Pharmacovigilance Unit 2 PDF | PPT
Description: This resource provides comprehensive insights into Pharmacovigilance Unit 2, covering drug and disease classification, coding systems, information resources, and establishing pharmacovigilance programs. It includes downloadable PDFs and PowerPoint presentations for academic and professional use.
Keywords: Pharmacovigilance, Drug Classification, Disease Classification, WHO Adverse Reaction Terminologies, MedDRA, Daily Defined Doses, PDF Download, PPT Slides
Pharmacovigilance Unit 2 PDF | PPT
Introduction:
Pharmacovigilance is a critical discipline that ensures the safe and effective use of medicines by monitoring adverse drug reactions (ADRs) and other drug-related issues. Unit 2 of this subject focuses on foundational aspects such as drug and disease classification, terminologies used in pharmacovigilance, and the establishment of robust pharmacovigilance programs. This guide provides an in-depth exploration of these topics, making it an invaluable resource for students, researchers, and healthcare professionals.
A. Drug and Disease Classification:
Understanding how drugs and diseases are classified is essential for effective pharmacovigilance. Key classifications include:
- Anatomical, Therapeutic, and Chemical (ATC) Classification: A system developed by the WHO to classify drugs based on their therapeutic, anatomical, and chemical properties.
- International Classification of Diseases (ICD): A standardized system for categorizing diseases and health conditions.
- Daily Defined Doses (DDD): A statistical measure of drug consumption, representing the assumed average maintenance dose per day for a drug used for its main indication in adults.
- International Nonproprietary Names (INN): Unique names assigned to pharmaceutical substances to ensure global uniformity.
B. Drug Dictionaries and Coding in Pharmacovigilance:
Standardized terminologies and dictionaries are crucial for consistent reporting and analysis of ADRs. Key tools include:
- WHO Adverse Reaction Terminologies: A structured vocabulary for describing adverse reactions.
- MedDRA (Medical Dictionary for Regulatory Activities): A globally recognized terminology for regulatory communication, including Standardised MedDRA Queries (SMQs) for specific safety concerns.
- WHO Drug Dictionary: A comprehensive database of drug information used in pharmacovigilance.
- EudraVigilance Medicinal Product Dictionary: A European database for tracking medicinal products and their safety profiles.
C. Information Resources in Pharmacovigilance:
Access to reliable information is vital for effective pharmacovigilance. Key resources include:
- Basic Drug Information Resources: Textbooks, journals, and online databases that provide general drug information.
- Specialised Resources for ADRs: Tools like VigiBase (WHO's global database of individual case safety reports) and national pharmacovigilance centers.
D. Establishing Pharmacovigilance Programmes:
Building a successful pharmacovigilance program requires careful planning and execution. Key steps include:
- Hospital-Based Programs: Setting up systems for monitoring and reporting ADRs within healthcare institutions.
- Drug Safety Departments in Industry: Establishing dedicated teams to manage safety data and comply with regulatory requirements.
- Contract Research Organizations (CROs): Outsourcing pharmacovigilance activities to specialized organizations.
- National Programmes: Developing nationwide initiatives to monitor drug safety and protect public health.
Benefits of Downloadable Resources:
This resource includes supplementary materials such as PDF documents and PowerPoint presentations, which enhance learning and teaching experiences. These materials are particularly useful for educators preparing lectures, students revising for exams, and professionals conducting training sessions.
Conclusion:
Pharmacovigilance Unit 2 provides a solid foundation for understanding the systems and processes involved in drug safety monitoring. By exploring topics such as drug classification, coding systems, and program establishment, this resource equips readers with the knowledge needed to contribute effectively to patient safety. Whether you're downloading the PDF or utilizing the PPT slides, you'll find valuable educational content tailored to your needs.
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