Best Practices report: 50% of participating companies fail collect AE reports from Internet sources

Drug safety remains front and center for the U.S. Food and Drug Administration as the agency strives to improve the public's perception of the organization. Likewise, the pharmaceutical industry is focused on improving its reputation among consumers and recognizes that its diligence in the reporting of adverse events plays an important role in that effort.

One issue that is impacting both these efforts is the approach to post-marketing surveillance for adverse events for gray areas like the Internet where reporting practices vary across the pharma industry. A Best Practices, LLC post-marketing surveillance study found that 50 percent of the participating companies don't collect AE reports from Internet sources such as blogs or interactive Web events.

Best Practices, LLC has published this report to help drug safety leaders navigate the gray areas of the regulations regarding the reporting of adverse events. Best Practices for Post-Marketing Surveillance of Adverse Events within the United States delivers not only metrics around drug safety reporting processes and sources, but also staffing, follow-up activities and compliance training. Drug safety leaders from 15 organizations shared their practices and insights into the evolving state of post-marketing surveillance of adverse events.

Key topics of this report include:

  • Staff Number (FTEs) and Makeup in Drug Safety Groups
  • Employee Groups Involved in AE Report Assessment
  • Process for Evaluating Adverse Event Reports
  • Most Common Reporting Sources of Adverse Event Reports
  • Main Methods for Follow-Up Activities
  • Adverse Event Report Training
  • Reporting Approach from Various Sources

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Study finds thousands of food-contact chemicals in humans, raising safety concerns