Download Essential Drugs Programs of Selected African Countries i Is the

Essential Drugs Programs of Selected African Countries
i
Is the World Health Organization Model List of Essential Drugs
Relevant to Member States?
National Essential Drugs Lists of Selected African Countries
in Comparative Perspective
By
Jean Claude Mugiraneza
A thesis
submitted to the Faculty of D’Youville College
School of Health and Human Services
in partial fulfillment of the requirements
for the degree of
Master of Science
in
Health Services Administration
Buffalo, NY
November , 2009
Essential Drugs Programs of Selected African Countries
ii
Copyright © 2009 by Jean Claude Mugiraneza. All rights reserved. No
part of this thesis may be copied or reproduced in any form or by any means
without written permission of Jean Claude Mugiraneza.
Essential Drugs Programs of Selected African Countries
iii
THESIS APPROVAL
Thesis Committee Chairperson
Name:
Discipline:
Health Services Administration
Committee Members
Name:
Discipline:
Health Services Administration
Name:
Discipline:
Thesis defended
on
(Date)
Essential Drugs Programs of Selected African Countries
iv
Abstract
The World Health Organization (WHO) published its first model essential drugs
list (EDL) in 1977, which member states used to produce their national EDLs.
Despite some progress in improving access to essential drugs, the availability of
medications is still grossly insufficient in developing countries. This study
revealed a significant relationship between immunization coverage for measles,
diphtheria, tetanus, pertussis and infant mortality rate. Results failed to show a
relationship between the adherence index to the WHO model list of
immunologicals and immunization coverage. The study revealed that national
EDLs do not include many drugs from the WHO model list. The general systems
theory was used to organize this work. A secondary data was analyzed using
Pearson’s correlation and coefficient of variation.
Essential Drugs Programs of Selected African Countries
v
Acknowledgement
Many thanks to Richard Laing. Without his advice, this thesis would never
have happened.
I would like to thank my committee: Dr. James Notaro, Dr. Judith
Schiffert, and Dr. Gary Stoehr, for taking the time to guide me through the thesis
process. Without their encouragement and advice, this study would have been
most difficult.
I would also like to thank my father and my mother for giving me the
inspiration to greater things, including completing this graduate program.
I am grateful to my wife, Louise Sano, for her invaluable advice and
support.
I want to express my gratitude to Dr. David Shank for his constructive
comments on this thesis.
My special thanks go to Dr. Geri Lyons for her support.
Essential Drugs Programs of Selected African Countries
vi
Table of Contents
List of Tables ................................................................................................
List of Figures ...............................................................................................
List of Appendixes ........................................................................................
viii
ix
x
Chapter
I.
II.
INTRODUCTION ............................................................................
1
Statement of Purpose ........................................................................
Theoretical Framework .....................................................................
Significance and Justification ...........................................................
Assumptions ......................................................................................
Research Questions ...........................................................................
Definition of Terms ...........................................................................
Variables ...........................................................................................
Limitations ........................................................................................
Summary ...........................................................................................
3
4
6
8
8
9
11
12
12
REVIEW OF THE LITERATURE ..................................................
14
Introduction .......................................................................................
Background .......................................................................................
Overview of National Drug Policy .......................................
Developing, Implementing, and Monitoring a
National Drug Policy ................................................
Role and Relationships of Actors in the Policy Process .......
Overview of the Concept of Essential Drugs
and Essential Drugs List ...........................................
Development Process of the WHO Model List ....................
Importance of EDL and Standard Treatment Guidelines
on Rational Use of Drugs ......................................................
Impact of Drug Policy Regulatory on Availability and Drug Use ....
Situation of Access to Essential Medicines in Africa .......................
Availability of Essential Drugs .............................................
Affordability of Essential Drugs ...........................................
Rational Use of Essential Drugs in Africa ........................................
Infant Mortality in Africa ..................................................................
Summary ...........................................................................................
14
14
14
16
17
21
23
24
30
39
40
41
43
54
59
Essential Drugs Programs of Selected African Countries
vii
III.
PROCEDURES FOR COLLECTION
AND TREATMENT OF DATA ......................................................
60
Introduction .......................................................................................
Setting ...............................................................................................
Population and Sample .....................................................................
Data Collection Methods ..................................................................
Human Rights Protection ..................................................................
Data Collection Tool .........................................................................
Treatment of Data .............................................................................
Summary ...........................................................................................
60
60
64
65
69
70
70
75
ANALYSIS OF DATA .....................................................................
76
Introduction .......................................................................................
Description of the Sample .................................................................
Research Questions ...........................................................................
Data Collection Tool .........................................................................
Summary ...........................................................................................
76
76
77
92
92
SUMMARY, CONCLUSIONS, IMPLICATIONS,
AND RECOMMENDATIONS ........................................................
94
Summary ...........................................................................................
Conclusions .......................................................................................
Relationship of the Results to the Conceptual Framework ...
Relationship of the Results to the Literature .........................
Implications for Policy Makers .........................................................
Recommendations for Future Research ............................................
94
95
95
96
98
99
References .....................................................................................................
Appendixes ...................................................................................................
101
111
IV.
V.
Essential Drugs Programs of Selected African Countries
viii
List of Tables
Table
1.
Matrix of Intercorrelations ................................................................
80
2.
Variation Among National EDLs in Pharmaceutical Groups
1 through 9 ........................................................................................
84
Variation Among National EDLs in Pharmaceutical Groups
10 through 18 ....................................................................................
85
Variation Among National EDLs in Pharmaceutical Groups
19 through 27 ....................................................................................
86
3.
4.
Essential Drugs Programs of Selected African Countries
ix
List of Figures
Figure
1.
Application of the Input-Output to the Study ...................................
7
2.
Overall Comparison Between National EDLs and
the WHO Model List ........................................................................
78
Scatter Plots--Correlation Between Adherence Index
and Immunization Coverage .............................................................
82
Scatter Plots--Correlation Between Immunization
and Infant Mortality ..........................................................................
89
3.
4.
Essential Drugs Programs of Selected African Countries
x
List of Appendixes
Appendix
A Process to Select an Essential Drug ........................................................
111
B D’Youville College Institutional Review Board Exempt
Review Application ................................................................................
113
C WHO Model List of Essential Drugs, 13th Edition .................................
115
Essential Drugs Programs of Selected African Countries
1
CHAPTER I
INTRODUCTION
More than 30 years has passed since the World Health Organization
(WHO) produced the first model list of essential drugs. At that time, it was
envisioned that a limited number of drugs selected to meet priority health needs
would lead to better health care, better drug management, better use of financial
resources, and ultimately better access to health care.
More recent work on medicine prices and availability in low- and middleincome countries found that poor availability and high prices keep medications
out of reach of many people in those countries. Consequently, millions of people
in the developing world cannot obtain the medications they need in the public
sector and, as a result, are forced to pay higher prices in the private sector or forgo
treatment altogether.
Although there is an increasing political commitment to ensure access to
essential drugs by sub-Saharan Africa countries, there is still a need to translate
the goals of providing safe and affordable medications into public health policies.
For the past 30 years, essential drugs have contributed to the reduction of
mortality and morbidity in the developing world. While much has been achieved
in expanding accessibility to medications, more than half of the population of
Essential Drugs Programs of Selected African Countries
2
poorer parts of Africa and Asia do not have regular access to essential drugs and
continue to be subject to poor health (WHO, 2003). The WHO reported that more
than 500 African mothers lose a child every hour (WHO, 2003). According to
ChildInfo, 9.2 million children under the age of five years died in 2007 with
sub-Saharan Africa accounting for almost half (49% or 4.5 million) of the deaths.
Indeed, sub-Saharan Africa reports some of the highest infant mortality
statistics in the world. The sub-Saharan Africa region reported 95 deaths for every
1,000 live births in 2006 (see www.who.int). According to United Nations
estimates, 2,400 African babies are stillborn every day and another 3,100
newborns die within their first 4 weeks of life (Mason, 2007). The main drivers of
disease burden among children are perinatal conditions associated with poverty,
diarrheal diseases, pneumonia, other lower respiratory tract conditions, and
malaria. All of these diseases are easily treated and prevented with vaccines and
medications readily accessible in developing countries.
The use of medicines and vaccines to reduce mortality and morbidity
cannot be disputed. But reducing the burden of disease in the developing world is
undermined, at least in part, by the irrational use, inefficient financing, and
unreliable delivery of medications (Quick, 2003b). In some developing countries
drug expenditures may comprise up to 40% of the entire health budget, making it
difficult to provide access to lifesaving medications and vaccines.
Effective, safe, affordable, and good quality medications are a central
component of a comprehensive health care program (Kanji, Hardon, Harnmeijer,
Essential Drugs Programs of Selected African Countries
3
Mamdani, & Walt, 1992). The WHO guidelines for the development of national
drug policies (NDP) are based on the concept of essential drugs and address the
problems of access, quality, and rational use of drugs. Laing, Waning, Gray, Ford,
and Hoen (2003) point out that “the implementation of the concept of essential
drugs is intended to be flexible and adaptable to many different situations; exactly
which drugs are regarded as essential remains a national responsibility” (p. 1723).
This definition implies that differences exist among national lists of essential
drugs because of variability in costs, morbidity patterns, and drug effectiveness
among nations of the developing world. A national drug policy expresses and
prioritizes goals set by the government for the pharmaceutical sector (WHO,
2003). Thus, the incorporation of an essential drugs program varies among
developing nations but can form the foundation of a rational and equitable drug
procurement and distribution system. The literature is limited on the extent to
which an essential drugs program has influenced medication utilization and health
outcomes.
Statement of Purpose
The purpose of this study was to compare selected African country’s
essential drugs lists (EDLs) by analyzing the percentage of drugs from the WHO
model drug list that are available on the national EDLs. The study also examined
similarities and differences among categories of drugs from the WHO model list
in selected African country’s EDLs. In addition, this study investigated the
relationship between the adherence index to the WHO model list, specifically the
Essential Drugs Programs of Selected African Countries
4
immunologicals pharmaceutical group and immunization coverage rate on the one
hand, and immunization coverage rate against measles, diphtheria, tetanus and
pertussis (DTP) and infant mortality rate on the other hand.
Theoretical Framework
The general systems theory (GST) provided the theoretical framework
used in this study. The GST was initially proposed by Ludwig von Bertalanffy,
and later discussed by William Ross Ashby who contributed in the field by
introducing a closely related field of cybernetics (Heylighen, 2003).
Von Bertalanffy (1968) defined a system as a set of elements in
interrelations. Heylighen and Joslyn (1992) define the systems theory as:
the transdisciplinary study of the abstract organization of phenomena,
independent of their substance, type, or spatial or temporal scale of
existence. It investigates both the principles common to all complex
entities, and the models (usually mathematical) which can be used to
describe them.
Von Bertalanffy posited that real systems are open to their environments
and interact with their environments and can thus emerge acquiring new
properties (as cited in Heylighen & Joslyn, 1992). This interaction with its
environment has two components: input, what enters the system from the outside,
and output, what leaves the system for the environment. A process of the system
that transforms inputs into outputs is called throughput, and a system boundary
separates the system from its environment (Heylighen & Joslyn, 1992). The GST
Essential Drugs Programs of Selected African Countries
5
emphasizes the synthesis of relationships as opposed to reductionistic analysis as
a way of learning how systems function. General systems theory is concerned
with the arrangement of those parts and the relations between them. The result of
analysis is how these properties or parts interact to create the whole, the
unification process (Heylighen & Joslyn, 1992).
Empirical evidence indicates that GST has been used in diverse fields and
disciplines such as organizational research, information theory, mathematical
modeling and practical application (Heylighen & Joslyn, 1992), policy making
(Easton, 1953), and medication system improvement (Hronek & Bleich, 2002).
Some authors have identified steps in building a systems model for use in
policy development and analysis. For instance, Easton (1953) has conceived a
model that applies the systems theory to political science. The simplified Easton’s
model has five steps. They are (a) there are demands for a certain output and
stakeholders or interest groups supporting those demands; (b) these demands and
groups would compete, giving way to decision making itself; (c) once the
decision is made, it will interact with its environment; (d) once the new policy
interacts with its environment, it will generate new demands and groups in
support or against the said policy (feedback); and (e) the feedback goes to step
one.
For the purpose of this study, the GST was used as the core methodology
for understanding NDP process and its complex stages. To explore the NDP
medicine program intermediate outcomes, which will lead to improvement in
Essential Drugs Programs of Selected African Countries
6
health outcomes of a country, a modified simple input-output model has been
adopted, which places the policy process in the center. Figure 1 depicts the main
components included in the proposed framework. As shown in the figure, the
pharmaceutical needs and demands are on the input side and access to safe and
good medicines are on the output side. The policy process (formulation,
implementation, and evaluation) is used by the system to convert the
pharmaceutical needs and demands from the environment into outputs (effective,
affordable, and good quality medicines) usable by the environment. Effective,
affordable, and good quality medicines will lead to improvement in health status
of the population (impact outcomes). The environment (social, economic,
education, health, and political) in which the system operates affects its
components. Information about some aspects of pharmaceutical needs and
demands are used to evaluate and monitor the system in order to guide the system
to more effective performance.
Significance and Justification
Several studies have explored the correlation between demographic,
socio-economic indicators, and infant mortality rate, however little comparative
work studying the impact of adherence index to the WHO model list on the
population health outcomes has been conducted. The findings of this work
provided some seminal understanding regarding the effect of NDP
implementation on the use of medications and provided the basis for additional
exploration in this area. To some extent the results of this type of work might
Essential Drugs Programs of Selected African Countries
7
Environment
Inputs
Environment
Throughput - Process
Formulation
Pharmaceutical
needs and
demands
Implementation
Evaluation
Environment
Outputs
Intermediate
outcomes:
access,
quality,
rational use
of essential
drugs
Prevent and treat
leading causes of
deaths in children
and adults
Environment
Environment
Figure 1. Application of the input-output to the study.
Environment
Essential Drugs Programs of Selected African Countries
8
be useful to international agencies, such as the WHO, and governments of
developing nations in advocating for the incorporation of effective NDP.
Conversely, the comparative aspects of the study might provide some insight in
which countries might learn and adopt best practices from each other. Finally, the
nature of cross-national comparative research improves researchers’
understanding of how policies affect peoples’ choices, and helps them identify
behavior that is common across different cultures and societies (Burkhauser &
Lillard, 2005).
Assumptions
The following assumptions were inherent to this study:
1. All 9 selected countries are geographically located in sub-Saharan
Africa, thus national epidemiological profiles do not vary greatly by selected
countries.
2. Selected countries share similar needs for essential drugs.
3. Factors contributing to the problem of access to essential drugs are
similar to all 9 selected countries.
Research Questions
The study was designed to answer the following questions:
1. How do the essential medicines lists of selected African countries differ
from the WHO model list?
2. How do the essential medicines lists of selected African countries vary
among themselves?
Essential Drugs Programs of Selected African Countries
9
3. What is the relationship between the adherence index to the WHO
model list of immunologicals and immunization coverage rate?
4. Is there a relationship between the immunization coverage rate against
measles and DTP and infant mortality rate?
Definition of Terms
The terms in the research question were defined theoretically and
operationally.
1. Adherence index--theoretically defined as the proportion of the drugs
from the WHO model list on each national EDL to the total number of drugs on a
national EDL. Operationally defined as the index of drugs from the WHO model
list included on a national EDL. The index is calculated by first determining the
number of drugs from the WHO model list on each EDL (positive occurrences)
divided by the total number of drugs on each national EDL.
2. Clinical guidelines--theoretically defined as “systematically developed
statements to assist practitioner and patient decisions about appropriate health
care for specific clinical circumstances” (Field & Lohr, 1990, p. 50).
Operationally defined as those guidelines that offer concise instructions on which
diagnostic or screening tests to order, how to provide medical or surgical services,
how long patients should stay in the hospital, or other details of clinical practice.
3. Count of essential drugs--theoretically defined as the number obtained
by counting of molecules on EDL. Operationally defined as the total number of
molecules on the national EDL of each selected country. The molecules from
Essential Drugs Programs of Selected African Countries
10
national EDLs were sorted out based on three criteria: drugs on national EDL are
on the WHO model list, drugs that are from the same therapeutic classes from
both the national EDL and the WHO model list, and drugs that are included in the
WHO model list but not in the national EDL.
4. Essential drugs--theoretically defined as those medicines that satisfy the
priority health care needs of the population and are absolutely necessary for health
care (WHO, 2001).
5. Infant mortality rate--theoretically defined as the infant mortality rate is
the probability (expressed as a rate per 1,000 live births) of a child born in a
specified year dying before reaching the age of one if subject to current age
specific mortality rates. Data were collected from the WHO database
(www.who.int/whosis/en/) and the World Bank Millennium Development Goals
database (web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/).
6. National drug policy--theoretically defined as a commitment to a goal
and a guide for action (WHO, 2001). Operationally defined as a framework within
which the activities of the pharmaceutical sector can be coordinated.
7. Primary health care--was defined in the Declaration of Alma-Ata as
essential health care based on practical, scientifically sound, and socially
acceptable methods and technology made universally accessible to individuals
and families in the community through their full participation and at a cost that
the community and country can afford to maintain at every stage of their
development in the spirit of self-reliance and self-determination (Apel, 1979).
Essential Drugs Programs of Selected African Countries
11
8. Rational use--theoretically defined as patients receiving medications
appropriate to their clinical needs, in doses that meet their own individual
requirements, for an adequate period of time, and at the lowest cost to them and
their community. Rational use is included in the policy documents of selected
countries.
9. Selection of essential drug--theoretically defined as the process to select
a limited number of drugs carefully chosen based on agreed clinical guidelines
and which leads to more rational prescribing, to a better supply of drugs, and to
lower costs (WHO, 2001). Operationally defined as the method used by the
selected countries to include the drugs on their EDLs based on the public health
relevance of the drugs. The methods are included in their policy documents.
Variables
For the purpose of this study, the national EDLs were used to compare the
selected countries, taking the WHO model list which serves as a reference for
state members. One can assume that the higher adherence index to the WHO
model list in the immunologicals pharmaceutical group on the one hand, and
higher immunization coverage rates on the other may yield better immunization
coverage rates and lower infant mortality rates, respectively. Therefore, a
correlation test was computed with immunization coverage rates and infant
mortality rates as dependent variables. Adherence index to the WHO model list in
the immunologicals pharmaceutical group was an independent variable in one
Essential Drugs Programs of Selected African Countries
12
test; immunization coverage rate against measles and DTP were separately used
in the second test.
Limitations
The following limitations were inherent to the study:
1. Although all selected countries have carried out the baseline survey
assessing the pharmaceutical situation based on level I and II indicators, which
are described in the WHO operational package for monitoring and assessing the
pharmaceutical situation in countries, their sampling methods varied. Some
countries included both the public and private sectors; other countries did not
include the private sector in their surveys.
2. Health status is determined by many other factors such as income and
female literacy, which the study was not able to control.
Summary
In response to the poor access to medications and the high cost of drug
therapy in developing countries, WHO developed an EDL. The EDL provided
developing countries with a reference for safe, effective, and affordable drugs.
According to the WHO (2001), “the core of the concept of EDL is that use of a
limited number of carefully selected drugs based on agreed clinical guidelines
leads to a better supply of drugs, to more rational prescribing, and to lower costs”
(p. 6 ). Hence, the EDL is the foundation of a NDP, and in many countries it is a
mechanism used to implement such policy (Laing, Hogerzeil, & Ross-Degnan,
2001). However, despite the development and incorporation of the WHO EDL,
Essential Drugs Programs of Selected African Countries
13
developing countries in Africa have witnessed little reduction in morbidity and
mortality.
This work sought to describe the extent to which the EDLs of selected
African countries adhere to the WHO model list, and the extent to which the
EDLs differ from country to country. In addition, this work examined the
relationship between the adherence index to the WHO model list of
immunologicals and the immunization rate and the relationship between the
immunization coverage rate for measles and diphtheria, tetanus, and pertussis and
infant mortality rate.
Essential Drugs Programs of Selected African Countries
14
CHAPTER II
REVIEW OF THE LITERATURE
Introduction
The focus of this literature review was to provide a detailed overview of
the work to date linking NDP and access to essential drugs, which leads to
improvement in health outcomes. In addition, to frame this work, a
comprehensive review of a NDP process is provided.
Background
Overview of National Drug Policy
The concept of NDP, as it has been used over the last 30 years, stems from
the World Health Assembly in 1975, which acknowledged the alarming lack of
access to good quality medicines in developing countries. In its resolution
WHA28.66, the Assembly called on the WHO to assist member states in
developing NDPs (WHO, 2001). In addition, it asked the WHO to advise member
states on developing strategies that could enhance the selection and procurement
of essential drugs at reasonable cost (WHO, 2001). During that period, it was
envisioned that such strategies could improve the availability of the most
indispensable drugs, especially in developing countries.
Essential Drugs Programs of Selected African Countries
15
In 1977, the WHO Expert Committee published the first WHO essential
medicines list of 205 items. The WHO model list was intended to be flexible and
adaptable to national needs since countries face varying challenges relating to
factors such as costs and disease patterns (Quick, 2003b).
One year later, the International Conference on Primary Health Care,
known as the Declaration of Alma-Ata, identified the provision of essential drugs
as one of the eight elements of primary health care (Quick, 2003b). The
declaration defined and recognized the concept of primary health care as an
integrated approach to reach the goal of Health for All in 2000 through a strategy
using appropriate health technologies which included essential drugs (Laing,
1999).
In 1985, the WHO held a conference of Experts on Rational Use of Drugs
in Nairobi to discuss the means and methods of ensuring the rational use of drugs
(Hamrell & Nordberg, 1985). The Nairobi Conference recognized the importance
of both the model list mainly for public sectors and rational prescribing (Laing et
al., 2003). The conference identified inadequate or ineffective drug regulation and
control as a major cause of poor drug quality and irrational drug use. Finally, this
conference recommended better drug information, proper training, and continuing
education (Laing, 1999).
In an effort to assist developing countries in incorporating the model list
into a country-specific NDP, the WHO Expert Committee on NDPs met in 1986
to develop guidelines aimed at providing directions to member states on the
Essential Drugs Programs of Selected African Countries
16
operation of an NDP. These guidelines provide a detailed description of nine key
components that a typical NDP should incorporate. They are (a) selection of
essential medicines, (b) affordability, (c) financing options, (d) supply systems,
(e) regulation and quality assurance, (f) rational use, (g) research, (h) human
resources, and (i) monitoring and evaluation. Each policy component is discussed,
with a focus on current problems and new challenges. The guidelines present
strategies and practical approaches that can be used to improve the
pharmaceutical situation of a country (WHO, 2001). The main objectives of an
NDP are to ensure (a) equitable availability and affordability of essential drugs;
(b) the quality, safety and efficacy of all medicines; and (c) the promotion of
therapeutically sound and cost-effective use of drugs by health professionals and
consumers (WHO, 2001).
As of 2007, 160 of the 193 WHO member states had an official NDP.
Although the majority of WHO member states officially published their NDPs,
still there is a need to translate the main goal of access to essential drugs into
specific actions across these countries (see http://www.who.int/en/).
Developing, Implementing, and Monitoring a National Drug Policy
Developing a national drug policy is a complex process that requires
meticulous planning, involvement of all parties, and a political will. According to
WHO guidelines, the national drug policy process is a three-phase process. The
policy development starts with formulation of the national drug policy which
comprises eight steps: (a) organize the policy process, (b) identify the main
Essential Drugs Programs of Selected African Countries
17
problems, (c) make a detailed situation analysis, (d) set goals and objectives for a
national drug policy, (e) draft the text of the policy, (f) circulate and revise the
draft policy, (g) secure formal endorsement of the policy, and (h) launch the
national drug policy (WHO, 2001).
Implementation of the strategies and activities carefully formulated is the
second phase. Throughout this phase, the development, by all parties, of an
overall implementation plan is critical to achieve policy objectives. Each key
element of the drug policy needs a detailed strategy and specific action plans.
Finally, the assessment of the impact of a national drug policy is needed to give a
picture of the implementation of planned activities and indicate whether targets
are being met (WHO, 2001). In summary, a political commitment to ensure the
access to essential drugs is central to a well-deployed NDP.
Role and Relationships of Actors in the Policy Process
Numerous studies have explored the NDP process at a country level, and
several aspects have been examined. Until the late 1980s, Laos was a centralized
socialist economy, which was gradually reformed to become a liberalized
economy in 1987. The implications of the liberalization of economy were
reflected in the health sector as well. The government developed an NDP which
particularly accommodated the private sector in what was the government
monopoly. This resulted in emergence of a market of pharmaceuticals. The
increase of registered private pharmacies rose from none in 1988 to 1,690 in
1993. The consultations have also followed the same trend. To regulate its
Essential Drugs Programs of Selected African Countries
18
pharmaceutical sector, the government decided to implement a comprehensive
NDP. To develop its NDP, the government of Laos adopted a strategy involving a
wide-range of consultations and participation with an objective to involve more
stakeholders as possible and gain their consensus. After these consultations, a
national seminar was held to discuss and formulate the NDP. In addition, a series
of seminars were also held to discuss priorities and strategies for the
implementation. The success of its drug policy was partly attributed to the
involvement of all stakeholders (Paphassarang, Tomson, Choprapawon, &
Weerasuriya, 1995).
To contain the higher rate of drug consumption in Korea, the Korean
government implemented a drug reform policy aimed at separating dispensing and
prescribing roles by both physicians and pharmacists for outpatient care (Kim,
Chung, & Lee, 2004). Physicians were allowed to implicitly profit from drug
price differential between the reimbursed price and the purchase price. This has
led to a situation where the more drugs the health care providers prescribed to
their patients, the more profit they made. As result, without a gradual approach,
the government implemented a drug policy reform with provisions related to (a)
separating the prescribing and dispensing roles of physicians and pharmacists; (b)
prohibiting all medical institutions from employing pharmacists for outpatient
care or establishing a pharmacy within their buildings; and (c) forcing all
outpatients to fill their prescriptions from community pharmacies elsewhere. By
implementing this reform policy, the government expected to reduce the cost of
Essential Drugs Programs of Selected African Countries
19
medications and improve use and appropriateness of medications. However,
unintended consequences, such as increasing the use of uninsured services and
prescribing high-priced drugs, occurred. This increase in drug expenditures was
attributable to the fact that some of the stakeholders who were excluded from the
policy process did not embrace the policy. For instance, drug expenditures by the
national health insurance system increased after the implementation of the policy
because the physicians no longer had any incentive to prescribe cheaper drugs to
outpatients after the policy was implemented. Patients, who were now able to
compare the prescriptions of various sources, also asked the clinics to replace
generic drugs with the original drugs. The authors concluded that further reforms
are needed to control unintended effects of the drug policy reform (Kim et al.,
2004).
The Korean experience illustrated the importance of involving all
stakeholders in the policy process. Unlike the Korean experience, numerous
studies have shown that carefully planned and well-implemented policy
initiatives, involving all stakeholders, produced expected results. Taiwan took a
gradual approach to implement the drug policy reform intended to separating drug
prescribing and dispensing by physicians (Chou et al., 2003). In 1997, Taiwan
began implementing a separation policy on an incremental basis. The stated
objectives of this policy were to control expenditures and improve physicians’
drug prescription practices. The study had to answers three hypotheses: (a) Will a
separation policy lead physicians to reduce prescription and drug expenditures;
Essential Drugs Programs of Selected African Countries
20
(2) will a separation policy have an impact on the prescription pattern of clinics
hiring on-site pharmacies, and (3) will a separation policy have an impact on total
health expenditure. The sample study consisted of all visits to clinics and
pharmacies in the six sites studied, with a total of 55.23 million claim records.
Four sites where separation policy was implemented and two sites which served
as the control group were chosen for the study. Their analysis used a pre/post
comparison of the experiment with the control sites. The impact of the separation
policy on the hypotheses of the study, as well as whether there were changes in
the total number of visits per clinic, was analyzed. Findings indicated that a
separation policy could be effective in reducing drug expenditures, primarily
through reducing the probability of prescription. They also found that physicians
did not make up for revenue losses due to the separation by increasing nondrug
treatments or quantity of visits. However, these results need to be interpreted with
caution, as the period considered for pre/post analysis was limited to a short
period of 3 months before and after the implementation of the policy (Chou et al.,
2003).
In summary, a rational pharmaceutical system depends on a well
formulated and implemented national drug policy. To achieve its main objectives
of access, quality, and rational use of drugs, the regulation of the pharmaceutical
sector needs to reconcile private and public sector.
Essential Drugs Programs of Selected African Countries
21
Overview of the Concept of Essential Drugs and Essential Drugs List
The rationale behind the concept of essential drugs is that there are a
limited number of drugs that are indispensable and should be available to the
majority of the population at all times. The WHO (2004) defines essential drugs
as:
those medicines that satisfy the priority health care needs of the
population. They are selected with due regard to public health relevance,
evidence on efficacy and safety, and comparative cost-effectiveness.
Essential medicines are intended to be available in the context of
functioning health systems at all times in adequate amounts, in the
appropriate dosage forms, with assured quality and adequate information,
and at a price the individual and community can afford. The
implementation of the concept of essential medicines is intended to be
flexible and adaptable to many different situations; exactly which
medicines are regarded as essential remains a national responsibility. (p. 1)
This definition implies that drugs selected on the basis of safe and
cost-effective clinical guidelines are central for nearly every public health
program aimed at reducing morbidity and mortality (Pẻcoul, Chirac, Trouiller, &
Pinel, 1999). Thus, safe, available in suitable amounts, affordable, and properly
used, drugs provide a simple cost-effective answer to many health problems.
The established link between the concept of essential drugs and
improvement in access to essential drugs by the population (Quick, Hogerzeil,
Essential Drugs Programs of Selected African Countries
22
Velásquez, & Rägo, 2002) cannot be disputed. Several studies examined the
progress of essential drugs list since the inception of the concept of essential
drugs to date. In their analysis of the 25 years of the WHO essential drugs list,
Laing et al. (2003) analyzed and highlighted the progress and challenges toward
access to essential drugs. The authors argued that the list helped to establish the
principle that some medicines were more useful than others and that essential
drugs were often inaccessible to many populations. Since then, the EDL has
increased in size; defining an essential drug has moved from an experience to an
evidence-based process, including criteria such as public health relevance,
efficacy, safety, and cost-effectiveness (Laing et al., 2003).
Quick et al. (2002) depicted the pharmaceutical situation prevailing in the
world before the introduction of NDP and essential drugs concepts as follows:
“The approach to drug selection for health services was relatively informal.
Independent, unbiased information on medicines was extremely limited with little
attention to systematic teaching about rational prescribing and generic
prescribing” (p. 1). It can be noted that some countries had initiated
pharmaceutical policy; however, the concept of NDP was barely unknown in
1977 (Quick et al., 2002).
In summary, the WHO model list was created with the aim at providing a
reference model for member states to select a subset of medicines to address local
public health needs and produce their national lists. Despite the progress made by
Essential Drugs Programs of Selected African Countries
23
selected countries to improve access to essential drugs, the situation of
pharmaceuticals in these countries remains alarming.
Development Process of the WHO Model List
Rational selection of drugs based on cost-effective clinical guidelines is
one of the key components of a national drug policy. The rationale behind the
selection is that careful selection of a limited range of essential drugs results in a
higher quality of care, better management of medicines, and more cost-effective
use of health resources (WHO, 2001). The task of the selection process is to select
and prioritize a limited number of pharmaceutical products from thousands
available on the market (WHO, 2001). An expert committee identifies an essential
drug to be included on the WHO essential drug model list based on the four main
criteria: (a) relevance for public health, (b) clinical effectiveness, (c) safety, and
(d) comparative cost-effectiveness. The detailed inclusion process of an essential
drug to WHO model list is in Appendix A.
The ideal selection of essential drugs would be linked to evidence-based
clinical guidelines. According to the WHO, a list of essential drugs would be
created with explicit criteria and would be reviewed and updated at least every
two years. In addition to the list of essential drugs, the WHO has initiated a
program to establish standard treatment guidelines (STG) for the drugs on the list.
The goal for the both the list and the guidelines is that they should be based on the
best available clinical evidence (WHO, 2002). In summary, the process to select
Essential Drugs Programs of Selected African Countries
24
essential drugs is critical, thus a transparent process involving all stakeholders is
necessary.
Importance of EDL and Standard Treatment Guidelines
on Rational Use of Drugs
Le Grand, Hogerzeil, and Haaijer-Ruskamp (1999), in an extensive
literature review on the rational use of drugs, examined the experiences of the last
decade in order to identify which interventions have proven effective in
developing countries and suggested a range of policy options for health planners
and managers. Their findings indicated that interventions such as STGs, EDLs,
pharmacy and therapeutics committees, problem-based basic professional
training, and targeted in-service training of health workers have proved effective
in some settings.
According to Laing et al. (2003), the success of clinical guidelines in
changing practice seems to depend on many factors, including the complexity of
the targeted practice, the credibility of the group developing the guidelines,
involvement of end-users in the development process, the format of the resulting
guidelines, and, most importantly, how they are disseminated. The WHO
recommends that the selection of drugs be based on a list of common conditions
and complaints and the treatments of choice for these conditions as defined in
STGs. The drugs included in the treatment guidelines for a certain level of health
care will constitute the EDL for that level (Laing et al., 2001).
Essential Drugs Programs of Selected African Countries
25
Numerous studies have documented the impact of clinical guidelines and
essential drug lists on the availability and proper use of medicines within health
care systems (Kafuko & Bagenda, 1994; Woolf, Grol, Hutchinson, Eccles, &
Grimshaw, 1999). Woolf et al. explored the potential benefits, limitation, and
harms of clinical guidelines. The authors examined the potential benefits and
harms for three distinct groups: patients, health care professionals, and health care
systems. For patients, the guidelines have the potential to reduce morbidity and
mortality and improve quality of life, at least for some conditions, and to improve
the consistency of care. For health care professionals, they have potential benefits
to improve the quality of clinical decisions, and to support quality improvement
activities. Clinical guidelines may be useful in improving efficiency and
optimizing value for money for health care systems. According to the authors, the
most important limitation of guidelines is that its recommendations may be
wrong. In addition, the recommendations included in the guidelines may be
influenced by other needs other than patients. The development group’s opinions
and clinical experience may be taken into account when making the
recommendations. The authors argued that guidelines that are not rigorously
developed based on evidence can harm patients, health care professionals, as well
as health care systems. They concluded that the clinical guidelines are only one
option for improving the quality of care.
It was suspected that inappropriate drug use was widespread in Uganda,
and the lack of national standard treatment guidelines was one reason identified
Essential Drugs Programs of Selected African Countries
26
for irrational drug use. Therefore, in 1992, the Minister of Health developed
National Standard Treatment Guidelines (NSTGs) to guide the process of
prescribing in all health facilities. To establish the baseline for drug use in the
country, Kafuko and Bagenda (1994) designed a randomized controlled study
with pre-post observations of outcomes using qualitative and quantitative research
methods. Their study covered 126 health units randomly selected in six districts
of four regions of Uganda and one health unit used as a control group. The
researchers divided these 126 health units into three groups, which they assigned
interventions A1, A2, and B. Data used for the study were retrospectively and
prospectively collected. One hundred twenty-seven (127) were covered and a total
of 13,631 general patient encounters and 1,463 diarrhea cases in children under 5
were studied. The interventions were as follows: intervention B was about
dissemination of NSTGs alone to health units; intervention A2 was about
dissemination of NSTGs plus timely feedback and targeted training of health
workers; and finally, intervention A1 was about dissemination of NSTGs plus
timely feedback and targeted training of health workers plus support supervision
for 6 months. Their findings showed that there was significant reduction in the
number of drugs prescribed for the general cases for interventions A1 and A2.
Intervention B increased the amount of drugs prescribed and the control group
had no change at all. There was no change in the antibiotic prescribing for
interventions A1 and a minimal reduction for intervention A2. There was,
however, significant reduction in injection prescribing for interventions A1 and
Essential Drugs Programs of Selected African Countries
27
A2. The authors concluded that the combination of regulatory, managerial, and
education measures may be required to realize tangible and beneficial effects.
Their study showed that the provision of educative materials like the NSTGs has
provided minimal improvement on rational drug use if compared to the two
alternatives which used a combination of educative and managerial strategies. The
study has also revealed standard treatment guidelines alone do not result in
behavior change in rational drug use.
Irrational use of drugs is a difficult problem, and yet it can be prevented as
shown by one study carried out in seven medical schools from both developed
and developing countries (de Vries et al., 1995). The study aimed to assess the
positive impact of the training of students who were about to enter the clinical
phase of their studies. Using the WHO manual on the principles of rational
prescribing, the students were taught to generate a standard pharmacotherapeutic
approach to common disorders. In addition, the students were taught to consult
existing national and international treatment guidelines, national formularies,
pharmacology textbooks, and other sources of drug information. A total of 219
students were randomly divided between study (111 students) and control (108
students) groups. Using the WHO manual, the study group had four weekly
pharmacotherapeutic training sessions focused on good prescribing related to pain
medication only. The impact of the training was assessed by means of a test for
both groups immediately before training, immediately after, and 6 months later.
Using multiple-analysis of variance, the researchers compared both groups. They
Essential Drugs Programs of Selected African Countries
28
found that the students who were trained to the principal of rational prescribing
performed significantly better than the students from the control groups. Their
findings indicate also that the students from the study groups have retained the
good prescribing principles 6 months after their training. The researchers
concluded that this approach seems to be an efficient way of teaching rational
prescribing.
A Dutch study evaluated the effectiveness of multiple interventions to
reduce antibiotic prescribing for respiratory tract symptoms in primary care. In the
Netherlands general practitioners prescribe almost 80% of all antibiotics and
nearly two thirds of these prescriptions are issued for infections of the respiratory
tract (Welschen, Kuyvenhoven, Hoes, & Verheij, 2004). Based on the standard
guidelines for infections of the respiratory tract developed by the Dutch College
of General Practitioners, multiple intervention strategies were implemented to
reduce antibiotic prescribing for respiratory tract symptoms such as training
doctors in communication skills, monitoring prescribing behavior, and sustaining
the achieved consensus by means of feedback on prescribing and reminders.
These strategies have never been evaluated, so this study evaluated the
effectiveness of group education meetings designed to provide feedback to
prescribers on their performance. Data from insurance claims were used to study
the prescription of antibiotics. Out of 42 peer review groups invited to be part of
the study, 12 groups of 100 general practitioners agreed to participate in the study.
These 12 groups were randomly divided into the intervention groups (6 groups of
Essential Drugs Programs of Selected African Countries
29
46 general practitioners) and control groups (6 groups of 54 general practitioners).
Only 42 and 47 of the general practitioners from the intervention and control
groups, respectively, completed the trial. The researchers used a t test to assess
differences between intervention and control groups, to evaluate the effectiveness
of the multiple interventions. The results of their study indicated that there was no
significant difference between the intervention and control groups in prescribing
antibiotics before the study. However, they found that antibiotic prescription rates
in the intervention group fell by 4% and rose by 8% in the control group. Their
findings showed also that there was no difference in patients’ satisfaction in the
two groups, thus the interventions did not alter patients’ satisfaction. The
researchers concluded that the multiple interventions have decreased the antibiotic
prescription rates while maintaining the same level of patients’ satisfaction.
Grimshaw and Russell (1993), studying the effect of clinical guidelines on
medical practice, provided additional evidence that clinical guidelines and lists of
essential drugs, when well formulated and well implemented with adequate
support, could improve quality and lead to better health outcomes. The authors
reviewed 59 published evaluations of clinical guidelines: 24 investigated
guidelines for specific clinical conditions, 27 studied preventive care, and 8
looked at guidelines for prescribing or for support services. Grimshaw and
Russell’s study found that explicit guidelines do improve clinical practice when
introduced in the context of rigorous evaluations.
Essential Drugs Programs of Selected African Countries
30
These studies highlight the impact of EDLs and STGs on attaining better
health outcomes if both interventions are adequately supported by a stronger
commitment to promote the rational use of drugs. Although there is an increasing
political commitment to promote the essential drugs programs in sub-Saharan
Africa, still there is a need for increased focus on both EDLs and STGs in those
countries.
Impact of Drug Policy Regulatory on
Availability and Drug Use
The EDLs can play a key role from both the medical and economic point
of view. Hogerzeil (2004) argued that from a medical point of view, essential
drugs lead to better quality of care and better health outcomes. He asserted that
economically they lead to better value for money, to lower costs through
economies of scale, and to simplified systems of procurement. Furthermore, lists
of essential drugs also guide the procurement and supply of medicines in the
public sector, reimbursement mechanisms for medication costs, medicine
donations, and local medicine production. According to the WHO, the rational
selection of essential drugs based on agreed clinical guidelines leads to better
supply of drugs, to more rational prescribing, and consequently to lower costs
(WHO, 2003).
In 1989, Hogerzeil, Walker, Sallami, and Fernando evaluated the impact
of an essential drugs program on its main objectives: availability and rational use
of drugs in Democratic Yemen. At the time of the study, the essential drug
Essential Drugs Programs of Selected African Countries
31
program had been operating in Yemen since 1984. A national formulary was in
place and drugs to be included have been clearly designated. The researchers
selected randomly a sample of 19 of the 122 peripheral health units from two
governorates in which the essential drugs program had been operating (program
area), and 7 out of 58 from a governorate where the program had not been
implemented (control area). The impact of the program was assessed by
comparing the health units from the program area with those from the control
area. Their findings have shown that, on average, 88% of essential drugs (27 of 31
labeled as essential drugs) were available in the program area compared to 55%
(17 of 31) essential drugs in the control area. They found that there was a
significant difference in patterns of drug use between both areas. About 24.8% of
the patients received an injection drug in the program area compared to 57.8% in
the control area. Similarly, there were fewer antibiotics being prescribed in the
program area (46.3%) compared to 66.8% in control area. The number of drugs
per prescription also differed when comparing the program area (1.5) with the
control area (2.4). The researchers concluded that essential drugs program has
significantly improved the availability and rational use of drugs (Hogerzeil et al.,
1989).
In 1990, the government of Pakistan intervened to deregister pediatric
formulations of antimotility drugs because of the higher incidence of paralytic
ileus in children suffering from acute diarrhea in 1989. At one hospital,
pediatricians recorded 19 cases of paralytic ileus within a period of 2 months in
Essential Drugs Programs of Selected African Countries
32
children given Imodium for diarrhea. Bhutta and Balchin (1996) assessed the
long-term effectiveness of the regulatory intervention to withdraw these
formulations and explored possible irrational substitution. Using a post-only
design, they conducted surveys of case management of acute diarrhea to collect
data on availability of the deregistered drugs in retail drug outlets and substitutes
suggested for the deregistered drugs. Seven centers reflecting the geographic,
cultural, and demographic diversity of Pakistan were selected for the survey. The
researchers have found that the regulatory intervention has removed the
deregistered drugs from circulation in 94.5% of stores surveyed; however, they
have found that the deregistered drugs were still available in one city. The
substitution practices posed a more serious problem. The deregistered drugs were
being accompanied by misuse of adult preparations. Because of the size of the
sample and the failure to conduct a follow-up obstructive survey in two regions, a
great caution must be exercised in any extrapolation to a country-level statistical
analysis and percentages given must be regarded as rough estimates.
One mechanism to make drugs more affordable is the use of generic drug
names. Thus, prescription of generics and substitution constitute two mechanisms
to reduce cost of drugs. A study carried out in South Africa (Karim, Pillai,
Ziqubu-Page, Cassimjee, & Morar, 1996) explored the extent of generic
prescribing by private medical practitioners and how private pharmacists carry out
the generic substitution. The researchers also attempted to estimate the potential
savings from the prescription and substitution of generics. On four randomly
Essential Drugs Programs of Selected African Countries
33
selected days, all prescriptions, together with the original prescription, were
collected from 10 pharmacists. They analyzed 1,570 prescriptions with a total
number of 4,086 products. They found that only 23.5% (961 out of 4,086) of the
drugs prescribed had generic equivalents, and 202 out of 961 (21.0%) were
prescribed as generic drugs. Their findings indicated that 45.7% of all the total
prescriptions had at least one item for which a generic equivalent existed. If the
generic substitution was carried out, 6.8% of the cost of the original doctor’s
prescriptions could have been saved. The authors concluded that if encouraged
and reinforced, generic prescribing and substitution could result in marginal cost
savings (Karim et al., 1996).
Ratanawijitrasin, Soumerai, and Weerasuriya (2001) explored the impact
of NDPs and essential drug programs on improvement of drug use. In their
extensive international literature review, the authors attempted to define the
current state of knowledge regarding drug policy effects on drug use. They
reviewed the archives and computerized databases, articles published in medical
and pharmacy journals, as well as published annotated bibliographies. Their
findings indicated that most of the studies utilized weak research designs that
evaluated programs solely on the basis of post-intervention measures. Only two
studies measured pre-policy utilization but did not include a control group. They
concluded that none of the results were conclusive, and the findings represented,
at best, hypotheses for more rigorous studies of policy impacts. Due to a lack of
reliable data, the authors were unable to determine whether national drug policies
Essential Drugs Programs of Selected African Countries
34
and essential drug programs improved drug use. Unlike the studies reviewed by
Ratanawijitrasin et al., for the purpose of this thesis, the writer analyzed some
recent publications that have utilized pre-post intervention design or have
included a control group.
One study analyzed the impact of a drug list policy and hospital revenue
capping policy on drug expenditure in Shangai (Hu et al., 2001). This policy was
implemented to reduce the rapid increase in medical drug expenditures in Shangai
from 1983 till 1993. The underlying factors of this increase were (a) the financial
incentives and profit-driven prescribing behaviors; and (b) the over-consumption
of drugs due to the fact that health of urban population was covered by the
government without control over drug expenditures. To contain this growth rate,
the authorities adopted a drug list of 936 molecules and 502 Chinese herbal
preparations. Only drugs included on the list were reimbursed. In addition, a new
policy was also put into effect in Shangai to limit total revenue of each hospital at
24% of the previous year’s revenue. Using data collected on general medical
expenditure and drug expenditure, the researchers compared three time periods:
(a) before the drug list policy; (b) after the drug list policy alone, and (c) after the
drug list and capping policies. Using a multiple regression analysis, they analyzed
the cost of 7,076 randomly selected prescriptions for pharmaceuticals and Chinese
herbal preparations. The results illustrated that physicians prescribed fewer
imported drugs and expensive antibiotics after implementation of the reform
policies. The proportion of total medical expenditure attributable to drugs
Essential Drugs Programs of Selected African Countries
35
declined from 67% in 1992 to 51% in 1996. The annual growth rate of drug
expenditure per ambulatory visit was reduced from 23.4% in 1992 to 0.3% in
1996. Over the same period, the growth rate of drug expenditure per bed-day
decreased from 28.2% to -2.4%. A multiple regression analysis of prescription
costs showed that the two policies did not alter the equity of utilization of
pharmaceuticals between insured and noninsured outpatients. The authors
concluded that the drug list and capping policies in Shangai appear to have
achieved their objectives of containing the escalation of drug expenditures and
improving the rational use of drugs without loss of equity (Hu et al., 2001).
The importance of the essential drugs list and national drug policy was
discussed by Kisa (2001). The author reviewed the performance of the Turkish
pharmaceutical industry in terms of technology and production in comparison
with that of some other countries. The study intended to answer if there is a need
to develop a national drug policy in Turkey. The study revealed that irrational use
of drugs, such as inappropriate and unnecessary use of antibiotics, is an important
problem in Turkey. The prescribing behavior of physicians has lead to an increase
in antibiotic use and, consequently, created highly resistant strains of bacteria.
The Turkish Medical Association has pointed out that overprescribing antibiotics
has led to a resistance of 60-70% for broad-spectrum antibiotics. Irrational use of
drugs among other factors influencing the pharmaceutical sector in Turkey has led
the author to conclude that government should adopt a clear policy toward
essential drugs (Kisa, 2001).
Essential Drugs Programs of Selected African Countries
36
Park et al. (2005) investigated the impact that a new drug policy in Korea,
which prohibited physicians from dispensing drugs, had on the quantity and
quality of their prescribing behaviors. They specifically explored changes in
antibiotic prescribing after the policy and whether the reduction in antibiotic
prescribing was greater for cases of viral disease, in which antibiotic prescribing
was likely inappropriate, than for bacterial disease, in which antibiotic prescribing
could be appropriate. Claims from the Korean National Health Institute were used
for the study. The studied period covered 6 months before and after policy
intervention, respectively. During this period no other policy changes occurred
which might have influenced drug utilization. The researchers identified two
primary diagnosis groups of interest: the viral illness group and the bacterial
illness group. The nationally representative sample consisted of 50,999 episodes-18,656 viral and 7,758 bacterial pre-policy, 16,736 viral and 7,849 bacterial postpolicy--from 1,372 primary care clinics. They used generalized estimating
equations to investigate changes in antibiotics prescribing after the policy and
multiple linear regressions to determine provider factors associated with
reductions in inappropriate antibiotic prescribing for viral illness. The findings
indicated that after the policy reform became effective, antibiotic prescribing
declined substantially for patients with viral illness, from 80.8% to 72.8%, and
only minimally for patients with bacterial illness (from 91.6% to 89.7%). The
number of different antibiotics prescribed per episode also decreased significantly
after the policy, but there were no significant differences in these reductions
Essential Drugs Programs of Selected African Countries
37
between viral and bacterial illness. The researchers concluded that prohibiting
doctors from dispensing drugs reduced prescribing overall, both antibiotics and
other drugs, and inappropriate antibiotic prescribing in viral illness (Park et al.,
2005).
The NDP in Iran, aimed at providing the population of the country with
affordable, good quality medicines, has been evaluated through one of its very
important elements, Iran drug list (Nikfar, Kebriaeezadeh, Majdzadeh, &
Abdollahi, 2005). The authors analyzed and evaluated the Iran Drug Selecting
Committee’s (IDSC) decision making as one necessary part of the process of
evaluating the NDP. They looked at 5 years of IDSC’s decision making to assess
the implementation of drug supply system in the country. The WHO’s four
standard questionnaires to identify the strengths and weaknesses in the
formulation and implementation of the NDP in Iran were used. They contained
structural and process indicators which served to assess the implementation of
NDP by measuring progress in key components and outcome indicators which
served to evaluate the outcomes of NDP. The study analyzed 59 drugs which had
been approved by the IDSC’s members from 1998 to 2002. The findings of the
study showed that 96.1% of drugs in the national EDL were produced locally.
They revealed the irrational use of drugs in Iran such as existence of at least one
injection in 47% of total prescriptions surveyed with an average number of 3.6
drugs prescribed for each patient. The study showed that the assessment of 59
dossiers of approved drugs for adding to the national EDL showed that the
Essential Drugs Programs of Selected African Countries
38
IDSC’s members pay more attention to efficacy, safety, and rationality in use of
drugs rather than accessibility and affordability. They concluded that the drug
system in terms of implementation of the processes to achieve the NDP’s
objectives needs to be revised in order to achieve the equity in access to
pharmaceuticals.
The growth of pharmaceutical expenditures in China, which has attained
44.4% of total health expenditures in 2001, has led the Chinese government to
intervene by changing its drug pricing policy from controlling the entire cascade
of prices for all pharmaceuticals to controlling retail prices for selected products
only (Meng et al., 2005). Meng et al.’s study was intended to examine whether the
retail price policy was actually implemented in the institutions studied, whether it
was effective in containing hospital drug expenditures, and the role of rationality
of drug use in influencing the expenditure patterns. It can be noted that a list of
drug prices which contains part A drugs, which were set by the government as
definitive ceilings for retailers, and B drugs, for which the government set guiding
prices, was implemented. Using a retrospective pre/post-reform case study in two
public hospitals, the researchers reviewed the financial records related to cerebral
infarction to analyze changes in prices, utilization, expenditures, and rationality of
drugs. In the two hospitals, a total of 104 and 109 cerebral infarction cases
hospitalized respectively before and after the reform, were selected. Prescribed
daily dose was used for measuring drug utilization. They found that drug
expenditures for all patients still increased rapidly in the two hospitals after
Essential Drugs Programs of Selected African Countries
39
implementation of the pricing policy. For instance, in the municipal hospital, drug
expenditure per patient increased by 50.1% after the reform, mainly due to greater
drug utilization. A large proportion of expenditures for the top 15 drugs, at least
65% and 41% in the provincial and municipal hospitals, respectively, was spent
on allopathic drugs without an adequate evidence base of safety and efficacy
supporting use for cerebral infarction. They concluded that the control of retail
prices, implemented in isolation, was not effective in containing hospital drug
expenditures in the studied hospitals. Drug expenditures were driven more by
utilization than price (Meng et al., 2005).
In summary, throughout the years, governments of developing countries
recognized access to safe, affordable, and good quality medicines as a public
priority. Substantial progress has been made toward the access to essential drugs;
however, it has not occurred evenly. For instance, availability of essential drugs is
still alarmingly insufficient, particularly in much of sub-Saharan Africa.
Situation of Access to Essential Medicines in Africa
Access to essential pharmaceuticals in Africa is far from ideal. The
situation is even more alarming in sub-Saharan Africa, where governments have
formulated and implemented national drug policies, created lists of essential
drugs, and established standard treatment guidelines for the drugs on their lists.
Yet, millions of people in these countries cannot pay for or obtain the medicines
they need.
Essential Drugs Programs of Selected African Countries
40
Availability of Essential Drugs
As Hodes and Kloos’s (1988) study indicated, the publication of a national
drug list is not enough to ensure the availability of essential drugs. Their study
looked at the experience of Ethiopia, 2 years after the Ethiopian government
adopted an essential drugs list. Their findings showed that only 7% of the
country’s health centers had a complete selection of the drugs on the national
EDL.
The baseline assessment of pharmaceutical sectors of selected countries
undertaken in 2002 and 2003 by Ministries of Health indicated that the median
percent of availability of key medicines in public facilities was 70% in Chad,
78.6% in Ghana, 93.3% in Kenya, 87.3 % in Mali, 46% in Nigeria, 80% in
Senegal, 75% in Uganda, and 87.28% in Tanzania. On the average, the stock-out
duration was 41 days in Chad, 75.5 days in Ghana, 38.59 days in Kenya, 45.4
days in Mali, 15.3 days in Senegal, 89.3 days in Uganda, and 28 days in Tanzania.
Information regarding stock-out duration for Nigeria was not available (Ministry
of Health, n.d.).
A further study examined a secondary analysis of data from 36 low- and
middle-income countries. Cameron, Ewen, Ross-Degnan, and Laing (2008)
analyzed medicines prices and availability in 45 national and sub-national surveys
conducted using the WHO and Health Action International (HAI) methodology.
The findings indicated that average public sector availability of generic medicines
ranged from 29.4% to 54.4% across surveyed countries. The availability of
Essential Drugs Programs of Selected African Countries
41
generics in the African region was 29.4%. The study showed also that even in the
private sector, the availability of generics was far from ideal. Chad had the lowest
availability of 14.8%, whereas Ethiopia had the highest availability of 79.1%.
Overall, the mean availability in the private sector was higher than in the public
sector across all WHO regions (Cameron et al., 2008).
These findings corroborated the results of the previous studies. The lack of
availability of essential drugs in public facilities implies that the populations use
less health facilities. The link between the availability and visits to health
facilities was illustrated by studies carried out in Nigeria, which showed that
when drugs are unavailable at health facilities, visits by patients dropped by 50%
to 75% (World Bank, 1994).
Sub-Saharan Africa countries face another major issue: the lack of
essential drugs for tropical diseases as a consequence of the lack of drug
discovery and development for tropical diseases (Pécoul et al., 1999). As Kapp
(2003) pointed out, of the 1,400 new products developed by the pharmaceutical
industry between 1975 and 1999, only 13 were for tropical diseases and three
were for tuberculosis. For the same period, developed countries accounted for
nearly 90% of global pharmaceutical sales, whereas developing countries
accounted for 90% of the 14 million deaths from infectious disease (Kapp, 2003).
Affordability of Essential Drugs
African countries face a broader range of problems, such as the alarming
lack of availability of medicines in public health facilities, which forces people
Essential Drugs Programs of Selected African Countries
42
who need them the most to obtain expensive drugs in the private sector or forgo
treatment altogether.
Several factors undermine the availability of essential medicines in Africa,
such as poor supply and distributions systems, insufficient health facilities and
staff, and low investment in health and the high cost of medicines. For example,
the World Bank study found that the lack of reliable supplies of medicines in
periurban and rural areas forces patients to purchase medicines from itinerant
traders or to travel a long distance to get them (World Bank, 1994).
Drug prices of originator brands and generics are considerably higher in
the private sector, making many treatments, particularly those for chronic
diseases, simply unaffordable (WHO, 2003). In Africa, for example, a low paid
worker has to pay between 2 to 8 days’ wages each month to buy glibenclamide
to treat diabetes. Across the surveys, in the private sector, originator brands cost
260% more than lowest priced generic equivalents, increasing to 1000% or more
in some countries. The average Tanzanian must work 500 hours to pay for a
course of tuberculosis treatment compared to a Swiss who would only have to
work 1.4 hours. The WHO study found that 30 days of ulcer treatment with the
innovator brand of ranitidine cost the equivalent of 50 days’ wages in Cameroon
and 20 days in Kenya, whereas the generic ranitidine cost 24 and 8 days’ wages,
respectively.
In summary, despite some progress in improving or increasing access to
essential medicines by several countries of the developing world, the inability to
Essential Drugs Programs of Selected African Countries
43
ensure continuously available and affordable medicines at public health facilities
remains alarming in several WHO member states. A well-formulated and
well-implemented national drug policy is a crucial political commitment that
Sub-Sahara Africa countries have to take to ensure availability of affordable and
good quality medicines to all citizens.
Rational Use of Essential Drugs in Africa
Like the lack of availability of essential drugs, the irrational use of drugs
can impact the reduction in morbidity and mortality if the drug therapy is
inappropriately used. According to the WHO (2001) “rational drug use requires
that patients receive medications appropriate to their clinical needs, in doses that
meet their individual requirements, for an adequate period of time, and at the
lowest possible cost to them and their community” (p. 19). It has been suggested
that mediating disease burden in the developing world is undermined, at least in
part, due to the irrational use, inefficient financing, unreliable delivery of
medication, and high medicine prices (Quick, 2003b). Among these factors,
irrational use of drugs remain problematic and its most common types are (a) the
use of too many medicines per patient--poly-pharmacy; (b) inappropriate use of
antimicrobials, often in inadequate dosage, for nonbacterial infections; (c) overuse
of injections when oral formulations would be more appropriate; failure to
prescribe in accordance with clinical guidelines; and (d) inappropriate selfmedication, often of prescription-only medicines (WHO, 2004). Le Grand et al.
(1999) found that the common problems of irrational use of medicines are over
Essential Drugs Programs of Selected African Countries
44
prescribing, multi-drug prescribing, misuse of drugs, use of unnecessary
expensive drugs, and overuse of antibiotics and injections.
The influences upon prescribing patterns should be considered in both
health institutions and retail pharmacies. According to Goel, Ross-Degnan,
Berman, and Soumerai (1996), influences upon prescribing in retail pharmacies
has shown that there are four sets of explanatory factors: pharmacy factors, client
factors, physician practice, and regulatory factors.
Few studies have explored the influence of pharmaceutical policy upon
rational use of drugs. Maiga, Haddad, Fournier, and Gauvin (2003) analyzed two
issues of the pharmaceutical policy in Mali: (a) whether or not implementation of
complementary measures in selected regions has led to a more rational use of
medication, and (b) whether or not patterns of prescription and utilization in
public facilities targeted by these policies differ from those observed in the private
sector. The researchers observed 700 medication transactions in each of the 14
private and public legal points of sale, and an average of 50 consecutive
transactions in each of the points of sale each day. Their observations were
focused on the interaction between the pharmacist and the customer followed by a
brief interview with the buyer to mainly record the reasons for the visit to the
pharmacy and the drugs prescribed and the prescriber’s location of practice. The
results of their study indicated that the objective of improving access to drugs
seems to have been achieved in the sites studied. Affordable generic drugs were
accessible and widely used, even in the private sector. However, measures
Essential Drugs Programs of Selected African Countries
45
intended to rationalize the prescription and delivery of drugs did not always have
the desired effect. Also their study showed that prescribers in the public sector
tended to prescribe fewer antibiotics, injectables, or brand-name drugs; however,
they found that there was absence of advice concerning the use or the side effects
of the drugs in both public and private sectors. Their conclusion was to broaden
the scope of NDPs to include the private sector. It should be pointed out that this
study did not include the buying practices in informal drug markets, which plays
an important role in irrational use of medicines. The role of the informal drug
market was discussed by Quick et al. (2002) as one of the factors that influenced
the effective use of medicines. Other factors included actions of health care
providers, formal distribution channels, and the pharmaceutical industry and the
public.
Numerous studies have explored the attitudes of prescribers toward an
essential drugs program. Krause et al. (1999) examined the rationality of
prescriptions in the general consultation in Burkina Faso according to the
individual diagnoses of the patients and to learn about the attitudes of the
prescribers toward the essential drug program. For a period of 2 weeks, 313
outpatient consultations were studied by methods of guided observation as well as
interviews with health care workers involved in the study. A total of 793 drugs
prescribed by 15 health care workers during the observation period, and 2,815
prescribed drugs copied from the patient register, were analyzed. The study found
that the average number of drugs prescribed per visit was 2.3. Regarding the
Essential Drugs Programs of Selected African Countries
46
adherence of prescription to treatment guidelines, the study showed that
prescriptions were correct for 59.3% of patients who received indications on drug
dosage, 88% of the prescribed drugs were on the essential drug list, 88.4% were
indicated according to the national treatment guidelines, and 79.4% had a correct
dosage. Despite their concern about the quality of certain items on the EDL, the
prescribers perceived the essential drug program to be a major improvement.
Other serious deficiencies in drug prescribing were absence of information on
length of therapy, which occurred in two-thirds of the cases, and errors in dosages
especially in children under 5 years. The study found also that 59.3% of all the
patients received a correct prescription and seven out of 21 pregnant women
received drugs contraindicated in pregnancy. The results of this study regarding
quality of prescription should be analyzed with caution because it was a guided
observation (Krause et al., 1999).
Uzochukwu, Onwujekwe, and Akpala (2002) conducted a study in Nigeria
with the purpose of comparing the level of availability and rational use of drugs in
primary health care facilities where the Bamako Initiative (BI) drug revolving
fund program has been operational, with primary health care facilities where the
BI-type of drug revolving fund program is not yet operational. The study focused
on the data about the essential and nonessential drugs stocked by the facilities.
They determined the drug use through analyses of prescriptions in each health
center and then determined the proportion of consumers that were able to
remember their dosing schedules. For each of the prescriptions, the variables
Essential Drugs Programs of Selected African Countries
47
collected were the average number of drugs prescribed per encounter, average
percentage of prescriptions with injections, the average percentage of
prescriptions with one or more antibiotics, the percentage of generic prescribing,
and percentage of prescriptions with essential drugs. The study found that an
average of 35.4 essential drugs was available in the BI health centers compared
with 15.3 in the non-BI health centers. The average drug-stock was adequate for
6.3 weeks in the BI health centers, but only for 1.1 weeks in non-BI health
centers. More injections (64.7 vs. 25.6%) and more antibiotics (72.8 vs. 38%)
were prescribed in BI health centers than in the non-BI health centers. The BI
health centers had an average of 5.3 drugs per prescription against 2.1 in the
non-BI health centers. The over-prescription was due to the fact that in the BI
scheme, finance is linked with drug supply and part of the proceeds of drug sales
is used for health workers’ remuneration. However, the drugs prescribed by
generic name and from the essential drugs list were higher in the BI health centers
(80 and 93%) than the non-BI health centers (15.5 and 21%, respectively). It is
difficult to confirm the accuracy of these findings as the study relied on patients
remembering their dosing schedules (Uzochukwu et al., 2002).
Although medicines are made available through reliable supply systems,
they still cause harm when they are inappropriately prescribed. For instance, the
inappropriate use of antimicrobial agents for nonbacterial infections is frequent
and leads to an increase of antimicrobial resistance (Calva & Bojalil, 1996).
According to Quick (2003a), studies from both developed and developing
Essential Drugs Programs of Selected African Countries
48
countries indicate that 25 to 75% of antibiotic prescriptions in teaching hospitals
are inappropriate and 30 to 60% of patients in primary health care centers receive
antibiotics. Failure to prescribe in accordance with clinical guideline is also a
source of irrational use. As analyzed by Quick (2003a), of 15 billion injections
administered worldwide each year, half are unsterile and a large share is
unnecessary. It has also been reported that injections are frequently and
unnecessarily overused when oral formulations would be more appropriate
(WHO, 2004).
Frequency of injection is a major problem of irrational use of medicines
and this issue has been extensively studied. For instance, Gumodoka et al. (1996)
explored prescription and sterilization practices in Mwanza Region, Tanzania,
prior to the interventions aimed at reducing HIV transmission by injections. For
their study, they randomly selected 66 health facilities, from which 9 were
hospitals, 11 health centers, and 46 dispensaries. Out of these 66 facilities, 49
were administered by the government, 12 by a mission, and 5 privately. Without
any notification, a medical officer, accompanied with an assistant medical officer,
visited all health facilities in the morning for a period of 4 months. Based on the
records from the outpatient registers, which included all patients with specified
conditions and the number of those receiving an injections, the percentage of
patients who received injections was estimated. Tools used to collect data
included interviews, questionnaires, structured observations, bacteriological
culture, and records analysis. The criteria for avoidable injections were based on
Essential Drugs Programs of Selected African Countries
49
recommendations of the Essential Drugs Program and on a regional consensus
workshop. The findings of the study have shown that 1 in 4 out-patients received
an injection, and that of all injections given, 70% could have been avoided. They
also found that for adequate knowledge of indications for injection, the lowest
proportion was demonstrated among nurse aides: 4% (1/25). The interviews of
120 patients have shown that they preferred to have injections over oral drugs for
almost all conditions. This demand of injections from patients was felt to be a
problem in 85% of the health facilities and led to over-prescription of injectables.
They concluded that a high proportion of injections given could have been
avoided, and that patient demand for injections was high (Gumodoka et al., 1996).
From December 1992 to February 1993, Vos et al. (1998) carried out an
evaluation aimed to assess changes in injection and sterilization practices after the
introduction of interventions to reduce the HIV transmission by injections. The
results of the baseline study were presented in a workshop to all senior health
workers who decided which patients would need an injection for specified
conditions. Treatment and sterilization guidelines were developed. Thereafter,
seminars were held at each health center of the region. Four months after the
intervention, data were collected at the same health facilities in order to assess
changes in prescribing practices. The same health facilities as for the baseline
study were used as well as the same research tools. The results of their evaluation
have shown that for adequate knowledge, the proportion increased from 4%
(1/25) to 58% (18/31) among nurse aides. The proportion of outpatients receiving
Essential Drugs Programs of Selected African Countries
50
an injection dropped from 23% to 10%, and the proportion of patients receiving
an avoidable injection dropped from 16% to 6%. They concluded that the
improvement in knowledge and prescription practices observed at dispensary
level was attributable to a training program. They suggested a model of
intervention program aimed at reducing avoidable injections: (a) determine
injection practices for common conditions, (b) obtain consensus among medical
supervisors on the role of injections in the treatment of common conditions, (c)
develop treatment guidelines and a health education program, and (d) carry out on
the job training targeting those who prescribe treatment (Vos J et al., 1998).
Logez, Hutin, Holloway, Gray, and Hogerzeil (2004) reviewed the way
the list of essential drugs addresses injection practices by reviewing the 11th WHO
EDL, using information they collected on injectable medicines, diluents, and the
recommendations regarding the procurement of injection devices. The researchers
constructed a database of all entries of the 11th WHO EDL and they found that of
306 active ingredients on the list, 135 (44%) are mentioned in injectable form. Of
those 135 active ingredients included as injectable form, 116 (86%) were core
medicines, 18 (13%) were complementary medicines, and 5 (4%) were
recommended for restricted indications as reserve antimicrobials. Their findings
suggested that the model list could address more clearly the need to use injections
safely and appropriately. Their review concluded that the adoption of an essential
drugs list is a key element to promote the rational use of medicines, hence the use
of injections. The model list could play a better role in ensuring that the injectable
Essential Drugs Programs of Selected African Countries
51
medicines included are limited to the minimum so that unnecessary injections can
be avoided. The large number of injectable formulations on the model list may
perpetuate injection overuse in countries (Logez et al., 2004).
Fewer studies have explored the impact of the national essential drugs
program on the use of injections. Logez, Hutin, Somda, Thuault, and Holloway
(2005) investigated the issue with the purpose of quantifying the improved access
to injection devices between 1995 and 2000. The researchers attempted to
determine whether an increased access to injection devices could have led to
irrational use of injections in Burkina Faso. The researchers reviewed the
outcomes of the new medicine policy implemented in 1995 by comparing the
findings of the first injection safety assessment carried out in 1995 with the results
of the second injection safety assessment carried out in 2000. The first assessment
indicated that sterile injection devices were used for each injection in 80% of the
urban health care facilities, 60% of provincial facilities, and 11% of the rural
facilities, and up to 48% of health care facilities visited reported insufficient
quantities of injection devices available. In contrast, the second assessment
indicated that the situation has considerably improved. In 96% of the 52 health
care facilities visited, a new syringe and a new needle were used for each patient
and there were no shortages of injection devices. At 49 of the 52 health care
facilities (94%), injection devices needed to administer injectable medicines were
systematically prescribed for treatment (Logez et al., 2005). This affirmation is to
Essential Drugs Programs of Selected African Countries
52
be analyzed with caution because both assessments (1995 and 2000) did not use
similar methodologies.
Having an EDL or NDP is not enough to achieve the goal of rational use
of drugs. For instance, failure to regulate the distribution and commercialization
of drugs will affect how doctors, pharmacists, health workers, and patients use
drugs. For an essential drugs program to be successful, there is a need to educate
and update doctors and pharmacists about the importance of prescribing and
dispensing only necessary drugs, and about the motives for self-medication and
drug consumption patterns of patients. Self-medication and nonadherence to
physicians’ prescriptions is a source of irrational use. According to Le Grand et
al. (1999), 60-80% of health problems are self-medicated. There has also been
research about factors influencing self-medication.
The issue of self-medication was addressed in a study conducted in Egypt.
Benjamin, Smith, and Motawi (1996) conducted 2- to 3-hour study visits to each
of 25 pharmacies to collect data on all drugs dispensed. During the period of the
study, a total of 1,174 products were supplied: 28% on prescription and 72%
over-the-counter sales. However, only 17% of the over-the-counter sales were
recommended by pharmacists. They concluded that the pattern of drug use in
Alexandria is similar to the one prevailing in the developing world. They asserted
that their findings raise question about the understanding and availability of drug
information by both health professionals and patients in Alexandria, a city which
is expected to promote rational drug use due to the presence of undergraduate and
Essential Drugs Programs of Selected African Countries
53
postgraduate education of pharmacists and other health care professionals
(Benjamin et al., 1996).
Self-medication was suspected to be high in Sudan because of the
availability and accessibility of drugs in pharmacies and drug stores with a
requirement of a prescription. As a result, Awad, Eltayeb, Matowe, and Thalib
(2005) carried out a study to estimate the prevalence of self-medication with
antibiotics and antimalarials in an urban area of Khartoum. Data were collected
about 600 households (1,750 adult persons) using a pretested questionnaire. The
analysis of data showed that 73.9% of the study population used antibiotics or
antimalarials without a prescription or medical advice within 1 month of the study
period. Nearly half (48.1%) of the respondents agreed that they had used
antibiotics, 43.4% used antimalarials, while 17.5% used both. The study also
revealed that self-medication was significantly associated with age, income,
gender, and level of education. The authors concluded that their findings had
major public implications; thus there is a need to regulate the pharmaceutical
sector.
In summary, rational prescribing implies that patients should receive
medications that meet the following criteria: appropriate indication, appropriate
drug, appropriate patient information, and appropriate evaluation. Unfortunately,
published articles indicate that prescribing practices do not conform to these
criteria throughout the world, especially in the developing world. Antibiotics and
antidiarrheals for nonspecific childhood diarrhea are still overprescribed,
Essential Drugs Programs of Selected African Countries
54
injections are overused when oral formulations would be more appropriate, too
many drugs are prescribed per patient, and inappropriate self-medication is still
reported across underdeveloped countries.
Infant Mortality in Africa
While acknowledging that the implementation of a national drug policy is
a complex process, and there must be a political commitment to ensure access to
essential medicines to all populations, the WHO pointed out that governments
nevertheless must play a key role in ensuring equitable access for populations in
need. Failure to ensure access to essential drugs and vaccines has substantial
consequences. For instance, diseases (diphtheria, pertussis, tuberculosis, and
tetanus) that could be prevented with access to basic interventions such as
immunization programs are among the reasons that there is lack of progress in
reduction of child mortality rates in sub-Saharan Africa. In 2000, the distribution
of causes of death among children aged under 5 in African regions were as
follows: neonatal (26.2%), diarrhea (16.6%), measles (4.3%), malaria (17.5%),
and pneumonia (21.1%) (WHO, 2000). Even children who were not immunized
against these conditions could be treated by administering antitoxin and
antibiotics if the latter were available.
The WHO defines infant mortality rate (IMR) as “the probability
(expressed as a rate per 1,000 live births) of a child born in a specified year dying
before reaching the age of one if subject to current age specific mortality rates”
(see http://www.who.int/whosis/en/). The associations between deaths from
Essential Drugs Programs of Selected African Countries
55
preventable diseases and demographic and socio-economic factors are also seen in
more recent studies on the one hand, and with availability of health services
including immunization on the other. The present study focused on the association
of immunization and IMR.
Numerous studies have shown that there is an association between
mortality and public health interventions such as oral rehydration therapy (ORT)
program, expanded programs on immunization, female literacy, and programs to
increase access to improved drinking water sources and improved sanitation.
Gutierrez et al. (1996) analyzed secondary data to evaluate the impact of ORT and
selected public health interventions on reduction of mortality from childhood
diarrheal diseases in Mexico. Their study analyzed secondary data collected
between 1978 and 1993. They then divided this period into three phases: (a)
before the widespread application of ORT, (b) the implementation and promotion
phase of ORT, and (c) implementation of other public health interventions such as
immunization and improvements in basic sanitation. Using a Pearson’s correlation
method, they correlated mortality trends with the use of ORT and selected public
health interventions. Their findings indicated that the reduction of mortality was
important in the third phase (17.8%) compared to the first (1.8%) and the second
(6.4%) phases. A greater reduction in mortality rates was attributable to a massive
immunization against measles and to improvements in sanitation (r = 0.9586).
In an attempt to quantify more specifically the contribution of
immunization interventions to changing IMR in developing countries, Shimouchi,
Essential Drugs Programs of Selected African Countries
56
Ozasa, and Hayashi (1994) looked at the association between immunization
coverage and IMR. The findings of a multiple regression test showed that partial
correlation coefficients for IMR with immunization coverage (-0.224), logarithm
of per capita GNP (-0.294), total fertility rate (0.269), and adult literacy rate
(-0.325) were all statistically significant (p < 0.001) across 97 developing
countries studied. Multiple correlation coefficients of IMR with these variables in
97 countries were 0.921. Hence, much of the variations (> 80%) were explained
by immunization, logarithm of per capita GNP, total fertility rate, and adult
literacy rate. Their analysis did not control other socioeconomic factors, such as
access to improved drinking water and improved sanitation.
Anand and Bärnighausen’s (2007) study examined whether health worker
density was positively associated with childhood vaccination coverage in
developing countries. They undertook a multiple regression analysis with
coverage of three vaccinations: MCV (measles-containing vaccine); DTP3
(diphtheria, tetanus, and pertussis); and (Polio3) polyiomyelitis as dependent
variables. In one set of regressions, they used aggregate health worker density as
the independent variable, whereas doctor and nurse densities were used separately
in another set. Their analysis controlled other factors, namely national income per
person, female adult literacy, and land area. The results showed that the health
worker density was significantly associated with coverage of all three
vaccinations (MCV, p = 0.0024; DTP3, p = 0.0004; polio, p = 0.0008). Like
previous studies, female adult literacy was positively associated. The researchers
Essential Drugs Programs of Selected African Countries
57
concluded that the shortage of health care personnel is a constraining factor on
vaccination coverage in developing countries (Anand & Bärnighausen, 2007).
Similar findings have also been reported from studies of determinants of
infant mortality in developing countries. In their study of a comparison of
determinants of IMR between countries with high and low IMR, Megawangi and
Barnett (1993) carried out a weight least squares regressions and pooled
regression models and demonstrated a significant association between the female
literacy rate and IMR. Their findings also confirmed that access to clean water
and the number of population per nurse had significant association (Megawangi &
Barnett, 1993).
The estimated IMRs per 1,000 lives births for the most recent period
(which was 2006) in selected countries were: 87 in Cameroon, 127 in Chad, 76 in
Ghana, 79 in Kenya, 119 in Mali, 99 in Nigeria, 60 in Senegal, 78 in Uganda, and
74 in Tanzania (see www.who.int/whosis/en/). The WHO estimates indicated that
six causes accounted for 72% of the 10.6 million yearly deaths in children
younger than age 5 years: pneumonia (19%), diarrhea (18%), malaria (8%),
neonatal pneumonia or sepsis (10%), preterm delivery (10%), and asphyxia at
birth (8%). The four communicable disease categories account for more than half
(54%) of all child deaths. The great communicable disease killers are similar in all
WHO regions with the exception of malaria; 94% of global deaths attributable to
this disease occur in the Africa region. Undernutrition is an underlying cause of
Essential Drugs Programs of Selected African Countries
58
53% of all deaths in children younger than age 5 years (Bryce, Boschi-Pinto,
Shibuya, & Black, 2005).
It can be argued that most of the communicable diseases could be
prevented with access to basic immunization. For instance, it was estimated that
506,000 deaths occurred in Africa due to measles in 1999. That number declined
to 126,000 in 2005. The routine measles vaccine first dose coverage in 1990 was
50% and it was 65 % in 2005. The introduction of routine measles vaccination in
most developing countries during the 1980s as part of the expanded program on
immunization saved 380,000 lives (Wolfson et al., 2007).
The slow reduction in infant mortality in Africa is due, in part, to other
socioeconomic conditions such as lack of better nutrition and housing, rising
standard of living, lack of access to improved drinking water and sanitation, as
well as lack of public health interventions and better medical practices, including
access to medications. The observed progress in reduction of infant mortality
from preventable diseases is a result of increased access to immunization services
(Shimouchi et al., 1994).
In summary, the decline of infant mortality from measles in 2005 is the
proof of what can be accomplished to reduce infant mortality in the developing
world when safe, cost-effective, and affordable interventions are backed by
country-level political commitment and an effective international partnership.
Essential Drugs Programs of Selected African Countries
59
Summary
This chapter provided a comprehensive overview of a NDP and essential
drugs programs. Moreover, empirical evidence that links the interventions in
improving the access to essential drugs to improvement in health outcomes was
provided.
Essential Drugs Programs of Selected African Countries
60
CHAPTER III
PROCEDURES FOR COLLECTION
AND TREATMENT OF DATA
Introduction
This chapter describes the methods used to compare the national EDLs
and the WHO model list and the national EDLs among themselves. The methods
used to study the relationship between the adherence index and immunization
coverage rates on the one hand and the immunization coverage rates and IMR on
the other are also described.
Setting
For this study, the setting was the results of assessment of the
pharmaceutical sector carried out by selected countries. The assessment carried
out in Ghana showed that the median percentage availability of key drugs was
78.6%, and 89.2% of prescribed drugs were actually dispensed to patients. It
revealed also that the average number of drugs prescribed per patient contact was
3.33. The assessment found that 43.3% of patients have received antibiotics, 30%
of patients have received injections, and 96.1% of prescribed drugs were on the
EDL. The prescribing behavior according to NSTG was also assessed. The results
of the assessment indicated that to treat diarrhea in children, 80% of children were
Essential Drugs Programs of Selected African Countries
61
prescribed oral rehydration salt (ORS) formulations compared to 50% who were
prescribed antibiotics. In 94.4 % of cases, the NSTG was found in the facility
compared to 88.9% for EDL (Ministry of Health, n.d.).
Uganda assessed its pharmaceutical sector and the results indicated that
the median percentage availability of key drugs was 75%. The assessment
revealed that 82% of prescribed drugs were actually dispensed to patients. It also
revealed that the average number of drugs prescribed per patient contact was 3.2.
The assessment found that 63.2% of patients received antibiotics, 23.1% of
patients received injections, and 93.5% of prescribed drugs were on the EDL.
Regarding the prescribing behavior according to NSTG, the results of the
assessment indicated that to treat diarrhea in children, 80% children were
prescribed ORS formulations compared to 40% who were prescribed antibiotics.
In 65% of cases, the NSTG was found in the facility compared to 25% for EDL
(Ministry of Health, n.d.).
Kenya carried out its assessment which found that the median percentage
availability of key drugs was 93.3%, and 80.15% of prescribed drugs were
actually dispensed to patients. According to the results of the assessment, the
average number of drugs prescribed per patient contact was 2.80. In addition, it
revealed that 8.35% of patients received antibiotics, 28.35% of patients received
injections, and 81.33% of prescribed drugs were on the EDL. The prescribing
behavior according to NSTG was also assessed, and it was found that to treat
diarrhea in children, 25% of children were prescribed ORS compared to 50% who
Essential Drugs Programs of Selected African Countries
62
were prescribed antibiotics. In 13 % of cases, the NSTG was found in the facility
compared to 17% for EDL (Ministry of Health, n.d.).
The assessment of Nigeria’s pharmaceutical sector showed that the
median percentage availability of key drugs was 46%, and 89% of prescribed
drugs were actually dispensed to patients. It found that the average number of
drugs prescribed per patient contact was 4.7. The results of the assessment
indicated that 59% of patients were prescribed antibiotics, 55% of patients were
prescribed injections, and 90% of prescribed drugs were on the EDL. The
prescribing behavior according to NSTG was also assessed. The results indicated
that to treat diarrhea in children, 54% of children were prescribed ORS compared
to 62% who were prescribed antibiotics. In 38% of cases, the NSTG was found in
the facility compared to 24% for EDL (Ministry of Health, n.d.).
Tanzania carried out the assessment of its pharmaceutical sector, which
revealed that the median percentage availability of key drugs was 87.27%. The
average number of drugs prescribed per patient contact was 1.8 according to the
results of the assessment. It also found that 42% of patients were prescribed
antibiotics, 14% of patients were prescribed injections, and 98.5% of prescribed
drugs were on the EDL. Regarding the prescribing behavior according to NSTG,
the results indicated that to treat diarrhea in children, 82% of children were
prescribed ORS compared to 44% who were prescribed antibiotics. Only 5
facilities out of 20 had the guidelines in their premises (Ministry of Health, n.d.).
Essential Drugs Programs of Selected African Countries
63
The assessment of the pharmaceutical sector carried out in Mali found that
the median percentage availability of key drugs was 87.3%, and 89.3% of
prescribed drugs were actually dispensed to patients. It also revealed that the
average number of adherence to NSTG was estimated to be 48%. The average
number of drugs prescribed per patient contact was 2.8. The assessment found
that 61.6% of patients were prescribed antibiotics, 35.4% of patients were
prescribed injections, and 90.8% of prescribed drugs were on the EDL. The
prescribing behavior according to NSTG was also assessed. The results indicated
that to treat diarrhea in children, 46.8% children were prescribed ORS compared
to 77.7% who were prescribed antibiotics (Ministry of Health, n.d.).
Senegal assessed its pharmaceutical sector. The results of the assessment
showed that the median percentage availability of key drugs was 80%, and 88.7%
of prescribed drugs were actually dispensed to patients. According to the
assessment, the average number of drugs prescribed per patient contact was 2.4. It
also found that 45.8% of patients were prescribed antibiotics, 25.3% of patients
were prescribed injections, and 85.3% of prescribed drugs were on the EDL.
Regarding the prescribing behavior according to NSTG, the results of the
assessment indicated that to treat diarrhea in children, 30% of children were
prescribed ORS compared to 80% who were prescribed antibiotics. It also
revealed that in 87% of cases, the NSTG was found in the facility compared to
10% for EDL (Ministry of Health, n.d.).
Essential Drugs Programs of Selected African Countries
64
The assessment of the pharmaceutical sector carried out in Chad indicated
that the median percentage availability of key drugs was 70%, and 89% of
prescribed drugs were actually dispensed to patients. The assessment also
revealed that the average number of drugs prescribed per patient contact was 2.4.
According to the results of the assessment, 54% of patients were prescribed
antibiotics, 29% of patients were prescribed injections, and 97% of prescribed
drugs were on the EDL (Ministry of Health, n.d.).
The results of the assessment of the pharmaceutical sector in Cameroon
were not available.
Population and Sample
The nine countries chosen were Cameroon, Chad, Kenya, Ghana, Mali,
Nigeria, Senegal, Tanzania, and Uganda. These countries were chosen to
represent diversity in geographical location, sociocultural and their degree of
economic development, and their approach to pharmaceuticals regulation. All
nine countries are located in the sub-Saharan Africa region. Cameroon and Chad
are located in Central Africa; Kenya, Uganda, and Tanzania are located in Eastern
Africa; and Ghana, Nigeria, and Senegal are located in Western Africa.
Cameroon, Chad, Mali, and Senegal share the same historical heritage; they all
are former French colonies; whereas Kenya, Ghana, Nigeria, Tanzania, and
Uganda share the historical heritage to be former British colonies.
The inclusion criteria for the analysis were (a) availability of the EDL, (b)
baseline assessment of each country pharmaceutical sector, and (c) share the same
Essential Drugs Programs of Selected African Countries
65
historical heritage. Thus, based on the historical criterion, Ethiopia and Rwanda
were not included in the study. Ethiopia has never been colonized and Rwanda is
a colony from Belgium. Among the selected countries, Cameroon was the only
country that had not performed the assessment of its pharmaceutical sector.
However, it was included in the study as its EDL was used to compare national
EDLs and the WHO model list.
Data Collection Methods
For the infant mortality, data were collected from the WHO database
(http://www.who.int/whosis/en/) and the World Bank–Millennium Development
Goals database (http://web.worldbank.org/wbsite/ external/countries/africaext/).
The latter is a harmonized estimate of the WHO, UNICEF, and the World Bank,
based mainly on household surveys, censuses, and vital registration.
The demographic characteristics per country in 2006 (in thousands)
according to World Bank–Millennium database were: Cameroon (18,175), Chad
(10,468), Ghana (23,008), Kenya (36,553), Mali (11,968), Nigeria (144,720),
Senegal (12,072), Uganda (29,899), and Tanzania (39,459). This study analyzed a
secondary data set that was used primarily to monitor and assess the
pharmaceutical situation of each country, except Cameroon. The sampling
methods used, as well as inclusion criteria, varied among the countries studied
(Ministry of Health, n.d.).
For the study conducted in Ghana, the 10 regions in Ghana were divided
into four categories according to the following criteria and four of them
Essential Drugs Programs of Selected African Countries
66
subsequently selected based on the socioeconomic profile, the proximity to the
central medical stores, and the presence of a particular strong support to the
regional drugs program. Within each region, five private pharmacies/drug
outlets/chemical sellers close to the selected public health facility, one
central/district drugs warehouse/storage facility, and 15 households within 5 km
of each selected public health facility were randomly selected (Ministry of Health,
n.d.).
In Kenya, five provinces were selected from a possible eight. Nairobi and
Eastern provinces were chosen as the highest and lowest income-generating areas,
respectively. The other three provinces were chosen randomly, taking into
account reasonable accessibility by the data collectors. In each province, the
following units were surveyed: six public health facilities treating outpatients and
with pharmacy or dispensary units; six private pharmacies; one regional
medicines warehouse; 150 households, divided equitably into those within 5 km,
those between 5-10 km away and those more than 10km away from a surveyed
health facility (Ministry of Health, n.d.).
For the study carried out in Mali, the following units were surveyed:
health centers, private pharmacies, drug outlets, private medicines warehouse, and
households. The study also focused on the outpatients who visited the health
centers during the study. For data collection, the following were chosen: 20 health
centers, four4 drug outlets, 20 private pharmacies, 30 patients receiving medicines
Essential Drugs Programs of Selected African Countries
67
from each health center, and 30 prescriptions from each health center,
retrospectively collected for a period of 1 year (Ministry of Health, n.d.).
For the assessment conducted in Chad, the health districts where the study
took place were randomly selected. In order to ensure a fair representation, 20
health centers were chosen from four health districts (Ministry of Health, n.d.).
In Tanzania, the survey was conducted on the mainland, which was
divided into 21 administrative regions. It was further divided into 121 districts.
Each district was subdivided into divisions, wards, villages, and hamlets. For a
situational analysis in a country, a minimum of four geographical areas was
selected and the capital city was usually included. The other three geographical
regions were purposely selected to represent the different geographical,
demographic, and socioeconomic situations in the country. In each region, one
district was randomly selected. From these four identified districts, 20 public
health facilities were randomly selected within 10 km distance from the different
districts. Around each health facility, 15 households were randomly selected from
a total number of households from the same area, making a sample size of 300
households in total; 20 private outlets were also randomly selected (Ministry of
Health, n.d.).
In Uganda, the country was divided into four regions. The capital city and
one randomly selected district from each region were identified. Districts where
security risks existed were excluded from the sampling due to safety concerns.
Within each district, the following facilities and households were selected: four
Essential Drugs Programs of Selected African Countries
68
public health facilities plus the district hospital (in this survey, public health
facility refers to either government or private-not-for-profit/non-governmental
organization health facility); five private pharmacies/drug outlets close to the
selected public health facility, one central/district medicines warehouse/storage
facility, and 15 households within 5 km of each selected public health facility
(Ministry of Health, n.d.).
Nigeria has 36 states and a Federal capital territory. These states are
grouped into six geopolitical zones with five to seven states in each. From each of
the geo-political zones of the country, one state was randomly sampled. In the
sampled state, the state hospital (secondary health care facility) and the state
central medical stores were selected for study. Thereafter, 10 primary health care
facilities, which represent the lowest level of care and are usually manned by a
community health worker or a nurse, were selected by systematic random
sampling and listed for the data collectors. The data collectors went on to any
private pharmacies/drug outlets within 5 km of the primary health care facility.
From the city center, consecutive households or persons found in the vicinity of
these households were interviewed to ascertain whether they were household
members who had been ill in the preceding 2 weeks (Ministry of Health, n.d.).
In Senegal, the public health facilities were randomly sampled. The
southern regions were excluded from the sampling due to the security concerns.
Five regions were selected for the study, including the capital city, the poorest
region, and three regions from the South, Center, and East. Within each region,
Essential Drugs Programs of Selected African Countries
69
three districts were sampled. In each district, the following facilities and
households were selected: 13 health centers, 17 health facilities, 24 private
pharmacies/drug outlets, four central regional medicines warehouses, and one
district storage facility (Ministry of Health, n.d.).
With an estimated population of 28.8 million in 2004, Uganda had the
highest expenditure on health per capita (International $135) and Tanzania had
the lowest expenditure (International $29). The leading causes of death in children
under 5 years of age for all countries from 2000 through 2003 were neonatal
causes (including diarrhea during neonatal period), pneumonia, malaria, diarrheal
diseases, measles, and HIV/AIDS. The common causes of death for all ages in
2002 were lower respiratory infections, HIV/AIDS, malaria, diarrheal diseases,
perinatal conditions, and tuberculosis.
Among the selected countries, Kenya was the first country to publish its
own list in 1981 based on the WHO model, whereas Ghana has the highest
number of revisions, the latest of which is the 5th edition produced in 2004
(Ministry of Health, n.d.).
Human Rights Protection
This comparative study of NDP did not utilize human subjects. It used
existing data, documents, and records from publicly available sources. The project
was granted an exemption by the IRB (see Appendix B). This researcher’s study
did not expose the subjects to any physical or psychological risk or discomfort.
This research did not expose the subjects to any deception or coercion. A
Essential Drugs Programs of Selected African Countries
70
secondary data set was used by this study, thus it did not require any subject
consent.
Data Collection Tool
This research study analyzed a secondary data set that was used primarily
to monitor and assess the pharmaceutical situation in selected African countries.
The surveys were carried out in 11 countries using the WHO operational package.
The package contains survey tools for two levels of core indicators and a
household survey. For level I indicators, a questionnaire on structures and
processes of country pharmaceutical situations was used to collect data. For level
II indicators, survey forms were used to measure the degree to which each country
is achieving the strategic objectives of their NDP (WHO, 2004).
Treatment of Data
To address the research questions, data were analyzed from two
perspectives: (a) analysis of similarities and differences between selected African
countries EDLs and the WHO model list on the one hand, and selected countries
among themselves on the other hand; and (2) analysis of the relationship between
the adherence index of immunological pharmaceutical group and immunization
coverage and immunization rate and infant mortality rates. Each research question
is listed and the methods used to address that question described.
1. How do the essential drugs lists of selected countries vary from the
WHO model list?
Essential Drugs Programs of Selected African Countries
71
The WHO EDL 13th edition was used as a standard to compute the
adherence index for each of the nine selected countries (see Appendix C). To
build the adherence index, a comparative table was created in MiniTab version
15. Along the left side of the table was listed the molecules from the WHO model
list, whereas across the top was listed the names of selected countries. With this
process a box per item was created for each molecule. Each box was filled in by 1
if the molecule was the same and from the same therapeutic group for both the
WHO model list and the national EDL. The box was filled in by 0 if the molecule
from the WHO model list was not included in the national EDL. The MiniTab
function was then used to count the positive occurrences (box filled in by 1). To
calculate an adherence index for each of the pharmaceutical groups, the number
of positive occurrences was divided by the total number of drugs for each
therapeutic group. The formula: Adherence index = number of similar drugs from
both national EDL and WHO model list / total number of drugs of each
pharmaceutical group.
2. How do the essential medicines lists of selected African countries vary
among themselves?
To compare the selected countries’ EDLs among themselves, the Pearson
correlation coefficients were used. The correlation coefficients measured the
resemblance between each pair of countries, using the adherence scores computed
to compare the national EDLs and WHO model list. To calculate the correlation
coefficients, a second summary table was created in MiniTab. Firstly, along the
Essential Drugs Programs of Selected African Countries
72
left side of the worksheet was listed each of the 27 pharmaceutical groups.
Secondly, the names of each selected country were listed across the top, creating a
box per item for each pharmaceutical group. Each box was filled in by the
adherence index for the corresponding pharmaceutical group. As a result, the
correlation coefficient between each pair of countries measures how the
pharmaceutical groups are similar or different between the two countries. The
higher correlation coefficient (r) indicates how two countries are similar and the
lower (r) indicates how a pair of countries is different with respect to the
pharmaceutical groups. To present the correlation coefficients for all pairs of
countries, the matrix of intercorrelations was used. From the latter, the adherence
index of 1 on the diagonal indicated the perfect correlation of each selected
country with itself. The significance of the correlation coefficients was
determined by performing the test of significance. The observed values of r were
compared to the critical values of r to determine whether selected countries
significantly share the same features from the WHO model list.
Portney and Watkins (2000) offered general guidelines to evaluate
correlation coefficients:
Correlations ranging from 0.00 to 0.25 indicate little or no relationship;
those from 0.25 to 0.50 suggest a fair degree of relationship; values of
0.50 to 0.75 are moderate to good; and values above 0.75 are considered to
be good to excellent. (p. 494)
Essential Drugs Programs of Selected African Countries
73
For this study, the cut-off point was 0.60 (0.50-0.75) to measure the strength of
association between two pair of countries. If the observed values of r (correlation
between pair of two countries) are not generally greater than or equal to 0.60 (r ≥
0.60), this concluded that selected countries did not share the same features from
the WHO model list.
In addition, the coefficient of variation was computed. Adherence index
data on selected countries was recorded using MiniTab. Along the left side of the
worksheet (row) was listed nine selected countries. Then, the names of each
pharmacological class was listed across the top (column), creating a box per item
for each selected country. Each box was filled in by the adherence index for the
corresponding pharmaceutical group. To calculate the coefficient of variation, the
mean and the standard deviation for each pharmaceutical group was computed.
Coefficient of variation equaled mean divided by standard deviation. The highest
coefficient of variation indicated how countries particularly vary, whereas the
smallest coefficient of variation determined the similarities among countries.
3. What is the relationship between the adherence index to WHO model
list in immunologicals pharmaceutical group and immunization coverage rate?
The Pearson’s correlation coefficient was used to quantify the strength of
association between the adherence index to the WHO model list in
immunologicals group and immunization coverage rate against measles and
DTP3. Null hypothesis is that there is no relationship between the adherence
Essential Drugs Programs of Selected African Countries
74
index to the WHO model list (immunologicals) and immunization coverage rate
against measles and DTP3.
The significance of the correlation coefficients was determined by
performing the test of significance. The observed values of r were compared to
the critical values of r to determine whether selected countries significantly share
the same features from the WHO model list. If the majority of observed values
were not greater than or equal to the critical values, it was concluded that selected
countries did not share the same features from the WHO model list. The higher
correlation coefficient (r) denoted a strong association, whereas the lower (r)
indicated little or no relationship. The observed values were subjected to a test of
significance. The observed values of r were compared to the critical values of r to
determine whether the higher adherence indices were significantly associated with
the higher immunization coverage rates. If there was not a statistically significant
association, it was concluded that the essential drugs programs alone did not
improve immunization coverage. The general systems theory was used to
organize this work; therefore the data were interpreted in relation to the
input-throughput-output model.
4. Is there a relationship between the immunization coverage rate against
measles and DTP and infant mortality rate?
The Pearson’s correlation coefficient was used to quantify the strength of
association between the immunization coverage rates against measles and DTP3
and infant mortality rate. Null hypothesis is that there was no relationship
Essential Drugs Programs of Selected African Countries
75
between the immunization coverage rates against measles and DTP3 and infant
mortality rates.
The higher correlation coefficient (r) denoted a strong association,
whereas the lower (r) indicated little or no relationship. The observed values were
subjected to a test of significance. The observed values of r were compared to the
critical values of r to determine whether there was strength of association between
immunization coverage rates and infant mortality rates. If the values of these two
variables were significantly associated, the null hypothesis would be rejected. The
general systems theory was used to organize this work; as a result the findings of
this research question were analyzed in relation to the input-throughput-output
model.
Summary
This chapter discussed the population under study, the setting of the
research, how the data were collected, the tool utilized, and the treatment of the
data. In addition, procedures for human rights protection, including confidentiality
and informed consent, were outlined.
Essential Drugs Programs of Selected African Countries
76
CHAPTER IV
ANALYSIS OF DATA
Introduction
How the WHO model list has served as reference to national EDLs has
been the focus of this study. In a comparative perspective, this work analyzed
similarities in the selected African countries’ EDLs and whether there are
differences both between them and the WHO model list and among the selected
African countries themselves. In addition, this study investigated the relationship
between the adherence index to the WHO model list in immunological and
immunization coverage rates, and immunization coverage rates against measles
and DTP3 and IMR.
Description of the Sample
This study used a secondary data that was primarily used to monitor and
assess the pharmaceutical situation in nine selected African countries: Cameroon,
Chad, Kenya, Ghana, Mali, Nigeria, Senegal, Tanzania, and Uganda. These
countries were chosen to represent diversity in geographical location,
sociocultural and their degree of economic development, and their approach to
pharmaceutical regulation. All nine countries are located in the sub-Saharan
region. Cameroon and Chad are located in Central Africa; Kenya, Uganda and
Essential Drugs Programs of Selected African Countries
77
Tanzania are located in Eastern Africa; whereas Ghana, Nigeria, and Senegal are
located in Western Africa.
Research Questions
This work was designed to answer four research questions:
1. How do the essential drugs lists of selected African countries vary from
the WHO model list?
2. How do the essential drugs lists of selected African countries vary
among themselves?
3. What is the relationship between the adherence index to the WHO
model list in immunologicals pharmaceutical group and immunization coverage
rate?
4. Is there a relationship between the immunization coverage rates against
measles and DTP3 (diphtheria, tetanus, pertussis) and infant mortality rates?
To highlight similarities and differences between national EDLs with
respect to 27 pharmaceutical groups was the focus of this study. Minitab version
15 was used to analyze how well selected countries have incorporated the WHO
model list. Figure 2 presents how selected African countries’ EDLs have included
essential drugs on their lists from the WHO model list, from the farthest to the
closest.
To the first research question, the study found that Uganda had included
the most number of drugs from the WHO model list with adherence index of 0.63,
followed by Nigeria (0.61), and Mali (0.57). Senegal was the country that
Essential Drugs Programs of Selected African Countries
78
0.7
Adherence Index
0.6
0.5
0.43
0.47
0.49
0.49
0.53
0.49
0.61
0.57
0.63
0.4
0.3
0.2
0.1
Ug
an
da
er
ia
Ni
g
al
i
M
G
ha
na
Ta
nz
an
ia
Ch
ad
Ca
m
er
oo
n
Ke
ny
a
Se
ne
g
al
0
Country
Adherence Index
Figure 2. Overall comparison between national EDLs and the WHO model list.
Essential Drugs Programs of Selected African Countries
79
included fewer drugs on its national EDL from the WHO model list with
adherence index of 0.43. Selected African countries’ EDLs included
approximately 43% to 63 % of drugs from the WHO/EDL model list.
The analysis of the pharmaceutical groups indicated a strong similarity
between selected African countries and the WHO model list in the following
pharmaceutical therapeutic groups: oxytocics and antioxytocics (0.89),
anticonvulsants (0.82), antiallergics and drugs used in anaphylaxis (0.80), drugs
affecting the blood (0.79), immunologicals (0.74), and anesthetics (0.71). Selected
African countries’ EDLs were very different from the WHO model (adherence
index > 0.40) in the following pharmacological classes: Muscle relaxants
(peripherally acting) and cholinesterase inhibitors (0.31), diagnostic agents (0.39),
cardiovascular drugs (0.36), and blood products and plasma substitutes (0.33).
The second question sought to compare selected countries’ EDLs among
themselves. Using the WHO model list as reference, the Pearson correlation
coefficient was used to compute the resemblance between each pair of countries.
The correlation coefficients between two countries measured the proximity
between two countries with respect to the 27 pharmaceutical groups. The higher
correlation coefficient (r) indicated how two countries have similar features and
the lower correlation coefficient indicated how the pair of countries differs.
The matrix of intercorrelations (see Table 1) presents the correlation
coefficients for 27 pharmaceutical groups for each pair of countries. It shows that
Cameroon and Mali (r = 0.743) on the one hand, and Mali and Chad (r = 0.722)
Essential Drugs Programs of Selected African Countries
80
Table 1
Matrix of Intercorrelations
Country
Cameroon
Chad
Ghana
Kenya
Mali
Nigeria
Senegal
Uganda
Tanzania
Cameroon
1
Chad
Ghana
Kenya
Mali
Nigeria
Senegal
Uganda
Tanzania
0.625
0.409
0.465
0.743
0.035
0.189
0.236
0.552
1
0.401
0.163
0.722
0.180
0.242
0.156
0.491
1
0.629
0.432
0.233
0.440
0.495
0.276
1
0.243
0.333
0.495
0.527
0.339
1
0.045
0.198
0.207
0.568
1
0.491
0.221
0.279
1
0.270
0.313
1
0.212
1
Essential Drugs Programs of Selected African Countries
81
on the other hand, share the same features from the WHO model list. Kenya and
Ghana (r = 0.629), as well as Cameroon and Chad (r = 0.625) have also included
many similar drugs on their EDLs from the WHO model list. By contrast,
Cameroon and Nigeria (r = 0.035) and Nigeria and Mali (r = 0.045) strongly
differ in including essential drugs from the WHO model list to their national
EDLs. The following three pairs of countries did not share the same features from
the WHO model list. The following pairs of countries are also opposites in
incorporating the features of the WHO model: Chad and Uganda (r = 0.156),
Chad and Kenya (r = 0.163); and Chad and Nigeria (r = 0.180).
The correlation coefficient of each pair of countries was subjected to the
critical value of r for two-tailed test of significance with n-2 degrees of freedom.
The r at 0.05 level (α1 = (0.05) r (25)) = 0.36. Based on the general guidelines
stated above, r = 0.36 falls between 0.25 and 0.50, which range suggests a fair
degree of relationship. Based on the same general guidelines, r ≥ 0.60 was the
cut-off point because it denoted a strong relationship. In general, the correlation
among selected African countries was not significant because 4 pair of countries
of 36 pairs present a correlation coefficient greater or equal to 0.60 (see Figure 3).
Based on little or fair degree of relationship among pairs of countries, it can be
concluded that selected countries did not share many similar essential drugs from
the WHO model list.
The coefficient of variation was used to compare the selected African
countries’ EDLs on the pharmaceutical groups. To obtain the relative variation
Essential Drugs Programs of Selected African Countries
82
Correlation between Adherence index and immunization coverage
100
Variable
MCV
DTP3
Immunization coverage
90
80
70
60
50
40
30
20
0.60
0.65
0.70
0.75
0.80
0.85
Adherence index of Immunologicals
0.90
Figure 3. Scatter plots--Correlation between adherence index and immunization
coverage.
Essential Drugs Programs of Selected African Countries
83
among countries, the adherence indexes computed to compare countries with the
WHO model list were used. Tables 2, 3, and 4 show that selected African
countries did not substantially vary on the anti-infective drugs pharmaceutical
group with the smallest coefficient of variation (coefficient = 0.07). The
immunologicals was the pharmaceutical group with the second smallest
coefficient (0.11), hence indicating that there were less differences among
countries in this category. On the other hand there were substantial differences
among countries in the pharmaceutical group of muscle relaxants with the
coefficient of 1.02. Selected African countries were also different on peritoneal
dialysis (coefficient = 0.95) and blood products and plasma sub (coefficient =
0.92).
The third research question asked: Is there a relationship between the
adherence index to the WHO model list in immunologicals pharmaceutical group
and immunization coverage against measles and DTP3? Figure 3 shows that there
was no linear relationship between these two variables. To provide a quantitative
measure of the relationship, the correlation coefficient between both variables was
computed. The correlation coefficients confirmed that there was no linear
relationship between adherence index of immunologicals and immunization
coverage against measles (r = 0.234, p-value = 0.545). Similarly, there was no
linear relationship between adherence index and immunization coverage against
DTP3 (r = 0.028; p-value = 0.943). The correlation coefficient of each of the pair
of variables was subjected to the critical value of r for two-tailed test of
Essential Drugs Programs of Selected African Countries
84
Table 2
Variation Among National EDLs in Pharmaceutical Groups 1 through 9
Country
Group
1
0.71
Group
2
0.58
Group
3
1.00
Group
4
0.36
Group
5
0.63
Group
6
0.45
Group
7
0.75
Group
8
0.38
Chad
0.71
0.58
1.00
0.50
0.88
0.44
0.25
0.15
0.50
Ghana
0.71
0.42
1.00
0.29
0.75
0.49
1.00
0.46
0.50
Kenya
0.57
0.50
0.80
0.57
0.75
0.51
0.75
0.23
0.50
Mali
0.64
0.75
1.00
0.21
0.88
0.52
0.75
0.38
0.50
Nigeria
0.93
0.42
0.60
0.64
0.88
0.50
0.25
0.62
1.00
Senegal
0.57
0.33
0.40
0.21
0.63
0.43
0.00
0.31
0.00
Uganda
0.93
0.58
0.80
0.79
1.00
0.47
1.00
0.65
0.50
Tanzania
0.64
0.58
0.60
0.43
1.00
0.46
0.25
0.42
0.50
Mean
0.71
0.53
0.80
0.44
0.82
0.47
0.56
0.40
0.50
Stand Dev
0.13
0.12
0.22
0.20
0.14
0.03
0.37
0.16
0.25
Coef. Var.
0.19
0.24
0.28
0.45
0.17
0.07
0.67
0.41
0.50
Cameroon
Group
9
0.50
Note.
Group 1: Anesthetics.
Group 2: Analgesics, antipyretics, non-steroidal anti-inflammatory medicines
(NSAIMs), medicines used to treat gout and disease modifying agents in
rheumatoid disorders (DMARDs).
Group 3: Antiallergics and medicines used in anaphylaxis.
Group 4: Antidotes and other substances used in poisoning.
Group 5: Anticonvulsants and antiepileptics.
Group 6: Anti-infective medicines.
Group 7: Antimigraine medicines.
Group 8: Antineoplastic, immunosuppressives, and medicines used in palliative
care.
Group 9: Antiparkinsonism medicines.
Essential Drugs Programs of Selected African Countries
85
Table 3
Variation Among National EDLs in Pharmaceutical Groups 10 through 18
Country
Group
10
0.75
Group
11
0.25
Group
12
0.44
Group
13
0.36
Group
14
0.25
Group
15
0.67
Group
16
0.60
Group
17
0.58
Chad
0.75
0.25
0.28
0.32
0.38
0.50
0.60
0.75
0.63
Ghana
1.00
0.00
0.32
0.36
0.25
0.33
0.60
0.67
0.42
Kenya
0.63
0.25
0.32
0.36
0.25
0.50
0.80
0.25
0.53
Mali
0.88
0.50
0.52
0.41
0.63
0.50
0.80
0.67
0.68
Nigeria
0.63
0.50
0.32
0.68
0.75
0.50
0.80
0.67
0.84
Senegal
0.63
0.00
0.36
0.09
0.50
0.33
0.60
0.50
0.47
Uganda
1.00
1.00
0.48
0.68
0.50
0.50
0.60
0.50
0.58
Tanzania
0.88
0.25
0.24
0.55
0.00
0.67
0.80
0.33
0.32
Mean
0.79
0.33
0.36
0.42
0.39
0.50
0.69
0.55
0.57
Stand Dev
0.15
0.31
0.09
0.19
0.23
0.12
0.11
0.17
0.15
Coef. Var.
0.19
0.92
0.26
0.44
0.59
0.24
0.15
0.31
0.27
Cameroon
Note.
Group 10: Medicines affecting the blood.
Group 11: Blood products and plasma substitutes.
Group 12: Cardiovascular medicines.
Group 13: Dermatological medicines (topical).
Group 14: Diagnostic agents.
Group 15: Disinfectants and antiseptics.
Group 16: Diuretics.
Group 17: Gastrointestinal medicines.
Group 18: Hormones, other endocrine medicines, and contraceptives.
Group
18
0.63
Essential Drugs Programs of Selected African Countries
86
Table 4
Variation Among National EDLs in Pharmaceutical Groups 19 through 27
Country
Group
19
0.60
Group
20
0.00
Group
21
0.45
Group
22
1.00
Group
23
0.00
Group
24
0.78
Group
25
0.57
Group
26
0.33
Group
27
0.30
Chad
0.70
0.80
0.64
1.00
0.00
0.78
0.43
0.56
0.30
Ghana
0.75
0.60
0.82
1.00
1.00
0.56
0.71
0.89
0.30
Kenya
0.70
0.00
0.55
0.67
1.00
0.56
0.57
0.44
0.20
Mali
0.75
0.40
0.64
1.00
0.00
0.67
0.43
0.89
0.40
Nigeria
0.80
0.40
0.64
1.00
1.00
0.56
0.57
0.78
0.80
Senegal
0.75
0.00
0.64
0.67
1.00
0.89
0.29
0.56
0.50
Uganda
0.90
0.60
0.73
1.00
1.00
0.78
0.57
0.67
0.60
Tanzania
0.70
0.00
0.73
0.67
0.00
0.56
0.43
0.78
0.70
Mean
0.74
0.31
0.65
0.89
0.56
0.68
0.51
0.66
0.46
Stand Dev
0.08
0.32
0.11
0.17
0.53
0.13
0.12
0.20
0.21
Coef. Var.
0.11
1.02
0.17
0.19
0.95
0.19
0.24
0.30
0.45
Cameroon
Note.
Group 19: Immunologicals
Group 20: Muscle relaxants (peripherally acting) and cholinesterase inhibitors.
Group 21: Ophthalmological preparations.
Group 22: Oxytocics and antioxytocics.
Group 23: Peritoneal dialysis solution.
Group 24: Psychotherapeutic medicines.
Group 25: Medicines acting on the respiratory tract.
Group 26: Solutions correcting water, electrolyte, and acid-based disturbances.
Group 27: Vitamins and minerals.
Essential Drugs Programs of Selected African Countries
87
significance with n-2 degrees of freedom. The r at 0.05 level (α1 = (0.05) r (7)) =
0.582. The observed values, r = 0.234 and 0.028, are less than the critical value,
thus the null hypothesis is not rejected. The statistical output shows that p = 0.545
and 0.943, respectively. These results did not support a relationship between the
adherence index to the WHO model list in pharmaceutical group and
immunization coverage rates against measles and DTP.
The general systems theory was used to organize this work. This inputoutput model argues that the inputs (pharmaceutical needs and demands) are
converted by the throughput (the policy process) into output (effective, affordable
and good quality medicines) usable by the environment. Then, the availability and
the accessibility to good quality medicines will lead to improvement in health
status of the population (impact outcomes). The pharmaceutical systems of
selected countries do not yield the expected outcomes because things do not
function very well. Figure 3 shows that all selected countries have set up the basic
structure (EDL) that is considered necessary to ensure the availability and
accessibility of essential drugs, quality and rational use of drugs. Obviously,
having an official EDL is not enough for a program of essential drugs to be
successful. In light of the findings of this study, it can be argued that having the
structures in place does not mean the processes by which an essential drugs list is
implemented will be achieved. In this case, the availability and accessibility of
vaccines could be undermined by various factors such as the poor supply and
Essential Drugs Programs of Selected African Countries
88
distribution systems, insufficient health facilities and staff, low investment in
health, and the high cost of medicines.
Although the EDL is used by selected countries as a tool aimed at
managing the purchasing and distribution of medicines and the selection of good
quality and cost-effective drugs, the findings of assessment of their
pharmaceutical sectors indicated otherwise. The baseline assessment of
pharmaceutical sectors of selected countries undertaken in 2002 and 2003 by
Ministries of Health found that the median percent of availability of key
medicines in public facilities was 70% in Chad, 78.6 % in Ghana, 93.3% in
Kenya, 87.3 % in Mali, 46% in Nigeria, 80% in Senegal, 75% in Uganda, and
87.28% in Tanzania. In addition, the long stock-out duration on average indicated
that medicines were not always available: 41 days in Chad, 75.5 days in Ghana,
38.59 days in Kenya, 45.4 days in Mali, in 15.3 days in Senegal, 89.3 days in
Uganda, and 28 days in Tanzania (Ministry of Health, n.d.).
The fourth research question explored the relationship between the
immunization coverage rates against measles and DTP3 (diphtheria, tetanus,
pertussis) and infant mortality rates. Figure 4 shows that there is a strong
relationship between the percentage of children who have been immunized
against measles and diphtheria, pertussis, and tetanus and infant mortality rates.
The analysis of the scatter plots indicates that the infant mortality rates decreased
as the immunization coverage against the selected diseases increased. The
computation of the relationship between mortality rates and immunization rates
Essential Drugs Programs of Selected African Countries
89
Correlation between Infant Mortality and Immunization Coverage
130
Variable
MCV
DTP3
Infant Mortality rate
120
110
100
90
80
70
60
20
30
40
50
60
70
Immunization coverage
80
90
100
Figure 4. Scatter plots--Correlation between immunization coverage and infant
mortality
Essential Drugs Programs of Selected African Countries
90
found that there is a strong linear and negative relationship between the
percentage of children immunized against measles and DTP and infant mortality
rates. The correlation coefficient of immunization rate against measles and IMR
was -0.639 with p-value = 0.064. Similarly, there was a negative relationship
between DTP3 and IMR, with r = -0.693 and p-value = 0.038. The r at 0.05 level
(α1 = (0.05) r (7)) = 0.582. The observed values, r = -0.639 and -0.693, were
greater than the critical value, thus the null hypothesis was rejected. The statistical
output showed that p = 0.064 and 0.038, respectively. These findings do support a
relationship between the immunization coverage against measles and DTP and
infant mortality rate.
One can assume that if the vaccines were available within the context of
functioning health systems, and always in suitable amounts and dosage forms,
then immunization coverage against measles and diphtheria, tetanus and pertussis
would be the same from country to country; and as a result the IMR would be the
same across the countries. Obviously, the data revealed that there were
disconnects between what goes into the pharmaceutical systems of selected
countries at the beginning (inputs) and what comes out at the end (outputs). The
analysis of the data in relation to the input-output model indicated that the inputs
do not necessarily produce the expected outcomes. For instance, the IMR of
selected countries improved slightly despite the fact that the vaccines were listed
on their national EDLs. Figure 4 shows that if vaccines are available and listed on
the national EDLs, and then infants are immunized, therefore infant mortality
Essential Drugs Programs of Selected African Countries
91
rates should decrease. The infant mortality rates of selected countries, which
provide a good picture of the health situation, indicated that there were problems
with the processes (throughputs) by which the vaccines are made available,
accessible, and administered.
The problems with the throughputs included the lack of resources (health
facilities and staff), the poor supply and distribution systems, the poor financing
of drugs in the public sector, and the high pricing of drugs in the private sector.
According to the UNICEF statistics, the percentage of the money that the
government can allocate to finance vaccines affects the availability and the
accessibility of vaccines. The available statistics in 2006 indicated that the
percentage of the expanded program on immunization vaccines financed by
government were 20% in Cameron, 55% in Chad, 80% in Kenya, 77% in Mali,
100% in Nigeria, 37% in Senegal, 83% in United Republic of Tanzania, and 8%
in Uganda. In spite of vaccines that are listed on national EDLs and financed up to
100% by the Nigerian government, the Nigerian immunization coverage rates
against measles (62%) and DTP (72%) were ranked 8th out of the 9 selected
countries. Donations also affected the access and availability of vaccines. Unlike
Nigeria, vaccines were financed by the government only up to 8% in Uganda.
With the immunization coverage of 89% against measles and 89% against DTP,
the government of Uganda was able to immunize 89% of its infants against
measles and DTP, probably through donations (www.unicef.org). In addition to
the financing problems, the availability and accessibility of vaccines was also
Essential Drugs Programs of Selected African Countries
92
affected by how they were purchased, distributed, and managed through the
health facilities.
Even though the vaccines are available, still the selected countries would
face the shortages of qualified personnel to administer them. Anand and
Bärnighausen (2007) found that health worker density was significantly
associated with coverage of vaccinations of measles p = 0.0024; DTP3 p =
0.0004, and polio3 p = 0.0008.
Data Collection Tool
The selected countries used the WHO operational package to monitor and
evaluate their pharmaceutical situations. Using a questionnaire included in this
package, selected countries collected data on structures and processes of their
pharmaceutical situations. Then, survey forms were used to measure the degree to
which each country achieved the strategic objectives of their NDP. To analyze the
secondary data set obtained through these pharmaceutical assessments, this study
used Excel to sort out drugs and the MiniTab version to compute the relationship
between adherence index and immunization rates, and immunization rates and
infant mortality rates.
Summary
This chapter analyzed a secondary data set that was used primarily to
assess the pharmaceutical sectors of selected African countries. This chapter
discussed the description of the sample, the analysis of data in light of the
research questions, as well as the tools used to collect data. The comparison of the
Essential Drugs Programs of Selected African Countries
93
WHO model list and the national essential lists revealed that there were many
drugs on the model list that were not on national EDLs as well as drugs on
national EDLs that were not listed on the WHO model list. The computation of
the correlation coefficient revealed a strong association between infant mortality
rates and immunization rates against measles and DTP3. There was no linear
association between the adherence index to the WHO model list in the
immunologicals pharmaceutical group and immunization rates.
Essential Drugs Programs of Selected African Countries
94
CHAPTER V
SUMMARY, CONCLUSIONS, IMPLICATIONS,
AND RECOMMENDATIONS
Summary
The main goal of a NDP is to ensure the access to safe and affordable
medications and their rational use. The list of essential drugs is central for
achieving this goal. For the past 30 years, essential drugs have made a substantial
contribution to the reduction of morbidity and mortality in sub-Saharan Africa.
Although the access to essential drugs has slightly improved, the situation of lack
of availability of essential drugs in public facilities remains alarming. The levels
of infant mortality remain too high compared to the rest of the world.
The purpose of the study was to compare selected African countries’
essential drugs lists. It analyzed similarities in the African selected countries’
EDLs and whether there are differences both between them and the WHO model
list and among the selected African countries themselves. In addition, it examined
whether adherence index to the WHO model list in the immunologicals
pharmacological class is correlated to the immunization coverage rates, and if
immunization coverage rates are correlated to infant mortality rates.
Essential Drugs Programs of Selected African Countries
95
The general systems theory was used to organize this work. Secondary
data were analyzed using Pearson’s correlation and coefficient of variation
methods.
The comparison of the WHO model list and the national EDLs revealed
that there are many drugs on the model list that were not on national EDLs as well
as drugs on national EDLs that were not listed on the WHO model list. The
computation of the correlation coefficient revealed a strong association between
infant mortality rates and immunization coverage rates against measles and DTP3.
There is no linear association between the adherence index to the WHO model
list, immunologicals class, and immunization coverage rates.
Conclusions
This section discusses the conclusions with respect to the relationship of
the results to the conceptual framework, literature, and research questions.
Relationship of the Results to the Conceptual Framework
For the purpose of this study, the GST (von Bertalanffy, 1968) was used
as the core methodology for understanding NDP process and its complex stages.
To explore the intermediate outcomes of essential drugs programs, which will
lead to improvement in health status of a country, a modified simple input-output
model was adopted, which placed the policy process in the center. The
pharmaceutical needs and demands from the environment are on the input side
and access to safe and good medicines are on the output side. The policy process
(formulation, implementation, and evaluation) is used by the system to convert
Essential Drugs Programs of Selected African Countries
96
the pharmaceutical needs and demands from the environment into outputs
(available, effective, affordable, and good quality medicines) usable by the
environment. Available, effective, affordable, and good quality medications will
lead to prevent and treat diseases, ultimately improving the health status of the
population (impact outcomes). The environment (social, economic, education,
health, and political) in which the system operates affects its components.
Information about some aspects of pharmaceutical needs and demands are used to
evaluate and monitor the system in order to guide the system to more effective
performance.
Relationship of the Results to the Literature
The literature review focused on the work assessing the impact that the
implementation of NDP and essential drugs programs has had on access to
essential drugs and their rational use. In their review of the 25 years of the WHO
essential medicines lists, Laing et al. (2003) described how the concept of
essential drugs has evolved throughout these years, the progress made, as well as
challenges that EDLs face. The authors argued that the WHO model list helped to
establish the principle that there is a subset of drugs that are more useful than
others on the one hand, and to highlight the situation of lack of access to essential
drugs to many populations of the developing world. Their article drew attention to
the fact that there are differences between the WHO model list and national EDLs
because countries face varying challenges related to factors such as costs and
morbidity patterns. Although all selected African countries used the WHO model
Essential Drugs Programs of Selected African Countries
97
list to produce their own essential drugs lists, nearly half of the drugs from the
WHO model list were included on the national EDLs (average = 52%).
Surprisingly, two neighboring countries (i.e., Cameroon and Nigeria) that had
similar morbidity patterns were opposites in incorporating the WHO model list of
essential drugs (correlation coefficient = 0.035). It can be argued that the
difference between their essential drugs lists is attributable to other factors such as
costs, selection of drugs, and regulation of their pharmaceutical sectors.
According to the WHO, 30 years after the inception of the concept of
essential drugs, 156 of the 193 WHO member states have official essential drugs
lists (WHO, 2007). Nevertheless, progress is still grossly insufficient, particularly
in much of sub-Saharan Africa. In 2003, the WHO estimates indicated that one
third of the world’s population did not have regular access to essential drugs
(Quick, 2003a). He argued that the underlying factors of inaccessibility to
essential drugs in the developing world are economic, social, and educational.
Other factors that the author discussed lie within the health sector: irrational use
of drugs, inefficient financing, unreliable delivery of medications, and high
medicine prices.
This study found that there is a significant negative relationship between
immunization rates and IMR, indicating that higher immunization rates mean
fewer infant deaths. These findings support the results of previous studies.
Shimouchi et al. (1994) used a multiple regression analysis and found a
significant association between immunization and IMR, with a partial correlation
Essential Drugs Programs of Selected African Countries
98
coefficient of -0.224. The significant negative association between immunization
rate and IMR implies that infant mortality rate would decline in the developing
world if the populations have access to basic interventions such as immunization
programs. In light of the findings of this study, it can be argued that measles,
diphtheria, tetanus, and pertussis could be prevented with access to MCV and
DTP3 vaccines. Gutierrez et al. (1996) analyzed secondary data to evaluate the
impact of oral rehydration therapy and selected public health interventions on
reduction of mortality from childhood diarrheal diseases in Mexico. Their study
analyzed secondary data collected between 1978 and 1993. Using a Pearson’s
correlation method, they correlated mortality trends with the use of ORT and
selected public health interventions. Their findings indicated that the reduction of
mortality was important in the third phase (17.8%) compared to the first (1.8%)
and the second (6.4%) phases. A greater reduction in mortality rates was
attributable to a massive immunization against measles and improvements in
sanitation (r = 0.9586).
In summary, the role of vaccines in preventing diseases such as measles or
tuberculosis cannot be disputed. Similarly, the availability of effective drugs such
as antibiotics has played an important role in treating infections such as acute
respiratory infections.
Implications for Policy Makers
African countries should adopt policy making tailored to their specific
needs. A recent study carried out by the WHO and HIA (Cameron et al., 2008)
Essential Drugs Programs of Selected African Countries
99
indicated that availability of essential drugs is as much important as their
affordability in ensuring access to essential drugs. Therefore, public health
interventions intended to ensure access to essential drugs should focus on
promoting partnerships between governments of the developing world,
pharmaceutical industries, and nongovernmental agencies in order to provide
access to affordable essential drugs to their populations.
Although there is an increasing political commitment to ensure the access
to essential drugs by African countries, still there are great opportunities for
ensuring access to essential drugs for the majority of the population while
adopting cost-effective interventions. For instance, policymakers in Africa should
promote and enforce the utilization of generics instead of originator brand names.
Cameron et al. (2008) found that the average public sector availability of generic
medicines in the African region was 29.4%.
To improve the access to essential drugs, African governments should
effectively regulate their pharmaceutical sector by keeping their national drug
policies and essential drugs lists up-to-date, as well as monitor routinely the
availability and prices of drugs. This would lead to prevent wasteful and
inadequate use of drugs.
Recommendations for Future Research
The comparative aspects of this study might provide some insight in
which countries might learn and adopt best practices from each other. Thus, this
study could be repeated by policymakers to measure the strength of association
Essential Drugs Programs of Selected African Countries
100
between public health interventions and health status indicators in order to
identify interventions that matter.
In light of the lack of similarities between the WHO model list and
national EDLs and among national EDLs themselves, one can ask why these
EDLs are different even for countries that face similar challenges related to costs,
drug effectiveness, morbidity patterns, and rationality of prescribing. Future
research in essential drugs should examine other demographic and socioeconomic
factors that impair countries of the developing world.
Future research is needed to understand how national drug policies and
essential drugs programs affect choices of the population in the developing world.
The findings of such research would help researchers to identify common
knowledge, attitude, and beliefs toward use of drugs across surveyed countries.
Future research is also needed to investigate why and how national drug policies
and essential drugs programs do not perform well as expected or deliver less than
expect.
Essential Drugs Programs of Selected African Countries
101
References
Anand, S., & Bärnighausen T. (2007). Health workers and vaccination coverage
in developing countries: An econometric analysis. Lancet, 369(9569),
1277-1285.
Apel, H. (1979). The WHO/UNICEF conference on primary health care, almaata, September 6-12, 1978. Z Gesamte Hyg, 25(6), 498-504.
Awad, A., Eltayeb, I., Matowe, L., & Thalib, L. (2005). Self-medication with
antibiotics and antimalarials in the community of Khartoum State, Sudan.
Journal of Pharmacy & Pharmaceutical Sciences, 8(2), 326-331.
Benjamin, H., Smith, F., & Motawi, M. A. (1996). Drugs dispensed with and
without a prescription from community pharmacies in a conurbation in
Egypt. Eastern Mediterranean Health Journal, 2(3), 506-514.
Bhutta, T. I., & Balchin, C. (1996). Assessing the impact of a regulatory
intervention in Pakistan. Social Science and Medicine, 42(8), 1195-1202.
Bryce, J., Boschi-Pinto, C., Shibuya, K., & Black, R. E. (2005). WHO estimates
of the causes of death in children. Lancet, 365, 1147–1152.
Burkhauser, R. V., & Lillard, D. R. (2005). The contribution and potential of data
harmonization for cross-national comparative research. Journal of
Comparative Policy Analysis, 7(4), 313-330.
Essential Drugs Programs of Selected African Countries
102
Calva, J., & Bojalil, R. (1996). Antibiotic use in a peri-urban community in
Mexico: A household and drug store survey. Social Science and Medicine,
42(8), 1121-1128.
Cameron, A., Ewen, M., Ross-Degnan, D., & Laing, R. (2008). Medicine prices,
availability, and affordability in 36 developing and middle-income
countries: A secondary analysis. The Lancet, 373(9659), 240-249. doi:
10.1016/s0140-6736(08)61762-61
Chou, Y., Yip, W. C., Lee, C. H., Huang, N., Sun, Y. P., & Chang, H. J. (2003).
Impact of separating drug prescribing and dispensing on provider: Taiwan’s
experience. Health Policy and Planning, 18(3):316-329.
De Vries, T. P., Henning, R. H., Hogerzeil, H. V., Bapna, J. S., Bero, L., Kafle, K.
K., . . . Smith, A. J. (1995). Impact of a short course in pharmacotherapy for
undergraduate medical students: An international randomized controlled
study. The Lancet, 346, 1454-1457.
Easton, D. (1953). The political system. An inquiry into the state of political
science. New York: Alfred A. Knopf.
Field, M. J., & Lohr, K. N. (Eds.). (1990). Clinical practice guidelines: Directions
for a new program. Washington, DC: National Academic Press.
Goel, P., Ross-Degnan, D., Berman, P., & Soumerai, S. (1996). Retail pharmacies
in developing countries: A behavior and intervention framework. Social
Science and Medicine, 42(8), 1155-1161.
Essential Drugs Programs of Selected African Countries
103
Grimshaw, J., & Russell, I. T. (1993). Effect of clinical guidelines on medical
practice: A systematic review of rigorous evaluations. Lancet, 342,
1317-1322.
Gumodoka, B., Vos, J., Berege, Z. A., van Asten, H. A., Dolmans, M., &
Borgdorff, M. W. (1996). Injection practices in Mwanza Region,
Tanzania: Prescriptions, patient demand, and sterility. Tropical Medicine
and International Health, 1(6), 874-880.
Guitierrez, G., Tapia-Conyer, R., Guiscafre, H., Reyes, H., Martinez, H., &
Kumate, J. (1996). Impact of oral rehydration and selected public health
interventions on reduction of mortality from childhood diarrhoeal diseases
in Mexico. Bulletin of the World Health Organization, 74(2), 189-197.
Hamrell, S., & Nordberg, O. (Eds.). (1985). The rational use of drugs and WHO.
Retrieved from http://www.dhf.uu.se/pdffiler/85_2.pdf
Heylighen, F. (2003). Ashby's book “Introduction to cybernetics.” Retrieved
March 1, 2003, from http://pespmc1.vub.ac.be/ASHBBOOK.html
Heylighen, F., & Joslyn, C. (1992, November 1). What is systems theory?
Retrieved March 1, 2008, from
http://pespmcl.vub.ac.be/SYSTHEOR.html
Hodes, R. M., & Kloos, H. (1988). Health and medical care in Ethiopia. New
England Journal of Medicine, 319(14), 918-924.
Hogerzeil, H. V. (2004). The concept of essential medicines: Lessons for rich
countries. British Medical Journal, 329, 1169-1172.
Essential Drugs Programs of Selected African Countries
104
Hogerzeil, H. V., Walker, G. J. A., Sallami, A. O., & Fernando, G. (1989). Impact
of an essential drugs programme on availability and rational use of drugs.
Lancet, 21, 141-142.
Hronek, C., & Bleich, M. R. (2002). “The less-than-perfect medication system”:
A systems approach to improvement. Journal of Nursing Care Quality,
16(4), 17-22.
Hu, S., Chen, W., Cheng, X., Chen, K., Zhou, H., & Wang, L. (2001).
Pharmaceutical cost-containment policy: Experiences in Shangai, China.
Health Policy and Planning, 16(2), 4-9.
Kafuko, J., & Bagenda, D. (1994). Impact of national standard treatment
guidelines on rational drug use in Uganda health facilities. Kampala:
Unicef/Uganda. Retrieved from
http://dcc2.bumc.bu.edu/prdu/ICIUM_Posters/2f3_text.htm
Kanji, N., Hardon, A., Harnmeijer, J. W., Mamdani, M., & Walt, G. (1992).
Drugs policy in developing countries. London, UK: Zed Books.
Kapp, C. (2003). WHA acts on health regulations and intellectual property. The
Lancet Infectious Diseases, 3(7), 392.
Karim, S. S. A., Pillai, G., Ziqubu-Page, T. T., Cassimjee, M. H., & Morar, M. S.
(1996). Potential savings from generic prescribing and generic substitution
in South Africa. Health Policy and Planning, 11(2), 198-205.
Essential Drugs Programs of Selected African Countries
105
Kim, H. J., Chung, W., & Lee, S. G. (2004). Lessons from Korea’s
pharmaceutical policy reform: The separation of medical institutions and
pharmacies for outpatient care. Health Policy, 68, 267-275.
Kisa, A. (2001). The performance and problems of the Turkish pharmaceutical
industry: Is there a need to develop a national drug policy? Journal of
Medical Systems, 25(5), 309-318.
Krause, G., Borchert, M., Benzler, J., Heinmüller, R., Kaba, I., Savadogo, M., . . .
Diesfeld, H. J. (1999). Rationality of drug prescriptions in rural health
centres in Burkina Faso. Health Policy and Planning, 14(3), 291-298.
Laing, R. (1999). The world health and drug situation. International Journal of
Risk & Safety in Medicine, 12(12), 51-57.
Laing, R., Hogerzeil, H. V., & Ross-Degnan, D. (2001). Ten recommendations to
improve use of medicines in developing countries. Health Policy and
Planning, 16(1), 13-20.
Laing, R., Waning, B., Gray, A., Ford, N., & Hoen, E. (2003). 25 years of the
WHO essential medicines lists: Progress and challenges. The Lancet, 361,
1723-1729.
Logez, S., Hutin, Y., Holloway, K., Gray, R., & Hogerzeil, H. V. (2004). Could
the WHO model list of essential medicines do more for the safe and
appropriate use of injections? Journal of Clinical Pharmacology, 44,
1106-1113.
Essential Drugs Programs of Selected African Countries
106
Logez, S., Hutin, Y., Somda, P., Thuault, J., & Holloway, K. (2005). Safer
injections following a new national medicine policy in the public sector,
Burkina Faso 1995-2000. BioMed Central Public Health, 5, 136. Retrieved
from http://www.biomedcentral.com/content/pdf/1471-2458-5-136.pdf
Le Grand, A., Hogerzeil, H.V. & Haaijer-Ruskamp, F.M. (1999). Intervention
research in rational use of drugs: a review. Health Policy and Planning,
14(2), 89-102.
Maïga, F. I., Haddad, S., Fournier, P., & Gauvin, L. (2003). Public and private
sector responses to essential drugs policies: A multilevel analysis of drug
prescription and selling practices in Mali. Social Science & Medicine, 57,
937-948.
Mason, E. (2007). Newborns in Sub-Saharan Africa. How to save these fragile
lives. UN Chronicle Magazine, XLIV(4), 60-61, 85. Retrieved from
http://www.un.org/Pubs/chronicle/2007/issue4/0407p60.html
Megawangi, R., & Barnett, J. B. (1993). A comparison of determinants of infant
mortality rate (IMR) between countries with high and low IMR. Majalah
Demografi Indones, 20(39), 79-86.
Meng, Q., Cheng, G., Silver, L., Sun, X., Rehnberg, C., & Tomson, G. R. (2005).
The impact of China’s retail drug price control policy on hospital
expenditures: A case study in two Shandong hospitals. Health Policy and
Planning, 20(3), 185-196.
Essential Drugs Programs of Selected African Countries
107
Ministry of Health. (n.d.). Medicines policy documents from selected African
countries. Retrieved from http://collections.infocollections.org/
whocountry/en/cl/CL1.2/#hlCL1_2
Nikfar, S., Kebriaeezadeh, A., Majdzadeh, R., & Abdollahi, M. (2005).
Monitoring of national drug policy (NDP) and its standardized indicators;
conformity to decisions of the national drug selecting committee in Iran.
BioMed Central International Health and Human Rights, 5, 5. Retrieved
from http://www.biomedcentral.com/1472-698X/5/5
Paphassarang, C., Tomson, G., Choprapawon, C., & Weerasuriya, K. (1995). The
Lao national drug policy: Lessons along the journey. The Lancet, 345,
433-435.
Park, S., Soumerai, S. B., Adams, A. S., Finkelstein, J. A., Jang, S., & RossDegnan, D. (2005). Antiobiotic use following a Korean national policy to
prohibit medication dispensing by physicians. Health Policy Planning, 20,
302-309.
Pécoul, B., Chirac, P., Trouiller, P., & Pinel, J. (1999). Access to essential drugs
in poor countries: A lost battle? Journal of the American Medical Association,
281, 361-367.
Portney, L. G., & Watkins, M. P. (2000). Foundations of clinical research,
applications to practice (2nd ed.). Upper Saddle River, NJ: Prentice-Hall.
Essential Drugs Programs of Selected African Countries
108
Quick, J. D. (2003a). Ensuring access to essential medicines in the developing
countries: A framework for action. Clinical Pharmacology and
Therapeutics, 73, 279-283.
Quick, J. D. (2003b). Essential medicines twenty-five years on: Closing the
access gap. Health Policy and Planning, 18(1), 1-3.
Quick, J. D., Hogerzeil, H. V., Velásquez, G., & Rägo, L. (2002). Twenty-five
years of essential medicines. Bulletin of the World Health Organization,
80(11), 913-914.
Ratanawijitrasin, S., Soumerai, S. B., & Weerasuriya, K. (2001). Do national
medicinal drug policies and essential programs improve drug use? A review
of experiences in developing countries. Social Science & Medicine, 53,
831-844.
Shimouchi, A., Ozasa, K., & Hayashi, K. (1994). Immunization coverage and
infant mortality rate in developing countries. Asia-Pacific Journal of Public
Health, 7(4), 228-232.
Uzochukwu, B. S. C., Onwujekwe, O. E., & Akpala, C. O. (2002). Effect of the
Bamako-Initiative drug revolving fund on availability and rational use of
essential drugs in primary health care facilities in south-east Nigeria. Health
Policy and Planning, 17(4), 378-383.
Von Bertalanffy, L. (1968). General system theory: Foundations, development,
applications. New York: George Braziller.
Essential Drugs Programs of Selected African Countries
109
Vos, J., Gumodoka, B., van Asten, H. A., Berege, Z. A., Dolmans, W. M., &
Borgdorff, M. W. (1998). Improved injection practices after the introduction
of treatment and sterility guidelines in Tanzania. Tropical Medicine and
International Health, 3(4), 291-296.
Welschen, I., Kuyvenhoven, M. M., Hoes, A. W., & Verheij, T. J. M. (2004).
Effectiveness of a multiple intervention to reduce antibiotic prescribing for
respiratory tract symptoms in primary care: Randomized controlled trial.
British Medical Journal, 329, 431-443.
Wolfson, L. J., Strebel, P. M., Gacic-Dobo, M., Hoekstra, E. J., McFarland, J. W.,
& Hersh, S. B. (2007). Has the 2005 measles mortality reduction goal been
achieved? A natural history modeling study. Lancet, 369, 191-200.
Woolf, S. H., Grol, R., Hutchinson, A., Eccles, M., & Grimshaw, J. (1999).
Potential benefits, limitations, and harms of clinical guidelines. British
Medical Journal, 318(20), 527-530.
World Bank. (1994). Better health in Africa: Experience and lessons learned.
Washington, DC: Author.
World Health Organization. (2000). WHO medicines strategy: 2000-2003. WHO
policy perspectives on medicines, no 1. Retrieved from
http://www.who.int/publications/en/
World Health Organization. (2001). How to develop and implement a national
drug policy. Second Edition. ISBN 92 4 154547 X. Retrieved from
http://apps.who.int/medicinedocs/en/d/Js2283e/
Essential Drugs Programs of Selected African Countries
110
World Health Organization. (2002). Promoting rational use of medicines: Core
components. WHO policy perspectives on medicines, No.5.
WHO/EDM/2002.3. Retrieved from http://www.who.int/publications/en/
World Health Organization. (2003). How to develop and implement a national
drug policy. WHO policy perspectives on medicines, No. 6.
WHO/EDM/2002.5. Retrieved from http://www.who.int/publications/en/
World Health Organization. (2004). Equitable access to essential medicines: A
framework for collective action. WHO policy perspectives on medicines,
No.8. WHO/EDM/2004.4. Retrieved from
http://www.who.int/publications/en/
World Health Organization. (2007). 10 facts on essential medicines. Retrieved
from http://www.who.int/features/factfiles/essential_medicines/
en/index.html
Essential Drugs Programs of Selected African Countries
111
Appendix A
Process to Select an Essential Drug
Essential Drugs Programs of Selected African Countries
112
Process to Select an Essential Drug
The seven steps from development of a new drug to inclusion on the WHO Model
List of Essential Drugs are summarized in the following table.
Steps to be taken
1. Identification of a medical or publichealth need for a certain drug
2. Development of the drug; Phase I, II,
III trials
3. Request for regulatory approval in a
number of developed and developing
countries
4. More experience with the drug under
controlled field circumstances; post
marketing surveillance
5. A price indication for public sector
use in developing countries
Intended endpoint
A safe and effective drug, ready for
regulatory approval
Regulatory approval
Evidence on effectiveness and safety
under field conditions
Price indication for public sector use in
developing countries; evidence on costeffectiveness
Recommendation of the drug in an official
WHO (model) treatment guideline
6. Review by the relevant WHO
departments and Expert Committees;
comparison with other treatment
alternatives with regard to:
• efficacy, effectiveness and safety
of the drug in real-life situations
• relative cost-effectiveness
• public health relevance
7. Submission of the drug, by the
Inclusion of the drug on the WHO Model
relevant WHO department, for inclusion List of Essential Drugs
on the WHO Model List of Essential
Drugs; review by the Expert Committee
on Essential Drugs of:
• efficacy, effectiveness and safety
of the drug in real-life situations
• relative cost-effectiveness
• public health relevance
Reference: World Health Organization. The definition and selection process for an
EDL, WHO Department of Essential Drugs and Medicines Policy, Technical Briefing
Paper, Prepared by: Dr Hans V. Hogerzeil, WHO/EDM/PAR, October 27, 2000.
Essential Drugs Programs of Selected African Countries
113
Appendix B
D’Youville College Institutional Review Board
Exempt Review Application
Essential Drugs Programs of Selected African Countries
114
Essential Drugs Programs of Selected African Countries
115
Appendix C
WHO Model List of Essential Drugs, 13th Edition
Essential Drugs Programs of Selected African Countries
116
Essential Medicines
WHO Model List (revised April 2003)
Explanatory Notes
The core list presents a list of minimum medicine needs for a basic health care system, listing the most
efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the
basis of current and estimated future public health relevance, and potential for safe and cost-effective
treatment.
The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or
monitoring facilities, and/or specialist medical care, and/or specialist training are needed. In case of doubt
medicines may also be listed as complementary on the basis of consistent higher costs or less attractive costeffectiveness in a variety of settings.
When the strength of a drug is specified in terms of a selected salt or ester, this is mentioned in brackets; when
it refers to the active moiety, the name of the salt or ester in brackets is preceded by the word "as".
The square box symbol (‫ )ٱ‬is primarily intended to indicate similar clinical performance within a
pharmacological class. The listed medicine should be the example of the class for which there is the best
evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for
marketing; in other instances, subsequently licensed compounds may be safer or more effective. Where there is
no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally
available at the lowest price, based on international drug price information sources.
Therapeutic equivalence is only indicated on the basis of reviews of efficacy and safety and when consistent
with WHO clinical guidelines. National lists should not use a similar symbol and should be specific in their final
selection, which would depend on local availability and price.”
Drugs are listed in alphabetical order, within sections.
Essential Drugs Programs of Selected African Countries
117
1. ANAESTHETICS
1.1 General anaesthetics and oxygen
ether, anaesthetic *
inhalation
* the public health relevance and/or safety of this item has
been questioned and its continued inclusion on the list will be
reviewed at the next meeting of the Expert Committee.
halothane
inhalation
ketamine
injection, 50 mg (as hydrochloride)/ml in 10-ml vial
nitrous oxide
inhalation
oxygen
inhalation (medicinal gas)
‫ٱ‬
powder for injection, 0.5 g, 1.0 g (sodium salt) in ampoule
thiopental
1.2 Local anaesthetics
‫ٱ‬
bupivacaine
injection, 0.25%, 0.5% (hydrochloride) in vial
injection for spinal anaesthesia, 0.5% (hydrochloride) in 4-ml
ampoule to be mixed with 7.5% glucose solution
‫ٱ‬
lidocaine
injection, 1%, 2% (hydrochloride) in vial
injection for spinal anaesthesia, 5% (hydrochloride) in 2-ml
ampoule to be mixed with 7.5% glucose solution
topical forms, 2-4% (hydrochloride)
lidocaine + epinephrine
(adrenaline)
injection 1%, 2% (hydrochloride)+ epinephrine 1:200 000 in
vial; dental cartridge 2% (hydrochloride) + epinephrine 1:80
000
‫ٱ‬
Complementary List
ephedrine
injection, 30 mg (hydrochloride)/ml in 1-ml ampoule (For
use in spinal anaesthesia during delivery, to prevent
hypotension)
1.3 Preoperative medication and sedation for short-term procedures
atropine
injection, 1 mg (sulfate) in 1-ml ampoule
‫ٱ‬
diazepam
injection, 5 mg/ml in 2-ml ampoule; tablet, 5 mg
morphine
injection, 10 mg (sulfate or hydrochloride) in 1-ml ampoule
promethazine
elixir or syrup, 5 mg (hydrochloride)/5ml
2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTIINFLAMMATORY MEDICINES (NSAIMs), MEDICINES USED TO
TREAT GOUT AND DISEASE MODIFYING AGENTS IN
RHEUMATOID DISORDERS (DMARDs)
Essential Drugs Programs of Selected African Countries
118
2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs)
acetylsalicylic acid
tablet, 100-500 mg; suppository, 50-150 mg
ibuprofen
tablet, 200 mg, 400 mg
paracetamol *
tablet, 100-500 mg; suppository, 100 mg; syrup, 125 mg/5ml
* not recommended for anti-inflammatory use due to lack of
proven benefit to that effect
2.2 Opioid analgesics
codeine
tablet, 30 mg (phosphate)
morphine
injection, 10 mg in 1-ml ampoule (sulfate or hydrochloride);
oral solution, 10 mg (hydrochloride or sulfate)/5 ml; tablet,
10 mg (sulfate)
2.3 Medicines used to treat gout
allopurinol
tablet, 100 mg
colchicine *
tablet, 500 micrograms
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
2.4 Disease modifying agents used in rheumatoid disorders (DMARDs)
chloroquine
tablet, 100 mg, 150 mg (as phosphate or sulfate)
Complementary List
azathioprine
tablet, 50 mg
methotrexate
tablet, 2.5 mg (as sodium salt)
penicillamine
capsule or tablet, 250 mg
sulfasalazine
tablet, 500 mg
3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
‫ٱ‬
chlorphenamine
tablet, 4 mg (hydrogen maleate); injection, 10 mg (hydrogen
maleate) in 1-ml ampoule
dexamethasone
injection, 4 mg dexamethasone phosphate (as disodium salt)
in 1-ml ampoule
epinephrine (adrenaline)
injection, 1 mg (as hydrochloride or hydrogen tartrate) in 1ml ampoule
hydrocortisone
powder for injection, 100 mg (as sodium succinate) in vial
Essential Drugs Programs of Selected African Countries
119
‫ٱ‬
prednisolone *
tablet, 5 mg, 25 mg
* there is no evidence for complete clinical similarity
between prednisolone and dexamethasone at high doses.
4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONING
4.1 Non-specific
charcoal, activated
powder
4.2 Specific
acetylcysteine
injection, 200 mg/ml in 10-ml ampoule
atropine
injection, 1 mg (sulfate) in 1-ml ampoule
calcium gluconate *
injection, 100 mg/ml in 10-ml ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
deferoxamine
powder for injection, 500 mg (mesilate) in vial
dimercaprol
injection in oil, 50 mg/ml in 2-ml ampoule
DL-methionine
tablet, 250 mg
methylthioninium chloride
(methylene blue)
injection, 10 mg/ml in 10-ml ampoule
naloxone
injection, 400 micrograms (hydrochloride) in 1-ml ampoule
penicillamine
capsule or tablet, 250 mg
potassium ferric hexacyanoferrate(II) ·2H20 (Prussian
blue)
powder for oral administration
sodium calcium edetate
injection, 200 mg/ml in 5-ml ampoule
sodium nitrite
injection, 30 mg/ml in 10-ml ampoule
sodium thiosulfate
injection, 250 mg/ml in 50-ml ampoule
5. ANTICONVULSANTS/ANTIEPILEPTICS
carbamazepine
scored tablet, 100 mg, 200 mg
‫ٱ‬
diazepam
injection, 5 mg/ml in 2-ml ampoule (intravenous or rectal)
magnesium sulfate*
injection, 500 mg/ml in 2-ml ampoule; 500mg/ml in 10-ml
ampoule
* for use in eclampsia and severe pre-eclampsia and not for
other convulsant disorders.
Essential Drugs Programs of Selected African Countries
120
phenobarbital
tablet, 15-100 mg; elixir, 15 mg/5ml
phenytoin
capsule or tablet, 25 mg, 50 mg, 100 mg (sodium salt);
injection, 50 mg/ml in 5-ml vial (sodium salt)
valproic acid
enteric coated tablet, 200 mg, 500 mg (sodium salt)
Complementary List
‫ٱ‬
clonazepam *
scored tablet 500 micrograms
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
ethosuximide
capsule, 250 mg; syrup, 250 mg/5ml
6. ANTI-INFECTIVE MEDICINES
6.1 Anthelminthics
6.1.1 Intestinal anthelminthics
albendazole
chewable tablet, 400 mg
levamisole
tablet, 50 mg; 150 mg (as hydrochloride)
‫ٱ‬
mebendazole
chewable tablet, 100 mg, 500 mg
niclosamide *
chewable tablet, 500 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
praziquantel
tablet, 150 mg, 600 mg
pyrantel *
chewable tablet 250 mg (as embonate); oral suspension, 50
mg (as embonate)/ml
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
6.1.2 Antifilarials
ivermectin
scored tablet, 3 mg, 6 mg
Complementary List
diethylcarbamazine
tablet, 50 mg, 100 mg (dihydrogen citrate)
suramin sodium
powder for injection, 1 g in vial
Essential Drugs Programs of Selected African Countries
121
6.1.3 Antischistosomals and antitrematode medicines
praziquantel
tablet, 600 mg
triclabendazole *
tablet, 250 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
Complementary List
oxamniquine *
capsule, 250 mg; syrup, 250 mg/5ml
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
6.2 Antibacterials
6.2.1 Beta Lactam medicines
amoxicillin
capsule or tablet, 250 mg, 500 mg (anhydrous); powder for
oral suspension, 125 mg (anhydrous)/5 ml
amoxicillin + clavulanic acid
tablet, 500 mg + 125 mg
ampicillin
powder for injection, 500 mg, 1 g (as sodium salt) in vial
benzathine benzylpenicillin
powder for injection, 1.44 g benzylpenicillin (=2.4 million
IU) in 5-ml vial
benzylpenicillin
powder for injection, 600 mg (= 1 million IU), 3 g (= 5
million IU) (sodium or potassium salt) in vial
‫ٱ‬
cloxacillin
capsule, 500 mg, 1 g (as sodium salt); powder for oral
solution, 125 mg (as sodium salt)/5 ml; powder for injection,
500 mg (as sodium salt) in vial
phenoxymethylpenicillin
tablet, 250 mg (as potassium salt); powder for oral
suspension, 250 mg (as potassium salt)/5 ml
procaine benzylpenicillin
powder for injection, 1 g (=1 million IU), 3 g (=3 million IU)
in vial
Complementary List
ceftazidime
powder for injection, 250 mg (as pentahydrate) in vial
‫ٱ‬
ceftriaxone
powder for injection, 250 mg (as sodium salt) in vial
imipenem * + cilastatin *
powder for injection 250 mg (as monohydrate) + 250 mg (as
sodium salt), 500 mg (as monohydrate) + 500 mg (as sodium
salt) in vial
* the public health relevance and/or efficacy and/or safety of
Essential Drugs Programs of Selected African Countries
122
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
6.2.2 Other antibacterials
azithromycin *
capsule, 250 mg or 500 mg; suspension 200 mg/5 ml
* only listed for single dose treatment of genital
C.trachomatis and of trachoma.
chloramphenicol
capsule, 250 mg; oral suspension, 150 mg (as palmitate)/5
ml; powder for injection, 1 g (sodium succinate) in vial; oily
suspension for injection 0.5 g (as sodium succinate)/ml in 2ml ampoule
‫ٱ‬
ciprofloxacin *
tablet 250 mg (as hydrochloride)
* final selection depends on indication for use
doxycycline *
capsule or tablet, 100 mg (hydrochloride)
* final selection depends on indication for use
‫ٱ‬
erythromycin
capsule or tablet, 250 mg (as stearate or ethyl succinate) ;
powder for oral suspension, 125 mg (as stearate or ethyl
succinate); powder for injection, 500 mg (as lactobionate) in
vial
‫ٱ‬
gentamicin *
injection, 10 mg, 40 mg (as sulfate)/ml in 2-ml vial
* final selection depends on indication for use
‫ٱ‬
metronidazole
tablet, 200-500 mg; injection, 500 mg in 100-ml vial;
suppository, 500 mg, 1 g; oral suspension, 200 mg (as
benzoate)/5 ml
nalidixic acid *
tablet 250 mg, 500 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
nitrofurantoin
tablet, 100 mg
spectinomycin *
powder for injection, 2 g (as hydrochloride) in vial
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
sulfamethoxazole +
trimethoprim
tablet, 100 mg + 20 mg, 400 mg + 80 mg; oral suspension,
200 mg + 40 mg/5 ml; injection, 80 mg + 16 mg/ml in 5-ml
and 10-ml ampoules
trimethoprim
tablet, 100 mg, 200 mg
Essential Drugs Programs of Selected African Countries
123
Complementary List
clindamycin
capsule, 150 mg; injection, 150 mg (as phosphate)/ml
sulfadiazine
tablet, 500 mg; injection, 250 mg (sodium salt) in 4-ml
ampoule
vancomycin
powder for injection, 250 mg (as hydrochloride) in vial
6.2.3 Antileprosy medicines
Medicines used in the treatment of leprosy should never be used except in combination.
Combination therapy is essential to prevent the emergence of drug resistance. Colour coded
blister packs (MDT blister packs) containing standard two medicine (paucibacillary leprosy) or
three medicine (multibacillary leprosy) combinations for adult and childhood leprosy should be
used. MDT blister packs can be supplied free of charge through WHO.
clofazimine
capsule, 50 mg, 100 mg
dapsone
tablet, 25 mg, 50 mg, 100 mg
rifampicin
capsule or tablet, 150 mg, 300 mg
6.2.4 Antituberculosis medicines
ethambutol
tablet, 100 mg-400 mg (hydrochloride)
isoniazid
tablet, 100 -300 mg
isoniazid + ethambutol
tablet, 150 mg + 400 mg
pyrazinamide
tablet, 400 mg
rifampicin
capsule or tablet, 150 mg, 300 mg
rifampicin + isoniazid
tablet, 60 mg + 30 mg; 150 mg + 75 mg; 300 mg + 150 mg;
60 mg + 60 mg (For intermittent use three times weekly);
150 mg + 150 mg (For intermittent use three times weekly)
rifampicin + isoniazid +
pyrazinamide
tablet, 60 mg + 30 mg + 150 mg; 150 mg + 75 mg + 400 mg
150 mg + 150 mg + 500 mg (For intermittent use three times
weekly.)
rifampicin + isoniazid +
pyrazinamide + ethambutol
tablet, 150 mg + 75 mg +400 mg + 275 mg
streptomycin
powder for injection, 1 g (as sulfate) in vial
Complementary List
thioacetazone * +
isoniazid *
tablet, 50 mg + 100 mg; 150 mg + 300 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
Essential Drugs Programs of Selected African Countries
124
Reserve second-line drugs for the treatment of multidrug-resistant tuberculosis (MDR-TB)
should be used in specialized centres adhering to WHO standards for TB control. (D)
amikacin
powder for injection, 1000 mg in vial
p-aminosalicylic acid
tablet, 500 mg; granules, 4 g in sachet
capreomycin
powder for injection, 1000 mg in vial
ciprofloxacin
tablet, 250 mg, 500 mg
cycloserine
capsule or tablet, 250 mg
ethionamide
tablet, 125 mg, 250 mg
kanamycin
powder for injection, 1000 mg in vial
levofloxacin *
tablet, 250 mg, 500 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
ofloxacin
tablet, 200 mg, 400 mg
6.3 Antifungal medicines
‫ٱ‬
fluconazole
capsule 50 mg; injection 2 mg/ml in vial; oral suspension 50
mg/5-ml
griseofulvin
capsule or tablet, 125 mg, 250 mg
nystatin
tablet, 100 000, 500 000 IU; lozenge 100 000 IU;
pessary, 100 000 IU
Complementary List
amphotericin B
powder for injection, 50 mg in vial
flucytosine
capsule, 250 mg; infusion, 2.5 g in 250 ml
potassium iodide
saturated solution
6.4 Antiviral medicines
6.4.1 Antiherpes medicines
‫ٱ‬
aciclovir
6.4.2 Antiretrovirals
tablet, 200 mg; powder for injection 250 mg (as sodium salt)
in vial
Essential Drugs Programs of Selected African Countries
125
Adequate resources and specialist oversight are a pre-requisite for the introduction of this class
of drugs. The antiretroviral drugs do not cure the HIV infection, they only temporarily suppress
viral replication and improve symptoms. They have various adverse effects and patients
receiving these drugs require careful monitoring by adequately trained health professionals. For
these reasons, continued rigorous promotion of measures to prevent new infections is essential
and the need for this has not been diminished in any way by the addition of antiretroviral drugs
to the Model List. Adequate resources and trained health professionals are a prerequisite for the
introduction of this class of drugs. Effective therapy requires commencement of three or four
drugs simultaneously, and alternative regimens are necessary to meet specific requirements at
start-up, to substitute for first-line regimens in the case of toxicity, or to replace failing
regimens. The Committee strongly recommends the use of three- or four-drug combinations as
specifically recommended in the WHO treatment guidelines. The use of fixed dose preparations
for these combinations is also recommended, with assured pharmaceutical quality and
interchangeability with the single products as approved by the relevant drug regulatory
authority.
6.4.2.1 Nucleoside reverse transcriptase inhibitors
abacavir (ABC)
tablet, 300mg (as sulfate), oral solution, 100mg (as
sulfate)/5ml
didanosine (ddI)
buffered chewable, dispersible tablet, 25mg, 50mg, 100mg,
150mg, 200mg
buffered powder for oral solution, 100mg, 167mg, 250mg
packets
unbuffered enteric coated capsule, 125mg, 200mg, 250mg,
400mg
lamivudine (3TC)
tablet, 150mg, oral solution 50 mg/5ml
stavudine (d4T)
capsule 15mg, 20mg, 30mg, 40mg, powder for oral solution,
5mg/5ml
zidovudine (ZDV or AZT)
tablet, 300mg
capsule 100 mg, 250 mg
oral solution or syrup, 50mg/5ml
solution for IV infusion injection, 10 mg/ml in 20-ml vial
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors
efavirenz (EFV or EFZ)
capsule, 50mg, 100mg, 200mg
oral solution, 150mg/5ml
nevirapine (NVP)
tablet 200 mg; oral suspension 50 mg/5-ml
6.4.2.3 Protease inhibitors
Selection of two or three protease inhibitors from the Model List will need to be determined by
each country after consideration of local treatment guidelines and experience, as well as the
comparative costs of available products. Ritonavir is recommended for use in combination with
indinavir, lopinavir and saquinavir as a booster, and not as a drug in its own right.
indinavir (IDV)
capsule, 200mg, 333mg, 400mg (as sulfate)
Essential Drugs Programs of Selected African Countries
126
ritonavir
capsule, 100mg, oral solution 400mg/5ml
lopinavir + ritonavir (LPV/r)
capsule, 133.3mg + 33.3mg, oral solution, 400mg +
100mg/5ml
nelfinavir (NFV)
tablet, 250mg (as mesilate), oral powder 50mg/g
saquinavir (SQV)
capsule, 200mg
6.5 Antiprotozoal medicines
6.5.1 Antiamoebic and antigiardiasis medicines
diloxanide
tablet, 500 mg (furoate)
‫ٱ‬
tablet, 200-500 mg; injection, 500 mg in 100-ml vial; oral
suspension 200 mg (as benzoate)/5 ml
metronidazole
6.5.2 Antileishmaniasis medicines
‫ٱ‬
meglumine antimoniate
injection, 30%, equivalent to approximately 8.1% antimony,
in 5-ml ampoule
Complementary List
amphotericin B
powder for injection, 50 mg in vial
pentamidine
powder for injection, 200 mg, 300 mg (isetionate) in vial
6.5.3 Antimalarial medicines
6.5.3.1 For curative treatment
Medicines for the treatment of P. falciparum malaria cases should be used in combination.
amodiaquine *
tablet, 153 mg or 200 mg (base)
* amodiaquine should preferably be used as part of
combination therapy
artemether + lumefantrine *
tablet, 20 mg + 120 mg
* recommended for use in areas with significant drug
resistance and not in pregnancy or in children below 10kg
chloroquine
tablet 100 mg, 150 mg (as phosphate or sulfate); syrup, 50
mg (as phosphate or sulfate)/5 ml; injection 40 mg (as
hydrochloride, phosphate or sulfate)/ml in 5-ml ampoule
primaquine
tablet, 7.5 mg, 15 mg (as diphosphate)
quinine
tablet, 300 mg (as bisulfate or sulfate); injection, 300 mg (as
dihydrochloride)/ml in 2-ml ampoule
Complementary List
artemether
injection, 80 mg/ml in 1-ml ampoule
Essential Drugs Programs of Selected African Countries
127
artesunate
tablet, 50 mg
doxycycline
capsule or tablet, 100 mg (hydrochloride)
(for use only in combination with quinine)
mefloquine
tablet, 250 mg (as hydrochloride)
sulfadoxine + pyrimethamine
tablet, 500 mg + 25 mg
6.5.3.2 For prophylaxis
chloroquine
tablet, 150 mg (as phosphate or sulfate); syrup, 50 mg (as
phosphate or sulfate)/5 ml
doxycycline
capsule or tablet, 100 mg ( hydrochloride)
mefloquine
tablet, 250 mg (as hydrochloride)
proguanil
tablet, 100 mg (hydrochloride)
(for use only in combination with chloroquine)
6.5.4 Anti-pneumocystosis and antitoxoplasmosis medicines
pyrimethamine
tablet, 25 mg
sulfamethoxazole +
trimethoprim
injection 80 mg + 16 mg/ml in 5-ml ampoule
80 mg + 16 mg/ml in 10-ml ampoule
Complementary List
pentamidine
tablet 200 mg, 300 mg
6.5.5. Antitrypanosomal medicines
6.5.5.1 African trypanosomiasis
melarsoprol
injection, 3.6% solution
suramin sodium
powder for injection, 1 g in vial
Complementary List
eflornithine
injection, 200 mg ( hydrochloride)/ml in 100-ml bottles
pentamidine
powder for injection, 200 mg, 300 mg (isetionate) in vial
6.5.5.2 American trypanosomiasis
benznidazole
tablet, 100 mg
nifurtimox
tablet, 30 mg; 120 mg; 250 mg
6.6 Insect repellents
diethyltoluamide *
topical solution, 50%, 75%
* the place of this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert Committee.
Essential Drugs Programs of Selected African Countries
128
7. ANTIMIGRAINE MEDICINES
7.1 For treatment of acute attack
acetylsalicylic acid
tablet, 300 -500 mg
ergotamine *
tablet, 1 mg (tartrate)
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
paracetamol
tablet, 300-500 mg
7.2 For prophylaxis
‫ٱ‬
propranolol
tablet, 20 mg, 40 mg (hydrochloride)
8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES AND MEDICINES
USED IN PALLIATIVE CARE
8.1 Immunosuppressive medicines
Complementary List
azathioprine
tablet, 50 mg; powder for injection, 100 mg (as sodium salt)
in vial
ciclosporin
capsule, 25 mg; concentrate for injection 50 mg/ml in 1-ml
ampoule for organ transplantation
8.2 Cytotoxic medicines
Complementary List
asparaginase
powder for injection, 10 000 IU in vial
bleomycin
powder for injection, 15 mg (as sulfate) in vial
calcium folinate
tablet, 15 mg; injection, 3 mg/ml in 10-ml ampoule
chlorambucil
tablet 2 mg
chlormethine
powder for injection, 10 mg (hydrochloride) in vial
cisplatin
powder for injection, 10 mg, 50 mg in vial
cyclophosphamide
tablet, 25 mg; powder for injection, 500 mg in vial
cytarabine
powder for injection, 100 mg in vial
dacarbazine
powder for injection, 100 mg in vial
dactinomycin
powder for injection, 500 micrograms in vial
daunorubicin
powder for injection, 50 mg (as hydrochloride)
Essential Drugs Programs of Selected African Countries
129
doxorubicin
powder for injection, 10 mg, 50 mg (hydrochloride) in vial
etoposide
capsule, 100 mg; injection, 20 mg/ml in 5-ml ampoule
fluorouracil
injection, 50 mg/ml in 5-ml ampoule
levamisole
tablet, 50 mg (as hydrochloride)
mercaptopurine
tablet, 50 mg
methotrexate
tablet, 2.5 mg (as sodium salt); powder for injection, 50 mg
(as sodium salt) in vial
procarbazine
capsule, 50 mg (as hydrochloride)
vinblastine
powder for injection, 10 mg (sulfate) in vial
vincristine
powder for injection, 1 mg, 5 mg (sulfate) in vial
8.3 Hormones and antihormones
Complementary List
dexamethasone
injection, 4 mg dexamethasone phosphate (as disodium salt)
in 1-ml ampoule
hydrocortisone
powder for injection, 100 mg (as sodium succinate) in vial
‫ٱ‬
prednisolone *
tablet, 5 mg, 25 mg
* there is no evidence for complete clinical similarity
between prednisolone and dexamethasone at high doses.
tamoxifen
tablet, 10 mg, 20 mg (as citrate)
8.4 Medicines used in palliative care
The WHO Expert Committee on the Use of Essential Drugs recommended that all the drugs
mentioned in the WHO publication Cancer Pain Relief: with a Guide to Opioid Availability,
second edition, be considered essential. The drugs are included in the relevant sections of the
Model List, according to their therapeutic use, e.g. analgesics.
9. ANTIPARKINSONISM MEDICINES
‫ٱ‬
tablet, 2 mg (hydrochloride); injection, 5 mg (lactate) in 1-ml
ampoule
biperiden
‫ٱ‬
levodopa + carbidopa
tablet, 100 mg + 10 mg; 250 mg + 25 mg
10. MEDICINES AFFECTING THE BLOOD
10.1 Antianaemia medicines
ferrous salt
tablet, equivalent to 60 mg iron; oral solution equivalent to
25 mg iron (as sulfate)/ml
Essential Drugs Programs of Selected African Countries
130
ferrous salt + folic acid
tablet equivalent to 60 mg iron + 400 micrograms folic acid
(nutritional supplement for use during pregnancy.)
folic acid
tablet 1mg, 5mg
hydroxocobalamin
injection, 1 mg in 1-ml ampoule
10.2 Medicines affecting coagulation
heparin sodium
injection, 1000 IU/ml, 5000 IU/ml, 20,000 IU/ml in 1-ml
ampoule
phytomenadione
injection, 10 mg/ml in 5-ml ampoule; tablet, 10 mg
protamine sulfate
injection, 10 mg/ml in 5-ml ampoule
‫ٱ‬
tablet, 1 mg, 2 mg and 5 mg (sodium salt)
warfarin
11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES
11.1 Plasma substitutes
‫ٱ‬
dextran 70
injectable solution, 6%
‫ٱ‬
polygeline *
injectable solution, 3.5%
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
11.2 Plasma fractions for specific use
All plasma fractions should comply with the WHO Requirements for the Collection, Processing
and Quality Control of Blood, Blood Components, and Plasma Derivatives (Revised 1992).
(WHO Technical Report Series, No. 840, 1994, Annex 2).
Complementary List
‫ٱ‬
factor VIII concentrate *
dried
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee. (rare disease)
factor IX complex coagulation
factors, II, VII, IX, X)
concentrate *
dried
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee. (rare disease)
‫ٱ‬
12. CARDIOVASCULAR MEDICINES
12.1 Antianginal medicines
Essential Drugs Programs of Selected African Countries
131
‫ٱ‬
atenolol
tablet, 50 mg, 100 mg
glyceryl trinitrate
tablet (sublingual), 500 micrograms
‫ٱ‬
isosorbide dinitrate
tablet (sublingual), 5 mg
verapamil
tablet, 40 mg, 80 mg (hydrochloride)
12.2 Antiarrhythmic medicines
‫ٱ‬
atenolol
tablet, 50 mg, 100 mg
digoxin
tablet, 62.5 micrograms, 250 micrograms; oral solution 50
micrograms/ml; injection 250 micrograms/ml in 2-ml
ampoule
epinephrine (adrenaline)
injection, 1 mg (as hydrochloride)/ml in ampoule
lidocaine
injection, 20 mg (hydrochloride)/ml in 5-ml ampoule
verapamil
tablet, 40 mg, 80 mg (hydrochloride); injection, 2.5 mg
(hydrochloride)/ml in 2-ml ampoule
Complementary List
isoprenaline *
injection, 20 micrograms (hydrochloride)/ml in ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
‫ٱ‬
procainamide*
injection, 100 mg (hydrochloride)/ml in 10-ml ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
‫ٱ‬
quinidine *
tablet, 200 mg (sulfate)
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
12.3 Antihypertensive medicines
‫ٱ‬
atenolol
tablet, 50 mg, 100 mg
‫ٱ‬
enalapril
tablet, 2.5 mg
hydralazine*
tablet, 25 mg, 50 mg (hydrochloride); powder for injection,
20 mg (hydrochloride) in ampoule
* hydralazine is listed for use in the acute management of
severe pregnancy-induced hypertension only. Its use in the
treatment of essential hypertension is not recommended in
Essential Drugs Programs of Selected African Countries
132
view of the availability of more evidence of efficacy and
safety of other medicines.
‫ٱ‬
hydrochlorothiazide
scored tablet, 25 mg
methyldopa *
tablet, 250 mg
* methyldopa is listed for use in the management of
pregnancy-induced hypertension only. Its use in the
treatment of essential hypertension is not recommended in
view of the availability of more evidence of efficacy and
safety of other medicines.
‫ٱ‬
sustained release formulations, tablet 10 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
nifedipine *
Complementary List
sodium nitroprusside
powder for infusion, 50 mg in ampoule
12.4 Medicines used in heart failure
digoxin
tablet, 62.5 micrograms, 250 micrograms; oral solution, 50
micrograms/ml; injection, 250 micrograms/ml in 2-ml
ampoule
‫ٱ‬
enalapril
tablet, 2.5 mg
‫ٱ‬
hydrochlorothiazide
scored tablet, 25 mg
Complementary List
dopamine
injection, 40 mg (hydrochloride)in 5-ml vial
12.5 Antithrombotic medicines
acetylsalicylic acid
tablet, 100 mg
Complementary List
streptokinase
12.6 Lipid-lowering agents
powder for injection, 1.5 million IU in vial
Essential Drugs Programs of Selected African Countries
133
The WHO Expert Committee on Use of Essential Drugs recognizes the value of lipid-lowering
drugs in treating patients with hyperlipidaemia. HMG-CoA reductase inhibitors, often referred
to as "statins", are a family of potent and effective lipid-lowering drugs with a good tolerability
profile. Several of these drugs have been shown to reduce the incidence of fatal and non-fatal
myocardial infarction, stroke and mortality (all causes), as well as the need for coronary by-pass
surgery . All remain very costly but may be cost effective for secondary prevention of
cardiovascular disease as well as for primary prevention in some very high-risk patients. Since
no single drug has been shown to be significantly more effective or less expensive than others
in the group, none is included in the Model List; the choice of drug for use in patients at highest
risk should be decided at the national level.
13. DERMATOLOGICAL MEDICINES (topical)
13.1 Antifungal medicines
benzoic acid + salicylic acid
ointment or cream, 6% + 3%
‫ٱ‬
miconazole
ointment or cream, 2% (nitrate)
sodium thiosulfate
solution, 15%
Complementary List
selenium sulfide
detergent-based suspension, 2%
13.2 Anti-infective medicines
‫ٱ‬
methylrosanilinium chloride
(gentian violet)
‫ٱ‬
aqueous solution, 0.5%; tincture, 0.5%
neomycin sulfate + bacitracin
ointment, 5 mg neomycin sulfate + 500 IU bacitracin zinc/g
potassium permanganate
aqueous solution 1:10 000
silver sulfadiazine
cream, 1%, in 500-g container
13.3 Anti-inflammatory and antipruritic medicines
‫ٱ‬
betamethasone
ointment or cream, 0.1% (as valerate)
‫ٱ‬
calamine lotion
lotion
‫ٱ‬
hydrocortisone
ointment or cream, 1% (acetate)
13.4 Astringent medicines
aluminium diacetate
solution, 13% for dilution
13.5 Medicines affecting skin differentiation and proliferation
benzoyl peroxide
lotion or cream, 5%
coal tar
solution, 5%
dithranol
ointment, 0.1%-2%
Essential Drugs Programs of Selected African Countries
134
fluorouracil
ointment, 5%
‫ٱ‬
podophyllum resin
solution, 10-25%
salicylic acid
solution 5%
urea
ointment or cream, 10%
13.6 Scabicides and pediculicides
‫ٱ‬
benzyl benzoate
lotion, 25%
permethrin
cream 5%; lotion 1%
13.7 Ultraviolet blocking agents
Complementary List
topical sun protection agent
with activity against ultraviolet
A and
ultraviolet B *
cream, lotion or gel
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
14. DIAGNOSTIC AGENTS
14.1 Ophthalmic medicines
fluorescein
eye drops, 1% (sodium salt)
‫ٱ‬
eye drops, 0.5%
tropicamide
14.2 Radiocontrast media
‫ٱ‬
amidotrizoate
injection, 140-420 mg iodine (as sodium or meglumine
salt)/ml in 20-ml ampoule
barium sulfate
aqueous suspension
‫ٱ‬
iohexol
injection 140 –350 mg iodine/ml in 5-ml, 10-ml and 20-ml
ampoule
‫ٱ‬
iopanoic acid
tablet, 500 mg
‫ٱ‬
propyliodone
oily suspension, 500-600 mg/ml in 20-ml ampoule (For
administration only into the bronchial tree.)
Complementary List
‫ٱ‬
meglumine iotroxate
solution, 5-8 g iodine in 100-250 ml
15. DISINFECTANTS AND ANTISEPTICS
15.1 Antiseptics
Essential Drugs Programs of Selected African Countries
135
‫ٱ‬
chlorhexidine
solution, 5% ( digluconate) for dilution
‫ٱ‬
ethanol
solution, 70% (denatured)
‫ٱ‬
polyvidone iodine
solution, 10%
15.2 Disinfectants
‫ٱ‬
chlorine base compound
powder (0.1% available chlorine) for solution
‫ٱ‬
chloroxylenol
solution, 4.8%
glutaral
solution, 2%
16. DIURETICS
amiloride
tablet, 5 mg (hydrochloride)
‫ٱ‬
furosemide
tablet, 40 mg; injection, 10 mg/ml in 2-ml ampoule
‫ٱ‬
hydrochlorothiazide
scored tablet, 25 mg
mannitol
injectable solution, 10%, 20%
spironolactone
tablet, 25 mg
17. GASTROINTESTINAL MEDICINES
17.1 Antacids and other antiulcer medicines
aluminium hydroxide
tablet, 500 mg; oral suspension, 320 mg/5 ml
‫ٱ‬
ranitidine
tablet, 150 mg (as hydrochloride); oral solution 75 mg/5-ml;
injection, 25 mg/ml in 2-ml ampoule
magnesium hydroxide
oral suspension, equivalent to 550 mg magnesium oxide/10
ml
17.2 Antiemetic medicines
metoclopramide
tablet, 10 mg (hydrochloride); injection, 5 mg
(hydrochloride)/ml in 2-ml ampoule
promethazine
tablet, 10 mg, 25 mg (hydrochloride); elixir or syrup, 5 mg
(hydrochloride)/5 ml; injection, 25 mg (hydrochloride)/ml in
2-ml ampoule
17.3 Antihaemorrhoidal medicines
‫ٱ‬
local anaesthetic, astringent
and anti-inflammatory
medicine *
ointment or suppository
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
Essential Drugs Programs of Selected African Countries
136
17.4 Anti-inflammatory medicines
‫ٱ‬
sulfasalazine
tablet, 500 mg; suppository 500 mg; retention enema
Complementary List
‫ٱ‬
hydrocortisone
suppository 25 mg (acetate); retention enema
‫ٱ‬
(the only applies to hydrocortisone retention enema)
17.5 Antispasmodic medicines
‫ٱ‬
atropine *
tablet, 1 mg (sulfate); injection, 1 mg (sulfate) in 1-ml
ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
17.6 Laxatives
‫ٱ‬
senna
tablet, 7.5 mg (sennosides) (or traditional dosage forms)
17.7 Medicines used in diarrhoea
17.7.1 Oral rehydration
oral rehydration salts * (for
glucose-electrolyte solution)
glucose:
sodium:
chloride:
potassium:
citrate:
osmolarity:
glucose:
sodium chloride:
potassium chloride:
trisodium citrate dihydrate+:
75 mEq
75 mEq or mmol/l
65 mEq or mmol/l
20 mEq or mmol/l
10 mmol/l
245 mOsm/l
13.5 g/l
2.6 g/l
1.5 g/l
2.9 g/l
+ trisodium citrate dihydrate may be replaced by sodium
hydrogen carbonate (sodium bicarbonate) 2.5 g/l. However,
as the stability of this latter formulation is very poor under
tropical conditions, it is only recommended when
manufactured for immediate use.
* in cases of cholera a higher concentration of sodium may
be required
17.7.2 Antidiarrhoeal (symptomatic) medicines
codeine *
tablet, 30 mg (phosphate)
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
Essential Drugs Programs of Selected African Countries
137
18. HORMONES, OTHER ENDOCRINE MEDICINES AND
CONTRACEPTIVES
18.1 Adrenal hormones and synthetic substitutes
Addison’s disease is a rare condition; adrenal hormones are already included in section 3.
18.2 Androgens
Complementary List
testosterone
injection, 200 mg (enantate) in 1-ml ampoule
18.3 Contraceptives
18.3.1 Hormonal contraceptives
‫ٱ‬
ethinylestradiol +
levonorgestrel
tablet, 30 micrograms + 150 micrograms
ethinylestradiol +
norethisterone
tablet, 35 micrograms + 1.0 mg
levonorgestrel
tablet, 30 micrograms, 750 micrograms (pack of two), 1.5 mg
norethisterone enantate
oily solution, 200 mg/ml in 1-ml ampoule
‫ٱ‬
‫ٱ‬
‫ٱ‬
Complementary List
medroxyprogesterone acetate
depot injection, 150 mg/ml in 1-ml vial
18.3.2 Intrauterine devices
copper-containing device
18.3.3 Barrier methods
condoms
diaphragms
18.4 Estrogens
‫ٱ‬
ethinylestradiol
tablet, 10 micrograms, 50 micrograms
18.5 Insulins and other antidiabetic agents
glibenclamide
tablet, 2.5 mg, 5 mg
insulin injection (soluble)
injection, 40 IU/ml in 10-ml vial, 100 IU/ml in 10-ml vial
intermediate-acting insulin
injection, 40 IU/ml in 10 ml vial; 100 IU/ml in 10 ml vial (as
compound insulin zinc suspension or isophane insulin)
metformin
tablet, 500 mg (hydrochloride)
Essential Drugs Programs of Selected African Countries
138
18.6 Ovulation inducers
Complementary List
clomifene
tablet, 50 mg (citrate)
18.7 Progestogens
norethisterone
tablet, 5 mg
Complementary List
medroxyprogesterone acetate *
tablet, 5 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
18.8 Thyroid hormones and antithyroid medicines
levothyroxine
tablet, 50 micrograms, 100 micrograms (sodium salt)
potassium iodide
tablet, 60 mg
‫ٱ‬
tablet, 50 mg
propylthiouracil
19. IMMUNOLOGICALS
19.1 Diagnostic agents
All tuberculins should comply with the WHO Requirements for Tuberculins (Revised 1985).
WHO Expert Committee on Biological Standardization Thirty-sixth report, (WHO Technical
Report Series, No. 745, 1987, Annex 1).
tuberculin, purified protein
derivative (PPD)
injection
19.2 Sera and immunoglobulins
All plasma fractions should comply with the WHO Requirements for the Collection, Processing
and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992).
WHO Expert Committee on Biological Standardization Forty-third report, (WHO Technical
Report Series, No. 840, 1994, Annex 2).
anti-D immunoglobulin
(human)
injection, 250 micrograms in single-dose vial
antitetanus immunoglobulin
(human)
injection, 500 IU in vial
antivenom serum *
injection
* exact type to be defined locally
diphtheria antitoxin
injection, 10 000 IU, 20 000 IU in vial
Essential Drugs Programs of Selected African Countries
139
‫ٱ‬
rabies immunoglobulin
injection, 150 IU/ml in vial
19.3 Vaccines
All vaccines should comply with the WHO Requirements for Biological Substances.
19.3.1 For universal immunization
BCG vaccine
diphtheria vaccine
hepatitis B vaccine
measles vaccine
pertussis vaccine
poliomyelitis vaccine
tetanus vaccine
19.3.2 For specific groups of individuals
influenza vaccine
meningococcal meningitis
vaccine
mumps vaccine
rabies vaccine (inactivated:
prepared in cell culture)
rubella vaccine
typhoid vaccine
yellow fever vaccine
20. MUSCLE RELAXANTS (PERIPHERALLY ACTING) AND
CHOLINESTERASE INHIBITORS
‫ٱ‬
alcuronium
injection, 5 mg (chloride)/ml in 2-ml ampoule
neostigmine
tablet, 15 mg (bromide); injection, 500 micrograms in 1-ml
ampoule; 2.5 mg (metilsulfate) in 1-ml ampoule
suxamethonium
injection, 50 mg (chloride)/ml in 2-ml ampoule;
powder for injection (chloride), in vial
Complementary List
pyridostigmine
tablet, 60 mg (bromide); injection, 1 mg in 1-ml ampoule
vecuronium
powder for injection, 10 mg (bromide) in vial
Essential Drugs Programs of Selected African Countries
140
21. OPHTHALMOLOGICAL PREPARATIONS
21.1 Anti-infective agents
‫ٱ‬
gentamicin *
solution (eye drops), 0.3% (sulfate)
* final selection depends on indication for use
‫ٱ‬
idoxuridine
solution (eye drops), 0.1%; eye ointment, 0.2%
silver nitrate *
solution (eye drops), 1%
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
‫ٱ‬
eye ointment, 1% (hydrochloride)
tetracycline
21.2 Anti-inflammatory agents
‫ٱ‬
prednisolone
solution (eye drops), 0.5% (sodium phosphate)
21.3 Local anaesthetics
‫ٱ‬
tetracaine
solution (eye drops), 0.5% (hydrochloride)
21.4 Miotics and antiglaucoma medicines
acetazolamide
tablet, 250 mg
‫ٱ‬
pilocarpine
solution (eye drops), 2%, 4% (hydrochloride or nitrate)
‫ٱ‬
timolol
solution (eye drops), 0.25%, 0.5% (as maleate)
21.5 Mydriatics
atropine
solution (eye drops), 0.1%; 0.5%, 1% (sulfate)
Complementary List
epinephrine (adrenaline)
solution (eye drops), 2% (as hydrochloride)
22. OXYTOCICS AND ANTIOXYTOCICS
22.1 Oxytocics
‫ٱ‬
ergometrine *
tablet, 200 micrograms (hydrogen maleate); injection, 200
micrograms (hydrogen maleate) in 1-ml ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
oxytocin
injection, 10 IU in 1-ml ampoule
22.2 Antioxytocics
Essential Drugs Programs of Selected African Countries
141
‫ٱ‬
salbutamol *
tablet, 4 mg (as sulfate); injection, 50 micrograms (as
sulfate)/ml in 5-ml ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
23. PERITONEAL DIALYSIS SOLUTION
Complementary List
intraperitoneal dialysis
solution (of appropriate
composition)
parenteral solution
24. PSYCHOTHERAPEUTIC MEDICINES
24.1 Medicines used in psychotic disorders
‫ٱ‬
chlorpromazine
tablet, 100 mg (hydrochloride); syrup, 25 mg
(hydrochloride)/5ml; injection, 25 mg (hydrochloride)/ml in
2-ml ampoule
‫ٱ‬
fluphenazine
injection, 25 mg (decanoate or enantate) in 1-ml ampoule
‫ٱ‬
haloperidol
tablet, 2 mg, 5 mg; injection, 5 mg in 1-ml ampoule
24.2 Medicines used in mood disorders
24.2.1 Medicines used in depressive disorders
‫ٱ‬
amitriptyline
tablet, 25 mg (hydrochloride)
24.2.2 Medicines used in bipolar disorders
carbamazepine
scored tablet, 100 mg, 200 mg
lithium carbonate
capsule or tablet, 300 mg
valproic acid
enteric coated tablet, 200 mg, 500 mg (sodium salt)
24.3 Medicines used in generalized anxiety and sleep disorders
‫ٱ‬
diazepam
scored tablet, 2 mg, 5 mg
24.4 Medicines used for obsessive compulsive disorders and panic attacks
clomipramine
capsules, 10 mg, 25 mg (hydrochloride)
25. MEDICINES ACTING ON THE RESPIRATORY TRACT
Antiasthmatic and medicines for chronic obstructive pulmonary disease
‫ٱ‬
beclometasone
inhalation (aerosol), 50 micrograms per dose (dipropionate);
250 micrograms (dipropionate) per dose
Essential Drugs Programs of Selected African Countries
142
epinephrine (adrenaline)
injection, 1 mg (as hydrochloride or hydrogen tartrate) in 1ml ampoule
ipratropium bromide
inhalation (aerosol), 20 micrograms/metered dose
‫ٱ‬
salbutamol
tablet, 2 mg, 4 mg (as sulfate); inhalation (aerosol), 100
micrograms (as sulfate) per dose; syrup, 2 mg/5 ml; injection,
50 micrograms (as sulfate)/ml in 5-ml ampoule; respirator
solution for use in nebulizers, 5 mg (as sulfate)/ml
theophylline *
tablet, 100 mg, 200 mg, 300 mg
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
Complementary List
‫ٱ‬
aminophylline *
injection, 25 mg/ml in 10 ml ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
‫ٱ‬
cromoglicic acid *
inhalation (aerosol), 20 mg (sodium salt) per dose
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND
ACID-BASE DISTURBANCES
26.1 Oral
oral rehydration salts (for
glucose-electrolyte solution)
see section 17.7.1
potassium chloride
powder for solution
26.2 Parenteral
glucose
injectable solution, 5%, 10% isotonic; 50% hypertonic
glucose with sodium chloride
injectable solution, 4% glucose, 0.18% sodium chloride
(equivalent to Na+ 30 mmol/l, Cl- 30 mmol/l)
potassium chloride
solution, 11.2% in 20-ml ampoule, (equivalent to K+ 1.5
mmol/ml, Cl- 1.5 mmol/ml)
sodium chloride
injectable solution, 0.9% isotonic (equivalent to Na+ 154
mmol/l, Cl- 154 mmol/l
sodium hydrogen carbonate
injectable solution, 1.4% isotonic (equivalent to Na+ 167
Essential Drugs Programs of Selected African Countries
143
mmol/l, HCO3- 167 mmol/l); solution, 8.4% in 10-ml
ampoule (equivalent to Na+ 1000 mmol/l, HCO3-1000
mmol/l)
‫ٱ‬
sodium lactate, compound
solution
injectable solution
26.3 Miscellaneous
water for injection
2-ml, 5-ml, 10-ml ampoules
27. VITAMINS AND MINERALS
ascorbic acid
tablet, 50 mg
‫ٱ‬
ergocalciferol
capsule or tablet, 1.25 mg (50 000 IU); oral solution, 250
micrograms/ml (10 000 IU/ml)
iodine
iodized oil, 1 ml (480 mg iodine), 0.5 ml (240 mg iodine) in
ampoule (oral or injectable); 0.57 ml (308 mg iodine) in
dispenser bottle; capsule, 200 mg.
‫ٱ‬
nicotinamide
tablet, 50 mg
pyridoxine
tablet, 25 mg (hydrochloride)
retinol
sugar-coated tablet, 10 000 IU (as palmitate) (5.5 mg);
capsule,
200 000 IU (as palmitate) (110 mg); oral oily solution 100
000 IU (as palmitate)/ml in multidose dispenser; watermiscible injection 100 000 IU (as palmitate) (55 mg) in 2-ml
ampoule
riboflavin
tablet, 5 mg
‫ٱ‬
sodium fluoride *
in any appropriate formulation
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.
thiamine
tablet, 50 mg (hydrochloride)
Complementary List
calcium gluconate *
injection, 100 mg/ml in 10-ml ampoule
* the public health relevance and/or efficacy and/or safety of
this item has been questioned and its continued inclusion on
the list will be reviewed at the next meeting of the Expert
Committee.