Chapter

4: Medication Management • Select medications for inclusion by considering

clinical, quality of life, safety &
Key Terms & Definitions pharmacoeconomic outcomes
• Drug monograph – written, unbiased • Evaluates med use outcomes
evaluation of a specific medication; drug name, • Monitors adverse drug reactions
therapeutic class, pharmacology, indications, • Develops policies & procedures for handling
clinical trials, ADE, drug interactions medications
• Educate health professionals
The Formulary System Formulary System Maintenance
– ongoing process whereby a HCO establishes policies on • Review medication list & guidelines on a regular
the use of drug products & therapies basis
• Drug Formulary – continually updated list of Medication Selection and Review
medications & related info, representing the • Established methods for medication selection &
clinical judgment of RPh, physicians & other review
experts in treatment of disease & promotion of • Med.selection criteria: med efficacy, safety & cost
health • Barriers to optimal formulary decisions
• List of medications routinely stocked o Physician experience w/ drug &
• developed in the 1950s as a management tool ; preference
discourage the use of marginally effective drugs o Detailing by pharmaceutical company
& treatments representatives
• Element of a system that includes med. Use o Unpublished / anecdotal studies
policies, PT&C, med use evaluation, & formulary Medication Use Evaluation ( MUE )
management • Method for evaluating & improving med-use
• Advantage: provides a systematic method to process w/ the goal of optimal patient outcomes
review scientific evidence on clinical • Foundation of med-use process
effectiveness in drug selection decision o Establish a specific criteria for use
• Disadvantage: overly restrictive formulary, o Review for compliance ; Routine review
limited access to medications of data
• Key to process – timely data to review, action
Pharmacy & Therapeutics Committee plan development , follow up
Organization Medication Safety Evaluation
• Committee is a policy recommending body to the • Evaluated through adverse drug reaction reports
medical staff & medication error reports
• Medical executive committee – grp of the Drug Therapy Guidelines
hospital medical staff in charge of institutional • Listing of the indications, dosage regimens,
governance & performance ; w/ primary duration of therapy, mode of administration,
authority for activities related to self governance monitoring parameters & special precautions
& performance improvement • Developed w/ the oversight of practitioners w/
• Health-system board - non-medical staff expertise in the management of disease
advisory committee of hospital members & o Use of pre-printed physician order sheet
community members that governs the affairs of Policy and Procedure Development
hospital • Medication administration process
• Subcommittees / task forces – facilitate meeting • Medications administered in specific locations
efficiency Education
o Medication safety – review of adverse • Newsletter that includes clinical info on drugs
drug events & med errors • Presentation at meetings, health-system website
o Medication use review – performance-
improvement method that focuses on Regulatory & Accrediting Bodies
evaluating & improving med-use • RB: State Dept of Health , Board of Pharmacy
processes for optimal pt outcomes • AB: TJC , AOA, Commission on Accreditation of
o Drug review panels – review drug in an Rehabilitation Facilities ( CARF )
area of specialty ( cardiology )
Pharmacist Role
Committee Membership • Establish P&T committee meeting
• RPh, nurses, physicians, administrators, risk / • Analyze & disseminate scientific, clinical
quality improvement managers information
• Medication management is a multidisciplinary • Conduct drug use evaluation
process • Record & archive P&TC committee actions
• Follow-up w/ research
Responsibilities • Communicate PTC decisions to other health care
• Establish & maintain the formulary system professionals

Formulary Management • Dosage form and cost – table listing comparable
• Open Formularies – generally large, no limitation agents may be useful in formulary addition
to access to a medication • Summary
• Recommendation – formulary addition, restriction,
• Closed formularies – limited list of medications
deletion
to specific physicians, patient care areas, disease
• References –peer-reviewed primary literature
states via formulary restrictions

• Formulary Restrictions –act of limiting the use fo
Therapeutic Class review
specific formulary medications to specific
• Should not be too broad or all inclusive
physicians based on areas of expertise
• New medical info, adverse event profiles,
• Institute of Medicine ( IOM ) evaluated the
purchase or use data
Veterans Administration ( VA ) National
• Objective; have the optimal agents w/in each
Formulary impact on health care costs in six
consideration
closed or preferred class of drugs

• FDS defines the equivalence of indiv chemical
Formulary Changes
entities or generic equivalents
• Process to continually update the formulary
o Approved Drug Products w/
must be established
Therapeutic Equivalence – Orange Book
• Submission of request for making additions &
• Therapeutic Equivalents
deletions ( agent to be added/deleted, rationale
o Drug products w/ diff chemical
for request, alternative agents )
structure but same pharmacologic /

therapeutic class and effects ( ex. 1st gen.
Nonformulary Drug Review
cephalosporin , histamine-2 blockers )
• Nonformulary agent – medication not part of
• Therapeutic Interchange
drug formulary ; not considered but P&TC
o Authorized exchange of therapeutic
choosing to add it
alternatives in accordance w/
• Automating medication prescribing process
previously approved guidelines ; must
o Computerized prescriber order entry
include dosage strength, frequency, &
o Order Entry Rules – logic established
route of administration
w/in the hospital info system order
• Guidelines for generic substitution
entry module to notify prescribers of
o RPh is responsible for selecting generic
adverse effects ; include weight based
drugs ; P&TC determines therapeutic
dosing, laboratory tests, allergy checks
equivalents
o Pop-ups – info that appears on a
o Prescribers may specify a specific brand
computer monitor when a specific
if clinically justified
actions are taken ; may contain clinical
• Formulary maintenance – ongoing process of
info about med use, drug interactions
assuring relative safety & efficacy of agents

available for use
Drug Use Evaluation ( DUE )
o New product evaluation
• Systematic process used to assess the
o Therapeutic class review – evaluation of
appropriateness of drug therapy by engaging in
a group of medications w/ an
the evaluation of data on drug use
established therapeutic class ; indication
• Medication Use Evaluation ( MUE ) –
for use, dynamics, ADE, drug
encompasses the goals & objectives of DUE in its
interactions
broadest application
o Formulary changes
• first established in 1980s
o Nonformulary drug use review
• provide an ongoing, structured, organized

approach to ensure that drugs are used
New Product Evaluation ( standard elements )
• Generic name – name of all chemical entities appropriately
• Trade name • Outcome assessment – systematic process of
• Therapeutic / Pharmacologic Class evaluating the appropriateness, safety, & efficacy
• Pharmacology – mechanism of action & of a medication ; review of pt medical records
pharmacologic effects • Multiple performance improvement models
• Pharmacokinetics – how drug is handled by the body, o FOCUS-PDCA ( or PDSA )
onset of effect, serum half-life, metabolic § Find process to improve
considerations, route of excretion § Organize a team that knows
• Indications for use § Clarify current knowledge
• Clinical studies – clinical study data supporting § Understand causes of process
indications for use ( statistical analysis, outcomes, info variation
on patient info ) § Select process improvement
• Adverse effects/ warnings – methods to reduce , risk § Plan ; Do ; Check ( or study ) ; Act
& benefit of drug therapy, precautions in pregnancy
• Drug interactions – drug-drug, drug-food
• Dosage range – dosage range for diff routes, age,
hepatic function
 • Medication use criteria • Floor Stock – criteria for selecting agents for floor
o Diagnosis-related DUE –criteria identify stock
indications for w/c select drugs may be • Definition of order interpretation – meaning of
appropriate for a given disease specific types of orders ( sliding scale orders, ranger
orders, needed, tapering, titrating orders)
o Prescriber-related DUE – identify
• Medication Administration times – specific time &
specific physicians whom the P&TC has
rules for interpretation
determined may use certain drugs • Adverse Drug Reactions
o Drug-specific DUE – focus on specific • Medication errors
aspects of select drug such as dose or
frequency Published Formulary
• Data should be collected during the patient visit ( • Should provide info on the medications
concurrent ) rather than retrospectively ( chart approved for use, basic therapeutic information
review ) about each item
• Technology: Personal Data Assistant ( PDA )
• Task force should develop an action plan & Medication List
criteria • Includes entries for each medication and indexes
• Action plan: devlpt of drug use guidelines,
to facilitate use
preprinted orders, med order entry rules,
• Generic name of Primary active ingredient
formulary changes
• Trade or Synonym name that is commonly used

• Dosage form, strength, & size stocked
Medication Use Policies
• Active ingredients ( formulation )
• Formulary management ; P&T committee ;
• DEA schedule
medication prescribing, dispensing,
administration • Special precautions
• Pediatric / adult dosage ranges
Formulary Management • Cost information
• Should include information on who use a specific • Index arranged alphabetically or generically by
agent ; how a drug is added / deleted, stocked therapeutic class
• Formulary Restriction policy –define how items
are selected for formulary restriction, rationale Medication Use Policy & Procedures
for selecting prescribers, method of managing • Info on prescribing, dispensing, administration
process
• Formulary policy – describe the method for drug Medication Use Guidelines
addition & deletion ( chemical entity , dosage • Detailed guidelines for medication use
forms, strengths ) • Antibiotic use guidelines ; antibiotic use in
surgical prophylaxis
Pharmacy and Therapeutics Committee • Weight-based heparin orders
• Should address the committee membership, • ICU sedation guidelines ; alcohol detox orders
operation and responsibilities • potassium replacement order
• thrombolytic therapy guidelines for stroke
Medication Prescribing, Dispensing, &
Administration Special information
• Writing Medication Orders – defines practitioners that • Health-system specific
may write Rx ; format of Rx • Tailored to the needs of the professional &
• Verbal Orders – defines who may accept a verbal medical staff based on the services
order & the transcription process ; address the
• Nutritional products approved ; equivalent
reading back of the order
dosage tab ; parenteral nutrition formula ;
• Stop Orders – defines the orders that are
pediatric dosage ; antidote list ; serum drug level
automatically terminated, method of reinstatement ;
for medications that require additional evaluation ; antibiograms ; common equations ; advanced
• Investigational Drug Orders –defines how cardiac life support
investigational drugs are managed in the health care
system; include review process & method for
prescribing, dispensing
• Controlled Substances – defines the flow of controlled
substances ; approved prescribers, order process,
distribution & tracking
• Generic & therapeutic Substitution – defines how a
drug is selected for generic substitution ; describe
alternative agent
• Self-administration of medications – conditions &
process for the adminis. of med by the pt.
• Medication Samples – conditions & process for the use
of med samples