Upload
chase-mcfarland
View
218
Download
2
Tags:
Embed Size (px)
Citation preview
National Medicines Policies& Monitoring Implementation
Richard Laing EMP/MIE
With materials developed by
Edelisa Carandang
Department of Medicines Policy and Standards
Department of Essential Medicines & Pharmaceutical Policy
2 |
Objectives
Review the history of NDPsDiscuss the background to NDP’sList the Components of a NDPReview actors involved in the NDP processDebate characteristics of an NDPDiscuss the Global Pharmaceutical MarketDiscuss Monitoring Implementation of
NMPs
Department of Essential Medicines & Pharmaceutical Policy
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 released1995 Expert Committee on NDPs met
report issued2002 New Guidelines published
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
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!
Department of Essential Medicines & Pharmaceutical Policy
7 |
Many Actors Involved! Some pro, some against!
Doctors, specialists, public/privatePharmacists retail and manufacturingLocal and international producers, importersConsumers/PatientsMediaRegulators Insurance CompaniesEtc, Etc,
Department of Essential Medicines & Pharmaceutical Policy
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.
Department of Essential Medicines & Pharmaceutical Policy
9 |
Global Pharmaceutical Market 2008 $740 billion
Source www.ims-global.com/insight/report/global/report.htm
US, Europe & Japan 78%
1.3%
Market projected
to grow 7.8% annually
5%
Situation in 2002
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
12 |
Develop Develop implementation implementation plans and identify plans and identify strategies & strategies & interventions interventions based on based on data/information data/information on: on: availability, availability, affordability, affordability, pricing, drug use pricing, drug use and regulatory and regulatory profile, TRIPS, drug profile, TRIPS, drug management management
situation.situation.
Support implementation of activities and advise in the execution of work plans
Indicator-based tools to evaluate structures, Indicator-based tools to evaluate structures, processes, outcomes of in countriesprocesses, outcomes of in countries
WHO Evidence-Based Planning and InterventionsGuiding Country Works in Medicines
WHO Evidence-Based Planning and InterventionsGuiding Country Works in Medicines
Department of Essential Medicines & Pharmaceutical Policy
13 |
National Medicines policy process
Formulation and Updating NMP
Identify problems Define objectives Develop strategies
Monitoring & evaluation
Develop system Identify tools Use results
Implementation
Develop and execute action plan based on available resources Prioritize and implement
strategies
Department of Essential Medicines & Pharmaceutical Policy
14 |
WHO hierarchical approach to monitoring and assessing pharmaceutical situations
Level I Core structure
& process indicators
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
Systematic survey
Questionnaire (Health Officials)
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
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
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
Department of Essential Medicines & Pharmaceutical Policy
19 |
Generic prescribing at public sector
0
20
40
60
80
100
Pe
rce
nta
ge
of
pa
tie
nts Brazil
Cambodia
Cameroun
Kenya
Laos
Nepal
Rwanda
Senegal
Department of Essential Medicines & Pharmaceutical Policy
20 |
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.
Department of Essential Medicines & Pharmaceutical Policy
21 |
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
Department of Essential Medicines & Pharmaceutical Policy
22 |
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
coverageMixed 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.
Department of Essential Medicines & Pharmaceutical Policy
23 |
Indicators: (few examples)
Rational Use of Medicines Percent of antibiotics kept for future use Percent of household medicines with adequate
label/ adequate primary packagingPerception 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.
Department of Essential Medicines & Pharmaceutical Policy
24 |
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)
Department of Essential Medicines & Pharmaceutical Policy
25 |
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
Department of Essential Medicines & Pharmaceutical Policy
31 |
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)
Department of Essential Medicines & Pharmaceutical Policy
41 |
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