Transcript Overview of Drug Policy Issues

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
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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Department of Essential Medicines & Pharmaceutical
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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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Department of Essential Medicines & Pharmaceutical
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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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Department of Essential Medicines & Pharmaceutical
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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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Department of Essential Medicines & Pharmaceutical
Policy
Global Pharmaceutical
Market 2008 $740 billion
Situation in 2002
US, Europe &
Japan 78%
5%
1.3%
Market
projected
to grow 7.8%
annually
Source
www.ims-global.com/insight/report/global/report.htm
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Policy
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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Department of Essential Medicines & Pharmaceutical
Policy
WHO Evidence-Based Planning and Interventions
Guiding Country Works in Medicines
Indicator-based tools to evaluate structures,
processes, outcomes of in countries
1. Assess and Monitor
Support
implementation of
activities and
advise in the
execution of work
plans
3. Implement
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2. Plan
Develop
implementation
plans and identify
strategies &
interventions
based on
data/information
on: availability,
affordability,
pricing, drug use
and regulatory
profile, TRIPS, drug
management
situation.
National Medicines policy
process
Implementation
Formulation and
Updating NMP
 Develop and execute action
plan based on available resources
 Prioritize and implement
strategies
 Identify problems
 Define objectives
 Develop strategies
Monitoring & evaluation
 Develop system
 Identify tools
 Use results
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Department of Essential Medicines & Pharmaceutical
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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
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Core structure
& process indicators
Systematic
survey
Level III
•More detailed indicators for monitoring and
evaluating specific areas/components
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Level I
Questionnaire
(Health Officials)
Department of Essential Medicines & Pharmaceutical
Policy
Level II
Core outcome/impact indicators
& household survey
Level III
Indicator tools for specific components
of the pharmaceutical sector
●Pricing
●HIV/AIDS
●TRIPS
●
●
Traditional medicine
Assessing regulatory capacity
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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Department of Essential Medicines & Pharmaceutical
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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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Generic prescribing at public
sector
Percentage of patients
100
80
60
40
20
Kenya
Laos
Nepal
Rwanda
Senegal
0
19
Brazil
Cambodia
Cameroun
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Department of Essential Medicines & Pharmaceutical
Policy
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 wellbeing 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)
Affordability
 Average household medicine expenditures as % of total/nonfood/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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Department of Essential Medicines & Pharmaceutical
Policy
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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Policy
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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Department of Essential Medicines & Pharmaceutical
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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
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Department of Essential Medicines & Pharmaceutical
Policy
THANK YOU

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Department of Essential Medicines & Pharmaceutical
Policy