ISPE Releases Drug Shortages Prevention Plan
The ISPE Drug Shortages Prevention Plan – a first for the industry – is a roadmap designed to help the pharmaceutical industry avoid drug shortages and maintain a robust and reliable supply of medications to patients world-wide. ISPE is providing this comprehensive and holistic Plan free to the industry.
Download the ISPE Drug Shortages Prevention Plan ( 3 MB)
The ISPE Drug Shortages Prevention Plan is based upon ISPE’s groundbreaking 2013 ISPE Drug Shortages Survey, which provided clear evidence that mitigating shortages requires a holistic approach and careful alignment of organizational aspects – people – as well as technical aspects of process and production .
A global and holistic response, the Plan lays out how industry can best prevent drug shortages from occurring by discovering shortage root causes and creating a quality culture that will ensure a robust, resilient and reliable supply of medications – some lifesaving – to patients worldwide.
The ISPE Drug Shortages Prevention Plan represents a collective effort by pharmaceutical and biopharmaceutical industry experts. It has been reviewed by regulators from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and by national competent authorities including the Spanish Agency of Medicines and Medical Devices (AEMPS) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
- See more at: http://www.ispe.org/drug-shortages-initiative#sthash.3XBDCDUR.dpuf