As a not-for-profit association with both industry and regulator Members in 90 countries, ISPE is uniquely positioned to facilitate communication between the different sectors of the pharmaceutical industry and global health authorities as they seek to address this complex problem. The survey goal is to leverage ISPE Members’ expertise to gather data on the technical, scientific, manufacturing, quality and compliance issues that have resulted in drug shortages. Preliminary results are expected in June 2013.
“The prevention of drug shortages is critically important to global health,” said Nancy S. Berg, ISPE President and CEO. “Any effort to effectively address the complex and multi-faceted issues contributing to drug shortages requires close technical collaboration and clear communication between the pharmaceutical industry and global health authorities. ISPE is committed to supporting efforts to uncover the root causes of drug shortages, and we believe this survey is a critical first step.”
The survey was developed by ISPE’s Drug Shortage Initiative, led by a task force of industry leaders with review and input by leading global health authorities and related organizations. By design, the task force has limited the scope of this survey to the technical, scientific, manufacturing, quality and compliance issues that have resulted in drug shortages. Survey responses will be completely anonymous, and all data will be tabulated by a third-party firm.
ISPE’s goal in collecting this survey data is to provide the pharmaceutical industry and health authorities with much-needed scientific data to support the development of risk-based approaches, using modern quality systems, to mitigate and prevent drug shortages. ISPE also plans to leverage its international network to lead collaboration between regulators and industry regarding drug shortages through meetings, conferences and industry groups like the International Leadership Forum.
For more information on this important initiative, please visit www.ISPE.org/DrugSurveyDetails.