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Best Practices for Post-Marketing Surveillance of Adverse Events within the U.S.
Best Practices LLC, Sep 2009, Pages: 37
Medical and scientific progress has been enormous in the past decades. However, this has also raised several safety issues leading to increased vigilance on bio-pharma companies by the U.S. Food and Drug Administration Authority. Under such circumstances, it is imperative for the bio-pharmaceutical industry to maintain a dynamic post-marketing surveillance system to ensure regulatory compliance.
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
Industries Profiled:
- Pharmaceutical
- Health Care
- Biotech
- Service
Key Findings:
Staff Resources and Makeup: 80 percent of companies use physicians to review adverse event (AE) reports, more than 50 percent of benchmark partners also use pharmacists and nurses as reviewers.
- 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.
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