1. What is Listedness/Expectedness?
Listedness (or Expectedness) is a term used in pharmacovigilance to describe whether a specific adverse event is listed (expected) in the product information of a drug. If an event is not listed, it is considered unlisted (unexpected).
2. How is Listedness/Expectedness assessed?
The assessment of Listedness/Expectedness involves a detailed review of the product information, scientific literature, and data from clinical trials.
3. Why is the assessment of Listedness/Expectedness important?
The assessment of Listedness/Expectedness is crucial in pharmacovigilance as it helps in identifying new safety signals and updating the product information to include new potential risks.
4. What are the challenges in assessing Listedness/Expectedness?
Some of the challenges in the assessment of Listedness/Expectedness include the evolving nature of scientific knowledge, differences in product information across regions, and the subjective nature of the assessment.
5. What is the impact of Listedness/Expectedness assessment on public health?
The assessment of Listedness/Expectedness has a significant impact on public health. It contributes to the safe and effective use of medicines, thereby protecting public health.
6. What are the latest developments in Listedness/Expectedness assessment?
The latest developments in Listedness/Expectedness assessment include the use of artificial intelligence and machine learning techniques to automate the process, and the use of real-world evidence in pharmacovigilance.
7. What is the future of Listedness/Expectedness assessment?
The future of Listedness/Expectedness assessment looks promising, with advancements in technology and a growing emphasis on patient safety. However, continuous efforts are needed to overcome the existing challenges.