SOURCE: Cutting Edge Information

Cutting Edge Information

June 01, 2016 08:36 ET

Pharma Executives Perceive Drug Safety Responsibility to Be 23% Higher Than Actually Present in Global or Country-Level Medical Affairs Teams

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 01, 2016) - When surveyed US and country-level team executives reported their perception of where drug safety belongs among various teams, it showed that they rated global and country-level medical affairs teams up to 23% higher than the actual percentage responsible for drug safety, according to pharmaceutical business intelligence provider Cutting Edge Information.

Medical Affairs Management: Igniting Innovative Global Strategies , published by Cutting Edge Information, found an 11% average misconception between the perceived medical affairs drug safety responsibility of 44% and actual responsibility of 33%. The largest misperception was among global medical affairs teams, which had a 33% perceived responsibility for drug safety, but an actual responsibility of 10%. With the exception of country level teams, less than 50% of teams at each region and company size equip medical affairs functions with responsibility over drug safety.

Drug safety -- or pharmacovigilance -- organizations perform a number of invaluable activities to uphold patient safety. These activities include developing risk mitigation strategies geared toward educating healthcare providers and consumers of any associated product risks and tracking adverse event report frequencies both before and well after products launch. These activities could explain why executives assumed the responsibilities mostly belonged to the medical affairs group.

"We found that although drug safety is commonly beneath the medical affairs group, executives foresee organizational responsibility shifting to the clinical function within the next several years," said Natalie DeMasi, senior analyst at Cutting Edge Information. "Executives believe that drug safety is best-suited within clinical or research groups because these personnel are often the most familiar with trial outcomes and any associated product risks."

Medical Affairs Management: Igniting Innovative Global Strategies, available at http://www.cuttingedgeinfo.com/research/medical-affairs/global-resource-allocation/, analyzes medical affairs subfunction budgets, staffing and outsourcing data by team region. Report highlights include:

  • Data showing spending per supported product and medical affairs budgets per FTE.
  • Data showing the number of outsourced medical affairs FTEs.
  • Budget allocations per year for total medical affairs budget (over a three-year period, including 2016).
  • Profiles illustrating 12 medical affairs teams' resource allocations.

Cutting Edge Information has also published detailed benchmarking research on drug safety and pharmacovigilance teams. 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 Cutting Edge Information's primary benchmarking research on medical affairs or drug safety, please visit http://www.cuttingedgeinfo.com.

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