Over the past two years, ISPE and a task team of global industry leaders and regulators have been working on ways to better understand the root causes and possible mitigations for drug shortages. ISPE announced in April 2014 that it would work with global stakeholders to develop a plan to guide the pharmaceutical and biopharmaceutical industry in establishing reliable, robust and resilient supply chains that can, without interruption, provide quality medicines to patients.  Today ISPE released a first look at its Drug Shortages Prevention Plan — a first for the industry— in the form of an Introductory Summary.

Drug ShortageThe ISPE Drug Shortages Prevention Plan is organized around a “six dimension” framework.  The Plan’s Introductory Summary released today provides a preview of what will be covered in each of the six dimensions:

Corporate Quality Culture – How can organizations foster practices, values and a philosophy that require employees at all levels to subscribe to quality?

  • Robust Quality Systems – What triggers can affect production and the integrity of the supply chain and potentially lead to a drug shortage? How can those triggers be identified and eliminated?
  • Metrics – How can metrics be tailored to help identify risks and mitigate them?
  • Business Continuity Planning – At a time when supply chains are more global and complex, how can quality and competence be assured in production, factories, materials, machines, equipment and expertise?
  • Communication with Authorities – How can rapid and comprehensive communication with health authorities help to prevent potential shortages before they occur or mitigate with expedience shortages that do materialize?
  • Building Capability– How can capability be built to identify the true root causes of drug shortages, train employees, improve knowledge and knowledge management, as well as strengthen employee commitment to quality?

The Plan was developed by the ISPE Drug Shortages Task Team that built upon ISPE’s landmark 2013 study on Drug Shortages in which shortages were shown to be caused not only by manufacturers who fail to implement “robust quality systems across the life cycle of the product,” but also by failures to implement “structured management controls” for ensuring quality compliance.  Based upon those conclusions, the Plan lays out how industry can best prevent drug shortages from occurring by discovering “true root causes” and by developing quality systems that will ensure a robust, resilient and reliable supply of medications— many lifesaving— to patients worldwide.

The complete Plan will be released in October

ISPE will release the complete Drug Shortages Prevention Plan during the 2014 ISPE Annual Meeting that will be held 12 – 15 October 2014 in Las Vegas, Nevada, US. The Plan’s recommendations will be presented publicly for the first time at a session led by members of the ISPE Drug Shortages Task Team on 14 October.