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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

National Medicines Policies& Monitoring Implementation

Richard Laing


With materials developed by Edelisa Carandang

Department of Medicines Policy and Standards

  • 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
history of national drug policies
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
background to ndp s
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
components of a ndp
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
overview of components
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!
many actors involved some pro some against
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,
characteristics of a national medicines policy
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.
global pharmaceutical market 2008 740 billion
Global Pharmaceutical Market 2008 $740 billion

Situation in 2002


US, Europe & Japan 78%


Market projected

to grow 7.8% annually


monitoring implementation of nmp s
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
who can use the results from assessment and monitoring
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

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

national medicines policy process


  • 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
who hierarchical approach to monitoring and assessing pharmaceutical situations
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
why is it important to use indicators
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
level i indicators structure and process indicators
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
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
measuring access to essential medicines household survey
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.
importance of household survey
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
indicators few examples
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.
indicators few examples22
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.
current issues on household survey process
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)
level iii indicators
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
who can be trained to do the survey
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)
the way forward on country monitoring
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