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MEDICINES SELECTION &
FORMULARY
MANAGEMENT
Charles Ouma
Management Sciences for Health
Outline
• Essential Medicines Concept
• Formulary system
– Key definitions
– Interrelationships- STGs, EML, Formulary Manual
– Formulary Management Principles
• Challenges and opportunities
Issues and Complexities with Medicine Use (1)
• Numerous medicinal
products are available in the
world
• Several therapeutic groups
and medicines are available to
treat many diseases
• New medicinal products and
new information about
existing medicines are
emerging
Issues and Complexities with Medicine Use (2)
• Developing countries spend up to 40% of their
health care budgets on medicines
• An estimated 70% of medicines are considered
duplicative or non-essential
• Lack of access to medicines is a major and chronic
issue in resource-constrained settings
• In low- and middle-income countries, most people
pay for medicines out-of-pocket
Source: Management Sciences for Health. 2012. MDS-3: Managing Access to Medicines
and Health Technologies. Arlington, VA: Management Sciences for Health.
http://www.msh.org/resource-center/publications/upload/MDS3-Ch16-Selection-Mar2012.pdf
Essential Medicines Concept
Select & use “essential medicines” that-
• Satisfy the priority health care needs of the population
• Selected with due regard to public health relevance,
evidence on efficacy and safety, and comparative costeffectiveness
• Intended to be available within the context of
functioning health systems at all times in adequate
amounts, in the appropriate dosage forms, with
assured quality and adequate information and at a cost
that individuals and the community can afford
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Formulary System and
Management
Key Definitions
 Formulary—A list of medicines approved for use in
the healthcare system by authorized prescribers
 Formulary manual—The document that describes
medicines that are available for use in a hospital or
clinic (i.e., indications, dosage, length of treatment,
interactions, precautions, and contraindications)
 Formulary system—A system of periodically
evaluating and selecting medicines for the formulary,
maintaining the formulary, and providing information
in a suitable manual or list
Interrelationships- STGs, EML & Essential
Medicines Formulary
Benefits of an Effective Formulary
System—Summary
• Supply
•
•
•
•
Easier procurement
Lower amount of stocks
Improved quality assurance
Easier dispensing
• Prescribing
• More experience with fewer
medicines
• Irrational alternatives not
available
• Focused medicine information
• ADRs easier to manage
• Patient Use
• Focused education efforts
• Better compliance
• Improved availability
• Cost
• Lower prices, more
competition
Steps to Add or Delete a New Medicine
Written request
Physician
Healthcare
or
pharmacist
Workers
DTCMTC
Meeting
MTC Secretariat
DTC
Secretary
Transparent decision
making
Request
approved/rejected
Information
disseminated
Drug literature
evaluation
Written report;
formulary
recommendations
Process- Selection & Formulary Changes
Health
Care
workers
MTC
Secretariat
Submission
of
motivations
or requests
Receipt and
processing of
motivation
MTC
Secretariat
Technical
Evaluation of
motivation
MTC or
Formulary
subcommittee
MTC
Secretariat
Discussion of
motivations
based on
evidence
Printing and
distribution of
new Formulary
Key success factors
Use
formulary for
procurement
and Patient
Management
Transparency,
fairness,
feedback to
‘motivators’
Compilation of
summary
document for
presentation to
MTC or
Formulary subcommittee
Composition of
committee
Timely decision
making
Communication
of decisions to
motivators
Dissemination
of approved
changes to
HCWs
Formulary Management Principles (1)
• Select medicines on the basis of need (diseases and
conditions that have been identified locally)
• Select “medicines of choice”
• Avoid duplications and use INN (generic) names
• Use combination (fixed-dose) products only in specific
proven conditions (e.g., TB)
Formulary Management Principles (2)
• Evaluate and select new medicines according to agreedupon explicit criteria (including efficacy, safety, quality,
cost)
• Ensure consistency between the formulary list and the
recommended standard treatment guidelines
• Regularly review and update the formulary
• Monitor and control the use of non-formulary medicines
• Restrict medicines to use by appropriate practitioners
Formulary Management Principles (3)
• Maintain reliable resources (human, financial,
references) for evaluating medicines
• Keep the formulary process ethically correct and
transparent
• Enlist support of key policy makers and influential
health professionals to advocate for the MTC and
the formulary system
Challenges
• Relentless push by HCWs for inclusion of new, costly
agents without considering formulary management
principles
• Weak (formulary) management systems
– Lack of comprehensive treatment guidelines
– Ad-hoc requests for changes & non-involvement of all
stakeholders
– Lack of comprehensive guidelines for submitting requests
& evaluating motivations/evaluations
– Issues of transparency
Challenges (2)
• Lack of resources and or expertise to conduct
evaluations and or pharmacoeconomic analyses at
institutional/ local setting to provide costeffectiveness data that is more relevant to the local
setting
• Non integration of medicine selection with guidelines
and formulary development
Formulary Management: Success Factors
• Robust compliance environment is required to operationalize
a formulary system
– procurement and use of essential medicines should be guided
by the formulary
• MTC comprising multi-disciplinary health workers that is
responsible for reviewing applications for changes
• An active body at the hospital responsible for coordinating
the formulary management process (MTC secretariat)
• High level institutional leadership and/or support for the
formulary process
• Transparency and feedback
Results — What should be
measured
• What are the expected results
•
•
•
•
•
•
Improved outcomes
Standardization of care
Most effective treatments prescribed
Improved procurement and supply
Forecast compares with utilization
Efficient use of funds
Thank you