National Medicines Policies & Monitoring Implementation Richard Laing EMP/MIE With materials...

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

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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


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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 released1995 Expert Committee on NDPs met

report issued2002 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/privatePharmacists retail and manufacturingLocal and international producers, importersConsumers/PatientsMediaRegulators Insurance CompaniesEtc, 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

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


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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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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


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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


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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


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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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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


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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)

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.


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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 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.


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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


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THANK YOU

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