Rational Use of Drugs _ppt 552KB_ - Rational Use of Drugs in the by chenboying

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									Rational use of drugs:
        an overview




       Kathleen Holloway
 Technical Briefing Seminar 2004
 Essential Drugs and Medicines Policy
             WHO Geneva
                        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


             WHO, Dept. Essential Drugs and Medicines Policy   2
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

                WHO, Dept. Essential Drugs and Medicines Policy              3
  % PHC patients treated according to guidelines
Africa/Asia 1990/1     1992/3   1994/5    1996/7   1998/9   2000/1
no.countries   5/5     3/3       10/3     12/5      12/5     3/2
no.surveys     9/7     4/6       16/6     15/6      14/7     3/4
         70
         60
         50
         40
         30
         20
         10
          0
              1990/1   1992/3   1994/5    1996/7   1998/9   2000/1

                                 Africa   Asia

                  Source: WHO database on drug use 2003
                                                                 4
% drugs that are prescribed unnecessarily
  estimated by a comparison of expected versus actual prescription

        Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000


  80
  70
  60
  50
  40
  30
  20
  10
   0
            Nepal                     Yemen                      Nigeria

          % antibiotics       % injections        % drugs         % cost

               WHO, Dept. Essential Drugs and Medicines Policy             5
       Adequacy of diagnostic process
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.

     Pakistan

  Bangladesh

Burkino Faso

      Senegal

      Angola

    Tanzania

                0           10          20           30          40     50        60
    % observed consultations where the diagnostic process was adequate

                    WHO, Dept. Essential Drugs and Medicines Policy           6
             5-55% of PHC patients receive injections -
                90% may be medically unnecessary
             A F R IC A

               G ha na

         C a m e ro o n

              N ige ria

                S uda n

            T a nza nia

          Z im ba bwe

                 A S IA

               Yemen

           Indo ne s ia

                N e pa l                      15 billion injections per year globally
                                              half are with unsterilized needle/syringe
L.A M E R . & C A R .

             E c ua do r

         G ua t e m a la                      2.3-4.7 million infections of hepatitis B/C
        E l S a lv a do r

             J a m a ic a
                                               and up to 160,000 infections of HIV per
E a s t e rn C a ribe a n                      year associated with injections

                       0%        10%        20%         30%         40%        50%       60%
                            % of primary care patients receiving injections
                             Source: Quick et al, 1997, Managing Drug Supply         7
30 to 60 % of PHC patients receive antibiotics -
          perhaps twice what is clinically needed
         AFRICA
          Sudan
      Sw aziland
      Cam eroon
          Ghana
       Tanzania
      Zim babw e
           ASIA
      Indonesia

          Nepal
     Bangladesh
 L.AMER. & CAR.
Eastern Caribean
     El Salvador
        Jam aica
      Guatem ala




               0%       10%      20%      30%      40%      50%       60%   70%

                    % of PHC patients receiving antibiotics
                    Source: Quick et al, 1997, Managing Drug Supply
                                                                            8
Overuse and misuse of antimicrobials contributes
          to antimicrobial resistance
   • Malaria
      – choroquine resistance in 81/92 countries
   • Tuberculosis
      – 2 - 40 % primary multi-drug resistance
   • Gonorrhoea
      – 5 - 98 % penicillin resistance in N. gonorrhoeae
   • Pneumonia and bacterial meningitis
      – 12 - 55 % penicillin resistance in S. pneumoniae
   • Diarrhoea: shigellosis
      – 10-90+ % amp, 5-95% TMP/SMZ resistance
            WHO, Dept. Essential Drugs and Medicines Policy   9
                    Source: DAP, EMC, GTB, CHD (1997)
           Adverse drug events
   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

               WHO, Dept. Essential Drugs and Medicines Policy   10
Drug Purchases through the Private Sector
• 50-90% of all drug purchases are private
   – 25% to 75% illness episodes self-medicated
   – 1/2 consumers buy 1-day supply at a time
   – 50% of people worldwide fail to take drugs correctly
• Results not always therapeutic
   –   over-treatment of mild illness
   –   inadequate treatment of serious illness
   –   mis-use of anti-infective drugs
   –   over-use of injections

               WHO, Dept. Essential Drugs and Medicines Policy   11
 Prescribing by dispensing and non-dispensing doctors in Zimbabwe
                                              Trap et al 2000



consultation time (mins)                   13
                                       8.65

  % Px with antibiotics                                                      48
                                                                                      58

   % Px with injections                 9.5
                                                           28.4

       no.drug items/Px        1.67
                                2.31

                           0           10         20       30       40       50        60        70

                                            dispensing doctors    non-dispensing doctors
                     WHO, Dept. Essential Drugs and Medicines Policy                        12
  Changing a Drug Use Problem:
                An Overview of the Process
                                   1. EXAMINE
                                 Measure Existing
                                    Practices
                                   (Descriptive
                                Quantitative Studies)

    4. FOLLOW UP                     improve                      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)

                    WHO, Dept. Essential Drugs and Medicines Policy             13
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
                   WHO, Dept. Essential Drugs and Medicines Policy                14
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


              WHO, Dept. Essential Drugs and Medicines Policy        15
                Educational Strategies
                 Goal: to inform or persuade
• Training for Providers
   –   Undergraduate education
   –   Continuing in-service medical education e.g. 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
                  WHO, Dept. Essential Drugs and Medicines Policy   16
          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

              WHO, Dept. Essential Drugs and Medicines Policy   17
     Impact of Patient-Provider Discussion Groups on
       Injection Use in Indonesian PHC Facilities
                  Hadiyono et al, SSM, 1996, 42:1185

       % Prescribing Injections

80



60

                                                       Pre
40                                                     Post



20



0
            Intervention            Control               18
Effects of Opinion Leader on Choice Antibiotic
    for Prophylaxis in a Teaching Hospital
       % of all C-sections                Discuss-
0.7                                       ion with
                                          Obstetric
                                          Chief                          !          ! !!
0.6                                                                                  !
                                                                                                Cefazolin
              ,                               !
        ,                                                                                       recommend-
0.5
                                                         !             !!
                                      !                             !                           ed
                         ,                                         !  !
        ,  ,                           !                     !!
0.4   ,  ,                ,
                                              !!                                          Cefoxitin
                    ,                                              !
                                                         !
0.3
                   ,        !,                                                            not
                             !!                                                           recommended
                              ,
0.2                        ,
                            ,
                          !!
0.1                                        ,             ,
                                      ,            ,
            !                             , , ,  ,
          !!                                   ,  , , ,,
 0    !!!!   !!                        , ,   ,  ,    ,  ,,
      Jan   Apr    Jul   Oct    Jan     Apr        Jul       Oct   Jan   Apr        Jul   Oct
                  84                              85                           86

                    WHO, Dept. Essential Drugs and Medicines Policy                         19
               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
• Avoidance of perverse financial incentives
   – prescribers’ salaries from drug sales, flat prescription fees,
   – insurance policies that reimburse non-essential drugs or incorrect doses

                  WHO, Dept. Essential Drugs and Medicines Policy     20
Review of 59 evaluations of clinical guidelines
     Grimshaw & Russell, Lancet, Nov.27 1993, 342:1317-1322

• Significant improvement found in:
   – 55/59 studies concerning the process of care
   – 9/11 studies concerning patient outcome
• Size of the improvement varied 5-60% and was
  higher if there was:
   – involvement of users in guideline development
   – a specific educational intervention
   – a patient-specific reminder at consultation e.g. a
     decision by a funding body not to reimburse
     prescriptions not meeting guidelines
              WHO, Dept. Essential Drugs and Medicines Policy   21
 RCT in Uganda of the effects of STGs, training &
supervision on the % of Px conforming to guidelines
                     Kafuko et al, UNICEF, 1996.

Randomised           No. health      Pre-         Post-               Change
group                 facilities intervention intervention

Control group             42              24.8%               29.9%   +5.1%


Dissemination of          42              24.8%               32.3%   +7.5%
guidelines

Guidelines + on-          29              24.0%               52.0%   +28.0%
site training

Guidelines + on-
site training + 4         14              21.4%               55.2%   +33.8%
supervisory visits
                 WHO, Dept. Essential Drugs and Medicines Policy       22
    Pre-post with control study of an economic
  intervention (user fees) on prescribing in Nepal
               Holloway, Gautam & Reeves, HPP, 2001


Fees (complete       control fee / Px 1-band item fee 2-band item fee
drug courses)             n=12             n=10            n=11

Av. no. items             2.9 2.9                   2.9 2.0          2.8 2.2
per prescription           (+/- 0)                    (-0.9)          (-0.6)

% prescriptions          23.5 26.3                 31.5 45.0        31.2 47.7
conforming to             (+2.7%)                   (+13.5%)        (+16.5%)
STGs

Av.cost (NRs)            24.3 33.0                 27.7 28.0        25.6 24.0
per prescription           (+8.7)                    (+0.3)           (-1.6)
                  WHO, Dept. Essential Drugs and Medicines Policy      23
 PHC prescribing with & without Bamako
 initiative in Nigeria Scuzochukwu et al, HPP, 2002

 no.EDL drugs avail                 15.3
                                                  35.4
  % pres EDL drugs                    21
                                                                              93
% Px with antibiotics                      25.6
                                                                 64.7
% Px with injections                               38
                                                                    72.8
   no.drug items/Px         2.1
                              5.3

                        0           20            40        60          80        100

             21 Bamako PHCs                12 non-Bamako PHCs
              WHO, Dept. Essential Drugs and Medicines Policy                24
Tetracycline prescription rate & tetracycline-resistant
E.Coli in hospital isolates, 2 municipalities in Denmark,
01/1994-12/1999
 19 (# prescriptions per 1,000 inhabitants)




                                        5            Change in subsidization: from 50 to 0% (01/1996)
                                                                                                              40
                                        4
               Tetracycline Use




                                                                                                              30
                                        3
                                                                                                              20
                                        2

                                        1                                                                     10


                                        0                                                                     0
                                  94




                                                     95




                                                               96




                                                                          97




                                                                                     98




                                                                                               99
                                                   19




                                                             19




                                                                        19




                                                                                   19




                                                                                             19
                                              Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.
                                              Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628].      25
               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
               WHO, Dept. Essential Drugs and Medicines Policy   26
        Choosing an Intervention
• A single educational strategy is often not effective and
  does not have a sustainable impact
• Printed materials alone are not effective
• Combination of strategies, particularly of different types
  (e.g. educational + managerial) always produces better
  results than a single strategy
• Focused small groups and face to face interactive
  workshops have been shown to the effective
• Audit and feedback, peer review, are very effective
• Economic strategies are very powerful strategies to change
  drug use but may be difficult to introduce

              WHO, Dept. Essential Drugs and Medicines Policy   27
  Review of 30 studies in developing countries
 size of drug use improvements with various interventions
                             Minor        Moderate             Large
      Large group training
      Small group training
Diarr. community case mgt
 ARI community case mgt

          Info/guidelines
           Group process
       Supervision/audit
        EDP/Drug supply
     Economic strategies

                             0       10      20      30   40      50      60

                                     Improvement in outcome measure (%)

             Source: Ross-Degnan et al, Plenary presentation, Conference on
             Improving the Use of Medicines, 1997, Chiang Mai, Thailand.
                                                                         28
Combined Intervention Strategy
Prescribing for Acute Diarrhea in Mexico City
        % cases treated in line with algorithm

 100
                                                  AfterPeer
                                                  Review                Study Physicians
                        After                                           Control Physicians
                                                  (n = 20)
  80                    Workshop      37/52
                                                      79/115


        BaselineStage                                              18-months
  60       (n = 20) 42/82                                          Follow-up


  40                                                           31/110
       25/102   20/84         16/70           11/46



  20



   0

                  WHO, Dept. Essential Drugs and Medicines Policy                    29
 Impact of Training on Use of Diarrhea Treatment
       Algorithm in Three Mexico Settings


 Intervention                Prescribers Baseline              Post   Change
 given by:                                  %                   %       %

 "Experts" in 2 clinics           31           24.5           71.2    +46.7
 (San Jeronimo)

 "Leaders" in 18 clinics          65           17.7           43.4    + 25.6
 (Coyoacan)

 "Coordinators" in 124           157           24.7           31.2    + 6.5
 clinics (Tlaxcala)
Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995)



                    WHO, Dept. Essential Drugs and Medicines Policy            30
Impact of multiple interventions on
    injection use in Indonesia
                        100%                       Interactive group discussion (IGC group only)
 Proportion of visits



                                                                Seminar (both groups)
    with injection


                        80%

                        60%                                                      District-wide monitoring
                                                                                 (both groups)
                        40%

                        20%

                         0%
                               1    3    5     7      9   11    13 15    17 19       21 23   25
                                                               Months
                               Comparison group           Interactive group discussion
Source: Long-term impact of small group interventions, Santoso et al., 1996

                               WHO, Dept. Essential Drugs and Medicines Policy                 31
Drug & Therapeutic Committee Activities
          very little data on drug use impact

    100
    80
    60
    40
    20
      0
          Australia 1996 USA 2001          Netherlands Germany 1995
                                              1999

     % hospitals with a DTC                Drug use monitoring / DUE
     Strategies to improve drug use

              WHO, Dept. Essential Drugs and Medicines Policy          32
   10 national strategies to promote RUD
  needs sufficient govt. investment for medicines & staff !
1. Evidence-based standard treatment guidelines
2. Essential Drug Lists based on treatments of choice
3. Drug & Therapeutic Committees in hospitals
4. Problem-based training in pharmacotherapy in UG training
5. Continuing medical education as a licensure requirement
6. Independent drug information e.g bulletins, formularies
7. Supervision, audit and feedback
8. Public education about drugs
9. Avoidance of perverse financial incentives
10. Appropriate and enforced drug regulation
              WHO, Dept. Essential Drugs and Medicines Policy   33
Why does irrational use continue?
  Very few countries regularly monitor drug use &
  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?

            WHO, Dept. Essential Drugs and Medicines Policy   34
          WHO future priorities
• Developing a model formulary process, the WHO
  Essential Drugs Library
• Training programmes
• Pilot projects to contain antimicrobial resistance
• Promoting drug & therapeutic committees
• Intervention research to promote RUD
   – cost-effectiveness of interventions, policies
• Advocacy for the rational use of drugs (RUD)
   – Essential Drug Monitor, effective drug information
   – ICIUM2004
             WHO, Dept. Essential Drugs and Medicines Policy   35
  Creating the WHO Essential Drugs Library
  to facilitate the work of national committees

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

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


                     WHO, Dept. Essential Drugs and Medicines Policy            36
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/WHO: Promoting rational
  use of drugs in the community
• Newcastle, Australia/WHO : Pharmaco-economics
• Boston University, USA/WHO: Drug Policy Issues

           WHO, Dept. Essential Drugs and Medicines Policy   37
  Local pilot projects to contain AMR
• Objectives
  – develop, implement & evaluate interventions to contain AMR
    using surveillance data in local sites
  – to develop a new method for the integrated surveillance, at
    community level, of antimicrobial use and resistance that can
    be used in many different countries
  – to build local capacity in developing a multi-disciplinary
    approach to the containment of AMR
• 3 phases
  – (1) set up surveillance,
  – (2) develop, implement & evaluate interventions
  – (3) expand to other sites

             WHO, Dept. Essential Drugs and Medicines Policy   38
       Promoting DTCs : impact of magt., training &
          planning though hospital DTCs in Laos
% Px with
                                                                             Av.no.drugs / Px
 Abs/Inj.
       100%                                                                                5
        80%                                                            No.drugs            4
        60%                                                            Antibiotics         3
        40%                                                                                2
                                                                       Injections
        20%                                                                                1
            0%                                                                             0
                 1          2        3        4         5        6      7         8
                                               Months
                     WHO, Dept. Essential Drugs and Medicines Policy                  39
 Identifying effective strategies to promote
         more rational use of drugs
• Joint research initiative between
  WHO/EDM, MSH and ARCH
  – over 20 intervention research projects in
    developing countries
• WHO database on drug use
  – quantitative data on drug use and interventions
    to improve drug use over the last decade


           WHO, Dept. Essential Drugs and Medicines Policy   40
                       ICIUM2004
2nd International conference for improving use of medicines
• Next milestone in assessing progress on global
  medicines agenda
• Chiang Mai, Thailand, Mar 30-Apr 2, 2004
• Objective: Examine state of the art in improving
  medicines use in focus areas:
   – Intl. policy & systems                  - Natl. policy & systems
   – Hospitals                               - Primary care
   – Private pharmacies                      - Community use


             WHO, Dept. Essential Drugs and Medicines Policy     41
       ICIUM2004: topic tracks
• “Meetings Within a Meeting”
  – Key constituencies and interest groups working on
    pharmaceutical issues – researchers, policy makers,
    donors and NGOs
  – Summarize topical lessons and research needs
• Topic tracks include
  –   Child health                           - Adult health
  –   TB                                     - HIV/Aids, STIs
  –   Malaria                                - Antimicrobial resistance
  –   Impact of access on use

             WHO, Dept. Essential Drugs and Medicines Policy     42
                              Activity
   Discuss in groups the following questions

• Choose a major drug use problem in your country or project
• Identify the causes underlying the problem
• What are the main 1-2 strategies being undertaken to address
  this problem?
• Are these 1-2 strategies being evaluated? If so, how?
• What should be the roles of government, NGOs, donors, and
  WHO be in filling the gap in strategies/policies to address this
  problem?


                WHO, Dept. Essential Drugs and Medicines Policy   43

								
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