RESEARCH TRIANGLE PARK, N.C.--(EON: Enhanced Online News)--56% of surveyed pharmaceutical companies increased their pharmacovigilance budgets from 2012 to 2013 — continuing a trend identified by Cutting Edge Information in 2011.
“Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting”
A recent study, “Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting,” discovered that companies with extremely complex or high-risk products need to adjust their drug safety budgets accordingly. Complex product portfolios — those containing novel drug classes or high-risk mechanisms of action — generate exhaustive caseloads for drug safety case managers and might require expert medical reviews. Both factors raise a global safety organization’s operation costs.
Pharmaceutical companies should strive to equip an effective pharmacovigilance team with the necessary infrastructure to meet its goals and responsibilities. With this support, the company can expand the team’s number of managed products without substantial budget increases — assuming the products are not significantly more complex compared to the rest of the portfolio.
As companies assess their drug safety budgets, it is extremely important to recognize the increased cost that accompanies a drug safety team’s effectiveness. Only two surveyed companies indicate a drop in drug safety funding from 2012 to 2013. Further data show that at least half of the pharmaceutical companies surveyed expect drug safety budgets to continue rising in 2014.
The increase in budgets is partially due to the steadily rising profile of drug safety groups. But also, the rising cost of regulatory compliance is driving drug safety budgets. According to an interviewed drug safety manager, “If you were to compare from five years ago, even with the same company, the same number of products, you will have to pay much more today to meet the patient safety and risk management requirements.”
The data in “Driving Pharmacovigilance Success: Risk Management Plans and Adverse Event Reporting” (http://www.cuttingedgeinfo.com/research/regulatory/drug-safety/) are designed to assist in companies’ drug safety efforts and elevate pharmacovigilance teams’ strategic impact through well-defined standard operating procedures and social media tools.
Pharmacovigilance teams can use this report to:
- Optimize drug safety budgets and outsourced spending.
- Build a strong team and cultivate a drug safety culture companywide.
- Improve efficiency and implement best-in-class practices.
For more information about drug safety programs, contact Cassie Demeter at 919-403-6583.