Pharmacovigilance (PH225)

Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations
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Published 2016
348 Pages
500+ Metrics
200+ Charts and Diagrams

Mobilize Drug Safety Teams to Prepare for Regulatory Changes and Improve Case Management

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.

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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:

  • Coordinate drug safety ownership prior to initializing co-licensing and/or co-marketing agreements.
  • Cater case management staffing allocations to annual expected frequency and complexity.
  • Determine which pharmacovigilance outsourcing factors are more important post-launch.
  • Consider the impact of social media and online monitoring in the drug safety space.
  • Leverage internal experts to contribute to drug safety initiatives throughout the product lifecycle.

 

Key Questions That This Study Answers About Drug Safety

  1. Which functions contribute to drug safety funding, and how much should they provide?
  2. How much of teams’ drug safety budgets should be allocated to key activities, such as case management, signal detection, and risk mitigation strategies?
  3. How much should global or country-level teams expect in percentage of outsourcing costs for specific pharmacovigilance activities?
  4. How should my company handle the distribution of drug safety responsibilities between in-house and outsourced staff?
  5. In what ways can we improve drug safety team structure to promote consistent strategy, save on costs and enhance interteam communication?
  6. How can we redistribute drug safety responsibilities to improve FTE workloads and ensure quality data?
  7. What processes and tactics have other companies used to outline drug safety responsibilities in the event of a co-marketing or co-licensing deal?
  8. When should we initiate specific drug safety activities, relative to the drug development cycle—and when do these responsibilities typically reach their peak?
  9. What pharmacovigilance tools are teams currently using, and how are they affecting or improving data analysis? In what ways can Big Data preserve data quality?
  10. What standard operating procedures (SOPs) can teams employ to smooth out case management processes and allow for greater flexibility?
  11. How are teams demonstrating the return on their REMS programs?

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Top Reasons to Read This Drug Safety Report

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 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.

Pharmacovigilance Metrics

Chapter 1: Identify Best-Fit Drug Safety Budgets, Activity Costs and Outsourcing Practices

Major Takeaways

  • Determine what percentage of drug safety funding should come from different groups within a life sciences organization.
  • Determine best-fit budget allocations to different pharmacovigilance activities.
  • Identify the percentage of costs teams should outsource for different drug safety activities.
  • Consider what percentage of different case management responsibilities teams want to entrust to vendors and what percentage to keep in-house.

 
Chapter Data

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).

  • Total drug safety budget for 2014–2016
  • Average percentage of drug safety budget contributed by function:
    • Standalone drug safety team
    • Clinical Development
    • Medical affairs
    • Regulatory affairs
    • Legal/Counsel
    • Compliance
    • Market access
    • Risk management
    • Marketing/brand teams
  • Percentage of drug safety funding provided by function, for individual teams
  • Monetary value of funding provided by function (2014, 2015, and 2016): upper-, middle-, and lower-level budgets
  • Average percentage of 2015 drug safety budget dedicated to specific activities
  • Actual budgets and percentage of drug safety budget (2014–16) for the following activities at individual teams:
    • Safety and technology
    • Case management
    • Aggregate report development
    • Regulatory submissions
    • Medical services
    • Literature services
    • Signal detection
    • Due diligence
    • Project management
    • Risk mitigation
    • Risk evaluation and mitigation strategies (REMS)/risk management planning (RMP) development
    • Periodic, periodic safety update report (PSUR) and annual safety report (ASR) development
    • Regulatory consulting
    • Drug safety training
  • Timing of drug safety budget allocations, by activity (2015)

Drug Safety Outsourcing

  • Average importance ratings of specific outsourcing factors during pre-launch and post-launch
  • Preferred vendor capabilities, by team type
  • Percentage of companies outsourcing drug safety activities, by team type
  • Percentage of costs outsourced for:
    • Safety and technology
    • Case management
    • Aggregate report development
    • Regulatory submissions
    • Medical services
    • Literature services
    • Signal detection
    • Due diligence
    • Project management
    • Risk mitigation
    • Periodic, periodic safety update report (PSUR) and annual safety report (ASR) development
    • Regulatory consulting
    • Drug safety training
    • Risk evaluation and mitigation strategies (REMS)/risk management planning (RMP) development
  • Distribution among in-house and outsourced staff for case management responsibility:
    • Bookend triage
    • Data entry
    • Medical coding
    • Medical review
    • Narrative writing
    • Other (signal detection and risk management; medical coding)

 

Chapter 2: Align Structure Designs and Staffing Allocations with Product-Driven Drug Safety Activity Levels

Major Takeaways

  • Centralize drug safety design structures to promote consistent and effective pharmacovigilance strategy development and execution.
  • Consolidate investigational and marketed product responsibilities if dealing with small product numbers to conserve costs and spark interteam communication.
  • Create segmented investigational and marketed product responsibilities for large pipelines to reduce FTE workloads and ensure that data do not become convoluted.
  • Outline drug safety responsibilities for all parties involved in drug development and marketing before approving co-licensing and/or co-marketing agreements.
  • Assign global and country-level drug safety staffing with anticipated activity workloads in mind.

 
Chapter Data

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

  • Overall drug safety decision-making structure
  • Executive in charge of drug safety
  • Status of standalone group dedicated to drug safety
  • Age of standalone drug safety group: all global teams and country-level teams with existing group
  • Function in charge of drug safety

Drug Safety Team Staffing

  • Standalone drug safety group size
  • Number of FTEs performing drug safety activities from the following functions:
    • Clinical
    • Medical Affairs
    • Regulatory Affairs
    • Legal
    • Compliance
    • Other
  • Number of FTEs from individual company teams performing the following activities;
    • Safety and technology services
    • Case management
    • Aggregate report development
    • Periodic, PSUR and ASR development
    • Regulatory submissions
    • Medical services
    • Literature services
    • Signal detection and management
    • Due diligence projects
    • Project management
    • Risk mitigation strategy development
    • Risk management planning development
    • Regulatory consulting
    • Drug safety training

Database Management

  • Life science teams’ global drug safety database organizational strategy and positioning
  • Percentage of database management responsibility outsourced
    • Data storage and/or back-up
    • Data migration
    • Dictionary management

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.

  • Global and country-level team structures, by company (4 tables)
  • Total product to staffing ratios, by company (4 tables)

 

Chapter 3: Harnessing Internal Databases and Subject Matter Expertise to Support Pharmacovigilance Activities

 Major Takeaways

  • Develop internal safety tools that can view and analyze data from a number of internal and external sources.
  • Research the Big Data space before initiating activities to develop an approach that preserves data quality and delivers useful outcomes.
  • Develop pharmacovigilance reports and conduct market research to evaluate REMS program success.

 
Chapter Data

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).

  • Percentage of teams:
    • Using selected resources to identify drug safety information
    • Using additional tools to identify drug safety information
    • Conducting drug safety activities
  • Percentage of functions involved in specific drug safety activities:
    • Case management
    • Periodic, PSUR and ASR development
    • Signal detection and management
    • Aggregate report development
    • Literature services
    • Drug safety training
    • REMS/RMP development
    • Risk mitigation strategy
    • Project management
    • Safety and technology services
    • Due diligence
    • US, EU and/or other regulatory consulting

Activity Timelines

  • The following charts show at which points certain pharmacovigilance activities start and peak during product development for individual company teams:
    • Regulatory submissions
    • Case management
    • Periodic, PSUR and ASR development
    • Signal detection and management
    • Aggregate report development
    • Literature services
    • REMS and/or RMP development
    • Medical services
    • Drug safety training
    • Risk mitigation strategy
    • Project management strategy
    • Safety and technology
    • Due diligence
    • US, EU and/or other regulatory consulting

Drug Safety Tools

  • Average company-rated importance of specific data when building a signal detection threshold
  • Frequency of risk-threshold parameter adjustment
  • Ownership of online channel adverse event monitoring responsibilities
  • Frequency of online channel monitoring activities
  • Percentage of teams using selected:
    • REMS materials
    • Communication plans
    • Post-marketing REMS strategies
    • Tools to evaluate the success of REMS programs
  • REMS timeline comparison
    • Time from receiving FDA REMS notification letter to REMS submission
    • Time from REMS submission to REMS approval

 

Chapter 4: Adverse Event Reporting, Case Management, Literature Searches and Upcoming Regulations

Major Takeaways

  • Simplify the AE reporting process — the easier companies can make the AE reporting process, the more likely they are to receive comprehensive information.
  • Develop online and mobile platforms that provide long-term end user value, not just another AE reporting channel.
  • Create case management SOPs that build-in extra time to allow teams greater flexibility in case the final report isn’t available within the required reporting period.
  • Be prepared for new ICH guidelines.

 
Chapter Data

32 charts detailing adverse event reporting, case management approaches and current and forthcoming drug safety regulations.

  • Percentage of total adverse event reports received, by channel:
    • General telephone number
    • Medical information team / physician hotline
    • MSL interactions
    • Company website
    • Company database
    • Social media
    • Other
  • Percentages of solicited and unsolicited adverse events received, by audience
  • Breakdown of total adverse events, by audience:
    • Physicians
    • Patients
    • Medical information teams
    • Sales reps
    • Patient assistance programs
    • Retail pharmacists
    • Specialty pharmacists
  • Percentages of solicited serious adverse events received, by audience
  • Percentage of unsolicited serious adverse events received, by audience
  • Breakdown of total serious adverse events, by audience:
    • Physicians
    • Patients
    • Medical information teams
    • Sales reps
    • Patient assistance programs
    • Retail pharmacists
    • Specialty pharmacists
  • Desired adverse event reporting process improvements
  • Number of investigational products supported in 2015
  • Number of marketed products supported in 2015
  • Number of marketed product cases in 2015
  • Percentage of teams conducting selected case management activities

 

Chapter 5: Case Management Profiles

Major Takeaways

  • Understand, at a glance, case management activities from 2014 to 2016, across product types, geographic regions and team responsibility levels.
  • Compare overall drug safety budgets and case management spend to expenses incurred by individual products’ caseloads.  Overall and case management budgets are available for 10 of the 11 profiled teams. Cost per case metrics are available for seven of the 11 profiled teams.
  • Use this information to help guide case management strategy and manage workloads.

 
Chapter Data

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.

  • Each profile contains the following information, to the extent available:
    • Company type
    • Team level
    • Region(s) of operation
    • Product therapeutic area
    • Product type (first-in-class, follow-on, next generation, etc.)
    • Product lifecycle stage (early investigational development, late-stage investigational development, 1-2 years on the market, etc.)
    • Number of cases per year (2014, 2015 and 2016).
    • Average cost per case
    • Case turnaround time

Pharmacovigilance Report Excerpt

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:

  • The largest percentage of all surveyed groups are responsible for regulatory submissions and case management — each at 88%. Another 85% of surveyed teams are responsible for periodic, PSUR and ASR development as well as signal detection and management activities.
  • More than three-quarters of surveyed teams are responsible for aggregate report development (82%), literature services (79%) and drug safety training (76%).
  • More than half of surveyed teams take on responsibilities related to REMS and RMP development (62%), medical services (59%), project management (56%), safety and technology services (53%) and risk mitigation strategy (50%).
  • Just under half of all surveyed teams take on due diligence projects and regulatory consulting — at 47% and 41% of groups, respectively. Another 3% of all surveyed teams — only global teams — are responsible for regulatory inspections and audits.

Pharmacovigilance Report Sample

The following excerpt is a key finding from the full report’s Executive Summary. 

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.