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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.
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.
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).
8 charts detailing drug safety team structure, responsibility distribution, and staffing.
33 charts detailing companies' transition into drug safety activities, pharmacovigilance teams' use of social media, and the importance of drug safety.
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.