Driving Pharmacovigilance and Drug Safety Success (PH187)

Risk Management Plans and Adverse Event Reporting
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Published 2013
128 Pages
500+ Metrics
90+ Charts and Diagrams

Elevate Pharmacovigilance Teams and Aid Drug Safety Efforts Through Well-Defined SOPs and Social Media Tools

Ever-changing regulatory requirements in today’s increasingly global landscape reinforce companies’ need for robust drug safety practices. Organizations falling short of compliance standards can incur strict penalties, from warning letters to monetary fines.

Forward-thinking companies go beyond meeting requirements to think of drug safety as a value-adding proposition. They leverage standard operating processes to ensure cohesion across global, country-level and local networks and establish accountability systems to ensure quality reports.

This report contains findings to help you elevate your drug safety efforts with team structure, staffing, outsourcing and budget benchmarks across global and country-level organizations.  Data are complemented by insights on the latest trends, including teams’ use of new technologies for pharmacovigilance reporting.

Top Reasons to Review this Report

Optimize drug safety budgets and outsourced spending: Pharmacovigilance teams require ample resource support as product portfolios expand alongside regulatory demands. Examine detailed drug safety budget benchmarks from 2010 to 2014 projections. Finally, leverage outsourcing to keep internal teams focused on compliance and best practices.

Build a strong pharmacovigilance team — and cultivate a drug safety culture companywide: Use staffing benchmarks to right-size pharmacovigilance teams, dedicating larger headcounts and higher-skilled personnel to account for more complex product portfolios.  Then, elevate drug safety awareness through stand-alone teams that sit alongside clinical and marketing.  Other steps to emphasize pharmacovigilance groups’ importance include providing additional training for all drug safety-facing functions.

Improve efficiency and develop best-in-class practices: Increasing data accessibility and creating standard operating procedures drive efficiency. Learn how top companies establish a global drug safety database, accountability systems and quality checks to ensure error-free reporting.  Prioritize responsibilities using data on 13 key pharmacovigilance activities and see how companies use social media to enhance adverse event reporting.

Pharmacovigilance Metrics

Chapter 1: Managing Drug Safety Budgets and Outsourced Spending

Chapter Benefits

  • Dedicated substantial initial investments to build effective drug safety teams able to accommodate growing product portfolios.
  • Leverage turnkey CROs to support drug safety for investigational products
  • Outsource regulatory submissions and case management to focus internal teams on compliance and best practices
  • Prepare to increase pharmacobigilance budgets to foster teams able to drive best practices companywide and keep pace with developing product portfolios.
  • Base pharmacovigilance budgets on complexity, age and risk-benefit profile of product.

Chapter Data

36 charts detailing the growth of drug safety budgets and companies' outsourced spending to CROs and other third-party vendors. Data are sometimes broken out by company type (Top 20, Top 20 affiliates, Top 50 and small) or size (small, mid-sized and large).

  • Total drug safety budgets for 2011, 2012, and 2013 (by company and by region)
  • Percentage change in drug safety budgets from 2012 to 2013 (by company and by region)
  • 2014 drug safety budget projections (by company type)
  • Projected budget change (by company type)
  • Drug safety budget centralization (2010 and 2013)
  • Source(s) of pharmacovigilance funding (Top 20, Top 50, Top 20 affiliates, small companies)
  • Departments that contribute to non-centralized drug safety budgets (2010 and 2013)
  • Number of investigational and marketed drugs covered by drug safety budgets provided
  • 2013 budgets per product covered (by company and by region)
  • Allocation of drug safety budget resources (2010 and 2013)
  • Percentage of companies that outsource pharmacovigilance activities (2010 and 2013)
  • Percentage of pharmaceutical companies that outsource some portion of their drug safety budget (2010 and 2013)
  • Responsibility distribution across  companies’ in-house and external pharmacovigilance teams (by company type)
  • Percentage of drug safety budget outsourced (by company)
  • Distribution of pharmacovigilance activities for investigational compounds and marketed drugs
  • Pharmaceutical companies’ use of vendors in 2010 and 2013 (by company size)
  • Types of products covered by vendors in 2010 and 2013
  • Most commonly outsourced drug safety activities (in 2010 and 2013 and by company size)


Chapter 2: Building Successful Global Drug Safety Organization Through Structure

Chapter Benefits

  • Elevate pharmacovigilance awareness through standalone drug safety teams that sit alongside clinical and marketing.
  • Foster better communication and coordination companywide with integrated drug safety teams responsible for both investigational and marketed products.
  • Learn how to coordinate drug safety in a licensing agreements or co-marketing agreement.
  • Leverage basic market analysis alongside a target ratio of FTEs per product to help determine adequate drug safety staffing levels.
  • Dedicate higher drug safety headcounts to support complex product portfolios.

Chapter Data

8 charts detailing drug safety team structure, responsibility distribution, and staffing.

  • Types of pharmacovigilance team structures (by company type)
  • Functions responsible for pharmacovigilance in 2010 and 2013
  • Functions responsible for pharmacovigilance (Top 20 companies,  Top 20 affiliates,  Top 50 companies,  small companies, and device companies)
  • Structure of companies’ investigational and marketed drug safety programs (by company type)
  • Real-company diagram of drug safety organizational structure
  • Global drug safety team staffing and FTEs per product (by company and company size)
  • Percentage of contract FTEs at global drug safety teams
  • Global  and country-level drug safety team FTE distribution (2013)
  • Country-level drug safety team staffing (by company type)
  • Country-level drug safety FTEs per product (by company type)
  • Percentage of contract FTEs at country-level drug safety teams (by company and company size)

Chapter 3: Align Pharmacovigilance Activities by Leveraging Available Resources

Chapter Benefits

  • Position regulatory submissions, case management and signal detection as the most important drug safety activities.
  • Prevent late cases with a first-in, first-out prioritization strategy.
    • Create accountability systems to ensure teams complete and submit adverse event reports within the required timeline.
    • Develop quality checks to ensure case materials make sense, accurately describe the adverse event outcome and are free from spelling and other grammatical errors.
  • Implement strong signal detection programs — that allow companies to observe, monitor and act on any new incoming information — by establishing preferred data types on a product-by-product basis.
  • Increase the visibility of pharmacovigilance by including drug safety in new employees’ training and hosting frequent, additional training for all drug safety-facing functions.
  • Draft the framework for products’ risk mitigation plans early — no later than Phase 2.
  • Establish a global drug safety database to centralize and increase data accessibility among companies’ dedicated teams.
  • Supplement traditional adverse event reporting channels (email, company website, telephone) with social media, particularly in more “consumer-driven” therapies.

Chapter Data

33 charts detailing companies' transition into drug safety activities, pharmacovigilance teams' use of social media, and the importance of drug safety.

  • Percentage of companies performing specific pharmacovigilance activities (Top 20, Top 20 affiliates, Top 50, small pharma)
  • Stage at which teams become involved in pharmacovigilance (Top 20, Top 20 affiliates, Top 50, small companies)
  • Phase of development companies begin specific pharmacovigilance activities
  • Companies’ perceived importance of specific pharmacovigilance activities
  • Phase at which companies begin preparing risk mitigation plans (by company type and by region)
  • Diagram of pharmacovigilance team’s interfunctional relationships
  • Percentage of companies involved in risk mitigation plans (by company type)
  • Percentage of companies leveraging:
    • Common REMS materials
    • Pharmacovigilance communication plans
    • Post-REMS strategies
    • Proactive safety resources
    • Specific adverse event tracking channels
    • Social media channels
    • Pharmacovigilance ROI tools
  • Percentage of pharmacovigilance teams reporting global drug safety database ownership
  • Ways in which companies organize their global drug safety databases (central repository, product and business unit)
  • Average distribution of companies’ serious and non-serious adverse event reporting channels
  • Percentage of pharmacovigilance teams using social media to report adverse events
  • Pharmacovigilance teams’ preferred social media adverse event reporting channels
  • Companies’ use of social media channels (by company type)
  • Percentage of adverse events received through social media channels (by company)
  • Pharmacovigilance companies’ level of social media governance — whether standard operating procedures are in place (by company size)

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.