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Revamped EudraVigilance System Could Improve Drug Safety Reporting

Preventable drug safety issues caused nearly 200,000 deaths across the European Union in 2017.  Now the European Medicines Agency is working to address that statistic by improving its drug track-and-trace system, known as EudraVigilance.

The EudraVigilance system compiles data about side effects caused by drugs that are either in the marketplace or being studied in clinical trials. Improvements include:

 

  • Simplified reporting
  • Enhanced interoperability
  • Increased searchability and better data analysis
  • Expanded system capacity.

 

The European Medicines Agency hopes the enhancements will better equip regulators to review and respond to suspected adverse events. In addition, the agency says the updates will aid collaboration with the World Health Organization, allowing for more robust global pharmacovigilance.

Pharmacovigilance –detecting, tracking, analyzing and preventing drug side effects – is critical to patient safety. Side effects are typically discovered during clinical trials, but drug testing does have its limits. Researchers cannot account for every variable, and once a drug is being used broadly, additional side effects may emerge.

In the case of complex drugs such as biologics or biosimilars, small distinctions between drugs or even between batches of the same drug can cause different patient responses.  That is why regulators, health care providers and patients must monitor side effects on an ongoing basis.

Being able to trace these side effects to their exact source allows regulators and health care providers to have complete records.  Health care providers can use these data to make informed treatment decisions for their patients.  Regulators, meanwhile, can detect if any patterns of adverse events occur.  They can then respond as needed.  That may mean requiring additional testing or new labeling of a drug. In extreme situations, they may recommend that a drug be removed from the market.

To learn more about pharmacovigilance, read GAfPA’s Fast Facts.

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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