Using indicators to measure country pharmaceutical situations by 7ZRRUmF

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									   Using indicators to
    measure country
pharmaceutical situations
                                Dr. Edelisa D. Carandang
                               Drug Action Program (DAP)
  Department of Technical Cooperation for Essential Drugs and Traditional Medicines (TCM)
                            World Health Organization, Geneva

                            Data analysis in Collaboration
                WHO Boston Collaborating Center on Pharmaceutical Policy
                               Marsha Pierre-Jacques

                                         Oct 2005
Session objectives
   The participants will have an overview and understanding of the following:

     •   The WHO hierarchical approach to monitoring and assessing country
         pharmaceutical situations
          •   Objectives of monitoring & assessing country pharmaceutical situation & core
              indicator approach to monitoring, assessment and evidenced based planning
          •   Level I and level II indicators
          •   Summary of progress and challenges

     •   Snapshots of current global pharmaceutical situations using Level I and
         Level II indicator survey

     •   New approach in the development of access indicators
          •   household survey
          •   composite scores for access
          WHO hierarchical approach to monitoring
          and assessing country pharmaceutical
          situations

                             Objectives
  1. Assess and Monitor         To develop prioritized pharmaceutical policy
                                 objectives based on evidence
                                To determine the effects, impact of
                                 pharmaceutical policy implementation over time
                                To establish pharmaceutical situation evidence
                                 for advocacy ( managers, policy makers, donors)


                             Indicator for evidenced based planning
                                Systematic data gathering
                                Enables comparisons between facilities, districts,
                                 regions, countries depending on sampling
                                Facilitates measuring trends
3. Implement                    Provides evidence for prioritising, planning and
                   2. Plan       identifying interventions
WHO core indicators to monitor
National Drug Policy

                          Level I               èQuestionnaire completed
                      Core structure &            by country officials
                     process indicators

                         Level II                            Systematic health facili
             Core outcome/impact indicators &                       survey
                     household survey

                          Level III
   Indicator tools for specific components of the
   pharmaceutical sector
        ● Pricing          ● Traditional medicine
        ● HIV/AIDS         ● Assessing regulatory capacity
        ● TRIPS
Level I indicator topics:
Pharmaceutical structures & processes

   National Medicines          Medicines financing
    Policy (NMP)                Access to essential
   Legislation/regulation       medicines
   Quality control of          Production
    pharmaceuticals             Rational use of
   Essential Medicines          medicines
    List (EML)                  Intellectual property
   Medicines supply             rights protection and
    system                       marketing
                                 authorization
Level I indicator
   Advantages
    •   Cheap way to get information across countries
    •   Can be done repeatedly/regular period
    •   Automated questionnaire and data encoding processing

   Limitations
    •   Validation of data
    •   Respondents from countries (resourcefulness to coordinate
        gathering of information, accurate responses)
    •   Interpretation of questions and accessibility of information
    •   Lots of missing data
Level II indicator topics:
Pharmaceutical outcomes

  • Access
     • Availability
     • Affordability
  • Quality
     • Adequacy of Storage
     • Drug Expiration
  • Rational Use
     • Quality of Prescribing
     • Availability of Information
Level II indicator


   Advantages
    • Practical survey based on small samples
      intended to highlight major issues

   Limitation
    • number of countries that can be covered
       Resources for training and conducting systematic
        survey
    Summarizing indicator measures
   Percentage: yes or no over total
   Measures of central tendency
    •   Mean: average value, sensitive to
        outliers, weighed toward skewed
        value, best summary of normally
        distributed values
    •   Median: middle value, resistant to
        outliers, good summary of any
        distribution
    •   Equivalent if data are normally
        distributed
   Measure of variation
    •   25th and 75th percentiles: boundaries
        of middle half of values, good
        summary of the overall spread of
        values, better summary of skewed
        data
Indicator measure: Ideal/logical
values

Example: % antibiotic prescribing (Logical value is <30 %)


                80
                                                Antibiotics
% of patients




                60       6 0 .0
                         51.7                           50 .0
                        4 6 .3                          4 3 .3
                40
                                                        3 6 .7

                20


                 0
                     Lo w                       M id d le
                                        C o unt r y Inco me Level

                                     25%ile     Median           75%ile


Ideal values
•Logical value exist for some
•Can be calculated empirically
Indicator measure: group norm
   Example: % antibiotic prescribing (logical value is <30%)
                                       % patients receiving an antibiotic - distribution of results

                  100%




                   80%




                   60%

                                                                                                      median
                                                                                                      value


                   40%




                   20%




                   0%
                                                                     facility

Group norm
•Easy for region/facilities to relate to peers
•Norms may be wrong
Snapshots of current global pharmaceutical
situations using Level I and Level II indicator survey



   Current status of process and structures
    in pharmaceutical sector
   Comparison of 1999 and 2003 Level I
    survey
   Results and outcomes from Level II
    survey
   Status of National Medicines Policy
   and monitoring


                                            Country Income Level
                                      Low            Middle           High
                                No.         %   No.       %     No.      %
NMP (Official or Draft)         51       86.0 47         69.1   10      47.6
NMP implementation plan         34      64.2    23      51.1    7       58.3
NMP integrated in health plan   36      66.7    31       64.6   6       54.6
Percentage of countries with official National Medicines
Policy (NMP) in 1999 and 2003


        80
        70
        60
        50
        40                                    1999
        30                                    2003

        20
        10
         0
             High   Medium   Low
Key pharmaceutical sector
legislation
                                                           Country Income Level


                                              Low                Middle                 High


                                        Number       %      Number       %        Number       %
Policy area covered:
                                        of Countries        of Countries          of Countries
Establishment of regulatory authority   53          98.2    52            89.7    17           94.4
Manufacturing of medicines              48          90.6    50            86.2    16           88.9
Distribution of medicines               54          98.2    50            89.3    17           94.4
Promotion & advertising of medicines    47          88.7    50            87.7    16           88.9
Importation of medicines                53          98.2    53            89.8    17           94.4
Empowerment to enter premises and       47          90.4    49            89.1    17           100
   collect samples and
   documentation
Requirement for regulatory              35          71.4    33            70.2    16            88.9
    transparency, accountability, and
    code of conduct
Regulation on registration of
medicines
                                                            Country Income Level

                                            Low                   Middle                    High

                                   Number     %            Number     %            Number     %
Component of registration:
                                   of Countries            of Countries            of Countries
Authorization for marketing of     47              83.9    49             81.7     17           94.4
    medicines are required
                                          Median                  Median                   Median
                                        [25th, 75th%]           [25th, 75th%]           [25th, 75th %]
Number of medicines approved               2413                    5000                     7296
   on the market                        [1500, 3708]            [2000, 9000]            [3621, 11459]
Written guidelines for medicines   41              73.2    50              80.7    14                82.4
     registration
WHO Certification Scheme           41               73.2   39               62.9   7                 41.2
   required for marketing
   authorization
Publicly accessible list of all    34               61.8   42               68.9   13                72.2
    registered products
Computerized registration system   27               49.1   32               51.6   13               72.2
   available
Generic prescribing and substitution
regulations in 1999 and 2003



100
 90                                          100
 80                                           90
 70                                           80
 60                           1999 Public     70
                              2003 Public     60                              1999 Public
 50
 40                           1999 Private    50                              2003 Public
 30                           2003 Private    40                              1999 Private
 20                                           30                              2003 Private
 10                                           20
  0                                           10
      Low    Middle    High                    0
                                                   Low   Middle    High



        Generic Prescribing                        Generic Substitution/Dispensing
Generic prescribing


                             Prescribing by generic name in public facilities

                             100
                                                                                Brazil
    Percentage of patients




                              80                                                Cambodia
                                                                                Cameroun
                              60
                                                                                Kenya
                              40                                                Laos
                                                                                Nepal
                              20                                                Rwanda
                                                                                Senegal
                               0
    Samples tested, and failing tests

                                       Country Income Level
                            Low               Middle               High
                      Median [25th,75th] Median [25th,75th] Median [25th,75th]
# of samples tested     763[172,2202       923[433,3382]       409[53, 744]


 (%) of samples       (11%) [3, 108]     (3.9%)   [4, 106]   (<1%) [1, 17]
that failed test
Storage and handling conditions
   Storage and handling conditions in public pharmacies and warehouses



                                    Public Health Facilities                        Warehouses
       % of maximum storage
        and handling score




                              100
                                                                                87.8       94.4
                              90                          90.5                             89.2
                                                                                87.5
                                                          83.2                  80.7       81.8
                              80             78.1
                                             75.0         76.5
                              70             70.1

                              60
                                         Low         Middle                 Low        Middle
                                        (n=11)       (n=10)                (n=11)      (n=10)
                                                         Country Income Level
                                                         25%ile   Median   75%ile
Countries with insurance that covers
medicines

     Public insurance                       Private insurance

90                                    100
80                                     90
70                                     80
60                                     70
                                       60
50
                               1999    50                              1999
40
                               2003    40                              2003
30                                     30
20                                     20
10                                     10
 0                                      0
     Low      Med.      High                 Low      Med.      High
  Medicines pricing policies

                                     Country Income Level
                               Low            Middle           High
                         No.         %   No.           % No.      %
Pricing policy public    29     53.7     32       60.4 8         66.7
sector
Pricing policy private   22      46.8 30          65.2 3         33.3
sector
Pricing policy NGO       7      17.5     15       27.8 2         28.6
    Public sector medicines supply

                                                              Country Income Level
                                                      Low                Middle            High

                                                No.         %      No.         %     No.      %

Ministry/Department of Health                   46       90.2      45        88.2    9       75.0

Non-governmental organization                   19        50.0     5         15.6    3       37.5
(NGO)
Private institution contracted by the           15        41.7     7         20.6    2       22.2
government
Individual health institutions                  25        58.1     21        55.3    6       66.7


 Question: Who is responsible for public sector drug procurement and distribution?
      Stock availability of key drugs in pharmacies


               Public pharmacy                   Private pharmacy


45
                                          60
40
35                                        50
30
25                               25-59                                 25-59
                                          40
20                               60-69                                 60-69
15                               70-79    30
                                                                       70-79
10                               80-89
 5                                        20                           80-89
                                 90-100                                90-100
 0
       Low      Middle                    10
     Income     Income
                                          0
      (n=12)     (n=9)                         Low (n=9)   Mid (n=4)
 Access to essential medicines
                           Level of Access to Essential Medicines Within One Hour Walking Distance

                      Very low access         Low to medium    Medium to high        Very high access
                             (<50%)               (50%-80%)        (81%-95%)                 (>95%)
                            n=18                   n=46             n=20                   n=20

                      No.          %      No.         %       No.          %     No.             %
WHO Region:
                      of Countries        of Countries        of Countries       of Countries
Africa                10          55.6    19         41.3     4          20.0    0               0.0
Americas              2           11.1    10         21.7     1           5.0    7                35.0
East. Mediterranean   1             5.6   2           4.3     4          20.0    1                5.0
European              3           16.7    6          13.0     2          10.0    9                45.0
South-East Asia       0            0.0    4            8.7    3          15.0    0                0.0
Western Pacific       2           11.1    5           10.9    6          30.0    3                15.0
Proportion of prescribed
medicines dispensed

                     100                 Cambodia                       100
                                         Cameroun                                             Brazil
 Percent dispensed




                      80                                                 80                   Bulgaria
                                         Ethiopia




                                                    Percent dispensed
                                         Kenya                                                China
                      60                                                 60
                                         Laos                                                 Columbia
                      40                 Mali                            40                   Guatemla
                                         Nepal                                                Indonesia
                      20                                                 20
                                         Rwanda                                               Iran
                       0                 Senegal                                              Oman
                                                                          0
                           Low Incom e   Tanzania
                                                                              Middle Income   Philippians
                            Countries
                                         Uganda                                 Countries     Malaysia
                       Affordability of pneumonia
                       treatment

                                             Adults
                           Private Pharmacies     Public Facilities                                                 Children
                                                                                                  Private Pharmacies       Public Facilities
                       8
to pay for treatment
No. of days' wages*




                                                                                              8




                                                                       to pay for treatment
                                                                       No. of days' wages*
                                           6.7
                       6
                                                                                              6
                       4                                                                                   5.0
                                           3.5
                                 2.6       3.1                                                4
                       2                                         2.2                                                             3.5
                                 1.7                     1.4     1.5
                                 1.0                     0.8     1.1                          2            1.9
                       0                                 0.2                                                                     1.4
                                                                                                           0.9
                           Low     Middle         Low      Middle                             0                                  0.2
                                   Country Income Level                                              Low                    Low
                                  25%ile     Median   75%ile                                                 Country Income Level

                                                                                                           25%ile     Median   75%ile
Rational use of medicines :
Prescribing and dispensing
                                                Country Income Level
                                      Low (n=12)               Middle (n=9)
                                Median % [25th, 75th]   Median % [25th, 75th]


Medicines adequately labeled    74.6 [42.6, 92.5]       87.0 [0.0, 100]


Patients knowing how to take    88.0 [71.0, 94.0]       80.4 [ 80.0, 88.3]
medicines

Patients prescribed             51.7 [46.3, 60.0]       43.3 [36.7, 50.0]
antibiotics


Patients prescribed injections 23.1 [11.3, 30.1]        6.7 [0, 10.5]
Rational use of medicines :
Prescribing on specific conditions
                                                    Country Income Level
                                       Low (n=12)                 Middle (n=9)
                                  Median % [25th,           Median % [25th, 75th]
                                  75th]
Children with diarrhea            80.0 [71.9, 87.5]         95.0 [90, 100] (Min. Max)
receiving ORS
Children with diarrhea            0 [0,40] (Min. Max)       5 [0,5] (Min. Max)
receiving antidiarhea
Children with pneumonia           90.0 [80, 100]            85.0 [70, 100] (Min. Max)
receiving first line antibiotic
Children with pneumonia           0 [0,25] (Min. Max)       0 [0,0] (Min. Max)
receiving +1 antibiotic
ARI patients receiving            90.0 [70, 98.8]           50 [20, 100] (Min. Max)
antibiotic treatment
Summary of progress and challenges
of the current indicators process

   Level I
    •   Large amount of data available
    •   Longitudinal monitoring possible with standard
        questions
    •   Lessons for questionnaire improvement (structure of
        items, skip patterns, missing data, clarity of items, length of
        survey, open ended questions, comparisons between years)
   Level II
    •  Refined methodology
    •  Trained individuals in countries for future work
   Process and Data Management
    •   Collection of Level I and Level II data
    •   Validation & integration of data
Household survey to measure
access and use of medicines

   currently one page survey instrument
    (13 questions)
   information covers the the following:
    • health seeking behaviour leading to use or non
        use of drugs
    •   if patients can afford, if they are available,
        where they are available , if able to get the
        medicine, reason why not,
Lower income groups do not get
all the medicines they need
           How much of the medicine prescribed was
                  obtained: Tanzania 2002

    100%
    80%
                                                 None
    60%
                                                 Some
    40%
                                                 All
    20%
     0%
              <$2        $2-$10        >$10
                     Weekly expenses
Availability and affordability are
the barrier to access
          Why households did not obtain all the medicines
                        Tanzania 2002

   100%
    80%                                       Other
    60%                                       Medicines not available
    40%                                       Price too high
    20%                                       Not enough money
    0%
            <$2        $2-$10       >$10
                  Weekly expenses
Composite indicators on access

         The access framework


    1. Rational          3. Sustainable
     selection              financing
                  ACCESS TO
           ESSENTIAL MEDICINES

    2. Affordable             4. Reliable
        prices                 systems
            Composite indicators
   Measure policy structures supporting access,
   Steps used in the current process
    •   Identify candidate variables
    •   Exclude variables with >50% missing responses
        and countries with >50% missing variables
    •   Compute maximum possible score per country
        •   Greater weight for some variables
        •   Maximum scores( access = 20.5; rational use = 16
    •   Composite score: Percent of maximum
        possible score, given items completed
Access composite score: an example




                             100                      100
       Composite Score (%)




                                          71                       69

                              50                      46
                                          35                       37
                                                      23
                                                                   14
                               0          0
                                    Low (n=35) Middle (n=35) High (n=15)
                                             Country Income Level
                                   Lowest score Median score Highest score




                                               Access
Next steps to develop composite
indicator scores


   Operational
    • Obtain complete data for candidate variables
    • Validate data accuracy
   Statistical
    • Formal statistical analysis to obtain
        appropriate factor weights
    •   Validate relationship between Level I structure
        and process and Level II outcomes indicators
Recommendations & directions
for future works
   Modify and Validate Level I Questionnaire
    •   Shorten questionnaire and simplify skip pattern ( key items)
    •   Identify key items and completion of questionnaire especially
        variables for composite indicators
    •   Validate by comparing responses within country
   Automate and Improve Data Collection Process
    •   Develop web-based data collection method
    •   Provide on-line glossary to aid in interpretation of questions
        Interpretation
    •   Process to do quality control/check of data
    •   Increase training on Level II indicators and support template
        completion
   Further development and experience on household survey

								
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