Session 2' Developing and Maintaining a Formulary

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• Session 2. Developing and Maintaining a Formulary

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Objectives

• Define the formulary system concept
• Understand basic formulary management principles
• Describe the benefits of an effective formulary
  system
• Identify criteria used for selection of medicines
• Describe basic pharmaceutical information
  resources for evaluating medicines

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Outline (1)

• Introduction
• Formulary Management Principles
• Maintaining a Formulary System
• Process for Selecting New Medicines
• Selection Criteria for New Medicines
• Nonformulary Medicines

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Outline (2)

• Restricted Pharmaceutical Use
• International Nonproprietary Pharmaceutical Names
• Information Sources for Evaluating New Medicines
• Formulary Manual
• Activities
• Summary

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Key Definitions

• FormularyA list of medicines approved for use in
  the healthcare system by authorized prescribers
• Formulary manualThe 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 systemA system of periodically
  evaluating and selecting medicines for the
  formulary, maintaining the formulary, and
  providing information in a suitable manual or list

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WHO Model Formulary (2004 and 2007)
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Benefits of an Effective Formulary System (1)

• Approved and efficacious medicines that all
  practitioners will have available for use
• Only the most effective and safest products
• Medicines have been evaluated systematically
• Medicines are chosen and approved to treat the
  diseases of the region or country
• Physicians develop greater experience with fewer
  medicines

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Benefits of an Effective Formulary System (2)

• Pharmaceutical therapy at lower cost
• Ineffective, high-cost medicines will be excluded
  from system
• Availability of most effective medicines leads to
  fewer visits, improved outcomes, and lower cost
• Reduced inventory cost

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Benefits of an Effective Formulary System (3)

• Consistent supply of medicines
• Regulating the number of medicines will improve
  procurement and inventory management
• Economies of scale will increase availability of
  essential medicines
• Saving money leads to consistency in purchasing
  essential medicines which in turn leads to
  increased availability

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Benefits of an Effective Formulary SystemSummary

• PRESCRIBING
• More experience with fewer medicines
• Irrational alternatives not available
• Focused medicine information
• ADRs easier to manage
• COST
• Lower prices, more competition

• SUPPLY
• Easier procurement
• Lower amount of stocks
• Improved quality assurance
• Easier dispensing
• PATIENT USE
• Focused education efforts
• Better compliance
• Improved availability

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Formulary Management Principles (1)

• Select medicines on the basis of need (diseases
  and conditions that have been identified locally)
• Select medicines of choice
• Maintain a limited number of medicines (avoid
  duplications)
• Use INN (generic) names
• Use combination (fixed-dose) products only in
  specific proven conditions (e.g., tuberculosis)

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Formulary Management Principles (2)

• Use explicit selection criteria that include
• Efficacy and effectiveness
• Safety
• Quality
• Cost
• Select medicines that are consistent with
  national and regional formularies and standard
  treatment guidelines
• Restrict medicines use to appropriate
  practitioners

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Maintaining a Formulary

• Evaluate new medicine requests and deletions
  regularly
• Conduct a systematic review of therapeutic groups
  and classes

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Steps to Add or Delete a New Medicine
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Steps to Evaluate a Medicine

• Compile information resources
• Perform evaluation using established criteria
• Write medicine monograph describing the
  evaluation and results
• Develop formulary recommendations to present to
  the DTC
• Obtain expert opinion and recommendations
• Make a decision at the DTC meeting
• Disseminate the results of the evaluation and DTC
  recommendations

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Criteria for Evaluating and Selecting Medicines
for Formulary (1)

• Disease patterns
• Efficacy and effectiveness
• Safety
• Quality (pharmaceutical products and suppliers)

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Criteria for Evaluating and Selecting Medicines
for Formulary (2)

• Cost and cost-effectiveness of the medicine
• Well-known medicines
• Health system personnel and expertise available
  to manage the medicine
• Financial resources available to buy the medicine

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Nonformulary Medicines

• Open formularies
• Closed formularies
• Management of nonformulary medicines
• Limit number of nonformulary medicines
• Limit access
• Keep a register of all requests for nonformulary
  medicines (medicine name, quantity, indication)
• Review frequently and discuss in DTC meetings

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Restricted Medicines (1)

• Medicines to be used by specific staff or for
  specific conditions only
• Defined and enforced by the DTC
• Necessary to control the use of medicines that
  should only be used by medical staff with
  specialized skills
• Monitor carefully to ensure the appropriate use

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Restricted Medicines (2)

• Examples
• Certain antimicrobials for infectious disease
  specialists
• Antipsychotic medicines for mental health
  professionals
• Antineoplastic products for oncologists and
  internal medicine specialists

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International Nonproprietary Names

• Trade or brand names
• Disadvantages
• Nonproprietary or generic names
• Advantages in the health care system

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Information Resources

• Primary Resources
• Secondary Resources
• Tertiary Resources

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Primary LiteratureExamples

• British Medical Journal
• Lancet
• New England Journal of Medicine
• Journal of the American Medical Association
• Annals of Internal Medicine
• American Journal of Health-System Pharmacists
  (AJHP)

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Secondary LiteratureExamples

• Medical letters, newsletters, or bulletins
  produced by national bodies that monitor medicine
  efficacy, safety, and cost
• Medical Letter (USA), Drug Therapeutics
  Bulletin (UK), The International Society of Drug
  Bulletins
• Peer-reviewed journals
• Australian Prescriber, Journal Watch, Prescrire
• Electronic databases
• MEDLINE and EMBASE abstracts
• International pharmaceutical abstracts
• Cochrane Library abstracts and evaluations

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Tertiary SourceExamples

• Martindale The Extra Pharmacopoeia
• British National Formulary
• USP DI Drug Information
• American Hospital Formulary Service (AHFS) Drug
  Information

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British National Formulary
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Internet ResourcesExamples

• MEDLINE
• World Health Organization
• Centers for Disease Control and Prevention
• National Institutes of Health
• U.S. Food and Drug Administration
• Cochrane Collaboration
• Agency for Healthcare Research and Quality

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Formulary Manual (1)

• Listing of formulary medicines
• Alphabetical
• Therapeutic category
• Medicine information section
• Generic name
• Dose and strengths
• Indications, contraindications, precautions
• Side effects
• Dosage schedule
• Instructions, warnings, interactions

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Formulary Manual (2)

• Supplementary information for medicines
• Price
• Regulatory category
• Storage guidelines
• Patient counseling information
• Labeling information
• Brand names and synonyms

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Formulary Manual (3)

• Prescribing and dispensing guidelines
• Rational prescribing techniques
• Prescription writing principles
• Guidelines on quantities to be dispensed
• Controlled medicine requirements
• ADR reporting requirements
• Dispensing guidelines
• List of precautionary labels
• Medicine interaction tables

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Formulary Manual (4)

• Treatment protocols
• IV medication administration guidelines
• Medicines used in pregnancy and lactation
• Medicines used in renal failure
• Poison guidelines
• Prescribing for the elderly

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Formulary Manual (5)

• Other components
• Metric tables
• ADR reporting form
• Product quality reporting form
• Request form for adding or deleting medicines
• Request form to use nonformulary medicines
• Abbreviations
• Indexes

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Formulary Manual (6)

• Acceptance of a formulary manual requires buy in
  by
• Opinion leaders
• Hospital administration
• Senior staff
• Professional associations
• Manuals must be prepared carefully
• Evidenced-based information
• Written by experts
• Reviewed frequently to be kept up to date

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Examples of Rational Drug Selection, Delhi, India

• The essential medicines list (EML) was developed
  by a multidisciplinary group of experts using
  criteria of efficacy, safety, and cost
• Revised EML saved nearly 30 of money which was
  used for procuring more medicines resulting in an
  80 improved availability in health facilities

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Activity 1. Adding a New Antibiotic to the
Formulary

• Your DTC received an application to add cefapime
  to the hospital formulary. See Participants
  Guide for more information about this new drug
  and its use.
• What criteria are necessary to evaluate this
  medicine for addition to the formulary?
• Using the principles of formulary management,
  what major concerns do you have before adding
  this medicine to the formulary?
• What pharmaceutical information resources would
  be used to analyze this medicine for the DTC?
  Which sources would be the most useful?

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Activity 2. Formulary Management of NSAIDs

• Review the list of nonsteroidal anti-inflammatory
  drugs provided in the Participants Guide
• Do you think the listed medicines appear logical
  and well chosen?
• How many chemical entities are available on the
  formulary?
• How many NSAID medicines are necessary for a
  formulary?
• What medicines would you recommend to be added or
  deleted?
• What is the best method to list medicines in a
  formulary? Is this list easy to read and
  understand?

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Summary (1)

• Formulary management principles
• 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)

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Summary (2)

• Formulary management principles (cont)
• Evaluate and select new medicines according to
  agreed-upon 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 nonformulary
  medicines
• Restrict medicines to use by appropriate
  practitioners

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Summary (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 DTC and the formulary system