Data Mining in PV and Drug Informatics

Data Mining in PV and Drug Informatics

• Descriptive Modelling: Identifies patterns and groupings in historical data, revealing reasons for successes or failures. Uses techniques like anomaly detection and principal components analysis.
• Diagnostic Modelling: Determines causes of trends and correlations between variables. Helps with hypothesis testing and understanding the difference between correlations and causation.
• Predictive Modelling: Classifies future events or estimates unknown outcomes. Uses techniques like decision trees.
• Prescriptive Modelling: Combines data from descriptive and predictive analytics with unstructured data for more accurate predictions. Uses methods like text and web mining to recommend courses of action.
• Disproportionality Methods: Identifies statistical associations between products and events, especially in patient safety. Compares observed counts with expected counts.
• Geographic Information Systems (GIS): Used for identifying geographic trends, performing surveillance, visualizing patient locations, and identifying clusters of events. Can incorporate social media data. Important for tracking disease spread, performing outbreak investigations, and providing patient education.
• Text and Information Mining: Helps detect specific text patterns and combinations, as well as trends, in unstructured data like narratives and event descriptions.
• Visualization Tools: Uses pictures and graphics to make complex data relationships easier to understand. Useful for displaying multi-source data.

Domestic and Global Regulatory Requirements

• Role of Regulatory Authorities: A public health function with the objective to ensure safe and effective use of medications.
• Role of Pharmaceutical Companies: Similar duties to regulatory authorities, but as a commercial entity, they also have business requirements.
• SFDA (Saudi Food and Drug Administration)
  • Coordinates the monitoring of medicinal products in KSA.
  • Provides advice on ensuring safe and effective use.
  • Implements legal pharmacovigilance requirements.
• Specific Quality System Processes of the SFDA:
  • Monitors and validates the use of specific terminology.
  • Assesses and processes pharmacovigilance data within legal timelines.
  • Ensures effective communication of safety announcements.
  • Maintains documentation of pharmacovigilance systems
  • Retains pharmacovigilance data as long as a product is marketed.
• Preparedness Planning for Public Health Emergencies:
  • Emphasizes adaptability of pharmacovigilance systems to public health emergencies.
  • Requires case-by-case assessments and notifications to marketing authorization holders.
  • Publishes notifications on the SFDA website.
• WHO's International Collaborative Program on Drug Safety:
  • Established in 1968 with a monitoring center in Uppsala, Sweden.
  • Collects, assesses, and communicates information about medication benefits and risks.
  • Develops and implements pharmacovigilance practices.
  • Alerts regulatory authorities about potential drug safety problems.
  • Uses 'Vigimed' for electronic information exchange.
  • Publishes regular newsletters and manages the WHO Drug Dictionary and WHO Adverse Reaction Terminology (WHOART).
  • Provides training and support to countries establishing pharmacovigilance systems.
  • Organizes annual meetings for collaborating center representatives.
• **Council for International Organization of Medical Sciences (CIOMS): **
  • Based in Geneva and operates under the WHO umbrella.
  • Serves as a forum for discussions between regulators and industry on pharmacovigilance topics.
  • Has been influential in shaping legislation and guidelines globally.
• International Conference on Harmonization (ICH):
  • A formal group with a wider remit for harmonization across the drug development process.
  • Has also been influential in shaping regulatory requirements for pharmacovigilance.
  • Represents regulators and industry from the EU, USA, and Japan.
  • Has observers from the WHO.
  • Harmonizes guidelines related to drug development and registration.
• ICH Guidelines
  • Cover four categories: Quality, Safety, Efficacy, and Mutil-disciplinary.
  • Authorities in all territories commit to implementation, though timing and extent vary.

Explore the various modeling techniques used in data mining for pharmacovigilance and drug informatics. This quiz covers descriptive, diagnostic, predictive, and prescriptive modeling strategies as well as disproportionality methods and geographic information systems. Test your knowledge of how these methods enhance drug safety and efficacy analysis.