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ISPE's Drug Shortages Initiative
“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.” Nancy S. Berg, ISPE President and CEO.
The prevention of drug shortages is critically important to public health. As a not-for-profit global organization with both industry and regulator Members in 90 countries, the International Society for Pharmaceutical Engineering (ISPE) is uniquely positioned to facilitate communication between the different sectors of the pharmaceutical industry and global health authorities as it seeks to understand and address this complex problem.
Since mid-2012, ISPE and a task force of industry leaders have been working on ways to better understand the root causes and possible mitigations for drug shortages. ISPE has also engaged leaders from more than 30 major companies, regulators from 10 agencies, and regional industry associations to ensure that ISPE is comprehensive in its approach to the problem of drug shortages – a critical issue affecting countless patients around the world.
Timeline and Milestones
- July 2012: ISPE and a task force of industry leaders met with Dr. Janet Woodcock , Director of the Center for Drug Evaluation and Research at the US FDA, and presented a concept paper concerning proposed activities aimed at helping regulators and industry understand and address the challenge of drug shortages.
- August 2012-January 2013: The task force developed a comprehensive survey for industry professionals after reviewing the existing body of knowledge on the topic of drug shortages and conducting a preliminary assessment of perceived contributing factors.
- February 2013: ISPE deployed its anonymous industry survey seeking information about root causes of shortages that can be attributed to technical, manufacturing and quality issues.
- May 2013: ISPE met with the US FDA to discuss the early findings and ways of working together to mitigate or address key issues.
- June 2013: ISPE announced its findings to US and European audiences and published the
highlights in a publicly available report. Download it at www.ISPE.org/DrugShortages/2013JuneReport (
959 KB) - Q3 2013: The ISPE Drug Shortages Task Force began designing a plan to learn more about key issues revealed by the survey and to develop recommendations for important changes that could help mitigate shortages or reduce them altogether.
- October 2013: The Report on ISPE’s Drug Shortages Survey is cited in FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages.
- October 2013: ISPE presented highlights of its emerging plan to the EMA as an invite guest at EMA’s London workshop on product shortages due to manufacturing and quality problems.
- November 2013: ISPE presented post-survey follow up activities and its 2014 plan at the ISPE Annual Meeting in Washington, DC.
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