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Rational Use of Drugs in the Public and Private Sectors

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					           Rational use of drugs:
                an overview



                             Kathleen Holloway
                          Technical Briefing Seminar
                                      November 2009


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Objectives

     • Define rational use of medicines and identify the
       magnitude of the problem

     • Understand the reasons underlying irrational use

     • Discuss strategies and interventions to promote
       rational use of medicines

     • Discuss the role of government, NGOs, donors and
       WHO in solving drug use problems


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
   The rational use of drugs requires that patients receive
   medications appropriate to their clinical needs, in
   doses that meet their own individual requirements for
   an adequate period of time, and at the lowest cost to
   them and their community.
                                              WHO conference of experts Nairobi 1985
  • correct drug
  • appropriate indication
  • appropriate drug considering efficacy, safety, suitability for the
    patient, and cost
  • appropriate dosage, administration, duration
  • no contraindications
  • correct dispensing, including appropriate information for patients
  • patient adherence to treatment

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Adequacy of diagnostic process
     Source: Thaver et al SSM 1998, Guyon et al WHO Bull 1994, Krause et al TMIH
     1998, Bitran HPP 1995, Bjork et al HPP 1992, Kanji et al HPP 1995.




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      5-55% of PHC patients receive injections -
      90% may be medically unnecessary
                                             Source: Quick et al, 1997, Managing Drug Supply




                                     15 billion injections per year globally
                                     half are with unsterilized needle/syringe
                                     2.3-4.7 million infections of hepatitis B/C
                                      and up to 160,000 infections of HIV per
                                      year associated with injections


                        % of primary care patients receiving injections

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
        Variation in outpatient antibiotic use
        in 26 European countries in 2002




              Source: Goosens et al, Lancet, 2005; 365: 579-587; ESAC project.

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
       Database on medicines use

   •    Database of all medicines use
        surveys using standard indicators in
        primary care in developing and
        transitional countries
   •    Studies identified from INRUD
        biliog, PUBMED, WHO archives
   •    Data on study setting, interventions,
        methods and drug use extracted &
        entered
   •    All data extraction and entry
        checked by 2 persons
   •    Now > 900 studies entered
   •    Systematic quantitative review
   •    Evidence from analysis used for
        WHA60.16 in 2007



Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      % compliance with guidelines by WB region




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Public / private treatment of acute diarrhoea
      by doctors, nurses, paramedical staff




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Treatment of ARI by prescriber type




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Overuse and misuse of antimicrobials
      contributes to antimicrobial resistance
                                                Source: WHO country data 2000-3
     • Malaria
        – choroquine resistance in 81/92 countries
     • Tuberculosis
        – 0-17 % primary multi-drug resistance
     • HIV/AIDS
        – 0-25 % primary resistance to at least one anti-retroviral
     • Gonorrhoea
        – 5-98 % penicillin resistance in N. gonorrhoeae
     • Pneumonia and bacterial meningitis
        – 0-70 % penicillin resistance in S. pneumoniae
     • Diarrhoea: shigellosis
        – 10-90% ampicillin resistance, 5-95% cotrimoxazole resistance
     • Hospital infections
        – 0-70% S. Aureus resistance to all penicillins & cephalosporins

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
    Community surveillance
    of AMR and use (1)
    •   Developing & piloting method for
        integrated surveillance of AMR & AB
        use & collection of baseline data in 2
        resource-constrained settings
    •   3 sites in India & 2 in S. Africa
    •   AMR & AB use data collected
        monthly for 1-2 years from same
        communities
    •   4 sites measured AMR in E.Coli & 1
        in S.pneum & H.influenzae
    •   AB use by private GPs, retailers,
        public & priv hospitals & PHCs by
        exiting patient interview or
        prescribing & dispensing records
    •   Qualitative study (FGDs) into
        provider & consumer behaviour

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
    Community surveillance of AMR and use (2):
    results
   • Antimicrobial resistance
        – pathogenic E.Coli in pregnant women's urine in India
           • Cotrim 46-65%; Ampi 52-85%; Cipro 32-59%; Cefalex 16-50%
        – S.Pneumoniae & H.influenzae in sputa in S. Africa
           • Cotrim > 50% (both organisms); Ampi >70% (H.influenzae)
   • Antibiotic use
        – About ½ patients in India & ¼ or less of patients in S.Africa get ABs
        – Much inappropriate AB use especially in India e.g. use of fluoroquinolones
          for coughs and colds in private sector
   • Motivation of providers & consumers
        – Patient demand – looking for quick cure
        – Lack of CME & unwillingness to attend for fear of losing custom
        – Uncontrolled pharmaceutical promotion, involving financial gain



Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Adverse drug events
                                                Source: Review by White et al,
                                                Pharmacoeconomics, 1999, 15(5):445-458


     • 4-6th leading cause of death in the USA
     • estimated costs from drug-related morbidity &
       mortality 30 million-130 billion US$ in the USA
     • 4-6% of hospitalisations in the USA & Australia
     • commonest, costliest events include bleeding,
       cardiac arrhythmia, confusion, diarrhoea, fever,
       hypotension, itching, vomiting, rash, renal failure



Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Changing a Drug Use Problem:
      An Overview of the Process

                                        1. EXAMINE
                                      Measure Existing
                                         Practices
                                        (Descriptive
                                     Quantitative Studies)
                                           improve
         4. FOLLOW UP                                              2. DIAGNOSE
        Measure Changes                   diagnosis              Identify Specific
          in Outcomes                                           Problems and Causes
     (Quantitative and Qualitative                            (In-depth Quantitative
           Evaluation)                                        and Qualitative Studies)
                                            improve
                                         intervention

                                          3. TREAT
                                     Design and Implement
                                        Interventions
                                       (Collect Data to
                                     Measure Outcomes)


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Many Factors Influence Use of Medicines
                                                         Intrinsic
                                            Prior
                                          Knowledge
                       Scientific
                                                                 Habits
   Information        Information

          Influence                                                         Social &
            of Drug                                                         Cultural
           Industry                                                         Factors
                                      Treatment                                  Societal
          Workload &
                                       Choices                         Economic &
           Staffing                                                   Legal Factors

   Workplace             Infra-                               Authority &
                       structure         Relationships        Supervision
                                          With Peers
                                                         Workgroup

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Strategies to Improve Use of Drugs

               Educational:                                Managerial:
      Inform or persuade                        Guide clinical practice
       – Health providers                         – Information systems/STGs
       – Consumers                                – Drug supply / lab capacity


                                      Use of
                                     Medicines

                Economic:                                  Regulatory:
     Offer incentives                           Restrict choices
      – Institutions                              – Market or practice controls
      – Providers and patients                    – Enforcement


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Educational Strategies
     Goal: to inform or persuade
   • Training for Providers
        –   Undergraduate education
        –   Continuing in-service medical education (seminars, workshops)
        –   Face-to-face persuasive outreach e.g. academic detailing
        –   Clinical supervision or consultation
   • Printed Materials
        – Clinical literature and newsletters
        – Formularies or therapeutics manuals
        – Persuasive print materials
   • Media-Based Approaches
        – Posters
        – Audio tapes, plays
        – Radio, television

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Impact of Patient-Provider Discussion Groups
      on Injection Use in Indonesian PHC Facilities
                                              Source: Hadiyono et al, SSM, 1996, 42:1185

                  % Prescribing Injections

          80



          60

                                                                                 Pre
          40                                                                     Post



          20



           0
                        Intervention                    Control

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Training for prescribers
     The Guide to Good Prescribing



    • WHO has produced a Guide for Good
      Prescribing - a problem-based method
    • Developed by Groningen University in
      collaboration with 15 WHO offices and
      professionals from 30 countries
    • Field tested in 7 sites
    • Suitable for medical students, post grads,
      and nurses
    • widely translated and available on the WHO
      medicines website


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Managerial strategies
     Goal: to structure or guide decisions

   • Changes in selection, procurement, distribution to
     ensure availability of essential drugs
        – Essential Drug Lists, morbidity-based quantification, kit systems

   • Strategies aimed at prescribers
        – targeted face-to-face supervision with audit, peer group
          monitoring, structured order forms, evidence-based standard
          treatment guidelines

   • Dispensing strategies
        – course of treatment packaging, labelling, generic substitution


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
    RCT in Uganda of the effects of STGs, training and
    supervision on % of Px conforming to guidelines
                                              Source: Kafuko et al, UNICEF, 1996.




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Economic strategies:
      Goal: to offer incentives to providers an consumers


     • Avoid perverse financial incentives
          – prescribers’ salaries from drug sales
          – insurance policies that reimburse non-essential
            drugs or incorrect doses
          – flat prescription fees that encourage polypharmacy
            by charging the same amount irrespective of
            number of drug items or quantity of each item




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Pre-post with control study of an economic
     intervention (user fees) on prescribing quality in Nepal
                                              Source: Holloway, Gautam & Reeves, HPP, 2001




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      PHC prescribing with and without Bamako
      initiative in Nigeria
                                                Source: Scuzochukwu et al, HPP, 2002




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     Regulatory strategies
     Goal: to restrict or limit decisions

    • Drug registration
    • Banning unsafe drugs - but beware unexpected results
        – substitution of a second inappropriate drug after banning a first
          inappropriate or unsafe drug
    • Regulating the use of different drugs to different
      levels of the health sector e.g.
        – licensing prescribers and drug outlets
        – scheduling drugs into prescription-only & over-the-counter
    • Regulating pharmaceutical promotional activities

          Only work if the regulations are enforced

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
    Intervention impact: largest % change in any
    medicines use outcome measured in each study
                                              source: database on medicines use 2009
   Intervention type                   No. studies Median impact           25,75th centiles
   Printed materials                   5               8%                   7%, 18%
   National policy                     6               15%                 14%, 24%
   Economic strategies                 7               15%                 14%, 31%
   Provider education                  25              18%                 11%, 24%
   Consumer education                  3               26%                 13%, 27%
   Provider+consumer education         12              18%                  8%, 21%
   Provider supervision                25              22%                 16%, 40%
   Provider group process              8               37%                 21%, 59%
   Essential drug program              5               28%                 26%, 50%
   Community case mgt                  5               28%                 28%, 37%
   Providr+consumr ed & supervis 7                     40%                 18%, 54%

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Impact of multiple interventions on injection
      use in Indonesia

                                   Interactive group discussion (IGC group only)
                                                Seminar (both groups)

                                                              District-wide monitoring
                                                              (both groups)




       Source: Long-term impact of small group interventions, Santoso et al., 1996

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
What national policies do countries have to promote rational use?
Source: MOH Pharmaceutical policy surveys 2003 and 2007




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
                      Increase




                                                                      Decrease




 For Iceland, total data (including hospitals) are used   Slide courtesy of Otto Cars, STRAMA, Sweden


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
                                             Co-ordination programs      and national campaigns




   For Iceland, total data (including hospitals) are used   Slide courtesy of Otto Cars, STRAMA, Sweden

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Why does irrational use continue?


         Very few countries regularly monitor drug
         use and implement effective nation-wide
         interventions - because…
     • they have insufficient funds or personnel?
     • they lack of awareness about the funds wasted
       through irrational use?
     • there is insufficient knowledge of concerning the cost-
       effectiveness of interventions?



Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     What are we spending to promote rational
     use of medicines ?

  • Global sales of medicines 2002-3 (IMS):                   US$ 867 billion

  • Drug promotion costs in USA 2002-3:                       US$ >30 billion

  • Global WHO expenditure in 2002-3:                         US$ 2.3 billion
       – Essential Medicines expenditure                      2% (of 2.3 billion)
       – Essential Medicines expenditure on
         promoting rational use of medicines                  10% (of 2%)
       – WHO expenditure on promoting
         rational use of medicines                            0.2% (of 2.3 billion)



Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
     2nd International Conference for Improving
     Use of Medicines, Chiang Mai, Thailand, 2004
     472 participants from 70 countries


     http://www.icium.org


      Recommendations for countries to:
      • Implement national medicines programmes to
        improve medicines use
      • Scale up successful interventions
      • Implement interventions to address community
        medicines use



Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      WHO priorities

     • Resolution WHA60.16
          – Urges Member States " to consider establishing and/or
            strengthening…a full national programme and/or
            multidisciplinary national body, involving civil society and
            professional bodies, to monitor and promote the rational use
            of medicines "
          – WHO to support countries to implement resolution

     • Continue to give technical advice to countries
          –   Model EML and formulary
          –   Training on promoting RUM in community, PHC, hospitals
          –   Research to identify cost-effective interventions
          –   Advocacy
Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
               Health systems with no national programs:
               •No coordinated action
               •No monitoring of use of medicines

                                              Situational analysis



                                               WHO facilitating
                                               multi-stakeholder         Develop
                     Modify
                                               action in countries       national plans
                     action plans
                                                                         of action

                                           Implement & evaluate
                                           national action plans using
                                           govt & local donor funds

                 Health systems with national programs:
                 •Coordinated action
                 •Regular monitoring of use of medicine

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
Health system rapid appraisal tool (1): structure
for national stakeholders to rapidly appraise their own health systems in
order to develop evidence-based national plans of action
   • Introduction
        – How to use the tool (in workbook format) and carry out the assessment
          (preparation, data collection, analysis)
        – Systematic data collection using document review, key informant
          interviews and observation with triangulation of results
   • Key respondent questionnaires
        –   MOH senior dept managers (incl. dept pharmacy, DRA),
        –   national drug supply organisation, insurance organisation(s),
        –   health training institutions, health professional organisations,
        –   health facility staff and health facility survey
   • Data collation and analysis by component
        – Identify recommendations for each component
   • Cross-cutting analysis & presentation to govt & donors
        – Analysis across components, prioritisation and formulation of national
          recommendations (to be completed)

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Health system rapid appraisal tool (2):
      components

   • Components
        – Medicines use surveys and activities
        – Medicines policy framework
        – Health system factors
           • Service delivery & human resources, insurance, drug supply,
             regulation, financial (dis)incentives
        – Specific technical areas for RUM
           • National program coordination, MTCs, EMLs, STGs, monitoring,
             provider & consumer education, independent medicines info, AMR
   • Data for each component
        – Taken from key informant questionnaires & health facility survey,
          identifying relevant data from coding system of questions
   • Analysis for each component
        – Compares actual practice against best practice, choosing solutions from
          a menu of interventions

Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Creating the WHO Essential Drugs Library
      to facilitate the work of national committees

       Evidence-                  Summary of clinical
     based clinical                  guideline
       guideline
                                                                         WHO Model
                                                                         Formulary
 Reasons for inclusion                      WHO
 Systematic reviews                       Model List
 Key references

           Cost:                                              Quality information:
           - per unit
           - per treatment                                    - Basic quality tests
           - per month                                        - Internat. Pharmacopoea
           - per case prevented                               - Reference standards


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      WHO-sponsored training programmes

   • INRUD/MSH/WHO: Promoting the rational use of drugs
   • MSH/WHO: Drug and therapeutic committees
   • Groningen University, The Netherlands / WHO:
     Problem-based pharmacotherapy
   • Amsterdam University, The Netherlands / WHO:
     Promoting rational use of drugs in the community
   • Newcastle, Australia / WHO: Pharmaco-economics
   • Boston University, USA / WHO: Drug Policy Issues


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
    Global monitoring and identifying effective
    strategies to promote rational use of medicines

     • WHO/EMP databases on drug use and policy
          – quantitative data on medicines use and interventions to
            improve medicines use from 1990 to present day
          – data from MOHs on pharmaceutical policies every 4 years –
            1999, 2003, 2007
     • ICIUM3 in 2011
          – 3rd international conference on improving the use of
            medicines (ICIUM3)
     • Surveillance of antimicrobial use & resistance
          – method for community-based surveillance in poor settings
          – interventional approach for improving use in private sector


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Conclusions

    • Irrational use of medicines is a very serious global
      public health problem.

    • Much is known about how to improve rational use of
      medicines but much more needs to be done
         – policy implementation at the national level
         – implementation and evaluation of more interventions,
           particularly managerial, economic and regulatory interventions

    • Rational use of medicines could be greatly improved if
      a fraction of the resources spent on medicines were
      spent on improving use.


Department of Essential Medicines and Pharmaceutical Policy
TBS 2009
      Activity
      Discuss in groups the following questions


    • What should be the roles of:
             • government,
             • NGOs and donors,
             • WHO,
        in promoting the rational use of medicines?




Department of Essential Medicines and Pharmaceutical Policy
TBS 2009

				
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