Pharmacovigilance Overview
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Questions and Answers

What defines an adverse drug event?

  • Any negative reaction that occurs only at high doses of a drug.
  • A harmful and unintended response at any dose.
  • Any untoward medical occurrence during drug treatment that may not have a causal relationship. (correct)
  • An intended effect of a drug that is not related to its pharmacological properties.

    • Which of the following best explains a side effect?

  • An effect that is related to the pharmacological properties of a drug used at normal doses. (correct)
  • A medical occurrence that does not relate to the use of drugs.
  • An allergic reaction that occurs only in rare cases.
  • An occurrence that happens outside of normal doses.

    • What describes drug interactions?

  • Alteration of a drug's pharmacological activity due to another drug, substance, or disease. (correct)
  • Only interactions that occur between two drugs.
  • Interactions that cause the body to ignore the effects of a drug.
  • Interactions that enhance the therapeutic effect of a drug.

    • According to the WHO definition, what qualifies as an adverse drug reaction (ADR)?

    <p>A harmful, unintended response related directly to the drug at normally used doses. (A)</p> Signup and view all the answers

    Which type of adverse drug reaction is categorized as idiosyncratic?

    <p>Type B (C)</p> Signup and view all the answers

    What is the primary focus of pharmacovigilance?

    <p>To detect, evaluate, and prevent adverse effects of medicines (B)</p> Signup and view all the answers

    Which of the following describes one of the aims of pharmacovigilance?

    <p>Improving public health and safety regarding medicine use (C)</p> Signup and view all the answers

    What term is sometimes used interchangeably with pharmacovigilance?

    <p>Post market surveillance (D)</p> Signup and view all the answers

    Which statement accurately reflects a component of the scope of pharmacovigilance?

    <p>It includes vaccines and biologicals (A)</p> Signup and view all the answers

    What does the WHO define as pharmacovigilance?

    <p>Activities relating to the detection and prevention of adverse drug effects (B)</p> Signup and view all the answers

    What is a key objective of pharmacovigilance?

    <p>To provide timely safety information to stakeholders (A)</p> Signup and view all the answers

    Which of the following medical products is NOT covered by pharmacovigilance?

    <p>Cosmetic products (A)</p> Signup and view all the answers

    Which activity contributes to the protection of patients in pharmacovigilance?

    <p>Assessing the safety of medications (A)</p> Signup and view all the answers

    What is the first step in the further process of data entry in pharmacovigilance?

    <p>Seriousness determination (C)</p> Signup and view all the answers

    What does the query process in pharmacovigilance involve?

    <p>Raising queries to the reporter (D)</p> Signup and view all the answers

    Which document is NOT used to understand the drug safety profile?

    <p>Case Closure Report (A)</p> Signup and view all the answers

    What is a Serious Adverse Event (SAE)?

    <p>An adverse event that is fatal or life-threatening (B)</p> Signup and view all the answers

    What is included in the action taken to prevent adverse drug reactions?

    <p>Performing Risk Minimization Activities (A)</p> Signup and view all the answers

    Which of the following is considered when identifying adverse drug reactions (ADRs)?

    <p>Signs and symptoms of the reaction (D)</p> Signup and view all the answers

    What does causality assessment focus on in medical review?

    <p>The relationship between the drug and the event (C)</p> Signup and view all the answers

    What is a characteristic of an adverse drug reaction (ADR)?

    <p>It occurs at doses normally used in humans (C)</p> Signup and view all the answers

    What characteristics define type A adverse drug reactions?

    <p>Dose-related, predictable, and low mortality (D)</p> Signup and view all the answers

    Which example best represents a type B adverse drug reaction?

    <p>Anaphylaxis (A)</p> Signup and view all the answers

    What type of adverse drug reaction is characterized by time-related effects that often appear after drug use?

    <p>Delayed (D)</p> Signup and view all the answers

    Which of the following is true regarding type E reactions?

    <p>Withdrawal reactions after stopping a drug (B)</p> Signup and view all the answers

    What common characteristic defines type F adverse drug reactions?

    <p>Unexpected failure of therapy (D)</p> Signup and view all the answers

    Which example is associated with type C adverse drug reactions?

    <p>Thromboembolic events (D)</p> Signup and view all the answers

    Which statement correctly differentiates between an adverse drug event and an adverse drug reaction?

    <p>Adverse drug events can occur without a causal relationship to the drug. (C)</p> Signup and view all the answers

    Which type of ADR is considered uncommon and usually arises from prolonged use without accumulation?

    <p>Type D (B)</p> Signup and view all the answers

    What characterizes a severe adverse drug reaction (ADR)?

    <p>Potentially life threatening or causes permanent damage (B)</p> Signup and view all the answers

    Which agency in Ghana is responsible for receiving and processing adverse drug reactions?

    <p>Food and Drug Authority (B)</p> Signup and view all the answers

    What is the primary source of information in pharmacovigilance?

    <p>Spontaneous reporting of ADRs (A)</p> Signup and view all the answers

    Which of the following elements is NOT included in a case report for reporting an ADR?

    <p>Patient's bank account information (B)</p> Signup and view all the answers

    Who among the following can report an adverse drug reaction?

    <p>Any healthcare professional (D)</p> Signup and view all the answers

    What should be reported about the suspected drug(s) in an ADR report?

    <p>Name, dose, route, and manufacturer (C)</p> Signup and view all the answers

    What is the purpose of the confidentiality clause regarding the reporter's information in an ADR case report?

    <p>To keep the reporter’s identity secret for safety purposes (A)</p> Signup and view all the answers

    What should healthcare professionals do when they observe adverse experiences with medications?

    <p>Report them immediately (D)</p> Signup and view all the answers

    Study Notes

    Pharmacovigilance

    • Pharmacovigilance is the process of detecting, evaluating, and preventing adverse effects of medicines.
    • It aims to improve patient care and safety, public health, and the assessment of benefits and risks of medicines, encouraging their safe and effective use.

    WHO Pharmacovigilance Program

    • The World Health Organization (WHO) defines pharmacovigilance as the science and activities related to detecting, assessing, understanding, and preventing adverse effects or drug-related problems.
    • The WHO Pharmacovigilance Program aims to ensure the safe and effective use of medicines globally.

    Pharmacovigilance Process

    • The pharmacovigilance process involves collecting, analyzing, and evaluating safety data to identify and manage potential risks associated with medicines.
    • It involves four key stages:
      • Case Collection: Gathering information about suspected adverse drug events (ADEs) through spontaneous reporting.
      • Case Processing: Analyzing, reviewing, and processing the collected ADE reports.
      • Signal Detection: Identifying potential patterns or signals in the data suggesting a possible link between a drug and an adverse effect.
      • Risk Management: Implementing measures to mitigate the identified risks and ensure the safe use of the medication.

    Adverse Drug Reactions (ADRs)

    • An ADR is a harmful and unintended response to a medicine that occurs at doses normally used in humans.
    • ADRs are categorized based on different mechanisms and types:
      • Type A (Augmented): Dose-related, predictable, and linked to the pharmacology of the drug.
      • Type B (Bizarre): Non-dose related, unpredictable, and often related to allergic reactions.
      • Type C (Chronic): Dose and time-related, usually occurring with prolonged use.
      • Type D (Delayed): Time-related, occurring sometime after drug use.
      • Type E (End of Use): Withdrawal reactions that occur after stopping a drug.
      • Type F (Failure): Unexpected failure of therapy due to drug interactions or other factors.

    Reporting of Adverse Drug Reactions

    • Spontaneous reporting is the most common method of collecting ADR data.
    • Healthcare professionals are encouraged to report any suspected ADRs to relevant authorities to ensure patient safety.
    • Reporting forms are available at pharmacies, clinics, and hospitals.
    • FDA is the agency mandated to receive, process, and forward ADRs to the UMC.
    • Reporting ADRs allows for the further evaluation of drugs and the implementation of necessary safety measures.

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    Description

    This quiz explores the essential aspects of pharmacovigilance, including its definition, processes, and the WHO program aimed at ensuring safe medicine use. Test your knowledge on key concepts related to the detection and prevention of adverse drug reactions.

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