Drug shortages are a complex, global problem. While the primary impact of shortages will be felt most acutely by patients who have difficulty getting the medication they need when the supply chain suffers an interruption, shortages also have serious implications for the pharmaceutical industry in terms of costs and reputation.

Since 2012, the International Society for Pharmaceutical Engineering (ISPE) has been facilitating communication between the pharmaceutical industry and global health authorities to address this multi-faceted problem. ISPE recently announced that it will publish an actionable plan aimed at helping the pharmaceutical industry avoid drug shortages resulting from manufacturing and quality issues. An Introductory Summary to the plan has been released to highlight the Plan's key areas. The complete ISPE Drug Shortages Prevention Plan will be released during the 2014 ISPE Annual Meeting, which will be held 12 - 15 October, 2014 in Las Vegas, Nevada, USA.

ISPE's Plan - a first for the industry - was developed by ISPE's Drug Shortages Task Team of expert pharmaceutical and biopharmaceutical industry members, and describes how industry can best prevent drug shortages from occurring by discovering true root causes and by creating and sustaining organizational cultures supported by leadership, business processes and quality systems that will ensure a robust, resilient and reliable supply of medications - many lifesaving - to patients worldwide. By design, the Task Team limited the scope of its work to the manufacturing, quality and compliance issues associated with a company's supply chain and related to its ability to source, manufacture, and distribute products that have resulted in drug shortages.

The Plan is based in part on ISPE's groundbreaking 2013 study of the issues and root causes of drug shortages. While results of the ISPE survey pointed towards key areas such as quality systems and strong management controls as key levers to avoiding shortages, the ISPE Task Team augmented the survey findings through discussions with leaders of more than 30 major pharmaceutical companies and regulators from EMA, FDA, and MHRA, and for more than a year gathered stakeholder input from hundreds of industry professionals at ISPE conferences and workshops. Industry senior management, which has considerable influence on organizational culture and alignment, was highly engaged in the Plan's development. This analysis helped dispel common perceptions behind shortages (such as excessive number of recalls, non-availability of material, poor product quality), and identified strategies that can help address the underlying root causes behind shortages whether due to aging facilities and equipment, lack of product robustness, or poor cultural and behavioral aspects that can contribute to poor design and execution.

The ISPE Drug Shortages Prevention Plan is organized into a "six dimension" framework comprised of: Corporate Quality Culture, Robust Quality Systems, Metrics, Business Continuity Planning, Communication with Authorities, and Building Capability. The Plan provides recommendations and real-world case studies in each of the dimensions to answer the following questions:

• 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 end "product" and strategic objective for these efforts is a "resilient end-to-end supply chain." ISPE recognizes that there are many other factors that may impact the supply of drugs, including regional economic factors, differing regulatory requirements, insurance programs, and government procurement procedures, which are outside the scope of its Drug Shortages Prevention Plan.

Because drug shortages are a critical public health issue, ISPE believes that efforts to address the multi-faceted problem require close technical collaboration and clear communication between the pharmaceutical industry and global health authorities. In the US, ISPE's report on its drug shortages survey was cited by the US Food and Drug Administration (FDA) in its Strategic Plan for Preventing and Mitigating Drug Shortages (October 2013), confirming the FDA's intention to engage with ISPE to analyze data on the technical, scientific, manufacturing, quality, and compliance issues that have resulted in drug shortages.  In Europe, ISPE was invited to present an overview of its drug shortages survey findings to the European Medicines Agency (EMA) at a November 2013 workshop. Noting that an effective drug shortages prevention plan would require a broad representation of industry experts, the EMA charged the associations attending the workshop with working together to develop and deliver a single, collaborative action plan for the prevention of drug shortages. When published, ISPE's Drug Shortages Prevention Plan will form part of a multi-association collaborative plan which will be delivered to the EMA in November 2014. Other associations taking part are the Parenteral Drug Association (PDA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), and the Plasma Protein Therapeutics Association (PPTA).

Given the common goal of industry and regulating agencies to prevent drug shortages, consensus has been reached not only regarding the importance of communication with authorities, but also regarding the need for building capability by improving the scientific and technical knowledge of individuals and organizations. ISPE will continue to act as global facilitators and integrators in the effort to prevent drug shortages through facilitating forums with industry leaders and regulators, and through developing and holding training and education programs to help industry build capability in the areas critical to building resilient supply chains.