Paper Details 
Original Abstract of the Article :
PURPOSE: To evaluate the impact of including a medicine in the list of medicinal products subject to additional monitoring (AM) on the reporting of adverse drug reactions (ADRs) in the european economic area (EEA). METHODS: Interrupted time series using the monthly number of EEA ADR reports in Eudr...See full text at original site
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引用元:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898803/

データ提供:米国国立医学図書館(NLM)

Monitoring Status and Adverse Drug Reaction Reporting: A Closer Look at EudraVigilance Data

This study examines the impact of including a medicine in the list of medicinal products subject to additional monitoring (AM) on the reporting of adverse drug reactions (ADRs) in the European Economic Area (EEA). The researchers analyzed data from EudraVigilance, the European database for ADRs, to determine if the AM status influenced ADR reporting rates. Their findings suggest that, while there was no immediate increase in reporting after a drug was added to the AM list, a gradual increase in reporting was observed for some newly introduced products. The study also noted a gradual decrease in reporting for some existing drugs subject to AM, highlighting the complex relationship between monitoring status and ADR reporting.

Monitoring Drug Safety: A Deep Dive into EudraVigilance Data

This research delves into the complex world of drug safety monitoring, examining the impact of additional monitoring status on the reporting of adverse drug reactions (ADRs). The researchers analyzed data from EudraVigilance, a vast European database of ADR reports, to understand how monitoring status influences reporting patterns. This research is like navigating a vast desert of drug safety data, seeking to uncover hidden patterns and trends.

Navigating the Sands of Drug Safety: The Role of Additional Monitoring

This research sheds light on the complex relationship between monitoring status and ADR reporting. The findings suggest that while additional monitoring may not immediately increase reporting, it can lead to a gradual increase in reports over time, particularly for new drugs. This research is like a guidebook for navigating the shifting sands of drug safety, helping us to understand how monitoring systems influence reporting patterns and ultimately contribute to safer drug use.

Dr. Camel's Conclusion

This study reveals a complex relationship between monitoring status and ADR reporting. While additional monitoring may not immediately increase reporting, it can lead to a gradual increase in reports over time for some drugs, highlighting the importance of ongoing vigilance and careful analysis of ADR data for ensuring drug safety.

Date :
  1. Date Completed 2021-11-24
  2. Date Revised 2022-10-05
Further Info :

Pubmed ID

33197106

DOI: Digital Object Identifier

PMC7898803

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Languages

English

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