National Medicines Policies & Monitoring Implementation

1. National Medicines Policies& Monitoring Implementation Richard Laing EMP/MIE With materials developed by Edelisa Carandang Department of Medicines Policy and Standards

2. Objectives • Review the history of NDPs • Discuss the background to NDP’s • List the Components of a NDP • Review actors involved in the NDP process • Debate characteristics of an NDP • Discuss the Global Pharmaceutical Market • Discuss Monitoring Implementation of NMPs

3. History of National Drug Policies • 1985 Nairobi Conference of Experts on rational Use of Drugs • 1987 Working group of Experts to draft guidelines for NDP’s • 1988 Guidelines for NDP’s released • 1995 Expert Committee on NDPs met report issued • 2002 New Guidelines published

4. Background to NDP’s • Need for common framework to coordinate many different actors in the pharmaceutical field: • These include regulators (quality, safety and efficacy), producers (local & international), users (prescribers & consumers), health planners & managers, health finance authorities and researchers. • Each have valid interests in the field which may be contradictory or supportive • Involves both public & private sectors

5. Components of a NDP • Legislation, Regulation and Guidelines • Selection of Drugs • Supply (incl. procurement & production issues) • Quality Assurance • Rational Drug Use • Economic Strategies for Drugs • Monitoring & Evaluation of NDP’s • Research • Human Resources Development • Technical Cooperation among Countries

6. Overview of Components • Each component has a crucial part in the overall policy! • Emphasizing one component at the expense of others, weakens the entire policy • Many different actors are involved. Some are outside MoH, some outside government, some outside country • Means that NDP planners need to be aware, though not expert, in all areas!

7. Many Actors Involved! Some pro, some against! • Doctors, specialists, public/private • Pharmacists retail and manufacturing • Local and international producers, importers • Consumers/Patients • Media • Regulators • Insurance Companies • Etc, Etc,

8. Characteristics of a National Medicines Policy • Essential part of health policy, must fit within the framework of a particular health care system. • Goals should be consistent with broader health objectives • Health policy and the level of service provision in a particular country are important determinants of drug policy and define the range of choices and options. • Implementation of an effective drug policy promotes confidence in and use of health services.

9. Global Pharmaceutical Market 2008 $740 billion Situation in 2002 5% US, Europe & Japan 78% 1.3% Market projected to grow 7.8% annually Source www.ims-global.com/insight/report/global/report.htm

10. Monitoring Implementation of NMP's • Concepts on pharmaceutical assessment/monitoring • The WHO process on assessing and monitoring pharmaceutical situation • Undertaking survey, sampling and concepts on indicators

11. Who can use the results from assessment and monitoring? • Countries - focus action, prioritize, measure achievement • National policy-makers • International agencies • Professional groups, NGOs and academia • Health facilities to be aware of institutional problems & improve situations

12. WHO Evidence-Based Planning and Interventions Guiding Country Works in Medicines Indicator-based tools to evaluate structures, processes, outcomes of in countries Develop implementation plans and identify strategies & interventions based on data/information on: availability, affordability, pricing, drug use and regulatory profile, TRIPS, drug management situation. Support implementation of activities and advise in the execution of work plans

13. Implementation • Develop and execute action plan based on available resources • Prioritize and implement strategies • Formulation and Updating NMP • Identify problems • Define objectives • Develop strategies • Monitoring & evaluation • Develop system • Identify tools • Use results National Medicines policy process

14. WHO hierarchical approach to monitoring and assessing pharmaceutical situations • Level I • Questionnaire/rapid assessment/checklist • Arrays achievement & weaknessess, 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 I Core structure & process indicators Questionnaire (Health Officials) Systematic survey Level II Core outcome/impact indicators & household survey • Level III • Indicator tools for specific components • of the pharmaceutical sector • Pricing ● Traditional medicine • HIV/AIDS ● Assessing regulatory capacity • TRIPS

15. Why is it important to use indicators? • Standard indicators facilitates: • comparing the performance of facilities, districts, urban vs rural, private & public sector, overall situations in countries • seeing trends over time • setting target

16. Level I indicators: structure and process indicators • Regular survey questionnaire • Inexpensive process to get information across countries • Can be done repeatedly/regular period • Automated questionnaire and data encoding processing • Contents • National Medicines Policy • Regulatory system (marketing authorization, licensing, regulatory inspection, etc) • Medicines supply system, medicines financing, production and trade • Rational use of drugs

17. Level II- facility outcome and impact indicators:WHO Operational Package for Monitoring and Assessing County Pharmaceutical Situations" • Systematic survey • Indicators • on availability, stock out, record keeping and expiry of key drugs • conservation conditions and handling of medicines • affordability (child and adult moderate pneumonia and option for other disease condition • drug prescribing, dispensing, patient knowledge • practical/operational system of managing a systematic survey and resources • 17 survey forms-public health facilities, public pharmacy/dispensary, private pharmacy, warehouses • manual calculation and automated system for descriptive analysis

18. Generic prescribing at public sector

19. Measuring access to essential medicines ( Household Survey) • Level I and Level II- facility surveys do not measure access from the patient/consumer perspective. • Only household surveys can provide population-based information about how pharmaceutical policies affect the well-being of individuals.

20. Importance of 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

21. Indicators: (few examples) Affordability • Average household medicine expenditures as % of total/non-food/health expenditures • Average household medicine expenditures for a reported illness (acute, chronic, by illness) • % of households with at least partial medicine insurance coverage Mixed Indicators of Access (availability) • Percent of households reporting a serious acute illness who sought care outside but did not take any medicine. • Percent of households who do not have at home a medicine prescribed to a chronically ill person.

22. Indicators: (few examples) Rational Use of Medicines • Percent of antibiotics kept for future use • Percent of household medicines with adequate label/ adequate primary packaging Perception of quality • Percent of respondents who agree that quality of services at their public health care facility is good / quality of services by private provider is good • Percent of respondents who agree that brand name medicines are better than generics/ imported medicines are of better quality than locally manufactured medicines.

23. Current issues on household survey process • Challenge to use population based data to policy evaluation, development and planning • Segregation by socio economic profile • No basic guideline standard???on household survey • What is a household / who is a household member • Sampling • Recall periods- ( number of days, self report, caregivers) • Type of survey (general population, disease based survey)

24. Level III Indicators • Systematic survey and monitoring • Drug price survey and monitoring • WHO/INRUD RDU indicators • Rapid assessment • Global survey on Paediatrics medicines • Questionnaire on public sector medicines procurement and supply management systems in countries • Assessment of regulatory capacity

25. Who can be trained to do the survey? • Physicians, nurses, pharmacists or paramedical staff • Health ministry/department staff and temporary employees (health related background and experience) • data collectors from different parts of the country (language differences)

26. The way forward on country monitoring • Evidence through systematic but feasible data collection process is necessary in policy making and activity implementation. This should include population based information • Should demonstrate that in the long run regular monitoring and evaluation is not difficult and can be done in a cost efficient manner • Portion of country support budget and project grants should be allotted to monitoring and evaluation using indicators • Timely report and information/data sharing

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