The "5 Rights of Medication Administration" are a fundamental framework in patient safety designed to prevent medication errors at the point of care. They serve as a critical final check for healthcare professionals, especially nurses, before a medication is given to a patient.
This guideline provides international standards and definitions for managing and reporting safety information for medicines after they have been approved and are on the market (the "post-approval" or "post-marketing" phase). Its goal is to ensure that safety data is collected, evaluated, and reported consistently and with high quality across different regions.
This document is an official release note from the Maintenance and Support Services Organization (MSSO) detailing the changes and updates introduced in MedDRA (Medical Dictionary for Regulatory Activities) Version 28.1, released in September 2025. MedDRA is a standardized medical terminology used for regulatory communication and data analysis in the healthcare industry.
In the complex, globalized world of pharmaceuticals, clear communication is a matter of patient safety. MedDRA (the Medical Dictionary for Regulatory Activities) is the critical, standardized terminology that ensures a "heart attack" in a report from Japan is understood identically by a regulator in Europe. This article explores how this universal language powers...
Imagine a patient harmed by a medication error. The old approach asked, "Who is to blame?" The modern approach, fueled by pharmacovigilance, asks, "Why did our system allow this to happen?" This article explores the critical, data-driven partnership between pharmacovigilance and patient safety that is transforming healthcare from a culture of blame to...
Your genes provide the instructions for making proteins, and many of these proteins are involved in how your body handles and responds to medicines. Genetic differences (variations) can lead to differences in these proteins, which in turn affect your response to a drug.
This document, published by the European Medicines Agency (EMA) in 2015, provides comprehensive regulatory guidance for the pharmaceutical industry and national competent authorities on minimizing and preventing medication errors throughout a medicinal product's life-cycle.
Advancing Medication Safety Through Knowledge and Vigilance
