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.

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).

Next Steps from ISPE
Any effort to effectively address the complex and multi-faceted issues contributing to drug shortages requires close collaboration and clear communication between the pharmaceutical industry and global health authorities. As a not-for-profit global organization 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 in addressing this complex problem.

ISPE will continue to act as global facilitators and integrators in the effort to prevent shortages through ongoing projects with other associations; holding forums with industry leaders and regulators; and helping companies build capability through the development of guidance documents, training and education programs.

• In November 2014, ISPE’s Drug Shortages Prevention Plan will form part of a multi-association action plan to be submitted at the request of the European Medicines Agency (EMA).
• In 2015, ISPE’s Drug Shortages Initiative will enter its third phase, which will consist of delivering solutions based on the Plan’s recommendations in ISPE conferences, training programs, and publications.