|200+ Charts and Diagrams|
Drug safety and pharmacovigilance teams fill a critical role, including processing adverse event cases, completing regulatory submissions and refining signal detection thresholds. As the safety landscape evolves, life science companies prepare for upcoming regulatory changes while rethinking existing structures and practices.
This report uncovers best practices and benchmarks associated with drug safety. Use its findings to understand upcoming regulatory guidances, improve case management, make best-fit budget allocations, and more. The report’s data were compiled from global and country-level teams for Top 20, Top 50, Top 20 Affiliate, small pharma and biotech companies, as well as medical device companies.
The following summary principles from the report will help improve your teams’ familiarity with drug safety resource and activity planning:
Understand the new regulatory environment: Thanks to evolving drug safety regulations worldwide, life science firms are becoming more familiar with REMS and RMPs as a whole. The study provides trend analysis and best practices to guide drug companies on developing REMs and RMPs, crafting risk mitigation strategies and tracking regulatory changes and their impact on pharmacovigilance.
Reconcile case management processes with industry requirements: Recent ICH updates have encouraged increased harmonization which — ideally — will make global drug safety reporting easier. Moving forward, this new regulatory guidance may impact how life science teams design their AE reporting and case management structures. The report explores companies’ adverse event processing and case management activities. This discussion includes the types of channels and healthcare audiences through which companies receive adverse events and the extent of cases that dedicated teams may handle annually. The study also addresses recently finalized ICH guidelines, which are set to take effect in Europe later in 2016.
Define drug safety team structures: This study emphasizes the importance of a dedicated pharmacovigilance team — a function that many organizations already leverage. Companies without a well-defined pharmacovigilance department structure and/or sufficient staffing may struggle to achieve all desired drug safety outcomes. The study includes detailed outlines of global and country-level drug safety team structures, as well as staffing ratios for 26 companies. Structure outlines include information about the number of drug safety groups and groups’ structural organization at both global and country-level levels.
Benchmark drug safety budget data. Budget-building and outsourcing management are key to devising a pharmacovigilance strategy. Spending and outsourcing practices vary by individual drug safety activity, so teams can strategize these decisions based on activity priorities. The data identify drug safety budgets, activity costs and the sources of drug safety funding. A comparison between budget allocations and activity timelines also provides how much money teams dedicate during the clinical and post-marketed drug development stages. These data are separated between global and country-level drug safety teams.
90 charts detailing drug safety budgets, activity costs and outsourcing for global and country-level teams across companies of various types (small pharma/biotech; top 20 and top 50 firms and affiliates; and vendors).
Drug Safety Outsourcing
CHAPTER 2: Align Structure Designs and Staffing Allocations with Product-Driven Drug Safety Activity Levels
70 charts and tables detailing drug safety team structure, staffing and decision making. Throughout the chapter, data are broken down by team scope of responsibility (global and country-level) and company size/type (small pharma/biotech, top 20 and top 50, affiliates and vendors).
Pharmacovigilance Team Structure and Decision Making
Drug Safety Team Staffing
Surveyed Team Data Tables
These tables compare the number of FTEs dedicated to case management against the total number of investigational and marketed cases received in a single year. Moreover, a look at these tables can help readers gauge the relationship between products and the number of cases they generate.
CHAPTER 3: Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities
43 charts detailing pharmacovigilance activities, tools and timelines. Throughout the chapter, data are broken down by team scope of responsibility (global and country-level) and company size/type (small pharma/biotech, top 20 and top 50, affiliates and vendors).
Drug Safety Tools
CHAPTER 4: Adverse Event Reporting, Case Management, Literature Searches and Upcoming Regulations
32 charts detailing adverse event reporting, case management approaches and current and forthcoming drug safety regulations.
CHAPTER 5: Case Management Profiles
This chapter profiles case information associated with 11 different products. It also includes an appendix graphic that compares caseloads generated by profiled products against total company-reported investigational and marketed cases in 2015.
The following excerpt is from Chapter 3: harnessing internal databases and subject matter expertise to support pharmacovigilance activities.
Vary Global and Country-Level Pharmacovigilance Responsibilities to Drive Drug Safety Excellence
Pharmacovigilance groups are responsible for a wide range of activities. However, these responsibilities vary across organizations. Team level — global versus country-specific — certainly impacts activities. While global teams have the perspective and resources to prepare drug safety information for worldwide initiatives, global groups are able to focus on market-specific needs. Company size, which may dictate internal drug safety resources, also impacts group responsibilities.
This chart (not shown) shows the percentage of surveyed teams taking on specific drug safety activities. All surveyed teams take on a wide variety of activities. Key findings for these data include:
Establish a culture of Pharmacovigilance training and accountability across functions
Ensuring that pharmacovigilance activities run smoothly begins with providing adequate training to all drug safety-facing functions. Many groups — from medical affairs teams to sales teams — report pharmacovigilance responsibility. Educating all functions on pharmacovigilance activities often serves as a best practice.
Company C has leveraged its dedicated pharmacovigilance team to develop training modules for the company’s new hires. Through brief presentations, the company’s drug safety team apprises new team members of the criteria behind adverse event identification. New hires must then undergo a second educational course. Finally, Company C confirms its teams’ knowledge via a required, short test following the training series. Likewise, Company C also provides the necessary training for its associated vendors and consultants — as well as its sales group on a biannual basis.
During face-to-face training sessions with sales teams, Company C’s drug safety group discusses current case studies and outlines the protocols behind adverse event reporting. Within these meetings, Company C’s pharmacovigilance head emphasizes the importance of engaging physicians during office visits. Teams work to uncover as much adverse event information as possible during their initial meeting with physicians. Thorough information allows dedicated drug safety teams to more easily follow up with these individuals and submit the necessary paperwork to regulatory bodies.
Likewise, companies benefit from establishing levels of drug safety accountability across all internal functions. For example, to ensure prompt case management — including timely adverse event reporting — Company C’s pharmacovigilance head developed a timeline to track companies’ incoming and outgoing case reports. Although companies have 15 days to submit serious adverse event reports to the FDA, Company C expects its team to send out information by Day 10. The earlier the drug safety team completes its case management activities, the more time affiliate groups have to submit data to their regulatory authorities.
To ensure teams uphold this schedule, Company C’s pharmacovigilance head frequently communicates with its pharmacovigilance and sales teams. In the event the company’s field force fails to deliver adverse reports within the initial required 24-hour reporting period, a Company C executive personally follows up with the responsible parties. By maintaining ongoing communications across its dedicated teams, companies address reporting challenges early and are able to develop protocols to prevent future delays.