Best Practices for Post-Marketing Surveillance of Adverse Events within the U.S.

This benchmarking study examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training.

Executives and managers in Drug Safety can use this research to compare their group's staffing, makeup, AE evaluation process, reporting sources, follow-up activities and training with those of leading organizations.

Study Snapshot

This benchmarking report examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training. Executives and managers in Drug Safety can use this research to compare their group's staffing, makeup, AE evaluation process, reporting sources, follow-up activities and training with those of leading organizations. Representatives from 15 leading companies have shared their practices, views and information, to facilitate post-market surveillance system. Following are the key topics covered in this report:

• Staffing and Workflow
• Drug Safety Processes and Reporting Sources
• Approach to AE Reports from Non-Traditional Sources
• Approach to AE Reports on Another Manufacturer’s Product
• Drug Safety Compliance Training
• Marketing Program Involvement
• Drug Safety Challenges

• Post-Marketing Surveillance Process: Some drug safety activities appear common in the industry, such as outsourcing low-level work and forwarding all AE reports of other manufacturers. Nearly 60 percent of the benchmark class outsource low-level work such as data entry within their drug safety groups.
• Post-Marketing Adverse Events Reporting: Most of the companies said they report from a list of varied sources, 50 percent said they do not report from non-traditional sources such as blogs and interactive Web events.

• Key Findings & Insights 4
• Benchmark Class 8
• Staff Number (FTEs) and Makeup in Drug Safety Groups 10
• Employee Groups Involved in AE Report Assessment 12
• Process for Evaluating Adverse Event Reports 16
• Most Common Reporting Sources of Adverse Event Reports 21
• Main Methods for Follow-Up Activities 27
• Adverse Event Report Training 31
• Reporting Approach from Various Sources 35

• Drug Safety Staffing by Function
• Functions Responsible for Assessing Adverse Events Reports
• Adverse Drug Event Reports Per Month
• Sources of Adverse Drug Event Reports
• Definition of "Affiliate" or "Company Representative" Clear at Company
• Handling of Adverse Event Report for another Manufacturer
• Follow-up Activities for Adverse Event Reports
• Definition of Due Diligence
• Obtaining Patient Consent to Contact Health Professional Regarding Adverse Event
• Responsibility for Adverse Event Training
• Methods of Training and Effectiveness Measures
• Reporting Approaches for Adverse Events from Different Sources