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					The concept of essential drugs and the
WHO Model List of Essential Medicines




       Hans V. Hogerzeil, MD, PhD, FRCP Edin



    Department of Essential Drugs and Medicines Policy
           World Health Organization, 2002
        Essential medicines

     The concept of essential medicines
  A limited range of carefully selected essential medicines leads to
  better health care, better drug management, and lower costs


     Definition of essential medicines
  Essential medicines are those that satisfy the priority health care
  needs of the population
                                   (Report to WHO Executive Board, January 2002)




EDC/Model List 2     Department of Essential Drugs and Medicines Policy
        History of the WHO Model List of Essential Drugs



      1977 First Model list published, ± 200 active substances
      List is revised every two years by WHO Expert Committee
      Last revision (Dec.1999) contains 306 active substances
      2002 Revised procedures approved by WHO


         The first list was a major breakthrough in the history
         of medicine, pharmacy and public health
                                           Médecins sans Frontières, 2000


EDC/Model List 3    Department of Essential Drugs and Medicines Policy
        Full description of essential drugs
        (Expert Committee Report, April 2002)

  Definition: Essential medicines are those that satisfy the priority
  health care needs of the population
  Selection criteria: Essential medicines are selected with due
  regard to disease prevalence, evidence on efficacy and safety,
  and comparative cost-effectiveness
  Purpose: Essential medicines are 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 at a price the individual and the community can afford.
  Implementation: The implementation of the concept of essential
  medicines is intended to be flexible and adaptable to many
  different situations; exactly which medicines are regarded as
  essential remains a national responsibility.

EDC/Model List 4   Department of Essential Drugs and Medicines Policy
        The Essential Medicines Target
                                                                            National list of
                                    Registered medicines                    essential medicines
       All the drugs
       in the world
                                                                               Levels of use




                             S                 CHW                    S
                                              dispensary

                                            Health center                       Supplementary
                                              Hospital                          specialist
                                          Referral hospital                     medicines

                                         Private sector



EDC/Model List 5       Department of Essential Drugs and Medicines Policy
        Relation between treatment guidelines
        and a list of essential medicines

             List of common diseases and complaints



             Treatment choice



             Treatment guidelines         List of essential drugs
                                          National formulary


             Treatment                       Supply of drugs
             Training
             Supervision


EDC/Model List 6      Department of Essential Drugs and Medicines Policy
      Number of countries with a national list of
      essential medicines




156 countries with EDLS
1/3 within 2 years                 National Essential Drugs List

3/4 within 5 years                          < 5 years (127)
                                            > 5 years (29)
                                            No NEDL (19)
                                            Unknown (16)




 EDC/Model List 7   Department of Essential Drugs and Medicines Policy
        Use of the WHO Model List of Essential Drugs

      156 countries have a national list of essential drugs, of which
       81% have been updated in the last 5 years
      Major international agencies (UNICEF, UNHCR, IDA) base
       their catalogue on the WHO Model List
      Sub-sets: UN list of recommended essential drugs for
       emergency relief (85 drugs); interagency New Emergency
       Health Kit (55 drugs for 10,000 consultations)
      Normative tools: WHO Model Formulary, International
       Pharmacopoea, Basic Quality Tests, and development of
       reference standards follow the WHO Model List



EDC/Model List 8    Department of Essential Drugs and Medicines Policy
        Example of challenge:
        New essential drugs are expensive



Antibiotics for gonorrhoea:        50-90x price of penicillins
Antimalarial drugs:                chloroquine $0.10 per treatment
                                   coartem® $3/pp developing country (30x)
                                   malarone® $40 per dose (400x)

Antituberculosis:                  $20 for DOTS vs $400 for MDR (20x)
Antiretrovirals:                   $300-600/year; but 38 countries with
                                   a drug budget <$2 pp/year




EDC/Model List 9    Department of Essential Drugs and Medicines Policy
       Perceived problems with updating and
       dissemination the WHO Model List
       (Expert Committee, 1999)


      Range of diseases covered by the Model List is not clear
      Discrepancies between Model List and treatment guidelines
      Selection is more consensus-based than evidence-based
      Use of data on cost and cost-effectiveness unclear
      Reasons for selection insufficiently recorded
      Drugs included without pharmacopoeal standard or supplier
      Official report comes out too late, and in English only




EDC/Model List 10   Department of Essential Drugs and Medicines Policy
       WHO Model List of Essential Drugs 1999 compared
       with drugs included in WHO Treatment Guidelines

    306 active substances on                                    405 drugs
    WHO Model List                                              mentioned in WHO
    of Essential Drugs                                          Treatment Guidelines



                     56*           250               155




 *e.g. cytotoxics, hormones, diagnostic agents, gastrointestinal drugs


EDC/Model List 11      Department of Essential Drugs and Medicines Policy
       Review process of the new procedures (1):
       Process and time table

  Nov „99     Seminar by WHO Expert Committee on Ess.Drugs
  Jan „00     Cabinet decision to develop standard procedures
  Mar „01     Informal consultation
  Jun         Presentation at MIP, Member States review
  Sep         Review by all stakeholders
  Oct         Discussion at Reg.C‟ees in PAHO and EMRO
  Nov         Cabinet discussion
  Jan „02     Report to Executive Board, resolution
  May „02     Discussion at WHA, resolution




EDC/Model List 12    Department of Essential Drugs and Medicines Policy
       Review process of the new procedures (2):
       Stakeholders consulted


     WHO clusters, regional and country offices
     Member States, essential drugs programmes
     Members of WHO Expert Panels
     UN agencies (UNICEF, UNFPA, UNHCR, UNAIDS)
     NGO‟s (ICRC, FRCS, WCC, Caritas Int, OXFAM, MSF, PSF)
     Pharmaceutical industry (IFPMA, IGMA, WSMI)




EDC/Model List 13   Department of Essential Drugs and Medicines Policy
       The outcome:
       The WHO Model List of Essential Medicines is a
       model process, model product and public health tool

     Independent Membership of the Committee, careful
      consideration of conflict of interest
     Transparent process, standard application, review
     Link to evidence-based treatment recommendations, in
      accordance with WHO Recommended Process for Developing
      Clinical Practice Guidelines
     Systematic review of comparative efficacy, safety and cost-
      effectiveness, and review of public health relevance
     Rapid dissemination, electronic access
     Regular review



EDC/Model List 14   Department of Essential Drugs and Medicines Policy
      Model process (1):
      Seven steps to get a new medicine on
      the WHO Model List of Essential Drugs

  1. Identification of public-health need for a medicine
  2. Development of the medicine; phase I - II - III trials
  3. Regulatory approval in a number of countries
          > Effective and safe medicine on the market
  4. More experience under different field circumstances; post-marketing
     surveillance
  5. Price indication for public sector use
  6. Review by WHO disease programme; define comparative
     effectiveness and safety in real-life situations, comparative cost-
     effectiveness and public health relevance
          > Medicine included in WHO treatment guideline
  7. Submission to WHO Expert Committee on Essential Drugs
          > Medicine included in WHO Model List


EDC/Model List 15   Department of Essential Drugs and Medicines Policy
        Model process (2):
        Link to Guidelines for Guidelines
        (approved by WHO Cabinet in January 2001)


   Systematic and transparent process
        Guideline development group with wide representation
        Careful consideration of conflict of interest
        Systematic computer search for evidence
        Evaluation of strength of evidence
        Systematic cost-effectiveness analysis
        for WHO: evaluation of public health considerations
        Graded recommendations with linked references
        External review of draft recommendations
        If there is insufficient evidence: consensus expert opinion



EDC/Model List 16    Department of Essential Drugs and Medicines Policy
       Model process (3):
       Steps in review of applications to the Model List

  1    Summary of application posted on WHO Medicines web site
  2    Specialist assessment of comparative efficacy, safety and
       cost-effectiveness
  3    Review of assessments by Expert Committee member
       (“presenter”); formulation of draft recommendation
  4    Review of draft recommendation by relevant Expert Advisory
       Panel members; and posted on WHO Medicines web site
  5    Review by presenter, prepares final draft recommendation
  6    Discussion of draft recommendation and proposed text for
       WHO Model Formulary by the Expert Committee


EDC/Model List 17   Department of Essential Drugs and Medicines Policy
       Model process (4):
       Role of treatment cost and
       global cost-effectiveness analyses

      High cost alone should not exclude an essential medicine
      Cost-effectiveness (C/E) comparisons will be made among
       alternative medicines within the same therapeutic group
      Price information from existing UN sources will be used; all
       information sources will be identified
      Simple indicators will be used: cost per unit, cost per
       treatment/month, cost per cure, cost per case prevented
      Emphasis on usual outcome measures, and use of existing
       and published comparative cost-effectiveness analyses
      New C/E calculations will be transparent and can be adapted


EDC/Model List 18   Department of Essential Drugs and Medicines Policy
       Model process (5):
       Presentation of recommendations, report

  Presentation of recommendations:
    Summary of reasons for each recommendation
    Reference to underlying evidence and systematic reviews
    Reference to existing clinical guidelines
    Inclusion in WHO Essential Medicines Library

  Report, web site, translations:
    Report of the meeting published on WHO Medicines web site
    Report issued in WHO Technical Report Series
    List and recommendations translated into other languages



EDC/Model List 19   Department of Essential Drugs and Medicines Policy
          The WHO Model List of Essential Medicines is a
          model process, model product and public health tool
          The WHO Essential Medicines Library

   WHO clusters                                             WHO/EDM
    Clinical guideline             Summary of clinical guideline
                                                                                       BNF

WHO/EC, Cochrane                                                              WHO Model
 Reasons for inclusion                                                        Formulary
 Systematic reviews                        WHO
 Key references                          Model List

                                                                                  WHO/QSM
  MSH   Cost:                                Statistics:           Quality information:
 UNICEF - per unit                           - ATC                 - Basic quality tests
  MSF   - per treatment
        - per month                          - DDD                 - Intern. Pharmacopoea
        - per case prevented                WCCs                   - Reference standards
                                         Oslo/Uppsala

  EDC/Model List 20      Department of Essential Drugs and Medicines Policy
       The WHO Model List of Essential Medicines is a
       model process, model product and public health tool

  Main public health advocacy messages:

      Essential drugs are the most cost-effective drugs for a given
       condition
      A limited range of carefully selected medicines can cater for
       most health care needs
      There is much waste through irrational selection and use
      Access to health care is a human right - to be progressively
       realized - and includes access to life-saving medicines
      The essential medicines concept is globally applicable


EDC/Model List 21   Department of Essential Drugs and Medicines Policy
       Outstanding issue for the next Expert Committee:
       Definition of core and complementary list
       Do we need affordability criteria or not?

     The  core list presents a list of minimum medicine needs for a basic
      health care system, listing the most efficacious, safe and cost-
      effective medicines for priority conditions. Priority conditions are
      selected on the basis of current and estimated future public health
      relevance, and potential for safe and cost-effective treatment.


     The  complementary list presents essential medicines for priority
      diseases which are efficacious, safe and cost-effective but not
      necessarily affordable, or for which specialised health care facilities
      or services may be needed.



EDC/Model List 22    Department of Essential Drugs and Medicines Policy
       Conclusion



      WHO clinical guidelines are the foundation for the
       Model List of Essential Drugs
      The Model List remains a strong public health tool
      The WHO Essential Medicines Library is a valuable
       information base for all Member States,
       international organisations, drugs and therapeutic
       committees and health insurance organisations




EDC/Model List 23   Department of Essential Drugs and Medicines Policy
        WHO Department of
Essential Drugs and Medicines Policy

      www.who.int / medicines



            Thank you

				
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