The series of events will begin with the ISPE Drug Shortages Task Force progress report Monday at ISPE's Annual Meeting in Washington, DC. The didactic portion of the session will focus on the possible connection between drug shortages and the lengthy chemistry, manufacturing, and control (CMC) process; a description of key operational elements in manufacturing that appear critical to avoiding shortages will also be provided. During the interactive portion of the session, Captain Valerie Jensen, R.Ph., Associate Director for FDA's Center for Drug Evaluation and Research's (CDER's) Drug Shortage Program, will join a panel hosted by ISPE for a question and answer session with the audience. Captain Jensen's participation on the panel comes just four days after the release FDA's Strategic Plan for Preventing and Mitigating Drug Shortages.
Published in June 2013, ISPE's Drug Shortages Survey report is available at www.ISPE.org/Drug-Shortages/2013JuneReport. The comprehensive global survey revealed no single technical or manufacturing cause for drug shortages. Instead, initial data analysis showed:
- Issues within the quality systems of manufacturing can lead to drug shortages.
- Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages.
- Improved regulatory interaction can mitigate the likelihood of a shortage.
The report was cited in the FDA's Strategic Plan for Preventing and Mitigating Drug Shortages published in October, and the survey data will provide the necessary context for the 2014 events.
"As a neutral organization focused on product quality and patient safety, ISPE is uniquely positioned to take a leadership role in bringing the pharmaceutical industry's stakeholders together around the challenge of drug shortages," says Nancy S. Berg, President and CEO of ISPE. "The survey revealed many new opportunities for ISPE to facilitate dialogue and work together with key influencers on solutions to mitigate or reduce shortages. We are committed to fulfilling that role." http://www.sacbee.com/2013/11/02/5874903/ispe-announces-plans-for-its-drug.html