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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, March 2004
        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
      2002 Revised procedures approved by WHO
      Last revision (April 2003) contains 315 active substances


         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
        Clinical guidelines and a list of essential medicines
        lead to better prevention and care
                          List of common diseases and complaints


                                         Treatment choice


                                                       Essential medicines list /
                   Treatment guidelines
                                                       National formulary



                       Training and                                Financing and
                       Supervision                                Supply of drugs

                                              Prevention
                                               and care

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 (1)



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:                  $10 for DOTS vs $250 for MDR (25x)
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
       New essential drugs are expensive (2)
       also in industrialized countries!


      Canada: 55% of prescription cost rise of 93% over 1987-1993
       was due to introduction of new drugs
      USA: Pharmaceuticals market grew with 16% in 1999, 18% in
       2000 and 17% in 2001; volume rise in 2000 only 5.5%
                    Growth due to * elderly population * new therapies
                    * increased prescriptions by managed care * direct-to-
                    consumer advertising
      Australia: Annual increase in drug costs for Pharmaceutical
       Benefit Scheme could pay for two new teaching hospitals



EDC/Model List 10       Department of Essential Drugs and Medicines Policy
       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 11   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 12   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 13    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, recommendation by Expert Committee



EDC/Model List 14   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 15      Department of Essential Drugs and Medicines Policy
       Example of a link: chloramphenicol

  Chloramphenicol is recommended for the following indications:
  Injectable: Severe pneumonia in children*, severe asthma-
      pneumonia*, brain abscess*, meningitis in children with ARI*,
      epiglottitis*, granuloma inguinale*, mastoiditis*, meningitis
      (various kinds), obstetrics, septicaemia*
  Oral: severe pneumonia in children, asthma pneumonia*,
      meningitis in children*, cholera*, louse borne typhus*,
      measles pneumonia, meningitis (empirical and
      meningococcal), abortion care, plague*, relapsing fever*,
      Rickettsia, typhoid fever*
  *recommended as alternative drug


EDC/Model List 16    Department of Essential Drugs and Medicines Policy
       WHO Model Formulary



      First edition issued in 2002; (SFr 40, SFr 20)
      Web version as PDF file and searchable database
      CD-ROM (searchable and downloadable)
      Translations ongoing in Arabic, Chinese, French, Russian,
       Spanish; electronic versions only (on CD)
      Edition 2004 follows 2003 Model List
      5-year commitment to RPS and BMJ
      Manual “How to develop a national formulary”



EDC/Model List 17   Department of Essential Drugs and Medicines Policy
       The New Emergency Health Kit
       1984, 1990, 1998


                                    Essential medicines and supplies
                                    for 10,000 people for three months




                                   Consensus between WHO, UNICEF,
                                   UNHCR, UNFPA, Red Cross,
                                   MSF, OXFAM, missions, IDA

EDC/Model List 18   Department of Essential Drugs and Medicines Policy
         Selection of emergency relief items

      WHO Model List 2002    325
                                                              UN List of
                                                              Emergency
UNDP                          88                              Relief Items

WHO
ICRC
FRC
MSF                                                             New Emergency
UNICEF
UNHCR
                             55                                 Health Kit 1998
UNFPA
IDA
EPN
OXFAM                                                         Adaptation needed: ORS,
                                                              antimalarials, syringes,
                                                              emergency contraception


 EDC/Model List 19   Department of Essential Drugs and Medicines Policy
         Essential medicines for Reproductive Health:
         Discrepancies in international RH lists


                                                            75 on UNFPA List
325 on WHO Model List                                  6
                                                 6



                         194                          63



                                                                     150 on Interagency RH
                                            65
                                                             22       medical commodities




  EDC/Model List 20   Department of Essential Drugs and Medicines Policy
       First comparison between lists (1):
       Alternative medicine preferred on WHO EML

                                                    U    R      E
  clotrimazole                                      x    x      miconazole
  zalcitabine, delavirdine, amprenavir                   x      see ARV guide
  dephenylhydramine                                      x      promethazine
  itraconazole, ketoconazole                             x      fluconazole
  labetalol                                              x      atenolol
  magnesium trisilicate, sodium citrate                  x      alum.hydroxide
  tinidazole                                             x      metronidazole
  ritodrine, terbutaline                                 x      salbutamol
  methylergometrine                                      x      ergometrine




EDC/Model List 21   Department of Essential Drugs and Medicines Policy
       First comparison between lists (2):
       (Recently) deleted from the Model List

                                                              U          R   E
  spermicides                                                 x
  contraceptive foams/gels                                               x
  pethidine                                                              x
  iron dextran                                                           x
  misoprostol (recently refused)                                         x




EDC/Model List 22   Department of Essential Drugs and Medicines Policy
       To include or not to include?
       Suggested for systematic review and submission
       to WHO Expert Committee

                                                              U          R   E
  levonorgestrel-IUDs                                         x
  norethisterone enantate + valerate                          x
  oestradiol cyprionate +med.prog.acetate                     x
  indometacin (tocolytic)                                                x
  cefazolin (geneal surgical prophylaxis)                                x
  cefixime (gonorhoea)                                                   x
  prostaglandins                                                         x
  subdermal contraceptive inplants                                       x
  hydralazine*                                                           x   x

  * Recently discussed but needs more review


EDC/Model List 23   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. This includes access to essential medicines
      The essential medicines concept is globally applicable


EDC/Model List 24   Department of Essential Drugs and Medicines Policy
       Conclusion



      The concept of essential medicines is a global
       concept
      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 25   Department of Essential Drugs and Medicines Policy
        WHO Department of
Essential Drugs and Medicines Policy

      www.who.int / medicines



            Thank you