Best Practices for Post-Marketing Surveillance of Adverse Events within the U.S. : Market Research Report

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

Published: Sep. 1, 2009 - 37 Pages

STUDY OVERVIEW: Research Objective & Methodology; Key Findings; Benchmark Class; Staffing; Staff Makeup; Contracted Third-Party Vendors; Adverse Event Reporting; Evaluating Adverse Events; Adverse Event Reporting Sources; Non-Serious Solicited Adverse Event Reports; Defining Roles of Affiliates; Handling Adverse Event Reports on Products from Other Manufacturer; Adverse Event Report Follow-Up; Due Diligence in Follow-Up; Obtaining Patient Consent for Follow-Up; Trusted Sources of Adverse Event Training; Methods for Conducting Adverse Event Training; Best Measures of Training Effectiveness; Marketing Programs and Drug Safety; Reporting Adverse Events Based on Source; About Best Practices, LLC

Abstract

STUDY OVERVIEW

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.

Industries Profiled:

Pharmaceutical; Health Care; Biotech; Service

Companies Profiled:

Novartis; Boehringer Ingelheim; Wyeth Pharmaceuticals; Novo Nordisk; Apotex; Stiefel; EMD Serono; Sepracor; Amgen; Biogen Idec; Vertex Pharmaceuticals; Eisai; Takeda Pharmaceuticals; Bracy Analytics Inc; ArthroWave

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

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

Table of Contents

Abstract