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    Clinical Pharmacy: By: Narendar Kumar

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    Alee Iz Har
    This document discusses pharmacovigilance and adverse drug reactions. It begins with an introduction to pharmacovigilance, including its aims to improve patient safety and prevent adverse effects. It then outlines the pharmacovigilance cycle of identifying, evaluating, and taking action on adverse drug reactions. It also classifies different types of adverse drug reactions and how pharmacists can help manage them. The overall goal of pharmacovigilance is to promote safe and effective use of medicines.

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    Clinical Pharmacy: By: Narendar Kumar

    Uploaded by

    Alee Iz Har
    48 views14 pages
    This document discusses pharmacovigilance and adverse drug reactions. It begins with an introduction to pharmacovigilance, including its aims to improve patient safety and prevent adverse effects. It then outlines the pharmacovigilance cycle of identifying, evaluating, and taking action on adverse drug reactions. It also classifies different types of adverse drug reactions and how pharmacists can help manage them. The overall goal of pharmacovigilance is to promote safe and effective use of medicines.

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    This document discusses pharmacovigilance and adverse drug reactions. It begins with an introduction to pharmacovigilance, including its aims to improve patient safety and prevent adverse effects. It then outlines the pharmacovigilance cycle of identifying, evaluating, and taking action on adverse drug reactions. It also classifies different types of adverse drug reactions and how pharmacists can help manage them. The overall goal of pharmacovigilance is to promote safe and effective use of medicines.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    48 views14 pages

    Clinical Pharmacy: By: Narendar Kumar

    Uploaded by

    Alee Iz Har
    This document discusses pharmacovigilance and adverse drug reactions. It begins with an introduction to pharmacovigilance, including its aims to improve patient safety and prevent adverse effects. It then outlines the pharmacovigilance cycle of identifying, evaluating, and taking action on adverse drug reactions. It also classifies different types of adverse drug reactions and how pharmacists can help manage them. The overall goal of pharmacovigilance is to promote safe and effective use of medicines.

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    © All Rights Reserved
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    of 14

    Clinical Pharmacy

    Pharm. 612
    4th Prof. Pharm. D (1st Semester)
    Week No. 16

    By: Narendar Kumar


    Lecturer,
    Department of Pharmacy Practice, Faculty of Pharmacy,
    1
    University of Sindh Jamshoro
    2
    Contents
    Introduction to Pharmacovigilance

    Aims of Pharmacovigilance

    Scope of Pharmacovigilance

    Pharmacovigilance Cycle

    Pharmacovigilance Cycle

    Adverse Drug Reactions

    Types of Adverse Drug Reactions

    Classification of Adverse Drug Reactions

    Management of ADRs
    3
    Introduction to
    Pharmacovigilance
     According to WHO;
     Pharmacovigilance (PV) is defined as
    the science and activities relating to
    the detection, assessment,
    understanding and prevention of
    adverse effects or any other drug-
    related problem.

     The ultimate goal of this activity is to


    improve the safe and rational use of
    medicines, thereby improving patient
    care and public health.

    4
    Introduction to
    Pharmacovigilance
     Thalidomide was developed in 1950s.
     Sedative
     Used for nausea in pregnancy
     10000 infants with deformed limbs (Phocomelia), blindness,
    deafness and heart problems
     >Half of children died
     Then WHO started pharmacovigilance
     Nowadays, Thalidomide is indicated for certain cancers and
    leprosy

     The World Health Organization (WHO) established its


    Programme for International Drug Monitoring in response to
    the Thalidomide Disaster revealed in 1961. This marked the
    beginning of international pharmacovigilance.

    5
    Aims of Pharmacovigilance
     To improve patient safety in relation to the
    use of medicines, medical and surgical
    interventions

     To enhance public healthy safety measure to


    rationalize the therapy

     To assess benefit versus harm ration

     To promote understanding, education and


    clinical decision making

    6
    Scope of Pharmacovigilance
     The scope of pharmacovigilance includes;
     Impact on patient welfare and public health
     It gives an outlook on the rules and laws to follow
    in Pharmacovigilance practice
     It maintains data safety in pharmaceutical industries
     It is involved in;
     Small molecule medicinal products, usually derived from
    chemical synthesis
     Herbal medicines and dietary supplements
     Traditional and complementary medicines
     Blood products
     Biological products (medicines or vaccines)
     Medical devices
     Substandard medicines and counterfeit medicines

    7
    Pharmacovigilance Cycle
    Identification
    (Data
    Collection)

    Information Investigation
    (Analysis of
    to others Data)

    Action
    ( To protect Evaluation
    Public Health)

    8
    Adverse Drug Reactions
     According to WHO, An ADR is “a response to a drug which
    is noxious and unintended, and which occurs at doses
    normally used in man for the prophylaxis, diagnosis, or
    therapy of disease, or for the modification of physiological
    function”
     An unwanted or unpleasant or unexpected result or
    condition that comes along with the desired effects of the
    drug is known as Side Effect.
     An adverse effect of a drug produced by an exaggeration of
    the effect that produce the therapeutic response is known
    as Toxic Effect.

    9
    Types of Adverse Drug
    Reactions
    Type of ADRs Characteristics Example
    Type A (Augmented) • Dose Related Nephrotoxicity due to
    • Related to Aminoglycoside
    pharmacological action
    • Predictable

    Type B (Bizarre) • Non Dose Dependant Penicillin induced


    • Uncommon urticaria
    • No relationship with
    action

    Type C (Chronic) • Uncommon Corticosteroids induced


    • Long term exposure hypothalmic pituitary
    adrenal axis suppression

    Type D (Delayed) • Prolonged Exposure of Tardive dyskinesis due to


    drug antipsychotic
    Type E (End of • Termination of Withdrawal effects of
    Treatment treatment effect opoid analgesics 10
    Classification of Adverse Drug
    Reactions

    Minor Moderate Severe Lethal


    • Tolerated • Requires change • Potentially life • Directly or
    • No therapy or in drug therapy, threatening indirectly
    antidote required specific treatment • Can causes contributes to
    or prolongs permanent death of the
    hospitalization damage patient.
    • May requires
    intensive medical
    treatment

    11
    How to Recognize ADRs
     Ensure, medicine received & actually taken by
    the patient at the dose advised
     Verify the onset of suspected ADR is after
    taking the drug
     Determine the time interval between drug taken
    – onset of event
     Evaluate the suspected ADR after discontinuing
    the drug / reduced dose, monitor status
     Analyze the alternate cause
     Use relevant literature & experienced physician
    opinion.
     Report the ADR
    12
    Role of Pharmacist in ADRs
    Management
    The pharmacist should facilitate
    1. Analysis of each reported ADR.
    2. Identification of drugs and patients at high risk for being
    involved in ADRs.
    3. The development of policies and procedures for the ADR-
    monitoring and reporting program.
    4. A description of the responsibilities and interactions of
    pharmacists, physicians, nurses, risk managers, and other
    health professionals in the ADR program.
    5. Use of the ADR program for educational purposes.
    6. Development, maintenance, and evaluation of ADR records
    within the organization.
    7. The organizational dissemination and use of information
    obtained through the ADR program.
    8. Reporting of serious ADRs to the FDA or the manufacturer (or
    both).
    9. Publication and presentation of important ADRs to the medical
    13
    community.
    14

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