Eml (Essential Medicine list)

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    CHAPTER # 02

    ESSENTIAL MEDICINES LIST

    Contents

    Iftikhar Ahmmad

    Session: 2009-14

    Definition and introduction

    Essential characteristics of EML

    General concept

    Categories of medicines

    Selection criteria and steps involved

    Uses of EML

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    CHAPTER # 02 ESSENTIAL MEDICINE LIST

    Definition:

    WHO define essential medicines as

    Essential medicines are those that satisfy the health care needs of majority of the population.

    They should therefore be available at all times in adequate amount and in the appropriate dosage

    forms.

    After the Second World War the development of medicines like antibiotics brought a revolution

    in the medical care. The effectiveness of these new pharmaceuticals and intensive marketing

    efforts combined to catalyze wide spread use of modern medicine. However, by 1970s it had

    become clear that developing nations were not even meeting the basic needs of their people for

    essential life-saving and health promoting medicines. As a result gradually a number of countries

    started concentrating on the development of a basic list of reliable medicines to meet the most

    vital basic needs of their people.

    A World Health Organization (WHO) Committee of Experts met in 1977 to determine the

    number of medicines, which were actually needed to ensure a reasonable level of health care for

    as many people as possible. Consequently, the first Model List of Essential Medicines was

    finalized in the same year. This list is being updated regularly after every two years by the WHO

    i.e to add new effective drugs and to exclude the obsolete drugs. The Model List of Essential

    medicines provide guidelines, about concept, contents and process, to the member countries to

    make their own EML called National Essential Medicine List.

    Currently, 156 countries have their NEML.

    EML is also preparedby UNICEF, High Commission for Refugees and NGOs.

    NEML of Pakistan

    The National Essential medicines List (NEML) of Pakistan was first prepared in 1994 in

    consultation with relevant experts. The list was previously reviewed in 1995, 2000 and 2003.

    The present list is the fourth revision (revised in 2007) containing 335 medicines of different

    pharmacological classes.

    Words in parenthesis represent health care settings.

    (P)- Primary health care setting e.g BHU, RHC.

    (S)- Secondary health care setting e.g DHQ

    (T)- Tertiary health care setting e.g Shaukat Khanum Memorial Cancer Hospital etc.

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    Essential Characteristics of Essential Medicines List

    1. In vivo efficacy data.

    Only those drugs should be selected which have well established in vivo efficacy data.

    2. In vitro stability data.

    There is variation in the environmental conditions, so the drugs should be tested for

    stability and then selected.

    3. Available at affordable price.

    The drugs should be available at low price, must be cost effective or economic.

    4. Must have disease prevalence.

    The drugs must have disease selection prevalence i.e. there are certain diseases which are

    common in certain area. So drugs should be selected according to the disease prevalence.

    5. Appropriate dosage form.

    The drug must be available all the time in appropriate dosage form.

    6. EML Must is prepared by every country and W.H.O model list will act as reference.

    General Concept

    1. Major factors

    i. W.H.O motto i.e. health for all.

    ii. Limited approach of population to the quality medicine.

    iii. Limited funds used/specified by the government.

    2. Minor Factors

    i. Ease of management for limited selective medicine.

    ii. Ease of practice by health profession.

    iii. Improve patient compliance.

    iv. Ease of procurement, transport, storage and dispensing.v. Major purchase by limited funds.

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    Categories of Medicines in EML:

    In EML medicines are divided into two categories:

    i. Core medicines

    The core list presents a list of minimum medicine needs for a basic healthcare system, listing the most efficacious, safe and costeffective 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.

    ii. Complementary medicines

    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.

    Selection Criteria for EML

    It includes:

    i. Scientific Justification

    ii. Unbiased selection

    iii. Need based selection

    i. Scientific Justification:Those drugs are included in EML which have in vitro stability as well as in vivo

    efficacy i.e. pharmacokinetic and pharmacodynamics considerations. Collectively,

    these are termed as Scientific Justification.

    ii. Unbiased selection:

    Selection should be unbiased.

    To avoid bias, drugs should be included by their generic names.

    iii. Need based:

    Disease prevalence is different in urban and rural areas i.e. certain disease may bemore common in an urban area and less common in rural area and vice versa, so

    drugs should be included in NEML according to disease prevalence in an area.

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    Selection steps:

    1. Establishment of committee

    2. Selection of drugs

    1. Establishment of committee:

    Committee of experts is established which then considers the criteria for including of

    drugs in EML. Preferably, the country own experts should be included in the committee.

    If in any country experts are not available, assistance may be taken from W.H.O.

    The experts include;

    a. Experts in clinical medicine.

    b. Experts in clinical pharmacology.

    c. Experts in physical sciences.

    2. Selection of drugs:

    The committee will select drugs on the basis of:

    d. Scientific justification

    e. Epidemiology

    f. Cost effectiveness

    Drugs should be selected on the basis of generic names.

    Regulation, implementation and facilitation to ensure quality production of

    pharmaceutical product are the responsibility of government.

    Among therapeutic equivalents, drug selection is based on benefits/risk ratio. Among

    drugs sharing same risk/benefit ratio, selection is done on:

    i. Highly evaluated scientific data.

    ii. Feasible pharmacokinetic in the patient.

    iii. Select the drug to be manufactured, transported and stored by the local firm.

    iv. Cost effectiveness.

    There are certain drugs which are available in fixed combination ratio e.g. anti T.B drugs.

    Following parameters are used for selection of such drugs;

    i. In vivo/in vitro no unwanted effects of combine drugs.

    ii. Proven efficacy.

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    Uses of EML:

    i. Health

    - Equality of provision of effective drugs for the majority of population.

    - Cost effectiveness.

    ii. Health Professional

    There are three important health professional: Physician, pharmacist and nurse.

    The major focus of all these three is patient.

    Physician is assisted by drugs in EML, making the prescription more rationale.

    Pharmacist has more scope to get excellence on limited number of drugs.

    Nurse has the convenience to ensure proper storage, administration and dose because

    of limited number of drugs.

    Major focus: Patient Compliance is improved if number of drugs is limited.

    iii. Economical

    The burden on the government is decreased and so more drugs can be purchased with

    in limited funds.

    iv. Facilitation

    NGOs, semi government and international organization can be attracted to make the

    required drugs available.

    v. DiseasesEML contain drugs for both communicable and non-communicable diseases.

    vi. Reviewing

    EML drugs must be reviewed every two years.