest application specific aspects of select drug
first established in 1980s such as dose or frequency
provide an ongoing, structured, Data should be collected during the
organized approach to ensure that drugs patient visit ( concurrent ) rather than
are used appropriately retrospectively ( chart review )
Outcome assessment systematic Technology: Personal Data Assistant
process of evaluating the ( PDA )
Task force should develop an action plan
appropriateness, safety, & efficacy of a
& criteria
medication ; review of pt medical records
Action plan: devlpt of drug use
Multiple performance improvement
guidelines, preprinted orders, med order
models
o FOCUS-PDCA ( or PDSA ) netry rules, formulary changes
Find process to improve
Organize a team that knows

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