About The ISPE Drug Shortages Initiative

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The prevention of drug shortages is critically important to public health. As a not-for-profit global organization with both industry and regulatory members in 90 countries, ISPE is uniquely positioned to facilitate communication between the different sectors of the pharmaceutical industry and global health authorities as it seeks to understand and address this complex problem.

The ISPE Drug Shortages Team focuses on the technical, scientific, 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. For example:

  • Insufficient manufacturing capacity, exacerbated by industry consolidation, leading to fewer firms making a product
  • Product quality issues that result in temporary or permanent halting of production
  • Lack of secure, consistent availability of active ingredients, components, containers, or closures of suitable quality, even reagents for quality control tests, which can be exacerbated by the increasing globalization of the supply chain for ingredients and manufacturing
  • Shifts in demand that arise from shortages of another drug – causing a chain reaction of shortages
  • Unexpected market outcomes from new approvals e.g. generic manufacturing capacity does not meet expectations, manufacturer of newly approved entity does not have sufficient capacity to meet market demands.

Beginning in 2011, ISPE’s Drug Shortage Initiative, led by a task force of industry leaders, has been working on ways to better understand the root causes and possible mitigations for drug shortages. As a first step, the ISPE Drug Shortages Team developed an anonymous survey seeking the input of pharmaceutical industry professionals and companies. See About the Survey for more information regarding the survey instrument.

As a second phase of the Initiative, ISPE developed a Drug Shortages Prevention Plan ( 3 MB) based on ISPE research with the input of its membership, company leaders and regulators. The Plan addresses optimal organizational strategies, such as aligned governance and communication practices, effective manufacturing and quality systems, and appropriate measures of supply chain robustness and quality. This effort addresses rising concerns around drug shortages within companies, among global health authorities, and for patients who depend on a reliable and available supply of quality medicines. The Plan will serve as a roadmap that, when implemented, can significantly reduce drug shortages.

“ISPE’s Drug Shortages Prevention Plan is part of a significant and continuing effort since 2011 to ensure a safe, quality and reliable drug supply,” said ISPE President and CEO John Bournas at the Plan’s release at the 2014 ISPE Annual Meeting.  “We owe patients a sense of security by meeting their expectations for a reliable and continuous supply of the medications that are so important to them and their families. When members of the pharmaceutical industry discover and put to work the valuable insights included in the Plan, particularly those promising to strengthen the integrity of the supply chain and those describing how to place a greater emphasis on end-to-end quality, a real difference can be made in the lives of patients.”

In May 2015, ISPE announced that it was developing a gap analysis tool to help ensure an uninterrupted supply of medicines. The tool represents an important element of the implementation stage, providing a succinct way to look at the DSPP and analyze risks in each of the dimensions cited, e.g. Business Continuity and mitigate those risks. ISPE envisions that companies will use the Tool and the DSPP as part of their overall Drug Shortages Prevention Program. It is a guide for industry to assess the robustness and resilience of the supply chain via a series of questions based on the Drug Shortages Prevention Plan.

ISPE is committed to the long term resolution and management of drug shortages. This gap analysis tool, once completed, will be part of our education and training programs to support implementation and effectiveness across the industry. Our goal is to have this tool completed in the second half of 2015.

“This tool provides manufacturers across the spectrum of the bio/pharmaceutical industry with methods to locate current and future inconsistencies across the pharmaceutical manufacturing supply chain,” said ISPE President and CEO John Bournas. “With this tool, manufacturers will mitigate problems before they arise allowing them to provide an uninterrupted supply of safe, quality medicines to patients worldwide.”

Through its Drug Shortages Initiative ISPE will also leverage its international network to lead industry-regulator collaboration regarding drug shortages through meetings and conferences. In addition, ISPE will continue to work with and through the International Leadership Forum, a group of global industry leaders who gather twice a year under the auspices of ISPE to explore issues of importance to industry.

Bournas extends his deep appreciation for the input from industry and regulators in Europe, the United States and representatives from the European Industry Associations on this critical initiative.


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