Module 1 Unit 2:

Essential Medicines
Concept and its Local
Application
 Unit Objectives
By the end of this unit participants should be able
to:
• Define the essential medicines concept
• Outline the historical development of the
essential medicines concept
• Discuss the local application of the essential
medicines concept
• Discuss the components of the essential
medicines concept and their interrelation
 Introduction
Numerous efforts have been made to
improve access to medicines
• Essential medicines concept (EMC) is one
of WHOs initiatives to alleviate the problem
• Global programs have supplemented
bilateral aid by funding supply of essential
medicines e.g. Global fund for HIV, Malaria
& TB
• Available resources are however often
poorly used or misused
 History of the Essential
Medicines Concept
• 1975: 28th World Health Assembly
o Resolution (WHA28.66)
o Establishment of WHO Expert Committee on
selection of Essential Drugs
• 1977: The selection of Essential Drugs. TRS
615- 1st report of the WHO Expert Committee
• 1978: Alma Ata Conference on Primary
Health care
• 1981: WHO Action Program on Essential
Drugs
 Essential Medicines Concept
(EMC)
The concept of essential medicines
A limited range of carefully selected
essential medicines leads to better health
care, better management of medicines and
lower costs
Definition of essential medicines
Essential medicines are those that satisfy the
priority health care needs of the population
 Basis of Selection of Essential
Medicines
Essential medicines are selected based on:

• Disease prevalence or public health

relevance

• Evidence on efficacy and safety

• Comparative cost-effectiveness
 Availability of Essential
Medicines
Essential medicines are intended to be
 available within the context of functioning
health systems at all times,
 in adequate amounts,
 in the appropriate dosage forms,
 of assured quality,
 at a price the individual and the community
can afford.
 Implementation of the EMC
The implementation of the essential
medicines
concept should be:
 Flexible
 Adaptable to many different situations
 Determining which medicines are
regarded as essential remains a national
responsibility
Tools Used to Implement the
EMC
– Essential Medicines List (EML)

– Standard Clinical Guidelines (SCGs) or

• Standard Treatment Guidelines (STGs)

– Formulary
 Interrelationship of EML and SCG

List of common diseases and

complaints

Treatment
choice

Standard clinical Essential medicines Essential medicines

guidelines Formulary list

Training and Financing and

supervision supply of drugs

Prevention
and care
 History of the WHO Model List of
Essential Medicines
• 1985: Nairobi Conference on Rational Use of
Drugs
• Revised strategy endorsed by all countries
• 1997: International Conference on Improving
Use of Medicines, Chiang Mai, Thailand
– Produced consensus on strategies/ interventions
to improve drug use and defined a global
research agenda to fill gaps in knowledge
• 2004: The 2nd International Conference on
Improving Use of Medicines, Chiang Mai,
Thailand
 Model Lists of Essential
•
Medicines
WHO Model List of Essential Medicines
o 1st edition in 1977
o List revised every two years
o 16th edition in 2009
• Interagency List of Essential Medicines for
Reproductive Health
o 1st edition in 2006
• WHO model list of Essential Medicines for
Children
o 1st edition in 2007
o 2nd edition in 2008
 What is the Current Situation?
• All low-income countries and most middle-
income countries have a national EML.
• EMLs are commonly used in public sector
procurement across all countries and in
public health insurance reimbursement in
high income countries.
• EMLs are not commonly used for private
health insurance reimbursement.
 WHO Strategy for Monitoring
Medicines Situations
• Status of national medicine policies and their
components, including:
– legislation and regulations; quality control
of medicines; essential medicines lists;
supply systems; financing; access to
medicines; production; rational use; and
protection of intellectual property rights
Monitoring is achieved through the use of
standard pharmaceutical indicators.
 Questionnaire
(Health
Officials)

Systematic
Survey

WHO strategy for monitoring country pharmaceutical situations

Countries with Essential Medicines
Lists

National Essential Medicines List

< 5 years (127)

> 5 years (29)

No EML (19)

Unknown (16)

There are 156 countries with an official selective list for training, supply,
reimbursement, or related health objectives. Some countries have selective
state/provincial lists instead of or in addition to national lists.
Source: WHO, 2005.
 COUNTRIES WITH NATIONAL
ESSENTIAL MEDICINES LIST IN 2007
Region BY
No. WHO
with EMLREGION
% Coverage

Africa 42/42 100

America 25/31 81

Eastern 13/15 87
Mediterranean

Europe 27/36 75

South-East 6/6 100

Asia

Western 21/25 84
Pacific
 The Kenyan Situation
The Kenya Essential Medicine List
• First Edition,
• 2nd Edition 2002, reprinted in 2003
• 3rd Edition revised and reprinted in 2010.
 Essential Medicines Target

National list of
Registered medicines essential medicines

Levels of use

All medicines
worldwide S CHW S
Dispensary
Health center
Supplementary
Hospital specialist
Referral hospital medicines

Private sector
 Categories- Model List
• Core List: minimum medicine needs for basic
health care system, listing the most cost-
effective drugs for priority conditions (selected
on the basis of burden of disease and potential
for safe and cost-effective treatment)
• Complementary List: Essential medicines for
priority diseases which are cost-effective but not
necessarily affordable for which specialized
health care facilities may be needed; and
essential medicines for less frequent diseases
 How many?
• Ideally the best in each class for the purpose
• Multiplicity confuses and may not help
access
• List one, up to 2-3 alternatives
 Clear message
Flexibility in procurement
Competition between generics rather than
within class
Number of Medicines on National
Essential Medicines Lists
1200

1000

800

600

400

200

0
Updating of Essential Medicines
Lists
• It incorporates the need to regularly update
medicine selections to
 reflect new therapeutic options and
changing therapeutic needs;
ensures drug quality;
and the need for continued development
of better medicines, medicines for
emerging diseases, and medicines to
meet changing resistance patterns
 Perceived Problems with the
EMLs
• Range of diseases covered by the list may
not be adequate
• Discrepancies between list and treatment
guidelines
• Use of data on cost and cost-effectiveness
unclear
• Reasons for selection insufficiently recorded
• Medicines included without pharmacopoeia
standard or suppliers
 Definition of a Standard
Treatment (Clinical) Guidelines

A systematically developed statement designed

To assist practitioners and patients in making
Decisions about appropriate treatment for
Specific clinical circumstances

Source: MSH and WHO. 1997. Managing Drug Supply. 2 nd ed. West Hartford, CT: Kumarian Press
Examples of Standard Treatment
(Clinical) Guidelines & Essential
Medicine List
Definition: Medicines Formulary/
Formulary Manual
Formulary manual:
• A document that describes medicines that are
listed on an EML/or are available for use in a
hospital/clinic
• Provides information and indications, dosage,
length of treatment, interactions and
contraindications
Source: MSH: Managing Drug Supply, 1997, p 136
 Group Activity (10 min)
• In your experience why do you think EMLs
and STGs not followed?
 Why are EMLs and STGs not
followed
• Do not reach the right people
• Pharmaceutical products available in
facilities not on EML or STGs
• Lack of appropriate training in the use of
STGs
• Lack of transparency during development
process which leads to the lack of
credibility and acceptance
 Why are EMLs and STGs not
Followed (2)
• Lack of involvement from respected
members of the professional community
• Not based on adequate evidence
• Not current
• Not realistic- finances not available for
purchase
Availability of EMLs in Health
Facilities
100%
90%
80%
70%
60%

50%
40%
30%
20%
10%
0%

Source: Selected MSH studies, 1993–2001.

 Percentage of Medicines
Prescribed from EML, by Sector
100%
97% Public
90% 93%
NGO/Mission
80% 82%
Private
70% 72% 70%
70%
66% 65%
60% 63% 62%
58%
50%
49%
40%

30%

20%

10%

0%
Cambodia India (R) El Salvador Brazil (MG)

Source: MSH Strategies for Enhancing Access to Medicines studies in 2001.

 National Medicines Policy
• A document that expresses and prioritizes the
medium- to long term goals set by the government
for the pharmaceutical sector and identifies the
main strategies for attaining them
• Provides a framework within which the activities of
the pharmaceutical sector can be coordinated
• Guide containing goals set by the government for
the pharmaceutical sector and strategies to
achieve them
• Covers both the public and private sector
Source: WHO. 2001. How to Develop and Implement a National Drug Policy. 2 nd ed.
General Objectives of a National
Medicines Policy
To ensure:
• Access:
– equitable availability and affordability of essential
drugs
• Quality:
– the quality, safety and efficacy of all medicines
• Rational use:
– the promotion of therapeutically sound and cost-
effective use of drugs by health professionals and
consumers.
 National Pharmaceutical
Policy: Goals (1)
Health Related Goals
• Availability of essential medicines
• Improved attendance at health facilities
• Safe, affordable and effective drugs
• Proper selection of drugs
• Efficient supply
 National Pharmaceutical
Policy: Goals (2)

Economic related goals

• Lower cost of drugs
• Reduced foreign exchange
• Employment
• Improved efficiency and cost effectiveness
 National Pharmaceutical
Policy: Goals (3)
Development Related Goals
• Human resource capacity building
• Improved Infrastructure
• National production of drugs
National Pharmaceutical Policy:
Components(1)
• Legislative Framework
– Drug Regulatory Authority
– Drug registration and Licensing
– Pharmaceutical QA
– Post marketing surveillance
– Regulation of prescription and distribution
National Pharmaceutical Policy:
Components(2)
• Choice/ Selection of Medicines
– Principles of drug selection; Selection process
& criteria
– EDL
– Traditional medicines
• Supply
– Local production, procurement mechanisms,
distribution and storage
Source: WHO 1995
 National Pharmaceutical Policy:
Components (3)
• Appropriate Use
– Appropriate use of medicines by health personnel
& consumers;
– Promotional activities
• Economic Strategies
– Public drug financing mechanisms
– Role of government in pharmaceutical market
• HR Development

Source: WHO 1995

 National Pharmaceutical Policy:
Components (4)
• Monitoring & Evaluation
– Indicators for Monitoring, periodic evaluation
• Research
– Operational Research, drug research and
development
• Technical cooperation among countries

Source: WHO 1995

 Development of National
Pharmaceutical Policy: Steps
1. Organize the policy process
2. Identify and analyze the problems
3. Set goals and objectives
4. Draft the policy
5. Circulate and revise the policy
6. Obtain formal endorsement
7. Launch the policy
 Factors Influencing the
Development of a National
Pharmaceutical Policy
• Facilitating • Limiting Factors
Factors – Economic Situation
– Lack of political will – Technical expertise
– Lack of resources – Support from key
– Corruption MOH personnel
– Support from
interest groups
 Global Situation
• In 1999, out of 152 countries which responded to
the survey question on national medicines policy:
– 71% had a national medicines policy supported
by an official document
– 44% had a document published within the last
10 years
– 24% had a draft document; and 3% had an
official document that was over 10 years old.
– 29% had no official medicines policy document.
 Components of Kenya National
Medicines Policy (1)
• Legislative framework (CAP 244)
• Choice of medicines (Drug registration, KEML)
• Supply (KEMSA, MEDS, private
wholesalers/manufacturers)
• Rational use of medicines (NMTCs, IMTCs)
• Economic strategies for medicines (Pricing
surveys, removal of tariffs on medicines and
selected medical supplies LLITNs)
Adapted from the World Health Organization, 1995
 Components of Kenya National
Medicines Policy (2)
• Human resource development (Local
training of personnel at University and
Medical Training Colleges, short courses
on management of medicines)
• Monitoring and evaluation (Hospital
reforms support supervisory visits)
• Adapted from the World Health Organization, 1995
 Components of Kenya National
Medicines Policy (3)
• Research (operational research on medicine
use)
• Technological cooperation among countries
(regional support to East Central and Southern
Africa to promote pharmaceutical agenda in
consultation of country ministry of health)
Adapted from the World Health Organization, 1995
National Medicine Policy Implementation
Table 1: Selected country progress 1999 2003 2007
indicators Target
Countries with an official national 41/106* 49/103
medicines policy implementation plan— 39% 48% 61%
new or updated within the last 5 years
Countries with a national list of essential 129/175 82/114
medicines – updated within the last five 74% 72% 75%
years
Countries implementing basic 70/138 90/130
medicines regulatory functions 51% 69% 74%

Source: WHO Medicines Strategy : Countries at the Core, 2004–2007.

 Group Discussion (10 min)
• How can the implementation of the EMC
be promoted locally and globally?
 Local Application of the EMC
• Kenya National Drug Policy 1994
• Kenya National Pharmaceutical Policy 2009
• Kenya Essential Medicine List (2 editions :
1994, 2003, 2010 version being developed)
• Kenya Standard Treatment Guidelines
– Kenya Rural Health Guidelines (’80s)
– Clinical Guidelines 1994, 2003
– Kenya Standard Clinical Guidelines 2010
• National Medicines & Therapeutic Committees
(NMTCs) (1998, 2003, 2009)
Medicines and Therapeutics
Committees (MTC)
 Medicines and Therapeutics
Committees (MTC)
MTCs are also known as:
• Drug and Therapeutics Committee (DTC)
• Pharmacy and Therapeutics Committee (PTC)
• Therapeutics and Drug Committee (TDC)
MTC is a multidisciplinary committee at various
levels of health care that:
• Evaluates the clinical use of medicines
• Develops policies for managing medicine use
and administration,
• Manages the formulary system
 Medicines and Therapeutics
Committees (1)
• An MTC is a tool for increasing efficiency
and promoting rational use of medicines
by providing a forum for all the relevant
people to meet.
• MTCs can provide the leadership and
structure to select , procure and distribute
appropriate medicines and promote their
rational use.
 Medicines and Therapeutics
Committees (2)
MTC operational levels in Kenya
• National level- National Medicines and
Therapeutics Committee
• Institutional level- Hospital Medicines and
Therapeutics Committees
 MTCs: Structure and
Organisation (1)
• Multidisciplinary
• Membership from medical, pharmacy,
administration nursing, public health- all
hospital clinical departments
• The medical superintendent (or his
appointee) or the district medical officer of
health will be the chairperson
 MTCs: Structure and
Organisation (2)
• A pharmacist (usually the pharmacy-in-charge or
the deputy), or a pharmaceutical technologist
where there is no pharmacist as the secretary
• Other non-members may be invited during
meetings discussing issues that require their
particular expertise
• documented terms of reference, goals &
policies are key pre-requisites for the
committee
 Institutionalizing the MTC
• Obtain mandate from most senior authority
in institution

• Develop TORS that specify the role,

functions and membership o the MTC
 Why have TORs
• It establishes a framework for the
committee to work
– To provide for selection of chair, vice
chair, secretary and any other office
– To establish regular times for meeting
– Provide for periodic evaluation
• Stipulate requirements for membership in
committee
 Components of TORs
The TOR should define and document;
• MTC Position in organization
• MTC Mandate
• MTC Goals and scope
• Membership of MTC :chairman, secretary,
criteria for membership
• Funding sources for MTC
• Process for assessment and evaluation of
MTC
 Summary
1. The essential medicines concept and policy is firmly
established worldwide.
2. Countries must shape their national medicines policies
to meet both their needs and available resources
3. The basic component of policies may be the same, but
national strategies may vary
4. The impact of national medicines policies and essential
medicines lists, standard treatment guidelines depends
on government commitment and support of various
stakeholders
Thank you