Case studies are like windows into the real world, giving us a glimpse of how theory translates into practice. Let’s look at a couple of hypothetical case studies related to Listedness/Expectedness assessment in Pharmacovigilance.
Case Study 1: A New Safety Signal
Imagine a situation where a new drug has been introduced in the market for the treatment of a chronic condition. After a few months, reports start coming in about a specific adverse event that was not listed in the product information. The Pharmacovigilance team conducts a Listedness/Expectedness assessment and determines that this is indeed a new safety signal. As a result, the product information is updated, and healthcare professionals are informed about this new potential risk. This case study highlights the role of Listedness/Expectedness assessment in identifying new safety signals and ensuring drug safety.
Case Study 2: Regional Differences in Product Information
Consider a scenario where a drug is marketed in multiple countries. The product information in one country lists a specific adverse event, but the same is not listed in another country. A patient in the second country experiences this adverse event, leading to a Listedness/Expectedness assessment. The assessment reveals the regional differences in product information, leading to an update in the product information in the second country. This case study underscores the challenges in Listedness/Expectedness assessment due to regional differences in product information.