Best Practices for Post MKT Surveillance Report Summary


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The reporting of adverse events continues to be a critical activity for the pharmaceutical industry and its importance is clear as the U.S. Food and Drug Administration increases its focus on post-marketing surveillance. As the agency puts more resources into post-marketing surveillance, the industry is responding by re-examining its reporting protocols and how it deals with the gray areas of the regulations regarding the reporting of adverse events.

With this in mind, Best Practices, LLC has created an important new benchmarking study that examines best practices for post-marketing reporting of adverse events.

This pharmaceutical and biotechnology-focused study is designed to explore where companies receive adverse event reports from and whether they report events from non-traditional sources. The study also examines the effectiveness of different methods for collecting follow-up data.

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Best Practices for Post MKT Surveillance Report Summary

  1. 1. Best Practices forPost-Marketing Surveillance ofAdverse Events within the U.S. Best Practices, LLC Strategic Benchmarking Research BEST PRACTICES, 1 ® Copyright © Best Practices®, LLC LLC
  2. 2. Table of Contents Study Overview Key Findings & Insights Benchmark Class 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 BEST PRACTICES, 2 ® Copyright © Best Practices®, LLC LLC
  3. 3. Study OverviewThis study was conducted for a member of the Best Practices, LLC Business ExcellenceBoard. Study Objective & Methodology Key Topic Areas Best Practices, LLC undertook this Staffing and Workflow research to identify best practices Drug Safety processes and for post-marketing surveillance reporting sources within the United States, as well as the processes for assessing reports Approach to AE reports from of adverse events, follow-up non-traditional sources activities and compliance training. Approach to AE reports on The research involved an online another manufacturer’s product survey of 15 drug safety leaders at Drug Safety compliance training 15 companies. Marketing program involvement Drug Safety challenges BEST PRACTICES, 3 ® Copyright © Best Practices®, LLC LLC
  4. 4. Key Findings 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.• Some snapshots of the benchmark class: • Fifty percent receive more than 1,000 AE reports a month. • Fifty-seven percent of the respondents said serious AE reports make up between 0 and 10 percent of the total reports received monthly. • There were only four reporting sources that 60 percent or more of participants denoted as sources for AE reports: Call Centers/Disease Mgmt Programs; Company Healthcare Field Professionals; Marketing Booth/Face-to-Face Events and Consumers Who May Represent Firm.• Nearly 60 percent of the benchmark class outsource low-level work such as data entrywithin their drug safety groups. BEST PRACTICES, 4 ® Copyright © Best Practices®, LLC LLC
  5. 5. Universe of Learning: Public Relations ExcellenceExecutives from 15 bio-pharmaceutical companies shared their strategies, lessonslearned and best practices on Post-Marketing Surveillance. Bracy Analytics Inc. BEST PRACTICES, 5 ® Copyright © Best Practices®, LLC LLC
  6. 6. Doctors and Nurses are Large Part of Drug SafetyStaff MakeupThe makeup of benchmark partners’ Drug Safety staff heavily favors doctors andnurses. Estimate the percentage of your Drug Safety employees in the following areas. Other Drug Safety Employees •PhDs Doctors, 19% •MPHs •IT •Allied health Other, 52% Nurses, 19% •Basic Science Degree •Scientists •Information management •Project management •EPI •Risk management administration Pharmacists,(n = 14) 10% BEST PRACTICES, 6 ® Copyright © Best Practices®, LLC LLC
  7. 7. Most AE Reports come from Call Centers Eleven out of the 15 research participants said they get AE reports from call centers and disease management programs, making that the largest reporting source for the benchmark class. Where do you receive adverse drug event reports from? Company call centers/ 73% Disease mgmt programs Company healthcare professionals in field 67% Marketing booth/ Face-to-face events 60% Consumers who may represent your firm 60%Other: Distributors, sales force,marketing partners, licensing 53%partners, patients, etc. (n=14) BEST PRACTICES, 7 ® Copyright © Best Practices®, LLC LLC
  8. 8. Most Companies Report AEs Regardless ofSource Most of the benchmark class report AEs from these sources. The exception is Internet sources such as blogs/chat rooms, which are ignored by more than half the respondents. How do you report adverse drug event reports from the following sources? (n=14) (n=12) (n=12) (n=12) (n=12) 14% 8% 17% 17% 33% 50% 50% 33% 8% 58% 8% 7% 33% 50% 42% 29% 25% 17%Company Web site Another Internet source Market Research Project Interactive Web event Consumers that may (blogs,etc) represent company All reports considered solicited and sent to health authority only when serious, unlabeled & causally related Solicited & unsolicited reports received from these sources and there are clear reporting obligations for each Does not report AEs at this time Does not apply (N/A) BEST PRACTICES, 8 ® Copyright © Best Practices®, LLC LLC
  9. 9. About Best Practices, LLC Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 BEST PRACTICES, 9 ® Copyright © Best Practices®, LLC LLC