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National Medicines Policies & Monitoring Implementation. Richard Laing EMP/MIE With materials developed by Edelisa Carandang. Department of Medicines Policy and Standards. Objectives. Review the history of NDPs Discuss the background to NDP’s List the Components of a NDP

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National medicines policies monitoring implementation l.jpg

National Medicines Policies& Monitoring Implementation

Richard Laing


With materials developed by Edelisa Carandang

Department of Medicines Policy and Standards

Objectives l.jpg

  • 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

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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

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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

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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

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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!

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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,

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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.

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Global Pharmaceutical Market 2008 $740 billion

Situation in 2002


US, Europe & Japan 78%


Market projected

to grow 7.8% annually


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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

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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

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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

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  • 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

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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


(Health Officials)



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

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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

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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

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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

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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.

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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

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Indicators: (few examples)


  • 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.

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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.

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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)

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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

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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)

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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