1. Country Pharmaceutical Profiles Dr Gilles Forte Mr Enrico Cinnella WHO/EMP/MPC 1 November 2010

2. Outline of the Presentation  Introduction- Why do we measure?  Level I  Level II Facility Survey Household Survey  Country Profiles

3. Why countries measure?  As a baseline to inform decisions Priority Setting  To check how well (or badly) you are performing

4. Knowing the situation Country A RATIONAL USE Last update of EML: 2009 Last update of STGs: 2008 Antiobiotics sold over the counter: NO QUALITY CONTROL System in place for quality control: NO Samples tested for post marketing surveillance: NO System in place for ADR: NO

5. The WHO System Level III Indicator tools for specific components of the pharmaceutical sector ● Pricing ●Traditional medicine ● Human Resources ● Assessing regulatory capacity ● Procurement and Supply Level II Core outcome/impact indicators & household survey Level I Core structure & process indicators Questionnaire (Health Officials) Systematic survey Level I Questionnaire/rapid assessment/checklist Arrays achievement & weaknesses, illustrate sectoral approaches Level II Comprehensive monitoring of pharmaceutical strategy outcome and impact Measures attainment of objectives Level III More detailed indicators for monitoring and evaluating specific areas/components Level II Core outcome/impact indicators & household survey Level I Core structure & process indicators

6. Level I Level III Indicator tools for specific components of the pharmaceutical sector ● Pricing ●Traditional medicine ● Human Resources ● Assessing regulatory capacity ● Procurement and Supply Level II Core outcome/impact indicators & household survey Level I Core structure & process indicators

7. Level I- A Global Survey  Questionnaires sent to MoH officials every four years (1999, 2003 and 2007). Mostly yes/no question.  Responses collected and compiled into a global database and global report.

8. Advantages of the Level I  Limited financial and human resources needed;  Easy to fill in; Mostly Yes/No question;  Information from a broad number of countries (156 in 2007);  Allows: An overview of the global situation Comparisons across regions and groups of countries i.e. by income levels Comparisons over time

9. Challenges of WHO Level I  Data source and date of publication not known;  Limited scope of information and no information about outcomes and impact;  No clear in-country mechanisms for data collection, validation and endorsement;  Lack of country ownership;  No clear value for countries in their policy process;

10. Level II Level III Indicator tools for specific components of the pharmaceutical sector ● Pricing ●Traditional medicine ● Human Resources ● Assessing regulatory capacity ● Procurement and Supply Level II Core outcome/impact indicators & household survey Level I Core structure & process indicators

11. From Structures to outcomes Level I- Is there a EML? Level II- Is the EML available at facility level? What is the percentage of medicines prescribed that are in the EML?  LEVEL II- Are policies achieving their effect? Availability- of a list of tracer medicines, and number of stock out days. Affordability- (number of days of pay to purchase treatment for selected illnesses). Quality- % Adequately labelled medicines, % expired medicines. Rational use- INRUD Prescribing indicators.

12. Some results

13. Household Survey  Household situations How they access their medicines, where they get them How much they pay  Identify access and affordability in relation to socio economic indicators, barriers  Examine use of medicines (acute and chronic diseases)  Perceptions on access, use and quality; handling of medicines

14. Households with medicines at Home

15. Pharmaceutical Country Profiles

16. WHO asked to conduct a baseline assessment in the 15 SADC countries. A few changes were introduced, namely:  Questionnaires were prefilled with information available in WHO/HQ such as World Health Statistics, WHO/HAI pricing surveys, Level I 2007 etc. (50% of data)  Structures and outcomes indicators (e.g. Level II surveys) were put together to give a better picture of the situation at country level.  Year and source were requested for each piece of information.  Formal endorsement clarified issues of data ownership and use. All countries signed it, thereby giving permission to publish data.  Individual Country Profiles were built. SADC survey 2009

17. Pilot Phase Country Profiles (as part of 2011 survey)  13 countries selected.  Main innovations: Electronic data collection instrument linked to database. Detailed manual and glossary linked to the tool. Assessment of project through process indicators. Development of narrative profiles based on template with quick turn around. Intellectual property of profiles vested with countries Regulatory Sector report developed Report on Pilot Phase available on Utrecht web site (Parsi)(Parsi)

18. Pilot Phase results  Good response rate (average 88%) and time of return: 5 countries by 48 days, 12 countries by 90 days.  Electronic data collection tool worked fine.  Quality of data good when possible to compare (China, GFTAM)  Sources of information have been provided as well as supporting documents.  Profiles can be developed from questionnaire in a relative short time (2 days) starting from template. First profiles endorsed and posted on-line.  Comments and data on response rate used to improve on the questionnaire.

19. Profiles Outcome

20. Scale up: Preparation Phase (Oct-Dec 2010)  Manual, Glossary, database already developed.  Tool, manual and glossary are being translated into French and Spanish.  Questionnaires will be prefilled in HQ (Anglophone countries) and AFRO (Francophone countries).  Templates will be developed for narrative profiles and sector analysis reports.

21. Questionnaire & help

22. Scale up: roll out (2011)  180 countries involved.  JANUARY 2011: Questionnaires sent out to countries.  Distance support and follow up with countries through regional offices.  Data collected by June 2011.  Country Profiles, Regional Reports and Global Reports drafted by September 2011.

23. GF Background  Information on systems and structures used to manage Pharmaceuticals and other Health Products during implementation of GF grants is captured in PSM Plans.  PSM Plans reflects a “Project-based Approach”: with PSM Plans, the same information has to be submitted separately for each grant, anytime a new grant is negotiated (both Phase 1 and Phase 2) and even if the Principal Recipient is the same.  However, many countries now have a substantial number of grants (even 20-25 in some cases).  In addition, there is a need to align to new funding mechanisms (Single Stream of Funding and National Strategy Applications).  Need to move to a “Program-based Approach”.

24. Move to a “Program-based Approach”  In December 2008, GF started developing the idea of simplifying the way used to gather the information relevant to Pharmaceutical Management required for grant signing (PSM Plans).  In June 2009, it decided to develop a new tool (Country Profile) that would capture in a different way the narrative information included in PSM Plans.  Comprehensive consultation was then carried on the first draft Country Profile with Technical Partners, Countries, internal and external stakeholders and LFA. A pilot testing was also carried out in 7 countries to feedback development of the second draft.  In December 2009, the Operational Policy Committee of the GF fully endorsed the first roll out for 2010.  At this time, around 40 countries have moved to use Country Profiles in place of PSM Plans

25. Country Profiles: harmonization with WHO  During 2010, WHO-EMP and GF worked together to harmonize the 2 tools: June-September 2010: series of technical meetings between WHO and GF staff to agree on a common instrument. Eventually this was developed in September and will cover PART I of GFTAM profiles.  PART 1- Context and System Description (country- specific)  Fully Harmonized with WHO.  PART 2- Operational Systems in Place (specific to the Principal Recipient).  Discussions are ongoing to identify GF priority countries for testing the common tool as well as procedures for collaboration at country level.

26. GF-WHO Harmonization

27. Content of Harmonized Pharmaceutical Country Profile  Health and Demographic Data  Health Services  Medicines Policies  Medicines Trade and Production  Medicines Regulation  Medicines Financing  Pharmaceutical procurement and distribution  Selection and rational use  Household data/access

28. Some readings…  Country Pharmaceutical Situations. Fact Book on WHO Level 1 Indicators, 2007 Country Pharmaceutical Situations. Fact Book on WHO Level 1 Indicators, 2007  http://www.who.int/medicines/areas/coordination/coordin ation_assessment/en/index1.html http://www.who.int/medicines/areas/coordination/coordin ation_assessment/en/index1.html  WHO Operational Package for Assessing, Monitoring and Evaluating Country Pharmaceutical Situations. Guide for Coordinators and Data Collectors WHO Operational Package for Assessing, Monitoring and Evaluating Country Pharmaceutical Situations. Guide for Coordinators and Data Collectors  http://www.who.int/medicines/areas/coordination/househ old_manual_february_2008.pdf http://www.who.int/medicines/areas/coordination/househ old_manual_february_2008.pdf