CHAPTER # 02 INTRODUCTION TO ESSENTIAL DRUGS

INTRODUCTION TO ESSENTIAL DRUGS

INTRODUCTION:

DEFINITION:

Essential medicines:

Essential medicines, as defined by the World Health Organization (WHO) are "those drugs that
satisfy the health care needs of the majority of the population; they should therefore be available
at all times in adequate amounts and in appropriate dosage forms, at a price the community can
afford."

Essential medicines list:

“A list of medicines or drugs category in accordance with their generic name (s), presented by a
committee from WHO comprised of qualified members, that fulfill basic healthcare needs of
majority of population in comparatively cost effective manner.

EXPLANATION:

Essential medicines are those 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 within 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 the
community can afford. The implementation of the concept of essential medicines is intended to
be flexible and adaptable to many different situations. Careful selection of a limited range of
essential medicines results in a higher quality of care, better management of medicines
(including improved quality of prescribed medicines) and more cost-effective use of health
resources.
The list of essential medicines relate closely to guidelines for clinical health care practice, which
are used for the training and supervision of health professionals. Lists of essential medicines also
guide the procurement and supply of medicines in the public sector, schemes that reimburse
medicine costs, medicine donations, and local medicine production.
The Essential Medicines List aims to identify cost-effective medicines for priority conditions,
together with the reasons for their inclusion, linked to evidence-based clinical guidelines and
with special emphasis on public health aspects and considerations of value of money.
The WHO has published a model list of essential medicines. Each country is encouraged to
prepare their own lists taking into consideration local priorities. At present there is over 150
countries have published an official essential medicines list. The WHO List contains a core list
and a complementary list.

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CHAPTER # 02 INTRODUCTION TO ESSENTIAL DRUGS

 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 cost-effectiveness
in a variety of settings.
The compilation of an essential medicines list enables health authorities, especially in developing
countries, to optimize pharmaceutical resources.

The list is important because:

 It forms the basis of national drugs policy in many countries, both developed and
developing (e.g. South Africa, Eritrea).
 Governments refer to WHO recommendations when making decisions on health
spending.
 This list is a dynamic list and revised every two years. The procedures for updating the
List are in line with the WHO recommended process for developing clinical practice
guidelines. Key components are a systematic approach to collecting and reviewing
evidence and a transparent development process with several rounds of review.

HISTORY OF EVALUTION OF ESSENTIAL MEDICINES LIST:

In 1897, aspirin was introduced as the first synthetic pharmaceutical. In the 100 years since, the
world has seen the introduction of the first modern antibiotic (1941), the first commercially
formulated antimalarial (1943), and the first antitubercular (1944). The 1950s saw the first
clinical use of oral contraceptives, of drugs for diabetes and of drugs for mental illness. The
development of drugs for other infectious diseases, for cardiovascular diseases and for a wide
range of other conditions quickly followed. When WHO published the first Model List of
Essential Drugs in 1977, it identified 208 individual medicines which together could provide
safe, effective treatment for the majority of communicable and non-communicable diseases.

The "WHO Model List of Essential Medicines" has been updated every two years since 1977.
The current version, the 17th, was published in 2011. There is also a "WHO Model List of
Essential Medicines for Children", whose third edition was also published in 2011.

A GLOBAL CONCEPT

The concept of essential medicines is forward-looking. It incorporates the need to regularly

update medicines selections to reflect new therapeutic options and changing therapeutic needs;
the need to ensure drug quality; and the need for continued development of better medicines,
medicines for emerging diseases, and medicines to meet changing resistance patterns.

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CHAPTER # 02 INTRODUCTION TO ESSENTIAL DRUGS

Essential medicines are intended to be available within the context of functioning health systems
at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a
price the individual and the community can afford.

The Model List is a guide for the development of national and institutional essential medicine
lists. It was not designed as a global standard. However, for the past 30 years the Model List has
led to a global acceptance of the concept of essential medicines as a powerful means to promote
health equity. Most countries have national lists and some have provincial or state lists as well.
National lists of essential medicines usually relate closely to national guidelines for clinical
health care practice which are used for the training and supervision of health workers.

CRITERIA FOR SELECTION OF ESSENTIAL MEDICINES

At the World Health Organization (WHO) the Expert Committee on the Selection and Use of
Essential Medicines makes recommendations about a model list of Essential Medicines, but no
country is expected to follow this directly. Each country makes decisions according to its own
needs. WHO makes sure the decision-making process is very transparent.

The important points of selection criteria are;

1. EML designing take place through official approval via committee comprises of various
members belonging to their area of specialization. Members of follow area (s) are
needed.
2. If any country do not have any relevant expert, an expert from WHO can become a
member of that committee.
3. The choice of essential medicines depends on several factors, including the public health
relevance and sound and adequate data on the efficacy, safety and comparative cost
effectiveness of available treatments. Stability in various conditions, the need for special
diagnostic or treatment facilities and pharmacokinetic properties are also considered if
appropriate.
4. When adequate scientific evidence is not available on current treatment of a priority
disease, the Expert Committee may either defer the issue until more evidence becomes
available, or choose to make recommendations based on expert opinion and experience.
Most essential medicines should be formulated as single compounds. Fixed-ratio
combination products are selected only when the combination has a proven advantage in
therapeutic effect, safety or compliance over single compounds administered separately.
5. Various medicines/drugs belonging to same group need to be selected on the basis of
benefit/risk ratio (comparatively).
6. If some member of same group have identical benefit/risk ratio values, then consider that
member, while having comparatively extended, justified data for;
 Safety profile
 Feasible pharmacokinetic profile
 Local manufacturing facilities existence.
Its example is beta blocker and Ca++ channel blockers.

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CHAPTER # 02 INTRODUCTION TO ESSENTIAL DRUGS

7. In cost comparisons between medicines, the cost of the total treatment, and not only the
unit cost of the medicine, is considered. Cost and cost-effectiveness comparisons may be
made among alternative treatments within the same therapeutic group, but generally not
be made across therapeutic categories (for example, between treatment of tuberculosis
and treatment of malaria). The absolute cost of the treatment will not constitute a reason
to exclude a medicine from the List that other wise meets the stated selected criteria. The
patent status of a medicine is not considered in selecting medicines for the List.
8. Selection of the medicine will on the basis of generic names.
9. Concerned country must have to facilitate the availability of EML through designing,
implementation and practicing all required activities for manufacturing, transportation,
storage and dispensing of all medicine enlisted there by.
10. If any fixed ratio of medicines are required to be presented and enlist in EML for any
disease, then it can only be included if;
 Proven data available for more effective in that proportion rather alone.
 More safer (in combination) as compare to respective member.
 Increase patient compliance through affordability, availability and acceptability.
11. Essential medicines list is preferably revisable every year, but must be after 2 years.

Other factors which are also considered factors such as local demography and pattern of disease,
treatment facilities, training and experience of the available personnel, local availability of
individual pharmaceutical products, financial resources, and environmental factors.

Selection of essential medicines at country level:

Selection of essential medicines at country level is a two step process.

1. Firstly governments have to decide, what medicines do you allow in your country?
Usually a national medicines regulatory agency or similar regulatory body decides this. It
selects what medicines are allowed onto a national market according to efficacy, safety
and quality of medicines made as part of good manufacturing practices. The medicine is
then on the market but it doesn’t necessarily mean that the government or national health
insurance scheme are going to fund it.
2. The next step of developing a national essential medicines list is for the government to
decide what medicines to stock, store and supply at different levels of hospitals and
clinics. It looks at which medicine is the most effective in its therapeutic class. It
compares costs, quality and effectiveness. This is what is called making an essential
medicines list and the list can contain between 100 and 600 items. For example, a full list
of 600 is enough for a teaching hospital, but a much smaller list is appropriate for a
district hospital, and smaller still for a local clinic.

This means the government decides which medicines to use when and where. The list should be
created according to clinical guidelines, and these guidelines should be evidence based. The
quality of the essential medicines list depends on the quality of the clinical guidelines.

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CHAPTER # 02 INTRODUCTION TO ESSENTIAL DRUGS

KEY FEATURES OF ESSENTIAL MEDICINE LIST:

These features are;

1. 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.
2. 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.
3. The square box symbol (􀂆) is 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. Not all square boxes are applicable to medicine selection for children.
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.
4. The a symbol indicates that there is an age or weight restriction on use of the medicine;
5. Where the [c] symbol is placed next to the complementary list it signifies that the
medicine(s) require(s) specialist diagnostic or monitoring facilities, and/or specialist
medical care, and/or specialist training for their use in children.
6. Where the [c] symbol is placed next to an individual medicine or strength of medicine it
signifies that there is a specific indication for restricting its use to children.
7. The presence of an entry on the Essential Medicines List carries no assurance as to
pharmaceutical quality. It is the responsibility of the relevant national or regional drug
regulatory authority to ensure that each product is of appropriate pharmaceutical quality
(including stability) and that when relevant, different products are interchangeable.
8. Medicines and dosage forms are listed in alphabetical order within each section and there
is no implication of preference for one form over another. Standard treatment guidelines
should be consulted for information on appropriate dosage forms.
9. The main terms used for dosage forms in the Essential Medicines List can be found in
Annex 1.
10. Definitions of many of these terms and pharmaceutical quality requirements applicable to
the different categories are published in the current edition of The International
Pharmacopoeia

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CHAPTER # 02 INTRODUCTION TO ESSENTIAL DRUGS

ADVANTAGES OF ESSENTIAL MEDICINES LIST:

The application /advantages of essential drug list are given below;

1. Promoting rational use: The selection of essential medicines is only one step to improve
the quality of health care. It should be followed by the appropriate use of the selected
medicines. Each individual should receive the right medicine, in an adequate dose for an
adequate duration, with appropriate information, planning of treatment follow up, and at
an affordable cost. For the safe, effective and prudent use of essential medicines,
relevant, reliable and independent medicines information should be available. Health care
professionals should receive education.
2. Quality of products: Priority is given to ensuring that available medicines have been
made according to good manufacturing practices and are of assured quality. Factors that
are to be considered are:
 Knowledge of, and confidence in the origin of the product;
 The pharmaceutical stability of the product, particularly in the environment that it
will be used.
 Where relevant, bioavailability and bioequivalence information.
 It is recommended that medicines be purchased from known manufacturers, their
duly accredited agents or recognized international agencies known to apply high
standards in selecting their suppliers.
3. Health care uniformity: With the help of EML, we can progress towards the healthcare
uniformity. Each individual will receive the right medicine, in an adequate dose for an
adequate duration.
4. Government liability for facilitation: By developing EML, it shows the government
liability for facilitating the population by reducing the monopoly of some peoples. It
helps in providing rational therapy.
5. Professionalism practicing: When there is essential medicine list available, it will bound
as well as facilitate physician to professionalism practicing.
6. Economical: The treatment should be economical. In cost comparisons between
medicines, the cost of the total treatment, and not only the unit cost of the medicine is
considered. Cost and cost-effectiveness comparisons may be made among alternative
treatments within the same therapeutic group, but generally not be made across
therapeutic categories (for example, between treatment of tuberculosis and treatment of
malaria). The absolute cost of the treatment will not constitute a reason to exclude a
medicine from the List that other wise meets the stated selected criteria.
7. Help in training and supervision of health workers: National lists of essential
medicines usually relate closely to national guidelines for clinical health care practice
which are used for the training and supervision of health workers.
8. Financial assistance: By this list, as we move towards the rational therapy, so the drug
should be cost effective. According to WHO guidelines, there should also some financial
assistance.

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AN EASY APPROACH TO CLINICAL PHARMACY