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    Essential Medicine

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    Pavan Sahit
    The document discusses essential medicines and counterfeit medicines. Essential medicines are intended to be available at all times to satisfy priority healthcare needs at a price people can afford. National lists guide medicine procurement, reimbursement and local production. Counterfeit medicines undermine health systems and can cause treatment failure or death. Stringent regulation and public awareness are needed to address the issue.

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    Essential Medicine

    Uploaded by

    Pavan Sahit
    9 views35 pages
    The document discusses essential medicines and counterfeit medicines. Essential medicines are intended to be available at all times to satisfy priority healthcare needs at a price people can afford. National lists guide medicine procurement, reimbursement and local production. Counterfeit medicines undermine health systems and can cause treatment failure or death. Stringent regulation and public awareness are needed to address the issue.

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    The document discusses essential medicines and counterfeit medicines. Essential medicines are intended to be available at all times to satisfy priority healthcare needs at a price people can afford. National lists guide medicine procurement, reimbursement and local production. Counterfeit medicines undermine health systems and can cause treatment failure or death. Stringent regulation and public awareness are needed to address the issue.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
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    9 views35 pages

    Essential Medicine

    Uploaded by

    Pavan Sahit
    The document discusses essential medicines and counterfeit medicines. Essential medicines are intended to be available at all times to satisfy priority healthcare needs at a price people can afford. National lists guide medicine procurement, reimbursement and local production. Counterfeit medicines undermine health systems and can cause treatment failure or death. Stringent regulation and public awareness are needed to address the issue.

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    © All Rights Reserved
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    of 35

    Essential and Counterfeit

    Medicine

    DR. Prachi singh


    Assistant professor
    community medicine
    RDJMMCH
    Essential medicine

    • Satisfy the priority health care needs of the population.


    • Essential medicines are intended to be available within
    the context of functioning health systems at all times
     Adequate amounts
     Appropriate dosage forms
     Assured quality
     At a price the individual and the community can afford.
    ESSENTIAL MEDICINES

    Sustainable Development Goals:


    • Target 3.8
    • Achieve universal health coverage, including financial risk protection, access to
    quality essential health-care services and access to safe, effective, quality and
    affordable essential medicines and vaccines for all

    Earlier it was covered under Millennium Developmental Goal 8


    ESSENTIAL MEDICINES

    • Implementation of Essential Medicines concept – flexible and adaptable


    • National Responsibility – which all medicines to be included

    Careful selection of limited medicines

    Higher quality of care Better management of medicines

    Cost effective use of resources


    Criteria for Selection of Essential Medicines

    • Essential medicines are selected with due regard to


     Disease prevalence
     Evidence on efficacy and safety
     Comparative cost‐effectiveness

    • Cost‐effectiveness comparisons are made between


    alternative medicines within the same therapeutic group.
    • Currently ,private practices are at boom (70%) and even the
    treatment regimens are .diverse (not scientifically optimum)

    DRUG RESISTANCE
    Essential Medicines Lists
    • List is a guide for the development of national and
    institutional essential medicine lists.
    • 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
    • Applications for inclusion, changes or deletions to the
    List are submitted to the secretary of the Expert
    Committee for the Selection and Use of Essential
    Medicines
    • The Expert Committee:
    • Responsible for reviewing the evidence provided in
    an application and deciding whether to include or
    delete a medicine.
    • Identifies knowledge gaps and makes
    recommendations for future research that may be
    needed about medicines for the treatment of priority
    health problems
    A medicine will be considered for deletion from the
    WHO Model List if:
    • Its public health relevance has been questioned and/or
    • There are concerns – about its safety and efficacy and
    – comparative cost‐effectiveness compared to other
    medicines for the same condition.
    The evolution of medicine and the WHO
    Model list of essential medicines
    • 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 anti-tubercular
    (1944).
    • The 1950s saw the first clinical use of oral contraceptives,
    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.
    Current list

    • The WHO model lists of essential medicines has been updated


    every two years since 1977.
    • The current versions are the 22nd WHO essential medicines
    list.
    • 7th WHO essential medicines list for children updated in June
    2019.
    How is the Model List used?

    • The WHO Model List of Essential Medicines is an evidence‐


    based resource that can be used by countries as a guide to
    develop their own national essential medicines list.
    • Since the first WHO Model List of Essential Medicines was
    developed in 1977, many countries have developed their own
    national list.
    • National lists of essential medicines can be used as the basis for:

    • Procurement and supply of medicines in the public and private sector

    • Schemes that reimburse medicine costs, medicine donations and to guide local
    production
    • India – adopted the concept of Essential Medicines by WHO

    • WHO – updated every 2 year. Latest – 2023 (23 rd edition)

    • But, different from WHO Model List of Essential Medicines

    • WHY?

    • Differences in national circumstances – like, disease burden, national health


    programmes, emerging and re-emerging infections etc
    • 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.
    • Essential medicines are one of the most cost‐ effective
    elements in modern health care and their potential health
    impact is remarkable.
    The national list of essential medicine (NLEM) 2022
    • 384 medicines

    • Government of india has opened Aan aushadhi Kendras

    • Around 7500 medical stores to make quality generic

    • All medicines are available at sub centres,PHC and CHC.

    • PROMOTING

    1. Use of generic medicines

    2. Rational use of drugs adopting standard treatment gudilines

    3. Use of standard treatment guidelines especially for national programmes on


    MALARIA,TB,STI,IMNCI,ARI,AIDS AND Diarrhoel Diseases.

    • Note - Essential list of medicines at sub centres or wellness centres is under


    ANM
    WHAT’S NEW COMPARED TO 2015?

    • 34 new medicines. 26 medicines dropped


    • 27 sections instead of 30 sections (NLEM 2015)
    • 1 new section – Medicines for COVID-19 Management
    Indian list of essential medicines
    • 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
     The need for continued development of better medicines,
    medicines for emerging diseases, and medicines to meet
    changing resistance patterns.
    COUNTERFEIT MEDICINE
    Counterfeit medicine
    • According to WHO: Counterfeit medicine is a drug which is
    produced with an intention to cheat.
    • Includes:
     Mislabelling
     No active ingredient
     Wrong ingredient
     Insufficient quantity.
    Counterfeit medicine

    • Both branded and generic products are subject to


    counterfeiting.
    • All kinds of medicines have been counterfeited, from
    medicines for the treatment of life‐threatening conditions to
    inexpensive generic versions of painkillers and antihistamines.
    • Can result in treatment failure or even death.
    • Public confidence in health systems may be eroded
    Extent of the problem
    • Defining the extent of counterfeiting is difficult for a
    number of reasons
    • Sources of information:
     Ad hoc studies on specific geographical areas or
    therapeutic groups.
     Reports from: National medicines regulatory
    authorities, enforcement agencies, pharmaceutical
    companies and nongovernmental organizations.
    • Counterfeiting is greatest in regions where regulatory and
    enforcement systems for medicines are weakest
    • In most industrialized countries with effective regulatory
    systems and market control, incidence these medicines is
    extremely low – less than 1% of market value according to the
    estimates of the countries concerned
    Public health risks
    • Result in treatment failure and contribute to increased
    resistance
    • Difficulty in tracing the manufacturing and distribution
    channels
    • It undermines the credibility of national health and
    enforcement authorities
    Contributory factors
    • Some people seek medicines that are sold more cheaply.
    • These are often available from non ‐regulated outlets.
    • No regular supply from regulated authority
    • Lack of consumer awareness
    • Self medication
    • High cost of genuine medicines
    • Weak legislation
    • Prevalence of internet pharmacies
    Response

    • Stringent regulatory control of medicines and


    enforcement by national medicines regulatory
    authorities contributes significantly to the prevention
    and detection of such medicines.
    • Education of people
    • WHO provides direct country and regional support
    for strengthening medicines regulation
    Consumers should be cautious of the following:

    • Spam advertisement mails, unregulated websites, social


    media platforms and smartphone applications
    • lack of authenticity or no verification logo or certificate

    • spelling mistakes on packaging

    • websites with no physical address or phone number

    • websites offering medicines without a prescription


    How to identify sub-standard or falsified medical product?

    • Almost visually identical to the genuine product and very difficult to


    detect.
    • Examine package for spelling mistakes, expiry dates and ensure details
    on outer packaging match the dates shown on the inner packaging;
    • Ensure medicine looks correct, not discoloured, degraded or unusual
    smell
    • Discuss with pharmacist, doctor or other healthcare professional if you
    suspect the product is not working properly or you have suffered an
    adverse reaction
    Quality control in Drug sector in India
    • The Drugs and Cosmetics Act, 1940
    • Drug and Cosmetics Rule, 1945
    • Central Drug Standard Control Organization (CDSCO):
     Quality control of the imported drugs
     Coordination of the activities of States/UTs
     Approval of new drug proposed to be manufactured or
    imported.
     Lying down standards and regulatory measures.
     Acting as the Central License Approving Authority .
    CDSCO Network:

    • Six Zonal Offices – Mumbai, Ghaziabad, Kolkata, Hyderabad,


    Ahmedabad and Chennai,
    • Six sub-zonal offices
    • 16 port offices responsible for ensuring quality of imports
    • 7 laboratories
    National programme on containment of
    antimicrobial resistance
    • ICMR 2016 WITH WHO -50% OR MORE OF
    HOSPITAL ANTIMICROBIAL USE WAS
    INAPPROPRIATE.
    • Lancet 2019-4.95 million deaths across the world were
    attributed to AMR.
    • Lancet India –use of unapproved antibiotics to around 47%.
    • Most common Azithromycin
    • cephalosporin>penicilline>macrolides .
    Objective
    1. To generate data for common bacterial pathogens
    2. To determine trends and magnitude of AMR
    3. To follow std treatment regimens
    4. Rational use of antibiotics
    5. Spread knowledge about infection control
    6. Standardize national treatment guidelines
    Activities

    • Surveillance
    • Development and implementation of national infection control
    guidelines
    • IEC
    • National treatment guidelines
    Achievements

    • Standard treatment guidelines in all infectious diseases and


    health programs
    • THANK YOU

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