WHO Essential Drugs Strategy - Download as PowerPoint

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					WHO Medicines Strategy
  Priorities: 2004-2007




         Dr Guitelle Baghdadi
   Essential Drugs and Medicines Policy
       World Health Organization
               August 2004
         WHO Medicines 2004 – 2007: 4 objectives,
         7 components and 44 expected outcomes

    OBJECTIVES               COMPONENTS
     Policy                 1. Implementation and monitoring of medicines policies
                             2. Traditional medicine and CAM


       Access               3.   Fair financing and affordability
                             4.   Medicines supply systems

       Quality and safety   5.   Norms and standards
                             6.   Regulations and QA systems

       Rational use         7.   RU by health professionals and consumers




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      Medicines Strategy 2004 – 2007: development process
      of 1 year with three main phases

     Phase    I: internal update with 5 working groups
       WHO   staff: HQ, Regional offices and country offices
       5 areas: policy, TRM/CAM, access, quality & safety, and RUM
       Means: telephone conferences and emails
     Phase    II: external review
       Sent to full range of partners (259): Member States, WHO collaborating
        centres, WHO expert committees, UN family, NGOs, etc.
       71replies received
     Phase    III: finalization
       Telephone conferences with Member States
       Videoconference between WHO/HQ and Regional Offices




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      WHO Medicines Strategy 2004-2007: 5 priorities
      Objectives: policy, access, quality & safety, rational use


    1. National medicines policies that focus on human rights, need
        for innovation, health-oriented approach to trade agreements,
        stronger ethical dimension
    2. Access to traditional medicine by protecting knowledge and
        access, expanding evidence base, ensuring safety, informing
        consumers
    3. Access to essential medicines, with emphasis on HIV medicines
        for 3-by-5, medicines for malaria, tuberculosis, childhood illness,
        reproductive health
    4. Safer medicines through expanded safety monitoring and
        continued strengthening of quality assurance
    5. Rational use through continuing education, initiatives linked to
        health insurance


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    Ethical Criteria for Promotion of
                Medicines




                   Dr Guitelle Baghdadi
             Essential Drugs and Medicines Policy
                 World Health Organization
                         August 2004

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    WHO definition of promotion


       "all informational and persuasive
        activities by manufacturers and
      distributors, the effect of which is to
        induce the prescription, supply,
    purchase and/or use of medicinal drugs"




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     Overview


    1. Promotion of medicines: current challenges



    2. WHO ethical criteria for drug promotion



    3. Some countries practices…




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     Overview


    1. Promotion of medicines: current challenges



    2. WHO ethical criteria for drug promotion



    3. Some countries practices…




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          Examples of promotional tools and target audiences

        Prescribers      Sales Representatives
                          Education events
                          Journal advertisements
                          Gifts
                          Samples
                          Enter patients in clinical trials against payment
                          Physicians or opinion leaders paid as speakers
        Pharmacies       Discounts
                          Gifts
                          Educational events
                          Monitoring of prescriptions
        Consumers        Direct to consumer advertising (DTCA)
                          Medicalisation or "illness promotion"
                          Support to patient-help organizations

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          "Imbalance between commercially produced and
          independent drug information"                                                 (1)




        Large amount spent around the world for drug promotion:
            US:        US$ 13 – 15 billion (2000) (1)
            Australia: US$ 1.3 – 2 billions per year (2)
            Italy:     US$ 1.1 billion (1998) (1)
            Low-income countries: 20 – 30% of sales revenue (1)

        Growth spending on DTCA for prescription drugs
            US:      US$ 55 million (1991) to US $ 2.4 billion (2001) (3)
        Others figures (US):
                     80,000 sales reps (1)
            currently
            314,000 physician events in 2003 (sponsored industry) (1)
            free samples: $ 11 billion (retail value) or $ 2-3 billion (prod. cost)

        Only 50% countries have drug information centres (1999) (1)

     (1) WHO Medicines Strategy 2004 – 2007
     (2) www.healthyskepticism.org
     (3) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001

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           Increasing evidence that promotion techniques
           influence physicians' prescribing

         Medical journals ads: information content generally poor (1)
              Headlines   can be misleading (32%)
              Lead to improper prescribing if no additional information (44%)
              Little or no educational value (57%)
              Often minimize risks and harmful effects (50% to 60%)

         Advertisement material: only 6% material supported by scientific
          evidence (2)
              15% of brochures did not contain any citations
              22% citations listed could not be found
              63% info correctly referenced but articles did not reflect results

         Sponsored medical conferences
              Attendance           associated with increased prescribing of sponsored product (3)


     (1) Wilkes M. Pharmaceutical Advertisements in Leading Medical journals: Experts' Assessment. Ann Intern Med. 1992;116:912-9
     (2) Tuffs A. Only 6% of drug advertising material is supported by evidence [news]. BMJ 2004; 328: 485
     (3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380

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        Sales representatives too often only source of
        information for health professionals

                  start during medical school (2)
      Interactions
      80 – 95% doctors see sales reps regularly (1)
           average 4 times a month (2)
           US: 1 sales rep for 15 to 30 physicians                               (3)


      Seen as important source of info (new drugs) (3)
      10% sales reps statements are inaccurate (3)
      25% doctors recognize inaccurate statements (3)
      Impacts
           prescribing  costs
           irrational prescribing
           preference of new drugs
           decreased prescription of generics (2)

      (1) Moynihan R. Who pays for the pizza? BMJ 2003; 326: 1189-1192
      (2) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
      (3) Ziegler M. & al.. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273: 1296-1298
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                Gifts, trips, dinners influence prescribing habits &
                power needs to be acknowledged

           Most           doctors deny gifts influence their prescribing                                                                  (1)


           Recognized      as conflict of interest and established "ceilings"
              (e.g. $ 100 in US) (2)
           Small            gifts play important role (2)
                  Pens, note pads, etc. act as "reminder items" (2)
                  Sole or among top reasons to see sales reps (1)

           Psychological                         aspects: indebtedness, reciprocity(2)
                  Food,          flattery and friendships: powerful tools of persuasion



     (1) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380
     (2) Katz D & al. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. AM J Bioethics.2003;3:39-46



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            DTCA of prescription-only medicines is legal only in US
            and New Zealand

      DTCA raises concerns, despite advocacy that
       US since 1980s
      it creates better informed patients: radio and TV
           FDA decision 1997: relax restrictions on
             2003: US$ 3 billion per year
          Increases prescription costs (1)
             8.5 m. people request & receive prescription after advertisement
          Misleading statements lead to irrational use and undue risks 1)
       New          Zealand
            2003: GPs regulation (1)
           Often breachlaunched campaign for ban
       Rejected by EU health ministers in
        Strains on physicians-patient relation                                                June 2003 and EU
                                                                                              (1)


      
          parliament in December 2003(2)
          No evidence of health benefits
       All      other countries (internet, satellite, etc.)
          Promotes medicalisation of normal life (1)


     (1) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001
     (2) Mansfield P. & al. DTCA is more profitable if it is misleading. NZ Med J 2003; 116 (1182)

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     Some DTCA examples




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      Overview


     1. Promotion of medicines: current challenges



     2. WHO ethical criteria for drug promotion



     3. Some countries practices…




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     WHO ethical criteria (1988) still relevant today, more
     than ever

               Objective    to promote "proper behaviour"
                        accurate, truthful, informative, balanced,
               Reliable,
               up-to date, and in good taste
               NOT   misleading or unverifiable or omissions
               Scientific   data available in public domain
               Nofinancial/material benefit offered to health
               professional
                        and educational activities not used for
               Scientific
               promotional purposes




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     WHO ethical criteria cover wide arrange of promotional
     activities

              Advertising:
                   Professionals: min. summary scientific information
                   Consumers: help make rational decisions, no DTCA
              Medical      representatives
                   Technical knowledge and ethical conduct
                   Complete/unbiased information and no offer          of inducement
              Samples
                   Modest      quantities for prescription drugs
                   Difficult   to justify for non-prescription drugs
              Symposia           and scientific meetings
                   Objective scientific content & independent scientists
                   Sponsorship clearly stated, gifts secondary to main purpose
                Post-marketing scientific studies
                   Inform health authorities and validated relevant committees
                   "… not be misused as a disguised form of promotion."



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      Overview


     1. Promotion of medicines: current challenges



     2. WHO ethical criteria for drug promotion



     3. Some countries practices…




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             Examples of country practices include regulation,
             policy and training interventions

           Increase awareness of physicians (e.g. "no free lunch")
           Independent drug information centres (professionals and
            consumers)
           Code of conduct (professional associations, pharmaceutical
            industry)
           Publicly funded continuing education of staff
           Training of medical students to critically assess
            pharmaceutical promotion
                 successful            experience in Indonesia with long-term impact (1)
           Others…


         (1) Drug advertisements: a critical lesson for Indonesian students, WHO, Essential Drugs Monitor, 1997, Issue n° 23




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     Questions for discussion in your countries:

                 What are drug promotion data in your countries?
                 Amount spent on drug promotion (vs. independent
                  information)?
                 How many violations have been found in the last few
                  years? Any sanctions?
                 Are students trained to analyse pharmaceutical
                  promotion?
                 Are there codes of conduct for health professionals
                  and/or industry?
                 Etc.




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     For more information visit:
     http://www.drugpromo.info/




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