Pharmacovigilance
Causality assessment in pharmacovigilance (PV) is the process of determining the likelihood that a drug or medical product caused an adverse event (AE). This assessment is crucial in identifying whether the reported adverse effects are truly due to the drug or are coincidental, related to other factors, or due to underlying conditions. Importance of Causality … Read more
The reconciliation of CRF data and the reconciliation of Non-CRF data are essential processes in clinical trials to ensure that all data collected is accurate, complete, and consistent. Here’s a breakdown of the differences and key elements of each: 1. Reconciliation of CRF Data CRF Data:The Case Report Form (CRF) is a structured document (either … Read more
The Naranjo Adverse Drug Reaction Probability Scale is a widely used tool in pharmacovigilance for determining the likelihood that a specific drug causes an adverse drug reaction (ADR). Developed in 1981, it helps standardize the assessment of drug-related adverse events, allowing healthcare professionals to assess the likelihood of causality. How Naranjo Adverse Drug Reaction Probability … Read more
Pharmacovigilance is an essential area of pharmaceutical practice that ensures patient safety through the detection and management of adverse drug reactions (ADRs). For pharmacists stepping into this field, having the right tools and resources can make a significant difference in success. Here are five key tools that every pharmacist should be familiar with: 1. VigiFlow: … Read more
Pharmacovigilance is the process of monitoring the safety of medicines to make sure they don’t cause harmful side effects. After a drug is approved and starts being used by people, pharmacovigilance helps to spot any problems or unexpected reactions that might occur. The goal is to protect people by ensuring that medicines remain safe and … Read more