Drug and Disease Classification Overview
29 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the primary objective of EudraVigilance?

  • To ensure the safe and effective use of medicinal products by providing standardized information resources for healthcare professionals.
  • To facilitate the reporting and analysis of adverse drug reactions, supporting drug safety monitoring and evaluation. (correct)
  • To provide a comprehensive database of all approved and investigational medicinal products worldwide.
  • Standardization and organization of data on investigational drugs for pharmacovigilance activities.

    • Why is MedDRA considered a key component of EudraVigilance?

  • It allows for the direct collection of patient data from healthcare professionals, enhancing the accuracy of adverse event reporting.
  • It serves as a central platform for disseminating information about drug interactions and contraindications.
  • It is used for registering and listing all authorized medicinal products in the European Union and globally.
  • It provides a standardized terminology for coding adverse events, facilitating consistent data analysis and reporting. (correct)

    • Which of the following is NOT a primary objective of pharmacovigilance?

  • To identify potential risks associated with marketed drugs.
  • To understand the causes of adverse drug reactions.
  • To ensure the effectiveness of drug treatments in clinical settings. (correct)
  • To implement measures to prevent serious adverse drug effects.

    • What is a defining characteristic of 'current' drug information?

    <p>It refers to the most recent and up-to-date data, incorporating latest research and developments. (C)</p> Signup and view all the answers

    What is 'relevant' drug information?

    <p>It is information that is tailored to the specific patient's needs and circumstances. (D)</p> Signup and view all the answers

    Which type of information source typically provides the most in-depth and comprehensive analysis of a specific medical topic?

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

    What is a distinguishing feature of tertiary resources in drug information?

    <p>They focus on summarizing and synthesizing information from primary and secondary resources. (A)</p> Signup and view all the answers

    Which of the following is NOT a component of EudraVigilance's core functionality?

    <p>Development and maintenance of a global drug safety database for clinical trials. (A)</p> Signup and view all the answers

    What does the Anatomical Therapeutic Chemical (ATC) classification primarily consider for drug classification?

    <p>The organ or system affected by the drug (B)</p> Signup and view all the answers

    What is the Defined Daily Dose (DDD) in pharmacovigilance?

    <p>An assumed average maintenance dose per day for a drug used for its main indication (D)</p> Signup and view all the answers

    Why is the ATC/DDD methodology recommended for drug utilization research?

    <p>It facilitates the presentation and comparison of drug consumption statistics across different regions (B)</p> Signup and view all the answers

    According to the general principles for ATC classification, how many ATC codes can a drug have for one route of administration?

    <p>One ATC code (A)</p> Signup and view all the answers

    What kind of information does WHO's drug dictionary provide?

    <p>Adverse drug reaction terminologies (C)</p> Signup and view all the answers

    How does the ATC/DDD methodology benefit drug utilization monitoring?

    <p>It allows valid comparisons of drug use across countries despite nomenclature differences (C)</p> Signup and view all the answers

    What does the Standardised MedDRA Queries (SMQs) focus on in pharmacovigilance?

    <p>Identifying specific safety concerns related to drug use (A)</p> Signup and view all the answers

    What role do Contract Research Organizations (CROs) typically play in pharmacovigilance?

    <p>They conduct clinical trials and drug safety evaluations (C)</p> Signup and view all the answers

    What is the primary purpose of the Anatomical Therapeutic Chemical (ATC) classification system?

    <p>To obtain accurate information in epidemiological studies. (C)</p> Signup and view all the answers

    Which of the following is a key benefit of using the International Nonproprietary Name (INN) for drugs?

    <p>It provides clear identification and safe prescription of medicines. (A)</p> Signup and view all the answers

    Who is responsible for revising and publishing the International Classification of Diseases (ICD) every ten years?

    <p>World Health Organization (WHO) (C)</p> Signup and view all the answers

    The WHO Drug Dictionary primarily serves what function?

    <p>To provide a structured database of medicinal products. (D)</p> Signup and view all the answers

    What was the first model of systematic collection of hospital data created by Florence Nightingale in 1860 intended to improve?

    <p>Public health reporting mechanisms. (D)</p> Signup and view all the answers

    What does the acronym MedDRA stand for?

    <p>Medical Dictionary for Regulatory Activities (B)</p> Signup and view all the answers

    Which of the following is NOT a user of the International Classification of Diseases (ICD)?

    <p>Drug marketing agencies (D)</p> Signup and view all the answers

    How often does the Maintenance and Support Service Organization (MSSO) release updated versions of MedDRA?

    <p>Twice a year (B)</p> Signup and view all the answers

    What is a major responsibility of the International Council for Harmonization (ICH) concerning MedDRA?

    <p>Overseeing maintenance and support services (D)</p> Signup and view all the answers

    What type of information does the Eudravigilance database analyze?

    <p>Reports of adverse drug reactions (B)</p> Signup and view all the answers

    What historical contribution did Jacques Bertillon make to the ICD in 1893?

    <p>Introduction of the classification of cause of death (D)</p> Signup and view all the answers

    What is the role of the Eudravigilance Clinical Trials Module (EVCTM)?

    <p>To report Suspected Unexpected Serious Adverse Reactions (SUSARs) (D)</p> Signup and view all the answers

    Which of the following is a unique characteristic of International Nonproprietary Names (INN)?

    <p>They are unique and globally recognized names for pharmaceutical substances. (B)</p> Signup and view all the answers

    Study Notes

    Drug and Disease Classification

    • ATC (Anatomical Therapeutic Chemical) Classification: Organ/system and therapeutic, pharmacological, and chemical properties define drug groups.
    • ATC/DDD Methodology: Uses ATC for classification and DDD (Defined Daily Dose) as a measurement unit; average daily maintenance dose in adults for primary indications.
    • DDD Importance: Facilitates comparing drug consumption data internationally despite varying nomenclature, packaging, pricing, and dosages.
    • ATC Classification Principles: Drugs are classified by primary therapeutic use, having single ATC codes per route of administration (ROA), multiple codes for distinct therapeutic uses with different ROAs or strengths.
    • International Classification of Diseases (ICD): Provides a global language for disease reporting and monitoring, enabling consistent data comparison across hospitals, regions, and time periods.
    • ICD History: Evolved from initial models, with ongoing revisions every decade. Florence Nightingale pioneered early data collection, Jacques Bertillon developed cause-of-death classifications, and the American Public Health Association recommended periodic revisions.
    • ICD Use: Used by physicians, nurses, researchers, health information professionals, policymakers, insurance companies, and patient groups. Translated into 43 languages, primarily for mortality data reporting.

    Drug Dictionaries and Coding in Pharmacovigilance

    • International Nonproprietary Names (INN): Globally recognized, unique names for pharmaceutical substances (active pharmaceutical ingredients) for clear identification, safe prescription, and communication among health professionals. Introduced in the 1950s.
    • MedDRA (Medical Dictionary for Regulatory Activities): Clinically validated international medical terminology developed by ICH (International Council for Harmonization) for regulatory authorities. Used for drug safety data entry, retrieval, evaluation, and presentations during pre- and post-authorization phases. Maintained by MedDRA's Maintenance and Support Services Organization (MSSO), with bi-annual updates.
    • WHO Drug Dictionary: International classification of medicines created by WHO for drug monitoring, detailed information on all medical products, providing standardized information and data groupings. Regularly updated.
    • EudraVigilance Medicinal Product Dictionary (EVMPD): Standard method for collecting, reporting, coding, and evaluating data on authorized and investigational medical products in the EU, considering data source uncertainties; supports data analysis. Provides multiple dictionaries within the EudraVigilance system for diverse applications.

    Information Resources in Pharmacovigilance

    • Pharmacovigilance: Science of detecting, evaluating, understanding, and preventing adverse effects or drug-related problems.
    • Drug Information Resources: Current, critically evaluated, relevant data on drugs and their uses in specific patient situations; using primary, secondary, and tertiary resources to gather appropriate information. Using the most recent and critically examined information is important for relevance.
    • Basic Drug Information Resources: Current data examining drug use; data must be relevant to the patient parameters, objectives, and alternative approaches.
    • Specialized Resources for Adverse Drug Reactions (ADRs): Focus on specific ADRs within broader drug information.

    Establishing Pharmacovigilance Programmes

    • Hospital Programs: Focused on establishing procedures, structures, and protocols for monitoring and reporting ADRs.
    • Industry Drug Safety Departments: Establishing structure and function for adverse event surveillance.
    • Contract Research Organizations (CROs): Offering support and services for the establishment and operation of programs, including data analysis.
    • National Programs: Ensuring that national-level programs are established to support the overall public health strategy.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Description

    This quiz covers the ATC classification system for drugs and the ICD for diseases. It explores the methodology behind drug classification and the importance of DDD for international comparisons. Gain insights into therapeutic use and the evolution of disease classification.

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser