An overview of current medication error reporting ICSR

PrimeVigilance is pleased to present an essential webinar led by Dr. Cvijeta Bielen, Medical Director and senior pharmacovigilance physician, on “An Overview of Current Medication Error Reporting in ICSRs.”

This session provides a comprehensive look at current requirements for Individual Case Safety Report (ICSR) submissions related to medication errors, including insights into periodic report requirements and updates to MedDRA guidance as of March 1, 2016. Dr. Bielen will focus on how these updates impact the classification and reporting of medication errors, offering practical strategies for accurate case processing.

Medication errors are a major preventable cause of patient harm. To address this, the European Medicines Agency released good practice guides that establish new standards for medication error processing, assessment, and prevention. Dr. Bielen will discuss the challenges of balancing reporting requirements while avoiding the mischaracterization of medication use and provide best practices for handling medication error cases in periodic safety reports. Attendees will gain insights into MedDRA coding, classifications (actual harm, potential errors, intercepted errors), and the effective development of risk management plans to mitigate medication errors.

Key Takeaways Include:

• Overview of current ICSR requirements for medication error reporting and periodic safety updates
• In-depth discussion of MedDRA updates for medication error classification, coding, and retrieval
• Practical guidance on accurate medication error case processing in post-marketing safety reports
• Effective strategies for developing risk management plans to prevent medication errors and assess their effectiveness