Drug Selection and Formulary Policies

1
Drug Selection and Formulary Policies EBM

• Richard Laing and Brenda Waning with materials
  provided by Budiono Santosa and WHO

2
Selection of drugs Towards an evidence-based
approach

• The importance of drug selection
• Common principles and pitfalls in drug selection
• Essential drugs committee
• WHOs new approach to developing the Model List
  of EDs
• Implementation of essential drugs list
  formulary
• The need for new approach

3
Challenges related to availability and use
of drugs

• Too many unnecessary doubtful drugs
• Lack or inconsistent supply of the needed drugs
• Variation of individual drug use prescribing
  preferences

A formulary list and Treatment Guidelines are
essential elements for efficient health care
service system!
4
Objectives of drug selection

• Improving sustainable supply of the needed
  medicines
• Improving quality of use of medicines
• Improving cost-efficiency

5
Development of Treatment Concept

• Magic mystical concept
• Based entirely on beliefs
• Common among less affluent community
• Crude natural products rituals
• Primitive empirical concept
• Based entirely on fact and experience
• Simple preparation of natural products
• Analytical empirical concept
• Based on fact, knowledge, expertise experience
• Modern medicines
• Methodological evidence based concept
• Knowledge, expertise, experience and external
  evidence

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Common pitfalls in making treatment decisions

• Decision on drug treatment is based on
  theoretical pharmacological concept
• Decision on drug treatment is based on individual
  clinical experience
• Decision is based on limited often biased
  external information
• Lack of support with evidence of efficacy and
  safety

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Common pitfalls in drug selection

• Dictated more by pharmacological concept and
• clinical needs and experiences (pharmacology
  clinical driven)
• Rarely take into account the burden of illness
  of
• the service system (morbidity driven)
• Dominated by pharmacologist, clinical
  specialists pharmaceutical experts
• Often lack of support of clinical evidence
• Lack of healthcare and public health
  perspective
• Lack of economic consideration
• More normative rather than pragmatic in
  improving access, availability and
  affordability

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What is Evidence-based Medicine?
Integrating individual knowledge and expertise
with the best available external clinical
evidence deriving from systematic research in
making decision about drug/treatment Decision
based entirely on individual expertise and
knowledge can be subject to individual bias

• 
  

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What kind of evidence for drug selection ?

• Evidence of efficacy
• Evidence of safety
• Evidence of quality
• Evidence of suitability

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Quality of evidence - Efficacy

• Category I
• A Meta-analysis of some RCT
• B At least one RCT
• Category II
• A At least one well-designed control study
  without randomization
• B At least one other type of well-designed
  quasi experimental study
• Category III
• Well-designed non-experimental descriptive
  studies, e.g. case control studies, comparative
  studies, correlation studies
• Category IV
• Expert committee reports/opinions and/or
  clinical experience or respected authorities

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Process of drug selection

• Normative approach (GOBSAT)
• External existing model
• Pharmacological approach
• Epidemiological approach (EBM)
• List of common diseases (burden of illness)
• Accepted treatment guidelines based on evidence
• List of drugs

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WHO Model List of Essential Drugs

• The first model list was devised in 1977 in
  response to the needs of
• developing countries to rationalize drug
  selection.
• The ED list is currently implemented in over
  150 countries.
• WHO List serve as a model. Countries should
  develop their own list
• Because of great differences between countries,
  the preparation of drug list of uniform and
  general applicability, is not feasible and
  possible.
• Each country has the direct responsibility of
  evaluating and adopting a list of essential
  drugs, according to its own policy in the field
  of health

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What is the WHO Model List of Essential Drugs
(ctd.)

• At the end of 1999, some 146 member states had
  an official EDL (115 regularly updated every 5
  years)
• Many EDL are linked to STGs and thus guide
  procurement in the public sector, training and
  supervision, reimbursements, donations, and local
  manufacture of drugs, and all aspects of the
  pharmaceutical system.

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Products linked to the WHO Model List of
Essential Drugs

• About 250 of the 306 active substances on the
  1999 Model List are included in WHO standard
  treatment guidelines.
• 55 active substances are included in the
  Interagency New Emergency Health Kit.
• All drugs on the Model List are included in the
  WHO Model Formulary and priority in International
  Pharmacopoeia

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The Essential Drugs Target
National list of essential drugs
Registered drugs
All the drugs in the world
Levels of use
S
S
CHW
dispensary
Health centre
Supplementary specialist drugs
Hospital
Referral hospital
Private sector
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WHO Essential drugs committee

• Experts in clinical medicine
• Pharmacology Clinical Pharmacology
• Pharmacy
• Clinical microbiology
• Heath-care workers
• Public health ?

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WHO selection criteria

• Favorable cost benefit in term of treatment cost
  (?)
• Preference for drugs that are well-known with
  good pharmacokinetic properties
• Single compound unless therapeutic indication

• Relevance to the prevalence of diseases
• Proven efficacy safety
• Evidence in performance in a variety of settings
• Adequate quality and stability

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Review and revision

• Review and revision of WHO model list is done
  every two years by the committee
• Based on propositions submitted to the
  secretariat
• Submission (addition, deletion, changes ) is
  accompanied with justification and references
• Prior to Expert Committee meeting the
  propositions are reviewed by Advisory Panel on
  Drug Evaluation
• Revision of country drug list may vary from 2 - 4
  years

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Questions for group Discussion

• Now it is your turn to discuss the difficult
  questions!
• These questions were posed by WHO in 2001 as it
  worked to reach a consensus on the best ways to
  revise the WHO Model List of Essential Drugs
• Please review questions in relation to US
  government policy document and RLs response

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Relation between treatment guidelines and a list
of essential drugs
List of common diseases and complaints
Treatment choice
Treatment guidelines
List of essential drugs
National formulary
Treatment
Supply of drugs
Training
Supervision
Examination
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Implementation issues

• A basis for drug procurement
• A basis for prescribing practices
• Implemented at various settings
• Primary vs Hospital care
• Public vs Private
• Monitoring of implementation
• National Drug List
• Application in different facilities
• as a model (minimal or maximal)

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Treatment GuidelinesProblems in development and
implementation

• Treatment Guidelines accommodating consensus of
  clinical experts with lack of supporting evidence
• Treatment Guidelines are developed without wide
  involvement of target users
• Treatment guidelines are developed in isolation
  from the essential drug list
• Treatment guidelines are developed without taking
  into account the existing health care
  infrastructure and the level of competence of
  providers at different levels
• Treatment guidelines are not introduced to the
  providers
• No reinforcement and monitoring of their use by
  providers

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The need for a new approach

• Evidence-based principles
• More healthcare public health perspectives
• Integrated approach of essential drug list
  treatment guidelines
• Regular monitoring of implementation impact
  evaluation